Guiding Principles for Application Jacl P Pekar Total Quality Management: Guiding Principles for Application J a c k P. Pekar ASTM Manual Series: MNL 22 ASTM Publication Code Number (PCN) 28-022095-34 1916 Race Street • Philadelphia, PA 19103 Library of Congress Cataloging-in-Publication Data Pekar, Jack P., 1940Total quality management: guiding principles for application/ Jack P. Pekar. p. cm. - - (ASTM manual series; MNL 22) Includes bibliographical references and index. ISBN 0-8031-2062-1 1. Total quality management. I. lqtle. II. Series. HD62.15.P46 1995 658.5'62~c20 95-12661 CIP Copyright © 1995 AMERICAN SOCIETY FOR TESTING AND MATERIALS, Philadelphia, PA. All rights reserved. This material may not be reproduced or copied, in whole or in part, in any printed, mechanical, electronic, film, or other distribution and storage media, without the written consent of the publisher. 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Printed in Philadelphia, PA June 1995 Foreword Committee F16 on Fasteners is very concerned with the Fastener Quality Assurance Act (FQA) of 1990, which is expected to be implemented in 1995. F16 is comprised of fastener manufacturers, users, and distributors, all of whom have a large stake in this law. As a consequence, F16 requested and sponsored me to write a manual that would show our members how to comply with the law and remain competitive. But this book goes beyond assisting those in the fastener industry to cope with the FQA. It can be of benefit to any industry or enterprise because it is about total quality management (TQM). This book was written so that others may share what I have learned during my 30 years in the quality profession. It is a book that presents principles and guidelines that, when applied, can be used to develop and implement a total quality management system. Today, more than ever, we in the business community face challenges at every turn from every corner of the world. Those businesses that survive will be those that demonstrate leadership and innovation and listen to the voices of their customers. Those who practice the teachings in this book have a better chance than most to achieve success. They may find the journey difficult and cluttered with obstacles that impede their progress, but, if they are true leaders, their message will be heard. They must not and will not be discouraged for they must lead us to and through the new global market. Acknowledgment I wish to thank all those who helped provide background information for this book. The list includes companies I've worked for past and present, people I worked with in the past, those with w h o m I currently work, and family members. There are a few whom I wish to give special thanks. I could not have completed my manuscript without my very talented administrative assistant, LaVerne Craven. The topics on futuristic quality planning and supplier partnerships are in large part an adaptation of programs developed in concert with my manager, Gary Fitzgerald, Kennametal's MWM Quality Manager. But most of all, I want to thank my wife, Liz, for all the encouragement I received while writing and editing this book. It took considerable time away from our personal life, but she never complained because she saw the value this work would provide to those who accept the challenge it presents. Contents vii Introduction PART 1: MANAGEMENT'S RESPONSIBILITY Chapter lmManagement's Role Chapter 2~Strategic Planning Chapter 3~Continuous Improvement 3 9 21 PART 2: QUALITY ORGANIZATION FUNCTION Chapter 4--Quality Systems Chapter 5~Quality Reporting Chapter 6---Supplier Qualification 31 37 40 PART 3: STATISTICAL QUALITY CONTROL Chapter 7~Statistical Quality Control 47 PART 4: THE QUALITY ASSURANCE MANUAL I n t r o d u c t i o n to Part 4: The Quality Assurance Manual Chapter 8mManufacturing Company Quality Assurance Manual Chapter 9~Service Industry Quality Assurance Manual Chapter 10~Distributor Industry Quality Assurance Manual 57 59 63 67 PART 5: FASTENER QUALITY ASSURANCE ACT Chapter l 1--Public Law 101-592 73 APPENDICES Appendix A--ASTM Standards F 1469, F 1470, and F 1503 Appendix B--IFI Standards IFI-139 and IFI-140 Appendix C--Public Law 101-592--Fastener Quality Act Appendix DmSupplier Quality Systems Survey Appendix E--Attribute Gauge Analysis Form 81 97 133 147 155 Index 157 Acronyms American National Standards Institute Quality Assurance Program Requirements for Fastener Manufacturers and Distributors ASQC American Society of Quality Control ASTM American Society for Testing and Materials CMM Coordinate Measuring Machine CPI Critical Performance Indicators E&I Empowerment and Involvement FAC Fastener Advisory Committee FMEA Failure Mode and Effects Analysis FQA Fastener Quality Act HRC Hardness Rockwell C JIT Just in Time NIST National Institute of Standards and Technology NVLAP National Voluntary Laboratory Accreditation Program P&IC Production and Inventory Control PIE Plan, Initiate, Evaluate QFD Quality Function Deployment R&R Repeatability and Reproducibility SCD value Severity rank times the Capability rank times the Detection rank SEM Scanning Electron Microscope SPC Statistical Process Control SPQP Service/Product Quality Planning SQC Statistical Quality Control TCQ Total Cost of Quality TQM Total Quality Management ANSI ASME-FAP-1 Introduction T H E PATH TO TOTAL QUALITY Training The organization must assess the current skill level and awareness of total quality principles of all employees. The idea is to start with top management and move through the organization. Begin by training top management; with their commitment and knowledge of total quality, it will he easy to train those who follow. This training will pay high dividends at every level in the organization. Through training, we assure that our employees have the necessary skills and technical knowledge to perform their jobs effectively. We can also count on them to be effective participants in contributing to the total quality process. Information should be provided to employees describing educational programs available to them through various professional organizations and community colleges. By creating an awareness of these opportunities, the organization demonstrates its commitment to a continuous improvement of employee skills. THERE IS NO single path to achieving total quality within an organization. There are no hard and fast rules to follow to become a world class company. The only constant are basic guidelines, that, when followed, lead to success. This is because all organizations have their own cultures, people, and technologies. What may work well for one company will not necessarily work for another. These guidelines are as follows. Leadership Commitment The leadership of an organization must be committed to continuous improvement. This commitment must be visible throughout all layers of management. Management must "walk the talk." Only when management is committed will employees excel at what they do. It takes time to change work cultures and work habits, but with perseverance the message of enlightened management will prevail. Employees want to do a good job. All they need are the right tools and the right systems. These can by supplied only by management. E m p o w e r m e n t and Involvement Soon after the commencement of training, management must provide opportunities for employees to apply what they have learned. They need to test their skills. They will not and should not be content with the way things are. Every aspect of their job should be evaluated and measured against the new paradigms. This will bring new challenges to their supervisors. The supervisors, in turn, through their own training will now be equipped with the attitudes and analytical skills to consider their suggestions. They will no longer feel the threat of losing control. Customer Focus The organization must be customer focused. Everyone in the organization must understand that without the customer there would be no purpose to their work, no paycheck, no capital investment, and no company picnic. What must also be understood is that the external customers are served by the internal customers (employees). There is, therefore, a need to focus on the requirements and expectations of both internal and external customers. One of the first steps management should take in this regard is to conduct surveys of external and the internal customers. Employees (internal customers) should be apprised of the results of external customer surveys. A truly committed management team will also allow employees to see the results of internal surveys. This brings "the good, the bad, and the ugly" to the table for discussion. The good can be improved upon. The bad can lead to opportunities for improvement. The ugly must be addressed through open, two-way communication with crossfunctional teams to find solutions. Measurement Before those of us in management can find out if we have made improvements, we need to know where we were. If we don't have historical data to let us know, we must at least determine where we are through a short-term study. The first step is to define the organization's critical performance indicators (CPIs). Critical performance indicators are defined as those measures that contribute to customer satisfaction. There are several tiers of indicators in any organization, and they can he broken down as primary, secondary, and tertiary. Examples of first-tier CPIs include On Time Delivery, Customer Satisfaction Indicators, and Cost of Quality. Second-tier CPIs are measures that contribute to the firsttier CPI's. Examples of second-tier CPIs to On Time Delivery may be quote turn around, manufacturing lead time reduction, and supplier performance. Third-tier CPIs are the em- 1Portions of this introduction were taken either in whole or in part from an SME technical paper by the author entitled, "Continuous Improvement--Managing Yesterday, Leading Today." Reprinted with permission of the Society of Manufacturing Engineers, Copyright 1993, from the Cold Forming '93 Conference. vii suppliers, and their customers. I cannot provide enough differentiation among this trilogy to say one is more important than the other. All participants in this trilogy of communication must interface for an organization to be truly successful. Within the organization, employees at all levels need information on continuous improvement projects so they can become aware of progress, their contribution, and the effect these projects have on critical performance indicators. Business goals must be communicated to suppliers. Suppliers should be viewed as extensions of the organization who contribute to the overall success of continuous improvement. They should be part of decisions to utilize purchased services. Suppliers are specialists in their fields of expertise; therefore, their input should be required when decisions are made to use them. World class purchasers understand the difference between price and value. As purchasers (customers) we expect, and should demand, products that contribute to our success. The voice of the customer must be heard. Customers are the reason we are in business. Without customers, no provider of goods or services could survive. To understand customers' needs, we must listen to their messages. Invite existing and potential customers to your facilities and ask them to apprise your teams of their business objectives. Let them tell you how you can assist them in achieving their goals. ployee involvement action items. Examples of third-tier CPIs for manufacturing lead time reduction could be (1) set up reduction and (2) scrap and rework reduction. CPIs are discussed in detail in Chapter 2. Recognition and Awards Everyone appreciates a pat on the back after they have achieved a noteworthy goal or successfully completed a difficult or important task. This encourages further participation by the employee and shows other employees that their efforts are appreciated. When a team has met an established goal, the entire team should be recognized. The form of recognition should fit the accomplishment; in other words, the value of the recognition should be commensurate with the value of the accomplishment. Too, when recognition is given, it should be consistent. To assure consistency, a panel of management and nonmanagement employees should be established to set up a recognition program to acknowledge those individuals and/Or teams who meet company objectives. Communication This last guideline is by no means the least important. The organization must communicate with the work force, their Vlll Part I: Management's Responsibility 1 Management's Role THE PRIMARY ROLE OF MANAGEMENT i s t o provide employees with the leadership necessary to meet the goals of the organization. This leadership must reflect the principles of total quality management. These principles were presented in the Introduction: leadership commitment, customer focus, training, empowerment and involvement, measurement, recognition and rewards, and communication. tomer. The customer rejects the part because it does not meet his requirements! (See Fig. l-1.) Management needs to break down silos in their organizations because they create waste, redundancy, and poor quality. We are getting better today at breaking down silos and allowing interaction through cross-functional team management. Management should evaluate themselves to determine if their management style is autocratic or team oriented. LEADERSHIP COMMITMENT Management must first examine how they manage. Is their style tailored to encourage input from other managers and departments? Or is their style that of not allowing other departments or disciplines to influence their decisions? In other words, do they operate as team leaders or as silos? When I refer to managers operating as silos, I mean that they stand alone within the organizational structure by excluding input from other managers or departments. This concept is explained further below. Silos Management in the past relied on experts in given disciplines to develop systems and procedures to guide the organization. These experts headed up their own departments (silos) and had specialists working for them who created the culture and systems for the silo master. The silo master made it clear to all other silo masters in the organization how his department functioned and that there would be no interference from other groups or departments. This allowed the silo master to keep control of his territory. This also assured that the other department managers did not fully understand the requirements for positive interaction between groups or departments within the organizational structure. Here's a classic example of how silos can thwart satisfying customer requirements. The marketing group receives an order from a customer and tells the design group what the customer wants. The design group gives their interpretation of the customer's needs to the manufacturing engineering group. Manufacturing engineering tells manufacturing what process to use to create the product that will satisfy the needs of the customer. Manufacturing does their very best to manufacture the part according to criteria supplied by manufacturing engineering. The quality department inspects the final product and decides it is manufactured incorrectly. Rework is performed and the part is shipped to the cus- Autocratic M a n a g e m e n t I remember when I first started working. I was told that in order to succeed and to keep my job, I had to remember two rules. Rule l: The boss is always right. Rule 2: When the boss is wrong, remember Rule 1. Those were the days when systems were more important than people. Employee involvement consisted of doing only what the boss told you to do, whether it made sense or not. Management felt that empowering the worker took control away from management. Switching to a management style that encourages employee involvement and empowerment is a tough transition for many. Unless special training is provided for middle and first-line management, the transition may never take place. And, unless upper management invests and participates in this training, the organization is bound to fail. It will be overtaken by other organizations who have invested in their most valuable resource, their employees, and are cashing in on that investment. Employees of an enlightened organization contribute every day to improved operations and systems. Once management has committed itself to breaking down silos, it must embrace the concept of Team Management. Team M a n a g e m e n t Gone are the days when managers are expected to be proficient in only one discipline. Today managers must be part of a management team, and they must have a working knowledge of their peers' responsibilities. For example, the quality manager needs to understand how design engineering, manufacturing engineering, purchasing, sales, production control, customer service, and every other department functions. And every other manager should know the roles of the others. This is not to say that they need to be as well trained in the other disciplines as their peers, but they must understand how the entire organization functions. We want to break down silos so we can move freely throughout the or- 4 TOTAL QUALITY MANAGEMENT MANUAL AS ENGINEERING DESIGNED IT AS MARKETING REQUESTED AS MANUFACTURING ENGINEERING SAW IT AS MANUFACTURED K , ¢ , ¢ . QUALITY REJECTS DESIGN DRAWING WHAT THE CUSTOMER WANTED Figure 1-1 --Customer requirements. ganization. This creates a n o t h e r d i l e m m a b e c a u s e n o w we n e e d to allow m a n a g e r s who are outside o u r responsibility to be p e r m i t t e d , even welcomed, to h a n d l e situations that s t r u c t u r a l l y m a y belong to us. It's t i m e for the goose story. We as m a n a g e r s should take a lesson f r o m the goose. I ' m sure y o u have observed geese in flight. They fly in a p a t t e r n t h a t forms a h o r i z o n t a l V. There is a g o o d r e a s o n w h y geese fly in a V pattern. The lead goose breaks the air c u r r e n t a n d creates a n uplift b e h i n d h i m t h a t the o t h e r geese can take a d v a n t a g e of. The second tier of geese likewise does the s a m e for the t h i r d tier a n d so on a n d so forth for the entire flock. The l e a d goose eventually tires of b u t t i n g his h e a d against the wind, so he d r o p s b a c k in the formation. Here's w h e n s o m e t h i n g interesting takes place. A n o t h e r goose from the flock moves to the front to a s s u m e the lead. This goose does so until he tires. Then he d r o p s b a c k a n d a n o t h e r goose moves in to lead. Geese in a flock are willing to follow the lead of whoever is l e a d i n g at the t i m e b e c a u s e they all have a c o m m o n goal. We can l e a r n a lot f r o m the goose! Geese have l e a r n e d h o w to w o r k as a team. All in the flock are willing a n d able to lead w h e n necessary. The l e a d e r w h o d r o p s b a c k is n o t int i m i d a t e d b y a n o t h e r t a k i n g his place. H e u n d e r s t a n d s t h a t for n o w it is best t h a t s o m e o n e else a s s u m e s leadership. CUSTOMER FOCUS M a n a g e m e n t m u s t develop an attitude t h a t puts the cust o m e r in every decision m a d e . The c u s t o m e r is the r e a s o n we are in business. W i t h o u t c u s t o m e r s there w o u l d be no CHAPTER 1 - - M A N A G E M E N T ' S ROLE job to perform, no requirements to be met, and no reason anyone would wish to purchase your company's stock. As explained in the Introduction, there are two kinds of customers: internal and external. External customers provide income for the organization through purchasing goods or services. Internal customers (employees) satisfy the requirements of the external customers and the requirements of others in their own organization. Both are important and need to be understood for an organization to succeed and prosper. External Customers The expression "The customer is always right" is not always true; however, one right of the customer is always true: "The customer has the right to purchase from whomever he wants." With this in mind, we should make every attempt to make sure the customer wants to buy from us. To assess the needs of your customers, utilize input from all customer contact personnel. In an organization that follows TQM principles, input can come from the sales representative, your marketing group, the quality department, manufacturing, customer service, and engineering. The method in which the input is provided can be reactive or proactive. Both sources should be looked upon as opportunities for satisfying your customers' needs. Reactive input is in the form of customer complaints or from interpreting customer purchase orders or sales inquiries. When customer complaints are received, either as written complaints or in the form of returned goods, most organizations react as fire fighters and focus on the hot spot. We sometimes ignore the system that created the problem in the first place. When a purchase order or sales inquiry is received, most organizations interpret their customer's requirements through the mirror of their own paradigms. Proactive input is solicited through visits to the customer's place of business, visits to your facility by your customer, customer satisfaction surveys, and by cross-functional teams consisting of employees from customer and supplier facilities. All these activities should be part of management's strategic business plan. The strategic business plan will be discussed further in Chapter 3. I n t e r n a l Customers In a TQM environment, the attention paid to employees is as important as, if not more important than, attention paid to the customer. The employee is the internal customer of the organization, the individual who can make things happen. His or her understanding of the organization's goals and commitment to the customer must be complete. This can be assured by following a three-step process that includes (1) an employee survey, (2) an employee training program, and (3) regular communication sessions to continually reinforce the organization's goals. Employee Survey The employee survey should be designed to provide an assessment of how the employee feels about the company and how he perceives his role to the customer. An example of a survey I used successfully is provided in Fig. 1-2. 5 The TQM steering committee (discussed in Chapter 3) should review and analyze employee survey results and determine the training program required to bring employees up to speed on company goals. Training can be conducted by inside experts or by using outside resources. There are advantages and disadvantages to both approaches. The advantages to using inside experts are cash flow containment and assuring that the training is tailored to existing company paradigms. The disadvantages of using in-house experts are having to overcome existing negative perceptions of the expert, if there are any, and removing the expert from his duties to provide preparation and training. The advantages of using outside sources for training are many. Among them is the natural perception that an outside consultant knows more about a subject than inside people. This advantage can create a more receptive learning environment for the employee. Another advantage is that no time is taken from anyone's schedule for preparation of lesson plans. Two major disadvantages are expense and the fact that the outside resource is not familiar with your company culture. Both options of training must be evaluated by the TQM steering committee, and selection of training resources should be made on the best fit analysis. The key is to assure that whatever training source is utilized that the source emulates the goals of the organization. Activities concerning customers need to be communicated to everyone in the organization in a timely manner. Most information can be distributed on a monthly basis, but special news should be disseminated as required. An ideal method of sharing news is through a company newsletter that contains information on employees, customers, and continuous improvement activities. TRAINING Continuous improvement cannot occur within an organization unless training is part of management's agenda. Leaders in respective departments should take the initiative to conduct an analysis of each employee's ability to perform his or her job. This is often referred to as a needs assessment analysis. The needs assessment analysis should be performed on the job function, not the individual performing the job. For example, suppose the job is to prepare an accurate product certification document. A flow diagram on completing a product certification is shown in Fig. 1-3. The focus should be on preparing an accurate product certification, not on the skills of the final product auditor, the material handler, or the typist. Study each step in the flow diagram for the job and determine exactly what is required for that step to be successful. For example, let's look at the seep: Inspect All Critical Characteristics Per Sample Plan. To be successful at this step, every step preceding must have been performed correctly and accurately. All critical characteristics must be identified on the inspection plan or engineering drawing. The sample plan should be available and germane to the product being inspected. The test equipment and inspection equipment should be in full calibration and acceptable for the tolerances being examined. The individual conducting the task must be qualified for the task. 6 TOTAL QUALITY MANAGEMENT MANUAL IN PLANT "ASK ME" BOX (4) Do you receive everything you need from the previous operation or department to do your job well? (1) How do you perceive your role in service for customers? Directly Involved Indirectly Involved Not Involved Yes No (circle one) If no suggestions: (2) How do feel about service you receive from related departments? Satisfied Not Satisfied No Opinion (5) If you could make one change in either your department or the company as a whole, what would you change to improve service for our customers? (3) Do you have enough authority to make improvements to better serve our customers? If No, Suggestions: (6) If you could rate overall the products and services provided to our customers, what would that rating be? Superior ~ Good Average _ _ Poor Other Please explain: Figure 1-2~Employee survey. Any deficiency found in any of the subgroups contributing to the successful completion of the main task of inspecting all critical characteristics per sample plan may require training for the individual doing the inspection or correcting some upstream activities. evaluate and suggest how to improve current systems. It is through these management teams that lower-level employee teams are created. The teams formed at all levels will concentrate on improving the organizations critical performance indicators (CPIs). CPIs are tracked and evaluated through measurement parameters established by management E & I teams. EMPOWERMENT AND INVOLVEMENT One of the more responsible acts management can perform is recognizing that their employees can make significant contributions to the success of the organization. If management provides the tools and training, a great deal can be accomplished through employee empowerment and involvement (E & I). However, the employee must be properly prepared for such responsibilities. The first employees that should be prepared for Employee E & I are managers and supervisors. The concepts of TQM must be provided through several training sessions and should be reinforced through appropriate actions from senior management. One of the better methods of demonstrating senior management's commitment to Employee E & I is by forming management teams and allowing these teams to MEASUREMENT Management should establish measurements to track progress on CPIs. The unit of measurement should fit the indicator being evaluated and should be understood by those who contribute to the improvement process for that indicaton For instance, the cost of quality CPI should be measured in dollars and compared to several key values, such as cost of sales or cost of manufacturing. Another example is on time performance. This CPI can be measured in several ways, which should all relate directly to customer requirements. For example, this CPI can track orders shipped to customer-required dates (external customer measure), or it could track design engineering input to manufacturing en- CHAPTER 1 - - M A N A G E M E N T ' S R O L E 7 i~ INSPECTOF~ .REVIEW ROUTING& DRAWING I DELIVER ORDER TO INSPECTION HOLD FOR MATERIAL REVIEW PULL INSPECTION PLAN FOR PART INSPECT ALL CRITICAL CHARACTERISTICS PER SAMPLE PLAN HOLD FOR MATERIAL REVIEW COMPLETE CERTIFICATION FORM TYPE ON STANDARD CERTIFICATION FORM DELIVER TO INSPECTION GIVE TO TYPIST .... _ ~ INSPECTOR REVIEW AND SIGN ATTACH CERTIFICATION TO PACKING SLIP Figure 1-3-- Productcertificationflow chart. gineering (internal customer measure), or it could track quote turn around from your suppliers (a measure of your needs as a customer of your supplier). CPIs will be discussed further in Chapter 2 when methods of continuous improvement are explored. RECOGNITION AND REWARDS Management has the responsibility to provide an environment for the work force that is safe and environmentally clean. This environment should also lay the foundation for supporting the employees' quality of work life. Once this foundation has been established, management must develop a recognition and rewards program designed to improve and maintain employee job satisfaction. A three-tiered system should be developed that includes: (1) day-to-day recognition, (2) informal recognition, and (3) formal recognition programs. The best way to get started is to create a steering committee made up of staff management. This committee can define the scope of the program and establish guidelines to be followed by employee teams established to implement the program. Employee teams should include participants from all levels of the organization. The steering committee can set the scope of the program to include as many systems as they feel the company can support and effectively manage, but some systems should always be included because of their proven effectiveness. 8 TOTAL QUALITY MANAGEMENT MANUAL The following systems, when properly structured and administered, are very cost effective and contribute directly to a company's profitability through various improvements. In no particular order, these proven systems are: pay-for-performance, perfect attendance, service awards, and continuous improvement programs. Pay-for-performance recognizes employees for their performance on the job and should include such criteria as quality of work produced, productivity, attendance, initiative, job knowledge, and safety. An attendance policy should establish rules to define when employees are to be on the job and when they are excused from their job. This may seem like a basic idea, but it is surprising how many companies do not have an established and documented policy on absence from the job. When there is no written policy, there is no consistency, and this leads to dissatisfied employees who see management as untrustworthy or at the very least prone to favoritism. A service awards policy recognizes employees for their length of service with the company and can be very rewarding in enhancing employee esteem and fostering employee loyalty. COMMUNICATION This guideline is one of the more important for both management and employees. It is a two-way street, and both should strive to keep the airwaves open. Even though communication is a two-way street, it must start with management. Management should set the standard by creating an environment conducive to openness without fear of reprisal or ridicule. At all times communication must be polite and conducive to enhancing self-esteem. The best way to get started is as with all the other guidelines: establish a steering committee to set the policy and the guidelines for implementation. Then create the opportunity for employee involvement teams to get the program underway. Some of the more common and effective programs include: company newsletters, staff and employee meetings, and an open invitation from management to allow employees at all levels to hold informal conversations or brainstorming sessions in employee lounges during breaks. Strategic Planning ONCE MANAGEMENT'SROLEAND commitment are defined and established, the top executives of the organization should establish a quality policy. The quality policy should state the organization's commitment to: (1) continuous improvement and (2) customer satisfaction. These seem like basic organizational goals, but, unless stated, the rest of the organization will not be aware of them or will not have a clearly stated policy from which to develop their own planning for improvement. Quality policies can be from one paragraph to a full page. The policy's length is not as important as its contents. For lasting impact on employees and customers, it is best to keep them short. After all, it is easier to recall one paragraph than an entire page. An example of a quality policy could be" (insert company name here) is committed to continuous improvement and providing products and services that are of the highest quality. At (insert company name here), we believe customer satisfaction is the most important service our employees can provide. Although short, this policy is very much to the point. It says a lot about the philosophy of the company's top executives. It says, "The most important goal of this organization is to satisfy the customer and to find better ways to manufacture products and/or provide services." I do not want to become too involved with what quality means in this quality policy statement. There are as many definitions of this word as there are words on this page. The following are a few definitions of the word quality that should provide a basis for developing many more. Quality is: 1. When a product is consistently represented. 2. An attitude of excellence with an objective of error-free performance shared by all employees. 3. Achieved through dedicated and Skilled employees, mode m facilities, controlled manufacturing processes, continuing education, and a positive work environment. 4. Directly related to superior value and performance and is provided to customers in terms of productivity improvements, reduced operating costs, and outstanding service. For the rest of this book, quality is simply defined as: providing goods and services that meet or exceed customer requirements. To provide goods and services that meet this definition, the executives of the organization must have a strategic plan to lead the company along this path. The plan should contain both long-term and short-term objectives. The window for long-term objectives should be no more than four years and preferably three years. The world changes so fast that planning more than four years ahead is not practical. Markets change at almost a constant pace. Customers' requirements do the same. A long-term strategic plan should consist of four main programs. There should be: (1) a program for futuristic quality planning, (2) a program for service and product improvement, (3) a program for employee involvement and education, and (4) a program for business systems. These programs require a mission statement so that the goals of the program are understood. As with the quality policy statement, the mission statements for these programs should be short and to the point. This gives precise direction to steering committees implementing these programs. Mission statements for the programs I recommend are: 1. Futuristic quality planning--Develop and drive business decisions that utilize quality tools and concepts to assure the successful introduction and implementation of new products, processes, and services to our customers. 2. Service and product improvement--Develop and implement programs to improve office and manufacturing operations, processes, and systems leading to improvements and consistency in service and products, and reductions in internal waste. 3. Employee involvement and education--Utilize the inherent knowledge and expertise of our employees to identify and participate in opportunities for improvement, and provide appropriate education as needed in support of these goals. 4. Business systems--Develop and manage the business systems required to assure quality, improve operations, and support our internal and external customers. These programs require further definition to understand how they are applied to effect continuous improvement. FUTURISTIC QUALITY PLANNING Futuristic quality planning is necessary to assure successful applications of new systems, processes, and products. Futuristic quality planning applies equally well to existing processes or products because it perpetuates continuous improvement. This planning program almost always requires the use of cross-functional teams. The core members of this team should consist of people who have the necessary authority to make decisions that support the program. During the course of planning activities, it will often be necessary to recruit employees who have special insight or knowledge of the process being evaluated. 10 TOTAL QUALITY MANAGEMENT MANUAL It is best to use a structured approach for this planning process. This will assure consistency of purpose and allow easy inclusion of participants who have had experience on other quality planning teams. A method I have applied over the years fits the needs of both service and product manufacturing. Both activities require futuristic quality planning to assure efficiency of operations and customer satisfaction. Service/product quality planning (SPQP) is a structured approach that can be applied to any business activity. It does not matter if we are working in a manufacturing or service environment. It does not matter if we are looking to improve office systems or manufacturing processes. The principles are the same: (1) flow chart the process chain for the activity or product; (2) assess the current method and effectiveness of quality control; (3) do a failure mode and effects analysis of highrisk process steps; and (4) develop a control plan to assure quality. The SPQP process is designed to improve the quality of current services and products. When new services or products are under consideration, another quality tool should be applied to achieve maximum customer satisfaction. This other tool is quality function deployment (QFD). QFD is a very structured and extensive analysis of customer requirements and needs. The study and application of QFD warrants a book of its own and will not be covered in this manual. We can still develop a strategic plan for customer satisfaction using only the tools contained within SPQP when applied toward new services or products if the customer is permitted to participate. I feel that most readers of this book are more interested in finding methods to improve current services, processes, or products. The study of QFD is recommended for marketing functions and design engineers. The steps and tools required to prepare an SPQP are as follows: Phase 1: Flow Chart There are universal rules to follow when preparing a flow chart. A square box should be used to describe each major process step involved in creating the service or product. Arrows should be used to show the direction each process step takes as the total process evolves. Diamonds should indicate decision points along the process chain. Either inside or adjacent to the diamond is usually a question. Process flow lines (arrows) from the diamond points are used to act upon the answer and lead to the next process step. Other universal symbols are used to reduce the amount of text contained in a flow chart. One example is an inverted triangle to indicate that an evaluation or an inspection must take place at a particular process step. An example of a flow chart using these symbols is shown in Fig. 2-1. This is a flow chart for heat treating a threaded bolt in a molten salt bath. This flow chart has ten process steps. Each individual process step could be expanded to describe the actions necessary to complete its task, but generally this is not necessary unless that particular step needs to be improved upon. This process has two decision points controlled by the furnace operator. A "yes" answer by the fur- nace operator allows the process to continue, but a "no" answer requires assistance from quality control. Phase 2: F l o w Chart A n a l y s i s After the process is defined so that each major process step is identified, the next phase is to assess the contribution each step has in reaching the desired end result of the process. In this case, the end result is a bolt (or a processing lot of bolts) meeting all metallurgical and design requirements after the salt heat-treating process. Let's review the process step LOAD PARTS IN BASKET (see Fig. 2-1). This step requires the furnace operator to verify several facts to assure compliance with meeting all quality requirements of his work order. These quality requirements are the contributions that this step has in satisfying the metallurgical and design requirements for salt heat treating. The operator has to assure that all paperwork received with the product matches. This includes drawings, manufacturing routings, the heat treat process sheet, the quality assurance control plan, etc. The operator must assure that when the parts are loaded into the basket the parts are positioned so there will be an even transfer of heat during the heat-treating operation. The operator must assure that the parts are positioned to minimize distortion. And the operator must assure that if there are parts from other orders in the same basket, that these parts have weight and mass similar to the parts for the current order. All aspects of this one step, LOAD PARTS IN BASKET, can be evaluated as to its overall effectiveness. In flow chart analysis, we evaluate each step in a process as to the severity of failing to perform the step correctly, the capability of the process itself to perform the step correctly, and the probability of knowing when the process is not performing as expected. We assign values to the severity, capability, and detection criteria to weigh the results so it is possible to prioritize required actions when the failure mode and effects analysis (FMEA) is prepared. The guideline values for severity, capability, and detection are presented in Tables 2-1, 2-2, and 2-3, respectively. To see how these guidelines apply, let us continue to work with our example for heat treating. In Step three (see Fig. 2-1), LOAD PARTS IN BASKET, the SPQP team made the following decisions as shown in Table 2-4. 1. For "paper work matches," the team chose a severity rating of 3 because they felt that incorrect information as to material type, for instance, would prevent the product from responding as expected in the high-heat furnace. A capability of 3 was chosen because past experience has been positive with hardly any cases of mixed paperwork. For detection, the team chose "1," because mixed paperwork is very easy to detect when it occurs. 2. For "parts are positioned to assure even heat transfer," a 4 was chosen on severity because failure to satisfy this requirement could result in nonconformance to metallurgical properties. A 3 was chosen for capability because the baskets are designed with a partition that properly spaces the parts for even heat transfer. When it came to detection, the team picked "2" because if the operator put more than one part in a partition it would most likely be detected. CHAPTER 2--STRATEGIC PLANNING 11 RECEIVE PARTS REVIEW ROUTING & DRAWING LOAD PARTS IN BASKET LOAD IN • HIGH HEAT I~l~ FORNACE I I QUENCH IN SALT r CALL FOR QC REVIEW J COOLTO "~ ROOMTEMP - ~ WATER WASH TEMPER IN SALTAND VERIFY HARDNESS NO UNLOAD PARTS STAGE FOR NEXT OPERATION Figure 2-1 m Basic salt bath heat treat process flow. 3. For "parts are positioned to minimize distortion," the team gave a severity rating of 4 because failure to satisfy this requirement could result in a dimensional defect. The capability was 3 because of operator experience with the effects of incorrect positioning. The selection of 2 for detection was assigned because a double check of position prior to moving the parts to the high-heat furnace is performed by another operator. 4. For "parts have similar mass and cross-sectional area," ratings of 4, 3, and 2 were assigned for severity, capability, and detection, respectively, based upon the quality history and experience of the operators involved. This process is completed for each step in the process of salt heat treating. The end result is a compilation of values that allow's management to prioritize the analyses and improvements to be made by the SPQP team. An example of the completed process flow analysis for salt heat treating is provided in Fig. 2-2. In this example, one can see that the SCD values (severity rank times the capability rank times the detection rank equals the SCD value) vary from one step to the other and within each step depending on the controlled characteristic. Management must decide which controlled characteristics require further evaluation through a FMEA. Companies usu- 12 TOTAL QUALITY MANAGEMENT MANUAL TABLE 2-1--Service/product quality plan--severity assessment guidelines. The severity assessment rates the overall importance of each potential product nonconformance Severity Assessment 5 to the process and final customer. Safety related characteristic. Failure to satisfy this requirement could result in unexpected and/or catastrophic failure, leading to personal injury or property damage. Critical characteristic. Failure to satisfy this requirement could either result in a significant loss in performance or cause the end user to produce a product that does not conform to his or her customer's requirements or would prevent or significantly h a m p e r a following operation from performing its function. Functional characteristic. Failure to satisfy this requirement could prevent the product from being assembled and used as intended, lead to more variability in performance than is normally anticipated, could be perceived as poor quality by the final customer, or a subsequent operation would have some difficulty in its process due to the nonconformance. Nonfunctional characteristic. Failure to satisfy this requirement will not have any appreciable impact on performance. Most cosmetic requirements shall be considered nonfunctional characteristics unless there is a history of customer complaints. Cosmetic requirements that have resulted in complaints will be considered a functional characteristic. Subsequent operations would see no appreciable difference in performance. Process characteristic. Failure to satisfy this requirement has no impact on the finished product or the manufacturing process. 4 3 2 1 TABLE 2-2--Service/product quality plan--capability assessment guidelines. Capability Assessment For Manufacturing Processes with Documented Process Capability Data Cpk > 2.0 1.67 < Cpk < 2.0 or Ppk < 2.0 1.33 < Cpk < 1.67 or 1.67 < PPK < 2.0 1.00 < Cpk < 1.33 or 1.33 < Ppk < 1.67 Cpk < 1.0 For Manufacturing Processes Without Documented Process Capability Data N/A N/A Although documented process capability data are not available, past experience with this process on similar products has been very positive. Very few known problems have occurred w h e n using this process on similar products in the past. This process has been known to be a source of scrap and/or discrepant material when used on similar products or there are no historical data for this process. NOTE: This assessment uses the formula rain [x - 3g L_SL' USL 3~- x]J for both Cpk and Ppk. TABLE 2-3--Service/product quality plan--detection assessment guidelines. Detection Assessment 1 2 3 4 5 The detection assessment rates the probability that the current inspection and SPC system will find a nonconformance should it occur. A nonconformance will almost always be detected. Either the process automatically detects a failure or a high capability has been established and SPC is appropriate, understood, and used to run the process. There is a good chance of detecting a nonconformance. SPC is generally understood and usually reacted to in a capable process, or some form of 100% inspection is used. The current system may detect a failure. SPC is in place, but not fully understood and or reacted to, or sample inspections are done throughout the run. A nonconformance will probably not be detected. Control charts are done incorrectly or are incomplete, or inspections are limited, such as setup only. There is absolute certainty that a nonconformance will not be detected. No inspection is done. NOTE: "Detection" must take place before reaching the next applicable process/customer. Inspection by the next process or final inspection is not appropriate in determining this rating. CHAPTER 2 - - S T R A T E G I C PLANNING Process Step Load parts in basket TABLE 2-4--Load parts in basket. Controlled Characteristic SCD Severity Paper work matches Parts are positioned to assure even heat transfer Parts are positioned to minimize distortion Parts have similar mass and crosssectional area ally do n o t have u n l i m i t e d resources a n d m u s t limit the n u m b e r of projects t h r o u g h the use of Pareto analysis. Before going further, I feel it beneficial to p r o v i d e definitions of Pareto analysis a n d Pareto chart. Pareto analysis: Analyses of the frequency of events d e s c r i b e d on a Pareto c h a r t t h a t c o n t r i b u t e to a n outcome. I n the quality profession, o u t c o m e s could be rejects, scrap, a n d o t h e r c o n t r i b u t o r s to cost of quality such as incorrect invoices, p u r c h a s e orders, m i s s i n g information, etc. Pareto chart: A simple statistical tool t h a t r a n k s cont r i b u t i n g factors to an o u t c o m e a c c o r d i n g to either cost o r frequency of occurrence. This allows for easy priorit i z a t i o n of c o n t r i b u t i n g factors for analysis, t h e r e b y keeping cost of analysis low by focusing on the vital few a n d t e m p o r a r i l y not a n a l y z i n g the trivial many. I n o u r example, m a n a g e m e n t d e c i d e d to p e r f o r m a F M E A on all controlled characteristics t h a t h a d a n SCD value t h a t exceeded 50. The c a n d i d a t e s for FMEAs are s h o w n in Table 2-5. I n general, m a n a g e m e n t w o u l d also c o n s i d e r a n y controlled characteristic t h a t h a d a 5 for either c a p a b i l i t y o r detection regardless of the SCD's value rank. P h a s e 3: F M E A The F M E A is a d o c u m e n t designed to a c c e p t change. It acts as a futuristic p l a n n i n g tool b y identifying p o t e n t i a l causes of failure t h a t s h o u l d be c o n s i d e r e d in the developm e n t of control plans. As n e w controls are i m p l e m e n t e d , the F M E A is revisited a n d revised to reflect n e w process capabilities. FMEAs c a n be d e v e l o p e d for processes or p r o d u c t s . In o u r example, we are c r e a t i n g a Process F M E A for the salt h e a t treating process. A F M E A is an analytical t e c h n i q u e utilized to assure to the b e s t o f its ability t h a t all p o t e n t i a l concerns (failures) are identified a n d a d d r e s s e d t h r o u g h s o m e control m e c h a n i s m . The g r o u p best suited to develop a F M E A is m a n u f a c t u r i n g engineering o r a s i m i l a r g r o u p o r individual t h a t u n d e r s t a n d s the process ( m a n u f a c t u r i n g o r service). The Process F M E A identifies failure modes, explores the effects of the failure on customers, d e t e r m i n e s the p o t e n t i a l causes of those failures, looks at c u r r e n t controls to avoid o r identify the failure, a n d suggests actions to improve control. The t e a m assigned to c o m p l e t e the F M E A s h o u l d consist of those close to the process b e i n g evaluated. As m e n t i o n e d earlier, for a m a n u f a c t u r i n g o p e r a t i o n such as h e a t treating, the b e s t p e r s o n to l e a d the t e a m is a m a n u f a c t u r i n g engineer. F o r o u r example, o t h e r p o t e n t i a l m e m b e r s are the p l a n t metallurgist, l a b o r a t o r y technician, furnace operator, a n d super- Capability Detection 9 3 3 1 24 4 3 2 24 4 3 2 24 4 3 2 13 visor o f the h e a t t r e a t d e p a r t m e n t . An e x a m p l e o f the F M E A f o r m a t is s h o w n in Fig. 2-3. Let's w o r k t h r o u g h a n e x a m p l e of c o m p l e t i n g a FMEA. E a c h c o l u m n c o n t a i n s i n f o r m a t i o n t h a t leads to i n f o r m a tion/action for the s u b s e q u e n t column. O u r t e a m c a m e u p w i t h the F M E A s h o w n in Fig. 2-4 for Process Step 4: H i g h H e a t F u r n a c e . The following logic is a p p l i e d to fill the columns with information: Process I n this c o l u m n , list the p r o c e s s step t h a t creates the controlled c h a r a c t e r i s t i c u n d e r analysis. F o r o u r example, the first e n t r y in this c o l u m n is H i g h H e a t Furnace. This process step is the first p r o c e s s step o f t h e process flow analysis t h a t h a d a n SCD value t h a t exceeded 50. To c o m p l e t e the FMEA, following in order, the next entries f r o m Table 2-5 w o u l d b e Cool, Temper, a n d H a r d n e s s Test. Controlled Characteristics~Fail Mode I n this column, list the c o n t r o l l e d c h a r a c t e r i s t i c a n d t h e a n t i c i p a t e d failure mode. F o r the process step, H i g h H e a t F u r n a c e , the c o n t r o l l e d c h a r a c t e r i s t i c is P a r t Microstructure. The p o t e n t i a l failure m o d e s are: incorrect a t m o s p h e r e , i n c o r r e c t f u r n a c e t e m p e r a t u r e , a n d incorrect t i m e at temperature. Effects I n this c o l u m n , list the effect the failure m o d e w o u l d have o n the c o n t r o l l e d characteristic. I n the case of o u r example, all failure m o d e s identified w o u l d cause the w r o n g m i c r o structure, l e a d i n g to p r o d u c t failure at a s u b s e q u e n t o p e r a tion o r in p r o d u c t application. Likely Causes At this juncture, we e x a m i n e the likely cause(s) of the i d e n tiffed failure modes. The likely cause of i n c o r r e c t a t m o s p h e r e is c o n t a m i n a t e d salt. The likely cause for i n c o r r e c t tempera t u r e is a defective furnace t h e r m o c o u p l e . The likely cause of i n c o r r e c t t i m e at t e m p e r a t u r e is an i n c o r r e c t setting o f t h e f u r n a c e timer. Current Control Methods I n this column, list the p r e s e n t m e t h o d of controlling the likely cause(s) o f the failure mode(s). I n o u r example, t h e f u r n a c e salt is evaluated every six m o n t h s b y the c h e m i c a l c o m p a n y the supplies the salt. The m a i n t e n a n c e d e p a r t m e n t changes the furnace t h e r m o c o u p l e s every two weeks. The r e m o v e d t h e r m o c o u p l e s are r e t u r n e d to the t h e r m o c o u p l e s u p p l i e r to b e c a l i b r a t e d a n d r e b u i l t as r e q u i r e d for future 14 TOTAL QUALITY MANAGEMENT MANUAL SERVICE / PRODUCT Q U A L I T Y PLAN P h a s e I - P r o c e s s Flow Analysis Revised Salt Bath Heat Treat Product Une: Manufacturing Location: ABC Company Original S C D S e a e C v Original Issue Date: January 1994 Approved By: p t a b i ti I e c t i i o t n e r i y Process Flow Diagram Controlled Characteristics D (9/30/93) S Ci D S e v e r alI e p t ~ e c C D i i t t y I i t Y i o n 4 3 1 12 Y 1) Receive Parts 1) Parts are ready for Heat Treat. 2) Review RoutJngs and Drawings 2) Parts match metallurgical requirements of the routing and drawing. 4 3 4 48 5 3 2 30 3) Load Parts Into Rack or on Wire and Match Paperwork. 3) - Paperwork for each load match, - Parts are positioned to ensure even heat transfer - Parts are positioned to minimize distortion. - Parts have similar mass and cross sectional area. 3 3 1 9 3 3 1 9 3 3 3 27 4 3 2 24 4 3 4 48 4 3 2 24 3 3 3 27 4 3 2 24 4) High Heat Furnace J,) Part microstructure 5 3 5 75 5) Quench 5) Part hardness Part microstructure. 3 5 3 3 5 5 45 75 8) Cool ~) Part microstructure. 5 3 5 75 7) Water Wash ~') Parts free of salt. 3 4 2 24 8) Temper 3) Part hardness Part microstructure. 5 5 5 3 3 5 75 75 9) Clean a) Parts free of Heat Treat scale. Parts free of Hea-tTreat salts. 2 3 3 1 9 3 4 2 24 10) Hardness Test 10) Meet part hardness requirement. 4 5 5 3 75 11) Unload Parts From Rack or Wire and Match Paperwork. 11) Parts are free from: - Damage - Distor'don - Cracks - Salt - Paperwork matches parts in individual orders. 3 3 5 3 4 3 4 3 4 3 2 4 3 2 1 18 48 45 24 12 12) Stage For Subsequent Operations, Black Oxide or Further Processing. 12) Parts are as represented. 3 3 1 9 1 of 1 2 SaRHtIA) 3 3 3 1 2 2 6 12 24 Page Figure 2 - 2 m P r o c e s s f l o w analysis. CHAPTER 2--STRATEGIC PLANNING TABLE 2 - 5 - - S a l t Bath Heat Treat Phase 1 Results: operations in the process that exceed 50 in the SCD rating. Operation Step 4: High heat furnace Step 6: Cool Step 8: Temper Step 10: Hardness test Characteristic Part microstructure Part microstructure Part hardness Part microstructure Meet part hardness requirement SCD Rating 75 75 75 75 75 use. The furnace o p e r a t o r s m o n i t o r the t i m e at h e a t as ind i c a t e d on the electronic furnace controller. Responsibility (Resp. and Date) I n this column, list the person(s) held a c c o u n t a b l e for applying the c u r r e n t controls. F o r o u r example, the h e a t t r e a t supervisor is held a c c o u n t a b l e for having the furnace salts e v a l u a t e d every six m o n t h s , the m a i n t e n a n c e d e p a r t m e n t is a c c o u n t a b l e for c h a n g i n g the furnace t h e r m o c o u p l e s every two weeks, a n d the furnace o p e r a t o r s are a c c o u n t a b l e for m o n i t o r i n g the t i m e at heat. Recommended Actions This c o l u m n is used w h e n the t e a m identifies a n opport u n i t y for i m p r o v e m e n t on one of the c u r r e n t m e t h o d s of control. In o u r example, the t e a m felt t h a t the six-week interval was too a r b i t r a r y a n d n o t b a s e d on historical data. This m e a n t t h a t d u r i n g s o m e six-month periods, the salt b a t h was o u t of control o r specification a n d n o t k n o w n except b y s p o r a d i c m e t a l l u r g i c a l failures. So the t e a m d e c i d e d to a p p l y statistical process control (SPC) to the salt b a t h analysis. A p r o g r a m was e s t a b l i s h e d to analyze the b a t h every w e e k a n d c h a r t the m a i n variables of the b a t h on an individual's chart. The b a t h could then be rejuvenated/replaced b a s e d on outof-control data. In the long r u n the t e a m felt t h a t m o n e y could be saved using this a p p r o a c h b y e l i m i n a t i n g metallurgical rejections necessitating r e w o r k or scrap. The c h e m i c a l s u p p l i e r was p r o v i d i n g the b a t h analysis free of charge a n d was m o r e t h a n h a p p y to acquire statistical d a t a on the life cycle of his c h e m i c a l s for m a r k e t i n g purposes. Date In this c o l u m n list the n a m e of the i n d i v i d u a l r e s p o n s i b l e for the r e c o m m e n d e d action(s) a n d the d a t e the action(s) are expected to be i m p l e m e n t e d or completed. All FMEAs should be p u t on a review p r o g r a m to evaluate a n d a s c e r t a i n the c u r r e n t n e s s of the d o c u m e n t . One of the b e t t e r m e t h o d s is to p u t d o c u m e n t n u m b e r s on the SPQP a n d a d d t h e m to the c o m p a n y c a l i b r a t i o n software system. This way, a one y e a r "calibration" cycle can be p r o g r a m m e d , a n d the review process c a n n o t be overlooked. The review does not require a team; all t h a t is r e q u i r e d is t h a t the individual m a k i n g the review be k n o w l e d g e a b l e of the process u n d e r review. The individual can always solicit, as necessary, the council of others in the o r g a n i z a t i o n for expert or specific assistance. Phase 4: C o n t r o l P l a n The final p h a s e of an SPQP is the d e v e l o p m e n t of a control plan. As with the FMEA, a control p l a n can be designed for 15 a process o r for a product. The decision to m a k e a process o r p r o d u c t control p l a n is u s u a l l y d e c i d e d by the type of organization. An o r g a n i z a t i o n t h a t provides a service, such as a m a c h i n e shop m a n u f a c t u r i n g c o m p o n e n t s for a larger m a n u f a c t u r e r o r a c o m p a n y t h a t provides office cleaning services, w o u l d m o s t likely e m p l o y a p r o d u c t control p l a n so t h a t t h e y are confident of satisfying all t h e i r c u s t o m e r s ' u n i q u e requirements. On the o t h e r hand, a m a n u f a c t u r e r of s t a n d a r d ASTM A325M 1 s t r u c t u r a l bolts o r a b a n k clearing c u s t o m e r checks w o u l d find the process control p l a n m o r e apropos. In either case, the control p l a n f o r m a t is the s a m e a n d is s h o w n in Fig. 2-5. The control plan, as the FMEA, is divided into c o l u m n s w i t h h e a d i n g s to provide a n a t u r a l sequence of events enabling users of the control p l a n a concise a n d clear guide for controlling the quality of the process o r product. We will n o w w o r k o u r w a y t h r o u g h a process c o n t r o l p l a n for h e a t t r e a t i n g an ASTM A325M s t r u c t u r a l bolt with a salt-bath furnace. Process Point Control This c o l u m n contains the s a m e i n f o r m a t i o n in the s a m e sequence as the like c o l u m n in the process flow analysis for the salt h e a t t r e a t process. It is a listing of all steps r e q u i r e d in the process of h e a t treating via this m e t h o d in the exact o r d e r the steps are p e r f o r m e d . Controlled Characteristic This c o l u m n c o n t a i n s the s a m e i n f o r m a t i o n in the s a m e sequence as the like c o l u m n in the process flow analysis for the salt h e a t treat process. All characteristics controlled at the process step in the s a m e r o w m u s t be listed in this column. Control Methods~Sample Plan In this c o l u m n the m e t h o d of controlling the c h a r a c t e r i s t i c along w i t h the specified s a m p l i n g m e t h o d is detailed. Several m e t h o d s of control are available including first article verification, in-process i n s p e c t i o n to a s a m p l e p l a n b a s e d on lot size o r p r o d u c t i o n rate/hour, statistical process control, a n d 100% inspection. The m e t h o d of control is b a s e d u p o n the capability of the process step to m a i n t a i n design criteria. Method of Evaluation In this c o l u m n we describe the process, equipment, o r ins t r u m e n t a t i o n u s e d to evaluate e a c h controlled characteristic. Methods m a y include visual i n s p e c t i o n w i t h o r w i t h o u t a microscope, a metallograph, a p a i r of dial calipers, a scanning electron m i c r o s c o p e (SEM), a h a r d n e s s testing machine, etc. Of i m p o r t a n c e here is the r e q u i r e m e n t t h a t for w h a t e v e r m e t h o d of evaluation we employ, a n evaluation of the r e p e a t a b i l i t y a n d r e p r o d u c i b i l i t y of t h a t m e t h o d be determined. One m e t h o d of c o n d u c t i n g an evaluation of the r e p e a t a b i l i t y a n d r e p r o d u c i b i l i t y of an evaluation m e t h o d is d e s c r i b e d in ASTM Guide for C o n d u c t i n g a R e p e a t a b i l i t y a n d R e p r o d u c i b i l i t y S t u d y on Test E q u i p m e n t for Nondestructive Testing (F 1469). 1Specification for High-Strength Bolts for Structural Steel Joints [Metric]. 16 TOTAL Q U A L I T Y M A N A G E M E N T M A N U A L °~ °1 t- tO) 4"00 W -0 t" t~ o -0 0 ® rw "¢o w ta @ n,, | ® -g ¢- ~: n ~ .o ~ Q. W o 0 e. ¢5 ¢J 0 "0 e.. m 0 | =3 m 0 "0 0 E 2 I ? 2"1 R. U.I °o n e 0_ 0 CHAPTER 2--STRATEGIC PLANNING fl) ~0 (0 42 irl ~6 o "6 E ~ o ~ o if2 0 ~ .0_ o~ - "~n o~ ~ ~l ~ W m m o ~ ~ r~ 0 r., m o "o o .o I 2 lit I° g ~ .. o ~ ~0 i |7 18 TOTAL QUALITY MANAGEMENT MANUAL tt~ Q. r. o o tO t.) ! (I) U) t~ t" o n o .° t~ tY 0 ..J t" or" r~ tr, t~ t" t~ m_ Q. 0 0 c I u? E "0 0r-. 2 c 0 o Z 5 tu r.- o "0 2 to o o t" o~ ...I W tl) -0 0 t~. 2 I"1 t..) CHAPTER 2--STRATEGIC PLANNING __ B ~ .~ 1- ¢,- ~- . ~ = o ! == ®.o ¢~ > ::3 0 0 o ~---~,~ ~ < , i - i = U,I ~ t/~ a. a. Q I-- ~ E ~..~ = 20 TOTAL QUALITY MANAGEMENT MANUAL Responsibility In this column, list the person(s) or department held accountable for evaluating the controlled characteristic. In the case of persons, avoid the use of personal names; instead, refer to the job title. This practice allows wider use of the control plan and eliminates the need for revisions when an individual is no longer performing the task detailed in the plan. Reaction of Plan to Out of Control or Specifications In this column we specify what to do if during the course of evaluation we find the characteristic either out of control or out of specification. This is an important consideration, and the team developing the control plan should be very specific so the person/department making the evaluation has clear instructions on how to handle the situation. Failure to properly handle an out-of-control or out-ofspecification characteristic could result in allowing the situation to continue or even permit a defective product to reach the customer. It is recommended that the team refer to standard operating procedures that describe in detail how to deal with these situations. Any referenced procedure should be available and completely understood by the individual/department that must act upon the problem. A partially completed process control plan is shown in Fig. 2-6. So that we know how it is constructed, we will go through the process step, Temper. The columns entitled Process Point Control and Controlled Character in the Phase III Control Plan shown in Fig. 2-6 list the process step and the controlled characteristics, respectively, for the temper operation. Two characteristics are affected by the temper operation: one is "part hardness," and the other is "part microstruc~re." A separate line is used for each of these characteristics. In the Control Methods/Sample Plan column adjacent to Part Hardness, the team put the phase "X & R Chart, 5 pieces per furnace per order." This lets the furnace operator or anyone viewing the control plan know the statistical process control is to be applied to this characteristic at this process step. It also specifies the type of chart and the frequency and size of subgroup sampling. In the Method of Evaluation column, the team inserted the name of the instrument required to check part hardness, in this case, a Newage digital hardness machine. In the colunm entitled Responsibility, the team inserted the job title, Furnace Operator. In all cases, when assigning accountability for action, name the individual performing the task. With this directive comes responsibility from management. Management must assure that the person understands what is required and is properly trained to perform the task. The column entitled Reaction of Plan to Out-of-Control Specification must provide enough information for the person named for responsibility to take appropriate action. In this case, the team chose to reference a procedure that details how to deal with nonconforming material. The controlled characteristic, part microstructure, is addressed in similar manner. However, due to the time and cost involved in preparing metallurgical micromounts, the team decided to check this characteristic only once per shift/furnace/material grade. This action was made possible because the team earlier initiated more frequent check analyses of the salt bath when an opportunity for improvement was taken on the FMEA. Although the SPQP program is very powerful, it does require a great deal of effort and resources to apply. This downside, however, is nothing compared to the business consequences of failing to plan for quality. Futuristic quality planning pays high dividends in terms of reduced scrap and rework. Other benefits include more satisfied customers both in terms of the shear number of customers and in the degree to which your customers are satisfied. This alone should be enough incentive for the top executives of an organization to fully support such a program. Once the full support of top management is acquired, the staff management should review their operations and make recommendations for application of the SPQP process. It is best to choose a process or product fairly well understood by all involved in the process flow and one that shows promise for improvement. By starting with a process or product that is going to show success, confidence in the program is instilled in those who participate and in those who are on the sidelines watching to see how it goes. After two or three successes, you will find a grass roots movement by others to apply this new technique to their own areas of responsibility. The other three programs mentioned earlier in this chapter are best covered under continuous improvement, the topic of Chapter 3. In Chapter 3, we will discuss critical performance indicators (CPIs), and the plan, initiate, evaluate (PIE) processes for continuous improvement. These two programs include strategic methods for service and product improvement, employee involvement and education, and business systems. Continuous Improvement Analysis of the survey results should identify the critical performance indicators (CPIs) that drive your organization. If you recall, we earlier defined CPIs as those measures that contribute to customer (internal and external) satisfaction. It may not be surprising to find such factors as on-time delivery and cost of quality among the concerns of your customers and employees. Once you have identified your CPIs, you need to know how to track and measure these indicators so that you may find out whether your efforts toward continuous improvement are effective. This requires a structured and systematic approach and a few tools of statistics. Structured and systematic means that procedures are established to assure that everyone knows what is expected and that they do things the same way. It is important that everyone work with the same set of data and that these data be factual. The statistical tools are basic problem-solving techniques employing the use of brainstorming, flow chart analysis, and cause and effect analysis. These are simple yet powerful techniques that anyone can apply. A more detailed study of these techniques is discussed in Chapter 7, Statistical Quality Control. The next step is to flow chart the process that affects the CPI. An example of a flow chart was presented in Chapter 1, Fig. 1-3. A flow chart is simple to construct and can be done by the employees who do the processes that lead to the final output of that process. For example, let's say that one of our company CPIs was to ship the customer order on time. If we examine the processes (steps) that affect shipping the customer's order on time, we may find, depending on the size of the organization, that as many as 30 processes contribute to that CPI. For the sake of simplicity, let's cut the number of processes to a more manageable level for this example. The first step is to assemble representatives from each department that have an influence on shipping the customer's order on time. In our fictional company, these representatives will come from the customer service, design engineering, manufacturing engineering, production control, purchasing, manufacturing, quality, and the shipping departments. The entire process is represented in Fig. 3-1. Each of the steps in this Ship Customer Order On Time flow chart has flow charts of its own. For instance, the last step, Shipping Packs & Ships Order, requires several steps before the customer order is actually shipped out the door. Documents must be assembled, packing and shipping instructions read, boxes selected and assembled, labels prepared, the product containerized, and the method of transportation scheduled. IN THE FIRST CHAPTERwe discussed management's role in providing the leadership necessary for the company to meet its business objectives. One business objective of primary importance is continuous improvement. If a company is dedicated to continuous improvement, it will constantly improve its internal performance, customer service, and quality. Such improvement automati~cally strengthens the company's competitive position and its ability to respond to customer needs. Continuous improvement begins with an understanding of where you are and where you want to be. Everyone wants to be the best in their field; however, our ambitions should be realistic and in line with our resources. Goals should be obtainable while providing enough challenge to allow employees the opportunity to extend their current abilities. While moving along the path of continuous improvement, keep in mind that the journey never ends! The present is now and the future is only the next step along the way. You cannot stop because, if you do, someone will pass you by. There is a saying from the Great North: "If you're not the lead dog, the scenery never changes." This saying applies to a company's journey along the path of continuous improvement. If you're not the leader in your industry, you won't see future opportunities until your competitor has passed that point, leaving only the spoils for you. So, where do we begin to move along this path of continuous improvement? Like any journey, we have to determine where we are and where we want to go. Most companies have a pretty good idea of where they are through historical data that provide a measure of how well they are meeting the needs of their customers. These data include ratings on customer quality system surveys, customer returns, the number of Service requests, employee absentee rates, efficiency ratios, the ratio of quotes accepted to those given, employee turnover, customer certification awards, cost of quality, JIT delivery performance, lost time injuries, and hundreds, even thousands more. The data include information from internal as well as external customers. The two cannot be separated, as both contribute to the strength of the company. In the first chapter, we talked about utilizing surveys to assess the current pulse of the company. This is a good place to begin. Top management should form a steering committee to evaluate all the summary information available from the data acquired from this historical data mentioned earlier. From that information, intelligent questions can be formed to ask employees, customers, and suppliers in the form of a survey. The purpose of this survey is to discover your strengths and weaknesses. 21 22 TOTAL QUALITY MANAGEMENT MANUAL Customer Service Received CustomerOrdeI Design Engineering Gets Customer Requirements ManufacturingEngineering ReceivesManufacturing Drawings PurchasingContractsFor OutsideService& Components Production Control Schedules Order Manufacturing Processes Order t~ Shipping Packs & Ships i Order I Figure 3-1 inFlow chart for processing a customer order. Every step requires time and employee input. Does each step contribute value to the product and is each step necessary? These basic questions must be answered by everyone along the process chain. If a step is required, the next questions center around the overall efficiency of that step. Throughout this analysis, the collection and evaluation of data should be observed by the employee team from the process. Some of the best methods of presenting data are the simplest. The run chart is very effective in tracking progress over time (Fig. 3-2). The on time shipment chart in Fig. 3-2 shows improvement over a twelve-month period. The chart could very well have shown a downward or even a random pattern. It is important to know when to react to trends on run charts. It is a mistake to assign cause every time the chart makes a move in either the positive or negative direction. Normal forces of variation are ever present, and until a process is in control and control limits are calculated via statistical calculations of control chart data, reaction to movement should be with caution. More on control charts will be discussed in Chapter 7. Through analysis of data collected, opportunities for improvement will become evident. Management must determine which opportunities to work toward first. These decisions are usually based upon cost effectiveness, quality improvement, or criticality of correcting an undesirable conclifton. Whatever the reasons for choosing a particular op- portunity as a project for improvement, the process is the same• The improvement process has been defined by more than one quality guru as the plan, act, measure, and evaluate cycle. I call the process PIE (plan, initiate, evaluate) (Fig. 3-3). PLAN The most important part of a project is the planning phase; this is certainly true for continuous improvement projects. The better the plan, the better the implementation and the results. When developing a plan, the team needs to consider all action steps in the process expected to lead to the improvement desired. Once all action steps are identified, the next step is to decide the sequence in which these steps should be implemented. After the sequence is determined, the time allotted to complete each step is calculated, and responsibility for each step is assigned. This planning process can work only if a few basic guidelines are applied during this phase. Planning Guidelines • Obtain upper management commitment through sponsorship. • Form the right combination for the team. CHAPTER 3--CONTINUOUS IMPROVEMENT 23 92% 91% 90% 89% 88% 87% 86% 85% 84% 83% 82% -- Jan I I I I I I I I I I I Feb March April May June July August Sept Oct Nov Dec Figure 3-2--On-time-shipments trend chart. • Develop a vision and a policy statement for the team. • Develop objectives and guidelines. • Review current programs and projects. A closer study of each of these planning rules will make your planning easier. Obtain Upper Management Commitment Through Sponsorship Whenever a project is being considered, it is wise, indeed imperative, that the most senior m e m b e r of the organization be firmly established as sponsor of that project. The project needs his endorsement and the understanding that his door is always open to discuss progress on the project. Form the Team This phase of planning should not be taken lightly. Picking names and then throwing these individuals together in a room does not create a team. Each function involved in the project should be represented, and these representatives should have a good working knowledge of the area they rep- PLAN resent. They must possess attributes that foster teamwork. These attributes include honesty, good communication skills, dependability, leadership, empathy, and a willingness to work with others and share. Develop a Vision and a Policy Statement The team needs to know when they have achieved their objective. The vision is where the organization wishes to be when all phases of the program are implemented and successful. The vision statement should be concise and easy to understand. It should be measurable and should fit with the organization's business policy. It becomes a policy statement when endorsed and signed by the senior manager at the facility. Develop Objectives and Guidelines The team must be provided with the objectives of their project and the guidelines to be followed to achieve those objectives. For instance, an objective may be to reduce the lead time in turning around a "request for quote" to a customer. A guideline (or restriction) may be that we are only interested at this point in reducing in-house lead time. We wish to tackle the outside sales and marketing function at another time. Review Current Programs and Projects EVALUATE INITIAT Figure 3-3--PIE. After the team has been formed and several meetings have been held describing the project and its vision statement, policy statement, objectives, and guidelines, the team should thoroughly review the project. The objective of this review is to determine if the team has everything at their disposal to initiate the project and to successfully achieve the vision. A list of needs should be prepared and submitted to the senior manager for his consideration and action. The two previous examples provide a good starting point for describing how we can work with CPIs and the PIE method to achieve continuous improvement. Management provides the resources for service and product improvement, 24 TOTAL QUALITY MANAGEMENT MANUAL employee involvement and education, and business systems, discussed in Chapter 2, to gain the fullest benefits of these terms as follows: SERVICE AND PRODUCT IMPROVEMENT Service and product improvement comes from initiating new programs or techniques and monitoring the CPIs associated with the process undergoing change. Advantages of service and product improvement are many and varied as shown below: • Reduced scrap. • Less rework. • Improved capacity. • Fewer returned goods. • Less service calls. • Improved earnings through lower cost of quality. • Improved earnings through more efficient operations. • Satisfied customers. • Satisfied employees. • Gaining a competitive advantage over your competition. REASONS FOR EMPLOYEE INVOLVEMENT Employee involvement and education is one of the main ingredients in creating continuous improvement and cannot be avoided when using the PIE methodology. The reasons for gaining employee involvement are described below: • To bring, to the fullest extent possible, common values and procedures to the workplace. • To produce the lowest-cost, highest-quality products and services for world markets and meet customer expectations. • To put employees in the decision process to: • Provide capable systems and manufacturing processes. • Provide clear expectations in terms of operations and quality. • Provide a means to measure progress. • Provide a means to correct any situation not meeting expectations. • Provide the environment for all employees to work together toward the accomplishment of organizational goals. • To strive to achieve "total" commitment to quality and productivity by all employees. • To have an action plan developed through representation of all employees. • To desire all employees to have ownership of the process of continuous improvement and an understanding and commitment to the organization's goals. • To have total commitment to customer service, whoever that customer may be. • To create an interesting, challenging, enjoyable, and safe work environment. • To develop a system of communication and feedback to solve organizational problems and to keep employees informed by: • Intra/inter department communications. • Management-level communications. • Employee-to-employee communications. • Horizontal and vertical. • External and internal. • To have sufficient knowledge of company operations, customer needs, and individual job responsibilities. • For all employees to have a better or complete knowledge of the working part of the company's product or service to be a better judge of acceptable quality. It is difficult to dispute the advantages employee involvement brings to an organization, yet many company executives still feel threatened by employees who "know too much." The truth of the matter is that the more employees know about their business contribution, the better they are able to contribute to the overall success of the organization. New business systems are created and existing ones refined through the CPI and PIE programs. There has never been a business system that worked perfectly the first time, but how many times have you heard somebody say, "But we always did it like that!" Why are some people so afraid to change the way things are done? The answer lies in the company's management style. A management philosophy should embrace W. Edwards Deming's 14 Points of Management Obligations. 1 His 14 management obligations are paraphrased below: 1. Create constancy of purpose toward improvement of product and service with the aim to become competitive, stay in business and provide jobs. 2. Adopt the philosophy: We are in a new economic age created by global competition. A transformation of management style is necessary to halt the continued decline of industry. 3. Cease depending on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place. 4. End the practice of awarding business on the basis of price tag alone. Purchasing must be combined with design of product, manufacturing, and sales when dealing with chosen suppliers. The aim is to minimize total cost, not just initial cost. 5. Improve constantly and forever every activity in the company to improve quality and productivity and thus constantly decrease costs. 6. Institute training and education on the job for everyone, including management. 7. Institute supervision. The aim of supervision should be to help people and machines do a better job. 8. Drive out fear so that everyone may work effectively for the company. 9. Break down barriers between departments. People in the research, design, sales, and production departments must work as a team to tackle usage and production problems encountered with the product or service. 10. Eliminate slogans, exhortations, and targets for the work force that ask for zero defects and new levels of productivity. Such exhortations only create adversarial relationships; the bulk of the causes of low quality and 1"Out of the Crisis," Massachusetts Institute of Technology, Center for Advanced Engineering Studies, 1986. CHAPTER 3--CONTINUOUS IMPROVEMENT 25 low productivity belong to the system and lie beyond the power of the work force. 11. Eliminate work standards that prescribe numerical quotas for the day. Substitute aids and helpful supervision. (Such aids would be CPIs.) 12a. Remove the barriers that rob hourly workers of their right to pride of workmanship. The responsibility of supervisors is to change the goal from sheer numbers to quality of the product or service. 12b. Remove the barriers that rob people in management and in engineering of their right to pride of workmanship. This means, among other changes, abolition of the annual or merit rating and of management by objective. 13. Institute a vigorous program of education and retraining. New skills are required for changes in techniques, materials, and service. 14. Put everybody in the company to work in teams to accomplish the transformation. Let's work through an example of how CPIs can be used to bring about awareness and thus improvement. Let's take another look at the run chart we created for on time shipments. Our management team has decided that our on time shipment performance may not continue to improve unless a greater emphasis is placed on that goal. At a meeting that included all staff management, a decision was made to create an employee team to study and find ways to improve our on time shipment performance. A representative from the management team was selected to serve on this employee team as a facilitator. The management team also set objectives for the employee team. Among these were an overall improvement of on time shipments to 96%. The management team felt that, with a concerted effort by the employees and with full support of management, this goal was obtainable. During the last quarter, the company achieved an average of 91.4%, and the last two months nearly 92%. During the last twelve months, each month was an improvement over the previous month's performance with only two exceptions. The goal of 96% represents a 5% improvement over the last quarter results. A 5% improvement can be significant or insignificant. It all depends on the time block during which management wishes this goal to be reached and on the level of difficulty of change to reach each milestone. As discussed earlier, by the time management has come up with the vision, most obstacles have been thought out and addressed, making it possible to reach that vision through the talent pool that makes up the improvement team. For our example, let's say the vision is to reach a level of 96% on time shipment in six months. The vision has been approved, and the general manager has affixed her signature to the vision statement securing her support and making it management policy. With our team in place and the objectives and guidelines understood, responsibilities are established to carry out the project. It is important to point out that the team was made aware that, even though the goal is to improve on time shipments, there is a broader objective--to improve on time performance in each process step along the process chain from receiving the order from the customer to shipping the order out the door. Even with this expanded objective, you can see that management put in some guidelines or restrictions. For this project, we are not concerned with the process chain between the customer's request for quote and the moment the customer receives our quote. Management, at this time, is also not interested in the process from the time the order leaves the facility to the time it reaches the customer's dock. These two process chains certainly contribute significant time to the overall process, but there is little this facility can do to influence these process steps, with the possible exception of design engineering the concept. Let's go back to the flow chart shown in Fig. 3-1 for processing a customer order. The team formed to improve upon this process consists of talented employees from each of the departments represented in the process chain. Working together, they conclude that each department in the chain needs to track the amount of time an order spends in their area. This may differ for different departments_ For example, the time spent in the quality department can be measured in hours, whereas the time spent in the manufacturing department should be measured in days. Also, it is clear that some departments require further breakdown in their contribution. For instance, in manufacturing there are possibly several cost centers that make up the entire department. In manufacturing an ASTM A325M2 fastener, for instance, we could have wire annealing, wire draw, boltmaker, heat treat, and hot dip galvanizing all contributing time to the process. And let's not forget the queue time between operations; sometimes these delays take more time than value-added steps. Even these subprocesses need steps of their own to make them effective. Let's look at the boltmaker step in manufacturing the ASTM A325M fastener. Steps in this process may include gathering process drawings, tooling, and inspection gauging. All aspects of the process are under investigation when our task is to improve our on time shipment CPI. At this point it is usually important to have each team member construct a detailed flow chart of their department's process. They may wish to enlist help from their department and form an ad hoc team to give a full evaluation of each process step performed in their department. They would be the ones closest to the action and should know the ins and outs of their operations better than anyone. The ad hoc team would try to identify opportunities for improvement and eliminate redundant or unnecessary steps. After a new section of the process is selected for evaluation, a CPI can be chosen and data collected and tracked. As a change is made to the process, it can be determined if that change has an effect by seeing a shift in the CPI. Let's take a closer look at this example. Assume the team for the boltmaker department decided they would track how long it took the boltmaker operator to acquire tooling, gauging, and process drawings to run an order. They decide to do this for a six-month period to see if any one category might benefit from more attention. The results of their sixmonth study are shown in Fig. 3-4. If we rearrange the above data to include only the CPIs and occurrences, it becomes evident that the time spent 2Specification for High-Strength Bolts for Structural Steel Joints [Metric]. 26 TOTAL QUALITY MANAGEMENT MANUAL JUN MAY \\\\\\\\\\\1 \\\\\\\\\\\\\\\ APR MAR l[] DRAWINGSI [3TOOLING I • GAUGING J \\\\\\\\\\'l I \\\\\\\\\\\\\\1 \\\\\\\\\\\\] FEB JAN \\\\\\\\\\\ 0 \\\1 I ! I I I I 50 100 150 200 250 300 Figure 3-4--Set-up CPI analysis. waiting for tooling is an opportunity for improvement. The result is Fig. 3-5. Now the boltmaker team has an area of focus to isolate reasons for delays in getting tooling to the boltmaker. They will choose to select CPIs that contribute to having tooling available. Examples may be tool location, setup time, or tool availability. The process goes on until all causes are identified and presented to management for resolution. There are times when an identified opportunity requires extra planning to initiate change. Let's look at another example. This one was identified by the quality department. The representative from that department found that orders were sometimes delayed at final inspection because the inspector on duty was not always familiar with the product or the inspection techniques necessary to determine if the product met requirements. A separate employee involvement team was established to develop the plan to improve the knowledge of inspection techniques of the inspectors. The team was comprised of the inspection supervisor, several inspectors, a design engineer, and a quality engineer. After several brainstorming sessions, the team came up with a progression of steps that would lead to a well-informed and educated quality technician. Note that the team felt so strongly that the training to be provided to the inspectors was so much beyond the current job description that a new job title had to be created. After all steps in the process were finalized, the team created a project timetable for developing quality technicians. The project timetable they came up with is shown in Fig. 3-6. This project time table represents an overview of the project to train inspectors to be certified quality technicians through the American Society of Quality Control (ASQC), Milwaukee, WI. Each and every step in the process has its own project timetable detailing the progression necessary to complete that objective and the individual responsible to make it happen. Some of these activities may be only a few steps, such as Steps 5 and 6, while some may be as large and detailed as the overview, such as Step 7. INITIATE The next step in the PIE process is initiating actions identified in the planning phase. In my example for the planning phase, it was important to demonstrate how plans are initiated through the use of identifying and tracking CPIs. We also explored how to expand upon acquired data to further analyze avenues to improvement. CHAPTER 3--CONTINUOUS IMPROVEMENT 27 Six Month Sum for Boltmaker CPIs CPI DRAWINGS TOOLING GAUGING ! 200 g 400 | 600 * 800 g 1000 | 1200 ! 1400 i 1600 Figure3-5--Six-monthParetoanalysis ~rboltmakerCPIs. What's i m p o r t a n t to r e m e m b e r in initiating a c t i o n to act u p o n a p l a n is to involve the people w h o m a k e things happen. It m a y be necessary to provide t r a i n i n g for selected individuals o r groups of individuals to p r e p a r e t h e m to cont r i b u t e to the success of the p r o g r a m . This i n v e s t m e n t in people is a n i n v e s t m e n t in b o t t o m line i m p r o v e m e n t , as detailed earlier in this chapter. Involvement is a two-way street. In a d d i t i o n to involving employees, supervisors a n d m a n a g e r s m u s t be active m e m bers of the action teams. M a n a g e r s a n d supervisors m a k e for g o o d t e a m facilitators to assure t h a t the t e a m stays the course. The t e a m s m u s t be ever m i n d f u l of the vision statem e n t a n d p l a n objectives. Once the t e a m has achieved the goals of the project, three steps s h o u l d be taken. First, the t e a m s h o u l d be congratulated, a n d d e p e n d i n g on the significance of the achievement, r e w a r d s should be a w a r d e d . Second, the t e a m s h o u l d be disbanded; otherwise, t e a m s could go on m e e t i n g forever with no agenda. This is n o t only a waste of resources, b u t prevents t h e m from pursuing n e w o p p o r t u n i t i e s for i m p r o v e m e n t . Third, the CPIs i m p r o v e d u p o n should be m o n i t o r e d for a p e r i o d of t i m e to assure t h a t the gains are held. EVALUATE Total quality m a n a g e m e n t is a b o u t m e a s u r e m e n t a n d evaluation. The only w a y to k n o w if i m p r o v e m e n t is taking place is b y m e a s u r i n g w h e r e we are a n d c o m p a r i n g it to w h e r e we were a n d w h e r e we w a n t to be. If we develop a p l a n for i m p r o v e m e n t , initiate action to improve, a n d do not m e a s u r e the o u t c o m e of o u r actions, we are u n a w a r e . We do n o t k n o w if we are improving, r e m a i n i n g constant, or losing ground. During the initiation p h a s e of the i m p r o v e m e n t project, evaluation should be frequent, s o m e t i m e s daily. As the prog r a m continues for six m o n t h s o r more, less frequent studies can be m a d e on results. W h e n a project is d e e m e d complete, the frequency of evaluation will vary w i t h the d y n a m i c s of the CPI. I r e c o m m e n d , at a m i n i m u m , that m o n t h l y summ a r y reports be a n a l y z e d to look for changes due to business swings on first-tier CPIs. This simple philosophy, w h e n a d o p t e d b y m a n a g e m e n t , will a l m o s t always g u a r a n t e e success: Make continuous improvement a way of life in your organization. This applies to all m a n a g e r s in the orgapization. Obviously, the m o s t s e n i o r m a n a g e r should share this philosophy, b u t so s h o u l d all dep a r t m e n t heads a n d supervisors b e c a u s e their o r g a n i z a t i o n s are those w h o w o r k for them. D e m o n s t r a t e to all m e m b e r s of y o u r o r g a n i z a t i o n that y o u expect i m p r o v e m e n t . We n e e d to d e m o n s t r a t e t h a t we will not be satisfied w i t h the status quo. E n c o u r a g e y o u r people to ask, "Why can't things be better?," "How can I i m p r o v e this process?," etc. W h e n p r o b l e m s o r issues arise, treat t h e m as o p p o r t u n i t i e s to i m p r o v e u p o n the situation. Every solved p r o b l e m contributes to i m p r o v e m e n t . We s h o u l d be on the l o o k o u t for p r o b l e m s b e c a u s e we i m p r o v e o u r competitive a d v a n t a g e b y identifying a n d solving them. Pay a t t e n t i o n to W. E d w a r d s Deming's p o i n t of driving o u t fear. At all levels of the organization, people s h o u l d be able to discuss p r o b l e m s a n d mistakes. The m e s s e n g e r s h o u l d never be shot. We are all h u m a n a n d subject to the actions of the systems in place. If there is a p r o b l e m , c h a n c e s are the system is at fault b e c a u s e the issue was never a d d r e s s e d o r b e c a u s e a change has o c c u r r e d external to the system. To the fullest extent possible, b a s e decisions on fact, n o t intuition. Look to d a t a a n d assure t h a t these d a t a are true. 28 TOTAL QUALITY MANAGEMENT MANUAL CLua!ity Techfii~!~ D~Veidpm~t :~ :i: : , ! r e e d by i ~ b ~ e , t y / ~ ~ ~DmUU~It~ ~WE ~i~i~i~i:~i~ii~ :l ~ii~Def~i~:i~:bi~!~i~!i~!~i~i~:i!~!~!!~!:~:;~ii~i:!~i~i!;~au~i~i!~!Ma~ager:~!:!~!~!~ i~i!!:!i!~ii !Pli~:i!~::i~!~i~i~li~!ii~i~!![;~!i:~i~!!i]i!:i~!~i~:ii:ii~ili :!i~]i:!~i ~i~ili::ii! !!~!~i i~i!:i~!:it~/!:i!i~]:~i:~i~il ~ 5 :.~onsu!t::::wtheach:::: :6::: Deve!op:t~aini~g:~:::: ] i:]~i/I Q u a l i t y SuperVisor: OAStaff ::: ::: Evaluate effective- ~ess:~of~tralnmg~ :10: A ] :: ]:: C o m m e n c e : t r a i n i n g : Qgality,Sta~f::& : ;: ]:;:;; : : 9 : : A ]: ] :: ::: : : :::: : : ~!:~:1 ~ :1 : ,~i~1:~::::I 1 7 :~] Develop::tmining] Quality: Supervisor &: I QualityEng,eer: I: : i t :: i : I :: l :: :: I ~1: i A :l t~ : ~:1 ~:~1:~1 I~ :t I ~ l I I I ~i certifY:::inspec~o~s:as Gene~:al: Manager & : : ~,: : Figure 3-6--Project time table. Decisions based on intuition are almost always wrong at the operations level. For higher-level continuous improvement, intuition sometimes cannot be avoided and oftentimes is the basis for decisions that move an organization to the next level of achievement. Marketing sometimes m u s t m a k e decisions based on customer innuendo, but a shop f o r e m a n or office m a n a g e r should rely on data. Utilize statistical methods to evaluate and study processes. Once processes are under statistical control, the need for extensive inspection is eliminated. You will still need to carry out audit inspections (or verifications), but total inspection time should be reduced. Concentrate on doing the job right the first time. Do not rely on inspecting quality into the job after it is complete. Th e process of quality by inspection only perpetuates the hidden "rework and remake" departments of your organization. Part 2: Quality Organization Function Quality Systems QUALITY SYSTEMS are made up of the quality organization and the written guidelines used to define the quality organization as they relate to the rest of the organization. Quality systems are the result of the quality policy established by the executive management team. The two most important elements of quality systems are the quality manual and the organization's standard operating procedures. When developing the quality manual, it is recommended that attention be paid to following the guidelines established by the ANSU ASQC Q9000-1, Q9001-1, Q9002-1, Q9003-1, and Q9004-1 standards. These are the American equivalents to the ISO 9000 series of quality standards. The ANSI/ASQC standards are available from the American Society for Quality Control, 611 East Wisconsin Avenue, Milwaukee, WI 53202 and from ASTM. Even if the organization has no intention of applying for ISO registration, the quality guidelines in the ANSI/ASQC Q9000-1 series of quality systems are among the best available to control quality. To proceed further at this point without defining who in the organization is responsible for quality would possibly lead some down the wrong path when we discuss the contents of the quality manual and associated procedures that supplement implementation of manual policies. I don't want to start off with the notion that quality is the responsibility of the quality department. Nor do I want to simply state that quality is everybody's responsibility. Let's look one more time at the definition of quality I provided in Chapter 2, which is: Quality is achieved when we provide goods and services that meet or exceed customer requirements. To meet this definition, the part or service provided must conform to design or process requirements. The design or process must conform to its market requirements, and market requirements must conform to customer expectations. Therefore, three major groups with their necessary support groups are responsible for quality: marketing, engineering, manufacturing/operations, and their support groups. For the purposes of simplicity, I would like to call manufacturing/ operations by the single term: manufacturing. This one word will mean either a facility that produces a part or a facility that provides a service. And I would like to use the term product to mean either a part or a service. The question of who is responsible for quality is now easier to define. Responsibility for quality in an organization rests with marketing, engineering, and manufacturing along with the support groups that provide services to them. Each must be held accountable for their contribution to the overall effort. Marketing must make sure their concept of customer needs and requirements is fully understood and that they convey this information to the engineering group. Engineering must assure that they fully translate the marketing requirements to designs and processes that allow manufacturing to produce the product. Manufacturing must assure that the end product they provide to the customer conforms to the facility's design engineering requirements. You may be asking, "Where does the quality department fit into this picture?" First let me say that we must agree that the quality department or any of its people should not be held responsible for the quality of the product provided by the organization. How can they be if they did not market, design, or manufacture the product? The quality department's function is to facilitate continuous improvement by providing services to marketing, engineering, manufacturing, and all their support groups. Their role is similar to that of another service group in the organization, the accounting department. I do not think I would find too many people who suggest that the accounting department is responsible for the organization's profit and loss statement. The results on this statement are only a report of what actually happened. So to with the quality department's r o l e - - t h e y report on what took place. And, like the accounting department, the quality department provides assistance in identifying opportunities for improvement through measurement and communication. The quality department also has experts in the area of quality engineering and reliability, and technicians and inspection equipment to assist all other facility functions in their improvement projects. The Quality Manual With all this in mind, who is responsible for the quality manual and the standard operating procedures that augment it? In my opinion, the quality department. The quality department must work with all other departments within the organization to provide them with the guidelines they need to assure quality in their operations. Each individual department should have a hand in developing the quality manual, but the ultimate responsibility for writing and maintaining it rests with the quality function. The guidelines for quality management and quality system elements are fully described in the ANSI/ASQC Q9004-1 document. I recommend that readers acquire and review this document when establishing their own quality system and manual. I provide, for convenience, in Fig. 4-1 the table of contents of the guidelines recommended in that standard. The list of topics in Fig. 4-1 looks very much like the table 31 32 TOTAL QUALITY MANAGEMENT MANUAL Contents Page 1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4 Management responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5 Quality-system elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6 U~nancial considerations of quality systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 7 Quality in marketing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 8 Quality in specification and design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 9 Quality in purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 lO Quality of processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 l l Control of processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 12 Product verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 13 Control of inspection, measuring, and test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 14 Control of nonconforming product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 15 Corrective action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 16 Postproduction activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 17 Quality records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 18 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 19 IMxtuct safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 20 Use of statisfi~ methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Annex A Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Figure 4-1 mANSI/ASQE Q9004-1-1994. of contents to be f o u n d in the ANSI/ASQC 91, 92, a n d 93 s t a n d a r d s , b u t the difference is t h a t the Q9004-1 d o c u m e n t describes the m a n a g e m e n t p h i l o s o p h y b e h i n d each topic, w h e r e a s the Q9001-1, Q9002-1, a n d Q9003-1 d o c u m e n t s describe the w o r k i n g systems. In Chapters 8, 9, a n d 10, I pro- vide a s a m p l e quality mar/ual for a m a n u f a c t u r i n g , a service, a n d a d i s t r i b u t o r organization, respectively. F i g u r e 4-2 r e p r e s e n t s the different levels of d o c u m e n t a t i o n r e q u i r e d for ISO 9001 a n d 9002. The quality m a n u a l discussed earlier is called a Level 1 d o c u m e n t a n d translates CHAPTER 4--QUALITY SYSTEMS 33 Translates ISO 9000 requirements to your organization'slanguageand includesthe quality policy. I Procedures I Translates the requirements of the quality manual into proceduresrequiredfor departx mental complianceto quality requirements. Documents specific tasks performed to '~atisfy the requirements established y department/facility procedures including forms and records. I Work Instructions I / Figure 4-2--1S0 documentation pyramid. ISO 9000 r e q u i r e m e n t s to the language of y o u r organization. M a n a g e m e n t procedures are Level 2, a n d they d o c u m e n t dep a r t m e n t (or division) r e q u i r e m e n t s for compliance to the quality m a n u a l . Work i n s t r u c t i o n s a n d forms are Level 3 a n d c o n t a i n document-specific tasks necessary to complete a n activity defined i n the m a n a g e m e n t procedures. Quality records are Level 4 d o c u m e n t s a n d c o n t a i n the necessary docum e n t a t i o n or records of quality activities to meet the requirem e n t s of the quality m a n u a l . As you c a n deduce from the chart, the lower the level of d o c u m e n t a t i o n , the more detail is provided. The quality m a n u a l need n o t be as thick as the New York City telephone book, n o r does it need as m u c h detail as the i n s t r u c t i o n m a n u a l for the space shuttle. A welldeveloped quality m a n u a l need only c o n t a i n between 20 a n d 50 pages d e p e n d i n g on the size a n d complexity of the organization. Procedures Let's take a closer look at how m a n a g e m e n t procedures a n d work i n s t r u c t i o n s tie together. For a n organization's metrology d e p a r t m e n t (the area i n which technicians apply the science of m e a s u r e m e n t to calibrate test a n d m e a s u r i n g equipment), m a n a g e m e n t will have a procedure o n how to calibrate a n d m a i n t a i n gauges a n d m e a s u r i n g e q u i p m e n t , b u t in order for the facility to i m p l e m e n t that procedure, there has to be a work i n s t r u c t i o n o n how to calibrate each category of gauge a n d m e a s u r i n g i n s t r u m e n t in use at the facility. I n this case, one could have u p to 25 work instructions to satisfy a single m a n a g e m e n t procedure. I'll provide a n example of each for clarification. The first example is a m a n a g e m e n t procedure o n equipm e n t calibration, a n d the second is a work i n s t r u c t i o n for calibrating a dial a n d vernier caliper. STANDARD PROCEDURE ANY COMPANY SUBJECT: Certification I n s t r u c t i o n s E q u i p m e n t Calibration PROCEDURE NO.: REVISION: PAGE: DATE: PREPARED BY: ANY 11-01 1.0 1 OF 4 Insert date Insert a u t h o r 1.0 Purpose 1.1 The purpose of this procedure is to define the general conditions and requirements for implementing and maintaining a certified calibration program for our test equipment. 1.2 Compliance with this procedure will ensure through the consistent examination and control of measuring devices and accessories the means for manufacturing accuracy. 2.0 Application 2.1 This procedure shall apply to all equipment, whether privately or company owned, that is used or may be used for the appropriate measuring and/or judging of the manufactured products' conformance to specification. 3.0 Materials and Equipment 3.1 IBM PC computer and PQ systems Gage Pack®calibration software (or equivalent). 3.2 Test equipment serialization procedure, ANY 11-02. 3.3 Gauge Repeatability and Reproducibility Study work instruction ANY 11-01-01. 4.0 Procedure 4.1 All test equipment that is used or may be used to determine the acceptability of manufactured product must be certified as accurate by the metrology department. 4.1.1 Employees must submit their test equipment to the metrology department for certification prior to use in manufacturing. 4.1.2 New company purchased test equipment must be certified by the metrology department prior to use in manufacturing. 4.1.3 All test equipment of new or unique design is subject to qualification through a Gage Repeatability and Reproducibility study in accordance with work instruction ANY 10-45. 34 TOTAL QUALITY MANAGEMENT MANUAL 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 All test equipment submitted for initial certification will be permanently marked, if possible, with an identification/serial number, in accordance with ANY 11-02. Test equipment will be certified in accordance with appropriate Quality Assurance Work Instructions, and shall be tested against devices certified and traceable to the National Institute of Standards and Technology (NIST). Test equipment determined to be accurate and reliable through examination by Metrology will be certified and the results of the examination recorded on the computer through application of the calibration software. Certified test equipment then shall be released by Metrology for approved use within the limitations of the test equipment's intended application. Test equipment determined to be inaccurate/unreliable through this process will be routed to an appropriate calibration or repair facility and the results of this action recorded. All test equipment returned from calibration or repair facilities must be routed through Metrology for reexamination. Following the initial examination and certification of each type of test equipment, subsequent test equipment examinations will be scheduled using the gauge calibration software system. Test equipment due for examination and recertification will be printed out off the gauge calibration software on a weekly basis. Metrology will exchange due test equipment with certified test equipment so as not to interrupt the manufacturing process. Test equipment may be submitted to Metrology for additional examinations at any time, regardless of the scheduling program. Test equipment found to be in use with expired certification tags or labels will be confiscated and/or prohibited from use until the appropriate recertification of the test equipment can be accomplished. Test equipment examination intervals shall be scheduled on the basis of frequency of use, fragility, and the accuracy required of the test equipment. Except for test equipment being returned for routine certification, rejection tags must be affixed to uncertified test equipment in inventory to prevent accidental reuse. 5.0 Auditing Procedure 5.1 Metrology shall be responsible for conducting sporadic, unannounced shop-wide audits/inspections for the test equipment governed by this procedure. 5.2 Audits shall evaluate the present condition of the test equipment audited versus the same test equipment at the last recorded Metrology examination. 5.3 Audits will ensure control of measuring devices and accessories by requiring corrective action for any violations of this procedure. 5.4 Test equipment found to be in violation of this procedure, or designated tolerances and parameters, through Metrology auditing, may be confiscated and/or prohibited from use until appropriate recertification of the test equipment can be accomplished. 5.5 The auditor may grant an "operational deviation" for any equipment found to be in violation of this procedure or of the designated tolerances and parameters established for the test equipment. 5.6 Test equipment cited with an "operational deviation" must be submitted to Metrology within five working days of the citation for examination and appropriate adjustment. Example: A gauge block is out of specification, but used to complete an order. A correction factor is calculated to compensate for the error. The p r e c e d i n g ex am p l e is the system m a n a g e m e n t procedure i m p l e m e n t e d to co n t r o l test e q u i p m e n t calibration a nd certification. The method(s) by w h i c h the m e t r o l o g y departm e n t carries out this p r o c e d u r e is detailed in w o r k instructions. Fo r m o s t o r g an i zat i o n s t h er e are m u c h m o r e w o r k instructions than m a n a g e m e n t p r o c e d u r e s simply be c a us e of the b r e a d t h of the area b ei n g m a n a g e d . In o u r e xa mpl e for calibration, this p r o c e d u r e applies, as stated in 2.0, to application to all test e q u i p m e n t w h e t h e r privately or c o m p a n y owned. There m a y be t h o u s a n d s of m e a s u r i n g devices covered by this definition. At least each category of m e a s u r i n g device should have a w o r k i n st r u ct i o n that details h o w it is to be certified. H e r e is an ex am p l e of a w o r k i ns t r uc t i on that ties in with the calibration p r o c e d u r e p r e s e n t e d as ANY 11-01. ANY COMPANY STANDARD WORK INSTRUCTIONS SUBJECT: Calibration Procedure For Digital Calipers, Dial Calipers, and Vernier Calipers Work Instruction No. Page 1 of 2 Date Prepared Prepared By: Approved By: 11-01-24 Insert Date Insert Name Insert Name 1.0 Purpose 1.1 The following work instruction is for use by Quality Control in establishing accuracy requirements of digital, dial, and vernier calipers. 2.0 Application 2.1 This work instruction is applicable to all calipers which are either in use or may be used to measure and/or determine the manufactured product's conformance to specifications. 3.0 Equipment 3.1 Gauge blocks certifiable to NIST. 3.2 Calibration test stand. 3.3 Cleaning solvent. 3.4 Lint free towels. 4.0 Documentation 4.1 Calibration control software. 4.2 Test equipment calibration data sheet (form 11-01-90) 5.0 Procedure 5.1 Clean all surfaces of the caliper with cleaning solvent and line-free towels. 5.2 Readings are taken at 0.500-in. (1.27 cm) and 1.000-in. (2.54 cm) intervals throughout the measuring range of the measuring device for outside measurements using gauge blocks. 5.3 Readings are taken in three random locations along the measurement range for inside and depth measurements using the calibration test stand. 6.0 Acceptance Criteria 6.1 All readings are to be within one graduation mark of true value to the nearest 0.001 in. (0.002 54 cm). 6.2 The caliper must repeat within +.0005 in. (0.001 27 cm) on a second test at the same value. 6.3 Any caliper failing to pass all check points must be repaired before releasing for production. CHAPTER 4 - - Q U A L I T Y S Y S T E M S 6.3.1 All repaired calipers must be examined by Metrology and meet the requirements of this work instruction for acceptance. 6.3.2 Calipers not meeting the requirements after repair shall be removed from service. 6.4 All calipers meeting all criteria shall be certified and released to manufacturing. 7.0 Records 7.1 Results of this examination shall be recorded on both the software system and on the calibration data sheet for hard copy backup. 7.2 The data entered into the software system shall be backed up daily on a disk and on the main computer's hard drive. This provides for three records, one of which is offsite. 8.0 Calibration Schedule 8.1 Calipers shall be recalled for calibration and certification every twelve months. The w o r k i n s t r u c t i o n provides i n f o r m a t i o n the m e t r o l o g y t e c h n i c i a n can follow so t h a t the r e q u i r e m e n t s of the m a n a g e m e n t p r o c e d u r e can be satisfied. W o r k instructions should be p r e p a r e d by s o m e o n e in the d e p a r t m e n t w h o is actually p e r f o r m i n g the t a s k being defined. The reasons for this are many, b u t a very obvious one is that the only p e r s o n w h o fully u n d e r s t a n d s the a c t u a l p r o c e d u r e for d o i n g the t a s k is the one w h o p e r f o r m s it. If we have the individual closest to the t a s k p r e p a r e the w o r k instruction, we m u s t a s s u r e that he o r she u n d e r s t a n d s the c o n t e n t a n d intent of the m a n a g e m e n t p r o c e d u r e t h a t governs t h e i r responsibilities. Therefore, it is i m p e r a t i v e to have involvement f r o m the d e p a r t m e n t t a s k p e r f o r m e r s 35 w h e n m a n a g e m e n t p r o c e d u r e s are p r e p a r e d . The b e s t w a y to a c c o m p l i s h this is to ask for assistance f r o m the t a s k performers w h e n the p r o c e d u r e s are going t h r o u g h p h a s e one of their development. If you take a n o t h e r look at the two e x a m p l e procedures, you will notice s o m e t h i n g else if y o u are f a m i l i a r with the ISO standards. In ISO 9001, the table of contents has Inspection, Measuring, and Test Equipment listed in Section 11. The p r o c e d u r e n u m b e r a n d the w o r k i n s t r u c t i o n n u m b e r s b o t h start with the n u m b e r 11. This f o r m a t of n u m b e r i n g will be of assistance to y o u r employees a n d to outside auditors w h e n reviewing y o u r c o m p l i a n c e to ISO r e q u i r e m e n t s o r to a n y quality system if you t a i l o r y o u r p r o c e d u r e topic n u m b e r s to coincide with the n u m b e r s in the table of contents of y o u r quality m a n u a l . A n o t h e r w o r t h w h i l e a d d i t i o n to y o u r p r o c e d u r e s a n d w o r k instructions is to include a process flow chart. This allows for two advantages; one, the flow c h a r t provides a g r a p h i c d i a g r a m of the s t e p s necessary to c o m p l y with the proced u r e / w o r k instruction; secondly, it allows the p r o c e d u r e to be short on w o r d s b e c a u s e a p i c t u r e truly is w o r t h a thous a n d words. Organizing For Quality Setting u p the quality o r g a n i z a t i o n is as i m p o r t a n t a t a s k as anything we have discussed earlier. However, titles in the quality o r g a n i z a t i o n are n o t as i m p o r t a n t as the j o b descriptions of the individuals assigned to assure that quality systems are followed. M e d i u m to large o r g a n i z a t i o n s will find Marketing Design Engineering Manufacturing Engineering QUALITY Figure 4-3--TQM interaction. 36 TOTAL QUALITY MANAGEMENT MANUAL it beneficial to have a separate group in the organization responsible for maintaining the systems. Smaller companies will have many key individuals who perform multifunctional tasks. Even if the quality organization is a separate group or is an individual who has other duties, the checks and balances should be in place. There should not, for instance, be conflict between producing the product and making the product to customer requirements. With this in mind, there are a few guidelines that should be observed. An individual responsible for assuring that the product is shipped on time is not always a good choice for quality manager. When organizing, conflicts of interest must be identified and avoided. Obviously this is easier to accomplish in medium to large companies than in smaller ones. Before assigning responsibility for quality, look at what the primary duties are for those in the quality function. There are two main responsibilities. First and most important is preventing nonconforming products from reaching the customer. The second is finding ways to improve all functional activities. Preventing nonconforming products from reaching the customer applies to both internal and external customers. Focusing on this responsibility not only satisfies those who purchase the product but, just as importantly, provides for efficiency of operations, reducing internal costs. A great deal can be saved by doing the job correctly the first time. Some estimates have put the cost of nonconformance as high as 35% of production costs. This cost is totally unacceptable and can be avoided through training and leadership. The second function of a quality organization is to find methods of improvement. This function is carried out through measurement, analysis, evaluation, management reports, and participation on continuous improvement teams. These two functions do not necessarily fit in with other job functions whose task is to produce a product in a certain time p e r i o d - - t h e y are even opposing. The quality department's role is not to expedite or "move" a product through the process c h a i n - - t h a t responsibility rests solely with the group responsible for the process chain. If a job is held up by the quality department due to some nonconformance, it is not the responsibility of the quality department to find a solution to this problem. The quality department should assist, but the primary responsibility rests with the responsible group. To satisfy these two main functions, quality must be in a liaison with all other functions. Figure 4-3 displays the interaction that must take place between quality and all other functions when seeking continuous improvement through the SPQP process. It also is a good example of an organization chart of interactions. All functions have a dotted line relationship with each other under the team management concept. All department managers in Fig. 4-3 ideally will report to the general manager or equivalent senior manager in the organization. No matter what the organizational structure, what's important is that the quality manager is on a par with other department managers. And the quality manager usually needs a persuasive personality that can influence his peers in day-to-day interaction to make quality the number one objective. Quality Reporting CONTRARYTO SOME who believe that quality is free, I submit that customer satisfaction has costs associated with it. These costs are a legitimate business expense, and like all business expenses we would like a return on that investment. I like to think of the cost of quality as an investment in both the hard and soft technologies of the business. The hard technologies are office equipment, machinery, buildings, gauges, test equipment, and similar items. The soft technologies are the people and their interactions with the hard technologies. TCQ as a percent of manufacturing cost, and (4) scrap as a percent of total pieces produced. The collection of these data, as you can see, requires information from both the quality and the accounting departments. The quality department usually has the information on customer returns, the number of pieces scrapped and reworked, and the number of items recalled due to nonconformance. The accounting department has all cost data associated with the data supplied by Quality, as well as information on labor, shipments, and overhead. A simple cost-of-quality report may look like the sample shown in Fig. 5-1. To provide more visibly to the CPIs at lower levels in the organization, one can develop run charts that display the TCQ over time. This allows everyone the opportunity to see just how well the facility is performing. If the TCQ CPIs are exhibiting continuous improvement, the employees gain a sense of achievement for their efforts. If the trend is in the opposite direction for any given CPI, the employees can see where they must seek better ways. A run chart could look like Fig. 5-2. In this example, both the percent scrap and the cost of quality show a continuous improvement curve. This information is vital to reinforce employee self-esteem and to give everyone in the organization direction for future efforts. The input for future direction comes from analysis of the various components that make up the cost of quality. Many of the largest gains in continuous improvement oftentimes come from departments outside of quality. This is what can be expected when the quality function and the other functions work as teams as I discussed in Chapter 4. COST OF QUALITY The cost of quality is generally 5 to 20% of sales, and this accounts only for costs that can be quantified. Some costs cannot be determined, such as the price a company pays for dissatisfying a customer. Sure, we can count the cost of the returned item and the time we spend analyzing the complaint, but we cannot count the negative impression we made on our customer. Even when we look just at assignable costs, in a manufacturing facility this can amount to $1500 to $2500 per year per employee. This certainly gives management reason to study the cost of quality and find ways to reduce it. This figure can be reduced effectively through a well-managed cost-of-quality program. Experience with effective cost-of-quality programs has shown the return on investment to be approximately 5:1 to 10:1. Now that we have demonstrated how valuable these costs can be to management, let us see how a good cost-of-quality program can be structured. First and foremost, the top executive management of the organization must support the program. The quality department and the accounting department become business partners in this management tool. Together they collect the data necessary to assemble the report for staff management. The output from the Cost of Quality Report are CPIs that can and should be displayed for employee awareness. A few basic components are required to provide enough information to analyze accounting expenses and statistics. One needs certain pertinent data, such as cost of shipments (sales), cost of manufacturing (production), facility labor and overhead rates, rework hours, scrap costs, and cost of returns. These are broken down to: (1) total prevention costs, (2) total appraisal costs, (3) total internal failures, and (4) total external failures. Then, through analysis, we can arrive at our critical performance indicators. The CPIs as a minimum are: (1) total cost of quality (TCQ), (2) TCO/product shipped, (3) QUALITY S Y S T E M S AUDITS Another management tool is the quality systems audit. I have found this tool to be my most effective key to achieving continuous improvement. Properly applied, it gives an honest and candid appraisal of how your organization is following the established quality systems and how effective t h e y are. There are different levels of system audits, and most segments of the organization can find one that can be used for their own self-assessment. Quality systems audits can be conducted on top management all the way down the organization chart to the person doing the actual labor on any given task. All it takes is for someone to format the survey to fit the scope of the audited system. Everyone can benefit 37 38 TOTAL QUALITY MANAGEMENT MANUAL ANY C O M P A N Y COST OF QUALITY REPORT FY 1 9 9 4 1.00 PERTINENT INFORMATION 1.1 1.2 Total Direct Labor Hours Total Shipments 1.3 1.4 1.5 1.6 1.7 Ave. Mfg. Cost of Shipments Scrap Pieces Rework Pieces Rework Hours Plant Overhead & Labor Rate • ::: : : : :: :::::::::::::::::::::::::::::::::::::::::::: 45,580 46,425 46,245 125,877 127,630 125,721 3~9~i228 Pcs 2.00 25.02 1,546 1,865 578 57.00 28.73 1,285 1,279 599 57.00 20,553 19,975 23.76 :;::i:::::::25i84: 1,115 ::::ii3:~9~6 1,042 :: ~i!~1~.!8;6i 475 ; i:i65i2: 57.00 57i50 ======================= :::::::::::::::::::: PREVENTION COSTS 2.1 2.2 2;3::: : Plant Prevention Costs Miscellaneous ~otai Pteye~yi~ C~sts :::: :: 19,575 20i553 : : i 9 i 9 7 5 19,575 49,345 35,754 48,222 : i ~5~888 34,875 1 0 4 i 8 5 6 APPRAISAL COSTS 3.00 3.1 3.2 3.3 Quality Assurance Labor Quality Assurance Expenses Miscellaneous 48,321 34,227 ::::: i 83,097 2 5 O i 7 ~ 4.00 INTERNAL FAILURE COSTS 4.1 4.2 ::: 5.00 :::::::: Scrap Rework 38,681 32,946 4i3 ...... :: To~ai I~tem~i Fa!lurb Costs ::. . . . 36,918 34,143 : : : ::::: 26,492 ~i 02;09 i 34,143 :::10t;;!i232 60,635 : 203,323 i:::: EXTERNAL FAILURE COSTS 5.1 5.2 5.3 Justified Customer Returns Stock Recalls Miscellaneous 9,100 875 8,975 0 10,100 28,1:75: 500 ::: :::/:t375:: ::: ::::: :: ::::: :::: ::::: ::::: 10,600 6.00 .... !~iiiii~iiii:i iiiiiiiiiiiiii CRITICAL PERFORMANCE INDICATORS ::: ............ : : 6.2 6.3 6.4 Plant Scrap Rate (% pcs) TCQ/Product Shipped TCQ / Manufacturing Costs i87;2:54:182~5:59 173,907 1.21 % 1.00% 0.88% ; i ilO3% 1.49 1.43 1.38 i:;': t i 4 3 5.95% 4.98% 5.82% 5!55 ~: Figure 5-1 --Cost of quality report. from this exercise because no one can ignore themselves. Examples of systems that can be audited are numerous; I include a few here so one can appreciate the magnitude of scope: the quality manual, contract review, drawing control, calibration records, purchasing procedures, personnel train- ing records, customer service procedures, manufacturing inspection procedures, invoicing procedures, and preventive maintenance schedules. Some audits will be formal, while others can be informal. This depends on the management procedure on quality sys- CHAPTER 5 - - Q U A L I T Y REPORTING 39 6 COST OF QUALITY 5 }Z UJ tJ 4 3 UJ 2 SCRAP 1 0 FEB i i i i i i , i i i MAR APR MAY JUN JUL AUG SEP OCT NOV DEC 1994 Figure 5-2mPercent scrap and percent cost of quality. tern audits and on how each department develops its own work instructions to satisfy those requirements. Formal audits require documentation and follow-up corrective action on deficiencies discovered during the audit. Informal audits are usually management tools used to assess day-to-day operations. Reports as a result of informal audits are generally verbal and used as personnel development aids. The structure of the survey used in formal system audits should follow in sequence the steps in the procedure or work instruction. For instance, if we were developing a system audit of the management procedure explained in Chapter 4 (ANY 11-01), there would be questions designed to assure that the requirement in Paragraphs 1.0 through 5.6 of the management procedure were being adhered to. A sample question for Paragraph 4.1.1 may be: "Is all employee-owned test equipment certified? Submit a list of all production employees that shows test equipment owned and the date of last certification. Are there any exceptions to being current?" The formal quality systems audits should be conducted by a cross-functional team and contain no one from the system being audited. In other words, the audit must be conducted free of bias. As an example, if we were auditing purchasing procedures, we may have on our auditing team members from quality, engineering; and customer service. This auditing team would tour the purchasing department with the purchasing manager or supervisor. Immediately after the survey, the team and the person representing the audited system should sit down and discuss the results, including any deficiencies. This is very important because disagreements can be resolved much easier then, instead of a week or two later when the request for corrective action is received. This brings us to the next phase of the quality systems audit, the request for corrective action. Each deficiency requires a corrective action request to be sent to the department manager for resolution. The department manager should be given sufficient time to respond, but a response should be expected in a reasonable time frame. Usually 15 working days is provided unless the deficiency is a threat to customer satisfaction, which would demand immediate action. The quality department along with the human resources department are responsible to assure that auditors are properly trained and qualified to conduct audits. Only personnel who have received and successfully completed the training should be permitted to conduct audits. Special attention is given to working in teams, understanding differences, and problem solving to assure constructive and positive audits. Documentation of all formal audits is best channeled through the quality department for retention and followthrough. A system should be established to assure that corrective action identified on the Request for Corrective Action reports is in fact in place. Usually a member of the audit team from that area is given the responsibility to revisit the department and reaudit the deficient item after a sufficient amount of time has elapsed for the department to initiate corrective measures. This follow-through is only required on more serious problems. What is important to understand is that quality systems audits are a look at your own operations and are intended to be constructive. Many times procedures are revised because systems audits find that deviation from original procedures result in an improvement. It is only natural for people to continually seek better methods to do their jobs. Supplier Qualification PARTNERSHIPS mended. Depending on the current order status, these meetings can be conducted as brief telephone conversations or as face-to-face meetings at either party's place of business. In addition, time should be devoted annually for an information seminar at your facility or off-site in which you present your business plan to all key suppliers. This will be discussed later in this chapter when we discuss supplier involvement. Depending on the nature of your business, another major objective is maintaining and controlling confidential and/or proprietary information. Your business is your business; to survive in today's global economy, only those who have a common interest in your organization's goals and objectives should know the details of your journey to satisfy these objectives. Some common sensitive areas are: pricing, bid/ quote information, process information, design specifications, company plans and goals, profit information, wage and salary scales, customer lists, supply sources, and supplier information. ORGANIZATIONS that consider their suppliers to be part of their overall business strategy are going to be way ahead of their competition. Suppliers are an integral part of any organization's ability to operate in a cost-effective way. Companies who realize they are not always best at performing certain tasks and utilize the expertise and experience of suppliers will be rewarded with long-lasting business partnerships with selected suppliers. When developing a business partnership with a supplier, certain objectives need to be considered. Objectives One of the more important objectives is improved product quality. Business partners need to share information from the earliest stages of product development. I recommend that suppliers in a partnership relationship be permitted and encouraged to participate in your SPQP (service/product quality planning) process. Through this interaction, there may be processes or design changes identified that result in significant cost savings. Improved quality is also achieved through analysis of your supplier's quality systems. Through quality system audits, opportunities for supplier improvement are identified, and by working w i t h the supplier to meet these challenges, both benefit. Meeting this objective is discussed later. Another objective is to maintain or reduce costs associated with purchased material. In some organizations the material costs associated with purchased items can approach 100% in the case of companies whose value-added contribution to the end product is mainly to assemble/build that product. A similar situation exists with distributors; they rely solely on their supplier for product cost, as the value added comes from the service they can provide. Even in organizations whose purchased material costs are only 20%, there is considerable saving to be gained through a well-orchestrated supplier partnership. To consider in a supplier partnership are blanket orders versus spot or single-purchase orders one lot at a time, value analysis through the SPQP process, and reduction in your supplier base. Creating or maintaining outstanding supplier delivery performance is another objective. This objective is achieved by opening up those communications necessary in partner relationships. Much can be gained when purchaser and supplier meet on a regular basis. Weekly meetings are recom- Sourcing Considerations There are three main considerations when selecting suppliers. One is the effectiveness of their quality systems, another is their process capability or capacity, and the other is their price. In a nutshell it comes down to quality, delivery, and value. The key to assessing the expected quality performance of a future supplier is the Supplier Quality Systems Survey as part of the overall "partners in quality" concept. The survey should be designed to give objective analysis of the supplier's quality systems, management goals, drawing and change control, procurement methods, production control, fixture and gauge control, process control, product control, documentation and records, packaging and shipping methods, and employee awareness of these systems. Supplier Measures The Partners In Quality Program should also provide for methods of measuring a supplier's performance to established criteria, including such things as on-timeperformance, quality of supplied product, response to corrective action requests, cost containment, and meeting other value-added benefits. Many of these criteria are easily reported as CPIs and can be distributed to the supplier on a monthly or quarterly basis. Examples of purchasing reports will now be discussed and 40 CHAPTER 6--SUPPLIER QUALIFICATION 41 TABLE 6-1--Partner's in quality supplier rating summary. Supplier~ Survey Score 2 Audit Inspection3 SupplierStatus4 A B C D E F G H I J K L M N O P Q R 91.10 90.00 90.00 81.40 79.60 78.20 77.70 76.40 72.90 72.50 72.10 71.40 67.10 55.40 55.00 48.60 26.40 26.10 100.00 100.00 97.00 98.10 99.80 99.20 99.40 98.60 100.00 98.50 98.30 100.00 100.00 91.60 99.50 99.20 94.70 100.00 Certified Certified Preferred Preferred Preferred Preferred Preferred Preferred Approved Approved Approved Approved Approved Conditional Conditional Conditional Conditional Conditional tSupplier code identifier. achieved on an on-site quality systems survey. 3Measure of incoming inspectionresults on a pieces received/acceptedbasis. 4Status of supplier based on composite of survey and audit scores. 2Score displayed for i n f o r m a t i o n a n d suggestions. The three examples given are very powerful CPIs w h e n shared with y o u r suppliers. All key suppliers would receive m o n t h l y the report s h o w n in Table 6-1, allowing t h e m to observe their c u r r e n t p e r f o r m a n c e as c o m p a r e d with other suppliers who share your p a r t n e r s h i p agreement. By coding the suppliers as A t h r o u g h R, n o confidentiality is compromised, as the supplier knows only that he is A or Q a n d does n o t k n o w w h a t code applies to others. Figure 6-1, the PIQ Rating Summary, allows the supplier to see how the overall p e r f o r m a n c e of the supplier base is 87.5 m e e t i n g established goals. By k n o w i n g his individual score, he has a feel for how valuable his individual c o n t r i b u t i o n is to that effort. If the supplier's score is below the average, we can assume we are n o t getting as m u c h value added as we would from a supplier who is above average. This assists y o u r p u r c h a s i n g d e p a r t m e n t at negotiation time. Figure 6-2 is a n overall picture of y o u r ability to receive orders from suppliers o n time, which i n t u r n provides confidence to y o u r o w n p r o d u c t i o n scheduling d e p a r t m e n t i n your ability to m a n a g e the p u r c h a s i n g function. SUPPLIER INVOLVEMENT One of the better ways to c e m e n t a p a r t n e r s h i p a n d to show y o u r suppliers you are serious is to sponsor a "supplier day" at your facility. If you don't have adequate facilities, c o n d u c t the s e m i n a r off site at a local conference center. The objectives of the s e m i n a r are to review y o u r company's business p l a n a n d goals, to discuss y o u r c o n t i n u o u s improvem e n t progress, to establish supplier goals a n d i m p r o v e m e n t objectives, a n d to encourage i n v o l v e m e n t a n d participation. One m e t h o d for s t r u c t u r i n g a p r o g r a m such as this is detailed i n the following paragraphs. If you do n o t have a list of your top 20 or so suppliers, prepare one u s i n g criteria that provide some m e a s u r e to identify supplier worth such as dollar volume or critical c o m p o n e n t s . After you k n o w your top suppliers, send t h e m a letter telling t h e m a b o u t the s e m i n a r a n d invite t h e m to attend by enclosing a n RSVP form a n d a self-addressed envelope. If you do n o t get a response from some of your key suppliers, you m a y wish to consider asking suppliers w h o m you w a n t to develop as future top suppliers to assure full attendance. After you receive responses a n d k n o w which suppliers are • PIQ G O A L 87 86.5 D A V E . PIQ R A N K 86 ~ ¢n 85.5 85 83.5 83 . J . F . . M . A M J J 1994 Figure 6 - 1 - PIQ rating summary. A S O N D 42 TOTAL QUALITY MANAGEMENT MANUAL interested, send a follow-up letter with a simple survey for them to complete. The survey should be designed to allow your suppliers to appraise your company as a business partner. A sample survey is shown as Fig. 6-3. The rating scale goes from 5 to 1, with 5 representing excellent and 1 meaning a very poor performance. The results of this survey should be analyzed carefully and shared with your suppliers. Where improvement is indicated, it should be pursued with a team approach including your suppliers whenever possible. Shortly before the seminar, provide the attendees with an agenda for the program. This gives the attendees time to develop the frame of mind you are hoping they bring to the meeting. Included in the program should be a general business update by the top manager of the facility. This manager should also introduce the staff management and give a brief description of the continuous improvement programs underway. Each staff manager should give at least a 20-minute talk on the continuous improvement projects in their respective departments. This demonstrates to the audience that continuous improvement can be applied to any discipline. It's not just a quality thing. This should consume most of the morning. In the afternoon, devote attention to your purchasing department's quality improvement objectives for suppliers. This part of the program should be shared by the purchasing and quality managers. Leave an hour open for reviewing the supplier survey (Fig. 6-3) and for open discussion. I have participated in several of these types of supplier involvement programs, and every one of them h a s been a success. When they are properly administered, both parties go away with a feeling of cooperation. Supplier Quality Systems Survey The Supplier Quality Systems Survey is a management tool that does many things for both the customer and the supplier. As the customer, you share with your supplier the quality philosophy your organization has chosen to apply to your business. You also have a consistent measure by which your can evaluate each supplier against their systems and each supplier with their competition. The survey requires communication between organizational counterparts in quality, purchasing, and others in each organization and develops understanding and relationships. The supplier gains because the survey provides a critical look at how well he is doing business and to what extent he is satisfying the customer. All in all, the survey can serve both the customer and the supplier as they journey along the path of continuous improvement. It is recommended that the quality systems survey be developed to follow closely your own quality manual since this survey will transfer your quality philosophy to your supplier. As an aid, I have prepared a model survey that follows the quality manual I present in Chapter 8. The Supplier Quality Systems Survey is in Appendix D. When setting up the parameters of the supplier quality survey, special attention should be focused on assessing the supplier's management and their attitude toward teamwork and continuous improvement. Control systems to be assessed include document and change control, materials control, fixture and test equipment control, process control, product control, auditing methods, and quality reporting. Let us look at each of these elements in detail beginning with supplier management. Supplier Management A sense of the attitude carried by management in regard to TQM principles has to be gained through the survey. We discussed these at length in Chapter 1. Is the management committed to team-oriented management and activities? Is there a customer focus that includes internal as well as external customers? Are there programs in place and planned for the future that assure the continued upgrading of employees through training? Does the management utilize the inherent job knowledge of their employees through empowerment and involvement of the workforce? And, is there a 95 9O 80 75 7O 1Q93 2Q93 3Q93 4Q93 1Q94 i i 2Q94 3Q94 Figure 6-2--Supplier on-time performance. 4Q94 CHAPTER 6--SUPPLIER QUALIFICATION 43 SUPPLIER SURVEY FORM 5 4 3 2 1 Requests for quotation are clear and complete. Blueprints and job specifications are accurate and legible. I I Satisfactory follow-up is given if a contract is not awarded on a quote. I Purchase order format is clear. I I I I I I I I I I Purchase order information is accurate. I I I I Invoices are paid according to stated terms and conditions. I I I I Purchase orders are issued within stated leadtimes. I I I I Adequate planning information is provided beyond your leadtime horizon. I I I I Our company provides the following information on a regular basis. Production plans Current supplier delivery and quality ratings Quarterly and annual financial summaries Significant personnel changes We communicate the level of quality that is required for our products. I You are notified within a reasonable period of time after shipment that material does not meet specification. I Returned material is properly packaged and identified. I I I I I I We communicate sampling and inspection plans for our product. I I I I I I I I I I I I Purchasing / Quality Assurance employees are cooperative and respond to requests for information on a timely basis. In the following space, or on additional paper please list any questions or issues you want us to discuss at our seminar. Figure 6-3--Supplier survey form. 44 TOTAL QUALITY MANAGEMENT MANUAL measurement system in place to track progress, such as CPIs? Document and Change Control There must be a system in place to assure that current documents and procedures are available to all users at the supplier's facility. It should also be established that obsolete documents and procedures are not available to those who are not aware of possible revisions. Finally, the documents under control should be available at all locations where operations essential to the effective functioning of the quality system are performed. Materials Control There should be a system in place to assure that material, either purchased or produced, that is in inventory is identified as to inspection status and part identification. There should be a procedure for controlling suppliers, nonconforming material, corrective action, receiving inspection, packaging, and shipping. Work instructions for those who perform these functions should also be available. Fixture 1 and Test Equipment Control Periodic calibration of test equipment and fixturing are essential for control and verification of product quality. Controlled master standards shall be maintained and traceable to either national standards or manufacturer's standards. Key elements of a successful fixture and test equipment program are: • Calibration and certification of analytical equipment used to determine physical, chemical, or mechanical properties. • Repeatability and reproducibility studies for equipment used to collect variable data. • Equipment history and inventory data. • Records that include location, method of calibration, date of next certification, and current status. • Marking system to identify equipment and its due date for certification. • Procedures/work instructions for disposition of nonconforming equipment and fixturing. Process Control The supplier should have systems in place that provide a plan for production and identification of product. Better sys~This applies only if fixtures are used as a final acceptance inspection device. tems assign production to process proven to be capable of achieving high levels of quality and output. This requires an analysis of the process through statistical methods discussed in Chapter 7. As a minimum, a supplier's system should provide for: • Documented work instructions. • Compliance with the quality manual. • Monitoring and controlling process parameter and product critical characteristics during production and assembly. • Workmanship acceptance criteria via work standards or samples where possible. • A safe, dean, and well-organized work environment. Product Control Product inspection and quality should be controlled to the fullest extent possible by the individual doing the job. I call this point of control responsibility; where it can be applied, it is the most effective method of assuring product quality. The supplier's elements of product control should include: • Receiving inspection. • First article inspection. • Measurement system verification. • In-process inspection to statistical sampling plans that specify zero defects. • Final product audits. Auditing Methods Procedures must be in place to assure that all quality systems are functioning as written. This is carried out through quality system audits as discussed in Chapter 5. These audits should be scheduled according to the current status and importance of the activity. Results of the audits must be documented and deficiencies noted. All identified deficiencies require documented corrective action. Management responsible for the activity under evaluation should initiate and assure effective corrective action. Quality Reporting The supplier should have a cost-of-quality report in place that, at a minimum, tracks rework and scrap. The report should be distributed to appropriate management that can effect process and product improvements. When all eight criteria described above are in place and effectively implemented, one can be confident in the supplier's ability to satisfy your requirements and provide quality products. Part 3: Statistical Quality Control Statistical Quality Control When the industrial revolution began, other influences arose that determined the quality of a product, the market, or the end user. In the beginning o f this period, factories were small and located in the "industrial" cities. It was difficult to move commerce across the landscape, so industries served local communities. This provided for small lot sizes and screening (100% inspection) as a method to control quality. During the 1920s and into the 1940s the pace of manufacturing changed from small production lots to larger and larger production runs. Included with this increase in production were advances in engineering, which led to more complex design and assemblies. It was during this period that lot-by-lot inspection gained wide acceptance by management. During the 1940s and 1950s, lot-by-lot inspection was the only way quality control personnel (i.e., inspectors) could keep up with production because screening slowed the process too much. However, it was not long before everyone realized that lotby-lot inspection, although fast, had serious shortcomings, not the least of which was the possibility of accepting a lot containing nonconforming parts simply because the sample taken was free of these parts. Thus, the customer or end user would receive a percentage of parts that were either useless, or worse yet, dangerous. During the 1960s and 1970s, the shortcomings of both screening (time consuming and ineffective) and lot-by-lot inspection (not fully acceptable to the customer) encouraged management to develop what came to be known as inprocess inspection. In-process inspection was usually accomplished by an inspector who patrolled the manufacturing floor checking on equipment, materials, methods, people, and output. In-process inspection was also sometimes carried out by the machine operator responsible for a particular phase of the manufacturing process. For example, a machine operator may measure a few pieces every hour during the production run to make sure the parts are within engineering specifications, or a plater may check the coating thickness on a fastener on one or two pieces every tenth barrel or rack to assure conformance. In-process inspection coupled with lot-by-lot inspection was much more acceptable from the consumers' point of view because they were assured of a better chance of receiving a product to their requirements. But it still had its short comings: ONE OF THE MORE effective tools available to organizations that apply total quality management (TQM) is found in the applications of statistical quality control (SQC). The more common applications in use today include: • Pareto analysis. • Frequency distribution analysis. • Multivari analysis. • Measurement error analysis. • Control charts. • Cause and effect diagrams. • Process capability analysis. • Correlation analysis. • Design of experiments. • Acceptance sampling. Some of these applications can be used by nonstatisticians, and others require in-depth knowledge of statistical theory. The point is that everyone in the organization from top management to employee can use at least some or all of these techniques to improve their effectiveness. As discussed in earlier chapters, the commitment and understanding of upper management must be present for any program to succeed; this is especially true with a statistical quality control program. More often than not, when we apply statistical tools such as process capability and process control, we find out more about the process than we may have expected. We may find that our fixturing is not capable of positioning our part piece to assure precise contact with the tool or die. This may require significant expense to remedy. Unless there is commitment from upper management, the decision more often than not is: Do the best you can, we'll sort any defects if necessary. It is not my intent to present a complete study on statistical methods. Primarily, this is a book on TQM; however, it is important to provide a brief overview on the subject so those in upper management understand how SQC came to be and how some of the applications are applied to propel practitioners along the path of continuous improvement. QUALITY CONTROL Quality control has been with us for thousands of years, but it was not until about 200 years ago, at the beginning of the Industrial Revolution, that we began to drift away from the craftsman method of assuring quality. The craftsman's method of controlling quality was a very personal one. He made sure that whatever he produced was, to his way of thinking, acceptable for commerce. It met his standards. • There was no way of knowing what went on between visits by the inspector. • Lot-by-lot inspection still permitted nonconforming parts 47 48 TOTAL QUALITY MANAGEMENT MANUAL to be shipped, even w i t h zero as the a c c e p t a n c e n u m b e r for rejects. • W h e n n o n c o n f o r m i n g p a r t s were discovered, it c a u s e d prod u c t i o n delays t h a t were u n p l a n n e d . • The costs of s c r a p a n d r e w o r k for the m a n u f a c t u r e r were very high. • The system b r e d m i s t r u s t b e t w e e n i n s p e c t o r a n d m a c h i n e operator. The ineffectiveness of screening, lot-by-lot inspection, a n d in-process i n s p e c t i o n along with a business c l i m a t e t h a t dem a n d e d b o t h i n c r e a s e d profits a n d c o n s u m e r i s m led m a n a g e m e n t to a n i n c r e a s e d interest in m o d e r n SQC m e t h o d s . c a u s e v a r i a t i o n - - a source of c h a n c e v a r i a t i o n t h a t is always present; p a r t of the n a t u r a l v a r i a t i o n i n h e r e n t in the process itself. • S p e c i a l c a u s e v a r i a t i o n - - a source of v a r i a t i o n that is intermittent, u n p r e d i c t a b l e , a n d unstable. It is signaled b y a n out-of-control c o n d i t i o n on a control chart. • C o n t r o l c h a r t - - a g r a p h i c r e p r e s e n t a t i o n of the o u t p u t of a p r o c e s s showing plotted values of s o m e statistic g a t h e r e d f r o m t h a t output, a central line, a n d one o r m o r e c o n t r o l limits. It is u s e d to detect special causes of variation. • Common STATISTICAL APPLICATIONS The n e e d to better u n d e r s t a n d o u r m a n u f a c t u r i n g processes led to a p p l i c a t i o n of statistics a n d statistical process control (SPC). M a n a g e m e n t saw the use of SPC as a m e a n s of providing a b e t t e r p r o d u c t for their c u s t o m e r s while at the s a m e t i m e r e d u c i n g the overall cost of quality. W h e n imp l e m e n t i n g a n effective SPC p r o g r a m , o r g a n i z a t i o n s n e e d e d to w o r k u n d e r m a n y o f the p h i l o s o p h i e s f o u n d in W. Edw a r d s Deming's 14 Points of M a n a g e m e n t (see C h a p t e r 3). These 14 points, a l t h o u g h m e a n t for m a n a g e m e n t , have wide a p p l i c a t i o n for all employees once u p p e r m a n a g e m e n t is applying TQM principles t h r o u g h o u t the organization. DESCRIPTIVE STATISTICS Variation is p r e s e n t in all "like" things in the universe. There have never b e e n a n y two things t h a t are exactly alike. No two p e o p l e are exactly alike, no two grains of sand, no two m e t a l stampings, a n d so on. As long as we have the Raw Material means, w e c a n e x a m i n e a n d analyze until we find a difference. This is an i m p o r t a n t c o n c e p t to u n d e r s t a n d b e c a u s e v a r i a t i o n is the c o r n e r s t o n e of o u r f o u n d a t i o n for SPC. I n a n y industry, v a r i a t i o n is c a u s e d b y c o m m o n a n d special causes t h a t are p r e s e n t in any process stream. F i g u r e 7-1 r e p r e s e n t s a typical process s t r e a m m a d e u p of r a w m a terials, people, m e t h o d s , equipment, a n d t h e e n v i r o n m e n t s u r r o u n d i n g the process. All o r any one of the elements of a process s t r e a m m a y c o n t a i n variation t h a t could affect the output. By accepting v a r i a t i o n as a fact of a n y process, we c a n deal w i t h it in a scientific m a n n e r as statisticians. The v a r i a t i o n one can e n c o u n t e r in this process s t r e a m m a y be c o m m o n or special: People I n the process stream, m a t e r i a l s are expected to have certain properties, a n d the elements t h a t c o n t r i b u t e a n d define those p r o p e r t i e s are a source of variation. W h e n the process m a k i n g the m a t e r i a l contains only c o m m o n causes of variation, the process is said to be in control. If one of the p r o p erties s h o u l d exhibit a n e w trait or characteristic, it m a y be a source of special variation. This m u s t be evaluated carefully so as n o t to identify this v a r i a n c e as special w h e n it m a y b e c o m m o n - - w e just d i d n o t see this side of the material before. M a n y sources of special v a r i a t i o n can be influenced b y the p e r s o n r u n n i n g the process a n d to s o m e extent Methods 7-> Equipment Environment Figure 7-1 --Typical process stream, CHAPTER 7--STATISTICAL QUALITY CONTROL H a r d n e s s Data 36 34 35 36 36 34 35 36 38 36 36 36 37 36 35 37 35 37 35 37 35 37 37 36 38 35 36 37 35 36 36 35 35 36 36 35 35 37 37 34 38 36 34 36 36 37 34 36 36 37 37 37 35 38 35 35 36 37 37 38 36 37 37 38 38 38 36 39 37 36 Figure 7-2mHistogram of 70 hardness tests. can be overcome. The sources of c o m m o n v a r i a t i o n are n o t controllable b y the process operator. They are p r e s e n t a n d will influence the process no m a t t e r w h a t the p e r s o n r u n n i n g it a t t e m p t s to do to o v e r c o m e t h a t influence. Only a c h a n g e in the process s t r e a m will change the v a r i a t i o n i n h e r e n t in the process. We could look at e a c h of the o t h e r e l e m e n t s of the process s t r e a m - - p e o p l e , environment, m e t h o d s , a n d e q u i p m e n t - a n d see the s a m e d i l e m m a . They all c o n t a i n v a r i a t i o n - s o m e we can c o n t r o l a n d s o m e we cannot. A h e a t - t r e a t i n g process has all kinds of elements t h a t c o n t r i b u t e to the successful e n d of m e e t i n g all the m e c h a n i c a l p r o p e r t i e s specified in the engineering specification. Let us look at a n e x a m p l e of the h a r d n e s s of an ASTM A 4901 bolt h e a t t r e a t e d to a specified core h a r d n e s s of HRC ( H a r d n e s s Rockwell C-Scale) 33/39. Data were collected on 1Specification for Heat-Treated, Steel Structural Bolts, 150 ksi (1035 MPW) Tensile Strength. ASTM Committee F16 on Fasteners. a 50-piece s a m p l e a n d the following values were observed as s h o w n in Fig. 7-2. A statistician could describe these d a t a in the form of a h i s t o g r a m as s h o w n in Fig. 7-3. W h e n one looks at the two m e t h o d s of d e s c r i b i n g the h a r d n e s s data, it b e c o m e s obvious that the h i s t o g r a m provides a m u c h clearer view t h a n the table of values for the s a m e data. W h e n we look at the table, it is n o t readily app a r e n t w h a t the range of values is, w h a t the m o s t c o m m o n value is, w h a t d a t a are in specification, o r h o w the d a t a are distributed. By having the s a m e d a t a in h i s t o g r a m format, we see at a glance t h a t the r a n g e of values is f r o m HRC 34 to 38; we see HRC 36 as the m o s t c o m m o n value; we see the values of all fall w i t h i n the HRC 33-39 specification; a n d we k n o w t h a t the values are evenly d i s t r i b u t e d a b o u t the m i d p o i n t of the specified range. It would be useful to further evaluate the d a t a in Fig. 7-2 a n d l e a r n a little m o r e a b o u t the central tendency. There a r e three m e a s u r e s of central t e n d e n c y t h a t find a p p l i c a t i o n in statistical analysis; they are the mean, the m e d i a n , a n d the mode. The mean is the n u m e r i c a l average calculated b y adding all n u m b e r s in the set of d a t a a n d dividing the s u m b y the n u m b e r of I n d i v i d u a l values in the d a t a set. The median is the m i d d l e value in a set of d a t a a r r a n g e d f r o m the smallest to the largest. The mode is the m o s t frequently o c c u r r i n g value in a d a t a set. A small set of d a t a (Fig. 7-4) will serve to illustrate these definitions. In this set of data, the m e a n is (33 + 36 + 35 + 37 + 37) + 5 o r 35.6. The m e d i a n value is 36, a n d the m o d e is 37. To the i n d u s t r i a l u s e r of statistics, the mean, usually referred to as the average, is the m o s t u s e d statistic from a set of data. The average along with m e a s u r e s of d i s p e r s i o n is u s e d to further define h o w the process is performing. There are two t e r m s t h a t relate to dispersion; they are range a n d standard deviation. The r a n g e is defined s i m p l y as the difference b e t w e e n the highest a n d lowest values in a set of data. The r a n g e of the d a t a in Fig. 7-2 is 5, the difference b e t w e e n the high value of 39 a n d the low value of 34. There are m a n y ways to define standard deviation, b u t the one generally u s e d in classic examples for SPC is: standard 25 2O >0 Z UJ ;;) 0 uJ r~ I.I. 15 10 5 33 34 35 49 36 HARDNESS Figure 7-3mHardness data. 37 38 39 50 TOTAL Q U A L I T Y M A N A G E M E N T M A N U A L Test Data [ 33 36 35 37 37 I Figure 7-4--Test data. deviation--a m e a s u r e of the d i s p e r s i o n of a series of d a t a a r o u n d their average (mean), expressed as the square r o o t of the q u a n t i t y o b t a i n e d b y s u m m i n g the squares of the deviations from the average of the results a n d dividing b y the n u m b e r of d a t a points m i n u s one. This looks m o r e complic a t e d t h a n it is. Today, the calculation of the s t a n d a r d devia t i o n (or) is a c c o m p l i s h e d w i t h only an u n d e r s t a n d i n g of the b a s i c m a t h e m a t i c a l skills of addition, subtraction, multiplication, a n d division. And if we are lucky, it can all be h a n d l e d b y a simple c o m p u t e r m a c r o c o m m a n d once the r a w d a t a are entered. F o r the sake of c o m p l e t i n g the example, the s t a n d a r d deviation for the d a t a in Fig. 7-2 is: a = 1.178 723, o r r o u n d e d off to two significant figures, 1.18, the m e a n is 36.28, the m e d i a n is 36, a n d the m o d e is 36. This t e c h n i q u e is useful w h e n studying r a w d a t a collected f r o m a larger p o p u l a t i o n of d a t a a n d has a p p l i c a t i o n to b o t h office a n d l a b o r a t o r y analysis. Better techniques are available to i n d u s t r i a l a p p l i c a t i o n s t h a t n o t only provide the descriptive statistics p r e s e n t e d above, b u t that also give the a n a l y s t an i d e a of w h a t the process is doing a n d c a p a b l e of doing. This is called statistical process control or SPC. SPC SPC is a m e t h o d of studying a process t h r o u g h the use of c o n t r o l charts. A control c h a r t is a tool for the o p e r a t o r of a process, the m a n u f a c t u r i n g engineer w h e n evaluating the process, or a n y o n e else w h o has a n interest in the process. Control charts are b a s e d u p o n data. The d a t a m u s t be collected in such a m a n n e r as to r e m o v e as m u c h bias as possible. This requires the evaluation Of devices u s e d to m e a s u r e the characteristics that b e c o m e data. There are two definitions of data: • Variable d a t a - - C h a r a c t e r i s t i c s that can be m e a s u r e d a n d expressed in values f r o m a c o n t i n u o u s scale. This type of d a t a m u s t be collected t h r o u g h a gauge o r test device. • Attribute data--Characteristics t h a t can be defined as eit h e r pass/fail, yes/no, c o n f o r m i n g / n o n c o n f o r m i n g , etc. A gauge or test device m a y be used as well as a c c e p t a n c e criteria. F o r example, the h a r d n e s s values in Fig. 7-2 are variable d a t a b e c a u s e the values are f r o m a c o n t i n u o u s scale (i.e., 20 to 70 on a C-scale of a h a r d n e s s tester). If we were determ i n i n g w h a t d a t a in Fig. 7-4 are less t h a n 36 b e c a u s e any value less t h a n 36 was defective, we are w o r k i n g with attribute d a t a in the f o r m of c o n f o r m i n g / n o n c o n f o r m i n g . In this case, t h e r e are two values n o n c o n f o r m i n g a n d three values conforming. Typical gauges u s e d in the collection of variable d a t a w o u l d include: m i c r o m e t e r s , calipers, dial indicators, coord i n a t e m e a s u r i n g m a c h i n e s (CMMs), electronic testers, h a r d n e s s testers, etc. Gauges for a t t r i b u t e d a t a include go/ no-go fixtures, c o l o r charts, t h r e a d ring gauges, etc. Regard- less of the type gauge u s e d in evaluating the object u n d e r investigation, the gauge m u s t have r e p e a t a b i l i t y a n d r e p r o ducibility. There are several tests to a p p l y to d e t e r m i n e a n i n s t r u m e n t ' s r e p e a t a b i l i t y a n d r e p r o d u c i b i l i t y (R&R); the one p r o v i d e d for y o u in Appendix A is ASTM F 1469, G u i d e for Conducting a R e p e a t a b i l i t y a n d R e p r o d u c i b i l i t y S t u d y on Test E q u i p m e n t for N o n d e s t r u c t i v e Testing. This s t a n d a r d describes fully h o w to c o n d u c t the test a n d h o w to i n t e r p r e t the results. It also contains a n e x a m p l e for the u s e r to follow. Briefly, w h e n we evaluate for r e p e a t a b i l i t y we are analyzing the i n s t r u m e n t ' s precision, bias, a n d accuracy. In evaluating reproducibility, we are d e t e r m i n i n g the i n s t r u m e n t ' s ability to p r o d u c e the s a m e m e a s u r e m e n t on the s a m e piece b e t w e e n two o r m o r e operators. There are several r e a s o n s one s h o u l d c o n d u c t a gauge R&R. A m o n g t h e m are: • To provide a criterion to a c c e p t n e w m e a s u r i n g devices. • To c o m p a r e one m e a s u r i n g device a g a i n s t another. • To c o m p a r e m e a s u r i n g devices before a n d after c a l i b r a t i o n o r repair. • To provide a basis for evaluating a m e a s u r i n g device susp e c t e d of b e i n g deficient. • To p r o v i d e a reliable m e a s u r i n g device for collecting d a t a for SPC. Variable Gauge Analysis The variable gauge analysis is c o n d u c t e d with two o r three o p e r a t o r s a n d k test parts of different values. E a c h of the two o r three o p e r a t o r s m e a s u r e s e a c h test p a r t in such a m a n n e r as to prevent o p e r a t o r bias in evaluation. It is advisable to have a t h i r d o r f o u r t h p a r t y p a r t i c i p a t e in the s t u d y by collecting d a t a f r o m the o p e r a t o r ' s m e a s u r e m e n t s . This w a y n e i t h e r o p e r a t o r will k n o w w h a t the o t h e r got for a m e a s u r e m e n t until all d a t a are collected. All d a t a are listed on a w o r k sheet, a n d the n e c e s s a r y calculations are p e r f o r m e d to c o m p l e t e the analysis. I n m o s t cases, a gauge e r r o r of 10% of the specification tolerance, o r less, is c o n s i d e r e d an a c c e p t a b l e v a r i a n c e for statistical control. If the e r r o r is greater t h a n 10%, the device m u s t either be i m p r o v e d or r e p l a c e d w i t h one t h a t is acceptable. M o r e detail is p r o v i d e d in ASTM F 1469. There is also a study for a t t r i b u t e d a t a one can a p p l y to test devices t h a t provide a go or no-go evaluation of the test part. The study is not as scientific as the one for variable type equipment, b u t it provides for s o m e a s s u r a n c e of the m e a s u r i n g system. Attribute Gauge Analysis The a t t r i b u t e gauge analysis is c o n d u c t e d w i t h two operators t h a t each evaluate 20 test parts a g a i n s t two s t a n d a r d s of k n o w n value, one c o n f o r m i n g a n d the o t h e r n o n c o n f o r m ing. I n c o n d u c t i n g this evaluation, it is desirable t h a t s o m e of the parts being tested be either slightly above o r b e l o w the specification limits so as to truly test the m e a s u r e m e n t system. The test is r u n twice b y e a c h operator, a n d the results are r e c o r d e d on the analysis w o r k sheet. A s a m p l e attribute gauge analysis w o r k sheet is p r o v i d e d in Appendix E. As w i t h the variable gauge analysis, it is r e c o m m e n d e d t h a t a t h i r d p a r t y be involved so as to lessen o p e r a t o r bias. The m e a s u r e m e n t system is c o n s i d e r e d a c c e p t a b l e if all CHAPTER 7--STATISTICAL Raw Material \ INPUT People Methods \ \ \\ 2 Equipment QUALITY CONTROL 51 \ OUTPUT Environment Figure 7-5--Cause and effect diagram. evaluation decisions are in agreement with each other. If any of the evaluations disagree, the system must be improved and then reevaluated for effectiveness. If the measuring system cannot be improved, it is considered unacceptable and an alternate measuring system must be developed. Understanding variability, data, the process, and gauge R&R are requisites to evaluating the process through the use of control charts. There are many control charts available to study processes. There are variable and attribute control charts. & R c h a r t - - C o n t r o l chart for averages and range. & s c h a r t - - C o n t r o l chart for averages and sigma (a). • Median c h a r t - - C o n t r o l chart for median and range. • Chart for individuals--Control chart for a moving range. • X • ~: We apply attribute charts whenever we are collecting data that have only two options, right or wrong, yes or no, etc. The more common attribute control charts are: • p - c h a r t - - C o n t r o l chart for fraction defective. • n p - c h a r t - - C o n t r o l chart for number defective. • c - c h a r t - - C o n t r o l chart for defects per unit (constant subgroup). Variable Control Charts • u-chart--Control We can apply variable control charts whenever we are able to collect variable type data. The more common variable control charts are: Raw Material AIAnneal S1038 I e~~d chart for defects per unit (variable subgroup). All of the above control charts have unique characteristics that render them useful under given conditions. I will not People Methods Noset~ Mary ~ ~ Joe 1"diameter~ / filledu ~ ~ Low INPUT Atmosphere/ lig" Furnace/ ~ Heavy fume/ Equipment Environment Figure 7-6--Cause and effect diagram. Hardness 52 TOTAL Q U A L I T Y M A N A G E M E N T M A N U A L --Investigatesteelwithboronadded RawMaterial~-J°eneed;~oi~leg withthe fumacI Methods Annealed ~ Mary ~ 1"diameter \ ~ ~ INPUT '~ / / Noset --~ procedure ~ x" , Atmosphere/ S ~2_.__~Low Hardness / Poorlighting~ / U,omon, Writeprocedure Improvelighting . /~Addexhaustfans nv,ronmon, z---Contml chartthe fumaceparameters Figure7-7--Causeandeffectdiagram. a t t e m p t in this study to p r o v i d e a step-by-step m e t h o d for c o n s t r u c t i n g the eight c h a r t s listed above, b u t I will provide s o m e b a s i c guidelines t h a t s h o u l d b e followed regardless of the type c h a r t selected to m o n i t o r a process. There are two b o o k s I r e c o m m e n d for t h e r e a d e r w h o is interested in learning m o r e a b o u t the c o n t r o l charts a n d their construction. The first is Understanding Statistical Control,2 a n d the s e c o n d is Recommended Practices for Statistical Process Control. 3 Guidelines for Control Charting • Management training--Management m u s t u n d e r s t a n d the value of SPC a n d the basics of application. They m u s t drive fear f r o m the c o r p o r a t e culture so t h a t a c c u r a t e r e p o r t i n g can occur. E m p l o y e e s m u s t b e p e r m i t t e d to c o n c e n t r a t e on quality, n o t n u m b e r s . M a n a g e m e n t m u s t u n d e r s t a n d t h a t SPC will identify o p p o r t u n i t i e s for i m p r o v e m e n t t h a t m a y require capital i n v e s t m e n t in the process. • Employees training--Employees n e e d to be t r a i n e d in b a s i c SPC. They n e e d to k n o w h o w to d e t e r m i n e w h e n a subg r o u p is o u t of control. They n e e d to be able to recognize t r e n d s a n d runs for sequential subgroups. They n e e d to realize that all opportunities identified for improvement m a y not be addressed in the short t e r m due to the need for capitol expenditures. They need to understand what they can control a n d what m u s t be changed by m a n a g e m e n t in a process. • Understand the process--Flow c h a r t the process to unders t a n d h o w a n d w h e r e p a r t characteristics are affected during the process stream. D e t e r m i n e all c o n t r i b u t i n g elem e n t s f r o m the process stream: material, m e t h o d s , people, e q u i p m e n t , a n d environment. Ask w h a t e a c h c o n t r i b u t e s to 2Wheeler, D. J. and Chambers, D. S., Understanding Statistical Control, Statistical Process Controls, Inc., Knoxville, TN, 1986. 3Compilation from contributing authors, "Recommended Practices for Statistical Process Control," Industrial Fastener Institute, Cleveland, OH, 1991. the characteristics being evaluated d u r i n g the c h a r t i n g process. • Choose the characteristics for charting--Base y o u r decisions on n e e d for i m p r o v e m e n t . Do n o t a t t e m p t to c h a r t every c h a r a c t e r i s t i c a process produces. Paretoize to determ i n e w h i c h ones have the m o s t effect on c h a n g i n g the output. Use the SPQP process to c h a r a c t e r i z e c h a r a c t e r i s t i c s as to t h e i r i m p o r t a n c e in satisfying the c u s t o m e r a n d c h a r t high achievers f r o m that list. • Choose your method of measurement--Determine the test a n d m e a s u r i n g e q u i p m e n t by c h o o s i n g ones t h a t m e a s u r e to at least 10% of the characteristic's stated t o l e r a n c e a n d one t h a t has a gauge R & R -< 10%. • Remove sources of variation--When the process is studied, find ways to r e m o v e as m a n y sources of v a r i a t i o n as possible. The e n d result s h o u l d leave only c o m m o n causes of v a r i a t i o n in the process s t r e a m to the greatest extent possible. As the process is charted, m a n a g e m e n t s h o u l d evalu a t e the results to find ways to reduce the c o m m o n causes f r o m the system b y c h a n g i n g the process. • Process capability analysis--Prior to allowing the o p e r a t o r to c h a r t the process, one s h o u l d first evaluate the p r o c e s s TABLE 7-1 ~ P a r e t o analysis. 1st week 2nd week 3rd week 4th week 5th week 6th week Missing B/P B/P clarification Service Off-load Priority Tooling/ fixtures System down 35 60 37 58 25 42 30 52 27 75 23 50 65 15 5 30 78 12 8 25 60 20 7 20 88 18 6 11 79 5 8 21 72 10 5 15 3 5 0 0 3 4 CHAPTER 7--STATISTICAL QUALITY CONTROL System Down 53 I Priorities Off-Load Tool'g/Fixtures Missing BIP B/P Clarification Service 0 i i t i i t i i i 50 100 150 200 250 300 350 400 450 Figure 7-8--Pareto Chart 1. for process capability. The first thing a process capability s t u d y will tell us is if the process is in a state of statistical control. There is no p o i n t in going f u r t h e r with c h a r t i n g until this state has been achieved. This gives m a n a g e m e n t a starting p o i n t in d e t e r m i n i n g h o w well the process will a n s w e r the call to p r o d u c e p r o d u c t w i t h i n engineering specifications. A m e t h o d to c o n d u c t process capability analysis is p r o v i d e d in ASTM F 1503, S t a n d a r d Practice for Machine/Process Potential S t u d y Procedures. 4 F o r y o u r convenience, this s t a n d a r d is r e p r o d u c e d in Appendix A. Cause and Effect Diagrams A very simple yet powerful tool is the cause a n d effect diagram, o r fishbone analysis. This tool utilizes the process s t r e a m m o d e l with a few modifications. A typical cause a n d effect d i a g r a m starts off as s h o w n in Fig. 7-5. You can see w h y it is s o m e t i m e s referred to as a fishbone diagram. This tool has its greatest p o t e n t i a l w h e n a t e a m is a s s e m b l e d to b r a i n s t o r m a process. It w o u l d be good at this p o i n t to provide an e x a m p l e of h o w this tool is used. We will a s s u m e we have a t e a m p u l l e d t o g e t h e r to evaluate the heattreating process for ASTM A 325 bolts. The h a r d n e s s requirem e n t is HRC 25-32, a n d we are having difficulty m e e t i n g this specification on a consistent basis. S o m e thoughts the t e a m m i g h t c o m e u p with are s h o w n in Fig. 7-6. The next step w o u l d be to find ways to i m p r o v e the system o r to r e m o v e variables that c o n t r i b u t e to the u n d e s i r a b l e output, low hardness. Our t e a m f o u n d m a n y a r e a s in the present system that n e e d e d i m p r o v e m e n t . Not all w o u l d contribute to resolving the low h a r d n e s s p r o b l e m , b u t even those c o n t r i b u t e to quality of w o r k life, so it was d e c i d e d to reco m m e n d all i m p r o v e m e n t s to m a n a g e m e n t for action. The t e a m ' s r e c o m m e n d a t i o n is r e p r e s e n t e d as Fig. 7-7. 4ASTM Committee F16 on Fasteners. Pareto Analysis It is s o m e t i m e s useful to g r o u p d a t a in d e s c e n d i n g o r d e r to d e t e r m i n e w h a t inputs have the m o s t i m p a c t on the d a t a o r situation. The tool used to a c c o m p l i s h this is called Pareto analysis, n a m e d after the I t a l i a n economist, Pareto. His theory was that to gain the m o s t from o u r resources we s h o u l d c o n c e n t r a t e on the vital few, a n d n o t w o r r y a b o u t the useful many. There are m a n y a p p l i c a t i o n s for this t h e o r y w h e n opp o r t u n i t i e s for i m p r o v e m e n t are so n u m e r o u s that full-scale analysis c a n n o t be d o n e on t h e m all. We can focus on the vital few that a c c o u n t for 80% o r m o r e of the total opportunities. A case study of a n a p p l i c a t i o n of the Pareto principle w o u l d serve as a g o o d example. At K e n n a m e t a l , Inc. in Solon, Ohio, we k n e w we h a d an o p p o r t u n i t y to i m p r o v e o u r o n - t i m e p e r f o r m a n c e to c u s t o m e r ship dates if we could reduce the l e a d t i m e in o u r process engineering d e p a r t m e n t . We e s t a b l i s h e d a t e a m f r o m the process engineering dep a r t m e n t to flow c h a r t the process. After the process was fully identified, we asked the t e a m to find ways to r e d u c e r o a d blocks to doing t h e i r j o b in an efficient manner. Several items were identified as c o n t r i b u t i n g to their failure to process a n order. These were: m i s s i n g blueprints, u n c l e a r blueprints, service, off-loading, priorities, tooling/fixturing availability, a n d system p r o b l e m s . An e x p l a n a t i o n is r e q u i r e d h e r e to m a k e you a w a r e of w h a t each category represented. We process an o r d e r t h r o u g h Process E n g i n e e r i n g b y w o r k i n g on a j o b p a c k e t f r o m C u s t o m e r Service. The j o b p a c k e t contains: p a r t blueprints, p r o m i s e d delivery date, special cust o m e r requirements, a n d the n u m b e r of pieces required. It is the j o b of Process E n g i n e e r i n g to develop a process routing to m a n u f a c t u r e the order. Offloading m e a n s the j o b could not be r u n on the equipm e n t originally s c h e d u l e d for processing. Service is w h e n a process engineer is called to clarify process instructions for an o p e r a t o r on a m a c h i n e or w h e n the engineer needs to call C u s t o m e r Service o r Design E n g i n e e r i n g for clarification. Priorities are j o b s t h a t i n t e r r u p t the j o b they are c u r r e n t l y 54 TOTAL QUALITY MANAGEMENT MANUAL Missing B/P Service BIP Clarification System Down Priorities Tool'g/Fixtures Off-Load 0 i i i i i i i 10 20 30 40 50 60 70 Figure7-9--Pareto Chart2. working on. System problems represented those times when the CAD/CAM program was down. The other categories are self-explanatory. This list became our CPIs, and systems were put in place to track the number of occurrences for each of these indicators. We tracked results for six weeks and paretoized the data to identify opportunities for improvement. The accumulated data are shown in Table 7-1. To make the data more meaningful and to present it in a fashion that would instantly define opportunities for improvement, we put the data in the form of a Pareto chart (Fig. 7-8). From the analysis, service had the greatest number of occurrences, blueprint clarification had the second most, and missing blue prints were next in number of occurrences. These three categories represented 79% of all reasons for delay. The next step was to develop an action plan to reduce the occurrences of these three factors. The strategies employed included cross training between design and process engineers and creating product-specific teams of design and process engineers, customer service representatives, and machine operators. Several opportunities were identified as the result of this exercise. Through better tolerancing of our product (based on capability) we reduced tooling costs, programming costs, and manufacturing costs. By utilizing geometric dimension- ing and tolerancing (GD&T), we improved our processing capabilities. Through a better understanding of our CAD geometric features and through silo tumbling we were able to utilize features of our standard parts on our customengineered parts. The results of this project included reduced service and blueprint clarification occurrences, better communications between departments, better quality programming, and better efficiencies. After six months had passed, another Pareto analysis was performed and other opportunities were identified. The problems identified in the first analysis were all but eliminated as causes of delay (see Fig. 7-9). The team now had a new set of challenges for continuous improvement, and they set about finding ways to reduce delays due to off-loading and the unavailability of tooling and fixtures and dealing more effectively with priorities. The other statistical tools listed in the beginning of this chapter require a broader knowledge of statistics than covered in this book. Information on multi-vari analysis, correlation analysis, and design of experiments should be pursued in text books dedicated to those subjects. The effort would be well worthwhile as these tools are very effective in defining the root causes of variance, which in turn should lead to better efficiencies. Part 4: The Quality Assurance Manual Introduction to Part IV: The Quality Assurance Manual THE DEVELOPMENTof the quality assurance manual is a task that requires close coordination between all members of the management team. The written quality assurance manual describes how the quality systems are applied to each operating unit in the organization. As King Ramses of Egypt (he was one of the eleven kings of Egypt, B.C.) said, "So it is written, so it shall be." This is how auditors will interpret the contents of your manual. It is how your top management should convey the written document to the entire organization. The quality assurance manual should be formatted after guidelines that satisfy organizational goals, customer requirements, and international standards on quality. This is a huge task and not the sole responsibility of the quality department. It becomes necessary for all department and operating unit managers to supply input to the quality department as they formulate the document. The model quality assurance manuals I provide in this book satisfy only national and international quality requirements. It is not possible to include organizational goals or customer requirements as they are dependent upon particular and unique demands. However, those requirements can be integrated where necessary throughout the models. The models are formatted to satisfy the quality requirements specified in ANSI/ASQC Q9000-1994 (the United States equivalent to ISO 9000). For the manufacturing model in Chapter 8, I use ANSI/ASQC Q9001-1994 and ASME FAP-1. For the service industry model in Chapter 9 (heat treaters, platers, contract machine shops, etc.), I use ANSI/ASQC Q9002-1994, for the distributor's model in Chapter 10, I use ANSI/ACQC Q9003-94 and ASME FAP-1. To provide more understanding with regard to the referenced standards, they are defined as follows: ASME FAP-1 is Quality Assurance Program Requirements for Fastener Manufacturers and Distributors. 1 ANSI/ASQC Q9000-94 is Quality Management and Quality Assurance Standards--Guidelines for Selection and Use. 2 ANSI/ASQC Q9001-1994 is Quality Systems--Model for Quality Assurance in Design/Development, Production, Installation and Servicing. 2 ANSI/ASQC Q9002-1994 is Quality Systems--Model for Quality Assurance in Production and Installation. 2 ANSI/ASQC Q9003-1994 is Quality Systems--Model for Quality Assurance in Final Inspection and Test. 2 1The American Society of Mechanical Engineers, United Engineering Center, 345 East 47th Street, New York, NY 10017, 1990. 2American Society for Quality Control, 611 East Wisconsin Avenue, Milwaukee, WI 53202, 1987. 57 Manufacturing Company Quality Assurance Manual MANUFACTURING COMPANY QUALITY ASSURANCE MANUAL through quality system audits in accordance with documented procedures. Audits are performed by trained personnel independent of the function being audited. 1.4 The Corporate Quality Assurance Manager functions as the management representative and has the responsibility and authority for assuring that the requirements of this manual are implemented and maintained. Facility Quality Assurance Managers act as management representatives for their facilities. 2.0 Quality System 2.1 Company's Quality system is documented and implemented through the following documents: 2.1.1 Corporate Quality Manual--Defines the scope of the corporation's Quality System and provides overall direction to the development of corporate and facility procedures. 2.1.4 CorporateProcedures--Provides direction to help manufacturing facilities comply with the Quality Manual by defining specific corporate requirements or providing general technical guidance. 2.1.5 Facility Procedures--Defines the standard operating practices at each manufacturing facility. Facility procedures satisfy corporate procedure requirements and the Corporate Quality Manual. 2.1.6 Company Facility Work Instructions--Provides specific directions for the completion of tasks affecting quality. 3.0 Order Review 3.1 New products are reviewed for manufacturabilityand to assure that adequate production capacity and tooling are available for product introduction. 3.2 After an item becomes a standard stocked item, the company's primary interface occurs between the manufacturing facility's production and inventory control (P&IC) department and the production scheduler in the company's distribution facilities. The interface between manufacturing P&IC and the distribution facilities is defined in written procedures. 3.3 Requests for customer special products may be entered to our manufacturing facilities from our distribution centers, field sales, or direct from the customer. Written procedures describe the order review process and ensure order completeness and manufacturability. Discrepancies are resolved before manufacturing begins. 3.5 Each facility maintains records of quotations, purchase orders, engineering drawings, and other documentation in accordance with written procedures. 4.0 Product Design and Development Control 4.1 The design and/or development of new standard products is the responsibility of corporate product engineering. Quality system requirements for the design and development of standard products are documented in their Procedures Manual. Table of Contents 1.0 2.0 3.0 4.0 5.0 6.0 ZO 8.0 9.0 10.0 11.0 12. 0 13.0 14.0 15.0 16. 0 17. 0 18.0 19.0 20. 0 21.0 Management Responsibility Quality System Order Review Product Design and Development Control Document Control Purchasing Control Customer Supplied Product Product Identification and Traceability Process Control Inspection and Testing Inspection, Measuring and Test Equipment Inspection and Test Status Control of Non-Conforming Product Corrective Action Handling, Storage, Packaging and Delivery Quality Records Internal Quality Audits Train ing Servicing Statistical Methods Quality Improvement Program 1.0 Management Responsibility 1.1 Company management is responsible for communicating the Company's Corporate Quality Policy throughout the organization. Corporate and facility management are responsible for assuring that this policy is understood and implemented. 1.2 Corporate and facility Quality Assurance is organized to be independent of production. Quality Assurance, working in conjunction with facility management, has the responsibility and authority to: 1.2.1 Initiate action to prevent the occurrence of product nonconformity; 1.2.2 Identify and record any product quality problems; 1.2.3 Initiate, recommend, or provide solutions through designated channels; 1.2.4 Verify the implementation of solutions; and 1.2.5 Control further processing, shipment, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected. 1.3 The quality system outlined in this manual is reviewed annually by Corporate Management and revised or reaffirmed as appropriate. Compliance is evaluated 59 60 TOTAL QUALITY MANAGEMENT MANUAL 4.2 The design of customer specials may be performed within the product engineering department at the manufacturing facilities. Customer specials are defined as nonstandard products, unique to a specific customer request or application. 4.3 Engineering functions at the manufacturing facilities maintain procedures that explain how: 4.3.1 Design work is completed and verified in a manner which assures that all specified requirements are met. 4.3.2 Design activities are assigned to qualified personnel. 4.3.3 Customer design requirements which are incomplete, ambiguous, or do not comply with internal engineering guidelines are reviewed with the customer for clarification and final approval before design documentation is released for manufacture. 4.3.4 Designs comply with appropriate regulatory and safety requirements where such requirements exist. 4.3.5 Design characteristics and tolerances are reviewed for manufacturability and contain or reference acceptance criteria, as appropriate. 4.4 Engineering maintains procedures to assure proper review, documentation, and approval of all design revisions. 5.0 Document Control 5.1 Manufacturing facilities maintain procedures which describe the approval process for all product drawings generated within their facility. These procedures also cover the approval of drawing revisions. 5.2. Plant drawing control procedures describe how and where drawings are maintained throughout the facility and the method used to collect and dispose of outdated drawings. 5.3 Procedural controls are documented and assure that: 5.3.1 Procedures are reviewed by those affected and any suggestions resolved before the procedure is approved by authorized personnel and issued; 5.3.2 Distribution is controlled and documented so that all recipients are notified of procedural changes; 5.3.3 Revisions to a procedure are reviewed and approved by the originating author or function, and the nature of the change is documented where practical; 5.3.4 Procedures are reviewed periodically to assure they are still current. 5.4 Unless otherwise stipulated, the Quality Assurance department is responsible for the control and issue of all procedures which impact product quality. Quality Assurance also maintains a current procedures index. 6.0 Purchasing Control 6.1 The purchase of raw materials, supplies, components, finished products or services is performed in accordance with written procedures which ensure that: 6.1.1 Purchasing documents clearly identify the product or service being purchased, including information regarding type, style, class, or grade, where such information is appropriate; 6.1.2 Special requirements, such as specifications, drawings, reference standards, technical data, or quality system/certification requirements are stated on the purchase order; 6.1.3 Purchase orders are reviewed for completeness and approved prior to release; and 6.1.4 An approved supplier list is used to select suppliers. The selection of suppliers for inclusion on the approved supplier list is dependent upon the type and criticality of product or service provided. Supplier evaluations may be based on their participation in the company's "Partners In Quality" supplier certification program or previously demonstrated capability and performance. 6.2 The company's customers may conduct source inspection at a manufacturing facility when stipulated in the purchase order. The company retains responsibility for quality regardless of such inspection. 6.3 Incoming audits may be initiated by Quality Assurance to assure conformance to dimensional, metallurgical, marking, and cosmetic requirements. 7.0 Customer Supplied Product 7.1 Products provided by customers for use or processing at our company (e.g., special gauges or templates) are controlled in accordance with written procedures. Standard processing, inspection, and test procedures are used unless otherwise specified. 7.2 Product which is lost, damaged, or scrapped is reported to the customer and returned to him if possible. 8.0 Product Identification and Traceability 8.1 Incoming raw materials are identified with a unique batch or heat number as appropriate in accordance with written procedures. 8.2 Company facilities identify each order or batch of product with a unique traceability code and maintain such code throughout all stages of manufacture. 8.3 Finished product and/or finished product packaging is marked with the traceability code and/or a date code in accordance with written procedures. 8.4 The degree of traceability required for a given product or product component is based on the item's criticality to the final customer as well as any physical limitations which would prohibit product marking. 9.0 Process Control 9.1 Company facilities plan and control production through the use of manufacturing routings. Routings specify the raw materials required, the sequence of operations necessary to produce the product, and the applicable drawing, including revision level. Individual facilities may include additional information with the routing to facilitate manufacturing. Routings are developed in accordance with written procedures. 9.2 Documentation is required for those aspects of manufacturing where the absence of such would adversely affect product quality. Documentation may consist of procedures, work instructions, control plans, reference standards, or Product/Service Quality Plans. 9.3 Processes are controlled through the monitoring of appropriate product or process characteristics. The method used to control the process is documented in written procedures, work instructions, or control plans. Where appropriate, statistical process control (SPC) is utilized to monitor manufacturing processes, reduce sources of variation, and identify opportunities for improvement. SPC is implemented in accordance with written procedures or accepted industry standard practice. 9.5 New processes or equipment are reviewed to assure compliance with specified requirements. When appropriate, new equipment is subject to process qualification tests in accordance with written procedures. 10.0 Inspection and Testing 10.1 Quality Assurance is responsible for approving inspection and test procedures to assure outgoing quality. In- CHAPTER 8--MANUFACTURING COMPANY QUALITY ASSURANCE MANUAL 11.0 spection and test will normally consist of the following elements: 10.1.1 Receiving Inspection 10.1.1.1 Quality Assurance is responsible for implementing adequate controls at receiving inspection. These controls may include 100% incoming inspections, audits, or reviews of supplier certification reports. Quality records of incoming inspections, tests, or certifications are retained in accordance with established record retention procedures. 10.1.1.2 Except as noted below, manufacturing follows procedures which prevent the use of incoming materials until all receiving inspection requirements are met. 10.1.1.3 Quality Assurance may release material for production before incoming inspections or material evaluations are completed. If this is done and subsequent receiving inspections identify a discrepant condition, production is halted and any suspect material is quarantined for further review and disposition. 10.1.2 In-Process Inspection 10.1.2.1 In-process inspections are performed by inspection and/or production personnel in accordance with approved product quality plans, internal procedures, work instructions or control plans. To the extent necessary, inspection documents define sampling requirements, the method of measurement used, a reaction plan if nonconforming material is found and qualitative standards for visual/cosmetic requirements. 10.1.3 Final Inspection 10.1.3.1 Final inspection is conducted, as required, in accordance with approved Product Quality Plans, internal procedures, work instructions, or control plans. 10.1.4 CertificationInspection 10.1.4.1 Product certifications are completed by Quality Assurance in accordance with specific customer requests and requirements. 10.1.4.2 Certificates of conformance must be approved by the plant QA Manager or his designate. 10.1.5 Nonconforming product found during inspection is identified, segregated from normal production, and placed on hold pending further review and disposition. 10.1.6 Critical in-process inspection and test results are documented. Inspection results are retained and are traceable to the order. Inspection, Measuring and Test Equipment 11.1 Quality Assurance is responsible for the control and calibration of measurement and test equipment and fixtures, including employee owned gauges, which are used to verify product quality. 11.2 61 Quality Assurance may select, or participate in the selection of, new gauging and test equipment and ensures that the gauging is of the proper type, accuracy, and repeatability for the intended measurement. 11.3 Calibrations are performed at prescribed intervals, using certified measurement standards traceable to the National Institute of Standards and Technology (NIST) or equivalent. Where standards do not exist, the basis or method for verifying accuracy is documented. 11.4 Calibration procedures are written which describe the frequency and method of calibration, the required equipment, whether or not an outside service is employed, records to be retained, applicable acceptance standards, and the actions to be taken when results are unsatisfactory. 11.5 Quality Assurance maintains a gauge identification and calibration scheduling system at each manufacturing location. The gauge scheduling system includes the type and serial number of the gauge to be calibrated, its physical location within the plant, and the date when the next calibration is due. Records of all calibrations are maintained. 11.6 Quality Assurance maintains metrology laboratory facilities for gauge, fixture, and test equipment calibration. Metrology facilities provide adequate security, environmental controls, and appropriate storage facilities to safeguard gauge masters, gauges under calibration, and gauging not currently in use. 12.0 Inspection and Test Status 12.1 The inspection and/or test status of product is identified by tag, marking, authorization stamp, or other suitable means in accordance with written procedures. 12.2 All required tests, inspections, and documentation must be complete before the product can be released for shipment. Inspection documentation may be retained with order packet, or in various Quality Assurance databases as deemed appropriate. Inspection records must provide actual inspection results or a signoff (e.g., approval tags, employee signature or number, approval stamp, etc.) which verifies that the inspection was completed. 12.3 Inspection records identify the individual(s) responsible for releasing conforming product. 13.0 Control of Nonconforming Product 13.1 Products which do not conform to specified requirements are segregated from normal production and clearly identified with the reason for rejection in accordance with approved procedures. Final disposition of nonconforming product may involve rework or repairs to comply with product specifications, scrapping the product under review, or requesting a waiver (concession) from specification. 13.2 Quality Assurance and production review significant nonconformances to determine root cause and to make final disposition on the product in question. 13.3 Requests for waivers are initiated by Quality Assurance and approved by the appropriate product engineering personnel in accordance with approved waiver procedures. 13.3.1 Waivers to deviate from customer requirements on special products must be approved by the customer. 13.4 Product which is reworked or repaired is reinspected in accordance with approved procedures. 14.0 Corrective Action 14.1 Corrective action procedures are used to identify, analyze, and eliminate conditions which adversely affect product or service quality. 14.2 Requests for corrective action may be initiated as the 62 TOTAL QUALITY MANAGEMENT MANUAL result of recurring customer complaints, scrap, rework, po()r service quality, or any other issue where improvement is required. 14.3 Corrective action procedures consist of the following elements: 14.3.1 A dear, concise description of the problem or concern. 14.3.2 Appropriate containment actions as required to prevent the further processing, shipment, or sale of suspect material. 14.3.3 An analysis of the problem for the purpose of determining root cause. Problem analysis may include a review of individual processes or process flows, Product/Service Quality Plans, failure mode and effects analyses, scrap, rework, customer returns data, quality records, or other pertinent information. 14.3.4 Development and implementation of permanent corrective actions to prevent a recurrence. 14.3.5 Provisions for followup to assure that corrective actions are implemented and effective. 14.4 Quality Assurance documentation, such as procedures, work instructions, Product/Service Quality Plans, or control plans, are updated as appropriate to reflect implemented improvements. 15.0 Handling, Storage, Packaging and Delivery 15.1 16.0 Manufacturing follows procedures which protect product from damage, contamination or deterioration during storage and manufacture. 15.2 Raw materials and scrap awaiting shipment for disposal or reprocessing are controlled and stored in accordance with written procedures. Quality Records 16.1 Quality records are retained and maintained for the time periods specified in written corporate procedures. 16.2 Quality records consist of documentation generated during purchase, manufacture, or testing which demonstrates that the required quality levels were met or that the quality system in place was effective. 16.3 Quality records are stored in a manner which assures legibility and facilitates sorting. Adequate storage facilities are provided which prevent deterioration or loss. 17.0 Internal Quality Audits 17.1 17.2 Corporate Quality Assurance conducts periodic audits at manufacturing facilities to ensure conformance to the Quality Manual and selected procedures. In addition, Corporate Quality Assurance conducts periodic product audits on material in inventory in accordance with approved Corporate Quality Assurance procedures. Manufacturing facilities conduct internal quality system audits to assure conformance to relevant Corporate and plant procedures. Quality system audits are conducted in accordance with written procedures. 17.3 Manufacturing facilities conduct final product audits in accordance with approved audit procedures. 17.4 Audit results are reported to appropriate levels of management for review. Management personnel in the department audited are responsible for corrective action responses in a timely manner. 18.0 Training 18.1 The company maintains procedures for identifying training needs and provides for the training of personnel performing activities affecting quality. 18.2 Training records and job requirements are documented and retained by the department manager or the Human Resources function. 18.3 Individuals assigned specific tasks which impact quality are qualified based on education, training, or experience, as appropriate. 19.0 Servicing 19.1 Where applicable, the company establishes and maintains procedures for providing appropriate levels of service to customers. 19.2 The company is responsible for direct customer service. Corporate Quality Assurance provides technical support to the manufacturing facilities, as well as analysis and disposition of performance related customer returns. 20.0 Statistical Methods 20.1 Statistical methods are employed, as appropriate, to facilitate problem identification and analysis and the control, improvement, or qualification of processes or systems. 20.2 When employed, statistical methods are conducted in accordance with internal procedures or accepted standard practice. 20.3 Management is responsible for providing adequate training for those employees using or interpreting statistical results. 20.4 Statistical methods may include, but are not limited to: 20.4.1 Pareto analysis 20.4.2 Process capability analysis 20.4.3 Statistical process control 20.4.4 Design of experiments 20.4.5 Regression analysis 21.0 Quality I m p r o v e m e n t P r o g r a m 21.1 Corporate and facility management are responsible for developing the company's Quality Improvement Program. The Quality Improvement Program consists of a three-year strategic plan, as well as detailed annual quality improvement projects. This plan is submitted to the Board of Directors for final approval. Quarterly updates are issued to management to monitor progress. 21.2 Cost of Quality reports are issued by each facility. 21.3 Where appropriate, quality improvement plans include provisions for advanced quality planning for significant new product developments. Service Industry Quality Assurance Manual S E R V I C E I N D U S T R Y QUALITY A S S U R A N C E MANUAL 1.4 The company's Quality Assurance Manager functions as the management representative and has the responsibility and authority for assuring that the requirements of this manual are implemented and maintained. 2.0 Quality System 2.1 The company's quality system is documented and implemented through the following documents: 2.1.1 Quality Manual--Defines the scope of the company's quality system and provides overall direction to the development of the company's procedures. 2.1.4 Procedures--Provides direction to help the production facility comply with the Quality Manual by defining specific company requirements or providing general technical guidance. 2.1.6 Work Instructions--Provides specific directions for the completion of tasks affecting quality. 3.0 Order Review 3.1 All orders are reviewed to assure that adequate instructions exist to fully understand the customer's requirements. 3.2 A through review of the requirements is made to compare them with existing requirements from the same customer. Quality plans are modified as required. 3.3 The company xadll assure that we have the necessary capacity to perform the job in the time requested on the order. 3.4 Records of quotations, purchase orders, engineering drawings, and other documentation will be maintained in accordance with written procedures. 4.0 Document Control 4.1 The company shall maintain procedures which describe the approval process for all product drawings procedures and specifications received by customers and regulatory agencies. These procedures also cover the approval of revisions to these documents. 4.2 Company drawing control procedures describe how and where drawings are maintained throughout the facility and the method used to collect and dispose of outdated drawings. 4.3 Procedural controls are documented and assure that: 4.3.1 Procedures are reviewed by those affected and any issues resolved before the procedure is approved by authorized personnel and issued; 4.3.2 Distribution is controlled and documented so that all recipients are notified of procedural changes; 4.3.3 Revisions to a procedure are reviewed and approved by the originating author or function, and the nature of the change is documented where practical; 4.3.4 Procedures are reviewed periodically to assure they are still current. 4.4 Unless otherwise stipulated, the Quality Assurance department is responsible for the control and issue of all procedures which impact product quality. Table of Contents 1.0 2.0 3.0 4.0 5. 0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0 17. 0 18.0 1.0 Management Responsibility Quality System Contract Review Document Control Purchasing Purchaser Supplied Gauging & Test Equipment Product Identification and Traceability Process Control Inspection and Testing Inspection, Measuring, and Test Equipment Inspection and Test Status Control of Nonconforming Product Corrective Action Handling, Storage, Packaging, and Delivery Quality Records Internal Quality Audits Training Statistical Techniques Management Responsibility 1.1 It is the policy of the company to market and provide products of such quality that they will reliably perform their intended function so that the company is recognized as a quality leader in the industry. It is the responsibility of company senior management to communicate the corporate quality policy throughout the company. 1.2 The company's Quality Assurance is organized tO be independent of production. Quality Assurance, working in conjunction with company management, has the responsibility and authority to: 1.2.1 Initiate action to prevent the occurrence of product nonconformity; 1.2.2 Identify and record any product quality problems; 1.2.3 Initiate, recommend, or provide solutions through designated channels; 1.2.4 Verify the implementation of solutions; and 1.2.5 Control further processing, shipment, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected. 1.3 The quality system outlined in this manual is reviewed annually by company management and revised or reaffirmed as appropriate. Compliance is evaluated through quality system audits in accordance with documented procedures. Audits are performed by trained personnel independent of the function being audited. 63 64 TOTAL Q U A L I T Y M A N A G E M E N T M A N U A L 4.5 5.0 6.0 7.0 8.0 Quality Assurance maintains an index of all procedures that affect the quality of our production and service to the customer. P u r c h a s i n g Control 5.1 The purchase of raw materials, supplies, components, finished products or services is performed in accordance with written procedures which ensure that: 5.1.1 Purchasing documents clearly identify the product or service being purchased, including information regarding type, style, class, or grade, where such information is appropriate; 5.1.2 Special requirements, such as specifications, drawings, reference standards, technical data, or quality system/certification requirements are stated on the purchase order; 5.1.3 Purchase orders are reviewed for completeness and approved prior to release; and 5.1.4 An approved supplier list is used to select suppliers. The selection of suppliers for inclusion on the approved supplier list is dependent upon the type and criticality of product or service provided. Supplier evaluations may be based on their participation in the company's "Partners In Quality" supplier certification program or previously demonstrated capability and performance. 5.2 The company may conduct source inspection at a supplier's facility when stipulated in the purchase order. The supplier retains responsibility for quality regardless of such inspection. 5.3 Incoming audits may be initiated by Quality Assurance to assure conformance to dimensional, metallurgical, marking, and cosmetic requirements. Customer Supplied Product 6.1 Products provided by customers for use or processing at our company (e.g., special gauges or checking fixtures) are controlled in accordance with written procedures. Standard processing, inspection, and test procedures are used unless otherwise specified. 6.2 Product which is lost, damaged, or scrapped is reported to the customer and returned to him if possible. P r o d u c t Identification a n d Traceability 7.1 Incoming raw materials are identified with a unique batch or heat number as appropriate in accordance with written procedures. 7.2 Each order or batch of product is identified with a unique traceability code which is maintained throughout all stages of production. 7.3 Finished orders and/or finished order packaging is marked with the traceability code and/or a date code in accordance with written procedures. 7.4 The degree of traceability required for a given order is based on the item's criticality to the customer as well as any physical limitations which would prohibit marking. Process Control 8.1 The company plans and controls production through the use of production routings. Routings specify the raw materials required, the sequence of operations necessary to complete the order, and the applicable drawing, including revision level. Routings are developed in accordance with written procedures. 8.2 Documentation is required for those aspects of production where the absence of such would adversely affect product quality. Documentation may consist of procedures, work instructions, control plans, reference standards, or Product/Service Quality Plans. 8.3 Processes are controlled through the monitoring of appropriate product or process characteristics. The 9.0 method used to control the process is documented in written procedures, work instructions, or control plans. Where 'appropriate, statistical process control (SPC) is utilized to monitor manufacturing processes, reduce sources of variation, and identify opportunities for improvement. SPC is implemented in accordance with written procedures or accepted industry standard practice. 8.5 New processes or equipment are reviewed to assure compliance with specified requirements. When appropriate, new equipment is subject to process qualification tests in accordance with written procedures. Inspection and Testing 9.1 Quality Assurance is responsible for approving inspection and test procedures to assure outgoing quality. Inspection and test will normally consist of the following elements: 9.1.1 Receiving Inspection 9.1.1.1 Quality Assurance is responsible for implementing adequate controls at receiving inspection. These controls may include 100% incoming inspections, audits, or reviews of supplier certification reports. Quality records of incoming inspections, tests, or certifications are retained in accordance with established record retention procedures. 9.1.1.2 Except as noted below, production follows procedures which prevent the use of incoming materials until all receiving inspection requirements are met. 9.1.1.3 Quality Assurance may release material for production before incoming inspections or material evaluations are completed. If this is done and subsequent receiving inspections identify a discrepant condition, production is halted and any suspect material is quarantined for further review and disposition. 9.1.2 In-Process Inspection 9.1.2.1 in-process inspections are performed by inspection and/or production personnel in accordance with approved product quality plans, internal procedures, work instructions or control plans. To the extent necessary, inspection documents define sampling requirements, the method of measurement used, a reaction plan if nonconforming material is found and qualitative standards for visual/cosmetic requirements. 9.1.3 FinalInspection 9.1.3.1 Final inspection is conducted, as required, in accordance with approved Product Quality Plans, internal procedures, work instructions, or control plans. 9.1.4 CertificationInspection 9.1.4.1 9,1.5 Product certifications are completed by Quality Assurance in accordance with specific customer requests and requirements. 9.1.4.2 Certificates of conformance must be approved by the plant Quality Assurance Manager or his designate. Nonconforming product found during inspection is identified, segregated from normal production, CHAPTER 9 - - S E R V I C E I N D U S T R Y QUALITY ASSURANCE MANUAL 9.1.6 10.0 and placed on hold pending further review and disposition. Critical in-process inspection and test results are documented. Inspection results are retained and are traceable to the order. 12.3.1 12.4 13.0 Inspection, Measuring and Test Equipment Quality Assurance is responsible for the control and calibration of measurement and test equipment and fixtures, including employee owned gauges, which are used to verify product quality. 10.2 Quality Assurance may select, or participate in the selection of, new gauging and test equipment and ensures that the gauging is of the proper type, accuracy, and repeatability for the intended measurement. 10.3 Calibrations are performed at prescribed intervals, using certified measurement standards traceable to the National Institute of Standards and Technology (NIST) or equivalent. Where standards do not exist, the basis or method for verifying accuracy is documented. 10.4 Calibration procedures are written which describe the frequency and method of calibration, the required equipment, whether or not an outside service is employed, records to be retained, applicable acceptance standards, and the actions to be taken when results are unsatisfactory. 10.5 Quality Assurance maintains a gauge identification and calibration scheduling system. The gauge scheduling system includes the type and serial number of the gauge to be calibrated, its physical location within the company, and the date when the next calibration is due. Records of all calibrations are maintained. 10.6 Quality Assurance maintains metrology laboratory facilities for gauge, fixture, and test equipment calibration. Metrology facilities provide adequate security, environmental controls, and appropriate storage facilities to safeguard gauge masters, gauges under calibration, and gauging not currently in use. Corrective action procedures are used to identify, analyze, and eliminate conditions which adversely affect product or service quality. 13.2 Requests for corrective action may be initiated as the result of recurring customer complaints, scrap, rework, poor service quality, or any other issue where improvement is required. 13.3 Corrective action procedures consist of the following elements: 13.3.1 A clear, concise description of the problem or concern. 13.3.2 Appropriate containment actions as required to prevent the further processing, shipment, or sale of suspect material. 13.3.3 An analysis of the problem for the purpose of determining root cause. Problem analysis may include a review of individual processes or process flows, Product/Service Quality Plans, failure mode and effects analyses, scrap, rework, customer returns data, quality records, or other pertinent information. 13.3.4 Development and implementation of permanent corrective actions to prevent a recurrence. 13.3.5 Provisions for foflow-up to assure that corrective actions are implemented and effective. 13.4 Quality Assurance documentation, such as procedures, work instructions, Product/Service Quality Plans, or control plans, is updated as appropriate to reflect implemented improvements. 14.0 Handling, Storage, Packaging and Delivery 14.1 11.1 12.0 Corrective Action Inspection and Test Status The inspection and/or test status of an order is identified by tag, marking, authorization stamp, or other suit° able means in accordance with written procedures. 11.2 All required tests, inspections, and documentation must be complete before the order can be released for shipment. Inspection documentation may be retained with order packet, or in various Quality Assurance databases as deemed appropriate. Inspection records must provide actual inspection results or a signoff (e.g., approval tags, employee signature or number, approval stamp, etc.) which verifies that the inspection was completed. 11.3 Inspection records identify the individual(s) responsible for releasing conforming product. 14.2 15.0 Products which do not conform to specified requirements are segregated from normal production and clearly identified with the reason for rejection in accordance with approved procedures. Final disposition of nonconforming product may involve rework or repairs to comply with product specifications, scrapping the product under review, or requesting a waiver (concession) from specification. 12.2 Quality Assurance and production review significant nonconformances to determine root cause and to make final disposition on the product in question. 12.3 Requests for waivers are initiated by Quality Assurance and approved by the appropriate management personnel in accordance with approved waiver procedures. 15.2 15.3 16.0 Production follows procedures which protect product from damage, contamination, or deterioration during storage and manufacture. Raw materials and scrap awaiting shipment for disposal or reprocessing are controlled and stored in accordance with written procedures. Quality Records 15.1 Control of Nonconforming Product 12.1 Waivers to deviate from customer requirements must be approved by the customer. Product which is reworked or repaired is reinspected in accordance with approved procedures. 13.1 10.1 11.0 65 Quality records are retained and maintained for the time periods specified in written corporate procedures. Quality records consist of documentation generated during purchase, production, or testing which demonstrates that the required quality levels were met or that the quality system in place was effective. Quality records are stored in a manner which assures legibility and facilitates sorting. Adequate storage facilities are provided which prevent deterioration or loss. Internal Quality Audits 16.1 16.2 16.3 The company conducts periodic audits of operations to ensure conformance to the Quality Manual and selected procedures. In addition, the company conducts periodic product audits on material in inventory in accordance with approved Quality Assurance procedures. The Quality Assurance manager conducts internal quality system audits to assure conformance to relevant company procedures. Quality system audits are conducted in accordance with written procedures. Audit results are reported to appropriate levels of management for review. Management personnel in the department audited are responsible for corrective action responses in a timely manner. 66 17.0 18.0 TOTAL QUALITY MANAGEMENT MANUAL Training 17.1 The company maintains procedures for identifying training needs and provides for the training of personnel performing activities affecting quality. 17.2 Training records and job requirements are documented and retained by the department manager or the Human Resources function. 17.3 Individuals assigned specific tasks which impact quality are qualified based on education, training, or experience, as appropriate. Statistical M e t h o d s 18.1 Statistical methods are employed, as appropriate, to facilitate problem identification and analysis and the control, improvement, or qualification of processes or systems. 18.2 When employed, statistical methods are conducted in accordance with internal procedures or accepted standard practice. 18.3 Management is responsible for providing adequate training for those employees using or interpreting statistical results. 18.4 Statistical methods may include, but are not limited to: 18.4.1 Pareto analysis 18.4.2 Process capability analysis 18.4.3 Statistical process control 18.4.4 Design of experiments 18.4.5 Regression analysis Distributor Industry Quality Assurance Manual INTRODUCTION their intended function so that the company is recognized as a quality leader in the industry. It is the responsibility of company senior management to communicate the corporate quality policy throughout the company. 1.2 The company's Quality Assurance is organized to be independent of production. Quality Assurance, working in conjunction with company management, has the responsibility and authority to: 1.2.1 Initiate action to prevent the shipment of nonconforming product; 1.2.2 Identify and record any product quality problems; 1.2.3 Initiate, recommend, or provide solutions through designated channels; 1.2.4 Verify the implementation of solutions; and 1.2.5 Control further acceptance or shipment, of nonconforming product until the deficiency or unsatisfactory condition has been corrected. 1.3 The quality system outlined in this manual is reviewed annually by company management and revised or reaffirmed as appropriate. Compliance is evaluated through quality system audits in accordance with documented procedures. Audits are performed by trained personnel independent of the function being audited. 1.4 The company's Quality Assurance Manager functions as the management representative and has the responsibility and authority for assuring that the requirements of this manual are implemented and maintained. 2.0 Quality System 2.1 The company's quality system is documented and implemented through the following documents: 2.1.1 Quality Manual--Defines the scope of the company's quality system and provides overall direction to the development of the company's procedures. 2.1.4 Procedures--Provides direction to help the operating departments comply with the Quality Manual by defining specific company requirements or providing general technical guidance. 2.1.6 Work Instructions--Provides specific directions for the completion of tasks affecting quality. 3.0 Order Review 3.1 All orders are reviewed to assure that adequate instructions exist to fully understand the customer's requirements. 3.2 A thorough review of the requirements is made to compare them with existing requirements from the same customer. Quality plans are modified as required. 3.3 Records of quotations, purchase orders, engineering drawings, customer specifications and other documentation will be maintained in accordance with written procedures. 4.0 Document Control 4.1 The company shall maintain procedures which describe the approval process for all product drawings proce- IN MY OPINION the ANSI/ASQC Q9003-1994 a n d ISO 9003 standards fall short w h e n specifying quality system requirem e n t s for final inspection a n d test facilities that typically are the general description of 80% of the distributor industry. I n reviewing the use of the s t a n d a r d guidelines in Q90001994, Q94 r e c o m m e n d s they use Q9003-1994 w h e n conform a n c e to specified r e q u i r e m e n t s are to be assured by the supplier solely at final i n s p e c t i o n a n d test. One would apply Q92 w h e n c o n f o r m a n c e to specified r e q u i r e m e n t s is to be assured by the supplier d u r i n g p r o d u c t i o n a n d installation. Very few distributors get involved in p r o d u c t i o n (i.e., mac h i n i n g or installation). However, m a n y are involved in services such as metallic coatings a n d parts kitting (the practice of c o m b i n i n g two or more different parts to make a whole, such as m a k i n g a kit consisting of five M20 b y 2.5 by 8 0 - m m heavy hex structural bolts, five M20 by 2.5 heavy hex nuts, a n d five h a r d e n e d washers). Therefore, I i n c l u d e d sections i n the quality m a n u a l that provide for the control of these activities. D I S T R I B U T O R S H I P QUALITY A S S U R A N C E MANUAL Table of Contents 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8. 0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0 Management Responsibility Quality System Order Review Document Control Purchasing Product Identification and Traceability Inspection and Testing Inspection, Measuring, and Test Equipment Inspection and Test Status Control of Nonconforming Product Corrective Action Handling, Storage, Packaging, and Delivery Quality Records Internal Quality Audits Training Statistical Techniques 1.0 Management Responsibility 1.1 It is the policy of the company to market and provide products of such quality that they will reliably perform 67 68 TOTAL Q U A L I T Y M A N A G E M E N T M A N U A L 4.2 4.3 4.4 4.5 5.0 dures and specifications received by customers and regulatory agencies. These procedures also cover the approval of revisions to these documents. Company document control procedures describe how and where documents are maintained throughout the facility and the method used to collect and dispose of outdated documents. Procedural controls are documented and assure that: 4.3.1 Procedures are reviewed by those affected and any issues resolved before the procedure is approved by authorized personnel and issued; 4.3.2 Distribution is controlled and documented so that all recipients are notified of procedural changes; 4.3.3 Revisions to a procedure are reviewed and approved by the originating author or function, and the nature of the change is documented where practical; 4.3.4 Procedures are reviewed periodically to assure they are still current. Unless otherwise stipulated, the Quality Assurance department is responsible for the control and issue of all procedures which impact product quality. Quality Assurance maintains an index of all procedures that affect the quality of our distribution and service to customers. ing quality. Inspection and test will normally consist of the following elements: 7.1.1 ReceivingInspection 7.1.1.1 7.1.1.2 7.1.1.3 Purchasing Control The purchase of supplies, components, finished products or services is performed in accordance with written procedures which ensure that: 5.1.1 Purchasing documents clearly identify the product or service being purchased, including information regarding type, style, class, or grade, where such information is appropriate; 5.1.2 Special requirements, such as specifications, drawings, reference standards, technical data, or quality system/certification requirements are stated on the purchase order; 5.1.3 Purchase orders are reviewed for completeness and approved prior to release; and 5.1.4 An approved supplier list is used to select suppliers. The selection of suppliers for inclusion on the approved supplier list is dependent upon the type and criticality of product or service provided. Supplier evaluations may be based on their participation in the company's "Partners In Quality" supplier certification program or previously demonstrated capability and performance. 5.2 The company may conduct source inspection at a supplier's facility when stipulated in the purchase order. The supplier retains responsibility for quality regardless of such inspection. 5.3 Incoming audits may be initiated by Quality Assurance to assure conformance to dimensional, metallurgical, marking, and cosmetic requirements. 7.1.3 FinalInspection 5.1 6.0 Product Identification and Traceability 6.1 6.2 6.3 7.0 Incoming materials are identified with a unique batch or lot number as appropriate in accordance with written procedures. Each order or batch of product is identified with a unique traceability code which is maintained throughout all stages of storage through shipping. Finished orders and/or finished order packaging is marked with the traceability code and/or a date code in accordance with written procedures. Inspection and Testing 7.1 Quality Assurance is responsible for approving inspection and test procedures to assure incoming and outgo- Quality Assurance is responsible for implementing adequate controls at receiving inspection. These controls may include 100% incoming inspections, audits, or reviews of supplier certification reports. Quality records of incoming inspections, tests, or certifications are retained in accordance with established record retention procedures. Except as noted below, the warehouse and distribution functions follow procedures which prevent the storage or shipment of incoming materials until all receiving inspection requirements are met. Quality Assurance may release material for inventory before incoming inspections or material evaluations are completed. If this is done and subsequent receiving inspections identify a discrepant condition, the material must be quarantined for further review and disposition. 7.1.3.1 Final inspection is conducted, as required, in accordance with approved Product Quality Plans, internal procedures, work instructions, or control plans. 7.1.4 CertificationInspection 7.1.4.1 Product certifications are completed by Quality Assurance in accordance with specific customer requests a n d requirements. 7.1.4.2 Certificates of conformance must be approved by the facility Quality Assurance Manager or his designate. 7.1.5 Nonconforming product found during inspection is identified, segregated from normal process flows, and placed on hold pending further review and disposition. 7.1.6 Inspection and test results are documented. Inspection results are retained and are traceable to the order. 8.0 Inspection, Measuring and Test Equipment 8.1 Quality Assurance is responsible for the control and calibration of measurement and test equipment and fixtures, including employee owned gauges, which are used to verify product quality. 8.2 Quality Assurance may select, or participate in the selection of, new gauging and test equipment and ensures that the gauging is of the proper type, accuracy, and repeatability for the intended measurement. 8.3 Calibrations are performed at prescribed intervals, using certified measurement standards traceable to the National Institute of Standards and Technology (NIST) or equivalent. Where standards do not exist, the basis or method for verifying accuracy is documented. 8.4 Calibration procedures are written which describe the frequency and method of calibration, the required equipment, whether or not an outside service is employed, records to be retained, applicable acceptance standards, and the actions to be taken when results are unsatisfactory. CHAPTER IO--DISTRIBUTOR INDUSTRY QUALITY ASSURANCE MANUAL 6 9 8.5 Quality Assurance maintains a gauge identification and calibration scheduling system. The gauge scheduling system includes the type and serial number of the gauge to be calibrated, its physical location within the company, and the date when the next calibration is due. Records of all calibrations are maintained. 8.6 Quality Assurance maintains metrology laboratory facilities for gauge, fixture, and test equipment calibration. Metrology facilities provide adequate security, environmental controls, and appropriate storage facilities to safeguard gauge masters, gauges under calibration, and gauging not currently in use. 9.0 Inspection and Test Status 9.1 The inspection and/or test status of an order is identified by tag, marking, authorization stamp, or other suitable means in accordance with written procedures. 9.2 All required tests, inspections, and documentation must be complete before the order can be released for shipment. Inspection documentation may be retained with order packet, or in various Quality Assurance databases as deemed appropriate. Inspection records must provide actual inspection results or a sign-off (e.g., approval tags, employee signature or number, approval stamp, etc.) which verifies that the inspection was completed. 9.3 Inspection records identify the individual(s) responsible for releasing conforming product. 10.0 Control of Nonconforming Product 10.1 Products which do not conform to specified requirements are segregated from the normal process flow and clearly identified with the reason for rejection in accordance with approved procedures. Final disposition of nonconforming product may involve rework or rejection to the supplier to comply with product specifications, scrapping the product under review, or requesting a waiver (concession) from specification. 10.2 Quality Assurance reviews significant nonconformances with the supplier to make final disposition on the product in question. 10.3 Requests for waivers are initiated by the supplier's Quality Assurance representative and reviewed with our customer by our quality assurance management in accordance with approved waiver procedures. 10.3.1 Waivers to deviate from customer requirements must be approved by the customer. 10.4 Pro.duct which is reworked is reinspected in accordance with approved procedures. 11.0 Corrective Action 11.1 Corrective action procedures are used to identify, analyze, and eliminate conditions which adversely affect service quality. 11.2 Requests for corrective action may be initiated as the result of recurring customer complaints, poor service quality, or any other issue where improvement is required. 11.3 Corrective action procedures consist of the following elements: 11.3.1 A clear, concise description of the problem or concern. 11.3.2 Appropriate containment actions as required to prevent further instances of the problem. 11.3.3 An analysis of the problem for the purpose of determining root cause. Problem analysis may include a review of individual processes or pro- 12.0 13.0 14.0 15.0 16.0 cess flows, Service Quality Plans, failure mode and effects analyses, customer returns data, quality records, or other pertinent information. 11.3.4 Development and implementation of permanent corrective actions to prevent a recurrence. 11.3.5 Provisions for follow-up to assure that corrective actions are implemented and effective. 11.4 Quality Assurance documentation, such as procedures, work instructions, Service Quality Plans, or control plans, are updated as appropriate to reflect implemented improvements. Handling, Storage, Packaging, and Delivery 12.1 All processes follow procedures which protect product from damage, contamination, or deterioration during product receipt, storage, and packaging. 12.2 Product awaiting shipment for disposal or reprocessing are controlled and stored in accordance with written procedures. Quality Records 13.1 Quality records are retained and maintained for the time periods specified in written procedures. 13.2 Quality records consist of documentation generated during purchase, rework or testing which demonstrates that the required quality levels were met or that the quality system in place was effective. 13.3 Quality records are stored in a manner which assures legibility and facilitates sorting. Adequate storage facilities are provided which prevent deterioration or loss. Internal Quality Audits 14.1 The company conducts periodic audits of all processes to ensure conformance to the Quality Manual and selected procedures. In addition, the company conducts periodic product audits on material in inventory in accordance with approved Quality Assurance procedures. 14.3 Audit results are reported to appropriate levels of management for review. Management personnel in the department audited are responsible for corrective action responses in a timely manner. Training 15.1 The company maintains procedures for identifying training needs and provides for the training of personnel performing activities affecting quality. 15.2 Training records and job requirements are documented and retained by the department manager or the Human Resources function. 15.3 Individuals assigned specific tasks which impact quality are qualified based on education, training, or experience, as appropriate. Statistical Methods 16.1 Statistical methods are employed, as appropriate, to facilitate problem identification and analysis and the control, improvement, or qualification of processes or systems. 16.2 When employed , statistical methods are conducted in accordance with internal procedures or accepted standard practice. 16.3 Management is responsible for providing adequate training for those employees using or interpreting statistical results. 16.4 Statistical methods may include, but are not limited to: 16.4.1 Pareto analysis 16.4.2 Gauge and test equipment repeatability and reproducibility studies 16.4.3 Statistical process control Part 5: Fastener Quality Assurance Act 11 Public Law 101-592 ON 16 NOV. 1990, President George Bush signed into law HR-3000, enacting Public Law 101-592 (hereafter referred to as the Fastener Quality Act, or FQA). The FQA was necessary in large part because there exists in the fastener industry those who are more interested in making money in fraudulent ways than in conducting business in an ethical manner. The business practices of these individuals included supplying fasteners with false certifications, unauthorized material substitutions, head marks inconsistent with performance levels, and other deviations from the standards they represented. This phenomenon surfaced during the mid-1980s, and because of the seriousness of the consequences of applying substandard fasteners, the U.S. Government became involved. The results of misapplied fasteners included: loss of life, human injury, equipment failure--including military tanks, and millions of dollars in costs associated with these losses. All of this could have been avoided if those who purchased the fraudulent fasteners had applied TQM principles. The fastener industry could have escaped becoming a regulated industry with all the added costs to the industry and to the American taxpayer if good business practices had existed. Many in the industry are bitter, and who can blame them? From a quality professional's point of view, I am both elated and disappointed by the result. On balance, however, I am more disappointed because the absence of continuous improvement in operations resulted in unnecessary costs. The added costs will affect the American taxpayer more than the fastener industry. As I read the FQA, I see easy compliance for those companies who follow the TQM guidelines discussed in this book. The vast majority of companies in the fastener industry are well positioned to comply with the FQA, with minor corrections to their operating practices. The minority contains a mix of companies willing to change their operating philosophy to comply, as well as those who will still attempt to circumvent compliance. A brief summary of the FQA would be appropriate and beneficial to those not familiar with its provisions. To date, the FQA is not in effect. There are still recommended amendments under consideration before the U.S. Senate. These amendments were recommended to Congress by a group of industry experts appointed to the Fastener Advisory Committee (FAC) by the Commerce Department. The FAC includes members from fastener manufacturers, distributors, users, testing laboratories, and standards organizations. The group is diverse and, as should be expected, did not always agree on what the FQA should contain. However, in spite of their differences they were able to reach consensus on many of their original points of contention. The FAC introduced three amendments to the House of Representatives. The three areas of concern were: (1) chemical testing, (2) sale of fasteners with minor deviations from standard, and (3) lot segregation. CHEMICAL TESTING The way the FQA is now prepared, it is necessary to conduct a chemical analysis on each shipping lot of fasteners covered by the FQA. The industry practice has been to apply the certified mill test report of chemistry to all lots of fasteners manufactured from the heat of steel applicable to that mill certification. This has been accepted by both manufacturers and users because fastener manufacturing has no affect on the original material's chemistry. If the requirement of providing a chemistry test on each shipping lot was imposed, it is estimated by the FAC that this would add between $100 million and $266 million to the cost of doing business. MINOR DEVIATIONS Many fastener specifications and standards now permit the use of fasteners that may contain minor deviations. Provisions exist within the standard or specification that require full disclosure from the seller to the buyer. This makes good economic sense when the deviation would have absolutely no impact on form, fit, or use for the fastener's intended application. The FQA as currently written would not allow the sale of fasteners with deviations from standard. It does not make sense for a Governmental body who knows nothing about fasteners or the engineered application of fasteners to have final judgment as to acceptance. This decision should be left to the fastener manufacturer and his customer! The FAC estimates the cost of this change of practice to the industry to be between $200 million and $1 billion. LOT SEGREGATION This area of the FQA has perhaps generated the most polarity among the FAC. At the present time, distributors commingle lots of like grades (property classes) of fasteners. This could mean different lots from the same manufacturer or 73 74 TOTAL Q U A L I T Y M A N A G E M E N T MANUAL t h a t lots from different fastener m a n u f a c t u r e r s could be supplied to users u n d e r the p r e s e n t system. This practice removes all t r a c e a b i l i t y w h e n r e c o r d s are n o t m a i n t a i n e d w i t h p r o p e r d o c u m e n t a t i o n b y the distributor. S o m e d i s t r i b u t o r s apply g o o d s o u n d business systems for c o m m i n g l i n g , while others do not. So as n o t to place an u n n e c e s s a r y b u r d e n on all distributors, the FAC has r e c o m m e n d e d t h a t the provision for iot t r a c e a b i l i t y be m a d e v o l u n t a r y for distributors. W h i l e fasteners offered for sale w o u l d be f r o m a c c e p t e d lots meeting the specification/standard requirements, a d i s t r i b u t o r could c o m m i n g l e fasteners f r o m different lots. If r e q u i r e d b y an application, a c u s t o m e r could go to a d i s t r i b u t o r w h o m a i n t a i n s lot control to o b t a i n fasteners f r o m segregated lots. The first two r e c o m m e n d a t i o n s were accepted b y the House. The Senate a p p r o v e d all three r e c o m m e n d a t i o n s on 16 M a r c h 1994. The battle continues as of this writing on 10 July 1994 over i n c l u s i o n of the v o l u n t a r y lot segregation provision as r e c o m m e n d e d b y the FAC. W h a t fasteners are affected b y the FQA? NIST (National Institute of S t a n d a r d s a n d Technology) estimates t h a t as it is n o w w r i t t e n 25% of the fastener m a r k e t is affected. This represents $1.5 billion w o r t h of fasteners a year! The fasteners i n c l u d e d are: • A screw, nut, bolt, or stud having internal or external t h r e a d s a n d l o a d - i n d i c a t i n g washers, m a d e of metal, t h a t is r e q u i r e d b y specification o r s t a n d a r d to be t h r o u g h - h a r d ened a n d is 5 m m o r g r e a t e r in t e r m s of the m e t r i c system o r a q u a r t e r i n c h o r g r e a t e r in t e r m s of the British system. • Screws, nuts, bolts, o r studs having internal or external t h r e a d s t h a t b e a r a g r a d e or p r o p e r t y class identification m a r k i n g r e q u i r e d b y a s t a n d a r d or specification, a n d washers if subject to this s t a n d a r d o r specification. • Any fasteners a d d e d f r o m t i m e to t i m e b y the S e c r e t a r y of Commerce, as necessity dictates. One m a j o r c h a n g e the fastener i n d u s t r y m u s t a d j u s t to is the use of a c c r e d i t e d l a b o r a t o r i e s for testing a n d inspection. This p r o v i s i o n has resulted in a whole n e w i n d u s t r y for NIST. U n d e r the FQA, NIST m u s t a p p r o v e a n d accredit laboratories for i n s p e c t i o n a n d testing of fasteners covered by the FQA. This activity will be a d m i n i s t e r e d t h r o u g h NVLAP (National Voluntary L a b o r a t o r y Accreditation Program). NVLAP held a w o r k s h o p in F e b r u a r y 1993 to g a t h e r inform a t i o n from the fastener i n d u s t r y on i n s p e c t i o n a n d test m e t h o d s a n d requirements. In August 1993 a n o t h e r workshop was h e l d d e s c r i b i n g the contents of a h a n d b o o k t h a t contained administration, operational, a n d technical requirements for fastener i n s p e c t i o n a n d testing laboratories. The FQA will be i m p l e m e n t e d 180 days after the S e c r e t a r y of C o m m e r c e issues final regulations on testing a n d certification, a n d a system has b e e n e s t a b l i s h e d to register m a n u facturers a n d private label insignias for the p u r p o s e of traceability if at t h a t t i m e t h e r e are e n o u g h NVLAP-approved testing laboratories. If there are not, provisions exist for a s i x - m o n t h delay to the effective date of the FQA. I m p l e m e n tation of the FQA will p r o b a b l y o c c u r no s o o n e r t h a n the t h i r d q u a r t e r of 1995. This s h o u l d n o t be a license for the fastener i n d u s t r y to fail to p r e p a r e for i m p l e m e n t a t i o n . S o m e things s h o u l d be c o n s i d e r e d n o w to p r e p a r e to c o m p l y w i t h the FQA, a n d I list s o m e of t h e m here. A full list can n o t be p r e p a r e d at this t i m e due to the u n c e r t a i n t y of the status of the F Q g s provisions. Let us begin at the b e g i n n i n g of the process chain. FASTENER MANUFACTURERS • Apply TQM principles to y o u r organization. • E s t a b l i s h total lot control a n d traceability. • Apply this to all fasteners regardless if t h e y are or are not covered by the FQA. • K n o w y o u r suppliers a n d establish s u p p l i e r qualification procedures. • Register y o u r logo o r m a n u f a c t u r e r ' s identification m a r k with NIST. • M a i n t a i n original test r e c o r d s for ten years. • E s t a b l i s h effective in-house testing criteria. • Use IFI-139 as a guide. A copy of IFI-139 is in Appendix B. • Apply this s t a n d a r d to y o u r outside testing l a b o r a t o r y as well. • P u r c h a s e steel t h a t is specially designed for the u n i q u e req u i r e m e n t s of fastener m a n u f a c t u r i n g . • Use IFI-140 as y o u r steel standard. A copy of IFI-140 is in A p p e n d i x B. • Apply the quality system r e q u i r e m e n t s of ISO 9000 a n d ASME-FAP-1 to y o u r operations. • N a m e s o m e o n e to be r e s p o n s i b l e a n d a c c o u n t a b l e for compliance. TESTING LABORATORIES • Apply TQM principles to y o u r organization. • B e c o m e f a m i l i a r w i t h the following standards: • IFI-139. • ISO/IEC G u i d e 25, General R e q u i r e m e n t s for Competence of Calibration a n d Testing Laboratories. • S t u d y NVLAP certification r e q u i r e m e n t s now. • Apply for NVLAP cet~tification as soon as you are ready. • M a i n t a i n original test records for ten years. • Test records m u s t include: • A d e s c r i p t i o n of the fastener. • P r o d u c t specification a n d lot identification. • The s a m p l i n g s t a n d a r d utilized. • The p r o d u c t i o n lot size a n d s a m p l e size tested. • A s t a t e m e n t of c o n f o r m a n c e or n o n c o n f o r m a n c e . • It m u s t be t a m p e r resistant. • It m u s t be w r i t t e n in English. • Apply the quality system r e q u i r e m e n t s of ISO 9003 (ANSI/ ASQC Q9003-1994) to y o u r operations. FASTENER DISTRIBUTORS • Apply TQM principles to y o u r organization. • E s t a b l i s h lot c o n t r o l a n d lot t r a c e a b i l i t y procedures. CHAPTER l l - - P U B L I C LA W 101-592 • Set procedures to provide traceability to customers who request it. • Know your suppliers and establish supplier qualification systems. • Understand the product standards/specifications for the fasteners you distribute. • Maintain original test records for ten years. • Apply the quality system requirements of ISO 9003 (ANSI/ ASQC Q9003-1994) to your operations. • Name someone to be responsible and accountable for compliance. FASTENER USERS • Apply TQM principles to your organization. • Know your suppliers and establish supplier qualification systems. • Purchase only from suppliers certified through ISO 9000 or ASME-FAP- 1. 75 • Verify that your suppliers are registered in compliance with Section 8 of the FQA. • Verify that the test report comes from an accredited NVLAP laboratory. • Understand your rights under the FQA. • Apply the appropriate fastener standard/specification for your application. • Apply the quality system requirements of ISO 9000 (ANSI/ ASQC Q9000-1994) to your organization. A central theme that applies to the entire fastener industry and market is to apply total quality management principles and establish quality systems that comply with the ISO 9000 and ASME-FAP-1 standards. Application of these systems will provide for accountability, responsibility, and traceability for any fastener supplied through these systems and will assure ease of compliance with the FQA. A copy of the Fastener Quality Act, Public Law 101-592, is provided for the reader in Appendix C. As provided, it does not contain the proposed amendments now before the U.S. Senate. The reader should stay informed and acquire the final version of the FQA as it becomes available. APPENDICES Appendix A: ASTM Standards F 1469, F 1470, and F 1503 (1~ ~) Designation: F 1469 - 93 Standard Guide for Conducting a Repeatability and Reproducibility Study on Test Equipment for Nondestructive Testing 1 This standard is issued under the fixed designation F 1469; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (0 indicates an editorial change since the last revision or reapproval. equivalent, and shall be current to the test equipment's calibration schedule. 1. Scope 1. l This guide describes the steps required to conduct a complete repeatability and reproducibility (RR) study on nondestructive test equipment. This guide is a manual (use of calculator) method. Other methods may utilize the application of computer driven software. 1.2 This guide can be used to evaluate all test equipment that provides variable measuring data. 5. Procedure 5.1 Although the number of operators, trials, and parts may be varied, the following guidelines represent the optimum conditions for conducting a study using the forms in Figs. 1a to ld. 5.2 Select three operators and identify them as Operators A, B, and C. 5.3 Calibrate the test equipment with a certified standard. 5.4 Select ten parts for measurements and number them from 1 to 10, such that the numbers are not visible to the operators. 5.5 Allow Operator A to inspect all ten parts in a sequential order and enter the results in the I st trial column for Operator A of the Repeatability and Reproducibility Data Sheet (Fig. l a). Part number identification and associated data entry shall be performed by an observer. 5.6 Repeat 5.5 with Operators B and C and enter the results in the corresponding 1st trial column for each operator. 5.7 Repeat 5.5 and 5.6 using a random selection of the ten parts. Enter data in the 2nd trial column for each operator. If three trials are needed, repeat the cycle and enter data in the corresponding 3rd trial column for each operator. 5.8 Steps 5.5, 5.6, and 5.7 may be changed to the following when large part size or simultaneous availability of parts is not possible: 5.8.1 Allow Operators A, B, and C to measure the first part and record their readings in the corresponding 1st trial columns for each operator. 5.8.2 Allow Operators A, B, and C to remeasure the first part and record their readings in the corresponding 2nd trial columns for each operator. If three trials are to be used, repeat the cycle and enter the results in the corresponding 3rd trial columns for each operator. 5.9 If the operators are not available at the same time, the following method may be used. Allow Operator A to measure all ten parts at once and enter the results in the I st trial column for Operator A. Repeat the measurements in a different order and enter the results in the corresponding 2nd and 3rd trial columns for Operator A. Do the same with Operators B and C, as soon as they are available entering their data in their corresponding 1st, 2nd, and 3rd trial columns. 5.10 Make all necessary calculations on the Repeatability and Reproducibility Data Sheet (Fig. l a) and Repeatability and Reproducibility Report (Fig. lb). For clarity, Figs. lc and ld are provided as examples. 2. Terminology 2.1 Definitions: 2.1. I repeatability--the variation in the values of measurements obtained when one operator uses the same gage for measuring identical characteristics of the same parts. 2.1.2 reproducibility--the variation in the average of measurements made by different operators using the same parts. 3. Significance and Use 3.1 This guide is recommended for the purpose of evaluating test equipment that may be utilized in statistical process control, testing laboratories, and for in-process control of manufacturing operations. 3.2 Ask the question: What effect does the operator have on the measurement process? If possible, the operators who normally use the test equipment should be included in the study. If operator calibration of the equipment is likely to be a significant cause of variation, then the operator should recalibrate the equipment prior to each group of readings. 3.3 The test equipment should provide direct readings in which the smallest digit is no larger than one tenth of the tolerance of the characteristic being evaluated. 3.4 It is recommended that a test equipment repeatability and reproducibility study be a mandatory part of all test equipment purchases and that acceptance criteria be <10 % for certification and statistical process control (SPC) use. 4. Equipment Certification 4.1 Test equipment shall be certified through use of certified standards as accurate to the manufacturer's/user's calibration systems with certified standards before a repeatability and reproducibility study is performed. 4.2 Certifications must be traceable to the National Institute of Standards and Technology (NIST), or recognized t This guide is under the jurisdiction of ASTM Committee 1:-16 on Fasteners and is the direct responsibility of Subcommittee F16.93 on Quality Assurance Provisions for Fasteners. Current edition approved Feb. 15, 1993. Published April 1993. 81 q~ F 1469 Operator A Sample # 1st Trial 2nd Trial Operator C Operator B RanRe 3rd Trial Ist Trial 2nd Trial Range 3rd Trial 1st Trial 2nd Trial 3rd Trial Ranl~e 1 2 3 4 5 6 7 8 9 10 Totals L F I L I ~R,A I =R,C I ~A= I I ~,A= I I Y B: I ~,Bol R × × R~B D-4 = UCL-R* ] R,c I Y.C= I ~,col # Trials D-4 2 3.27 3 2.58 ] I I X,A X,c Y. R A , B , C Reference : The D-4 Constant is obtained from the table of Factors for X-Bar, R charts, page 12, Western Electric Statistical Quality Control Handbook. dif Notes : FIG. la Gage Repeatability and Reproductibility Data Sheet 82 ~ F 1469 Operator A Sample # 1 2 3 4 5 6 7 8 9 10 Totals 1st Trial 2nd Trial 35.6 35.5 36.1 36.3 36.2 35,9 36.2 35.8 35.8 35.9 359.3 35.7 35.5 35.9 36.2 36.2 36.0 36.1 35.7 35.8 36.1 359.2 Operator C Operator B 3rd Trial Range 0 0.I 0 0.2 O. I 0 O.I 0.I 0, I 0 0,2 0.9 1st Trial 36.3 35.8 35.9 2nd Trial 36.1 35.7 36.1 36,0 36.3 35.6 35.7 36.4 36.2 36.0 360,2 35.8 36.2 35.5 35.7 36,3 36.3 36.0 359.7 3rd Trial Range 0.2 0.1 0,2 0.2 0.I 0.I 0 0.I O. I 0 I.I 0 Ist Trial 2rid Trial 35.7 35.9 36.1 35.8 36.3 36.2 35.5 35.8 36.0 35.7 359 35.8 36.0 35.9 35.5 36.3 36.0 35.7 36.0 36.1 35.7 359 L I -s ~.A= 1 ~ ZB= 0 0.1 0.1 0.2 0.3 0 0.2 0.2 0.2 0.1 0 1.4 ~ [ 0.14 ~ ~,B= ~ - - ~ - ] ~,. 0.09 R × D-4 = UCL-R" [ R~B 0.11 0.113333 × 3.27 = 0.3706 rC 0.14 [ ~, c = ~-g3-'--] # Trials D-4 ,A 35.925 2 3.27 1B 35.995 3 2.58 ~C 35.9 0.34 Reference : The D-4 Constant is obtained from the table of Factors for X-Bar, R charts, ~= Range =R,A X,A= ~ y. ~ A ~ B T C 3rd Trial 0.113333 page 12, Western Electric Statistical Quality Control Handbook. 35.995 Max 35.9 ~Un dif Notes: FIG. lb Gage Repeatability and Reproductibility Data Sheet 83 0.095 ¢l~ Part Name : Part Number : Characteristic: F 1469 Date Performed By: File Name : Gage Name : Gage No. Specification : From Date Shnet : ~= [ Measurement Unit Analysis Repeatability - Equ~ment Variation ( E. K ) F~W. = ( R )x( K - 1 % E.V. = ) = = =1 ( ) X ( ) ] I::iiiiiiiiiii~i~i~:ii~:iiiii!iiiil Reproducflbillty - Appraiser Variation A.V. = 4.56 3.05 :~ililililiii~iiiii!!!i!ii~iili~i~ilili~il 2 3 [iiiiiiiiiiiii~i~i~i~:iiiiiii*ii!i] 3.65 2.7 n = # parts r = # trials E.V. 100 [( [ ) / ( 100 I( Tol )1 ) /( )l ( A . V. ) ~[(Xdif) × ( K - 2 )]' - [(E.V,)2 / (. × r)l] = =[ ToleranceAna~l,~ % ] % A.V.= 100 [( = 100 [( g.V. ) / ( Tol ) / ( )] )1 =[ Repeatability and Reproductibility ( R & R ) R&R ffi ~ ( % E V 2 ) +(%A V. 2 )1 I ( ( E V.) 2 + ( A . V . ) 2 ) = ~(()2 + 02 ) =[ ] * Guidelines for acceptance are referenced in "Measurement System Analysis" by A.I.A.G., 1990, page 46. All ' calculations are based upon predicting 5.15 sigma (99.0% of the area onder the normal distribution curve). A . V . ifa negative value is calculated onder the square root sign, the apprmser variation (A.V.) defaults to Zoro (0). FIG. lc Part Name : Part Number : Characteristic: • Guidelines for acceptance are: Under 10% errm - gage system O.K. 10°,6 - 30% *='ror - may be acceptable besed on ~ of application, cost of gage, cost of r ~ , etc. Ovex 30% error - Gage system needs i m i ~ v e m e ~ Make evory effort to im~tffy the problems and have them omected. Gage Repeatability and Reproductibility Data Sheet 1/2 - 13 x 4 A490 A490 - 15 Hardness Gage Name : Gage No. : Specification : Rockwell Tester XYZ HRC 33 - 38 F.mDa. S..,: I °'1'3333 I Xdif = ] Measurement Unit Analysis Sepea~Ulty - F~uipr,~t Variation ( E. V. ) ]~V. = ( = =1 ( 0.095 Tolerance:[ ] 5 [ % Tolerance Am~tsis % E.V. = R )x( K - l ) 0.113333 )X (4.56) 0.5168 ] 03/11/92 Date Performed By: : File Name [ii::i:ii:i~i~!iiiI [iiiiiiiiiiiii~i~::~ii~~i~~::] 2 4.56 [ I 3 3.05 I IOO [( = E.V. lOO[( o.sz6s 1 I ) / ( Tol )1 )/( s )1 10.34 Reproductibility . Appraiser Variation ( A. V. ) A.V. = % A~V. = ~[(Xdif) x ( K - 2 )}a . [ ( E V )z / (n x r)]} = =l = 0.228994 I [~::~:ii:~i~~i~ ili: ~ ~~ili!:::i:~!i!i] 3.65 n = # parts [ 2.7 [ 100 [( E.V. ) / ( 100 [( 0.2289938 ) / ( = I Tol 5 )l )l 4.58 r = # trials Repeatability and Reproductibility ( R & R ) R&R = ((E.V) 2 + (A.V.) 2 ) = ~(%E.V.2 + ( % A . V . 2 )] = ~[(106. 8329) + (20. 97526)] ((0.5168) 2 + (0.228994) 2 ) 0.565261 [ = [ * Guidelines for ar,ceptaace are refereneed in " M ~ o n t System Analysis" by A.I.A.G., 1990, page 46. All calodations are based upon wedicti~ 5.15 sigma (99.0% of the area under the normal distribution curve). A.V. if a negative value is calculated under the square root sign, the appraisor variation (A.V.) defaults to Zero (0). IL3% • Guidelines for acceptance are: Undor 10% en~r - gage system O K . 10%- 30% error - may be aoceptable based on importance of application, cost of gage, cost of repairs, etc. o v ~ 30% error - Gage system ueeds iml~vemont. Make every effot~ to indontify the pfoblezns and have then corrected, FiG. ld Gage Repeatability and Reproductibility Data Sheet 84 ~I~ F 1469 ibility percentage between 10 and 30 % shall be reviewed by a qualified technician. If possible, the testing system should be improved or replaced; however, the system may continue to be used as is until an improvement is found. 6.1.3 Test equipment with a repeatability and reproducibility percentage greater than 30 % is unacceptable. Take immediate corrective action to replace or improve the testing system. 6. Analysis of Results 6.1 Evaluate the data following the steps on the data sheets to determine if the test equipment is acceptable for its intended application. The criteria for acceptability is dependent upon the vercentage of part tolerance that is consumed by the test equi, ment error. Acceptability is based upon the following criteria 6.1. l Test equipment with a repeatability and reproducibility percentage of l0 % or less is fully capable and may be used for certification testing. 6.1.2 Test equipment with a repeatability and reproduc- 7. Keywords 7.1 repeatability; reproducibility; statistical process control; test equipment The American Society for Testing and Materials takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility. This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years and ff not revised, either reepproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM Headquarters. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend, ff you feal that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards, 1916 Race St., Philadelphia, PA 19103. 85 (~) Designation: F 1470 - 93 ° Standard Guide for Fastener Sampling for Specified Mechanical Properties and Performance Inspection 1 This stanta..rd is issued under the fixed designation F 1470; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (~) indicates an editorial change since the last revision or reapproval. ¢~ NoTE--Title was corrected editorially in November 1993. INTRODUCTION Throughout this guide the terms detection and prevention apply to quality control systems. A brief description of both is provided to assist the purchaser in the application of this guide. The detection system relies on inspection as the primary means of controlling the quality of furnished material. Methods include in-process and final inspection. In-process inspection is typically performed by the individual performing the process and generally includes a first-piece inspection by someone other than the operator. Quality-control inspection may perform audit inspections on the process output during the course of the production run. In addition, a final inspection is performed by quality control inspectors according to a prescribed sample plan. The other sample plans utilize zero defects as their acceptance criteria. The prevention system uses advanced quality planning in addition to many of the techniques used in the detection system. Quality planning incorporates a systems approach to quality control that focuses on defect prevention and continual improvement. In addition, Statistical Process Control (SPC) is usually applied to control the process, thereby reducing the variability of the output. The ISO 9000 standards describe quality system models and either their use or those of the ASQC 90 series (ISO 9000 equivalent) are prevention-based quality systems. 1. Scope ASME/ANSI B I8.18.2M Inspection and Quality Assurance for High-Volume Machine Assembly2 ASME/ANSI Bl8.18.3M Inspection and Quality Assurance for Special Purpose Fasteners 2 ASME-FAP-1 Quality Assurance Program Requirements for Fastener Manufacturers and Distributors 2 ANSI/ASQC Q90 Quality Management and Quality Assurance Standards--Guidelines for Selection and Use2 ANSI/ASQC Q91 Quality Systems--Model for Quality Assurance in Design/Development, Production, Installation, and Servicing 2 ANSI/ASQC Q92 Quality Systems--Model for Quality Assurance in Production and Installation 2 ANSI/ASQC Q93 Quality Systems--Model for Quality Assurance in Final Inspection and Test2 ANSI/ASQC Q94 Quality Management and Quality System Elements--Guidelines 2 2.2 ISO Standards: ISO 9000 Quality Management and Quality Assurance Standards--Guidelines for Selection and Use2 ISO 9001 Quality Systems--Model for Quality Assurance in Design/Development, Production, Installation and Servicing 2 1.1 This guide provides sampling methods for determining how many fasteners to include in a random sample in order to determine the acceptability of a given lot of fasteners. 1.2 This guide is for mechanical properties, physical properties, coating requirements, and other quality requirements specified in the standards of ASTM Committee F-16. Dimensional and thread criteria sampling plans are the responsibility of ASME Committee B18. Therefore, unless otherwise specified in this guide, dimensional and thread fit sampling shall be in accordance with ANSI/ASME BI8.18.3M. 1.3 This guide provides for two sampling plans: one designated the "detection process," as described in 3.1.3, and one designated the "prevention process," as described in 3.1.8. 2. Referenced Documents 2.1 ANSI Standards: This guide is under the jurisdiction of ASTM Committee F-16 on Fasteners and is the direct responsibility of Subcommittee F16.93 on Quality Assurance Provisions for Fasteners. Current edition approved Feb. 15, 1993. Published April 1993. 2 Available from the American National Standards Institute, 11 West 42nd St., 13th Floor, New York, NY 10036. 86 F 1470 ISO 9002 Quality Systems--Model for Quality Assurance in Production and Installation2 ISO 9003 Quality Systems--Model for Quality Assurance in Final Inspection and Test2 ISO 9004 Quality Management and Quality System Elements-Guidelines2 some other nonrandom pattern of points within the control limits. 3.1.12 statistical controlwexists when all special causes of variation have been eliminated from a process and only common causes remain. 3.1.13 test--an element of inspection that generally denotes the determination by technical means of the properties or elements of supplies, or components thereof, and involves the application of established scientific principles and procedures. 3. Terminology 3.1 Definitions: 3.1.1 assembly lot--an assembly lot may consist of a 4. Significance and Use 4.1 Sampling shall be selected in a random manner, ensuring that any unit in the lot has an equal chance of being chosen. Sampling should notbe localized by selections being taken from the top of a container or from only one container of multi-container lots. 4.2 The purchaser should be aware of his supplier's quality assurance system. This can be accomplished by auditing the Supplier's quality system, if qualified auditors are available, or by third-party assessment certification, such as provided by ASME's Fastener Accreditation Program (FAP). combination of different products. As long as the products that make up the assembly are in accordance with 3.1.6, the quantity of assemblies determine the sample size. Example: ten assemblies consisting of a bolt, nut, and a washer would have a lot size of ten if the bolts, nuts, and washers meet the criteria of 3.1.6. However, if any of the components in the assembly are not in accordance with 3.1.6 then the ten assemblies will have to be separated into lots that meet all the requirements of 3.1.6. 3.1.2 common causewcommon cause variation affects all the individual values of the process output being studied. In control chart analysis, it appears as part of the random process variation. 3.1.3 detectionprocess--a past-oriented strategy of quality control that attempts to identify the nonconforming product after it has been produced, and then to separate it from the conforming product. 3.1.4 in-process sampling inspection--a random sample of product drawn from prescribed points to the processing stream (usually characteristic sensitive) and performing specific inspections and tests to determine conformance of the product at that point of the processing stream. 3.1.5 inspection--process of measuring, examining, testing, gaging, or using other procedures to ascertain the quality or state of, detect errors or defects in, or otherwise appraise materials, products, services, systems, or environments to a preestablished standard. 3.1.6 lot a quantity of product of one part number that has been processed essentially under the same conditions from the same heat treatment lot and produced from one mill heat of material and submitted for inspection at one time. 3.1.7 lot sampling inspection~a random sample drawn from a lot and performing specified inspections and tests to determine the acceptability of the lot. 3.1.8 prevention process--a future-oriented strategy that improves quality through continuous improvement activities by directing analysis and action toward correcting the process itself. Prevention utilizes statistical process control and other statistical techniques. 3.1.9 process flow--the current or anticipated sequential process steps required to produce a fastener. 3.1.10 random sampling--when every fastener in the lot has an equal and independent chance of being chosen for the sample. The sample may be returned to the lot if it has not been altered or destroyed during the inspection/test upon completion of sampling. 3.1.11 special cause--special cause variation is intermittent, unpredictable, and unstable. In control chart analysis, it is signaled by a point beyond the control limits, a run, or 5. Ordering Information 5.1 The purchaser shall specify at the time of order inquiry the specification number, issue date, and sampling plan (detection process or prevention process) required from the supplier. 5.2 Guidelines for sampling plan selection are provided in Section 9. 6. Acceptance Criteria 6.1 The acceptance criteria for Table 1 is to accept the lot if zero nonconforming parts are detected, and reject the lot if at least one nonconforming part is detected. 7. Disposition of Nonconforming Lots 7.1 Supplier's Options--The supplier has the following options in dispositioning nonconforming lots: 7.1.1 Lots may be scrapped. TABLE 1 S a m p l e Size NOTE--The acceptance number in all cases is zero defects. Lot Size 2to15 16 to 25 26 to 50 51 to 90 91 to 150 151 to 280 281 to 500 501 to 1200 1201 to 3200 3201 to 10 000 10001 to 35 000 35001 to 150 000 150001 to 500 000 500001 and over Sample Size A B C D 3 4 5 6 7 10 11 15 18 22 29 29 29 29 2 3 4 5 6 7 9 11 13 15 15 15 15 15 1 1 1 2 2 2 3 3 3 4 4 5 6 7 A A A 1 1 1 2 2 2 3 3 3 4 5 A Suppliers shall fumish certified test results ~'om which the shipping lots odginatecl. If certified test reports are not available, then the supplier must default to Sample Size C and conduct the tests required. 87 ~ ) F 1470 7.1.2 Lots may be 100 % sortedand all nonconforming parts removed. 7.1.3 Lots may be reworked or reprocessed to correct the nonconforming characteristic(s), if permitted by specification. See 7.3. 7.1.4 Lots may be "used-as-is" providing the purchaser is informed of the rejectable items and written approval is obtained. This disposition shall be documented with each shipment, including appropriate signatures and dates authorizing the release. tions should have no effect on the fastener's intended application or end tlsc. 7.2 Purchaser'sOptionsmThe purchaser has the following options in dispositioning nonconforming lots: 7.2,1 Lots may be rejected and returned to the supplier. 7.2.2 Lots may be accepted. If nonconforming lots are accepted, the responsibility for the lot is borne by the purchaser, provided the purchaser issues a written deviation to the supplier relieving him of responsibility for the nonconforming product. 7.3 Reinspection--When rework or reprocessing is performed to correct a nonconforming item, that lot shall be reinspected on completion of all rework or processing, using NOTE 1---Caution should be exercised when applying the option to "use-as-is." In the interest of safety and quality, all "use-as-is" condiTABLE 2 Sampling Level for the Detection Process NoTE--Lagend: WA--Where Applicable. NA--Not Applicable. Desc~ption of Contrdi Characteristic Adhesion (coating) Bond (body, nails) Bend (notched bolts) Body bend (track spikes) Breaking strength (eyeboits) Carbide precipitation Case dapth/decarbunzatlon Chemistry a Compression (washer direct tension) Cone proof Drive test Elongation--Machined specimen Extension at failure Grain size c Hardness° Head bend (track spikes) Humidity Hydrogen embrittlemant Impact Lubdcstion Msgnetic permeability Packaging E Plating/coating thickness (weight) Product identification marking F Proof Ioad--FuU size Reduction of areamMachined specimen Rivet bend Rivet flattening Rotational capacity Salt spray e Shear strangth Stress corrosion Surface discontinuities Surface roughness Tensile strength--Full size H Tensile strength--Machined specimen Torque t (prevailing) Torque (torsional strength) Yield strength~Full size Yield strength--Machined specimen Sample LevelA Internally Threaded Parts Externally Threaded Parts C A B C C C C -B C A C C -B C B B C B B -A -C C B B C B C B B B C C C C C C WA NA NA NA NA WA WA WA NA WA WA NA NA WA WA NA WA WA NA WA WA WA WA WA WA NA NA NA WA WA NA WA WA WA NA NA WA WA NA NA WA NA WA NA WA WA WA WA NA NA WA WA WA WA WA NA WA WA WA WA WA WA WA WA WA WA NA NA WA WA WA WA WA WA WA WA WA WA WA WA Non-threaded WA WA NA WA NA WA WA WA NA NA NA WA WA WA WA WA WA WA WA WA WA WA WA WA NA WA WA WA NA WA WA WA WA WA WA WA NA NA NA NA Washers WA NA NA NA NA WA WA WA WA NA NA NA NA WA WA NA WA WA NA WA WA WA WA WA NA NA NA NA WA WA NA WA WA WA NA NA NA NA NA NA '* Quantity of samples is in Table 3, Sample Size. • A certified copy of the material producer's chemical analysis shall be fumished with each shipping lot, and the shipping lot shall have documentation providing traceability to this chemical analysis. It is required that the purchaser of the raw material (used to manufacture) shall verify that the material is the material specified on the purchaseomer. c Grain size shall be included with the material producer's chemical analysis report. o Surface or core, or both, as applicable. All packaging requirements shall be in conformance with the applicable packaging standard. f=Visual inspection for conformance. e Continuous monitoring of salt spray performance in accordance with the recommendation of Table B in Appendix 1 of ASME/ANSI B18.18.2M constitutes compliance with the requirements for salt spray ~ outlined in this table. H Wedge angle or axial test as applicable. t Prevailing torque test includes thread start, all specified torque requirements, and retention of locking feature, when applicable. 88 (1~ F 1470 the same sample plan as used in detecting the nonconformance. The sample shall be inspected for the corrected criteria and any other criteria affected by the rework. The acceptance level shall be in accordance with 6.1. ASQC/ANSI 90, 91, 92, 93, or 94, or ISO 9000, 9001, 9002, 9003, or 9004, the purchaser may specify the prevention process in accordance with Table 3. 8. Selection of Sampling Plans 8.1 Except as specified in 8.2, the detection process sampling level in accordance with Table 2 shall be applied. 8.2 If the purchaser knows through documented evidence that his supplier conforms with ASME/ANSI B18.18.3M, 9. Keywords 9.1 detection systems; fasteners; inspection for mechanical properties; performance requirements; prevention systems; quality requirements; sampling plans; selection and size; statistical process control TABLE 3 Sampling Level for the Prevention Process NoTE--Legend: WA--Where Applicable. NA--Not Applicable. Description of Control Characteristic Adhesion (coating) Band (body, nails) Bend (notched bolts) Body bend (track spikes) Breaking strength (eyebolts) Carbide precipitation Case depth/decarburizatlon Chemistry c Compression (washer direct tension) Cone proof Drive test Elongation--Machined specimen Extension at failure Grain size ° HardnessE Head bend (track spikes) Humidity Hydrogen embrittlemant Impact Lubrication Magnetic permeability Packaging F Plating/coating thickness (weight) Product identification marking e Proof load--Full size Reduction of ares--Machined specimen Rivet bend Rivet flattening Rotational c&pedty Salt spray H Shear strength Stress corrosion Surface discontinuities Surface roughness Tensile strength--Full size I Tensile strength--Machined specimen Torque a (prevailing) Torque (torsional strength) Yield strength--Full size Yield strength--Machined specimen Sample LevelA.a Internally Threaded Parts Externally Threaded Parts D B C D D D D -C D B D D -C D C C D C C -B -D D C C D C D C C C D D D D D D WA NA NA NA NA WA WA WA NA WA WA NA NA WA WA NA WA WA NA WA WA WA WA WA WA NA NA NA WA WA NA WA WA WA NA NA WA WA NA NA WA NA WA NA WA WA WA WA NA NA WA WA WA WA WA NA WA WA WA WA WA WA WA WA WA WA NA NA WA WA WA WA WA WA WA WA WA WA WA WA Non-threaded WA WA NA WA NA WA WA WA NA NA NA WA WA WA WA WA WA WA WA WA WA WA WA WA NA WA WA WA NA WA WA WA WA WA WA WA NA NA NA NA Washers WA NA NA NA NA WA WA WA WA NA NA NA NA WA WA NA WA WA NA WA WA WA WA WA NA NA NA NA WA WA NA WA WA WA NA NA NA NA NA NA A Final inspection of a characteristic may be carded out at any stage of manufacture, provided the characteristic is not subject to change in any further manufacturing or processing operation. Therefore, the testing of those samples may be deducted from the sample leval specified. e Quantity of samples is in Table 3, Sample Size. c A certified copy of the material producer's chemical analysis shall be furnished with each shipping lot, and the shipping lot shall have documentation providing traceability to this chemical analysis. It is required that the purchaser of the raw material (used to manufacture) shall verify that the metedal is the material specified on the purchase order. D Grain size shall be included with the material producer's chemical analysis report. E Surface, core, or both, as applicable. F All packaging requirements shall be in conformance with the applicable packaging standard. o Visual inspection for conformance. H Continuous monitoring of salt spray performance in accordance with the recommendation of Table B in Appendix 1 of ASME/ANSI B18.18.2M constitutes ¢ompikmce with the requirements for salt spray testing outlined in this table. i Wedge angle or axial test as applicable. J Prevailing torque test includes thread start, all specified torque requirements, and retention of locking feature, when applicable. 89 (1~) F 1470 The American Society for Testing and Materials takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility. This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years and if not revised, either reepproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM Headquarters. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards, 1916 Race St., Philadelphia, PA 19103. 90 q~1~ Designation: F 1503 - 94 Standard Practice for Machine/Process Potential Study Procedure I Fhis standard is issued under the fixed designation F 1503; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (0 indicates an editorial change since the last revision or reapproval. quality assurance department shall be available to assist on an as-requested basis. 4.3 New manufacturing processes will not be accepted for use in production with Pp values less than 1.67. If a manufacturing process must be conditionally accepted, a process improvement/product control plan must be developed. 4.3.1 The process improvement/product control plan shall identify specific process improvement activities, which will be implemented to make the process fully capable as well as an interim inspection plan to ensure that nonconforming product is not shipped to a customer. 4.4 Product Specifications: 4.4.1 Prior to any process potential study, the product specifications (nominal dimension and tolerances) must be identified, and an appropriate method of variables type inspection selected. 4.4.2 This practice is limited to bilateral specifications whose distributions can be expected to approximate a n o r m a l curve. This practice should not be applied to unilateral specifications (flatness, concentricity, minimum tensile, maximum hardness, etc.). 4.5 Gage Capability Analysis: 4.5.1 All gaging systems used to evaluate product must have documentation for a gage repeatability and reproducibility study in accordance with Guide F 1469 before the process study is conducted. 4.5.1.1 Gaging systems which consume ___10% of the applicable product tolerance are considered acceptable. 4.5.1.2 Gaging systems which consume over I0 to 30 % of the applicable product tolerance are generally considered to be unacceptable. However, users of this guide may authorize their use depending on factors such as the criticality of the specification in question, the cost of alternative gaging systems, and so forth. 4.5.1.3 Gaging systems which consume more than 30 % of the product tolerance are unacceptable and must be replaced. 4.5.2 All gaging systems must be certified as accurate using standards traceable to NIST. 4.6 Process Parameter Selection: 4.6.1 For studies conducted at the equipment vendor's facility, all process parameters (for example, infeed rates, coolant, dies, pressures, fixtures, etc.) must be established and documented prior to the process qualification test so the requirements of 9.5 can be met. 4.6.1.1 Process parameters may not be changed once a process qualification test has begun. 4.6.1.2 All process adjustments made during the process qualification study must be documented and included with information required in Section l0 of this practice. 1. Scope 1.1 This practice covers the proper method for establishing process potentials for new or existing processes. 2. Referenced Documents 2.1 A S T M Standard. F 1469 Guide for Conducting a Repeatability and Reproducibility Study on Test Equipment for NonDestructive Testing2 2.3 ASME Standard." ASME-FAP-1 Quality Assurance Program Requirements for Fastener Manufacturers and Distributors 3 3. Terminology 3.1 Descriptions of Terms Specific to This Standard." 3.1.1 bilateral specifications--specifications that have both upper and lower values. 3.1.2 Pp---process capability index defined as Z/6a. 3.1.3 Ppk--process capability index defined as Zmin/3~'3.1.4 process parameters--combination of people, equipment, materials, methods, and environment that produce output. 3.1.5 unilateral specifications--specifications that have only upper or lower values. 3.1.6 Z n n u m b e r of standard deviation units from the process average to a value of interest such as an engineering specification. When used in capability assessment, Zusl is the distance to the upper specification limit; Zlsl is the distance to the lower specification limit; and Zmi n is the distance to the nearest specification limit. 3.1.7 g--an estimate of the standard deviation of a process characteristic. 4. Summary of Practice 4.1 A process potential study is conducted to provide a level of confidence in the ability of a machine/process to meet engineering specification requirements. This is accomplished through statistical process control techniques as defined in this practice. 4.2 For new equipment purchases, the purchaser's manufacturing engineering department, or equivalent discipline, shall have primary responsibility for ensuring that the requirements of this practice are met. The purchaser's This practice is under the jurisdiction of ASTM Committee F- 16 on Fasteners and is the direct responsibility of Subcommiltee F16.93 on Quality Assurance Provisions for Fasteners. Current edition approved Feb. 15, 1994. Published April 1994. 2 Annual Book of ASTM Standards, Vol 15.08. 3 Available from American Society of Mechanical Engineers, 345 E. 47th Street, New York, NY 10017. 91 (1~ F 1503 ] SAMPLESIZE/FREQUENCY MATERIAL I PARTNO. I CHARTNO.J FIG. 1 VariablesControl Chart (X and R) NOTEmProcess adjustments are defined as those adjustments made by the process due to internal process gaging (or other sources of feedback control), or by the operator as part of the normal operation of process. 4.6.2 The selection of process parameters is the responsibility of the purchaser's manufacturingengineering or equivalent discipline, or, in some cases, the machine supplier depending on preestablished contractual agreements. 4.6.2.1 The process parameters selected must be consistent with those intended to be used in production. 4.6.3 Process parameters may be systematically varied after a study is completed and additional process qualification studies performed for process optimization purposes. variations that may exist at the purchaser's facility. 5.2 Further comment on the significance of statistical analysis and capability studies can be found in ASME FAP-1. 6. Material Selection 6.1 Material (for example, steel slugs, bar, wire, prefinished parts, etc.) used for process qualification studies shall be selected at random. The variability of material used for process qualification studies should be consistent with the variability of material the machine is likely to see in production. 6.2 Presorting of material is not permissible for process qualification purposes. 6.3 In some cases, process potential results may be influenced by the specific product specifications selected for the study. The specific product selected for qualifying a new manufacturing process should be based on that which will yield the most conservative results. If the relationship between specific product specifications and process potential is unknown, two or more distinct studies should be performed with different products to qualify and accept the new process. 5. Signiticance and Use 5.1 This practice is designed to evaluate a machine or process isolated from its normal operating environment. In its normal operating environment, there would be many sources of variation that may not exist at a machine builder's facility; or put another way, this study is usually conducted under ideal conditions. Therefore, it should be recognized that the results of this practice are usually a "best case" analysis, and allowances need to be made for sources of 92 (1~ F 1503 I FMU I GAGING Capability Assessment: .. Individual Values Moving Range CP = UCL X = LCL X = UCL R = FIG. 2 Cpk = X bar = R bar = Individual and Moving Ranges valid. The root cause(s) of the out-of-control condition(s) must be identified and eliminated and the study repeated. 7.2.3.1 If the out-of-control condition is associated with no more than two subgroups on the range chart, one point on the .~ or individuals chart and the root cause of the 7. Procedure-Process Potential Study 7.1 Operate the process for a sufficient period of time to ensure that the process is stable and all initial setup adjustments are complete. 7.2 Control charting techniques should be utilized to determine the stability and capability of the process. 7.2.1 When possible, a standard X, R chart (Fig. 1) should be used with subgroup size n equals 2 through 5. 7.2.1.1 Sampling frequencies should be established to ensure that all likely sources of variability occur, and can be evaluated within the scope of the process potential study. 7.2.1.2 A minimum of 25 subgroups are required to establish control. 7.2.2 When the quantity of sample measurements cannot be practically obtained, it is permissible to utilize a chart for individuals and moving ranges, Fig. 2.4 7.2.2.1 A minimum of 25 subgroups are required to establish control. 7.2.3 After the study is complete, calculate and plot the control limits, X and /~ (or M/~), for each specification identified in 4.4.1 (see Table 1). If during the study the process was out of control, the process potential study is not Process Average and Range TABLE 1 Calculate the average Range (/~) and the Process Average ~ For the study period, calculate: R = R1 + R2 +. • .+ R, k ~_~, +~2 +...+ ~k k Where k is the number of subgroups, R~ and ,£1 are the range and average the first subgroup, Rz and ,£2 are from the second subgroup, etc. TABLE 2 Process Standard Deviation Estimate the process standard deviation (the estimate is shown as b "sigma hat"). Using the existingsamplesize calculate: Where R is the average of the subgroup ranges (for periods with the ranges in control) and d 2 is a constant varying by sample size, as shown in the table below: 4 of n d2 Understanding Statistical Process Control, Wheeler and Chambers, Statistical Process Controls, Inc., 5908 Toole Drive, Suite C, Knoxville, TN 37919. 93 2 1.13 3 1.69 4 2.06 5 2.33 6 2.53 7 2.70 8 2.85 9 2.97 10 3.08 (1~ F 1503 out-of-control condition is identified and corrected, new control limits may be calculated by excluding the outof-control points. A second study is not required. 7.2.3.2 In some instances, control chart analysis may reveal out-of-control conditions that are inherent to the process. Trends due to tool wear or grinding wheel wear are typical examples. If the cause of the out-of-control condition is known, the out-of-control condition is both repeatable and predictable, and the condition cannot be eliminated, the process potential study may be considered acceptable and Pp and Ppk values calculated in accordance with 8. l through 8.3. process average moves away from nominal, Ppk will decrease. 9.2 The decision to accept or qualify a manufacturing process shall be based on the following criteria: 9.2.1 AcceptbPpk equals 1.67 or greater. Process is capable of consistently producing product within specification, if controlled properly, using statistical process control (SPC) techniques. 9.2.2 Conditional Acceptance--Ppk equals 1.33 to 1.67. Process is marginally capable. SPC techniques may be used; however, special care must be taken to ensure that the process average is as close to nominal as possible. Occasional 100 % sorting of product may be required. 9.2.3 RejectbPpk equals less than 1.33. Process is incapable of producing product within specification. This will require 100 % sorting by the machine operator. 9.3 A process with Ppk < 1.33 may also be accepted if both of the following conditions exist. 9.3.1 Pp >_ 1.67, and 9.3.2 The process is such that the process average can be controlled by the machine operator through normal process adjustments. 9.3.3 The requirements identified in 4.3 shall be imposed on any process that receives conditional acceptance. 9.4 In many cases, capability may vary depending on the degree of control exercised during the study (that is, the type and frequency of adjustments made). The purchaser is responsible for reviewing all adjustments made during the study and ensuring that the same level of control can/will be used in production. 9.5 If the original process potential study is conducted at the equipment vendor's facility, a follow-up study must be performed after the process is set up and running in the appropriate manufacturing facility to confirm results. 8. Calculating Results 8.1 Estimate the process standard deviation as follows: = R/d2 where: d2 =constants for sample size 2 to 10, see Table 2. 8.2 Calculate Pp by dividing the total product tolerance b y 6 ~. 8.3 Calculate Ppk as follows: Ppk = minimum of(USL - X)/3 a or ( X - LSL)/3 a where: USL = upper specification limit, and LSL = lower specification limit. 9. Analysis of Results 9.1 The qualification of a manufacturing process shall be based on a review of the statistical parameters Pp and Ppk. Pp and Ppk are both numerical indexes that provide a measure of a process's variability relative to predefined product specifications. Pp considers the tolerance range only, whereas Ppk considers both the tolerance range as well as how close the process average was to the nominal specification. Pp and Ppk will have the same numerical value when the process average is centered around nominal. As the 10. Documentation 10. l Documentation of each gage repeatability/reproducibility study and process qualification analysis conducted must be forwarded to the purchaser's quality assurance department for review. The American Society for Testing and Materials takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility. This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years and if not revised, either reepproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM Headquarters. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards, 1916 Race St., Philadelphia, PA 19103. 94 A p p e n d i x B: IFI Standards IFI-139 and IFI-140 INDUSTRIAL FASTENERS INSTITUTE 1505 EAST OHIO BLDG. • 1717 E. 9TH ST. • CLEVELAND, OHIO 44114 U.S.A. IFI 125 1.0 SCOPE This standard establishes requirements for quality assurance systems and guidelines for technical competency of fastener testing laboratories. 1.1 REFERENCE 1.2 DOCUMENTS TESTING LABORATORY An organization that performs testing and/or inspection of dimensional, mechanical, chemical, metallurgio cal, and performance characteristics of mechanical fasteners and meets the requirements of this standare;. 1.2.2 FASTENER MIL-STD-45662-Calibration Systems Requirements MIL-STD-1312 - Fasteners, Test Methods MIL I 45208 - Inspection System Requirements MIL Q 9858 - Quality Program Requirements ASTME548 - P r a c t i c e For Preparation of Criteria For Use In The Evaluation of Testing Laboratories And Inspection Bodies ISOGuide25 -General Requirements For The Technical Competenceof Testing Laboratories ISO 9000: Quality Management and Quality Assurance S t a n d a r d s - Guidelines for Selection and Use ISO9003: Q u a l i t y Systems: Model for Quality Assurance in Final Inspection and Test ISO 9004: Quality Management and Quality System E l e m e n t s - Guidelines ASTM F606 - Standard Test Methods For Conducting Tests To Determine The Mechanical Properties Of Externally And Internally Threaded Fasteners, Washers, And Rivets SAEJ429 -Mechanical and Material Req u i r e m e n t s For E x t e r n a l l y Threaded Fasteners ANSI/ASME -Taper Pins, Dowel Pins, Straight B18.8.2 Pins, Grooved Pins, and Spring Pins Including The Double Shear Testing IFI100/107 -Prevailing-Torque Type Steel Hex and Hex Flanged Nuts IFI 124 -Test Procedure for the Locking Ability Performance of NonMetallic Locking Element Type Prevailing-Torque Lock Screws Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. DEFINITIONS 1.2.1 MECHANICAL FASTENER A mechanical device designed specifically to hold, join, couple, assemble, or maintain equilibrium of single or multiple components. Common families of fasteners include nuts, bolts, rivets, screws, pins, washers, and special parts. 1.1.1 S P E C I F I C A T I O N S AND STANDARDS The following specifications and standards served in part as resources in the creation of this IF1-139 standard: IFI STANDARD -Test Procedure for the Locking Ability Performance of Chemical Coated Lock Screws 1.2.3 INSPECTION Inspection of a fastener is the activity to evaluate and measure the required characteristics and properties which, by way of drawings, standards, or specifications, constitute the fastener's engineering definition. 1.2.4 INSPECTION PLAN A pre-established combination of inspection and testing to be performed including frequency, sample size, method, and acceptance criteria. 1.2.5 F A S T E N E R QUALITY Fastener quality is conformance of a fastener or fastener lot within its specified tolerances, limits, and requirements. Any fastener manufactured completely within its specified limits, regardless of how narrow or broad, is a "quality" fastener. 1.2.6 F A S T E N E R PRECISION The narrowness of its specified limits establishes whether or not it may be considered a "precision" fastener. Quality should not be confused with precision, which is the r e s u l t of being manufactured to close tolerances. 1.2.7 FASTENER LABORATORY ACCREDITATION Formal recognition that a laboratory has demonstrated capabilities to meet or exceed the requirements of this standard. This capability will be verifled by the completion of an on-site survey by a recognized laboratory accreditation body or agency. 1.2.8 STANDARDS/SPECIFICATIONS Fastener standards/specifications define the requirements for a mechanical fastener. These may include, as applicable, the dimensional, chemical, metallurgical, mechanical, and performance characteristics. QUALITY ASSURANCE REQUIREMENTS FOR FASTENER TESTING LABORATORIES Allstandards and specifications are advisory only. Their use by anyone is entirely voluntary.Reliance thereon for any purpose by anyone is at the sole risk of that personorthe user of the product, and the IFtis not responsible for any loss, claim IF1-139 Page 1 of 5 Issued: January, 1991 Revised: specifications, the I FI has not ~nvestigated and will not i nvestigate patents which may apply to the subject matter. Prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement liability which may arise out of such use. or damage arising therefrom. In formulating and approving standards and 97 INDUSTRIAL FASTENERS INSTITUTE 1505 EAST OHIO BLDG. • 1717 E. 9TH ST. • CLEVELAND, OHIO 44114 U.S.A. 1.2.9 CERTIFICATION The procedure by which written assurance is given that the chemistry, dimensional characteristics, mechanical properties, metallurgical properties, and performance characteristics conform to applicable standards and/or specifications and that data exists to assure those statements. 1.2.16 PERFORMANCE TESTING Tests conducted to verify th&t the functional design features of the fasteners which satisfy the specification requirements are present. Performance properties of the fastener may include, but are not limited to, fatigue, corrosion resistance, torque-tension, locking, drilling, thread forming, and sealing. 1.2.10EQUIPMENT CALIBRATION All testing equipment, measuring devices and gages used to inspect fasteners for conformance to standards/ specifications shall be controlled and, at specified periods, checked to assure maintenance of accuracy within specified limits. All checks and calibrations shall be traceable to applicable national or international standards. 1.2.17 METALLURGICAL EXAMINATION The evaluation of metallurgical characteristics imparted to fasteners through material selection, forming, and heat treatments. The evaluation may include such items as chemistry, grain size, microstructure, decarburization, effective case depth, and throughhardness. 1.2.18PHYSICAL PROPERTY TESTING These properties are inherent in the basic raw material and generally are unchanged or only slightly altered in the fastener following manufacture. Such properties are typically electrical resistivity, thermal conductivity, density, coefficient of thermal expansion, and magnetic susceptibility. 1.2.11 LOT OF FASTENERS A lot is a quantity of a fastener product having a single lot number produced consecutively at the initial operation from a single mill heat of material and processed essentially at one time by the same process in the same manner so that statistical sampling is validl 1.2.19 VISUAL EXAMINATION Macroscopic examinations are those which are used to examine general workmanship and the presence of surface discontinuities such as quench cracks, forging cracks, bursts, shear bursts, seams, folds, voids, tool marks, nicks, and gouges. 1.2.12 FASTENER TEST An activity during which chemical, mechanical, physical, metallurgical, or performance characteristics are evaluated to determine if they conform to the requirements of the standard, specification or purchase order. 1.2.13 TEST REPORT A fastener test report is a record including those characteristics which relate to the standards and/or specifications of manufacture. These items may include, as applicable, material certification, heat analysis, heat number, mechanical properties, metallurgical characteristics, performance requirements, surface discontinuities, and dimensions. 2.0 ORGANIZATION The f a s t e n e r l a b o r a t o r y shall be a b l e to demonstrate technical competency for those tests for which it seeks accreditation. A fastener testing laboratory shall have an organization/structure, functional responsibilities, levels of authority, and lines of communication for activities affecting quality. This shall be documented. 1.2.14DIMENSIONAL INSPECTION Actual measurement of product dimensions and/or geometry using as appropriate micrometers, dial indicators, comparators, functional gages, or other devices suitable for measurement or size conformation. 1 . 2 . 1 5 M E C H A N I C A L TESTING V e r i f i e s the mechanical properties which identify the reaction of a fastener to applied loads. These properties are the result of the manufacturing methods and metallurgical treatments employed for a given material. Typical mechanical tests are tensile (axial/wedge), yield, hardness, proofload, torsional strength, creep, stress rupture, shear, and ductility. IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. The quality assurance manager shall report to the highest operating officer in the company, division or organization, and have autonomy from influences by persons responsible for production. A description of the history of the organization, the type of users served and geographic areas served shall be available. 3.0 STAFF 3.1 There shall be a written job description for each technical position in the laboratory. The description QUALITY ASSURANCE REQUIREMENTS FOR FASTENER TESTING LABORATORIES All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the I FI is not responsible for any loss. claim or damage arising therefrom. In formulating and approving standards and IF1-139 Page 2 of 5 Issued: January, 1991 Revised: specifications, the I FI has not investigated and will not investigate patents wh ich may apply to the subject matter. Prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement liability which may arise out of such use, 98 INDUSTRIAL FASTENERS INSTITUTE 1505 EAST OHIO BLDG. • 1717 E. 9TH ST. • CLEVELAND, OHIO 44114 U.S.A. shall detail necessary education, training, technical knowledge and experience. accordance with the applicable requirements of the related standards, specifications, or purchase order for conformance. 3.2 A file shall exist for each employee which summarizes education, training and experience. Additionally, the file shall include evidence of the capability of each employee to perform specific tests, inspections and measurements. 6.0 FASTENER LABORATORY INSPECTION EQUIPMENT AND PROCEDURES 8,1 M I N I M U M 4.0 TRAINING Training for personnel involved in fastener evaluation shall be organized to reflect disciplines of fastener inspection and testing which are: dimensional, mechanical, performance, chemical and metallurgical. Where personnel certification is required, evidence of that certification shall be made available to the auditor. Fastener geometry Proof load Surface hardness Thread acceptability Tensile strength 5.0 QUALITY SYSTEM DOCUMENTATION The quality system shall be fully documented in a quality assurance manual or an appropriate set of documents. The elements of this manual or these documents shall include but not be limited to: • organization structure • organizational chart • quality organizational chart • facililties • scope of operation • outside services • statement of quality policy, authority, and frequency of review • proficiency testing • duties and responsibilities of personnel • personnel qualification and training • test procedures • document and change control • equipment list • calibration procedures • environment • control of test samples • procedure to handle technical complaints and/ or discrepant test results • equipment repair and maintenance • control of subcontractors • audit procedure • fraud and falsification control 5.1 Q U A L I T Y A S S U R A N C E Decarburization/ carburization Coating thickness Core hardness Surface discontinuities Characteristic Equipment Dimensional Measurements Gage Blocks Outside Micrometers Inside Micrometers Calipers Thread Gaging Rockwell, Vickers, or Brinell Tester Tensile Tester Hardness Tensile and Proof Decarburization/ Microscopic or microCarburization hardness Microscopic, magnetic, Coating thickness columetric Surface discontinuities Per specification Machining capabilitY shall be in place to prepare test specimens. T E S T I N G Accreditation of a 6.2 P R O F I C I E N C Y laboratory will require participation in an approved fastener proficiency testing program that verifies the laboratory's ability to achieve consistently accurate test results on standardized fasteners. 6.3 SUBCONTRACTING INSPECTION: CERTIFICATION REQUIREMENT For fasteners to be certified, they must meet chemical, mechanical and dimensional requirements as designated in the AND SPECIFICATIONS There shall be evidence that all fasteners are evaluated in Published and issued by the I n d u s t r i a l Fasteners Institute of Cleveland, Ohio. TEST CAPABILITY Equipment required shall at least include for applicable characteristics: 5.2STANDARDS IFI STANDARD REQUIRED A fastener laboratory must have appropriate measuring and testing equipment or access to that equipment and must be able to conduct the inspections or tests according to the applicable specifications. This includes the following measuring and testing capabilities. QUALITY ASSURANCE REQUIREMENTS FOR FASTENER TESTING LABORATORIES IF1-139 Page 3 of 5 Issued: January, 1991 Revised: AIIstandardsand specificationsare advisoryonly.Theiruse byanyoneisentirely voluntary.Reliancethereonfor any purposeby anyoneis at the sole riskof that personorthe userof theproduct,andtheIFIis notresponsibleforanyloss,claim or damagearising therefrom. In formulatingand approvingstandards and specifications,theIFIhasnotInvestigatedandwillnotinvestigatepatentswhich may apply to the subject matter, Prospectiveusersof the standardsand specificationsare responsible for advising themselves of and protecting themselves against any patent infringementliabilitywhich may arise out of such use. 99 INDUSTRIAL FASTENERS INSTITUTE 1505 EAST OHIO BLDG. • 1717 E. 9TH ST. • CLEVELAND, OHIO 44114 U.S.A. 7.4 Measuring and test equipment and measurement standards shall be calibrated at periodic in:~,. vals established on the basis of stability, purpose and degree of usage. Calibration intervals shall be defined for each type of measuring or testing equipment or measurement standard and documented in written procedures. Calibration intervals shall be reviewed and modified as required based on the evidence of previous calibrations. A program for recalibrating measuring and testing equipment shall be developed. Operational checks of testing equipment prior to use should be made between recalibrations. standards and/or the engineering drawings to which they were manufactured. A laboratory may be accredited even if it does not have all equipment required by the product standard to inspect fasteners, provided it uses exclusively a laboratory accredited in the subcontracted test or measurement. The laboratory ultimately issuing the fastener certification, and doing the majority of the tests is liable for the validity of that entire certification even if it subcontracts part of the inspection. The issuer of the certification is responsible for using only accredited laboratories. Inspection equipment and specific procedure requirements are determined, at least to a degree, by the specifications governing the fasteners being inspected and tested. For this reason, the laboratory must have a defined procedure to analyze the fastener specifications and d e m o n s t r a t e capabilities to inspect and test to fulfill the re. quirements of the applicable specifications. 6.4 ADDITIONAL T E S T I N G CAPABILITIES It is recognized that at least 52 separate tests for fasteners exist based on current specification requirements. A list of these tests are included for reference in Appendix A. A summary of mechanical fastener inspection including item for inspection, equipment commonly used and related specifications is in Appendix B. 7.5 Calibration records shall be maintained. The records shall identify the schedules and procedures followed. The records shall include a suitably identified individual file of calibration listing at least a description of the testing equipment or measuring system, the calibration interval, date and results of last calibration. 7.6 Testing equipment or measuring systems which require certification of calibrations shall have a calibration report or certificate which identifies it as such. 8.0 ENVIRONMENT IN THE LABORATORY 8.1 Measuring and testing equipment and measurement standards shall be calibrated and used in a controlled environment as applicable. Temperature, humidity, vibration, fumes, dust, illumination and other controllable factors potentially affecting precision measurements shall be identified and controlled. When applicable, compensating corrections shall be applied to calibration results obtained in an environment different from standard conditions. 7.0 CALIBRATION OF EQUIPMENT A documented equipment calibration system is required for testing laboratories which test or evaluate fasteners. 7.1 Each piece of measuring and testing equipment shall have a unique identification and be calibrated as appropriate prior to being put into service. 7.2 The calibration system shall be designed to assure that measurement results are traceable as applicable to national standards and/or international standards. Where applicable national or international standards do not exist, the testing laboratory shall establish and perform tests to prove accuracy of equipment. 8.2 Adequate storage facilities for equipment, standards and records shall be provided. Adequate steps shall be taken to ensure good housekeeping in the testing laboratory. 9.0 HANDLING TEST SAMPLES A system for identifying the items to be tested shall be used to ensure that no confusion regarding identity occurs during testing. Each item shall be maintained by manufacturing lot number or a unique number assigned by the testing laboratory traceable to a manufacturing lot number. 7.3 Reference standards shall be calibrated and be traceable to national or international standards. Reference or traceable standards used for calibration shall not be used for other purposes. IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. QUALITY ASSURANCE REQUIREMENTS FOR FASTENER TESTING LABORATORIES IF1-139 Page 4 of 5 Issued: January, 1991 Revised: All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, claim or damage arising therefrom. In formulating and approving standards and specifications, the i FI has not investigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement liability which may arise out of such use. 100 INDUSTRIAL FASTENERS INSTITUTE 1505 E A S T O H I O B L D G . • 1717 E. 9 T H ST. • C L E V E L A N D , There shall be a written policy regarding receipt, retention and disposal of samples tested. • identification of the product specification and test conducted • any deviations, additions to or exclusions from the test specification, and any other information relevant to a specific test • disclosure of any non-standard test method or procedure utilized • statement of conformance or non conformance to applicable specifications • listing of range of actual test results for given lot samples including the number of samples examined (all actual test results on file) • name and title of person(s) accepting technical responsibility for the test report and the date of issue • a statement that the report shall not be reproduced in part or in full without the approval of the testing laboratory, or alternately a system shall be in place to prevent unauthorized test report reproduction. 10.0 RECORDS A system shall be in place to record the dimensional, mechanical and performance testing event by date, equipment and operators. Each event shall be traceable to the manufacturer's lot number or purchase order. Records shall be legible, identifiable and retrievable and shall be retained for ten years. All records and test reports shall be maintained in such manner as to preserve their confidential nature. Adequate steps shall be taken so that test reports, certificates and other records are preserved and protected against loss and damage. 11.0 CERTIFICATIONS AND TEST REPORTS 11.1 TEST REPORTS Testing laborabory data shall be included in a report which accurately, clearly, and without prejudice presents the recorded parameters, the actual test ?esults, and all other relevant information. This report shall identify the standards and specifications applicable to the particular lot being tested and the number of pieces tested, and, in those cases where the importer or private labeled distributor assumes the responsibility for inspec. tion and testing, a letter from the manufacturing source indicating the standards or specifications to which the lot was manufactured. 11.2.2 LOT CERTIFICATION For lot certification the report shall include all of the information in paragraph 11.2.1 and information which includes lot number, lot size and sample test size and the basis of that sample selection. 11.3 Particular care and attention shall be paid to the arrangement of the test report, especially with regard to presentation of the test data and ease of assimilation by the reader. The format shall be carefully and specifically designed for each type of test carried out, but the headings shall be standarized as far as possible. 11.2 Each fastener test report shall include at least the following information: 11.4 Corrections or additions to a test report after issue shall be made only by a further document suitably marked, e.g. "Supplement to test report serial number....(or otherwise identified)," and shall meet the relevant requirements of the preceding paragraphs. 11.2.1 SAMPLE TEST REPORT • name and address of testing laboratory • unique identification of report and of each page of the report • name and address of the client • description and identification of the tested item, including manufacturer's name and address which shall be furnished by the source request. ing the testing • manufacturer's lot number • a statement to the effect that the test results relate only to the items tested IFI STANDARD and issued by the Industrial Fasteners Institute of Cleveland, Ohio. Published O H I O 4 4 1 1 4 U.S.A. 11.5 Certifications - The laboratory shall issue a written statement of assurance that the test report is complete and valid, and shall disclose the approved accrediting body in accordance with Section 6 of Public Law 101-592 applicable to its accreditation including its date of its expiration. QUALITY ASSURANCE REQUIREMENTS FOR FASTENER TESTING LABORATORIES All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, claim or damage arising therefrom. In formulating and approving standards and IF1-139 Page 5 of 5 Issued: January, 1991 Revised: specifications, the I FI has not investigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement liability which may arise out of such use. 101 APPENDIX A FASTENER TESTING Dimensional I1. Mechanical and Performance Testing 1.) Shear 2.) Proof Load 3.) Widening 4.) Tensile a.) Wedge b.) Axial 5.) Hardness a.) Macro b.) Micro 6.) Impact 7.) Torsional 8.) Torque/Tension 9.) Ductility 10.) Fatigue 11.) Drive 12.) Elongation 13.) Stress Rupture 14.) Hydrogen Embrittlement 15.) Proof Torque 16.) Torque- To Clamp Ratio 17.) Pull Through 18.) Push Out 19.) Twist 20.) Compression 21.) Clamp Load Torque 22.) Breakaway Torque 23.) Prevailing Torque 24.) Flow Lines I° 102 25.) 26.) 27.) 28.) 29.) 30.) 31.) 32.) 33.) 34.) 35.) 36.) 37.) 38.) 39.) 40.) 41.) 42.) 43.) 44.) 45.) 46.) 47.) 48.) 49.) 50.) 51.) 52.) Macro Etch Inclusions Kesternich Humidity Salt Spray Magnetic Particle Liquid Penetrant X-ray Ultrasonic Eddy Current Adhesion Chemical Stripping Chemical Drop Creep Rotational Capacity Vibration Drill Screw Chemical Analysis Case Depth Decarburization/ Carburization Grain Size Minimum Tempering Temperature Yield Magnetic Permeability Reduction of Area Part Elongation Thread Laps Thread Forming APPENDIX B MECHANICAL FASTENER INSPECTION I. Minimum Requirements A. DIMENSIONAL INSPECTIONS Feature Equipment Specification Threads Indicating Type Ring Gages ANSI BI.3M FED-STD-H28/20 M I L-S-7742 M I L-STD-8879 Linear Measurements Gage Blocks Outside Micrometers Inside Micrometers Calipers Plug Gages Tri-Micrometers MIL-STD-120 Angle and Radii Optical Comparators Functional Gages Radius Charts MIL-STD-120 Thread Runout Functional Gages Hex Socket Size Wall Thickness Hex Socket Depth Functional Gages Fixture and Dial Indicator Dial Indicator ANSI/ASME B18.3 ANSI/ASME B18.3 ANSI/ASME B18.3 Test Equipment Specification Hardness Rockwell Tester ASTM-E18 MIL-STD-1312-6 Micro-Hardness Micro-Hardness Tester Preparation Equipment ASTM-E92 ASTM-E384 MIL-STD-1312-6 ASTM-E3 Tensile and Proof including specimens Tensile Tester ASTM-F606 SAE-J429 SAE-J995 MIL-STD-1312-8 Discontinuities Macro-etch Microscope Magnetic Particle Liquid Penetrant ASTM F788 ASTM F812 SA E-J 122 SAE-J123 MIL-STD-1949 M IL-STD-6866 ASTM-E340 ASTM-E709 ASTM-E165 Stress Durability (Hydrogen Embrittlement) Torque Wrenches Test Plates Test Washers M IL-STD-1312-5 ASTM F606 Decarburization/ Carburization Macro-etch Microhardness SAE J419 ASTM A574 ASTM F606 B. PHYSICAL TESTING 103 C. CHEMICAL ANALYSIS II. Material Equipment Specification Steel Carbon Determiner Spectrometer ASTM-E30 Additional Requirements (when applicable) A. DIMENSIONAL Feature Recesses Equipment Recess Penetration Recess Wobble Specification ANSI/ASME B18.6.4 Straightness Straightness Gage IF1-136 ANSI/ASME B18.3 ANSI/ASME B18.2.1 Thread Runout Thread Runout Gage IF1-136 ANSI/ASME B18.2.1 Flat Head Protrusion Protrusion Gage ANSI/ASME B18.6.4 ANSI/ASME B18.6.2 Hex Head Height (across corners) Gaging Ring ANSI/ASME B18.6.4 Slotted Nut Slot Gage ANSI/ASME B18.2.2 Coating/Plating Thicknessss Various Microscopic MIL-STD-1312-12 ASTM-B487 Magnetic Tester ASTM-499 Coulometric Tester ASTM-B504 Test Equipment Specification Shear Tensile Tester Universal Tester Hydraulic Press ASTM-F606 MIL-STD-1312-13 MIL-STD-1312-28 MIL-STD-1312-20 Double Shear Shear Block and Support Block or Fixture ANSI/ASME B18.8.2 Impact Impact Tester ASTM-A540 ASTM-A370 Magnetic Permeability MU Gage MIL-STD-17214 ASTM A-342 Torsional Strength Torque Wrench Torque Fixture ANSI/ASME B18.6.4 ASTM-F738 Hex Socket Strength Torque Wrench Fixture ASTM-F880 ASTM-F912 Recess Torsional Strength Torque Wrench Fixture MIL-B-87114 MIL-STD-1312-25 B. PHYSICAL TESTING 104 Test Equipment Specification Ductility Ductility Block SAE-J78 SAE-J81 IF1-112 IF1-113 Salt Spray Salt Spray Cabinet ASTM-B117 MIL-STD-1312-1 Cas Depth Macro-etch Microhardness SAE-J423 Torque-Tension Torque Wrenches Load Cells SA E-J 174 IF1-101 MIL-STD-1312-15 Tensile (elevated temp) Tensile Tester w/heater MIL-STD-1312-28 Double Shear (elevated temp) Tensile Tester or Hydraulic Press w/heater MIL-STD-1312-18 Humidity Humidity Cabinet MIL-STD-1312-3 Vibration Vibration Tester M IL-STD-1312-7 Fatigue Fatique Tester MIL-STD-1312-11 Drill Drive Testing Drill-Drive Tester SAE-J78 IF1-113 Thread Forming Torque Wrench & Test Block SAE-J81 Clamp Load Torque Test Nut, Test Washer, Load Measuring Device Torque Measuring Device IF1-124 Break Away Torque Test Nut Torque Wrench iF1-125 Prevailing Torque Test Bolt Hardened Washer Torque Measuring Device Test Washer IF1-100/107 Metallographic Analysis: Grain Size Flow Lines Microstructure Metallographic Equipment Plating Adhesion ASTM-B571 Panel Fastener Tests: Push-out Tensile Torque-out Shear Pull-up MIL-STDo1312-22 M IL-STD.1312-23 MIL-STD-1312-24 M I L-STD-1312-26 MIL-STD-1312-27 Fastener Sealing MIL-STD-1312-19 Stress Relaxation M I L-STD-1312-17 105 Test Equipment Specification Stress Corrosion MIL-STD-1312-9 Blind Rivet Tests SA E-J 1200 IF1-114 IF1-116 IF1-117 IF1-119 C. CHEMICAL Material Specification Equipment Aluminum and Alloys ASTM-B316 ASTM-E34 ASTM-E101 ASTM-B211 Brass & Bronze ASTM-E54 Copper & Copper Alloys ASTM-E53 ASTM-E62 ASTM-E75 ASTM-E76 ASTM-E478 Stainless Steel ASTM-E353 Titanium AMS-4928 AMS-4967 AMS-4971 Coating Type ASTM-B568 X-Ray 106 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. INTRODUCTION total affected depth which may not be exceeded is found in Table 6. Free ferrite should not exceed the maximum depth of free ferrite at the worst location. Forming is the primary manufacturing operation in the fastener industry and the term includes heading, upsetting, extruding and forging. These formed parts are produced at very high speeds by metal flow due to machine-applied pressure. The primary forming operation selfinspects the quality of the raw material and imperfections such as seams, laps, and internal pipe which may not be visible are revealed when the material is upset. The absence of bursts, forging cracks and open seams is strong evidence that the quality of material selected was that intended for the severe upsets of today's fastener manufacturing. To prepare a material for cold forming it is often spheroidized, which is an annealing treatment that transforms the microstructure of steel to its softest condition with maximum formability. In the hot rolled or normalized condition, steels containing less than 0.80% carbon consist of the microconstituents pearlite and ferrite. Pearlite, the harder of the two constituents, causes the steels to resist deformation. The harder pearlite is comprised of alternating thin layers or shells of ferrite and cementite (iron carbide), a very hard substance. In spheroidize annealing, the cementite layers are caused by time and temperature to collapse into spheroids.or globules of cementite. This globular form of cementite tends to facilitate cold deformation in such processes as cold heading, cold rolling, forming and bending. RODS & BARS. While standard steel grades for rods and bars have been in existence for many years, and have, with modifications or restrictions of one or more elements, long been used for cold forming, this IFI-140 presents a distinct selected series of twenty steel grades for cold forming. These have been jointly developed by steel producers and cold heading and forging users under the aegis of the Industrial Fasteners Institute. These twenty grades are designated IFI steel grades and the ranges and limits for the thirteen carbon steel grades for carbon, manganese, phosphorus, and sulfur are shown in Table 1. Maximum residual limits for copper, nickel, chromium, molybdenum and tin are specified in paragraph 6.4. Silicon ranges and limits are shown in Table 3. The chemical limits for the seven alloy steel grades are shown in Table 4. Plate 1 displays variations in the transformation of pearlite to spheroidized cementite. Temperature variations within a charge or inadvertent heating either slightly below or slightly above the optimum temperature may produce a departure from the ideally spheroidized structure. Plate 1 displays material treated at a lower than ideal temperature exhibiting a granular structure and is shown at G1 through G5. Material treated at a higher than ideal temperature will exhibit a lamellar structure and is shown as L1 through L5. Latent energy from cold work will allow drawn wire to transform more readily to a higher degree of spheroidization than will hot rolled rod or bar. The degree of spheroidization is normally evaluated at 1,000X magnification. A significant area of improvement is in the decarburization control and measurement for cold heading rods and bars. A method to measure based upon the location of the worst decarburization position is described in paragraph 8.0 and shown in Drawing Number 1. The average IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio, When spheroidize annealed, Cold Heading Rods or Cold Heading Bars shall meet a maximum rating of G-2 or L-2 in Plate 1. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 1 of 23 Issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any lose, claim or damage arising therefrom. In formulating and approving standards end specifications, the IFt has not investigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement liability which may arise out of SlJCh use, ~ 1993 Industrial Fasteners Institute, 107 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. upsets or for standard trimmed hexagon head cap screws. While a fully spheroidized microstructure is desired for forming, material is rarely used in the "as spheroidized annealed" condition. Such material can cause processing difficulties because of its poor coil configuration, the formation of a "shear lip" during shearing, or result in undesirable bending of the fastener shank during cold heading. For these reasons almost all material is given a light wire drawing reduction after the thermal treatment either by the wire producer or in front of the fastener heading operation. Spheroidized structures are also known to retard austenization during short cycle heating, such as induction heating, in a subsequent hardening operation. Additional time may be required to dissolve the spheroidized cementite into the austenite at the heating temperature. As upsetting becomes progressively more demanding, wire drawn from annealed or spheroidize annealed rods is more appropriate. For demanding applications, annealed-in-process or spheroidized annealed-in-process wire is required. For thermally treated in process wire, the final drawing operation may be performed by the wire supplier or incorporated into the cold heading operation by drawing in tandem with that operation. Cold Heading Rods and Bars will not necessarily result in successful production of recess head and socket head quality wire. Wire mills desiring to produce recess head and socket head wire should consult steel manufacturers to secure material with additional restrictive requirements. The tolerances for rod and bar are reduced for IFI grades, reflecting the committee consensus that this feature would significantly improve control of cold working. Out-of-round material may cause localized die wear showing up as wear rings in the drawing die. The elliptical material cross section produces nonuniform cold work stresses around the circumference of the drawn cross section which contributes to distortion of the product and causes hardness variation across the section. Thus, serious efforts are anticipated now and in the future to bring about reasonable economic tolerance improvement. In the production of rods for heading, forging or cold extrusion in killed steels over 0.13% carbon, both austenitic grain size and decarburization are important features. Such steels can be produced either "fine" or "coarse" austenitic grain as required depending upon the type of heat treatment and application. Table 6 shows decarburization limits for the maximum permissible depth of free ferrite and the average total affected depth of decarburization. The examination is conducted as outlined in paragraph 8.0 of this Standard. If decarburization limits closer than those shown in Table 6 are required in a given manufactured product, it is sometimes appropriate for the purchaser to incorporate means for carbon restoration in his manufacturing process. Rods and bars are subject to mill testing and inspection to provide material soundness and freedom from detrimental surface imperfections. These features are required to assure satisfactory p e r f o r m a n c e of the wire produced from rods and bars. Thermal treatment as a part of wire mill processing is very important in the higher carbon grades of steel. Wire "direct drawn" from low carbon and medium low carbon steel wire rods is sometimes successfully used for simple two-blow IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. In cases of disagreement in the testing for decarburization, it is customary to make heat treatment tests of the finished product to d e t e r m i n e suitability for the p a r t i c u l a r application. CARBON AND ALLOY STEEL WIRE , RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 2 of 23 Issued: April 20, 1993 All standards and specifications are adviSory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpoee by anyone is at the Sole risk of that person or the user of the product, and the IFI is riot responsible for any loss, claim or damage arising therefrom. In formulating and approving standards and specifications, the IFI h i s not investigated and will not investigate patents which may apply to the subject matter, prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement hability which may arise out of such use. ~ 1993 Industrial Fasteners Institute 108 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. Rods and bars should be reasonably free from detrimental surface imperfections including seams, voids, pits, scratches and laps. Material, suitably thermally treated when appropriate, which bursts or splits when upset or formed, and having imperfections deeper than the greater of 0.003" or 0.5% of D (where D is the finished diameter in inches of material), is normally rejectable. of softening the wire. Annealing commonly involves heating the material to temperature near or below the critical temperature. A number of processes are employed which influence the surface finish obtained. If a particular finish is required on wire annealed at final size, the producer should be consulted. Regular Annealing, sometimes called pot annealing, is performed by heating coils of wire in a furnace followed by slow cooling without an attempt to produce a specific microstructure or a specific surface finish. Samples requiring assessment of such surface imperfections shall be prepared by careful metallographic technique, suitably etched, and the depth of imperfection measured radially from the surface at a magnification of 100X. Spheroidize Annealing involves prolonged heating at a temperature near or slightly below the lower critical temperature, followed by slow cooling, with the object of producing a globular (spheroidal) condition of the carbide to obtain maximum softness. Mechanical properties for thermally treated rods and bars are shown in Table 7. Rod size tolerances are shown in Table 9. Annealed in Process Wire is a term normally associated with cold heading wire. The product is manufactured by drawing rod or bar to a size larger than the finished diameter wire, and regular annealing to relieve the stresses of cold work and obtain softening. This is followed by cleaning, coating with a suitable lubricant, and redrawing to finished size, usually with an area reduction of between 7% to 20% depending upon wire size and application. See Table 7 for expected tensile strengths. Bar size tolerances are shown in Table 10. A selected series of steel grades has been developed for carbon steel rods and bars for cold heading and cold forging. See Table 1. WIRE. Wire for cold heading and forging is produced from bars or rods featuring closer than normal control of: chemical composition, size tolerances, decarburization limits, freedom from detrimental surface imperfections, and when appropriate, specified mechanical properties for thermally treated material, see Table 7; and when spheroidized, a maximum rating of G2 or L2, see Plate 1. Spheroidize Annealed in Process Wire is another term normally associated with cold heading wire. The product is manufactured by drawing rod to a size larger than the finished diameter wire, followed by spheroidize annealing to obtain maximum softness and to create a spheroidal structure as shown in Plate 1. The wire is then cleaned, coated with a suitable lubricant and redrawn to finished size, usually with an area reduction of between 7% to 20% depending upon wire size and application. Thermal treatment of wire involves heating and cooling the steel in such a manner as to achieve desired properties or structures. Annealing is the general term applied to a variety of thermal treatments for the purpose IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 3 of 23 Issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the soil risk of that person or the user of the product, and the IFI is not responsible for any lOSS,claim or damage arising therefrom. In formulating and approving standards and specifications, the IFI has not investigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against © 1993 industrial Fasteners Institute any patent infringement liability which may arise out of such use. 109 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 = CLEVELAND, OHIO 44114-2879U.S.A. Decarburization tests are made by the microscopic method described in paragraph 8.0. Table 6 shows the decarburization limits for the maximum depth of free ferrite and the maximum average total affected depth. The limits shown apply to wire made from killed steel over 0.13% carbon. When closer limits are required, it is sometimes appropriate for the purchaser to incorporate means for carbon restoration in his finished product. phate coated at ordered size. Wire phosphate coated at ordered size can be furnished with or without suitable lubricant coatings for subsequent drawing into smaller sizes or for direct use in cold formers. A drawn phosphate finish as discussed in the preceding paragraph, provides a more effective lubrication during cold forming than phosphate coated at finished size. Solid die heading machines, especially those used for extrusion heading, require a coating of special consistency, whereas with open or split die heading machines a light coating will perform satisfactorily. Cold heading finishes are varied considerably even for the same type of heading, in order to meet individual cold heading requirements. Those coatings are individual in character and involve manufacturing techniques that differ markedly from conventional wire mill practice when the only consideration is the provision of lubrication essential for the wire drawing operation. Finishes or coatings are designed to provide proper lubrication for the header dies. With modern developments in cold heading technique, the role of wire finishes has assumed much greater importance. In addition to performing the required upset in the dies, the cold heading operations may now include single or double extrusion, slotting, punching, trimming, pointing, etc. The wire coatings or finishes must have both the necessary lubricating quality and adherence to prevent galling or undesirable die wear. This necessitates special control of the various types of lubricants that are used and the correct amount of coatings for the type of heading operation involved. Size tolerances for wire for cold heading and cold forging are shown in Table 8. Mechanical properties for selected steel grades of wire for cold heading and cold forging when thermally treated are shown in Table 7. Whereas it is appropriate to establish mechanical properties for selected compositions of thermally treated carbon steel rods and bars, mechanical properties of wire drawn directly from rods or bars are substantially influenced by the amount of reduction in drawing the wire. The reduction is dependent on the incremental availability of nominal rod and bar sizes as well as the influence of size tolerances. Accordingly no values are included in Table 7 for wire drawn from annealed or spheroidize annealed rods or bars. Certain steel grades are available with differences in deoxidation practices. Suitable allowances for aluminum killed steel and rimmed steel are incorporated in the footnote to Table 7. The amount of reduction prior to thermal treatment, the size tolerance of the intermediate thermally treated wire, and the required percent While lime-soap finishes are widely employed, phosphate finishes are frequently used for the more demanding forming applications. Phosphate coated wire finishes are produced from material which has been chemically cleaned, coated with zinc phosphate, and suitably neutralized. The stock may be coated with lime or borax as a carrier if the lubricant is to be applied in the die box. The wire lubricant may be applied by immersing the phosphate coated coils in a dilute soluble soap bath, by pickup of a dry lubricant in the drawing die box, or by a combination of both methods. The drawn finish so produced is particularly beneficial in many severe cold working applications, especially those involving backward extrusion. Thermally treated wire can also be supplied cleaned and lime coated or cleaned and phos- IFI STANDARD Published and issued by the Industrial Fasteners institute of Cleveland, Ohio. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IFI-140 Page 4 of 23 issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely ~,ofuntary~ Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, claim or" damage arising therefrom. In formulating and appr~,ing standards and specifications, the IFI has not inv~itigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications are responsible foe advising themselves of and proWcling themselves against any patent infringement liability which may arise out of such use ~ 1993 Industrial Fasteners Institute, 110 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 ° CLEVELAND, OHIO44114-2879 U.S.A. reduction to final size which progressively increases as the final wire size decreases, influence the mechanical properties. An appropriate adjustment in values for annealed in process and spheroidize annealed in process wire as a function of size is included in the footnote to Table 7. include six or more stations permitting the cold forged production of very complex configurations which otherwise would require machining or a combination of forming and machining for their manufacture. Accordingly, it is not appropriate to merely examine the geometry of a finished fastener to establish the appropriate raw material, e.g., hard drawn, wire drawn from annealed rod or bar, or spheroidize annealed in process wire. The method of manufacture is also required information, as is the steel processing for a particular application. Communication between the steel supplier and the fastener producer is therefore of paramount importance to avoid the use of raw material which is unnecessarily costly on the one hand or inadequately processed on the other. Chemical compositions particularly suited to wire for cold heading and cold forging have been developed. For carbon steels these are included in Table 1 and for alloy steels in Table 4. Cold Heading and Cold Forging Wire have five application variations as follows: Cold Heading Recessed Head Socket Head Scrapless Nut Tubular Rivet Cold Heading Wire is produced by specially controlled manufacturing practices to provide satisfactory quality for heading, forging and roll threading. The wire is subject to mill tests and inspection for internal soundness, control of chemical composition and freedom from detrimental surface imperfections. Each of these variations is intended to be well suited to the fabrication of a particular fastener type and fastener manufacturing method. Fastener fabrication includes a wide variety of methods and complexity of machines and tooling. The simplest is a single die, single blow machine, common to the nail machines, but also used for simple shapes such as certain rivets. Single die, two blow machines which first gather stock, then rotate the die, and strike again, are widely used for larger headed rivets and most machine screws and tapping screws. By partitioning the cold work in two separate die cavities, progressively and selectively deforming the raw material, it is thus possible to produce larger overall deformations or upsets, of more complex shapes, without fracture. In many cases, the threads of bolts, screws, studs, etc., are cold formed by an operation known as roll threading. This consists of rolling the shank between rolling dies to provide the particular thread form required. Experience has shown that detrimental internal imperfections and detrimental surface imperfections in the wire will result in a crushed condition or imperfect thread which renders the product unfit for use. Therefore, particular care is required in the manufacture of the wire to provide freedom from detrimental imperfections. Precautions are also required of the fabricators in setting up and adjusting roll threading equipment. Faulty set-up or adjustment can produce defective threads even when the wire is of proper quality. Two die three blow machines permit extruding of the shank, thereby utilizing a larger diameter starting raw material, accommodating the production of larger heads without as much upsetting; or permitting the use of hard drawn wire where annealed material would otherwise have been required. Progressive headers can IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio, Hard drawn low carbon and medium low carbon steel wire is sometimes successfully used for simple two-blow upsets or for standard trimmed hexagon head cap screws. As upsetting CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IFI-140 Page 5 of 23 Issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, claim or damage arising therefrom. In formulating and approving standards and specifications, the iFI has not investigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications ere raspensible for advising themselves of and protecting themselves against any patent infringement liability which may arise out of such use. 1~1993 Industrial Fasteners Institute, 111 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. becomes progressively more demanding, wire drawn from annealed or spheroidized annealed rods is more appropriate, For demanding applications, annealed in process or spheroidize annealed in process wire is required. For thermally treated in process wire, the final drawing operation may be performed by the wire supplier or incorporated into the cold heading operation by drawing in process in tandem with that operation. Cold Heading wire is not appropriate for recessed head or socket head application. jected to mill tests and inspection designed to provide internal soundness and freedom from detrimental surface imperfections, thus providing satisfactory cold heading, cold expanding, cold punching, and thread tapping characteristics. This wire is produced for the manufacture of various shaped nuts, which are made in continuous operation on heading machines. The cold heading operation in the production of scrapless nuts is very severe, and the wire is specially prepared for that purpose. Recessed Head Wire is employed when screw heads incorporate a recess configuration such as a crossed or square recess. This wire involves more exacting precautions and controls than Cold Heading wire, such as improved surface quality and special wire processing. Exacting precautions and controls are necessary in the selection and internal soundness of the steel and in the preparation of billets for surface quality. Special attention to rod rolling and to inspection of the rods is essential. In order to provide wire that will be soft enough to withstand the very severe cold forming operations, wire for all types of recess head screws is generally spheroidize annealed in process or spheroidize annealed at finished size, with the final drawing incorporated into the heading operation by drawing in process in tandem with that operation. When spheroidize annealed at finish size wire is so employed, the fastener producer should ensure that the final reduction is not excessive. Low and medium low carbon hard drawn wire or wire drawn from annealed rods or bars is employed, depending on the severity of deformation. Medium carbon wire is normally drawn from annealed or spheroidize bars or rods, or produced annealed in process. For nuts not requiring a final heat treatment, the attainment of minimum required nut proof loads is partially dependent on the raw material, the selection of an appropriate steel grade, and the amount of wire reduction. Tubular Rivet Wire is suitable for cold heading and backward extruding the hole in the shank during cold heading. In order to obtain the properties essential for the production of tubular rivets, the wire is spheroidize annealed in process but with a final redrawing operation somewhat heavier than normal to prevent buckling in the extruding operations. Accordingly, the mechanical properties shown in Table 7 may not always be appropriate for spheroidize annealed in process tubular rivet wire. Wire may also be furnished spheroidize annealed at finished size with the final drawing incorporated into the heading operation by drawing in tandem with that operation. Wire finish to accommodate the individual conditions of severe cold extruding and cold heading is an important consideration. Tubular Rivet wire is normally produced from low carbon aluminum killed steel. Socket Head Wire is similar to Recessed Head wire but is intended for the deep sockets attendant with hexagon and TorxTM and similar internal drives, requiring still more exacting processing and controls to accommodate the substantially heavier deformation. Scrapless Nut Wire is produced by closely controlled manufacturing practices, and sub- IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 6 of 23 Issued: April 20, 1993 All standards and specifications ere advisory only. Their use by anyone is entirely vOluntary. Reliance thereon for any purDose by anyone is at the sole risk of that person or the user of the product, and the tFI is not responsible for any loss, claim or damage arising therefrom, in formulating end approving standards and specifications, the IFI has not investigated end will not investigate patents which may apply to the subject matter, prospective uaePs of the standards end specifications are responsible for advising themselves Of and protecting themselves against any patent infringement liability which may arise out of such u s e ~-1993 Industrial Fasteners Institute 112 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. SUMMARY. This IFI Standard has been developed by a joint effort of cooperation between the fastener manufacturer, the raw material manufacturer, and other important fastener industry suppliers. Following IFI approvals and subsequent publication, and in its traditional role of issuing IFI standards, it is intended that IF1-140will be introduced into the National Consensus Standards process. The IFI Raw Materials Study Committee includes: NAME COMPANY lan Park, Chairman Edward Kottcamp, Jr., Past Chmn. John Asimou Edward Frederick Bill Darm James Fox Daniel Bosko John Williams Jeff Easter John Herron Arthur Lukowicz Larry Mercer Michael Starozhitsky Anton Tendler Edward Bueche Ron Fultington Munekazu Tsuji Joe McAuliffe Bryan Burgy Christopher Wackrow Greg Johnson Peter Kasper Dick Adams Brian Murkey Richard Nebiolo Dick Hadden Rick Nishizaki Craig Hagopian Consultant sPs Technologies American Steel & Wire Corporation Bethlehem Steel Brainard Rivet Charter Steel Cuyahoga Bolt & Screw Cuyahoga Bolt & Screw Elco Industries, Inc. Herron Testing Laboratories, Inc. HI-Temp Inc. Huck International, Inc. Illinois Tool Works Inc. Ivaco Steel Mills Ltd. USS/Kobe Steel Company USS/Kobe Steel Company USS/Kobe Steel Company Lake Erie Screw Corp. Medalist Industrial Fastener Division MNP Corporation Nucor Fastener Nucor Fastener Raritan River Steel Co. RB&W Corporation Republic Engineered Steels, Inc. Sidbec-Dosco Inc. Sidbec-Dosco Inc. Stelco Fastener & Forging Co. Stelco Inc. Stelwire A Unit of Stelco Inc. Valleycast, Inc. Walker Wire & Steel Co. Wrought Washer Mfg., Inc. Geoffrey Boal Geoffrey Palmer Ron Ceselli David Zupancic IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IFI-140 Page 7 of 23 Issued: April 20, 1993 All standards arid specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk Of that person or the user Of the product, and the IFI is not responsible for any loss, claim or damage arising therefrom. In formulating and approving standards and specifications, the IFI has not investigated end will not investigate patents which may apply to the subject matter. Prospective users Of the standards end specifications are responsible for advising themselves Of and protecting themselves against any patent infringement liability which may arise out of such use. © 1993 Industrial Fasteners Institute 113 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. ',, SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. 1.0 Scope. 1.7 Conformance of all test data shall be determined in accordance with ASTM E29. 1.1 This specification includes the physical, mechanical and metallurgical requirements for carbon and alloy steel wire, rods and bars in coils intended for the manufacture of mechanical fasteners which include: bolts, nuts, rivets, screws, washers and special formed parts manufactured cold. 1.8 Heat treating terms not defined in this Standard are included in SAE J415. 2.0 Referenced Documents. 2.1 ASTM Specifications: 1.2 Wire size range includes 0.062 inches to 1.375 inches. A 370 Test Methods and Definitions for Mechanical Testing of Steel Products 1.3 Rod size range usually includes 7•32 inches to 47•64 inches and generally offered in 1/64th increments. A 700 Practices for Packaging, Marking and Loading Methods for Steel Products for Domestic Shipment 1.4 Bar size range includes 3/8 inches to 11/2 inches. E 10 Test Method for Brinell Hardness of Metallic Materials E 29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specification 1.5 Sizes for wire, rod and bar outside the ranges of paragraphs 1.2, 1.3 and 1.4 may be ordered by agreement between purchaser and supplier. E 30 Methods for Chemical Analysis of Steel, Cast Iron, Open-Hearth Iron, and Wrought Iron 1.6 Material is furnished in five application variations. The Steel Industry uses the term "quality" to designate characteristics of a material which make it particularly well suited to a specific fabrication and/or application and does not imply "quality" in the usual sense. The purchaser should advise the supplier regarding their manufacturing process and finished product application as appropriate. The five application variations are: E 112 Test Methods for Determining Average Grain Size E 1077 Standard Test Methods for Estimating the Depth of Decarburization of Steel Specimens 2.2 J403 Chemical compositions of SAE carbon steels Cold Heading Recessed Head Socket Head Scrapless Nut - - Tubular Rivet - - - - - - - - J404 Chemical compositions of SAE alloy steels J406 Methods of Determining Hardenability of Steels 1.6.1 Wire is furnished to all five application variations. J415 Definitions of Heat Treating Terms 2.3 1.6.2 Rod and bar are furnished to the single application variation; Cold Heading. IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. SAE Standards: IFI Standards: IFI Spheroidization Rating - - Plate 1 CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IFI-140 Page 8 of 23 Issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the ~ofe risk of that person or the user of the product, and the IFI is not responsiblo for any loss, claim or damage arising therefrom. In fofmulsting and approving standards and specifications, the IFI has not im,estigate(I and will investigate patents which may apply to the subH)ct matter. Prospective users of the standards and specifications ate responsible fOr adviain(3 themselves of and protecting themselves against any patent infringement liability which may arise out of such use r~ 1993 Industrial Fasteners Institute. 114 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST.. SUITE 1105 ,* CLEVELAND, OHIO 44114-2879 U.S.A. 3.0 and drawn, spheroidize annealed in process, and finally lightly drawn to size (SAIP). Wire size tolerances are shown in Table 8. Sizes include those specified in paragraph 1.2. Definitions. 3.1 Carbon Steel: Steel is considered to be carbon steel when no minimum content is specified or required for chromium, molybdenum and nickel, or any other element added to obtain a desired alloying effect; or when the maximum content specified for manganese does not exceed 1.65%. When specified, boron may be added to killed carbon steel with a maximum allowable of 0.003%. 3.6 Spheroidize annealed-at-finish size wire (SAFS) is wire that has been spheroidize annealed after final cold reduction. One or more annealing treatments may precede the final cold reduction. 3.7 Annealed-in-Process (ALP) or Spheroidize Annealed-in-Process (SAIP) wire is produced as drawn carbon or alloy steel wire. In producing AlP and SAIP wire, rods or bars are drawn to wire and thermal treatment (followed by a separate cleaning and coating operation) is done prior to final drawing to produce a softer and more ductile wire for applications in which direct drawn wire would be too hard, Thermal treatment may also be employed when controlled mechanical properties are required for a specific application. 3.2 Alloy Steel: Steel is considered to be alloy steel when the maximum of the range given for Manganese exceeds 1.65O/o or in which a definite range or definite minimum quantity for any of the following elements is specified or required within the limits of the recognized field of constructional alloy steels; chromium, molybdenum, and nickel or any other alloying element added to obtain a desired alloying effect. 3.3 Annealing: Annealing is a process of heating to and holding steel at a given temperature for a given time and then cooling at a given rate, used to soften and/or produce changes in the microstructure of the steel to enhance formability and reduce tensile strength. 3.8 Rods: Rods are produced from hot rolled or cast billets, usually rolled in a multiple strand mill to a round cross section then coiled into one continuous length to size tolerances shown in Table 9. Rods are furnished as-rolled, annealed or spheroidize annealed in sizes found in paragraph 1.3. 3.4 Spheroidizing: Spheroidizing, a form of annealing, involves prolonged heating at temperatures near the lower critical temperature, followed by slow cooling, with the object of forming spheroidal metallic carbides that have a higher degree of formability. 3.9 Bars: Bars are produced from hot rolled or cast billets, or blooms rolled single strand into coils. Bars have a greater precision in cross section than rods. Size tolerances are shown in Table 10. Bars are furnished as-rolled, annealed, or spheroidize annealed and in sizes found in paragraph 1.4. 3.5 Wire: Wire is produced from hot rolled or annealed rods or bars by cold drawing for the purpose of obtaining desired size, dimensional accuracy, surface finish and mechanical properties. Wire is furnished in the following conditions; direct drawn (DD); drawn from annealed rod or bar (DFAR or DFAB); drawn from spheroidized annealed rod or bar (DFSR or DFSB); drawn to size and spheroidized (SAFS); drawn, annealed in process, and finally lightly drawn to size (ALP); IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. 3.10 A lot is defined as a quantity of raw material of one size and heat number submitted for testing at one time, 3.11 Seams: A longitudinal discontinuity extending radially into wire, rod or bar. Seams in raw material used for the manufacture of fas- CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IFI-140 Page 9 of 23 Issued: April 20, 1993 All staff(lards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, claim or damage arising therefrom. In formulating and approving stanclarcls and specifications, the IFI has not investigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement liabitity which may arise out of such use - 1993 Industrial Fastene's Institute 115 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A, 4.4.1.3 Drawn from annealed rod or bar teners or formed parts may lead to the formation of bursts. 4.4.1.4 Drawn from spheroidize annealed rod or bar 3.12 Voids: A shallow pocket or hollow on the surface of the material. 4.4.1.5 Spheroidized at finished size wire 3.13 Laps: A longitudinal surface discontinuity extending into rod, bar, or wire caused by doubling over of metal during hot rolling. 4.4.1.6 Annealed-in-process wire 4.4.1.7 Spheroidize annealed-in-process wire 4.0 Manufacture. 4.1 Melting practice: The steel typically is melted in a basic oxygen or electric furnace process. 5.0 Ordering Information 5.1 Wire orders shall state the following: 5.1.1 Quantity 4.2 Casting practice: Steel may be either ingot cast or strandcast. 5.1.2 Wire diameter 4.3 Deoxidation practice and grain size: 5.1.3 Steel grade 4.3.1 Silicon killed fine grain: Ordinarily produced with aluminum for grain refinement. When vanadium or columbium are used for grain refinement, agreement by the material purchaser is required. 5.1.4 Deoxidization practice and grain size 5.1.5 Application variation per paragraph 1.5 5.1.6 Thermal treatment 4.3.2 Silicon killed coarse grain 5.1.7 Surface coating 4.3.3 Silicon killed coarse grain practice 5.1.8 Coil weight 4.3.4 Aluminum killed fine grain 5.1.9 Coil i.d. and o.d. as required 4.3.5 Rimmed (grain size not specified) 5.1.10 Packaging 4.4 5.1.11 Tagging Thermal treatment: 4.4.1 Material may be furnished without thermal treatment, but when required and depending upon end use, material may be ordered as follows: 5.1.12 Mill certification as required 5.1.13 Special requirements, e.g., steel making method and practice, special shipping instructions, single heat, etc. 4.4.1.1 Annealed Example: 40,000 Ibs., IF1-140, 0.250 inches, carbon steel wire, IFI-1022A, silicon killed 4.4.1.2 Spheroidized IFI STANDARD Published and issued by the Industrial Fasteners institute of Cleveland, Ohio. CARBON AND ALLOY STEEL WIRE,, RODS AND BARS FOR MECHANICAL FASTENERS IFI-140 Page 1 0 ~ 2 3 Issued: April 20, 1993 All standards and specifications are advisOry only. Their use by anyone is entirely voluntary. Reliance thereon lor Shy I~Jrpo~ by anyone is at the ~ risk of that person or the user of the product, and the IFI is not responsible for any loss, ¢lmm or damage arising therefrom. In formulatit~ lind ikoproving starld&rds and specifications, the IFI has riot irMS~igatlrd Ilod will riot investigate patents which may apply to the sul~ect matter. Prospective users of the standards arid specifications are resl)onsibkD lor advising themselves Of and protecting themsoNel against any patent infringement liability which may arise out ol such use ~ 1993 Industrial Fasteners Institute 116 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST ° SUITE 1105 * CLEVELAND, OHIO 44114-2879 U.S.A. coarse grain, Recessed Head, spheroidize annealed-in-process, phosphate and lube, 1500 lb. coils, 28 inch coil i.d., on 18 inch tubular carriers, three bands per carrier, one metal tag per coil, mill certification, do not ship Fridays. 5.2 5.3 Rod orders shall state the following: Bar orders shall state the following: 5.3.1 Quantity 5.3.2 Bar diameter 5.3.3 Steel grade 5.3.4 Deoxidation practice and grain size 5.2.1 Quantity 5.3.5 Cold Heading 5.2.2 Rod diameter 5.3.6 Thermal treatment 5.2.3 Steel grade 5.3.7 Surface coating 5.2.4 Deoxidation practice and grain size 5.3.8 Coil weight 5.2.5 Cold Heading 5.3.9 Coil i.d., o.d., as required 5.2.6 Thermal treatment 5.3.10 Packaging 5.2.7 Surface coating 5.3.11 Tagging 5.2.8 Coil weight 5.3.12 Mill certification as required 5.2.9 Coil i.d., o.d., as required 5.3.13 Special requirements, e.g., steelmaking method and practice, special shipping instructions, single heat, etc. 5.2.10 Packaging 5.2.11 Tagging Example: 90,000 Ibs., IF1-140, 0.610 inches, carbon steel bars, IF1-1038, silicon killed coarse grain, spheroidize annealed, Cold Heading, phosphate & lime, 5,400 lb. coils, 54 inch coil i.d., three bands per coil, one metal tag per coil, lead end of each coil paint red. 5.2.12 Mill certifications as required 5.2.13 Special requirements, e.g., descaling practice, steelmaking method and practice, special shipping instructions, etc. Example: 200,000 Ibs., IFI-140, 21/64 inches, carbon steel rod, IFI-1022B, silicon killed fine grain, Cold Heading, spheroidize annealed, pickled and limed, 3,000 lb. coils, 48 inch coil i.d., compacted and unitized in packages of two, banded with three steel straps per coil, two metal tags per coil attached to lead end on inside of bundle, put separators between coils. IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. 6.0 Chemical Requirements. 6.1 Standard carbon steel compositions are found in standards such as SAE J403 and alloy steel compositions in SAE J404. A number of compositions particularly appropriate to the cold forging industry processes have been developed in a joint producer/user effort and are included in this Standard as IFI designated steel grades. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 11 of 23 issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely VOluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, claim or damage arising therefrom. In formulating and approving standards and specifications, the IFI has not investigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications are responsible for advising themsel~s of and protecting themseNes against any patent infringement fiabilily which may arise out of such use ~ 1993 Industrial Fasteners Institute 117 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105, CLEVELAND, OHIO 44114-2879 U.S.A. The chemical composition range of these IFI grades may not necessarily be identical to those of SAE J403 or SAE J404. Note 1: Cr may be present to 0.20 max. if so specified. Note 2: Mo may be present to 0.06 max. if so specified. 6.2 Cast or Heat Analysis (Formerly Ladle Analysis) - - An analysis of each cast or heat shall be made by the producer to determine the percentage of the elements specified. Tha analysis shall be made from a test sample(s), preferably taken during the pouring of the cast or heat. The chemical composition shall be reported, if required, to the purchaser or his representative. 6.5 IFI Engineered Steel Grades: The carbon steel chemical ranges and limits are shown in Table 1. Permissible variations for product analysis of carbon steel are as shown in Table 2. The silicon limits as influenced by the deoxidation practice are shown in Table 3. The alloy steel chemical ranges and limits are shown in Table 4. Permissible variations for product analysis of alloy steel are shown in Table 5. 6.3 Product Analysis (Formerly Check Analysis) - - A product analysis may be made by the purchaser. The analysis is not used for a duplicate analysis to confirm a previous result. The purpose of the product analysis is to verify that the chemical composition is within specified limits for each element, including applicable permissible variations in product analysis. The results of analyses taken from different pieces of a heat may differ within permissible limits from each other and from the heat or cast analysis. The results of the product analysis obtained, shall not vary both above and below the specified range. 7.0 7.1 When a coarse austenitic grain size is specified, the steel shall have a grain size number of 1 to 5 inclusive, as determined in accordance with Test Methods El12. Conformance to this grain size of 70% of the grains in the area examined shall constitute the basis of acceptance. One test per heat shall be made. A. Grain size requirements do not apply to material ordered to "coarse grain practice." 6.3.1 Rimmed or capped steels are characterized by a lack of uniformity in their chemical composition, especially for the elements carbon, phosphorus, and sulfur, and for this reason product analysis is not technologically appropriate unless misapplication is clearly indicated. 7.2 When a fine austenitic grain size is specified, the steel shall have a grain size number of 5 or higher as determined in accordance with Test Methods El12. Conformance to this grain size of 70% of the area examined shall constitute the basis of acceptance. One test per heat shall be made unless the provision of 7.2.1 is exercised. 6.3.2 For referee purposes, Method ASTM E30 shall be used. 6.4 Residual Limits: Material grades defined in this Standard shall conform to the following residual limits to provide optimum formability and tool life during the cold forming operation: 7.2.1 When aluminum is used as the grain refining element, the fine austenitic grain size requirement shall be deemed to be fulfilled if, on heat analysis, the aluminum content is not less than 0.020% total aluminum or, alternately, 0.015% acid soluble aluminum. The aluminum content shall be reported. The grain size test specified in 7.2 shall be the referee test. Residual limits for Carbon and Alloy Steels Cu Ni Cr Mo Sn IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. = = = = = 0.20 0.10 0.10 0.04 0.02 Metallurgical Structure. max. max. max. (note 1) max. (note 2) max. 7.2.2 If specified on the order, one grain size test per heat shall be made and the austenitic CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 12of23 Issued: April 20, 1993 All standards and specificabons are advisop/only. Their use by anyone is entirely voJuntary. Ratisnce thereon for any purpoee by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, claim or damage wising therefrom. In formulating and approving standards and specifications, the IFI has not investigated and will not investigate patents which may Ikoply to the sul0~ectmatter. Prospective users of the standards and specifications a r e responsible for advising themselves of and protecting themselves against any patent infringement tiability which may arise OUt of such use ~ 1993 Industrial Fasteners Institute 118 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH S [ • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. 8.0 grain size of the steel, as represented by the test, shall be number 5 or higher. Using the basic procedures of ASTM E1077, the entire periphery of a sample prepared of the rod, wire or bar shall be examined for decarburization at a magnification of 100 diameters, unless otherwise agreed to. Free ferrite shall not exceed the maximum depth shown in Table 6. The worst location shall be used to draw perpendicular bisectors, and the depth of decarb at the points where the bisectors intersect the circumference, shall be measured and the four (4) readings averaged as shown in Drawing No. 1. 7.2.3 By agreement between purchaser and supplier, columbium or vanadium or both may be used for grain refining instead of or with aluminum. The maximum contents shall be: Cb V Cb + V Decarburization. 0.05 max. 0.08 max. 0.06 max. The content of the elements shall be reported with the heat analysis and the austenitic grain size test shall be required. 7.3 Spheroidize annealed material shall meet a maximum rating of G2 or L2 in the IFI spheroidization rating - - Plate 1. That average shall not exceed the limits for total affected depth shown in Table 6. Drawing No. 1 I I I i Bisectors @ 90 ° The worst location ~ for "Total Affected Depth" decarburization IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 13 of 23 Issued: April 20, 1993 Aft standards end specifications are advisory only. Their use by anyone is entirely votuntery. Reliance thereon for any purpo6e by anyone is st the sole risk of that person or the user of the product, end the IFI is not responsible for arty Ices, claim or damage arising therefrom, in formulating and approving standards and specifications, the IFI has not investigated and will not investigate patents which may apply to the subject me41er.Prospective users of the standards and specifications are responsible for advising themselves of arid protecting themselves against any patent infringement liability which may arise out of such use. ~!1993 Industrial Fasteners Institute. 119 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. 9.0 10.4 Hardness: May be used as an option when agreed to between producer and purchaser in lieu of tensile/reduction of area testing of wire or bar over 1" in diameter. Test method shall be in accordance with ASTM El0. Hardenability. Hardenability shall be determined in accordance with SAE J406: Methods of Determining Hardenability of Steels. The Appendix A or B of that standard may be used upon agreement between producer and purchaser. 10.5 No individual test value shall be out of specification, and for steels with a maximum specified carbon content over 0.30%, the maximum of the range shall not exceed the minimum by more than 10% in any lot. 10.0 Mechanical Properties. 10.1 Tensile strength is determined using the test methods of ASTM A-370. Values for tensile strength are included in Table 7 for the following conditions: e.g.: (80 KSI - 74 KSI) x 100 74 KSI Test one sample per coil/bundle on at least 20% of randomly selected coils/bundles in the lot, with no fewer than two (2) tests and no more than five (5) tests. Other sampling plans may be employed as agreed upon between the purchaser and the supplier. =,- annealed or spheroidize annealed rod & bar ~- spheroidize annealed at finish size wire =,- annealed-in-process or spheroidize annealedin-process wire 10.6 Traceability shall include the mill order and steel heat number with all specified mechanical data on mill test certification. Material which has not been thermally treated is not usually produced to a specific tensile strength. 10.7 Tensile/reduction in area equipment shall be calibrated and verified in accordance with ASTM A370, and operated by personnel with documented qualifications. The values listed in Table 7 are designed to provide optimum headability and tool life in the cold forming process. Modifications to those limits require agreement between producer and purchaser. Table 7 shows only maximum tensile strengths, however, minimum tensile requirements may be stipulated by agreement between producer and purchaser. 11.0 Size Tolerance. Reducing diameter variability increases control of both the physical and mechanical properties during the forming process. Less variability permits engineering for reduced tool wear and consistent product quality. 10.2 Percent reduction in area is determined by the test method included within ASTM A370. Values for minimum percentages are included in Table 7. 11.1 Wire tolerances are shown in Table 8. 10.3 Yield Strength/Percent Elongation: Used for special applications when agreed upon between purchaser and manufacturer. Method of determination shall be in accordance with ASTM A370. iF1 STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. = 8.1% accept 11.2 Rod tolerances are shown in Table 9. Note: Inherent mill design of rod mills does not permit the same control of size as bar mills CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 14of23 Issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sofa risk Of that person or the user Of the product, end the IFI is not responsible for any loss, claim or damage arising therefrom. In formulating and approving standstX~lSsad specificstione, the IFI has not invmlligated and will riot investigate patents which may apply to the subject matter. Prospective rulers of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement liability which may arise out of such use. ,~.1993 Industrial Fastenecs Institute. 120 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. 11.3 Bar tolerances are shown in Table 10. which bursts or splits when upset or formed, and having impertections deeper than the greater of 0.003 in. or 0.5% of D (where D is finished diameter in inches of material) shall be rejectionable. Samples requiring assessment of such surface imperfections shall be prepared by careful metallographic technique, suitably etched and the depth of imperfection measured radially from the surface at a magnification of 100X. 12.0 Mill Scale/Surface Condition. Material purchased as a hot rolled product shall have mill scale (surface oxides) as light as possible and be readily removable by an acid pickling or mechanical descaling process. The surface shall be free from excessive dirt or contaminants which would impede pickling or contaminate an acid pickle bath. Wire shall be substantially free from rust, shall not be kinked or tangled, and for wire drawn last, shall be properly cast. No welds are permitted, unless otherwise specified. 13.0 Coatings. 15.0 Identification/Tagging. Material coatings are generally used for two purposes: as a vehicle for the drawing compound used to draw wire or as a lubricant for cold heading or forming. A tag(s) shall be attached to each coil or banding as specified by the purchaser and shall include as a minimum the following information: Typical coatings for hot rolled bars and wire rods include: pickle and lime dip; zinc phosphate and lime dip; and zinc phosphate and reactive or non-reactive lube dip. Common coatings for cold drawn wire comprise those base coatings plus the drawing compound used in the wire drawing operations. 15.0.1 Supplier's name or trademark 15.0.2 Grade of steel 15.0.3 Heat number or traceable code 15.0.4 Diameter The supplied coatings for all materials are specified by the purchaser based upon the individual requirements of the purchaser. Adequate care should be taken during handling and transit to maintain the integrity of the coating. Extreme variation in temperature may adversely affect the applied coatings. When specified, the following may be added: 14.0 Workmanship, Finish and Appearance. 15.0.8 Secondary process description and source if applicable 15.0.5 Purchaser's name 15.0.6 Purchase order number 15.0.7 Mill order number Bar, rod and wire, shall be reasonably free from detrimental surface imperfections including seams, voids, pits, scratches and laps. Material, suitably thermally treated when appropriate, IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. 15.0.9 Bar coding (optional). It is suggested that bar coding in accordance with AIAG B-5 be used. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 15 of 23 Issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is nO( relq~onsible for any loss, claim or damage arising therefrom. In formulating and approving standards and specifications, the IFI has not invest~gatad and will not investigate patents which may apply to the subject matter, prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement hability which may arise out of such use ~" 1993 Industrial Fasteners Institute. 121 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. 16.0 Packaging and Loading. Unless otherwise specified, rod coils shall be wound counterclockwise which provides a right hand pitch to facilitate handling and uncoiling. Winding of bar coils varies and the direction of winding should be specified. The nature of compacting, banding and protection, shall be specified by purchaser. 16.1 The purchaser shall specify the method of packaging and loading for shipment. A recommended procedure for packaging and loading for shipment is found in ASTM A-700. 17.0 Certification and Test Reports. When specified in the purchase order, a producer's certification shall be furnished to the purchaser that the material was manufaco tured, sampled, tested, and inspected in accordance with this Specification and has been found to meet the requirements as specified. Test results shall be retained by the producer for a minimum period of ten (10) years. A test report shall be furnished which will meet the consumer's requirements for chemical analysis of the mill heat including the identification and the results of the chemical analysis of the primary steel melter. IFI STANDARD Publishedandissued by the Industrial Fasteners Institute o( CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 P,ge 18of 23 Issued: April 20, 1993 Cleveland, Ohio. All m n d a t d s and Ipecfficitioml are advisory only. Their use by anyone is antifl~y v o f u ~ t y . R i t i a ~ ~ for l a y ~Jrpoee by irtyone is I t the ~ risk Of that pemon ot the t~Nir Of the product, and the IFI is hot ¢seponlible for l a y lois. claim or damage u , l i n g therefrom, tn formulating and liplxoving c t a n d l r d l ~ apecificittofll, the IFI has nol inveltiOited l a d will riot investigate patents which may apply to the subject matter, proepec/i~e users Of the standards and specifications am reaponlible for Idvising themleh~s Of and protecting themaehqps against any patent infringement liability which may arise OUt of such use ~' 1993 Industrial Fasteners Institute 122 I N D U S T R I A L FASTENERS I N S T I T U T E 1717 E 9TH ST. * SUITE 1105 * CLEVELAND, OHIO 44114-2879 U.S.A PLATE 1 L .:,. ~.~, ~ ".- .~k'.e I - -~.C"o 4~':~':.' :..~ ,,-',-..~.~'%. ":..% MAGo 1000X ti .(¢.o~ :~- )t," ". ~ ~¢" . , ~ . i " ' : " ',(v.~ , G GRANULAR , ~ },:.'~ ,.. . \ " . . .. ' : ~ . ' -w ,;-\, • ,','~, "'~ 4,,:*~ • .~.-,'"- f . e4 ~t~. .~,~ < .... X ,%'I. " • ".' i ~. J ~' .*:.:, %.. TOTAL SPHEROIDIZATION RATING 0 ..] L LAMELLAR ~:.~....~",'t~.~?L.1 ,.;~W ,,. ;;.\' ~r ,"xa , ...": :', .% ,'-"C~¢," f'.,'.,/;(~'&L%'~_t": " ( ~ , " e ,.~ • ~_., ,v.,~o~. : 1 , . ~,'~, ~I" ~.'.!:.f. ,-~ .-, :..,%, ~ 7;-~---a4"~,-~ ,,, - r ; , y"~'-( ~,¢.6~' / ."4 <J•' " . "~ ."" P~~ '',-' , ~~' ~:L~-"~[_,,-~ ~" ~/' ' , .. ,~,~.,..,~';~,,,:#,77 ~ ~ , ,j,~..-...t : ¢i~ .~... , ~.'~..,. , , d ~-'-." , . ~ - < ~ . , ' , .,,': . ~,-°, ':9:,~./d. .: ~ .it. "" 12 ;ID,.~'~" ~ .~ ~"~,,,~:.~H.~ ,: # • ~ ,, :;.. • 2 • '.-' " * ; ' - ~ - ~ ' "* -:~-,.~-E,;?P. ~,., . . . . . , '---,~ ,~, IFI STANDARD Published and issued by t h e Industrial Fasteners Institute of Cleveland, Ohio. "(, ~ t e . o,"~..,;'~. , t t ~ ' / ' t,.~" ;,~ .: ' . - .",,t~.' '~. "~'~.:&~ ~,.~-Y,4l.,'k* ~,~ , tt " ...- ~ ' ~ , ~ ~ L.- , A ~ " . . Y ".,L .,#.*_.,Y'A /. #t~fl'~ ~ ~ . "' CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 Page 17 of 23 Issued: April 20. 1993 All standards and specifications are advisory only. Theft use by anyone is entirely voluntary. Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IF1 is not responsible for any loss, claim or damage arising therefrom. In formulating and approving standards and specifications, the IFI has not investigated and will not investigate patents which may apply to the suDlect matter. Prospective users of the standards and specifications are responsible for advising themselves of and protecting themselves against any patent infringement habdity whtch may arise out of such use ~ 1993 Industrial Fasteners institute 123 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. ,, SUITE 1105 ,= CLEVELAND, OHIO 44114-2879 U.S.A. L LAMELLAR G GRANULAR _.~ • ~,~;¢,~:'F.~, '~ -" ~,',':..":,'.: .~ ~,. "e" " "; 3 ." y. ....:,:~y#~ ,~,.~ :~'. ,~ ' ", ~'-~ ~'.,.,.~,~, ~ , "-" %"/"::; " ~"~ " ~:" r"2' , _ ' - ~ L ' % ...._ .~.....,~, .~, ' ~"" ' J'~..~ "~, " ] I / ~ " '~ '~ "" "' ~"~' " ~ :~.~~'~"~ .. • , ' ~'~-" "~" • ,. "~"~', ' ~.t,,', 'N 4 .¢~ ,,- ~ . . i " ~ ' ~ ,.:<:.~ 5 r . ~ ~.:~.,,~ ~<,~~~.,\~'.~ ','. ,~,~','", ,~, ~..~ FB~.-~',~ ¢; v n. ~-~ ~"~.~ ",'J ,~.= ,,':.~ ~ ' ~ , ~ X.; ~ , ! , ,,-:" -., ~; ~:t,~:.~ P,._~"~i II~:.~ ' ~ ~"~' ."~. ,,,~'..~:. ~i,-L'~~-~II~'.,~-. ,Z':.':.':.':.':.'~"~'_,.~,:; '-~:-,'~.', ,,,",,,..:,.--..~ E~'~.;~:-'~ Published and issued by the I n d u s t r i a l Fasteners Institute of Cleveland, Ohio. ,'~.Z~'5,'~_~.~.-; -":"' ~. ~-:~ ~.;~ IFI STANDARD .~ ~k..'~'.~ -"~-"~ CARBON A N D ALLOY STEEL WIRE, RODS A N D BARS FOR M E C H A N I C A L FASTENERS .~ ~.', : f . . ~ ~,-'.~:;~,~.~ I IF1-140 Page 18 of 23 Issued: April 20, 1993 Air standards and specifications are advisory only, Their use by anyone is entirely voluntary, Reliance thereon for any purpose by anyone is at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, claim or damage arising therefrom, In formulating and approving standards and specifications, the IFI has not investigated and will not investigate patents which may apply to the subject matter, Prospective users of the standards and specitications are responsible for advising themselves of and protecting Ihemselves against any patent infrinqement habilitv whgch may arise out of such use ~ 1993 Industrial Fasteners Institute 124 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. Table 1 Carbon Steels Chemical Ranges and Limits Conditions Furnished IFI S t e e l G r a d e Designation Carbon Min. Max. Phosphorus Sulfur Min. Max. Max. Max. 0.020 Manganese Silicon AIK IF1-1006 -- 0.08 0.25 0.40 0.020 R, AIK, SiFg, SiCg IFI-1008 -- 0.10 0.30 0.50 0.020 0.020 S R, AIK, SiFg, SiCg IFI-1Ol0 0.08 0.13 0.30 0.60 0.020 0.020 e AIK, SiFg, SiCg IF1-1018 0,15 0.19 0.65 0..85 0.020 0.020 e AIK, SiFg IFI-10B21 0.19 0.23 0.80 1.10 0.020 0.020 AIK, SiFg, SiCg IFI-1022/A 0.18 0,21 0.80 1.O0 0.020 0.020 AIK, SiFg, SiCg IFI-1022/B 0.20 0.23 0.90 1.10 0.020 0.020 AtK IF1-1033 0.31 0.36 0.70 0.90 0.020 0.020 AIK, SiFg, SiCg IF1-1035 0.33 0.38 0.70 0.90 0.020 0.020 AIK, SiFg, SiCg IFI- 1038 0.35 0.42 0.70 0.90 0.020 0.020 SiFg IFI-10B38 0.35 0.42 0.70 1.00 0.020 0.020 SiFg IFI-15411A 0.36 0.41 135 1.60 0.020 0.020 SiFg, SiCg, CgP IFI-1541/B 0.38 0.43 1.35 1.60 0.020 0.020 T a b I e N O T E : Carbon steels which have added boron use a B designation between the first and last two digits of the grade designation. A boron steel has a minimum boron content of 0.0005% and a maximum of 0.003%. AIK R SiFg SiCg CgP = = = = = Aluminum killed Rimmed Silicon killed fine grain Silicon killed coarse grain Coarse grain practice Table 2 Permissible Variations from Specified Chemical Ranges, and Limits for Carbon Steel Element Carbon Manganese Limit o r Max. of Specified R a n g e % % Over M a x L i m i t o r U n d e r Min L i m i t Variation To 0.25 incl Over 0.25 to 0.55 incl 0.02 0.03 To 0.90 incl Over 0.90 to 1.65 incl 0.03 0.06 Phosphorus Over max only 0.008 Sulfur Over max only 0.008 Silicon To 0.30 incl 0.02 Copper Over max only 0.03 Tin Over max only 0.01 Nickel Over max only 0.03 Chromium Over max only 0.03 Molybdenum Over max only 0.01 Vanadium Over max only 0.01 N/A t Boron N O T E 1: Unless misapplication is indicated. IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IFI-140 Page 19 of 23 Issued: April 20, 1993 All standards and specifications are advisoryonly. Their use by anyone is entirely voluntary. Reliance thereon for any purpo~leby anyone is at the sole risk of that person or the user of the product, and the IFI is no( maponsible for any loss. claim or damage arising therefrom, in formulating and approvingstandards and specifications,the IFI him not inwmtigatad and will not investigate patents which may apply to the subject matter, Pro6pectiveusersof the standardsand specificationsare responsiblefor advising themselvesof and prntectingthemselvesagainst any patent infringement liability which may arise out of such use ~ 1993 Industrial Fastene-s Institute. 125 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. • SUITE 1105 • C L E V E L A N D , O H I O 44114-2879 U.S.A. ~= oo oo ooooooo~~ o o d (5 0 O O 0 O o ~ ~ I 0 0 "0 m~ ,I ~ < < o ~ ~ g - ~ at ~.~-oo.~ _ o < ® ,o3 ~3 --I ) -- 0 E~ m ;3 I ::3 -- I I - - ~ ° ° ° o ~ o o o o o o o ~-~ 3.m mO I o ~. E .- ..-- U) ~. _=.o . o c E ~' ,': =. X 0 ~" o e- ~ O O o o o o o = o o o o .~ :~ oc:)o o o "10 C o~ u~ m )) -. mm ~' °-); •O) m~ Em 3= '~ :S, m -I (') -~= ~" ._c 3. ,,, I I I I I I ~o I I I I I o o " ~ ~, ~ ~, ~ ~ 8 c za. i = ® .S ll. O) c O® CO = ,< ~.._cat Z c=~ d " " v- O.c ,-r " IFI STANDARD Published by the Fasteners Cleveland, a n d issued Industrial Institute of Ohio. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS Z IFI-140 Page 20 of 23 Issued: April 20, 1993 All standards and specifications am advisory only. Their use by anyone is entimCy ~ u n t a r y . Reliance thereon for any purpose by anyone is at the sole rink of that person or the user of the product, and the IFI is not responsible for any Io6l, claim or damage afkling therefrom, in #ocmulating and ~)pro~hlg atandarda and specifications, the IFI h i l l no( ifl~lMigate¢l and will not investigate patents which may apply to the subjQct matter. Prospechve users of the standards and I~oecificationa am responsible for advising themseh'es of and protecting themselves against ~'1993 Industrial Fasteners Institute. any patent infnngement liabiflty which may arise out of such use. 126 INDUSTRIAL FASTENERS INSTITUTE 1 7 1 7 E. 9 T H ST. • S U I T E 1 1 0 5 • C L E V E L A N D , Table 5 O H I O 4 4 1 1 4 - 2 8 7 9 U.S.A. Permissible Variation from Specified Chemical Ranges and Limits for Alloy Steels Element Limit or Max of Specified Range, % Carbon TO 0.30 incl Over 0.30 to 0.75 incl 0.01 0.02 Manganese To 0.90 incl Over 0.90 0.03 0.04 Phosphorus Over Max only Sulfur Over Max only Silicon To 0.40 incl Variation, %, Over Max Limit or Under Min Limit 0.005 0.005 0.02 Nickel To 1.00 incl 0.03 Chromium To 0.90 incl Over 0.,90 0.03 0.05 Molybdenum To 0.20 incl Over 0,20 to 0.40 incl 0.01 0.02 Vanadium Over Max. only 0.01 Copper Over Max only 0.03 Table 6 Decarburization Limits for Killed Steels With Carbon Content Exceeding 0.13% Diameter Free Ferrite Depth Max. Inches Total Average Affected Depth Max. Inches through 25164 00015 0.005 over 25•64 through 5/8 0.0015 0.OO6 over 5/8 through 55164 0 0015 O.007 over 55•64 through 1 0.0015 0.008 over 1 through 1 ~/2 O0O15 0.010 (Inches) NOTES: 1. For purposes of determining conformance with this Start" dard, all specified limits are absolute as defined in ASTM E29. 2. Test conducted in accordance with paragraph 8.0 of this Standard. IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IF1-140 P a g e 21 of 2 3 I s s u e d : April 20, 1 9 9 3 All standards and specifications ate advisory only. Their use by anyoneis entirely voluntary. F~eliancethereonfor any purpose by anyoneis at the sole risk of that person or the user of the product, and the IFI is not responsible for any loss, cla=mor damage arising therefrom. In formulating and approving standards and specifications, the IFI has not investigated and will not investigatepatentswhich may apply to the subject matter. Prospectiveusersof the standardsand specificationsare responsiblefor advising themselvesof and protectingthemselvesagainst any patent infringementliability which may arise out of such use : 1993IndustrialFastenersInstitute. 127 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH ST. ,= SUITE 1105 • CLEVELAND, OHIO 44114-2879 U.S.A. ® m ¢',~- "-- 2"~2 ,,==,, ®--- ® C'~ ¢0 o < ~ ~ ~ ~ ~ ~ ~ ~ $ ~'; g g~ ~ ~ ®N® ®o..~ ~ ®J; 0 O. m O = U ~ ,< e- ~< ~. .lo<,9° 2 ,, • m g~N __'~'0 ~ 0 mU~ ... ~ ~~ P IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. P ~ O P P P i i CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS ...=E urn •c < IF1-140 Page 22 of 23 Issued: April 20, 1993 All standards and specifications are advisory only. Their use by anyone is entirely voluntary. Reliance thereon 1o¢ any putpo6e by anyone is st the sole risk of that person or the user Of the product, and the IFI is not responsible for any loss, claim or damage arising therefrom. In formulating end ~q0proving standards and specifications, the IFI has not investigated and will not investigate patents which may apply to the subject matter. Prospective users of the standards and specifications ere responsible for advising themselves of end protecting themselves against any patent mfr*rlgement liability which may arise out of such use. <~'1993(ndustrial Fasteners Institute 128 INDUSTRIAL FASTENERS INSTITUTE 1717 E. 9TH SE • S U I T E 1105 ,D C L E V E L A N D , O H I O 44114-2879 U.S.A. Table 8 Wire Size Tolerances and Out of Round Diameter Diameter Out of Round ± Tolerance Max. Inch Inch Inch < 0.076 0.0010 0.O010 0.076 < 0.500 0.0015 0.0015 >_ 0.500 0.0020 0.0020 Table 9 Rod Size Tolerances Diameter Diameter Out of Round ± Tolerance Max. Inch Inch Inch 7132 - 47•64 0,012 0.018 T a b l e 10 Bar Size Tolerances Diameter IFI STANDARD Published and issued by the Industrial Fasteners Institute of Cleveland, Ohio. Diameter + Tolerance Out of Round Max. Fractional Diameter in Inches Inch inch 7 / 1 6 to 5/8 0,006 0,009 >5•8 to 7/8 0.007 0.011 > 7 1 8 to 1 O008 0,012 >1 to 1-1/8 0.009 0.014 >1-1/8 to 1-1/4 0.010 0.015 > 1-114 to 1-3/8 0.011 0.017 > 1-3/8 to 1-1/2 0.013 0.020 CARBON AND ALLOY STEEL WIRE, RODS AND BARS FOR MECHANICAL FASTENERS IFI-140 Page 2 3 of 2 3 Issued: April 20, 1993 All atandatdsend specificationsam advisoryonly.Their use by anyoneis entirelyvoluntary.Reliancethereonfor any purposeby anyoneis at the solerisk of that personor the userof the product, and the IFI is not responsiblefor any loss, claim or damagearising therefrom.In formulatingand approvingstandardsand specifications,the IFI has not irlvoatigatedarid will not investigatepeten~which may applyto the subjectmatter.Prospectiveusersof the standardsand specificationsare responsiblefor advisingthemselvesof and protectingthemselvesagainst any patentinfringementliabilitywhichmayarise out of suchuse. c-1993IndustrialFaatenelsInstitute. 129 Appendix C: Public Law I01-592---Fastener Quality Act P u b l i c L a w 101-592 101st C o n g r e s s An Act To require that certain fasteners sold in commerce confirm to the specifications to which they are represented to be manufactured, to provide for accreditation of laboratories engaged in fastener testing, to require inspection, testing, and certification, in accordance with standardized methods, of fasteners used in critical applications to increase fastener quality and reduce the danger of fastener failure, and for other purposes) Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, 2 SECTION 1. SHORTTITLE. This Act may be cited as the "Fastener Quality Act". SEC. 2 FINDINGS AND PURPOSE. (a) Findings - The Congress finds that (1) the American economy uses billions of fasteners each year; (2) millions of mismarked, substandard, counterfeit, and other nonconforming fasteners have been sold in commerce to end-users in the United States, and their use has dramatically increased the risk of equipment and infrastructure failures; (3) both the military and civilian sectors of the economy have encountered unnecessary, unwarranted, and dangerous equipment and construction failures, as well as extraordinary expenses, as a result of the use of nonconforming fasteners; (4) the sale in commerce of nonconforming fasteners and the use of nonconforming fasteners in numerous critical applications have reduced the combat readiness of the Nation's military forces, endangered the safety of other Federal projects and activities, and cost both the public and private sectors large sums in connection with the retesting and purging of fastener inventories; (5) the purchase and use of nonconforming fasteners stem from material misrepresentations about such fasteners made by certain manufacturers, importers, and distributors engaged in commerce; (6) current fastener standards of measurement evaluate bolts and other fasteners according to multiple criteria, including strength, hardness, and composition, and provide grade identification markings on fasteners to make the characteristics of individual fasteners clear to purchasers and users; 1NOV.16, 1990(H.R. 3000) 2 FastenerQuality Act. Consumerprotention. 15 OSC 5401 note. 15 USC 5401 133 (7) current tests required by consensus standards, designed to ensure that fasteners are of standard measure, are adequate and appropriate for use as standards in a program of highstrength fastener testing; (8) the lack of traceability by lot number of fasteners sold in commerce is a serious impediment to effective quality control efforts; and (9) the health and safety of Americans is threatened by the widespread sale in commerce of mismarked, substandard, and counterfeit fasteners, a practice which also harms American manufacturers, importers, and distributors of safe and conforming fasteners, and workers in the American fastener industry. (b) Purpose In order to protect public safety, to deter the introduction of nonconforming fasteners into commerce, to improve the traceability of fasteners used in critical applications, and generally to provide commercial and governmental customers with greater assurance that fasteners meet stated specifications, it is the purpose of this Act to create procedures for the testing, certification, and distribution of certain fasteners used in commerce within the United States. SEC. 3. DEFINITIONS. As used in this Act, the term (1) "alter" means to alter (A) by through-hardening, (B) by electroplating of fasteners having a minimum tensile strength of 150,000 pounds per square inch, or (C) by machining; (2) "consensus standards organization" means the American Society for Testing and Materials, American National Standards Institute, American Society of Mechanical Engineers, Society of Automotive Engineers, or any other standardsetting organization determined by the Secretary to have comparable knowledge, expertise, and concern for health and safety in the field for which such organization purports to set standards; (3) "container" means any package of fasteners traded in commerce; (4) "Director" means the Director of the National Institute of Standards and Technology; (5) "fastener" means (A) a (i) screw, nut, bolt, or stud having internal or external threads, or (ii) a load-indicating washer, with a nominal diameter of 5 millimeters or greater, in the case of such items described in metric terms, or ¼ inch or greater, in the case of such items described in terms of the English system of measurement, which contains any quantity of metal and is held out as meeting a standard or specification which requires through-hardening, (B) a screw, nut, bolt, or stud having internal or external threads which bears a grade identification marking required by a standard or specification, 134 (C) a washer to the extent that it is subject to a standard or specification applicable to a screw, nut, bolt, or study described in subparagraph (B), or (D) any item within a category added by the Secretary in accordance with section 4(b), except that such term does not include any screw, nut, bolt, or study that is produced and marked as ASTM A 307 Grade A; (6) "grade identification marking" means any symbol appearing on a fastener purporting to indicate that the fastener's base material, strength properties, or performance capabilities conform to a specific standard of a consensus standards organization other person; (7) "importer" means a person located within the United States who contracts for the initial purchase of fasteners manufactured outside the United States for resale of such person's use within the United States; (8) "Institute" means the National Institute of Standard and Technology; (9) "lot" means a quantity of fasteners of one part number fabricated by the same production process from the same coil or heat number of metal as provided by the metal manufacturer and submitted for inspection and testing at one time; (10) "manufacturer" means a person who fabricates fasteners, or who alters any items so that it becomes a fastener; (11) "original equipment manufacturer" means a person who uses fasteners in the manufacture or assembly of its products and sells fasteners to authorized dealers as replacement or service parts for its products; (12) "private label distributor" means a person who contracts with a manufacturer for the fabrication of fasteners bearing the distributor's distinguishing insignia; (13) "Secretary" means the Secretary of Commerce; (14) "standards and specifications" means the provisions of a document published by a consensus standards organization, a government agency, or a major end-user of fasteners which defines or describes dimensional characteristics, limits of size, acceptable materials, processing, functional behavior, plating, baking, inspecting, testing, packaging, and required markings of any fastener; and (15) "through-harden" means heating above the transformation temperature followed by quenching and tempering. SEC. 4. S P E C I A L RULES F O R FASTENERS. 3 (a) Waiver Requirements. - If the Secretary determines that any category of fastener is not used in critical applications, the Secretary shall waive the requirements of this Act with respect to such category. (b) Additional Item. - If the Secretary determines that (1) a category of screw, nut, bolt, or stud which is not described in section 3(5)(A)(i) or (B), (2) a category of item which is associated with a fastener described in section 3(5)(A), (B), or (C), or (3) a category of item which serves a function comparable to that serveA by a fastener so described 3 15 USC 5403 135 is used in critical applications, the Secretary may include such category under section 3(5)(D) and therefore within the definition of fasteners under this Act. (c) Notice and Opportunity for Comments. - The Secretary shall provide advance notice and the opportunity for public comments prior to making any determination under subsections (a) and (b) and shall act through the Director in making any such determination. SEC. 5. T E S T I N G AND C E R T I F I C A T I O N O F FASTENERS. 4 (a) Requirement. - (1) No fastener shall be offered for sale or sold in commerce unless it is part of a lot which (A) conforms to the standards and specifications to which the manufacturer represents it has been manufactured; and (B) has been inspected, tested, and certified as provided in subsections (b) and (c) of this section. (2)(A) Paragraph (1)(B) of this subsection shall not apply to fasteners which are part of a lot of 50 fasteners or less if, within 10 working days after the delivery of such fasteners, or as soon as practicable thereafter (i) inspection, testing, and certification as provided in subsections (b) and (c) is carried out; and (ii) written notice detailing the results of such inspection, testing, and certification is sent (I) to all purchasers of such fasteners, except retail sellers and retail consumers, and (II) to any retail seller or retail consumer who, prior to delivery, requests such written notice. (B) If a fastener is sold under this paragraph, each purchaser of such fastener, except for retail sellers and retail consumers unless such retail sellers and retail consumers request such notice in advance, shall be provided, contemporaneously with each sale and delivery, written notice stating that such fastener has not yet been inspected, tested, and certified as required by this Act. (b) Inspection and Testing. - (1) The manufacturer of a lot of fasteners shall cause to be inspected and tested a representative sample, as provided in paragraph (2) of this subsection, of the fasteners in such lot to determine whether the lot conforms to the standards and specifications to which the manufacturer represents it has been manufactured. Such inspection and testing shall be performed by a laboratory accredited in accordance with the procedures and conditions specified by the Secretary under section 6. The standards and specifications to which the manufacturer represents such lot has been manufactured shall be disclosed by the manufacturer to the laboratory at the time the lot is submitted for inspection and testing under this paragraph. The manufacturer of a lot may perform the inspection and testing required by this paragraph in a laboratory which it owns or with which it is otherwise affiliated, if such laboratory is accredited in accordance with the procedures and conditions specified by the Secretary under section 6; unless the Secretary finds that, as to a specific type of fastener and as to a specific type of inspection or testing, a 4 15 USC 5404 136 ban on manufacturer ownership or affiliation with the accredited laboratory would increase the protection of health and safety of the public or industrial workers. (2) The size, selection, and integrity of the sample to be inspected and tested under paragraph (1) shall be governed (A) by the standards and specifications to which the manufacturer represents the fasteners in the sample have been manufactured; or (B) if such standards and specifications do not provide for the size, selection, or integrity of the sample, by sampling procedures prescribed by the Secretary, who shall to the extent practicable use consensus testing standards and related materials. Nothing in this paragraph shall prohibit a purchaser from requiring the inspection and testing of a greater number of fasteners from a lot than is specified in the applicable standards and specifications or in the applicable sampling procedures prescribed by the Secretary. (c) Laboratory Report of Testing. If a laboratory performing the inspection and testing under subsection (b)(1) determines, as to the characteristics selected under the sampling procedures prescribed by the secretary and based on the sample examined, that a lot conforms to the standards and specifications to which the manufacturer represents it has been manufactured, the laboratory shall provide to the manufacturer a written inspection and testing report with respect to such lot. The report, which shall be in a form prescribed by the Secretary by regulation, shall (1) state the manufacturer's name, the part description, and the lot number and note the grade identification mark and insignia found on the fastener; (2) reference the standards and specifications disclosed by the manufacturer with respect to such lot under subsection (b)(1) or, where applicable, certified by the manufacturer under section 7(c)(1); (3) list the markings and characteristics selected under the Secretary's procedures for testing, such as the chemical, dimensional, physical, mechanical, and any other significant characteristics required by the standards and specifications described in paragraph (2) and specify the results of the inspection and testing under subsection (b)(1); (4) state whether, based on the samples provided as representative of the lot, such lot has been found after such inspection and testing to conform to such standards and specifications; and (5) bear the original signature of a laboratory employee or officer determined by the Secretary to be responsible for the accuracy of the report and of the inspection and testing to which it relates. SEC. 6. LABORATORY ACCREDITATION.5 5 15 USC 5405 137 (a) Establishment of Accreditation Program. - (1) Within 180 days after the date of enactment of this Act, the Secretary, acting through the Director, shall issue regulations which shall include (A) procedures and conditions, including sampling procedures referred to in section 5, for the accreditation by the Institute of laboratories engaged in the inspection and testing of fasteners under section 5; (B) procedures and conditions (which shall be consistent with the procedures and conditions established under subparagraph (A)), using to the extent practicable the requirements of national or international consensus documents intended to govern the operations of accreditation bodies, under which private entities may apply for approval by the Secretary to engage directly in the accreditation of laboratories in accordance with the requirements of this Act; and (C) conditions (which shall be consistent with the procedures and conditions established under subparagraph (A)), under which the accreditation of foreign laboratories by their governments or organizations recognized by the Director shall be deemed to satisfy the laboratory accreditation requirements of this section. (2) Upon establishing a laboratory accreditation program under paragraph (1), the Secretary shall publish a notice in the Federal Register stating that the Secretary is prepared to accept applications for accreditation of such laboratories. (3) No accreditation provided under the terms of this subsection shall be effective for a period of greater than 3 years. (b) Laboratory Accreditation Procedures. - Existing Institute accreditation procedures stated in part 7 of title 15, Code of Federal Regulations, as in effect on the date of enactment of this Act, supplemented as the Secretary considers necessary, shall be used to accredit laboratories under the accreditation program established under subsection (a). (c) Ensuring Compliance. - (1) The Secretary shall ensure that (A) private entities accrediting laboratories under procedures and conditions established under subsection (a))(1)(B) comply with such procedures and conditions, and (B) laboratories accredited by such private entities, or by foreign governments pursuant to subsection (a)(1)(C), comply with the requirements for such accreditation. (2) The Secretary may require any such private entity or laboratory to provide all records and materials that may be necessary to allow the Secretary to carry out this subsection. (d) Operation of Laboratory Accreditation Program. - (1) The Director may hire such contractors as are necessary to carry out the accreditation program established under subsection (a). (2) Costs to the Institute and to the Secretary for the establishment and operation of the accreditation program under this section shall be fully reimbursable to the Institute or to the Secretary, as appropriate, through fees or other charges for accreditation services under such program. (e) Recommendations to Consensus Standards Organizations. - The Director shall periodically transmit to appropriate consensus standards organizations any 138 information or recommendations that may be useful in the establishment or application by such organizations of standards and specifications for fasteners. SEC. 7. S A L E O F F A S T E N E R S SUBSEQUENT TO M A N U F A C T U R E . 6 (a) Domestically Produced Fasteners. - It shall be unlawful for a manufacturer to sell any shipment of fasteners (except fasteners for which the Secretary has waived the requirements of this Act pursuant to section 4) which are manufactured in the United States unless the fasteners are accompanied, at the time of delivery, by a written certificate by the manufacturer certifying that (1) The fasteners have been manufactured according to the requirements of the applicable standards and specifications and have been inspected and tested by a laboratory accredited in accordance with the procedures and conditions specified by the Secretary under section 6; and (2) an original laboratory testing report described in section 5(c) is on file with the manufacturer, or under such custody as may be prescribed by the Secretary, and available for inspection. (b) Fasteners of Foreign Origin. - (1) Except as provided in paragraph (2) of this subsection, it shall be unlawful (A) for any person to sell to any importer, and (b) for any importer to purchase, any shipment of fasteners which are manufactured outside the United States unless delivery of such shipment to such importer is accompanied by a manufacturer's certificate as described in subsection (a), an original laboratory testing report described in section 5(c), with respect to each lot from which such fasteners were taken, and any other relevant lot identification information. (2) The requirement under paragraph (1) of this subsection that the delivery of such a shipment to such importer be accompanied by an original laboratory testing report shall not apply in the case of fasteners imported into the United States (A) as products manufactured within a nation which is party to a congressionallyapproved free trade agreement with the United States that is in effect, so long as the Secretary certifies that satisfactory arrangements have been reached by which purchasers within the United States can readily gain access to an original laboratory testing report for such fasteners; or (B) as Canadian-origin products under the United States - Canada Automobile Pact for use as original equipment in the manufacturer of motor vehicles. (c) Option for Importers and Private" Label Distributors. - (1) Notwithstanding section 5(a) and subsections (a) and (b) of this section, delivery of a lot, or portion of a lot, of fasteners may be made to an importer or private label distributor without the required original copy of the laboratory testing report if(A) the manufacturer provides to the importer or private label distributor a manufacturer's certificate certifying that the fasteners have been manufactured according to the requirements of the applicable standards and specifications; and (B) the importer or private label distributor assumes responsibility in writing for the inspection and testing of such lot or portion by a laboratory accredited in 6 15 U S C 5406 139 accordance with the procedures and conditions specified by the Secretary under section 6. (2) If the importer or private distributor assumes the responsibility in writing for the inspection and testing of such lot or portion, the provisions of section 5(a) and subsections (a) and (b) of this section shall apply to the importer or private label distributor in the same manner and extent as to a manufacturer; except that the importer or private label distributor shall provide to the testing laboratory the manufacturer's certificate described under paragraph (1) of this subsection. (d) Alterations Subsequent to Manufacture - (1) Any person who significantly alters a fastener so that such fastener no longer conforms to the description in the relevant certificate issued under section 5(c), and who thereafter offers for sale or sells such altered fastener, shall be treated as a manufacturer for purposes of this Act and shall cause such altered fastener to be inspected and tested under section 5 or this section as though it were newly manufactured, unless delivery of such fastener to the purchaser is accompanied by a written statement noting the original lot number, disclosing the subsequent alternation, and waming that such alteration may affect the dimensional or physical characteristics of the fastener. (2) Any person who knowingly sells an altered fastener and who did not alter such fastener shall provide to the purchaser a copy of the statement required by paragraph (1). (e) Commingling. - (1) Subject to paragraph (2), it shall be unlawful for any manufacturer or any person who purchases any quantity of fasteners for resale at wholesale to commingle like fasteners from different lots in the same container; except that such manufacturer or such person may commingle like fasteners of the same type, grade, and dimension from not more than two tested and certified lots in the same container during repackaging and plating operations: Provided, That any container which contain like fasteners from two lots shall be conspicuously marked with the lot identification numbers of both lots. (2) Paragraph (1) does not apply to sales by original equipment manufacturers to their authorized dealers for use in assembling or servicing products produced by the original equipment manufacturers. (f) Subsequent Purchaser. - (1) It shall be unlawful for any person to sell fasteners, of any quantity, to any person who purchases such fasteners (A) for sale at wholesale, or (B) for assembling components of a product or structure for sale, unless the container of fasteners sold is conspicuously marked with the number of the lot from which such fasteners were taken, except that this requirement shall not apply to sales by original equipment manufacturers to their authorized dealers for use in assembling or servicing products produced by the original equipment manufacturer. (2) If a person who purchases fasteners for purposes other than those described in paragraph (1) (A) and (B) so requests either prior to the sale or at the time of sale, the seller shall conspicuously mark the container of fasteners with the lot number from which such fasteners were taken. (g) Regulations. - The secretary may issue such regulations as may be necessary to ensure compliance with the provision of this section. 140 SEC. 8. M A N U F A C T U R E R S t INSIGNIAS. 7 (a) General Rule. - No fastener which is required by the standards and specifications to which it was manufactured to bear a raised or depressed insignia identifying its manufacturer or private label distributor shall be offered for sale or sold in commerce unless the manufacture or private label distributor of such fastener has complied with the requirements prescribed by the Secretary in connection with the program established under subsection (b) of this section. (b) Recordation. - The Secretary shall establish, by regulation, a program to provide for the recordation of the insignias of manufacturers and private label distributors described in subsection (a), to ensure the traceability of a fastener to its manufacturer or private label distributor. SEC. 9. R E M E D I E S AND P E N A L T I E S . 8 (a) Civil Remedies. (1) The Attorney General may bring an action in an appropriate United States district court for appropriate declaratory and injunctive relief against any person who violates this Act or any regulation under this Act. (2) An action under paragraph (1) may not be brought more than 10 years after the date on which the cause of action accrues. (b) Civil Penalties. - (1) Any person who is determined by the Secretary, after notice and an opportunity for a hearing, to have violated this Act or any regulation under this Act shall be liable to the United States for a civil penalty of not more than $25,000 for each violation. (2) The amount of the penalty shall be assessed by the Secretary by written notice. In determining the amount of the penalty, the Secretary shall consider the nature, circumstances, and gravity of the violation and, with respect to the person found to have committed the violation, the degree of culpability, and history of prior violations, the effect on ability to continue to do business, any good faith attempt to achieve compliance, ability to pay the penalty, and such other matters as justice may require. (3) Any person against whom a civil penalty is assessed under paragraph (2) of this section may obtain review thereof in the appropriate court of the United States by filing a notice of appeal in such court within 30 days from the date of such order and by simultaneously sending a copy of such notice by certified mail to the Secretary. The findings and order of the Secretary shall be set aside by such court if they are found to be unsupported by substantial evidence, as provided in section 706(2) of title 5, United States Code. (4) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which is subject to imposition or which has been imposed under this section prior to referral to the Attorney General under paragraph (5). (5) A civil penalty assessed under this subsection may be recovered in an action brought by the Attorney General on behalf of the United States in the appropriate district court of the United States. In such action, the validity and appropriateness of the final order imposing the civil penalty shall not be subject to review. (6) For the purpose of conducting any hearing under this section, the Secretary may issue subpoenas for the attendance and testimony of witnesses and the production of relevant papers, books, and documents, and may administer oaths. Witnesses summoned shall be paid the same 7 15 USC 5407 8 15 USC 5408 141 fees and mileage that are paid to witnesses in the courts of the United States. In case of contempt or refusal to obey a subpoena served upon any person pursuant to this paragraph, the district court of the United States for any district in which such person is found, resides, or transacts business, upon application by the United States and after notice to such person, shall have jurisdiction to issue an order requiring such person to appear and give testimony before the Secretary or to appear and produce documents before the Secretary, or both, and any failure to obey such order of the court may be punished by such court as a contempt thereof. (c) Criminal Penalties. - (1) Whoever knowingly certifies, marks, offers for sale, or sells a fastener in violation of this Act or a regulation under this Act shall be fined under title 18, United States Code, or imprisoned not more than 5 years, or both. (2) Whoever intentionally fails to maintain records relating to a fastener in violation of this Act or a regulation under this Act shall be fined under title 18, United States Code, or imprisoned not more than 5 years, or both. (3) Whoever negligently fails to maintain records relating to a fastener in violation of this Act or a regulation under the Act shall be fined under title 18, United States Code, or imprisoned not more than 2 years, or both. SEC. 10. RECORDKEEPING REQUIREMENTS.9 (a) Laboratories. - Laboratories which perform inspections and testing under section 5(b) shall retain for 10 years all records concerning the inspection and testing, and certification of fasteners under section 5. (b) Manufacturers, Importers, Private Label Distributors, and Persons who Make Significant Alternation. - Manufacturers, importers, private label distributors, and persons who make significant alterations shall retain for 10 years all records concerning the inspection and testing, and certification, of fasteners under section 5, and shall provide copies of any applicable laboratory testing report or manufacturer's certificate upon request to any subsequent purchaser of fasteners taken from the lot to which such testing report or manufacturer's certificate relates. SEC. 11. RELATIONSHIPTO STATE LAWS.l0 Nothing in this Act shall be construed to preempt any rights or causes of action that any buyer may have with respect to any seller of fasteners under the law of any State, except to the extent that the provisions of this Act are in conflict with such State law. SEC. 12. CONSTRUCTION.11 Nothing in this Act shall be construed to limit or otherwise affect the authority of any consensus standards organization to establish, modify, or withdraw any standards and specifications under any other law or authority in effect on the date of enactment of this Act. SEC. 13. R E G U L A T I O N S . 12 The Secretary shall within 180 days after the date of enactment of this Act issue such regulations as may be necessary to implement this Act. SEC. 14. ADVISORYC O M M I T T E E . 13 Within 90 days after the date of enactment of this Act, the Secretary shall appoint an advisory committee consisting of representatives of fastener manufacturers, importers, 15 USC 5409 l0 15 USC 5410 l! 15 USC 5411 12 15 USC 5412 13 15 USC 5413 9 142 distributors, end-users, independent laboratories, and standards organizations. The Secretary and Director shall consult with the advisory committee (1) prior to promulgating any regulations under this Act; and (2) in such other matters related to fasteners as the Secretary may determine. SEC. 15. APPLICABILITY. 14 The requirements of this Act shall be applicable only to fasteners fabricated 180 days or more after the Secretary issues final regulations required under sections 5, 6, and 8, except that the Secretary may extend such time period if the Secretary determines that an insufficient number of laboratories have been accredited to perform the volume of inspection and testing required. Upon any such extension, and every 6 months thereafter during such extension, the Secretary shall submit a report to the Congress explaining the reasons for such extension and the steps being taken to ensure the accreditation of a sufficient number of laboratories. Approved November 16, 1990. LEGISLATIVE HISTORY - H.R. 3000 HOUSE REPORTS: No. 101-211, Pt. 1 (Comm. on Science, Space, and Technology) and Pt. 2 (Comm. on Energy and Commerce). SENATE REPORTS: No. 101-388 (Comm. on Commerce, Science, and Transportation) CONGRESSIONAL RECORD: Vol. 135 (1989): Sept. 19, considered and passed House. Vol. 136 (1990): Oct. 26, considered and passed Senate, amended. House concurred in Senate amendment. 14 15 USC 5414 143 Appendix D: Supplier Quality Systems Survey SUPPLIER QUALITY SURVEY SURVEY NO. SURVEY DATE SUPPLIER NAME AND ADDRESS PRODUCT / SERVICE SUPPLIED RATING LAST SURVEY DATE LAST SURVEY CURRENT SURVEY S U P P L I E R STATUS [] CERTIFIED SUPPLIER All elements are present and operational in the supplier's system they meet the requirements for certification status. [] PREFERRED SUPPLIER The supplier has met our requirements for preferred status, and has planned commitments to obtaining certification status. [] APPROVED SUPPLIER The supplier displays the organization and future direction to achieve the requirements of certified status, and meets the requirements of approved supplier. [] CONDITIONAL SUPPLIER The supplier has not been surveyed, is in the process of being surveyed, or as a result of the survey has not obtained minimum criteria for a supplier rating Supplier Representatives: Survey Team: 147 SUPPLIER QUALITY RATING* SURVEY A. MANAGEMENT 1. Does the supplier management share the philosophy of partnership with its customers: to provide high quality products or service at competitive pricing with timely delivery in return for technical and quality support as well as a long term business relationship with (COMPANY NAME)? 2. Are there active programs or plans to facilitate participation in Continuous Quality Improvement? 3. Are programs for employee education and training present? B. O R G A N I Z A T I O N 1. Does the vendor have a clearly defined and documented Quality Control function? (Supply organization chart.) 2. Does the Quality Control function have clear and documented authority to act on quality and non-quality issues through disposition of product? 3. Is the Quality Control structure oriented for prevention instead of detection? C. F I X T U R E A N D T E S T E Q U I P M E N T CONTROL (METROLOGY) 1. Is there a separate unit dedicated to metrelogy? 2. Is there a documented procedure for calibration of all equipment (including analytical equipment) 3. Are capability studies performed and documented prior to use in production? (Repeatability and Reproducibility Studies?) 4. Are calibration records maintained which include fixture and test equipment identification, location, method of calibration and certification, results, date of current and next calibration, and current status? 5. Are fixtures and test equipment clearly marked with an identification, date of last calibration and date of next calibration? 6. Is there a clear definition of dispositioning non-certifiable fixtures and test equipment? D. I N S P E C T I O N 1. Is there a system to assure the quality of purchased materials, which may involve: a. incoming inspection b. vendor certification program c. source inspection 2. Is there a system to assure product conformance to specifications at the initial setup phase of product manufacture? 3. In the absence of SPC, is there a system with documentation to verify that product conforms to specification prior to shipment? 4. Is there a system which provides lot traceability through each process and includes traceability of all raw materials used during manufacture? 148 COMMENTS SUPPLIER QUALITY SURVEY RATING * 5. Is there a system that measures the effectiveness of the total quality systems through an evaluation of packaged, ready to ship product? (Final Product audit) 6. Is there a system with supporting documentation that assures nonconforming product is removed from the normal process flow and clearly marked for disposition? 7. Are inspection plans documented and do they include the following: a. sample size b. sample frequency c. acceptance criteria d. significant characteristics e. product disposition 8. Are inspection plans designed for zero defects? E. PROCESS CONTROL 1 Is statistical process control utilized to optimize processes and systems? 2. Does SPC include the following programs: a. process capability studies? b. significant characteristic selection? c. reports to top management for action on noncapable processes? 3. Are there documented process instructions for manufacturing and nonmanufacturing jobs? 4. Are critical process parameters monitored? 5. Are critical and functional part characteristics monitored and documented during processing? F. QUALITY SYSTEMS AND ANALYSIS 1. Are cost of quality reports generated and provided to management? 2. Is there a system for problem identification and resolution that looks for root causes? 3, Is there a documented system to provide and control changes to product and product specifications and processing? 4. Is there a documented system to address customer returns ensuring prompt response to corrective action inquires? survey points scored: survey points possible: survey score: *See supplement entitled QualitySurvey- EXPLANATION OF SCORING SYSTEM. 149 COMMENTS COMMENTS printed in US.A. 150 Explanation of Quality Survey Scoring System Each survey question will be rated on the basis of thefollowing point system: rating explanation 10 This element is present, documented, and successfully operational in the Supplier's/Subcontractor's quality system and displays a history of consistent application and continuous improvement. 9 This element is present, documented, and successfully operational in the Supplier's/Subcontractor's quality system. 6 This element is included in the Supplier's/Subcontractor's quality system; however, documentation is incomplete and/or additional development is required. 4 This element is included in the Supplier's/Subcontractor's quality system; however, documentation is inadequate and additional development is required. 2 This element is included in the Supplier's/Subcontractor's quality plan, but has no present application and requires substantial development. 0 This element is not included in the Supplier' s/Subcontractor's quality plan. 151 Appendix E: Attribute Gauge Analysis Form N 1 2 3 4 5 6 7 8 ;8 9 11 12 13 14 15 16 17 18 19 20 OPERATOR A Ilst Evaluation 2nd Evaluation OPERATOR B 1st Evaluation 2nd Evaluation FOR THE SYSTEMTO BE ACCEPTABLE,ALL EVALUATIONSPER LINE ITEMS MUSTAGREE. GAUGE TYPE GAUGE NO. OPERATOR A OPERATOR B ATTRIBUTE GAUGE ANALYSIS 155 DATE Subject Index A Annealing, 109 ANSI/ASME B18.8.2, 97 ANSI/ASQC Q90, 86 ANSI/ASQC 091, 86 ANSI/ASQC Q92, 86 ANSI/ASQC 093, 86 ANSI/ASQC Q94, 86 ANSI/ASQC Q9000-1994, 57, 75 ANSI/ASQC Q9001-1994, 57 ANSI/ASQC Q9002-1994, 57 ANSI/ASQC Q9003-1994, 57, 74-75 ANSI/ASQC Q9004-1-1994, 31-32 ASME/ANSI B18.18.2M, 86 ASME/ANSI B18.18.3M, 86 ASME-FAP-1, 57, 74-75, 86, 91 ASTM A-325, 15, 53 ASTM A-370, 114, 120 ASTM A-490, 49 ASTM A-700, 114 ASTM E-10, 114, 120 ASTM E-29, 114 ASTM E-30, 114, 118 ASTM E-112, 114, 118 ASTM E-548, 97 ASTM E-1077, 114, 119 ASTM F-606, 97 ASTM F-1469, 15, 50, 81-85, 91 ASTM F-1470, 86-90 ASTM F-1503, 53, 91-94 Attribute gauge analysis, 50-51, 155 Autocratic management, 3 C Cause and effect diagrams, 51 - 53 Chemical testing, Fastener Quality Assurance Act, 73 Coatings, IFI-140, 121 Communication, management role, 8 Continuous improvement, 21-28 employee involvement, reasons for, 2426 evaluation, 27-28 initiating actions, 26-27 planning, guidelines, 22-24 service and product improvement, 24 structured and systematic approach, 21 Control charting, guidelines, 52-53 Control plan, 15, 18-20 Costs of nonconformance, 36 of quality, 37-39 Critical performance indicators, 21 Customers, 5 D Decarburization IFI-140, 119 tests, 110-111 Distributor industry, quality assurance manual, 67-69 E Employees involvement in continuous improvement, 24-26 Employee survey, 5-6 Evaluation, 27-28 F Failure mode and effects analysis, 13, 1517 Fastener distributors, Fastener Quality Assurance Act and, 74-75 inspection, 103-106 manufacturers, Fastener Quality Assurance Act and, 74 testing, 102 users, Fastener Quality Assurance Act and, 75 Fastener Quality Assurance Act, 73-75, 133-143 advisory committee, 142-143 applicability, 143 chemical testing, 73 construction, 142 definitions, 134-135 findings and purpose, 133-134 laboratory accreditation, 137-139 lot segregation, 73-74 manufacturers' insignias, 141 minor deviations, 73 record keeping requirements, 142 regulations, 142 relationship to state laws, 142 remedies and penalties, 141 - 142 sale of fasteners subsequent to manufacture, 139-140 special rules, 135-136 testing and certification, 136-137 Flow chart, 10 - 11 analysis, 10-15 H Hardenability, IFI-140, 120 I IFI 100/107, 97 IFI 124, 97 IFI 125, 97 IFI-139, 74, 97-106 IFI-140, 74, 107-129 certification and test reports, 122 157 chemical requirements, 117-118 coatings, 121 decarburization, 119 definitions, 115-116 hardenability, 120 identification/tagging, 121 manufacture, 116 mechanical properties, 120 metallurgical structure, 118-119 mill scale/surface condition, 121 ordering information, 116-117 packaging and loading, 122 rods and bars, 107-109 size tolerance, 120-121 wire, 109-112 workmanship, finish and appearance, 121 Initiation, actions, 26-27 In-process inspection, 47-48 Inspection in-process, 47-48 lot-by-lot, 47-48 mechanical fastener, 103-106 ISO 9000, 74-75, 86, 97 ISO 9001, 32, 35, 86 ISO 9002, 32, 87 ISO 9003, 74-75, 87, 97 ISO 9004, 87, 97 ISO/IEC Guide 25, 74, 97 L Lot-by-lot inspection, 47-48 Lot segregation, Fastener Quality Assurance Act, 73-74 M Management commitment through sponsorship, 23 role, 3-8 autocratic management, 3 communication, 8 customer focus, 4-5 empowerment and involvement, 6 leadership commitment, 3 measurement, 6-7 recognition and rewards, 7-8 silos, 3 team management, 3-4 training, 5-6 Manufacturing, 31 quality assurance manual, 59-62 Materials control, suppliers, 44 Measurement, management's role, 6 - 7 Mechanical properties, IFI-140, 120 MILI 45208, 97 MIL Q 9859, 97 MIL-STD-1312, 97 MIL-STD-45662, 97 158 TOTAL QUALITY M A N A G E M E N T O Off-loading, 53 P Pareto analysis, 53-54 Partners In Quality Program, 40-41 Planning, guidelines, 22-24 Process control, suppliers, 44 Product improvement, 24 Public Law 101-592 (see Fastener Quality Assurance Act) O Quality cost of, 37-39 definitions, 9, 31 Quality assurance manual distributor industry, 67-69 manufacturing company, 59-62 service industry, 63-66 Quality control, 47-48 Quality manual, 31 - 33 Quality policy, 9 Quality reporting, 37- 39 suppliers, 44 Quality systems, 31 - 36 audits, 37-39 organizing for quality, 35-36 procedures, 33-35 R Recessed head wire, 112 Recognition, by management, 7-8 Repeatability, 50 Reproducibility, 50 Rewards, by management, 7-8 Rods, IFI-140, 107-109 S SAE J403, 114, 117-118 SAE J404, 114, 117-118 SAE J406, 114, 120 SAE J415, 114 SAE J429, 97 Scrapless nut wire, 112 Service and product improvement, 24 Service industry, quality assurance manual, 63-66 Service/product quality plan capability assessment guidelines, 12 detection assessment guidelines, 12 severity assessment guidelines, 12 suppliers in, 40 Silo, 3 Silo master, 3 Socket head wire, 112 Standard deviation, 49-50 Statistical process control, 50-54 attribute gauge analysis, 50-51 cause and effect diagrams, 51-53 pareto analysis, 53-54 variable control charts, 51-53 variable gauge analysis, 50 Statistical quality control, 47-54 applications, 48 descriptive statistics, 48-50 (see also Statistical process control) Strategic planning, 9-20 control plan, 15, 18-20 failure mode and effects analysis, 13, 15-17 flow chart, 10-11 analysis, 10-15 reaction of plan to out of control or specifications, 20 Suppliers, 40-44 auditing methods, 44 document and change control, 44 fixture and test equipment control, 44 involvement, 41-44 management, 42, 44 materials control, 44 measures, 40-41 objectives, 40 partnerships, 40-41 process control, 44 product control, 44 quality reporting, 44 quality systems survey, 42, 44, 147-151 sourcing considerations, 40 survey, 42-43 T Team management, 3 - 4 Testing laboratories, Fastener Quality Assurance Act and, 74 TQM interaction, 35-36 Training, 5-6 Tubular rivet wire, 112 V Variable control charts, 51-53 Variable gauge analysis, 50 W Wire, IFI-140, 107-112 About the Author Jack R Pekar is a graduate of Ohio University with a Bachelor of Science in Education, majoring in mathematics. He currently serves as Manager of Quality Services for Kennametal's Cleveland facility in Solon, Ohio. Jack has been active in the fastener and quality profession since 1964. His experience includes that of line inspector, supervisor, manager, and owner as he gained knowledge in his chosen profession. He worked for such fastener manufacturers as Lamson & Sessions, E. W. Ferry Screw Products, and SPS Technologies. At these organizations, he gained valuable experience in all phases of fastener processing. At Cleveland Twist Drill and Kennametal Inc., he gained knowledge as a fastener purchaser and user. Jack P. Pekar At both of these organizations, he set up programs to assure strong and viable supplier bases. Under his guidance, two of these companies were awarded Ford Motor Company's coveted Q1 quality certification. He led all of these companies to many successful certification awards from major corporations. Jack has been a member of ASTM since 1976 and serves as subcommittee chairman for F16.93, Quality Assurance Provisions for Fasteners, vice chairman of F16.01, Test Methods, and main committee chairman of F16 on Fasteners. He is also a senior member of SME and ASQC. In 1994 he was elected to the Board of Directors of the American Association for Laboratory Accreditation (A2LA). In addition to his business activities, he is active civically and serves on the Board of Directors and as Vice President of the Solon Chamber of Commerce. In 1991, Mr. Pekar received the President's Award from that organization for outstanding service. ISBN 0-8031-2062-1