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INTERACTIVE QUALITY CONTROL MANUAL

Abraham W. Bolden, Sr.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

ISO 9000 AND QUALITY MANUAL OUTLINE


This out line of The ISO 9000 requirements for quality control is presented to those who are engaged
in the production of machined items. The Forms referred to in the text may be acquired by emailing
me at Abraham.bolden@gmail.com. Interactive SPC Charts are also available. ISO 9000 interactive
form templates are also available for a nominal fee.

Quality Program Documentation


Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016


NAME OF COMPANY, Incorporated Quality Program is governed by comprehensive documentation as
referenced herein. Procedures, work instructions, forms, drawings, and similar documentation used by
organizations whose direct or supportive participation in processes affecting product Quality, are formally
documented and controlled. All such documents are contained in readily identifiable, easily accessible
controlled manuals or libraries placed at convenient locations throughout the company.

Manual Issuance

Date Issued:
Issued To:
Department:
Telephone:
Controlled Copy:

Uncontrolled Copy:

Control No.
If you need additional copies or additional information, please contact the Quality Control Manager.

By Abraham W. Bolden, Sr.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

ISO 9000 QUALITY MANUAL REVISION HISTORY

REVISION APPROVAL
CHANGE
DATE

PAGE
NO.

CHANGE
DESCRIPTION

COMMENTS

NAME

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

SIGNATURE
APPROVAL

This manual is hereby APPROVED as a complete documentation of those procedures and practices to be
used by the NAME OF COMPANY, INCORPORATED for the quality assurance of all manufactured
goods and contracted services. This manual should be considered as confidential and the contents of same
may not be revised, altered, copied or disseminated without the written permission of the President of
NAME OF COMPANY, INCORPORATED or the Quality Control Manager.

Signed By the Below Administrators

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

Table of Contents
Program Description
1.0

Introduction
1.1 Scope
1.2 Purpose
1.3 Authority
1.4 Issue of the Manual
1.5 Amendments
1.6 Review
1.7 ISO Program Representative
1.8 Cost of Quality
1.9 Definitions

2.0

Company Quality Policy

3.0

Organization Charts

4.0

Quality Policies and Responsibilities


4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document & Data Control
4.6 Purchasing
4.7 Control of Customer - Supplied Product
4.8 Product Identification and Tractability
4.9 Process Control
4.10 Inspection and Testing
4.11 Control of Inspection, Measuring and Test Equipment
4.12 Inspection and Test Status
4.13 Control of Non Conforming Product
4.14 Corrective and Preventive Action
4.15 Handling, Storage, Packing, Preservation and Delivery
4.16 Control of Quality Records
4.17 Internal Quality Audits
4.18 Training
4.19 Servicing
4.20 Statistical Techniques

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

1.0

Introduction
This manual outlines the policy of the company relating to its Quality Management
System (QMS).
The Quality Program Manual (QPM), issued and controlled by NAME OF COMPANY,
Inc. defines the Quality Management System, which is effective across all disciplines and
at all, levels within the company.

1.1

Scope
This Quality Program Manual applies to all activities and personnel within NAME OF
COMPANY, Inc.

1.2

Purpose
The primary purpose of this Quality Program Manual is to describe and document the
Quality Program currently in practice at NAME OF COMPANY, Inc.
This Manual is the central source of general policies, procedures, and responsibilities that
in turn authorize and govern creation of subsidiary quality related documentation and
activities.
This Manual provides comprehensive evidence to all customers, supplies, and employees
that NAME OF COMPANY, Inc. is committed to establishing and maintaining acceptable
levels of measurable Quality in its products and services.
The requirements and procedures addressed in the Quality Manual are intended to meet
the requirements of ANSI/ASQC Standard Q9000 - 1994 (ISO 9002) and customer QA
specifications.

1.3

Authority
This manual is issued under the authority of the President of NAME OF COMPANY, Inc.

1.4

Issue of the Manual


Controlled copies of the Manual will be numbered and registered. The Master copies of
the manual will be held by the Quality Control Manager and Management
Representative. The NAME OF COMPANY, Inc Management Representative is
responsible for the issuance of amendments to the Manual, withdrawal of obsolete
information and the maintenance of the master copies of the manual.
Uncontrolled copies may be distributed to organizations or persons at the discretion of
the Management Representative. These will be current at the date of issue only and will
not be subject to amendment action. These copies will be annotated "Uncontrolled
Copy."

1.5

Amendments

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

Controlled Manuals will be updated and revised as required. The issue of amendments
requires approval by the Management Representative.
1.6

Review
The Manual will be reviewed at a minimum annually and the Quality System audited
over this 12-month period to affirm that the current practices conform to the policies set
out in the manual.
The Quality Manual is to be treated as confidential and must not be copied, re-printed or
the contents divulged to a third party without the permission of the Quality Manager.

1.7

ISO 9000 Management Representative


The NAME OF COMPANY ISO 9000 Management Representative is responsible for all
matters concerning the Quality Manual and shall interface directly with the ISO 9000
Program Registrar on all matters in connection with the ISO 9000 program.
Representative:

1.8

Quality Control Coordinator

Cost of Quality
The President, vice-President and Administrative Assistant periodically address the Cost
of Quality. Actual cost data is considered company confidential. This quality program is
designed to produce continuous improvements in all operations. Improvements in quality
are measured and evaluated using the cost of quality information.

1.9

Definitions

Acceptance Criteria
Defined limits placed on characteristics, materials, products or services.
Audit
A systematic and independent examination to determine whether quality activities and
related results comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
Calibration
Comparison and adjustment to a standard of known accuracy.
Conformance
Compliance with specified requirements.
Concession
Written authority to use or release a quantity of material, components or stores already
produced, but which do not conform to the specified requirements.
Control
To exercise authority over and regulate.
Control Feature
A documented activity to ensure conformance with specific requirements of applicable
specifications.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

Corrective Action
Measures taken to rectify conditions adverse to quality and to minimize recurrence.
Defect
Not according to contractual specifications or fit for intended usage.
Documentation
Recorded information.
Equipment
Any simple completed unit that can be used for manufacture, processing or assembly.
Failure
Any condition which prevents the product or service from performing its specified
function.
Finding
Objective evidence that a control feature of the approved quality program was not
implemented.
Grade
An indicator of category or rank related to features or characteristics that cover different
sets of needs for products or services intended for the same functional use.
Inspection
Activities such as measuring, examining, testing, gauging one or more characteristics of a
product or service and comparing these with specified requirements to determine
conformity.
Job Work Instructions
A document that provides detail "how to" instructions to accomplish a task.
Quality System Review
A formal evaluation by top management of the status and adequacy of the quality system
in relation to quality policy and new objectives resulting from changing circumstances.
Non-conformity
The non-fulfillment of specified requirements.
Objective Evidence
Facts that are observed and documented.
Observation
Evidence that a survey able / auditable element exists which is not contrary to
documented requirements, but may warrant further qualification or improvement.
Part
Individual pieces used in the assembly of single equipment units.
Quality
Conformance to specified requirements.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

Quality Assurance
All those planned and systematic actions necessary to provide adequate confidence that a
product or service will satisfy given requirements for quality.
Quality Control
The operational techniques and activities that are used to fulfill requirements for quality.
Quality System
The organizational structure, responsibilities, procedures, processes and resources for
implementing Total Quality Management.
Servicing

Supplier activities at the interface with a customer and the results of all supplier activities
to meet the customer needs.

Quality Procedure (QP)


A document that specifies or describes how an activity is to be performed. It may include
methods to be used, equipment to be used and sequence of operations.
Subcontractor
Any individual or organization that furnishes materials, products or services.
Specification
The document that prescribes the requirements with which the product or service has to
conform.
Tractability
The ability to trace the history, application or location of an item or activity, or similar
items or activities, by means of recorded identification.
Vendor
Any individual or organization that furnishes materials, products or services.
Verify
To determine conformance to specified requirements.
Wkpro
Work Procedure and instruction detailing actions to be performed at specific work
station.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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2.0

Company Quality Policy


All products and services provided by NAME OF COMPANY, Inc. shall conform to the
requirements specified. All employees have the responsibility to carry out their work
assignments in accordance with this Quality Policy and other quality system
documentation.
We are committed to continually improving all products and services and to establish
NAME OF COMPANY, Inc. as a Quality leader in our field.
In order to meet our goals we will pursue the following objectives:
Provide our customers with only the highest quality products and services.
Provide those products on time.
Provide our customers with the best pricing and value for our products.
Provide totally open communications with our customers in order to meet the customer's
needs.
Provide a system for Continuous Quality Improvement in conformance with procedures
required by the International Standards Organization.
Provide for employee involvement, motivation and training.
Utilize Statistical Process Control where the absence of statistical data would be
detrimental to the quality of the product.
The quality program described in this Quality Program Manual has been specifically
designed to meet the requirements of International Standard ISO 9002 and to provide the
framework to allow accomplishment of the quality objectives and goals of the NAME OF
COMPANY, Inc.
The Management Representative has the responsibility for definition, implementation and
maintenance of this quality program. The Management Representative shall ensure that
this Quality Policy is understood, implemented, and maintained at all levels of the
organization.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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3.0

Organizational Charts

3.1

Organizational Reporting

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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4.0

Quality Policies and Responsibilities

4.1

Management Responsibility

4.1.1

Scope
This policy defines the corporate commitment to quality.

4.1.2

Reference
ISO 9002: 1994, Requirement 4.1.

4.1.3

Policy
The corporate quality policy of the NAME OF COMPANY, Inc. is stated in the
Company's Quality Policy that has been developed and agreed to by the Senior
Management of the Company. The companys Quality Policy is stated in Section 2.0 of
this manual.
The Company is committed to achieve this policy through the implementation and
maintenance of an ISO 9000 Quality Management System.
This commitment seeks continual improvement of the system to achieve the company
mission. Senior management will review the Quality Management System on an annual
basis to ensure its continued effectiveness.
The company is committed to ensuring that all staff is responsible for the quality of their
work, and so the personnel who perform the operations carry out verification.

4.1.4

Responsibilities
It is the responsibility of the President of NAME OF COMPANY, Inc. to provide the
resources necessary to implement and maintain the Quality Management System.
The Screw Machine Company, Inc. ISO 9000 Management Representative is responsible
for all matters concerning the Quality Manual and shall interface directly with the ISO
9000 Registrar on all matters in connection with the ISO 9000 Program. The
Management Representative shall ensure that the quality system is established,
implemented and maintained in accordance with ISO 9002:94.
The Management Representative is responsible for the coordination of the management
review activity.
The Management Representative is responsible for issuing a copy of the Company
Quality Policy to new employees, and all Managers are responsible for ensuring that their
subordinates are conversant with the company's Quality Policy and its Quality
Management System.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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4.1.5

Teamwork
Teamwork is the strategy for the company to promote continuous improvement by way of
employee involvement. Employee involvement is established and tracked in accordance
with the Management Review process.

4.1.6

Management Review
The President and Functional Department Heads shall review the Quality System
annually in conjunction with the Management Representative to ensure its continued
effectiveness.
The review shall address as a minimum the following:

Confirmation that the Statement of Policy and Authority is still valid


and requires no change

A review of the Quality Program Manual and Standard Procedures to


confirm that they meet the requirements of ISO 9002

The identification of weaknesses and deficiencies in the Quality


System, including those identified as a result of internal and external
quality audits and consideration of possible improvements

Wastage, loss and client complaints incurred throughout the year to


identify possible savings and reconsideration of existing working
practices

Verification that corrective action procedures are effective

The management review shall be conducted in accordance with the Standard Procedure
referenced in 4.1.7.
The result of this review shall be documented and agreed non-compliances shall be
processed in accordance with the Company's corrective action system (refer to Section
4.14 of this Manual).
4.1.7

Internal Quality Audit


The Management Representative shall be responsible for the planning and
implementation of scheduled and unscheduled quality audits to verify compliance with
the requirements of the Quality Management System.
Quality audits shall be conducted by suitably qualified personnel, as nominated by the
Management Representative in conjunction with the Quality Manager, in accordance with
the Standard.
Each element of the Quality Management System shall be audited at least once per
annum; however, the frequency of audit of each criterion may be altered on the basis of
previous results, at the discretion of the Quality Manager.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

14

The Management Representative shall report to the President and Functional Department
Heads the results of the audit and recommend corrective action as appropriate, to ensure
adequate implementation.
Agreed corrective action shall be implemented in accordance with the requirements of
Section 4.14 of this Manual.
4.1.7

Documents Implementing This Policy


QP 117 Internal Quality Audits

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

15

4.2

Quality System

4.2.1

Scope
This policy defines the quality system operated by NAME OF COMPANY, Inc. to ensure
that all products and services conform to customer requirements.

4.2.2

Reference
ISO 9002: 1994, Requirement 4.2

4.2.3

Policy
The Company will operate a Quality Management System based on policies and
procedures that are documented to meet ISO 9000 standards.
The Quality Management System is structured in three levels. Level One is documented
in the form of a Quality Program Manual and contains the corporate policies and
responsibilities. Level Two contains the operating standard procedures of the Company
that are referenced to the Quality Management System requirements of the Quality
Program Manual.
Level Three is the function specific support documentation and forms.

4.2.4

Responsibilities
The Quality Manager in conjunction with the Management Representative bears the
prime responsibility for establishing and maintaining an effective and economic Quality
Management System.
They will resolve any conflicts or difficulties involved in the implementation of the
Quality Management System and will ensure that corrective action necessary to prevent
recurrences of system shortcomings or non-conformance is implemented.
All Functional Department Heads and employees are responsible for the maintenance of
the Company Operating Procedures in their area required for the implementation of the
Quality Management System.
It is the responsibility of all members of Management to familiarize themselves with the
Quality Management System requirements and to ensure that these are observed
accordingly.

4.2.5

Documents Implementing This Policy


QP 107
Quality Policy, dated
Organization Chart
Wkpro-5 -Work Instructions, Quality Control

4.3

Contract Review

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

16

4.3.1

Scope
This policy defines the way in which customer requirements will be established and
reviewed.

4.3.2

Reference
ISO 9002: 1994, Requirement 4.3

4.3.3

Policy
The President of NAME OF COMPANY is responsible for ensuring that all quotations
and contracts are reviewed prior to acknowledgement to the customer. The President
ensures that contracts are adequately defined and documented. This function shall verify
that the company has the capability to fulfill the order. It is the policy of the company
that all quotations that are special orders or nonstandard product be reviewed according
to the Contract Review Procedure prior to release.
The President has the responsibility for organizing contract reviews for customer orders
for products and services, and assigning responsibilities for their execution as required.
Customer orders will be reviewed to ensure that the requirements are adequately defined
and documented to identify any differences between the order and the original quotation
and to determine the companys capability to meet the specified requirements.
Verbal orders will be documented by the President to ensure that the order requirements
are agreed upon before their acceptance.
The company will not accept any order for which it cannot meet the requirements as
stated in the contract or purchase order.

4.3.4

Contract Amendments
The Production Control Function is responsible for coordinating amendments to any
customer orders. This function shall communicate all changes between the company and
customer and notify all affected departments of relevant changes. Contract amendments
are coordinated, reviewed, approved, and communicated according to the Contact
Review Procedure.
Contract review activities are recorded and related correspondence are documented by
the company and maintained in the customer order file by the Administrative Assistant.

4.3.5

Responsibilities
The President is responsible for ensuring that all quotations or contracts are reviewed
prior to acknowledgement, organizing contract reviews, and documenting all review
activity to ensure that customer requirements are adequately defined and can be met.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

17

The Production Control Administrator is responsible for coordinating amendments to any


customer orders.
4.3.5

Documents Implementing This Policy


QP 100 Contract Review
Wkpro-1- Work Instructions, Production Control

4.4

Design Control

4.4.1

The NAME OF COMPANY is not engaged in the design activities or


development and therefore has no procedure regarding this element.

4.4.2

Documents pertaining to this Policy


QP 101 Design Review

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

18

4.5

Document and Data Control

4.5.1

Scope
This policy defines the way in which all documents and data pertaining to the Quality
System are controlled.

4.5.2

Reference
ISO 9002: 1994, Requirement 4.5

4.5.3

Policy
The NAME OF COMPANY, Inc. identifies and controls documents and data that relate to
the requirements of this Standard, as well as documents and data supplied by the customer or
other sources and used to provide products that meet defined requirements.

....
4.5.4

Responsibilities
The Production Control Manager has the authority to review and approve documents
pertaining to the manufacture of product and verifies that current versions of documents
referenced by customer drawings or specifications, or contract -related work instructions, are
readily available to personnel using the source documents.
The Production Control Manager assures that invalid or obsolete documents are promptly
removed from all points of issue or use.
The Management Representative is responsible for ensuring that all Quality System
Documents Quality Manual, Quality System Procedures, and the Quality System-related
Work Instructions are available as required by this Standard and is responsible for the
maintenance of the master list of quality oriented documents and data.
The Production Control Manager in conjunction with the Management Representative is
responsible for the issuance of revised documents pertaining to customer requirements and
specifications. The nature of the revision or change is identified in the document at the time
of issue.

4.5.5

Documents Implementing this Policy


QP 116 Control of Quality Records
QP 102 Document and Data Control
Wkpro-1- Work Instructions, Production Control

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

19

4.6

Purchasing

4.6.1

Scope
This policy defines the controls on the purchase of materials and services used in the
manufacture of the Company's products.

4.6.2

Reference
ISO 9002: 1994, Requirement 4.6

4.6.3

Policy
The Production Control Manager is responsible for ensuring that all purchased materials
and services required for the manufacture of products will be the subject of written
purchase orders that will clearly describe the type, class, or other precise identification of
the item or service being ordered. The positive identification and applicable
specifications, drawings, process requirements, inspection instructions or relevant
technical data bearing upon the approval of the purchased item shall be included in or
attached to the purchase order upon issuance.
The Production Control Manager is responsible for ensuring that purchasing documents
contain data clearly describing the product ordered.
In line with the Company's policy of using only materials that meet the required quality,
all materials used in manufacture will be purchased to the Company's written
specification.
Wherever possible the Company will procure materials or services from an assessed
source acceptable to the company.
Such assessment will be carried out in accordance with the Company's procedure for the
selection of suppliers. Preference will be given to ISO 9000 assessed and registered
suppliers.
The company will work closely with its suppliers to establish quality procedures that
eliminate the need for incoming inspection. Copies of suppliers quality test and/or
certifications of results will be used for this purpose. Pending being satisfied that a
supplier's quality system is adequate to permit identification testing/ inspection only,
instead of full incoming inspection quality test, incoming materials will be subject to
inspection on a sample basis.
The results of assessment and the subsequent level of supplier performance will be used
to determine the extent of receiving inspection necessary before acceptance of the
supplies by the company.
The Company's right to verify materials at source is specified in its conditions of
purchase. Source verification requirements will be identified at the contract review stage.

4.6.4

Responsibilities

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

20

It is the responsibility of the Purchasing Manager to ensure that the procedures


established for the control of the purchasing activity are implemented and maintained.
The Quality Function is responsible for establishing and maintaining the approved
supplier list.
The Manufacturing Function is responsible for ensuring that material specifications will
allow product specifications to be met.
The Quality Function will determine the extent of the receiving inspection activity
required and will coordinate the assessment of vendors quality systems.
It is the responsibility of the Quality Function to coordinate any source verification
activity required.
4.6.5

Documents Implementing this Policy


QP 100 Contract Review
QP 104 Supplier Survey
QP 103 Purchasing
Wkpro-1- Work Instructions, Production Control

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

21

4.7

Control of Customer-Supplied Product

4.7.1

Scope
This policy defines the way in which Purchaser Supplied Product (or GFP) will be
controlled.

4.7.2

Reference
ISO 9002: 1994, Requirement 4.7

4.7.3

Policy
All Purchaser Supplied Product is examined upon receipt for condition, quantity and
conformance with delivery details.
All items are positively identified and stored in a designated area.
Periodic inspection is performed to detect any damage or deterioration of materials.
Material will only be issued against those orders for which it was supplied.
Any customer product that is either lost, damaged, or is otherwise unsuitable for use is
recorded, and reported to the customer. Such reports and any investigation predicated
upon such reports are documented.

4.7.4

Responsibilities
The Production Control Function is responsible for identifying purchaser-supplied
product during the contract review activity and for communicating such information to
the appropriate company personnel.
The Quality Function is responsible for establishing, implementing and maintaining the
procedures required to meet the requirements of this policy.

4.7.5

Documents Implementing this Policy


QP 105 Control of Customer Furnished Material
Wkpro-4- Work Instructions, Shipping, Packaging, Receiving
Wkpro-5- Work Instructions, Quality Control

4.8

Product Identification and Tractability

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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4.8.1

Scope
This policy defines how product identification and trace ability will be established and
controlled.

4.8.2

Reference
ISO 9002: 1994, Requirement 4.8

4.8.3

Policy
The NAME OF COMPANY establishes and maintains a documented procedure for
identifying raw materials and supplies, parts and finished products by means of
applicable drawings, specifications and other documents from receipt and throughout all
stages of production and delivery.

4.8.4

Identification of Incoming Materials


The Material Handler is responsible for ensuring that all materials are clearly identified
either individually or as a lot while they are located at Shipping and Receiving or in
transit to storage or use in production. The Material Handler maintains records
identifying incoming materials by Part Number, and their corresponding purchasing
documentation such as specification and other pertinent data.
The Production Control Manager records the receipt of materials and maintains accurate
and timely records on inventory location and age, and updates inventory status on a semiannual basis.

4.8.5

Identification of In-Process Materials


The Production Manager and shop supervisory personnel are responsible for assuring that
in-process materials are clearly identified.
Manufactured items are traced by means of job cards and shop routing instructions which
identifies the material (part number and description) shows its routing, and denotes its
current state of processing. Stock items are identified by part number and customer.

4.8.6

Traceability
The NAME OF COMPANY maintains records for each finished product which include
the applicable routing sheets, engineering drawings, and contract specifications used for
manufacture. Records pertaining to traceability are maintained for a period of no less
than 3 years. Product traceability is controlled through this procedure.

4.8.7

Documents Implementing this Policy


QP 106 Product Identification & Trace ability
Wkpro-4- Work Instructions, Shipping, Packing, Receiving 4.9 Process Control

4.9.1

Scope

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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This policy defines the way in which the manufacturing processes are controlled.
4.9.2

Reference
ISO 9002: 1994, Requirement 4.9

4.9.3

Policy
Managers of departments involved in production processes which directly effect quality
of the end product are responsible for ensuring that these processes are identified,
planned and executed under controlled conditions. Controlled conditions are defined to
include the following requirements:

4.9.4

Documented procedures and / or work instructions for production items


where their absence would adversely affect quality.

Suitable equipment and working environment, to include compliance


with government safety, environment, and hazardous material-related
regulations.

Compliance with reference standards, codes, and quality plans and / or


documented procedures.

Monitoring and control of suitable process and product characteristics,


with an emphasis on those characteristics designated as special by the
customer or NAME OF COMPANY, during production. Special
characteristics are designated, documented and controlled as required
by the customer.

Approval of processes and equipment, as appropriate.

Criteria for workmanship, which are either written or expressed by


means of representative samples.

Suitable maintenance of equipment to ensure continuing capability of


the machine or process.

Process Control and Operator Instructions


The Manager of each department with process monitoring and operator instructions is
responsible for ensuring that these work instructions are understandable, sufficiently
detailed, and accessible at the work station and that they are periodically reviewed as the
need arises.
Process Monitoring and operator instructions shall include or reference, as appropriate

Operation Name and/or Number keyed to process flow requirements


Part Name and Number
Current engineering level / date.
Required tools, gages and other equipment.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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4.9.5

Material identification and disposition instructions.


Customer and supplier designated special characteristics.
SPC requirements.
Relevant engineering and manufacturing standards.
Inspection and test instructions where applicable.

Responsibilities
The Production Management Function is responsible for establishing Workmanship
Standards in the Process Instructions.
It is the responsibility of the Quality Function to ensure that the Quality Control
Instructions adequately specify requirements.
The Quality Manager is responsible for ensuring that the Process and Quality Control
Instructions are established and maintained.
The Production Planning Team is responsible for the planning and scheduling of work
orders.

4.9.6

Documents Implementing this Policy


QP 107 Process Control Production
QP 121 Machine Maintenance
Wkpro-2- Work Instructions, Automatic Screw Machine
Wkpro-3- Work Instructions, Secondary Setup & Operate
Wkpro-5- Work Instructions, Quality Control

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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4.10

Inspection and Testing

4.10.1

Scope
This policy defines the conduct of inspection and testing activities to verify conformance
with specified requirements.

4.10.2

Reference
ISO 9002: 1994, Requirement 4.10

4.10.3

Policy
The NAME OF COMPANY establishes and maintains procedures, work instructions, and
quality plans which define the required inspection and testing activities and related
records used to verify that all product requirements are met prior to product distribution,
processing, or use.
Acceptance criteria, unless otherwise specified by customer contract, in all cases is zero
defects. (C=0)
When specified in the contract or as the need arises to ascertain the quality of materials
used in the production process, the NAME OF COMPANY shall use accredited
laboratory facilities.

4.10.4

Receiving Inspection and Testing


The Production Control Function has the responsibility for ensuring that incoming
product is not used or processed until it has been verified as conforming to specified
requirements. When product is needed in an urgent production situation, the product or
materials are positively identified and recorded in order to permit positive recall in case
that the product or material does not meet customer requirements.
The amount and nature of receiving inspection and testing applied to incoming material
from suppliers is based upon the following factors:

The suppliers ability to provide statistical/analytical data to demonstrate


product quality.
Results of second or third party assessment of suppliers location.
Documented evidence of product quality obtained through accredited
contractors or test laboratories.
The suppliers ability to provide warrants or certifications, including records of
test results.
Records of supplier performance.
Customer requirements and/or recommendations.

Verification through inspection and testing is done in accordance with the Receiving
Inspection Procedure, which addresses such issues as:

Specification of proper work instructions and/or control plans for receiving


inspection.

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4.10.5

Reference to the Nonconforming Material Procedure for isolation, identification,


and control of nonconforming materials.
Methods for the identification and distribution of acceptable materials.
Documentation and storage of inspection records.

In-Process Inspection and Testing


The Production Manager is responsible for ensuring that in-process product is held and
not used or processed further until it has been inspected, tested, or otherwise verified as
conforming to specified requirements, except when product is released under positive
recall.
Inspection of in-process materials is done in accordance with In-Process Inspection
Procedures, which addresses such issues as:

4.10.6

Specification of proper work instructions, standards, and/or inspection plans for


inspection.
Reference to the Non-conforming Material Procedure for control on
nonconforming materials.
First Piece product inspection.
Urgent production situations and positive methods for recall.
Documentation, use, and storage of records.

Final Inspection and Testing


The Quality Control Manager is responsible for ensuring that no product is dispatched
until the following conditions are verified:

All final inspection and testing are complete according to the appropriate
documented procedure and/or work instruction or quality plan to show evidence
of product conformance to specified requirements.
All data and documentation covering inspections and tests specified in the
quality procedures and control plan are available and authorized to show
compliance and that the results meet specified requirements.
The requirements of Section I, element 4.10.4 are addressed in detail in the Final
Inspection Procedure, which addresses such issues as:

4.10.8

Specification of proper work instructions, standards, and/or inspection plans for


final inspection.
Reference to the Nonconforming Material Procedure for control of rejected
materials.
Documentation, use, and maintenance of records.
Layout inspection of products or other documentation specified by customer.

Inspection and Test Records


Inspection and test records are established and maintained to identify the persons
performing inspection activities, and the results of these verification activities. The
responsibility for generating, filing, and maintaining inspection and test records is
defined in the quality procedures referenced below.

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4.10.5

Documents Implementing this Policy


QP 108 Receiving Inspection
QP 109 Inspection & Test Status
QP 110 Final Inspection
QP 111 Quality Assurance
Wkpro-5- Work Instructions, Quality Control

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28

4.11

Control of Inspection, Measuring and Test Equipment

4.11.1

Scope
This policy defines the control of inspection, measuring and test equipment used by the
company.

4.11.2

Reference
ISO 9002: 1994, Requirement 4.11

4.11.3

Policy
The Manager of Quality Control is responsible for establishing and maintaining
documented procedures and work instructions for insuring that all inspection, measuring,
and test equipment used in any stage of production is controlled, calibrated, and properly
maintained to demonstrate the conformance of product to the specified requirements.
All equipment used for test and measurements will be subject to annual calibration or
calibration prior to use for the qualifying of any production, as detailed in the appropriate
calibration procedure. Calibration equipment will be traceable to a national or
international standard. Records of calibration will be maintained and a system of call-in
for calibration operated. When equipment is found to be out of calibration, the effect of
that error on product will be reviewed and appropriate corrective action taken.
The annual due date for the calibration of measuring devices shall include a period from
1 week before to 1 week after the due date as entered in the calibration records.
Measuring equipment belonging to any newly hired employee must be calibrated and
assigned an in- house ID number prior to use. The equipment is then documented and
re-scheduled for subsequent calibration.
The Screw Machine Engineering uses documented work instructions to perform gage
repeatability and reproducibility studies to address measurement uncertainty.
The Manager of Quality Control is also responsible for ensuring that the measurement
uncertainty of the inspection equipment is known and that such equipment is used in a
manner consistent with the required measurement capability.
The NAME OF COMPANY provides data regarding measurement device calibration to
its customers upon request.

4.11.4

Procedure
The NAME OF COMPANY has a formal, documented procedure and work instructions
for regularly certifying the accuracy of every inspection instrument that is used in the
manufacturing process, including instruments owned by employees. Instruments used to
verify dimensions or characteristics, or perform functional testing and thereby accept
parts are calibrated periodically.

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For each item of equipment, a Calibration Record is maintained which describes the
equipment, assigns an ID number, identifies its location as of the date calibrated, lists the
date calibrated and the next date re-calibration is due, and the acceptance criteria.
The calibration record also documents the history of all calibration activity including the
condition of the instrument at the time of calibration. The calibration record is
maintained by Quality Control for a period of 3 years.
Reference and attribute gages issued by quality control are calibrated and/or checked
prior to each issue and a gage issue and calibration record is updated at the time of issue.
The instrument calibration ID number affixed to each measuring device references a
complete history of that device as recorded in the computer based Gagecal file. A
condensed copy of the calibration record pertaining to the ID number is issued to each
employee at the time of calibration. The employee copy of the calibration record
describes the measuring device, shows date calibrated, the date that the next calibration is
due, the name of the person who owns the device, and comments as to the condition of
the instrument at the time of calibration.
All calibrations and related inspections are performed in environmentally controlled or
suitable conditions.
When necessary, outside sources are used to calibrate certain gages and equipment. For
each item of equipment, the Calibration Record is completed and a copy of the gage
certification is required. All calibration services, whether performed in or outside the
plant, are calibrated to standards that are traceable to the National Institute of Standards
and Technology (N.I.S.T.)
Inspection and measuring equipment that is not in current calibration is not used. Newly
acquired measuring instruments are impounded until calibration has been completed.
Employees that use the measuring equipment are responsible for checking the calibration
sticker (or equivalent tag/marker) to ensure that the calibration status is current.
Should calibration activity disclose the potential for discrepant material that has been
shipped, the customer shall be notified of all pertinent information. This notification may
be followed by a request for deviation or waiver.
Calibration activity that discloses the potential for discrepant material that is within the
facilities of the NAME OF COMPANY results in the initiation of a production audit of
parts produced and qualified by any measurement device found to be out of calibration.
If the production is found to be discrepant, a Non-conforming Material Report is
generated.
All inspection, measuring, and test equipment is handled properly and stored in a manner
that prevents accidental damage to ensure that the accuracy and fitness for use is
maintained.
Test hardware or software used as a suitable means of inspection are subject to the
requirements as listed above for inspection, measuring, and test equipment.
4.11.5

Quality Records

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The Manager of Quality Control is responsible for the maintenance of calibration records,
including communication to customers regarding the potential for nonconforming
product due to the out of calibration equipment and for ensuring that the control of
measurement equipment meets or exceeds customer requirements.
4.11.6

Measurement System Analysis


The Manager of Quality Control is responsible for the maintenance of gage repeatability
and reproducibility and other applicable statistical studies designed to analyze
measurement system uncertainty. The NAME OF COMPANY has documented work
instructions which include analytical methods and acceptance criteria that meet the
specified calibration requirements.

4.11.7

Documents Implementing this Policy


QP 112 Control of Measuring & Test Equipment
QCP 100 Calibration Procedures

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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4.12

Inspection and Test Status

4.12.1

Scope
This policy defines the way in which inspection and test status will be defined.

4.12.2

Reference
ISO 9002: 1994, Requirement 4.12

4.12.3

Policy
All materials and products will be suitably identified throughout each stage of
manufacture by the use of routing tags, labels, inspection records, physical location
designations, or other suitable means, which indicate the conformance or
nonconformance of the product with regard to the inspections performed. The
identification of inspection and test status is maintained, as defined in the companys
procedures and work instructions and as required by the customer, throughout production
to ensure that only product that has passed the required inspections is routed to the next
operation or for shipment.
Defective products discovered during the production process will be segregated from all
other material pending investigation and final disposition and all such material will be
clearly identified.
Inspection and test records will enable the identify of the inspection authority responsible
for the release of the finished product to the established.

4.12.4

Responsibilities
It is the responsibility of the Department Manager to ensure that the procedures required
to implement this policy are established and maintained.
It is the responsibility of all personnel to observe the requirements of the procedures that
implement this policy.
The Quality Manager bears the ultimate authority for the release of the Company's
products and is responsible for the delegation of such authority.

4.12.5

Documents Implementing this Policy


QP 109 Inspection & Test Status
Wkpro-5 - Work Instructions, Quality Control

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

32

4.13

Control of Non Conforming Product

4.13.1

Scope
This policy defines the manner of controlling material that does not conform to specified
requirements.

4.13.2

Reference
ISO 9002: 1994, Requirement 4.13

4.13.3

Policy
The Manager of Quality Control in conjunction with the Management Representative is
responsible for maintaining documented procedures and work instructions for ensuring
that product not conforming to specified requirements is clearly identified, quarantined
and segregated to prevent inadvertent use until the material disposition is determined.
All defective material is, immediately upon detection, identified and held pending
investigation and disposition.
Such arrangements apply to material received from suppliers or from internal or external
non-conformances.
All defective products are reviewed to determine the need for corrective/preventative
action and the subsequent material disposition.
Records of all non-conformance are maintained and are periodically reviewed to establish
trends and thereby determine the need for further preventative action.
Material that does not conform to the customers specification will be used only after
obtaining the customers written deviation or consent.

4.13.4

Nonconforming Product Review


The Quality Control Manager has the responsibility for the initial review and control of
all suspected nonconforming materials. After initial review, the company President,
Quality Control Manager and the person in charge of the department in which the
defective materials were produced have the authority to carry out the following
emergency actions:

Rework product to meet the specified requirement.


Accept product based upon customer grant of material deviation.
Use product for alternative applications where product meets required
specifications.
Scrap the product.

The occurrence of a nonconforming material condition is documented by use of the


Rejection and Sorting Report. This report describes the nonconformity, addresses the
disposition, and provides statistical information for possible corrective action and/or
process improvement activities to prevent reoccurrence. The information contained in
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these reports is tracked and documented in the computer files for the purpose of to
continuously reduce the level of nonconforming product.
Product that is reworked or repaired is re-inspected according to appropriate inspection
procedures and Quality Plans. Pertinent instructions for rework are either written or
delivered orally to appropriate personnel.
The Material Review Board is composed of the company President, Management
Representative, Quality Control Manager and the Manager of the department responsible
for the nonconforming materials. The MRB shall convene as necessary in order to
disposition nonconforming materials received from the customer or discovered during
production activity.
4.13.5

Control of Reworked Product


Reworking of product is controlled by the manager of the department responsible for
bringing the product within required specification. All reworked product is re-inspected
prior to shipment and the product supplied to the customer may not show visible evidence
of rework activity unless the customer has granted concession or deviation.

4.13.6

Engineering Deviations and Authorizations


The Management Representative is responsible for managing the customer authorizations
of products, including materials provided by suppliers that differ from those currently
approved according to the following guidelines that include:

Obtaining written customer approval of Deviation Requests, Engineering


Changes and Corrective Action Requests.
Ensuring that the proper documentation is available for materials shipped under
customer deviation or waiver.

It is the responsibility of all personnel detecting a non-conformance to ensure that it is


properly identified, segregated and reported.
The responsibilities for determining disposition of defective material are defined in the
Procedures that implement this policy.
4.13.7

Documents Implementing this Policy


QP 113 Non Conforming Material

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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4.14

Corrective and Preventive Action

4.14.1

Scope
This policy defines how corrective and preventive actions are identified, implemented
and reviewed for effectiveness.

4.14.2

Reference
ISO 9002: 1994, Requirement 4.14

4.14.3

Policy
The NAME OF COMPANY establishes and maintains documented procedures for
implementing both corrective and preventive action. These procedures specify actions
for eliminating the cause of actual or potential quality system problems and related
nonconformities to a degree commensurate with the magnitude of the problem, its
potential outcome, and the level of risk involved. Corrective Action Requests received
from the customer are resolved as required by the customer.
The Management Representative and the Quality Control Manager are responsible for
ensuring that all company personnel involved in the Corrective Action Process and
Preventive Action Program:

4.14.4

Understand their importance in achieving the goals of the Quality


Policy.

Are able to provide the personal commitment and resources necessary


to execute corrective and preventive actions in an efficient and timely
manner.

Are aware of the various problem-solving methods used in determining


corrective and preventive action plans.

Understand the importance of corrective and preventive action plans in


the Management Review Process.

Implementation of Corrective Action


Corrective Action functions are directed at revising the companys quality system,
policies, processes, procedures, and work instructions in order to eliminate the root cause
of the quality problem. Corrective Action Procedures are utilized in the following
situations:

To resolve quality system problems related to nonconformities found


during internal, external, or third party audits, and issues uncovered
during the Management Review process.

To revise the quality system, work processes, quality procedures, and /


or work instructions to eliminate the cause of a poor quality product,
customer complaint, or internal quality failure. External failures are

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35

handled as required with the customer, and are used as input to the
corrective action process.

To resolve quality system problems found through the analysis of


customer returns.

Corrective actions are initiated, controlled, and documented through the use of the
Corrective Action Request which is specified in the Corrective and Preventive Action
Procedure.
The responsibility for undertaking the corrective action lies with the Management
Representative in conjunction with the Quality Control Manager. For each corrective
action request, the Management Representative with the assistance of Administrative and
management personnel shall:

Investigate the extent of the problem.

Determine the root cause(s) of the problem.

Decide on corrective action.

Implement the corrective action.

Initiate permanent changes in any related procedure/instructions (if


appropriate).

The Management Representative is responsible for ensuring that the Corrective Action
Program is managed effectively. This involves, but is not limited to the following
activities:

4.14.5

Issue the Corrective Action Request form to the person responsible.

Follow-up on the progress of Corrective Action activities to help ensure


that the corrective action is completed by the promised date.

Verify that the corrective action taken is effective.

Sign off on the Correction Action Report for completed activities, and
close out the correction action.

Investigate the cause of failure and take appropriate action when the
correction action is not completed according to plan.

Maintain a system of records for managing the corrective action


documents, monitoring the status of corrective action activities, and
storing closed out Corrective Action Requests for a period of 3 years
minimum.

Implementation of Preventive Action

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Preventive action is directed at revising the companys quality process or tooling to


eliminate the root cause(s) of potential problems. Preventive and Corrective Action
Procedures are used when:

Potential problems are discovered or opportunities for improvement are


identified during internal, customer, or third party audits.

Quality records, past production history, customer feedback, process


capability studies, and/or management review reports reveal a need for
the undertaking of preventive action measures.

Preventive actions are initiated, controlled, and documented through the use of the
Corrective Action Request form.
The responsibility for the undertaking of preventive action lies with the Administrative
Staff consisting of the company President, Quality Control Manager, Management
Representative, and Production Manager who are responsible for the related quality
system elements and / or procedures. For each Preventive Action Request, the
aforementioned persons shall:

Investigate the nature of the weakness.

Determine the root cause(s) of the weakness.

Decide on preventive action.

Initiate permanent changes in any related procedure or instructions (if


appropriate).

The Management Representative is responsible for ensuring that the Preventive Action
Program is managed effectively. This function shall document preventive action
measures, monitor the status of the activity, and store the closed out preventive action
records for a period of 3 years minimum.
4.14.5

Documents Implementing this Policy


QP 114 Corrective and Preventive Action

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4.15

Handling, Storage, Packaging, Preservation and Delivery

4.15.1

Scope
This policy defines the controls employed within the Company for the handling, storage,
packaging and delivery of materials.

4.15.2

Reference
ISO 9002: 1994, Requirement 4.15

4.15.3

Policy
Material handling arrangements are made during all stages of manufacture, inspection
and test in order to prevent any risk to material quality.
The manner in which material is handled and protected is subject to written instructions
where critical handling and transportation considerations are identified. These will refer
to any special containers, and handling devices are provided accordingly.
Materials awaiting use or shipment are identified and segregated in secure storage areas.
Suitable measures are taken to prevent damage or deterioration including a periodic
inspection for materials condition.
The Company's products are packed in accordance with prescribed methods and using
materials designed to ensure that the product quality is maintained during transit. Order
and product identification are clearly marked and will provide for any contract or carrier
requirements.
The product description, destination and transit considerations are specified on the
Company's delivery/dispatch documentation.

4.15.4

Responsibilities
The Purchasing Materials Function is responsible for ensuring that material is properly
received, identified, protected, stored and issued in accordance with the prescribed
routines.
They are also responsible for ensuring that products are properly prepared for dispatch
and are accordingly identified.
The Purchasing and Materials Functions are responsible for the conduct of regular
audits of stock to determine that material is maintained in a satisfactory condition.
The Quality Function is responsible for ensuring that products are properly prepared for
dispatch and are accordingly identified. It is the responsibility of all personnel to adopt
good material handling practices and for observing the written procedures provided.

4.15.5

Documents Implementing this Policy

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QP 115 Handling, Storage, Packaging, Preservation, and Delivery


Wkpro-4

4.16

Control of Quality Records

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4.16.1

Scope
This policy defines the maintenance of quality records.

4.16.2

Reference
ISO 9002: 1994, Requirement 4.16

4.16.3

Policy
All essential quality related activities are the subject of records to fully demonstrate the
achievement of specified requirements and the effective operation of the company's
Quality Management System.
Records are suitably stored and maintained to ensure their safekeeping and subsequent
retrieval.
The retention periods and the authority for the disposal of records are defined. Access to
quality related records are made available to the purchaser or his representative as
required.

4.16.4

Responsibilities
The Quality Function is responsible for ensuring that the procedures that implements this
policy is maintained and is effective.
The Quality function will coordinate any access to the quality records required by the
customer.
It is the responsibility of all personnel to ensure that quality related records are compiled
in a complete, legible and accurate manner and are correctly filed and stored in the
location provided where applicable.

4.16.5

Documents Implementing this Policy


QP 116 Control of Quality Records
Wkpro-5- work Instructions, Quality Control

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

40

4.17

Internal Quality Audits

4.17.1

Scope
This policy defines the conduct of internal Quality Management System audits.

4.17.2

Reference
ISO 9002: 1994, Requirement 4.17

4.17.3

Policy
NAME OF COMPANY, INC. will ensure that all aspects of its Quality Management
System are objectively audited.
Audits are scheduled on the basis of thye status and importance of the activity to be
audited.
Results are documented and reviewed by the Management Team to ascertain that the
Quality Management System is effective in achieving its objectives and continues to
reflect the Company's mission.
Trained personnel independent of the department or process under surveillance will
conduct audits.

4.17.4

Responsibilities
The Management Representative will coordinate the audit activities and is responsible for
ensuring that there are sufficient trained auditors to meet the audit program requirements.
The Head of each department being audited is responsible for investigating, planning and
implementing any corrective action agreed upon as a result of the audit.

4.17.5

Documents Implementing this Policy


QP 117 Quality Audits

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4.18

Training

4.18.1

Scope
This policy defines the provisions made within the Company to ensure that all personnel
are adequately trained for the tasks that they are required to undertake.

4.18.2

Reference
ISO 9002: 1994, Requirement 4.18

4.18.3

Policy
All tasks within the Company that are adversely affected by the lack of acquired skill will
be identified and made the subject of a job description that reflects the extent and
evidence of skill required. The Company will use this to appraise the level of
competence of personnel both before and during engagement and to identify training
needs accordingly.
All staff will receive appropriate training before carrying out manufacturing or testing
operations. Training programs are devised to ensure complete familiarity with all
requirements of the process. Records will be maintained of training given, and
completion of training will be subject to an end of training review. Periodic reviews of
training requirements will be made to ensure that training remains effective, and to
identify needs for retraining.

4.18.4

Responsibilities
Functional Department Heads are responsible for ensuring that only personnel who are
suitably qualified perform tasks requiring acquired skill.
It is the responsibility of the Quality Function to analyze instances of non-conformance
for evidence of insufficient skill, job knowledge or training.
The Quality Function is responsible for establishing and maintaining the appropriate
training records.

4.18.5

Documents Implementing this Policy


QP 118 Training

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4.19

Servicing

4.19.1

The NAME OF COMPANY performs no customer service activities


and therefore has no documented procedure regarding this element.

4.19.2

Document pertaining to this policy


QP 120 Servicing of Customer Returns

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

43

4.20

Statistical Techniques

4.20.1

Scope
This policy defines the use of statistical techniques within the Company.

4.20.2

Reference
ISO 9002: 1994, Requirement 4.20

4.20.3

Policy
Where used within the Company, statistical techniques will be selected to be the most
appropriate statistically valid technique for the application.
The techniques used will be defined in procedures, which will prescribe the way the
technique is to be applied and the rules governing its use.
Where statistical techniques are used for product verification due regard will be made to
the contractual requirements of the customer.

4.20.4

Responsibilities
It is the responsibility of all staff specifying the use of statistical techniques to ensure that
the requirements of this policy are complied with.
It is the responsibility of all persons using statistical techniques to observe the relevant
procedures.

4.20.5

Documents Implementing this Policy


QP 120 Statistical Techniques
SPC Manual, dated 5-1-00

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

44

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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TABLE OF CONTENTS

PROCEDURE

NUMBER

PAGE

Contract Review

QP 100

Design Review

QP 101

Document Control

QP 102

Purchasing

QP 103

Supplier Surveys

QP 104

13

Customer Supplied Materials

QP 105

18

Product Identification and Trace ability

QP 106

22

Process Control

QP 107

26

Receiving Inspection

QP 108

29

Inspection Status

QP 109

33

Final Inspection

QP 110

35

Quality Assurance

QP 111

38

Control of Measuring Equipment

QP 112

41

Non Conforming Material

QP 113

44

Corrective Action

QP 114

49

Shipping And Packaging

QP 115

53

Quality Records

QP 116

57

Quality Audits

QP 117

59

Training

QP 118

63

Servicing Customer Returns

QP 119

66

Statistical Techniques

QP 120

67

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

CONTRACT REVIEW
1.

PURPOSE
1.1.

2.

QP 100

This procedure provides specific instructions for the review and acceptance of contractual
agreements, verifying that elements of the proposal effort have been mutually agreed upon
and ensuring implementation of customer contractual requirements.

SCOPE
2.1 This procedure applies to product all new or amended orders.

3.

4.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Administrative Staff

3.2.

Production Control

GENERAL
4.1.

The purchase order and associated documentation are reviewed by the President, Production
Manager, and Production Control to analyze the contractual requirements and note any
differences between the purchase order and the terms outlined in the initial Quotation. Any
significant differences will be discussed with the customer before proceeding.

4.2.

The purchase order contractual requirements are compared to existing company production
capabilities and the pre-established proposal summary to determine special requirements. A
contract requirements form is initiated to identify the responsible departments, the scheduled
completion dates and the documents and tasks that must be completed to meet contractual
requirements. Special attention is given to the customer's requirements noted as critical or
safety characteristics.

4.3.

Production Control and Administrative Staff representatives review the contract requirements
and all related documents to determine documentation and other tasks to be completed. The
required contractual documents, such as the quality control plan, are forwarded to quality
control for completion.

4.4.

Production Control coordinates the contract requirements, summarizing and defining all the
requirements specified on the purchase order or contract, with appropriate quality assurance
personnel.

4.5.

The completed and approved contract requirements and such associated documentation as the
quality control plan are forwarded to Production Control for submittal to the customer.

4.6.

All contractual agreements and documentation associated with the purchase order and
Contracts are filed in Central Files and maintained for a minimum period of 3 years.

4.7

Verbal orders for items previously manufactured under formal contract are received by the
President or Production Control. Such orders must be confirmed by customer purchase
order within seven (7)days. No verbal order will be processed for parts not previously
manufactured by this company until all aspects of the purchase order and contract
referenced documents for contractual agreements are complete.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

5.

4.8

The President in conjunction with Production Control is responsible for the coordinating
amendments to any customer order. Production Control shall communicate, by the
issuance of a temporarily revised drawing, all amendments to the purchase order to all
departments that might be affected by any amendment to the purchase order.

4.9

Contract amendments are reviewed, coordinated, and approved according to the Contract
Review Procedure.

PROCEDURE
Responsibility.
5.1.

President

Action
5.1.1. Reviews all aspects of the purchase order and contract and referenced documents for
contractual requirements and completes the contract requirements form. Advises the
customer of any significant differences from and exceptions to the pre-established
proposal summary.
5.1.2. Reviews contract schedule commitments for their impact on other contractual
requirements.
5.1.3. Assures that contractual requirements are adequately defined and documented. Where no
written statement of requirement is available for an order received by verbal means, the
president assures that the order requirements are agreed upon before acceptance.
5.1.4. Verifies that NAME OF COMPANY has the capacity to meet the contract
or accepted order requirements.
5.1.4. Approves or rejects the contract or Purchase Order.
Responsibility
5.2. Production Control
Action
5.2.1.

Receives proposed amendments to the purchase order, contract or referenced documents


for contractual requirements and notes differences from the pre-established proposal
summary

5.2.2.

Forwards proposed amendments to president for approval or rejection.

5.2.3.

Communicates all changes to acceptable contracts to relevant departments and


subcontractor, where applicable.

5.2.4.

Completes the Quote and forwards a formal serialized quotation to the customer with a
copy of Screw Machine Industry Conditions of Sale requirements.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

Responsibility
5.3. The Production Control Administrative Staff
Action
5.3.1.

Combines information received from quality and technical engineering.

5.3.2.

Prepares an estimate cost summary.

5.3.3.

Forwards the cost summary to the President for review.

5.3.4.

Distributes approved copies of the cost summary to:


President
Production Manager

5.3.5.
6.

Files all documentation associated with the purchase order and contract in central files.

ACCEPTANCE
6.1. Acceptable documents are approved and signed by the President where such approval and
signature is required for completion of the transaction.

7.

REJECTION
7.1. Unacceptable documents are returned to the customer for clarification and/or revision

8.

RECORDS
Contract review activities are recorded and related correspondence are documented by the company
President and Production Manager and maintained in the customer order file for a period of 3 years
minimum.

9.

10.

FORMS
9.1.

FO1-01 Quotation Cost Summary Worksheet.

9.2.

FO1-02 Parts Processing Worksheet.

9.3

Serialized Quotation.

9.4.

Purchase Order.

9.5.

Condition of Sale and Manufacturing Practices.

9.6.

Job Process Shop Paper.

DEFINITIONS
Not applicable

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

11.

REFERENCE DOCUMENTS
11.1 ISO 9002, paragraph 4.3.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

DESIGN CONTROL
1.

QP 101

The NAME OF COMPANY is not engaged in the design activities or


development and therefore has no procedure regarding this element.

DOCUMENT AND DATA CONTROL


Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

QP 102
5

1.

PURPOSE
1.1.

2.

SCOPE
2.1.

3.

4.

This procedure provides specific instructions for the release of drawings and documents,
including subordinate documents and subsequent changes to drawings.

This procedure applies to the control of drawings and documents, including subordinate
documents that explain the engineering requirements, manufacturing processes, assembly
methods, test procedures and inspection instructions related to manufacturing activity.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality Assurance

3.2.

Production Control

3.3.

Manufacturing

GENERAL
4.1.

Production Control has the primary responsibility for the preparation, release, initial
distribution and control of drawings, specifications and other design documentation.

4.2.

Production Control has the primary responsibility for the preparation, release, initial
distribution and control of subordinate documents that provide fabrication, assembly and
process methods and instructions, such as shop orders, assembly instructions, process
specifications and process procedures or instructions.

4.3.

Production Control administers all customer change notifications and subsequent revisions to
the subordinate documents.

4.4.

Quality Control has the primary responsibility for the preparation of inspection methods and
instructions and work standards (i.e., accept or reject criteria).

4.5.

Quality Control administers all change requests and subsequent revisions to inspection
instructions and work standards.

4.6.

The users of the documentation are responsible for the removal of obsolete documentation
from work areas.

4.8.

Quality Control audits compliance to this quality procedure.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

5.

PROCEDURE
Responsibility
5.1.

Production Control

Action
Upon the receipt of any customer document, drawing or written specification, the Production
Control Manager shall:
5.1.1.

Date Stamp the document or otherwise indicate in the document the day upon which the
document was received.

5.1.2.

Review the document for adequacy and completeness.

5.1.3.

Approve the document when such approval is necessary.

5.1.4.

Assign document, file, or drawing number .

5.1.5.

Release the document to Administrative and/or manufacturing personnel

5.1.6.

Receive, process, administer and control customer-engineering revisions in a timely


manner.

5.1.7.

Determine the number (stock items or work in process) of disposition parts in


manufacturing effected by the revision.

5.1.8.

Remove obsolete documents from Master files.

5.1.9.

Revise all subordinate documents as applicable.

Responsibility
5.2.

Management Representative

Action
5.2.1.

Maintains a Master list of quality system documents identifying the current revision
status.

5.2.2

Initiates Engineering change requests.

5.2.3.

Reviews and re-issues revised documents in conjunction with Production Control.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

Responsibility
5.3

Quality Control

Action
5.3.1.
6.

7.

RECORDS
6.1.

Customer change orders are maintained by purchasing.


incorporated into inspection and test records.

6.2.

Information relating to customer issued blueprints or other drawings are entered and stored in
the Job Boss computer files. These files show Customer Code Identification, Part number,
Job Number, Job Code Number, and current drawing revision. No additional or separate
Master list is maintained.

6.3.

One copy of an obsolete drawing is voided and filed in the VOID drawing cabinet in
Administrative files. The voided copy is stored until such time that the customer issues a new
revision.

9.

Change implementation is

FORMS
7.1

8.

Audits and ensures compliance

Form Listing and Revision Status

DEFINITIONS
8.1.

Drawings - Engineering prints, schematics and artwork

8.2.

Documents - Engineering specifications

8.3

Subordinate documents - Manufacturing, test, and inspection procedures or instructions

REFERENCE DOCUMENTS
9.1.

ISO 9002, paragraph 4.5.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

PURCHASING
1.

PURPOSE
1.1.

2.

4.

This procedure provides specific instructions to ensure that purchased product conforms to
specified requirements

SCOPE
2.1.

3.

QP 103

This procedure applies to all suppliers providing materials, parts, or other products purchased
by the NAME OF COMPANY.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality Control

3.2

Administrative Function

3.3

Production Control

GENERAL
4.1.

The approved suppliers list is initiated, documented, updated, maintained and distributed by
purchasing in conjunction with the Quality Control Function..

4.2.

Quality uses the supplier quality performance rating report, surveys, audits and questionnaires
to ensure that the selected suppliers can provide the specified product.

4.3.

The approved suppliers list contains the following information:

Supplier number
Commodity or Service.
Method of supplier approval (e.g., supplier surveys).
Method of supplier approval (e.g., supplier surveys).

4.4.

The commodity service that identifies the supplier's capabilities is determined by purchasing
from information supplied by the supplier.

4.5.

The method of supplier approval is classified (for purchasing department use) as follows:

Previous Record - The supplier has a previous record of supplying


high-quality articles of the type being procured. These records are
supported by documentation that includes the supplier history and the
supplier quality performance rating.

Survey - A survey of the supplier's facilities and quality program has


been performed and accepted. Results of the survey are documented.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

Mail - A questionnaire completed by the supplier denoting supplier's


capabilities and quality program has been reviewed and accepted. The
results are documented and on file.

Temporary - The supplier has only limited qualifications.


limitations are included in the approved suppliers list.

Distributor - The supplier is an authorized factory distributor,


contracted to supply commercial or military hardware.

The

Note: Suppliers not satisfying at least one of the above conditions are referred to the
quality manager for consideration and special provisions.

4.6.

Suppliers are removed from the approved suppliers list by the purchasing manager, at the
direction of the quality manager, for the following quality considerations:

An unacceptable quality performance rating that cannot be resolved.

An unsatisfactory survey, audit, unanswered corrective action request, or


specific quality problems that cannot be resolved.

4.7.

Suppliers are removed from the list at the discretion of the purchasing manager for reasons
other than quality considerations.

4.8.

The approved suppliers list is updated or revised every six months by purchasing. Additions,
disapprovals, and corrections are made as the need arises by means of an addendum issued by
purchasing and quality.

4.9.

The Administrative Function reviews purchase orders to ensure that Purchasing documents
contain data clearly describing the product ordered as to type, class, grade or other precise
identification. All purchase orders must include the title or other positive identification,
specifications or drawings, process requirements, inspection requirements (where applicable)
and other relevant technical data including approval requirements or qualification of the
product, or procedures.

4.10. The approved supplier list is checked to verify that the supplier specified on the purchase
order is an approved source for the products or services listed. New suppliers must be
approved.
4.11. Contracts requiring government inspection of sub-tier orders are presented to the local
government representatives for review and delegation.
4.12. Copies of acceptable purchase orders are reviewed for accuracy and completeness by the
Administrative Function and a copy of the accepted purchase order is filed in the supplier's
P.O. file.
4.13. Receiving/Inspection follows the P.O. requirements for the necessary inspection requirements.
If on-site inspection of supplier product a requirement of the purchase order, the Management
Representative will contact the supplier and arrange for the inspection to be carried out. Such
verification at supplier premises does not absolve the supplier of supplier responsibility to
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

10

provide an acceptable product and cannot be use by supplier as evidence of effective control
of supplier quality.
4.14 The Management Representative provides the pertinent inspection and audit forms to be used
for supplier quality confirmation purposes.
5. PROCEDURE
Responsibility
5.1.

Production Control

Action
5.1.1. Accumulates suppliers' names and addresses from a current listing of active suppliers.
5.1.2. Determines commodity and service for each supplier.
5.1.3. Coordinates with the Quality Function to determine the methods of supplier approval
and the quality-level approval.
5.1.4. Reviews Purchasing Documents for adequacy and accuracy of specified requirements.
5.1.5. Ensures that the current revision drawings, specifications and special requirements are
referenced and are applicable to the part number and distribution.
5.1.6. Verifies that the correct quality requirement codes are listed on the purchase order.
5.1.7. Verifies that the supplier specified is on the approved supplier list.
5.1.8. Reviews revised purchased orders.
Responsibility
5.2

Management Representative

Action
5.2.1. Performs surveys and audits of suppliers and views records of past performance to
choose methods of supplier approval and quality-level approval.
5.2.2. Forwards copies of survey results and audits to purchasing with the methods of supplier
approval, the quality-level and memos, if appropriate.
5.2.3. Completes the supplier performance rating report and forwards a copy to purchasing
with recommendations, if any, of suppliers to be disapproved and removed from the
list.
5.2.4. Documents the Approved Suppliers List in Audit XLS.
Responsibility
5.3

Purchasing

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

11

Action
5.3.1. Initiates the approved supplier list.
5.3.2. Informs the Management Representative when approved list is revised.
5.3.3. Reviews and revises approved suppliers list when necessary to:
5.3.3.1. Add new suppliers
5.3.3.2. Delete disapproved suppliers
5.3.3.3. Make other corrections
Responsibility
5.4.

The Management Representative and Administrative Function

Action
5.4.1. Evaluates suppliers yearly for active production controls.
5.4.2. Amends supplier lists accordingly.
6.

RECORDS
6.1.

7.

Master copies of the approved suppliers list are maintained by purchasing. The quality
department maintains master copies of supplier quality performance rating reports, surveys,
and audits. Documents pertaining to the Approved Supplier List are maintained for the active
life of the supplier.

FORMS
7.1 PFO1-16 SQAAL-Approved Supplier & Audit List

8.

DEFINITIONS
8.1.

9.

Not applicable

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.6.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

12

SUPPLIER SURVEY
1.

PURPOSE
1.1.

2.

4.

This procedure provides specific instructions for performing surveys and evaluations of
proposed suppliers to ensure the consistency of quality procedures and controls employed by
suppliers.

SCOPE
2.1.

3.

QP 104

This procedure applies to all suppliers who provide materials, parts, subassemblies,
assemblies or services.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality

3.2.

Purchasing

GENERAL
4.1.

Each supplier is evaluated before placement of any order. This evaluation is accomplished by
supplier quality and inspection evaluations. The objectives of this evaluation are:

4.2.

To establish uniform standards for evaluating the degree and


effectiveness of quality practices and control.
To identify quality problems for evaluation and correction
To evaluate various methods of controlling a specific area.

Suppliers are surveyed and evaluated for the following reasons:

To qualify a new supplier for future work.


To evaluate a supplier for specific work before awarding a purchaser
order.
To evaluate a supplier's capabilities for proposed supplies and services.
To ensure that a supplier has adequate quality control systems.
To re-qualify a supplier after one-year lapse in supplier contact.
To re-qualify a supplier after poor quality performance.

4.3.

The purchasing department asks the quality department to perform on-site surveys and
evaluations of suppliers who perform calibration, assembly or test operations to company
drawings or specifications and special processes. The quality department schedules the
survey in coordination with purchasing and the supplier.

4.4.

Quality, purchasing and any necessary technically qualified individuals perform the on-site
evaluation of the supplier's facilities and determine the supplier's capabilities. They then issue
a supplier quality and inspection system evaluation report.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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4.5.

When orders are considered for placement with an unapproved supplier, a supplier quality and
the supplier completes inspection system evaluation report. The form is forwarded to the
supplier by purchasing and reviewed and approved by the purchasing manager and quality
manager before orders are placed with that supplier. Disapproved suppliers may request an
on-site evaluation.

4.6.

Noted deficiencies must be corrected by the supplier before the award of a purchase order.

4.7.

Re-evaluation of previously qualified suppliers occurs when necessitated by a change in


supplier performance, supplier facility relocation, a change in ownership or changes in
specification or contractual requirements.

4.8.

Quality and purchasing review the evaluation report and:

Approve or disapprove the supplier.

Publish and update the approved suppliers list, including the approved
Suppliers name, address, type of service and quality capabilities.

4.9. Each supplier shall be given periodic notice of quality and delivery performance based upon
the suppliers past performance.
5.

PROCEDURE
Responsibility
5.1.

Purchasing

Action
5.1.1. Determines the need for a new supplier.
5.1.2. Forwards a questionnaire to the supplier.
5.1.3. Reviews completed questionnaire, approves or disapproves it and forwards it to quality.
Responsibility
5.2.

Quality Department

Action
5.2.1. Enters the questionnaire results in the log, reviews the data and approves or
disapproves it.
5.2.2. Issues an approved suppliers list addendum to list holders.
5.2.3. Forwards the questionnaire results to the purchasing manger for forwarding to the
supplier
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

14

5.2.4. Files the questionnaire and any associated documentation by supplier (alphabetically) in
quality records.
Responsibility
5.3.

Purchasing

Action
5.3.1. Updates the approved suppliers list if required.
5.3.2. Notifies the supplier of the questionnaire results and any corrective action that is
required before awarding a purchase order.
On-site Evaluations
Responsibility
5.4.

Purchasing

Action
5.4.1. Determines the need for a new supplier or the re-evaluation of an old supplier.
5.4.2. Requests an on-site evaluation from quality control.
5.4.3. Coordinates with quality department for additional technical staff.
5.4.4. Coordinates the evaluation with the supplier and quality department.
Responsibility
5.5.

Management Representative

Action
5.5.1. Enters the survey request in the log.
5.5.2. Schedules the evaluation visit and assigns personnel to perform the evaluation.
5.5.3. Issues periodic supplier ratings based upon records of suppliers past performance.
.
Responsibility
5.6.

Purchasing

Action
5.6.1. Accompanies quality personnel performing the survey.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

15

Responsibility
5.7.

Quality Department

Action
5.7.1. Performs the evaluation.
5.7.2. Completes the evaluation report and enters the results in the log.
5.7.3. Forwards a copy of the evaluation report with a cover letter listing the evaluation results
as follows:
5.7.3.1. Approves or disapproves the supplier.
5.7.3.2. Issues conditional approval as applicable (i.e., notes that corrective
action is required before approval can be granted).
5.7.4. Reschedules the evaluation, if required.
5.7.5. Issues an addendum to holders of the approved supplier's list.
5.7.6. Files the completed evaluation and any associated documentation by supplier name
(alphabetically) in quality records.
Responsibility
5.8.

Purchasing

Action
5.8.1. Updates the approved supplier's list as required.
5.8.2. Forwards a copy of the evaluation results to the supplier along with notice of any
corrective action that must be taken before a purchase order can be awarded.
6.

7.

RECORDS
6.1.

Supplier quality and inspection system evaluation reports and associated documentation are
filed in the quality department.

6.2.

Quality maintains a log of requests for supplier evaluations and evaluation reports.

FORMS

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

16

7.1.
7.2.
7.3.
7.4.
7.5.
8.

PFO1-13 SQCS - Supplier Quality Control Survey


PFO1-16 SQAAL Approved Supplier & Audit List
PFO1-18 SQAR Supplier Action Plan Response
PF01-17 SQES Supplier on-site Evaluation
PFO1-21 SQR Supplier Quality Rating

DEFINITIONS
8.1.

Special Process
An operation that alters the properties of parts or material. The results of these alterations
(e.g. plating, welding, soldering, and etching) cannot be readily determined by end item
inspection.

8.2.

Supplier Level Rating


Supplier level ratings are categorized as follows:

9.

E (excellent) - Capabilities exceed requirements in all phases of


operation.
G (good) Capabilities meet requirements.
F (fair) Good rating on work capability; minor deviation from
quality requirements, but capable of maintaining
acceptable quality.
C (conditional) Minor deviations must be corrected before approval,
or past performance requires re-evaluation before
awarding future orders.
U (unacceptable) Major deviations make the supplier unacceptable.

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.6.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

17

CONTROL OF CUSTOMER FURNISHED MATERIAL


1.

PURPOSE
1.1.

2.

5.

This procedure provides specific instructions for the control of customer furnished material or
equipment.

SCOPE
2.1.

3.

QP 105

This procedure applies to all customer furnished material and equipment used in the
development, manufacture, inspection and test of company products.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality/Assurance

3.2.

Production Control

3.3.

Shipping and Receiving

3.4

Production Manager

4.

GENERAL

4.1.

Customer furnished material and equipment is examined by the Receiving Clerk on receipt to
detect damage in transit.

4.2.

Customer furnished property is inspected by the Receiving Clerk for completeness, type and
adequacy of documentation.

4.3.

Functional testing is conducted by Quality Control before or after installation, or both, as


required by contract or by quality to determine whether operation is satisfactory.

4.4.

Precautions are taken by the Receiving Department to ensure adequate storage conditions and
to guard against damage from handling and deterioration during storage. Periodic inspections
are performed.

4.5.

Production Control reports to the customer any properly found damaged, malfunction, or
otherwise unsuitable for use, whether upon receipt or in subsequent use. In the event of
damage or malfunction during or after receipt, the company determines and records the
probable cause.

4.6.

The Quality Control and Receiving Department provides such identification as property
control or calibration labels, as appropriate.

4.7.

The Receiving Department maintains records of all material receipts of customer supplied
product.

4.8.

The Quality Control Manager maintains customer record of calibration of customer gages and
is responsible for the return of customer measuring devices when gages are no longer needed
for production purposes.

PROCEDURE

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

18

Responsibility
5.1.

Production Control

Action
5.1.1. Coordinates communication with the customer regarding customer furnished property
requirements.
5.1.2 Provides quality control and the end user with customer furnished
property specifications and requirements.
5.1.3. Administers property records forms when they are required by contract (with support
from the customer.)
5.1.4. Notifies customer when damaged property is received or when property is lost or
otherwise discovered to be unsuitable for the purpose intended. Such notification is
initiated immediately by telephone or fax and documented according to customer
instructions or confirming memoranda.
Responsibility
5.2

Quality Control

Action
5.2.1. Reviews customer-furnished property specifications and requirements to determine any
required action.
5.2.2. Coordinates with the department end-user and prepares, as required, receiving
inspection instructions and test or calibration plans.
Responsibility
5.3.

Receiving

Action
5.3.1. Receives customer property and records the date of receipt on documents
accompanying the product.
5.3.2. Notifies Production Control of the receipt of customer property.
5.3.3. Attaches an identification tag showing Customer Name, Part Number and date
received.
5.3.4. Prepares receiving records.
5.3.5. Forwards the property to receiving inspection when operational or dimensional
verification is required.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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Responsibility
5.4.

Production Control

Action
5.4.1. Notifies the customer that property has been received when required by prior
agreement.
5.4.2. Observes the condition of the property as received and unpacked.
Responsibility
5.5.

Shipping Manager

Action
5.5.1. Advises Production Control when customer product has been received.
5.5.2. Inspects the property for completeness, type, and damage during transit as well as
completeness of documentation and any other requirements outlined in the shipping
documents.
5.5.3. Fills out property tags and attaches them to customer property that is acceptable.
5.5.4. Forwards the property to the department that will be the custodian of the property (e.g.,
quality assurance, engineering or operations).
5.5.5. Notifies Quality Control when any property is found to be damaged or does not
meet required specifications.
5.5.6. Isolates damaged or otherwise questionable product pending customer notification
and/or final disposition
5.5.7. Delivers the Quality Control Rejection Report and any associated documentation
to Production Control for disposition.
Responsibility
5.6.

Production Control

Action
5.6.1. Maintains records pertaining to customer supplied product.
5.6.2. Assigns a property identification, if appropriate, to the customer furnished equipment.
5.6.3. Interfaces with the customer or government property administration representative by
telephone or in person.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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Responsibility
5.7

Quality Control

Action
5.7.1. Documents and stores customer gages or other measuring equipment
5.7.2. Prepares Inspection Plan where customer product dimensional verification is
appropriate.
Responsibility
5.8

Production Manager.

Action
5.8.1. Ensures that the customer or government equipment identification is preserved.
5.8.2. Ensures that the customer or government equipment is used only as specified in its
contract.
5.8.3. Notifies Production Control if the customer or government property is found damaged,
malfunctioning or otherwise unsuitable for use.
6.

RECORDS
6.1.

7.

FORMS
7.1.

8.

Property tag

DEFINITIONS
8.1.

9.

Such records as receiving, inspection, calibrations and maintenance are maintained in


accordance with the customer contract or other customer recommendatrions.

Customer-furnished property includes consumable material (e.g., raw stock, parts,


subassemblies and assemblies) used in the manufacture of products. It also includes
equipment used for the development, manufacture, inspection or test of products.

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.7.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

21

PRODUCT IDENTIFICATION AND TRACEABILITY


1.

PURPOSE
1.1.

2.

4.

5.

This procedure provides specific instructions pertaining to the identification and traceability
of deliverable products.

SCOPE
2.1.

3.

QP 106

This procedure applies to all records that establish trace ability of the various components of
all deliverable products (e.g., raw material, parts, processes, components, subassemblies and
assemblies).

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Material Handler

3.2.

Production Control

3.3.

Production Manager

GENERAL
4.1.

Production Control is responsible for the generation of the necessary documents used to trace
the various components manufactured items. Production Control is also responsible for
preparing special instructions required to implement a specific contract.

4.2.

All incoming raw material, purchased parts, and parts subjected to outside special processes
are assigned lot control numbers by Production Control. The numbers are recorded on
acceptance tags that are attached to and remain with the material through the various stages of
storage and fabrication.

4.3.

The Material Handler is responsible for the identification, receipt, and storage of raw
materials or finished product used in manufacturing processes.

4.4.

The Production Manager is responsible for the proper execution of all traceability documents
during the active production phase.

PROCEDURE
General
Responsibility
5.1.

Production Control

Action
5.1.1. Reviews the contract quality requirements to determine special trace ability
requirements.
5.1.2. Prepares additional procedures, if necessary.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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5.1.3. Specifies trace ability requirements on the purchase orders pass-down, if required.
5.1.4. Issues raw material purchase order to material receiving.
5.1.5. Originates Job Boss computer generated Shop Paper showing part number, number of
parts to be produced, routing of operations, materials required , and additional
information pertaining to the manufacture of the product.
Responsibility
5.2.

The Receiving Function

Action
5.2.1. Receives raw materials and checks materials against purchasing specifications.
5.2.2. Stores the material and attaches the identification tag to raw material bin.
5.2.3. Inspects material for size, cracks or other obvious defects.
5.2.4. Delivers material certifications to Production Control when received.
5.2.5. Stores raw material by Bin and Part numbers
5.2.6. Records date and number of bars or bar pounds received on the material purchase order.
5.2.7. Delivers material purchase order to Production Control after completion.
Responsibility
5.3.

Production Control

Action
5.3.1. Enters received raw materials in the material receipt log.
Responsibility
5.4.

Material Handler

Action
5.4.1. Receives material requirement from Production Supervisor.
5.4.2. Releases material to the machine shop.
5.4.3. Records amount of material issued on the reverse side of the job shop paper located at
the active production site.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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Responsibility
5.5.

Manufacturing

Action
5.5.1. Fabricates parts according to the drawing.
5.5.2. Completes Job Card showing number of parts required, part number, machine and
operator.
5.5.3. Delivers shop paper showing materials issued to Production Supervisor.
5.5.4. Completes Routing tag to next operation
5.5.5. Signs off on shop paper as evidence of completion of required operation.
5.5.6. Perform assigned duties of Material Handler under the direct supervision of the
Production Supervisor
Responsibility
5.6.

Washing

Action
5.6.1. Receives parts from manufacturing
5.6.2. Washes parts in degreaser or Turbocharge washer as required by Wash instruction
procedure guideline book or verbal instructions from Production Supervisor.
5.6.3. Completes routing tag to next operation.
5.6.4. Moves cleaned items to shipping for counting, packaging and /or further processing
Responsibility
5.7

Shipping and Receiving

Action
5.7.1. Receives finished items from final operation.
5.7.2. Checks items against requirements of shop paper and routing tag.
5.7.3. Counts and prepares items for shipment.
5.7.4. Draws sample of product and delivers to Quality Control Final Inspection.
5.7.5. Prepares shipping ticket and documents ticket number and number of parts shipped on
the reverse of the shop paper.
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6.

RECORDS
6.1.

7.

FORMS
7.1.
7.2.
7.3.
7.4.

8.

Job cards with completed operations are filed in accordance with


QP 116 Control of Quality Records.

FO1-11 C8516 Production Job Card


FO4-03 BINTAG Material Identification Bin Tag
FO4-02 MATRL Material Inventory Log
FO2-02 MOVE Production Move Ticket

DEFINITIONS
8.1.

Not applicable

9.

REFERENCE DOCUMENTS

9.1.

ISO 9002, 4.8.

PROCESS CONTROL
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

QP 107
25

1.

PURPOSE
1.1.

2.

SCOPE
2.1.

3.

4.

5.

This procedure provides specific instructions for the control of manufacturing process .

This procedure applies to all processes employed by manufacturing, such as turning,


threading, drilling, milling, marking, fabricating, grinding, and polishing. This procedure
applies to all products produced by NAME OF COMPANY..

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Production Control

3.2.

Production Planning

3.3.

Quality

GENERAL
4.1

The President and Production Control review Engineering drawings and specifications in
order to determine new process requirements or required revisions to existing processes. For
new orders the Production Planning Team conducts a documented review of the processes
and makes recommendations as necessary.

4.2.

Production Control prepares or revises process procedures for each process in sufficient stepby-step detail to control and define the material, equipment and process. Attention to detail
includes cleaning requirements before and after and the requirements for tolerances
(minimum, maximum, and margin of error for dimensions, time and special requirements).

4.3.

The process procedures are included in the operation sheets or computer generated shop paper
or are published separately.

4.4.

Quality, in conjunction with Production Control, identifies quality provisions associated with
specific processes. The quality provisions are incorporated in the operation sheets, assembly
instructions or process special work instructions.

4.5.

Manufacturing, in conjunction with quality, identifies certain processes as candidates for


process control charting, where applicable.

4.6.

Quality audits manufacturing processes on a random basis to ensure material, equipment and
process compliances.

4.7.

Plating, honing and finish grinding, if specified by the drawing, are identical as special
processes, requiring subcontractor participation.

4.8.

The Administrative function maintains the records for approved subcontractors and the
records of subcontractor audits are maintained by the Management Representative.

PROCEDURE

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Responsibility
5.1.

Production Control

Action
5.1.1. Reviews engineering drawings and specifications and prepares copies for distribution
to manufacturing operations, as applicable.
5.1.2. Initiates manufacturing process requirements and operation sheet.
5.1.3. Forwards process specifications and shop paper (operation and routing sheet) to all
departments for incorporation of applicable quality and material routing provisions.
5.1.4. Identifies process control charting requirements or other special quality considerations
when specified in customer purchase order.
Responsibility
5.2.

Quality Control

Action
5.2.1. Views manufacturing process requirements, operation sheets and drawing
specifications and incorporates applicable quality provisions.
5.2.2. Identifies and implements process control charts, Fmea Risk evaluation, and Control
Plan construction where required.
5.2.3. Constructs Quality Assurance Inspection Plans for distribution to manufacturing.
5.2.4. Verifies certification requirements for all special process subcontractors.
Responsibility
5.3

Production Manager

Action
5.3.1. Assigns qualified personnel to carry out the production tasks required and monitor the
process.
5.3.2. Issues tooling, gages, setup, sample part (where available) and work instructions to
operator.
5.3.3. Approves processes and equipment to be used in the process.
5.3.4. Issues Job Card, Shop Routing Paper and Routing tags.
5.3.5. Assigns suitable equipment and working environment and confirms compliance with
government safety, environment, and hazardous material requirements.
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5.3.6. Returns completed process control documents to Production or Quality Control for
processing.
6.

7.

RECORDS
6.1.

Documents requiring completion by production personnel such as process route sheets, Job
Cards, are delivered to Production Control by the Production Manager for record keeping and
disposition.

6.2

Documents pertaining to quality control applications are forwarded to the Quality Control
Department for storage and disposition.

FORMS
7.1.
7.2.
7.3.
7.4.
7.5.
7.6.

8.

DEFINITIONS
8.1.

9.

FO1-03 Fmea.
FO1-04 Control Plan.
FO1-05 Fmea Risk.
Internal Shop Paper.
PFO1-18 PPLRPT Production Planning Report
Material Inventory Report

Qualified Personnel = An operator with proven knowledge and/or experience (as evidenced
by past performance, training or previous record of employment) needed to perform the tasks
required.

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.9.

9.2.

AIAG (FMEA) 2nd Ed., 1995

9.3.

AIAG (PPAP) 3rd Ed., 1999

9.4.

AIAG (APQP) 2nd Ed, 1995

RECEIVING INSPECTION
1.

QP 108

PURPOSE
1.1.

This procedure provides specific instructions for performing receiving inspection of


purchased material or parts, including outside processes.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

28

2.

SCOPE
2.1.

3.

4.

This procedure applies to all purchased materials, parts and processes that are used (or could
be used) in the fabrication and ultimate delivery of a product.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality

3.2.

Production Control

3.3.

Production Manager

3.2.

Receiving

GENERAL
4.1.

The Quality Control Manager determines the acceptance criteria for all products received and
determines the inspection methods to be used. The quality function initiates or revises
receiving inspection instruction as necessary listing all characteristics to be checked, the
equipment to be used and the records to be completed.

4.2.

Items are sampled inspected in accordance with the applicable quality inspection plan.

4.3.

Purchased items are not released into stock until adequate inspection or test operations that
verify product conformance have been performed.

4.4.

When product is needed in an urgent production situation, the product or materials are
positively identified and recorded to permit positive recall if necessary.

4.5. A material discrepancy report is initiated for all defective material.


4.6.
5.

Records of inspection or test are filed and are maintained according to the Control of Quality
Records Procedure (QP 116).

PROCEDURE
Responsibility
5.1.

Production Control

Action
5.1.1. Forwards a copy of the blueprint and shop paper to quality.
5.1.2. Maintains record of materials received by Customer, Part Number, Job Number,
Amount, and date received.
5.1.3. Notifies Quality Control Manager if unverified product is needed in an urgent
production situation.
5.1.4. Notifies Production Manager if unverified product is needed in an urgent production
situation.
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5.1.5. Documents use of unverified product on the face of the shop paper pertaining to the
manufacture or other use of the items unverified.
Responsibility
5.2.

Quality Control Manager

Action
5.2.1. Prepares or revises the receiving inspection instructions, determining the characteristics
to be checked, the equipment to be used and the sampling plan.
5.2.2. Provides technical assistance and direction to receiving personnel, as required.
5.2.3. Documents the use of unverified materials on the face of the Quality Control copy of
the shop paper
Responsibility
5.3.

Receiving Clerk

Action
5.3.1. Checks the receiving ticket against incoming material or parts to ensure the accuracy
and completeness of the count and to find any apparent damage to parts.
5.3.2. Records incoming material or parts on the receiving report.
5.2.3. Delivers samples of the parts received to inspection using Mil. Spec. 105D (modified)
as guide to sample size.
5.2.4. Isolates and holds any incoming product until inspection is concluded.
Responsibility
5.4.

The Receiving Inspector

Action
5.4.1. Retrieves route ticket and parts from the applicable shelf.
5.4.2. Obtains the material or parts history folder and ensures that the drawings or
specifications Quality Control Inspection Plan is available.
5.4.3. Ensures that certifications or test reports are included with the paperwork, if required.
5.4.4. Performs inspection or tests in accordance with the receiving inspection instructions,
pulling the sample size indicated.
5.4.5. When material or parts are accepted:
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5.4.5.1.
5.4.5.2.
5.4.5.3.
5.4.5.4.

- Completes the Final Inspection Log, affixing initials and date.


- Completes the inspection report.
- Moves material or parts to the applicable outgoing shelf with acceptance tag.
- Returns the inspection data to the file.

5.4.6. When all material or parts are non-conforming:


5.4.6.1. - Completes a Rejection and Sorting Report and attaches a copy to the rejected
Materials.
5.4.6.2. - Oversee the isolation of rejected materials in the Inspection Hold Area.
5.4.6.3. - Initiates a copy of the DMR to be forwarded to the supplier.
5.4.7. When part of the material or parts are defective and the rest is accepted:
5.4.7.1. - Completes a Rejection and Sorting Report.
5.4.7.2. - Completes a supplier history report, noting the amounts accepted and nonconforming and initials the dates.
5.4.7.3. - Moves the acceptable material or parts to the applicable outgoing shelf.
5.4.7.4. - Affixes white copy Rejection and Sorting Report or red rejection ticket to
each container of a multiple-container lot of defective material.
5.4.7.5 Documents rejection of materials in Rejection Summary (REJSUM XLS)
report.
Responsibility
5.5.

Production Manager

Action
5.5.1. Ensures that in-process product is held and not used or processed further until it has
been inspected, tested, or otherwise verified as conforming to specified requirements.
5.5.2. Affixes Do Not Mix tag when information confirms that product has not been
inspected or otherwise verified as conforming to specified requirements.
6.

7.

RECORDS
6.1.

Inspection and test status on each lot of purchased material is recorded on the inspection
report and supplier history record.

6.2.

Inspection criteria for each part number are maintained on Quality Control Inspection Plan
(QAIP)

6.3.

Non-conforming material is entered on the material discrepancy report.

FORMS
7.1.
7.2.
7.3.

FO5-10 QCFINAL Final Inspection Log


FO4-01 SHLOG - Vendor / Supplier Shipping Log
FO5-16 REJ In House Sorting and Rejection Report

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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8.

7.4. FO5-21 REJSUM- Rejection Summary


DEFINITIONS
8.1.

9.

Lot - The shipment received, partial or whole, which is presented for inspection.

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.10.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

32

INSPECTION AND TEST STATUS


1.

PURPOSE
1.1.

2.

4.

This procedure is for the purpose of describing the company's system for indicating the
inspection status of materials and parts produced at the NAME OF COMPANY.

SCOPE
2.1.

3.

QP 109

This procedure applies to all deliverable materials whether in process or storage.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality

3.2.

Production

GENERAL
4.1. All departments who either inspect or sign off on manufactured products or inspect in-process
products will maintain associated records of the inspection activity and results of the inspection
or other operation monitoring activity.

5.

PROCEDURE
Responsibility
5.1.

Quality Control

Action
5.1.1. The status of materials, and production parts are recorded on color-coded routing tags.
5.1.2. Production routing tags (white) are issued by the Production Manager and are
completed by the operator after manufactured items have been cleared for further
processing.
5.1.3. The Rejection (red) and the three (3) copy Sorting and Rejection Reports, are to be
used for identifying and routing rejected parts for disposition.
5.1.4. The Accepted Tag (green) is to be used for identifying goods that have been inspected
and found to be fit for the purpose intended..
5.1.5. Items inspected at their source are to be identified with accepted tag, or accompanying
paperwork prior to release for further processing or shipment.
5.1.6. Rejection and Sorting Reports will be filled out in triplicate with the original white copy
attached to the container, the golden copy retained in Quality Control and the pink copy
forwarded to data entry.
5.1.7. Stamps, when required for product identification or routing purposes, are issued by the
Quality Control Manager with a record of issuance documented on the appropriate log.
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5.1.8. Inspection of in-process items must be conducted after each operation and the shop
paper pertaining to the produced items must be signed or initialed by the person
responsible for the inspection of the production.
5.1.9. Production not conforming to specification must be tagged and isolated in the
Inspection Hold Area until disposition is final.

6.

RECORDS
6.1.

All inspection records are to be retained and maintained, QP 116 Control of Quality Records.

6.2. Previous Move tags may be removed from the active production container at the startup or
completion of the current operation.
7.

8.

FORMS
7.1.

FO2-02 - Production Move Ticket (White)

7.2

FO5-13 - Rejection Tag (Red)

7.3

FO5-16 - Sorting & Rejection Report (3) copy

7.4

FO5-14 - Special purpose Move Ticket (Green)

7.5

FO5-15 - Final Inspection Move Ticket (Brown)

7.6

FO5-07- STAMP

DEFINITIONS
8.1.

9.

Not applicable

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.12.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

34

FINAL INSPECTION
1.

PURPOSE
1.1.

2.

4.

This procedure provides specific instructions for the final inspection of completed end items
to verify conformance to specified requirements.

SCOPE
2.1.

3.

QP 110

This procedure applies to the final inspection of all finished salable end items.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality

3.2.

Shipping

GENERAL
4.1.

Final inspection is conducted for all items being released for shipment to the customer or to a
subcontractor for intermediate processing.

4.2.

Quality, in coordination with manufacturing, determines the content and points of final
inspection. The final inspection is conducted for all manufactured items being shipped for
outside subcontracted services or to the customer as completed items. The inspection
methods are determined by the assigned quality personnel and included as part of the
inspection instructions.

4.3.

Inspection personnel ensure that only currently calibrated tools, gauges and test equipment are
used.

4.4.

Inspection and shipping personnel ensure that all previous operations, inspections and tests
have been completed as indicated on the route card or shop paper .

4.5.

Items to be inspected are referenced by Job Number to engineering drawings, route cards and
other documentation deemed necessary.

4.6.

Final inspection is performed on a 100% basis to the inspection instructions or acceptance test
procedures and recorded on final inspection log.

For accepted items an acceptance/ inspection tag is initiated and placed in the
product container. The end items are acceptance stamped when this is directed
by the instructions.

Rework of any rejected parts is determined by the Material Review Committee


unless defect is of obvious nature and can be sorted or otherwise corrected
immediately.

5.
PROCEDURE
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Responsibility
5.1.

Shipping

Action
5.1.1. Receives product from final manufacturing process.
5.1.2. Retrieves shop paper and drawing pertaining to items.
5.1.3. Pulls representative sample of lot based upon Mil 105D, Level II, S1.
5.1.4. Delivers samples and copy of shop paper to Quality Control for Final Inspection.
5.1.5. Prepares accepted items for shipment.
5.1.6. Contains rejected items for disposition by Quality Control.
Responsibility
5.2.

Quality Control Manager

Action
5.2.1. Determines inspection points, method and acceptance criteria.
5.2.2. Reviews job shop paper for completeness of operations.
Responsibility
5.3.

Final Inspector

Action
5.3.1. Inspects items in accordance with the drawing, manufacturing instructions, job shop
paper, and applicable inspection instructions.
5.3.2. Records the results of all inspections on the Quality Control Final Inspection Log,
noting defects discovered (if any).
5.3.3. When items are accepted:
5.3.3.1. Applies acceptance move ticket to items, if applicable.
5.3.3.2. Applies signature/date to route card or shipping log directly adjacent to the
operation performed.
5.3.3.3. Forwards items to the finished goods out shelf.
5.3.3.4. Forwards the route card or shipping log to shipping.
5.3.4 . When items are defective:
5.3.4.1. Forwards items and rework tags to production if the items can be
reworked or repaired.
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5.3.4.2 Inspects reworked items to the original specification and documents


results. Forwards acceptable items to the finished goods out shelf.
5.3.4.3. Forwards route cards (and rework tags) to Quality Control Manager.
6.

RECORDS
6.1.

7.

8.

9.

Completed job cards data are filed by Production Control.

FORMS
7.1.

FO5-10 QCFINAL

7.2

FO5-05 QAIP

7.3

FO5-11 GHFSTPCE

7.4

FO5-15 MOVE

7.5

FO5-16 Rejection And Sorting Report

DEFINITIONS
8.1.

Reworkable Non-conforming materials or items that can be reprocessed to conform


completely to drawings, specifications or contract requirements.

8.2.

Repair - The reprocessing of a defective item so that it is unusable but still does not
completely conform to the applicable drawing, specifications or contract requirements.

8.3.

Non reworkable - Items or materials that either do not meet the definition of reworkable as
stated in paragraph 4.6.B or require rework of such significance that written and planned
rework instructions are required.

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.10.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

37

QUALITY ASSURANCE
1.

PURPOSE
1.1.

2.

4.

5.

This procedure provides specific duties and responsibilities of Quality Assurance personnel
for the control of inspection operations, quality and/or tractability of manufactured items .

SCOPE
2.1.

3.

QP 111

This procedure applies to fabrication, test, and inspection operations used to verify the quality
of parts being fabricated, tested or inspected.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality Assurance

3.2.

Operations

GENERAL
4.1.

The Quality Control Manager or his or her designee controls the assignment of duties to all
subordinate inspectors.

4.3.

The quality control of all goods received or manufactured is the responsibility of the Quality
Control Manager who may at his discretion delegate responsibilities to supporting inspectors
either orally or by written job instructions with the consent of the President of NAME OF
COMPANY, Inc..

4.4.

The Layout Inspector is responsible for the dimensional verification of all first piece samples
submitted for review by manufacturing or outside source suppliers.

4.5.

The Line or Floor Inspector will make periodic inspection of all parts being produced and
communicate with production personnel for the purpose of maintaining acceptable quality
during active production.

PROCEDURE
Responsibility
5.1.

The Quality Assurance Director (or Designee)

Action
5.1.1. Assigns duties and responsibilities to subordinate inspectors.
5.1.2. Receives Shop papers, print and other necessary materials from Production Control.
5.1.3. Maintains quality control files.
5.1.4. Prepares First Article Inspection Report documents and Quality Inspection Plans.
5.1.5. Prepares PPAP, FMEA, Control Plan and FMEA Risk evaluations for completion
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and distribution when required.


5.1.6. Conducts process and capability studies as required by customer or Screw Machine
Engineering co., Inc.
5.1.7. Prepares Statistical Process Control charts for distribution.
5.1.8. Evaluates customer rejections and correspondence pertaining to corrective action
requests.
5.1.9. Calibrates (or causes to be calibrated or certified as necessary) gauges used in the
manufacture of production parts..
5.1.10. Maintains all records relating to inspection processes.
Responsibility
5.2.

Layout Inspection

Action
5.2.1. Assists the Quality Control Manager in the discharge of quality functions.
5.2.2. Inspects first piece samples presented by manufacturing and records results on data
reports.
5.2.3. Maintains first piece submission log.
5.2.4. Performs final inspection of completed items in conjunction with the Quality Control
Manager.
5.2.5. Records and files First Piece and Setup reports.
5.2.6. Assists production operators in dimensional verification when necessary.
Responsibility
5.3.

Line Inspection

Action
5.3.1. Inspects production items during active machining in Screw Machine and Secondary
Departments.
5.3.2. Notifies appropriate personnel if non-conformances are discovered during inspection
procedures.
5.3.3. Maintains a Floor Inspection Log showing Machine Inspected, Date, Part Number,
Accept or Reject and the cause of any rejection issued.

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5.3.5. Oversees parts being transported to the Inspection Hold Area during the active
production phase of the manufacturing process.
5.3.6. Assists Quality Control Manager in the maintenance, assignment, calibration, and
inventory of inspection materials.
5.3.7. Assists in the overseeing and monitoring of SPC charts or other quality control forms
issued to manufacturing personnel.
5.3.8. Accepts or rejects manufactured items and oversees sorting activity in conjunction with
the Production Manager.
6.

RECORDS
6.1.

7.

FORMS
7.1.
7.2.
7.3.
7.4.
7.5.
7.6.
7.7.
7.8.
7.9.
7.10.
7.11.
7.12.
7.13.

8.

FO5-01 FAQR First Piece Article Report


FO5-02 FSTPCE1- First Piece and Final Report
FO5-03 QAIP1 - Quality Assurance Inspection Plan
FO5-04 1ST PCE - Computerized First Piece Inspection
FO5-06 PROSPO - Computerized Process Potential Study
FO5-06A CHART - Computerized X bar & R chart
FO5-06B PRECONTRL - Computerized Pre-Control chart
FO5-08 GAGEISS - Gage Issue and Calibration Record
FO5-09 DATARPT - Measurement Data report
FO5-09A RANGECHT - X and Range chart
FO5-10 QCFINAL - Final Inspection Log
FO5-12 FLINSP - Floor Inspection Audit Report
FO5-16 REJ - In - House Sorting and Rejection Report

DEFINITIONS
8.1.

9.

Records are maintained by the Quality Assurance Department.

Not applicable

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.10.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

40

CONTROL OF MEASURING AND TEST EQUIPMENT


1.

PURPOSE
1.1.

2.

4.

This procedure provides specific instructions for the verification, calibration and maintenance
of measuring and testing equipment to ensure proper functioning and continued accuracy, thus
ensuring that parts, products and measurements adhere to prescribed design requirements.

SCOPE
2.1.

3.

QP 112

This procedure applies to all measuring equipment used by company personnel for
verification of part and product acceptability.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality

3.2

Calibration Technician

3.3.

Production Manager

GENERAL
4.1.

All adjustable inspection gauges and tools and adjustable production hand tools are annually
calibrated in a manner that complies with MIL-STD-45662A (or other N.I.S.T Standard
according to the type of measuring equipment being calibrated). The system provides for the
prevention of inaccuracy by ready detection of deficiencies and timely corrective action.

4.2.

Plain Plug and other nonadjustable gages are checked for accuracy and condition at the time
of issue and periodically checked by the operator during the active production phase using
standards issued by Quality Control.

4.3.

Adjustable Functional Gages are set by Quality Control at the time of issue and settings are
maintained with master blocks or setting masters placed at the gage location during
production.

4.4.

A commercial standards laboratory is used for all necessary calibration and repair of
comparators, gage blocks, or other measuring instruments requiring calibration to standards
not measurable in-house. The facility must comply with MIL-STD-45662A(or other N.I.S.T
Standard). Calibration certificates are required whenever outside calibration services are
utilized.

4.5.

Gages are calibrated in a humidity controlled 68 temperature whenever possible. Any gage
that fails to meet calibration standards during the calibration process is either adjusted or
removed from service and any current production manufactured using the failed gage
reviewed for conformance to specification.

4.6.

Records and documentation of calibration activity are maintained in the computer Gagecal
XLS. File.

4.7.

Each employees is issued a condensed record of calibration pertaining to the calibration status
of personally owned equipment

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4.8.

5.

The employee is responsible for the maintenance of all gages and measuring devices being
used during the production cycle and any gage suspected of requiring calibration due to
regular calibration schedule, accidental circumstances, or normal wear must be brought to the
attention of the Quality Control Manager.

PROCEDURE
Responsibility
5.1.

Quality Control Function

Action
5.1.1. Establishes an overall gauge log and assigns serial numbers to each adjustable gauge
subject to calibration
5.1.2. Directs or initiates a purchase requisition for outside calibration and maintenance.
5.1.3. Sets all adjustable gauges used in the production process.
5.1.4. Finds out-of-tolerance conditions and notifies calibration designee
5.1.5. Conducts gage repeatability and reproducibility studies when required using computer
program GageCpk XLS.
5.1.6. Checks plain plug, thread plug, thread ring, and all references gages before each issue.
5.1.7. Maintains records of production gages issued to and returned by manufacturing
personnel.
5.1.8. Determines validity of prior inspections if out of tolerance conditions are found
Responsibility
5.2. Calibration Technician
Action
5.2.1. Consults Gagecal XLS. Computer files on a weekly basis to determine the calibration
status of measuring equipment.
5.2.2. Notifies personnel when calibration activity is to begin.
5.2.3. Calibrates equipment per QCP 100.
5.2.4. Notifies Quality Control Manager when significantly out of calibration conditions are
discovered.
5.2.5. Enters calibration results in the Gagecal XLS record.
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Responsibility
5.3.

Production Manager

Action
5.3.1. Ensures that production-measuring equipment is properly maintained after issue.
5.3.2. Ensures that equipment used by new employees is presented for calibration.
5.3.3. Responsible for identification, isolation, and transportation of parts produced where
measuring equipment is found to be significantly out of calibration.
6.

RECORDS
6.1. Gauge or tool calibration records are maintained for a period of 3 years

7.

FORMS
7.1.
7.2.
7.3.

8.

FO5-18 GAGECAL
FO5-17 GAGECPK
FO5-17A GAGECPK

DEFINITIONS
8.1.

Significantly out of tolerance - An error in the calibration measurement process exceeding


20% of the allowed parameter tolerance. For example:
A. Caliper tolerance .001
20% x .001 - .00020
Total .00120 (significant)

9.

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.11.

NONCONFORMING MATERIAL
1.

QP 113

PURPOSE

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

43

1.1.

2.

SCOPE
2.1.

3.

This procedure provides specific instructions for identifying, reporting, segregating,


controlling and processing defective materials found during production, inspection or test in
order to prevent unauthorized use.

This procedure applies to all material, parts, and end items that do not conform to drawings,
specifications, procedures, standards or contract requirements.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Production Operators

3.2.

Quality Control

3.3.

Management Representative

3.4.

Management Review

3.5.

Department Managers

4. GENERAL
4.1.

Defective material is identified and segregated from the normal material


flow and placed in the Inspection Hold Area.

4.2.

A rejection ticket is issued and processed for material inspected and found to be nonconforming except in cases where rework can be completed during the current production
cycle or where a small quantity is found during the inspection or manufacturing process that
is obviously scrap by visual examination and can be sorted without delay.

4.3.

When initiating the rejection tag, the following requirements are adhered to:

Only one part number is used on each rejection and sorting report.

Nonconforming product must be immediately separated from other product in


process.

4.4.

Defective material reported on a material discrepancy report is analyzed, reviewed and


disposition is made by the material review board representatives (President, Quality Control
Manager, Management Representative and Department Manager).

4.5.

Defective material that can be reworked or repaired without an adverse effect on safety,
performance, interchange ability or reliability is isolated until appropriate rework is complete.
Material that has been satisfactorily reworked or repaired is returned to the normal flow of
material only after having been reviewed by quality control.

4.6.

Purchased items used in the production process found to be defective are rejected by Quality
Control and moved to the Inspection Hold Area. Such items are immediately returned to the
supplier unless, due to an emergency situation, the President, Quality Control Manager and
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016
44

the Department Manager agree to use the materials and that the use of the materials would not
compromise the quality of the final product.
4.7.

Defective material determined to be scrap is identified and segregated from all other material
pending final disposition.

4.8.

No defective materials are knowingly shipped to any customer except under grant of customer
deviation request or wavier of specified requirements.

4.9.

Corrective action is initialed, as required, by quality to prevent recurrence of nonconformities


reported on the material discrepancy report.

4.10. Records relating to the documentation of nonconforming materials are maintained for a
minimum period of 2 years.
4.11. In cases where defective material is discovered during processing procedures and records
indicate that there is a likelihood that defective products have been shipped to the customer,
the customer will be immediately notified by telephone or fax and will be given sufficient
information for the positive identification and subsequent isolation of the suspect shipment.
5.

PROCEDURE
Responsibility
5.1. Quality Control Function
Action
5.1.1. The Quality Control Manager is responsible for the routing, safekeeping and final
disposition of all nonconforming materials.
5.1.2. The Management Representative is responsible for the construction of all
documentation required for the disposition of all nonconforming materials.
5.1.3 The Management Representative shall notify the customer of nonconforming materials
inadvertently shipped and shall be responsible for documentation required by the
customer confirming such notification.
Responsibility
5.2. Production Personnel
Action
5.2.1.

Personnel engaged in the active production of any product shall follow the following
procedures if the production contains or is suspected of containing nonconforming
items:
5.2.1.1.
Cease production of the suspected parts until cause of
nonconformance can be determined.
5.2.1.2.
Contain all parts suspected of not conforming to specifications or
other requirements.
5.2.1.3.
Identify the product with Routing Tag showing Date, Part Number,

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5.2.1.4.
5.2.1.5.
5.2.1.6.
5.2.1.7.

Machine Number, and Operator.


Notify the Department Manager immediately.
Notify the Quality Control Manager.
Escort the items to Shipping & Receiving for wash and or count.
(Do not remove any Hold or Reject Ticket from the container).
Move all rejected parts to the Inspection Hold Area.

5.2.2. Sorting and rework of nonconforming product is governed by the following guidelines:
5.2.2.1
5.2.2.2.
5.2.2.3.
5.2.2.4.
5.2.2.5.

Parts may not be detailed in the immediate vicinity of the work station
or machine that produced the nonconforming materials except by
permission of the Quality Control Manager.
Gages to be used for sorting or re-work activity must be approved by
Quality Control.
Rejection tags, reports or other documentary evidence of
nonconformance must remain with the parts throughout all sorting
and/or rework activity.
Sorted or reworked product must conform to specification and product
may not show evidence of rework (visually or dimensionally) unless
the customer has granted concession, deviation, or waiver.
Sorted and/or reworked parts must be returned to Quality Control for
inspection and disposition. No sorted or reworked parts shall be
mixed with or included as a part and partial of past or current
production items without the permission of the Quality Control
Manager.

Responsibility
5.3.

Quality Control Manager

Action
5.3.1. The Quality Control Manager, or designate, shall take the following actions for the
documenting, containment, and final disposition of nonconforming products
manufactured at the NAME OF COMPANY:
5.3.1.1. Identify nonconforming product with rejection tag or Sorting and
Rejection Report.
5.3.1.2. Verify that all suspected defective items are properly transported to the
Inspection Hold Area for further processing or review.
5.3.1.3 Deliver the pink copy of the Rejection and Sorting Report to the
Management Representative or other data entry source for recording in
the Reject Summary (REJSUM XLS.) record.
5.3.1.4. Deliver the yellow copy of the Rejection and Sorting Report to
Production Control for review.
5.3.1.5. Close out the white copy of the Rejection Report after sorting and / or
re-work is concluded.
5.3.1.6. Issue any special gages or measuring equipment required for sorting or
re-work activities.
5.3.1.7. Re-inspect re-worked or sorted product for conformance to
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specifications.
Responsibility
5.4

Management Representative

Actions
5.4.1. The Management Representative is responsible for the following activities for the
documentation, containment and release of nonconforming product:.
5.4.1.1. The providing of forms or other documents required for the control of
nonconforming product.
5.4.1.2. Customer communication pertaining to Requests for Deviation,
Engineering Change Requests, Supplier and Customer Corrective
Action Requests, and clarification of drawing specification where
appropriate.
5.4.1.3. The maintenance and distribution of in-house and customer records
relating to nonconforming materials.
5.4.1.4. The scheduling of Material Review Board activities and agenda.
5.4.1.5. The issuance of supplier and in-house Corrective Action Requests.
Responsibility
5.5

Material Review Board

Actions
5.5.1. The Management Representative shall prepare the agenda, notify the respective
members, and document the meeting of the MRB.
5.5.2. The Material Review Board shall be composed of the President, Management
Representative, Quality Control Manager, and the Manager of the Department in
which the nonconforming materials were produced.
5.5.3. The Material Review Board shall meet as often as necessary to ensure that
nonconforming material is properly evaluated.
5.5.4. The Material Review Board shall investigate the nonconformity, address the
disposition, and determine corrective or preventative action measures required to
improve the process where appropriate.
5.5.5 The Material Review Board shall not release product that does not conform to
customer requirements except by customer grant of deviation or waiver.
6.

RECORDS
6.1.

Completed material discrepancy reports (masters) are forwarded to the quality department to
be audited and filed.

6.2.

The report log is maintained by the Management Representative.

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7.

8.

9.

FORMS
7.1.

FO1-06

Internal Corrective Action Report

7.2.

PFO1-07 Supplier Corrective Action Request.

7.3.

FO1-10

7.4.

PFO1-08 Deviation Request

7.5.

PFO1-15 Corrective Action Req. Log

Nonconforming Material Report

DEFINITIONS
8.1.

Use as is - The determination for defective material that considers the material to be
satisfactory for use as it is without adverse effects to safety, performance, interchange ability
or reliability.

8.2.

Rework - The process required to make a defective item conform in its entirety to the original
drawing or specification requirements.

8.3.

Repair - The process required to make an item fit for the functional purpose intended.

8.4.

Return to vendor - The return of unacceptable items to the supplier from which they were
purchased. (Normally, the supplier will have caused the unacceptable condition).

8.5.

Scrap - Material that cannot economically be made acceptable and is unfit for use.

REFERENCE DOCUMENTS
9.1. ISO 9002 4.13.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

48

CORRECTIVE ACTION AND PREVENTIVE ACTION


1.

PURPOSE
1.1.

2.

4.

This procedure provides specific instructions for identifying and determining the cause of
discrepancies or procedure violations and the methods used to obtain the required corrective
actions.

SCOPE
2.1.

3.

QP 114

This procedure applies to corrective and preventive action activities relating to the resolution
of complaints arising from internal or external sources.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality Control Manager

3.2.

Management Representative

3.2.

Production Manager

3.3.

Administrative Staff

GENERAL
4.1.

The quality department regularly reviews and analyzes inspection and test records from
incoming as well as in-process inspections for adverse quality trends. Corrective action
requests are initiated when needed.

4.2.

The quality function reviews complaints and in response to material discrepancy reports,
customer return reports, or deficiency reports, issues corrective action requests when
appropriate.

4.3.

Quality reviews each report and documents corrective action requests of internal or external
origin.

4.4.

Corrective Action Requests are generated for the following reasons:

Critical dimensions or performance characteristics are out of tolerance.

Repetitive discrepancies occur in fabrication, assembly, inspection or test.

Non conformance to system procedures, system and instructions occur.

Defective material is received from suppliers.

A Corrective Action Request is received from the customer.

Corrective Action is required by virtue of an audit process.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

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5.

4.5.

Quality Control initiates the Internal Corrective Action Request and follows up all corrective
and preventive action activity.

4.6.

The Management Representative is responsible for ensuring that the Corrective and
Preventive Action Programs are managed effectively. The Management Representative
maintains a system of records that document the requirements of this element.

PROCEDURE
Responsibility
5.1.

Administrative Personnel

Action
5.1.1. It is the responsibility of the Management Representative to resolve inquiries related to
Corrective and Preventive Action Requests received as a result of internal, external
(Customer), or third party audits. Upon receipt of a written Request for Corrective or
Preventive Action, Administrative Personnel shall:
5.1.1.1. Stamp the document with the date received.
5.1.1.2. Deliver the original copy of the Request to the Management Representative.
5.1.1.3. Deliver the original copy of any letter or other attachment received with the
request to the Management Representative.
5.1.1.4 In the absence of the Management Representative, the Quality Control Manager
shall receive all documents necessary for the resolution of all issues relating to
internal or external corrective action matters.
5.1.1.5 The Management Representative or Quality Control Manager shall approve and
close out corrective or preventive action proposals submitted by suppliers and
shall follow-up such actions or proposals to ensure implementation.
Responsibility
5.2.

Management Representative

Action
5.2.1. Upon receipt of an external Corrective or Preventive Action Request, the Management
Representative shall:
5.2.1.1. Make one copy of documents pertaining to the Request and deliver to the
Quality Control Manager.
5.2.1.2. Obtain a copy of any drawing, specification, shop paper or other documents
needed to investigate the Request.
5.2.1.3. Notify Production and Shipping Managers of the Request (if appropriate).
5.2.1.4. Investigate the extent of the problem.
5.2.1.5. Determine the root cause(s) of the problem.
5.2.1.6. Decide on corrective action.
5.2.1.7. Oversee the implementation of the corrective action.
5.2.1.8. Initiate permanent changes in any related procedure/instructions (if appropriate).
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5.2.1.9. Respond to the Request within the time period required and sign off on the
request.
5.2.1.10. Deliver a copy of the completed Request to the Quality Control Manager.
5.2.1.11. File one copy of completed Request in Customer Corrective Action Folder.
5.2.1.12. Periodically review Request for effectiveness of Actions undertaken.

Responsibility
5.3.

The Quality Manager

Action
5.3.1. Upon receipt of an external Corrective or Preventive Action Request, the Quality
Control Manager shall:
5.3.1.1. File one copy of the Request in the proper parts file or other folder pertaining
to the Request.
5.3.1.2. Halt the shipment or active production of any product that might contain
similar defects or nonconformities.
5.3.1.3. Oversee the movement of the same or similar product to the Inspection Hold
Area
5.3.1.4. Examine identical or similar product for the defect identified in the Request.
5.3.1.5 Examine prior Corrective or Preventive Action Requests pertaining to
identical or similar product.
5.3.1.6. Determine the root cause(s) of the problem.
5.3.1.7. Follow up on the progress of Corrective Action activity to ensure that the
Action is completed by the promised date and the problem has been
eliminated.
Responsibility
5.4.

Management Representative

Action
5.4.1. Internal Corrective Action Requests (when necessary) are initiated by the
Management Representative for investigative documentation of the causes of an
internal or external quality problem. When the issuance an Internal Corrective Action
Request is appropriate, the Management Representative shall take the following
actions:
5.4.1.1. Complete the Internal Corrective Action Request Form.
5.4.1.2. Investigate the problem by interview of the personnel associated with the
problem.
5.4.1.3. Determine the root cause of the problem.
5.4.1.4. Decide on corrective action and the personnel responsible for completion of
the action.
5.4.1.5. Verify that the production personnel responsible for the nonconforming
product, the manager of the department producing the defective product, and
the Quality Control Manager signoff on the report.
5.4.1.6. File the Request and maintain for a period of 3 years.
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Responsibility
5.5

Administrative Staff

Actions
5.5.1. The responsibility for the undertaking of preventive action lies with the Administrative
Staff consisting of the company President, Quality Control Manager, Management
Representative, and the Production Manager. The Administrative Staff is responsible
for the related quality system elements and procedures. For preventive action requests,
it is the responsibility of each member of the staff to:
5.5.1.1.
5.5.1.2.
5.5.1.3.
5.5.1.4.
5.5.1.5.

Investigate the nature of the weakness.


Determine the root cause(s) of the weakness.
Decide on preventive action.
Implement the preventive action.
Recommend permanent changes in any related procedure/instruction (if
appropriate.

5.5.2. The Management Representative is responsible for ensuring that the Preventive Action
Program is managed effectively and a system of records for managing the preventive
action documents exists, monitoring the status of preventive action activities, and
storing closed out Preventive Action Requests for a period of 3 years minimum.
6.

RECORDS
6.1.

7.

8.

FORMS
7.1.

PFO1-10 Supplier corrective action request

7.2.

PFO1-09 Corrective action request

7.3.

Customer corrective action request

7.4.

FO1-06 Internal Corrective Action Request

7.5.

PFO1-07 Corrective Action Request

DEFINITIONS
8.1.

9.

Copies of Corrective Action Requests are maintained by Quality Control for a period of 3
years minimum.

Not applicable.

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.14.

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52

Handling, Storage, Packaging, Preservation, and Delivery


1.

PURPOSE
1.1.

2.

4.

This procedure provides specific instructions for the performing of handling, storage,
packaging, preservation, and delivery requirements for product manufactured by the NAME
OF COMPANY.

SCOPE
2.1.

3.

QP 115

This procedures applies to all manufactured items processed by the shipping and packaging
department.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality Control

3.2.

Shipping Manager

3.3.

Shipping Clerk

3.4.

Production Control

3.5.

Parts Washer

GENERAL
4.1.

Handling, transportation and storage methods and procedures are determined by the Shipping
Manager

4.2.

Methods and procedures to prevent handling damage are implemented during all phases of
fabrication, processing, inspection, and transportation. The use of clean bags, racks,
containers, trays and tote boxes is required, and special attention is given to delicate items,
such as plated items, pre-finished materials, and precision machined parts. Special attention is
also given to the need for desiccants, covers, wrapping, cushioning, dividers or supplementary
containers (e.g., tubs and vials). Specific customer requirements are implemented as
applicable.

4.3.

Methods and procedures are implemented to define specific storage requirements and ensure
the necessary protection of materials in storage from damage, dust, moisture and
deterioration. Identification of material; preservation of the finished product; obsolete
material; first-in, first-out methods and procedures, and storage of flammable material will be
given special attention. Material may be stored in the same containers used for handling.

4.4.

Items will not accepted into the stockrooms or finished goods stores without evidence of
inspection acceptance (i.e., an acceptance tag). Items not processed through inspection for
acceptance will be returned to inspection.

4.5.

An internal auditor will perform periodic audits of the handling and storage methods to ensure
compliance to specific procedures and customer requirements. Finished products may be re
inspected or tested on a random basis to verify identification and detect any damage or
changes. The results are documented on an audit report.

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4.6.

5.

The Production Control function is responsible for the implementation of the process for
developing, evaluating, and tracking adherence to lead time requirements in order to optimize
delivery performance.

PROCEDURE
Responsibility
5.1.

Production Control

Action
5.1.1. Issues shop paper, including special instructions regarding shipping due date
requirements and special packaging or packaging instructions.
5.1.2. Stamps the back of the shop paper with format for shipping and packaging entry
showing date shipped, shipping ticket number and number of items shipped.
5.1.3. Issues standard packaging slip for items to be shipped.
5.1.4. Issues bar coded shipping label (when appropriate) showing:
5.1.4.1.
5.1.4.2.
5.1.4.3.
5.1.4.4.
5.1.4.5.
5.1.4.6.
5.1.4.7.
5.1.4.8.

Customer
Purchase Order No.
Part No.
Quantity Shipped
Release No.
Description of Product
No. of Packages Shipped
Total Weight of Each Parcel

Responsibility
5.2.

Parts Washer

Action
5.2.1. Receives finished product from manufacturing.
5.2.2. Washes parts in degreaser or Turbocharge washer as required.
5.2.3. Applies Rust inhibitor to parts as required.
5.2.3. Transports product to Shipping for processing.

Responsibility
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5.3.

Shipping Manager

Action
5.3.1. Count the items to be shipped.
5.3.2. Draw required number of samples of product and delivery to Final Inspection (see
MIL 105D, S1 sampling plan).
5.3.3. Store materials accepted by Final Inspection in metal or plastic containers if
product is destined for outside operations.
5.3.4. Identify contents of each container with:
5.3.4.1. Job Number.
5.3.4.2. Number of parts in the container.
5.3.4.3 Customer Name
5.3.5 Review Finished Order File for due date of finished product.
5.3.6

Pack items accepted by Final Inspection in cardboard boxes( 72 lbs. Maximum weight
per box) if product is destined for delivery to the customer.
5.3.6.1.

Parts being shipped to customers are packed in cardboard boxes with dividers
and/or additional reinforcement support as required in order to prevent
damage while in transit.

5.3.7. Document shipping record on the back of the shop paper showing:
5.3.7.1. Number of items shipped.
5.3.7.2. Date shipped.
5.3.7.3. Shipping Ticket Number
5.3.8. Deliver shop paper to Production Control when customer order is complete.
5.3.9. Store stock material in clean, dry area
Responsibility
5.4.

Quality

Action
5.4.1. Inspects the shipment in accordance with appropriate instructions and returns items to
shipping and packaging or rejects the items and places the shipment on hold.

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6.

RECORDS
6.1.

7.

FORMS
7.1.
7.2.
7.3.
7.4.

8.

PFO1-10 Nonconformance Material Report


FO5-14 Move Ticket
FO4-01 SHLOG
FO5-10 QCFINAL

DEFINITIONS
8.1.

9.

Not applicable

Not applicable

REFERENCE DOCUMENTS
9.1.

ISO 9002, 4.15.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

56

CONTROL OF QUALITY RECORDS


1.

PURPOSE
1.1.

2.

5.

This procedure applies to quality records generated during receiving inspection, fabrication,
assembly, testing and inspection and to other records required to implement the quality
program .

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.
3.2.

4.

This procedure provides specific instructions for the control and retention of quality records.

SCOPE
2.1.

3.

QP 116

Quality Manager
Administrative Assistant

GENERAL
4.1.

Quality identifies requirements for the control and maintenance of quality records generated
during receiving inspection, fabrication, assembly, and test and inspection operations.

4.2.

Active records are filed and maintained in a manner that provides for safe storage and ready
access.

4.3.

Records containing company confidential or classified information are identified; they are
maintained in secured files accessible only to those persons with a need to know as defined by
company policy or procedure.

4.4.

Quality records are reviewed yearly. Records that no longer need to be retained are destroyed
or discarded.

4.5.

The Administrative Assistant identifies requirements for the control and maintenance of office
records relating to quotations, purchase orders from customers and to suppliers, lost or
damaged customer supplied product, personnel records, and other documents relating to
financial matters.

PROCEDURE
Responsibility
5.1.

The Quality Control Manager

Action
5.1.1. Reviews records and data for completeness, accuracy and legibility.
5.1.2. Retains all quality records pending destruction.
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Responsibility
5.2.

Administration

Action
5.2.1. Files and stores records relating to, contracts, quotations, purchase orders, production
Histories, financial transactions, and other miscellaneous records pertaining to
general business procedures.
5.2.2. Reviews filed records yearly and discard any that have passed their retention date.
6.

RECORDS
6.1. Quality Records are stored and maintained by the Quality Control Manager and will be made
available for review upon authorized customer request

6.2. The retention period for records shall be as required by customer contract
and/or purchase order or by company requirement.
6.3. Where no customer requirement exists the retention period of inspection records are:
6.3.1.
6.3.2.
6.3.3.
6.3.4.
6.3.5.
6.3.6.
6.3.7.
6.3.8.
6.3.9.

Heat treat, grinding, and material certifications- 1 year minimum


Metallurgical inspection reports-1 year minimum
In process, receiving, final, first piece reports-1 year minimum
Process capability, FMEA, Control plan, SPC reports-1 year minimum
Internal Audit Reports-3 year minimum
Supplier Audit Reports-During active period of supplier plus 2 years
Gage Calibration Records-3 years
Customer generated reports and/or documents-3 years minimum
Deviation , Correction Action, Preventative Action Requests are maintained for
the life of the part plus 2 years
6.3.10. Records pertaining to Management Review Activity 3 years minimum
6.3.11. Training Records Active status of employee plus 1 year
6.4 Where no customer requirement exists, the retention periods of administrative records are:
6.4.1.
6.4.2.
6.4.3.
6.4.4.
7.

Quotations and allied documentation - 3 years minimum


Purchase Orders from customers 3 years minimum
Purchase Orders to Suppliers 3 years minimum
General Business Records 7 years

FORMS
Not applicable

8.

DEFINITIONS

9.

REFERENCE DOCUMENTS

9.1. ISO 9002, paragraph 4.5.


INTERNAL QUALITY AUDITS
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

QP 117
58

1.

PURPOSE
1.1.

2.

SCOPE
2.1.

3.

4.

This procedure provides specific instructions for auditing quality procedures, company
processes or products, the supplier base and associated documentation.

This procedure applies to engineering operations, quality assurance and supplier functions
that relate to the quality of company products.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Management Representative

3.2.

Quality Assurance

3.3.

Production Control

GENERAL
4.1.

The Management Representative plans, prepares and maintains records and schedules
pertaining to audit requirements. In general, audits are scheduled or planned because of:

A change in quality assurance provisions of contracts.

Deteriorating quality or reliability of the product.

Failure on the part of any department to take corrective action.

A request from an internal department.

A request from customer quality representatives.

A change in company quality procedures.

An annual complete audit of company procedures.

4.2.

The audit is performed by company trained or certified auditors. If possible, the audit is
performed by an individual who has no direct responsibility in the area selected for audit; if
necessary, a technically qualified individual evaluates any production activity being audited.

4.3.

The auditors randomly perform a detailed, step-by-step evaluation of the process,


specification, procedure or product that has been selected for audit.

4.4.

During an audit, the auditors evaluate conformity with (and effectiveness of) company
procedures and their continued conformance to ISO 9000 requirements.

4.5.

A quality audit report is generated for each audit performed, documenting the requirements
and results.

4.6.

Nonconformity found by the auditors is reported in writing to the responsible area supervisor
on a corrective action report.

Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016

59

5.

4.7.

Quality enters the audit report in the quality audit report log and maintains a complete history
of all audits, including the status of those requiring corrective action.

4.8.

Audits of supplier products or processes are conducted as necessary. Results of these audits
are documented on the supplier audit report. Supplier corrective action requests are initiated if
nonconformity is found.

PROCEDURE
Responsibility
5.1. Management Representative
Action
5.1.1.

Determines the documents, processes or products to be audited and prepares the schedule.

5.1.2. Assigns a quality representative to perform or direct the audit.


5.1.3. Assists purchasing in the initiation of supplier audits and/or reviews.
5.1.4. Obtains and reviews all associated documentation applicable to the product, operation and
area to be audited. Fills in the requirements section of the quality audit report or supplier
quality report before the actual audit
5.1.5.

Selects an auditor, if necessary, who does not have direct responsibility in the selected
audit area. Chooses any other technical personnel deemed necessary to make adequate
evaluations.

5.1.6. Advises the applicable department supervisor, in advance, to coordinate time and support
personnel, if appropriate.
5.1.7. Reviews all results and determines whether corrective action is needed.
5.1.8. Initiates a corrective action request if significant nonconformity is found at a supplier.
5.1.9. Initiates a supplier corrective action request if significant nonconformity is found at a
supplier.
5.1.10. Enters the audit results in the quality audit report log.
5.1.11. Reviews the audit results with applicable area supervisors.
Responsibility
5.2 Auditor
5.2.1. Audits the selected process, specification, procedure or product. Examines each one
step by step, including equipment, personnel and all related documentation. Carefully
observes materials, results, tools, facilities and documents used by the operators,
technicians or inspectors involved.
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5.2.2. Verifies on-station availability, use and revision level of required documents.
5.2.3. Verifies use of qualified personnel and equipment, as required.
5.2.4. Examines a product for conformity to specified requirements (e.g., engineering
documentation, test procedures, assembly instructions, route cards, inspection
instructions and work quality standards).
5.2.5. Records the results of the audit on the quality audit report or the supplier quality report.
Responsibility
5.3.

Management Representative

Action
5.3.1. Approves the audit report and applicable corrective actions by signing the quality audit
report.
5.3.2. Sends the supplier corrective action request to purchasing for forwarding to the
supplier. Reviews and approves the request upon return.
5.3.3. Maintains a current status file of audits and corrective action requests to ensure that
required follow-up action is taken.
5.3.4. Distributes copies of the audit reports to applicable department supervisors and
managers.
5.3.5. Reviews the quality audit report log weekly to update and close out audits by returning
corrective action requests.
6.

ACCEPTANCE
6.1.

Acceptable audit results are indicated by a check in the appropriate area of the Internal or
Supplier Audit Report.
An approval signature on the corrective action request or supplier corrective action request
indicates acceptable corrective actions.

7.

REJECTION
7.1.

8.

Unacceptable audit results (nonconformity) are indicated by a notation in the "FAILED" or


Unacceptable area on the quality audit or supplier audit report. Audits that reflect significant
nonconformity require corrective actions.

RECORDS
8.1.

All audit reports are maintained in a sequential file in quality. The quality audit reports log
reflects the status of pending and completed audits and corrective action.

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9.

10.

FORMS
9.1.

PFO1-14 SQAR

9.2.

PFO1-13 SQCS

9.3.

PFO1-16 SQAAL

9.4.

PFO1-17 SQES

9.5.

PFO1-15 SCALOG

DEFINITIONS
10.1. Audit -- A pre-planned thorough examination and evaluation of a defined product or activity
or portion thereof.
10.2. Product -- A part or combination of parts produced to meet requirements specified on
drawings, specifications or other controlled documents.

11.

REFERENCE DOCUMENTS
11.1 ISO 9002, 7.15.

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TRAINING
1.

PURPOSE
1.1.

2.

This procedure provides general instructions for establishing and maintaining an education
and training program for management, quality and other personnel who are participants in or
are directly responsible for the determination of product quality.

SCOPE
2.1.

3.

QP 118

This procedure applies to those functions within the company that have the responsibility to
plan, implement or evaluate product or data quality.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Administrative Staff

3.2.

Production

3.3.

Quality

4. GENERAL
4.1.

It is the policy of the NAME OF COMPANY to identify, and document the training needs and
provide for the training of all personnel performing activities affecting quality.

4.1.

For this procedure, education and training is divided into two categories:

General awareness and education

Planning awareness and education

4.2.

General awareness and education is typically informal and, as a result, does not necessarily
include a record of an event or who attended.

4.3.

Planning awareness and education is more formal and typically includes all or most of the
following processes:

5.

Policy statement and objectives for quality.


Concepts and documentation structure of ISO 9000.
Quality organization, responsibility, authority, and structure.
The employees job specific training.

PROCEDURE

Responsibility
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5.1.

The General Management Staff

Action
5.1.1. Identifies and assesses employee education and training needs
5.1.2. Evaluates the qualification of employees performing tasks affecting quality.
5.1.3. Maintains appropriate training records where appropriate.
5.1.4. Arranges for the mechanisms for delivery of training.
5.1.5. Evaluates the effectiveness of training activities.

Responsibility
5.2

Management Representative

Action
5.2.1. Announces kick-off meeting (what, who, where and when).
5.2.2. Conducts meeting, provides documents and agenda where appropriate.
5.2.3. Issues minutes and records action items and due dates.
5.2.4. Implements follow-up and closes specific requirements (product or data items).
5.2.5. Documents training activities and results in Training XLS. Files.
Responsibility
5.3.

Management Review Committee

Action
5.3.1. Annually reviews and re-evaluates training needs of employees.
6.

7.

RECORDS
6.1.

General awareness and education requires no records.

6.2.

Training records are documented in the computer Training XLS file and are maintained for
the length of active employment of the employee plus 1 year minimum.

FORMS
7.1.

Certificates where appropriate.

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8.

9.

DEFINITIONS
8.1.

General awareness and education - Includes awareness of general quality and reliability
information disseminated by the company, customer or industry through lecture, seminar or
film presentation conducted by senior management or its representatives.

8.2.

Planning awareness and education - Includes awareness of specific company, industry, or


customer purchase order and subcontract requirements about material, design, process,
inspection, test, data items, packaging or shipping by those functions responsible for their
implementation.

8.3.

Specific implementation and training and certification - Includes special process personnel
certification and employee accredited job specific training courses sponsored by state of
private educational sources.

REFERENCE DOCUMENTS
9.1.

ISO 9002, paragraph 4.18.

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SERVICING OF CUSTOMER RETURNS


1.

The NAME OF COMPANY performs no customer service activities


and therefore has no documented procedure regarding this element.

STATISTICAL TECHNIQUES
1.

4.

This procedure defines the method in which statistical techniques are used for control of
processes.

SCOPE
2.1.

3.

QP 120

PURPOSE
1.1.

2.

QP 119

This procedure applies to all manufacturing processes that qualify for statistical sampling, as
determined by quality control.

DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION


3.1.

Quality Assurance

3.2.

Production

3.3.

Administrative

GENERAL
4.1.

Quality Control determines the sample size to be used in determining the capability of the
process based upon the end-item use, inspection history, manufacturing methods,
classification and contractual requirements.

4.2.

Statistical Process Control is used :


To quantify and display current levels of quality.

To verify and control process capability and product characteristics .

To identify where to focus quality improvement resources and effort .

To show the effectiveness of improvement efforts.

4.3.

The responsibility for identifying the need for statistical techniques and establish methods and
instructions for the beneficial application is assumed by the Quality Function. The selection
of the appropriate statistical tools for individual processes is established through quality
planning and is documented in the Control Plan.

4.4.

Xbar and R , Pre-Control Charts, and Parts Verification Forms are used for the control and
monitoring of ongoing processes.

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4.5.

5.

The selection of the statistical method to be applied for individual processes is established by
Quality Planning or the Quality Control Manager and is documented in the Quality Control
Inspection Plan where appropriate.

PROCEDURE
Responsibility
5.1.

Quality Function

Action
5.1.1. Reviews the shop paper, and applicable documents for quality requirements on the
initial purchase of a new item.
5.1.2. Initiates Production planning meeting to discuss quality procedures.
5.1.3. Reviews drawing for customer critical dimensions and special dimensional
requirements.
5.1.4. Initiates FMEA, Control Plan, and Risk evaluation documents whenever the absence of
such planning would jeopardize the quality of the product.
Responsibility
5.2.

The Quality Control Manager

Action
5.2.1. Provides control charts, inspection plans and dimensional logs to operators for
completion.
5.2.2. Oversees and reviews charting activities, collects charts, and changes charts when
necessary.
Responsibility
5.3.

The Receiving Function

Action
5.3.1. Forwards any customer required statistical file and related documents to customer, with
shipment, if required.
Responsibility
5.4.

The In-Process or Final Inspector (Machine Shop)

Action

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5.4.1. Reviews the operation sheet, the inspection instruction and applicable specifications to
determine dimensions to be charted.
5.4.2. Reviews the special work instruction (QAIP) to determine the sample size to be pulled,
if applicable.
5.4.3. Pulls a random sample.
5.4.4. Records the results of the inspection on the chart and initials the form.
RESPONSIBILITY
5.5

Production Operator

ACTION
5.5.1.

Sets the machine according to furnished tooling and drawing received from Production
Manager

5.5.2. Presents five parts to Quality Control for first piece evaluation.
5.5.3. Runs a minimum of thirty consecutive parts for capability study and delivers parts to
Quality Control.
5.5.4. Receives SPC chart from Quality Control with instructions as to charting procedures
and requirements written on the face of the chart.
5.5.5. Charts the process as instructed noting problems encountered during charting activities
on the face or reverse of the chart.
5.5.6. Turns in completed charts at the end of the production run.
6.

RECORDS
6.1.

7.

FORMS
7.1.
7.2.
7.3.
7.4.
7.5.
7.6.

8.

Previous process studies if available. Records pertaining to statistical process controls are
maintained for a period of 1 year.

FO1-03 FMEA
FO1-04 CONTROL
FO1-05 RISK
FO5-02 FSTPCE1
FO5-06 PROSPO
FO5-06A CHART

DEFINITIONS
Not Applicable

9.

REFERENCE DOCUMENTS

9.1. ISO 9002, 4.20.


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9.2.

SPCMAN Statistical Process Control Manual

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