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QUALITY SYSTEMS MANUAL

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Procedure Manual How to write a procedure.

Issue date: Approval date: Page: 1 of 3

Procedure needs to include the following sections: Header, Purpose, Scope, Responsibility, Definitions, Instructions, Monitoring, Corrective Actions, Verification, Record Keeping, Records related to the procedure, Documentation Retention, Attachments, Amendment Sheet. HEADER: Each procedure needs to include header. This will allow recognizing the procedure, this will standarise entire quality manual. The header needs to include the following sections: General Subject: Example Quality Manual, as there may be several manuals within a company Subject: to inform users of the content, Issue No: issues of the procedure need to be counted and recorded, amendments to be recorded in the amendment sheet. Every amendment to the procedure must cause change in the issue number. Reference No: this is a unique number assigned to the each procedure Issued by: this refers to a person who created the procedure Approved by: this refers to a person who agreed and approved the procedure Issue date: each procedure needs to be dated Approval date: approval date needs to be stated Page numbers: this is designed for procedure controlling Example: above. PURPOSE: The reason why the procedure exists needs to be described. Example for purchasing procedure, the Purpose might read: "This procedure defines the process for obtaining raw materials and supplies for XYZ Company and the matter with which the requirements of these purchases are flowed down to XYZ Company's suppliers." SCOPE: This is to what extent the process will reach within the company. Example: "This procedure shall include all purchases directly used in the manufacture or processing of XYZ Company's product."

Issue: 1

Ref No:

QUALITY SYSTEMS MANUAL

Issued by:

Approved by:

Procedure Manual How to write a procedure.

Issue date: Approval date: Page: 2 of 3

RESPONSIBILITY: This is similar to a job description where as it defines the person that will manage and/or carry out the tasks described in the procedure. Example: "The purchasing manager will be responsible for managing this procedure and coordinating purchases. Managing shall include the implementation and enforcement of this procedure throughout XYZ Company." DEFINITIONS: These should not be common terms that anyone reading the document should already know; but, should be technical terms that pertain to the procedure or common terms that may have added meaning to the company. Example: "Supplier - XYZ Company defines a supplier as an approved company that supplies items used to produce and/or manufacture our product. This term does not include companies that supply general office product not used to produce or process XYZ Company's products." In this example the common term supplier has added meaning to XYZ Company that could differ from another company's definition of supplier. INSTRUCTIONS: This is the bulk of the procedure and is where the company will define the actual process. This can be detailed or simply call out what work inspection are to be used at each step of the purchasing process. It is important that all the elements of the quality standard that pertain to the procedure are defined in this part of the document. This section is usually broken into subsections. Example: this might include: "General procedures", "Purchasing Components and Raw Materials" "Purchasing Outside Services" Usually some kind of outline method is used to layout this section. MONITORING: The process must be monitored, as even the best written procedure will not assure that everything will be done correctly. This section will define how the process will be monitored. Example:

Issue: 1

Ref No:

QUALITY SYSTEMS MANUAL

Issued by:

Approved by:

Procedure Manual How to write a procedure.

Issue date: Approval date: Page: 3 of 3

A designated employee will inspect that each employee is following this SOP. CORRECTIVE ACTION: Corrective actions must be defined in every procedure. Users must be aware how to react when something goes wrong. Example: Any employee found not following the procedures in this SOP to be retrained. VERIFICATION AND RECORD KEEPING: This defines how the process is verified and how the records are controlled. Example: The manager will verify that employees are following the SOP by visually observing the employees during all hours of operation. The manager will complete the log daily. RECORDS APPLIED TO THIS PROCEDURE: The records related to the procedure should be pointed in this section. This will be a support during navigating through quality manual. DOCUMENTATION RETENTION: This usually defines the method of controlling records related to this process. Where they will be kept, how long they will be kept, in what type of media for which they will be stored. ATTACHMNETS: This will be references to other procedures, external information sources or other media used to supplement that procedure itself. AMENDMENT RECORD SHEET This will record amendments made to the procedure. This will allow tracing evaluation of the procedure starting from original. Example: Amendment Record Sheet Issue No Date Original Issue Revised Issue Details Revised by