What Is the Difference Between Quality Procedures & Work Instructions?
In the hierarchy of quality system documents, there are procedures and work instructions. The two support the policies established in the quality system manual [QSM]. Whether or not the quality system intends registration to a quality system standard, such as ISO 9001:2000, it is necessary to understand the hierarchy and purpose of the separate documents. This focus is on procedures and work instructions.
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Quality System Document Hierarchy
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The hierarchy of documents in a Quality System is 1.) QSM (Quality System Manual); 2.) Procedures; 3.) Work Instructions; and 4.) Forms / Records.
QSM Overview
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The Quality System Manual defines how the separate departments function to achieve quality objectives. Objectives are defined in a series of policy statements that support a corporate quality policy. An example of policy might be: "ABC Company will achieve a first-pass production yield of 99.7 percent acceptable product."
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Procedures
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Procedures document the methods employed to achieve the policy defined in the QSM. If the policy is to achieve 99.7 percent first-pass yield, a procedure will define how the Production Department will achieve the objective. Example: "Production will establish control points in the manufacturing process to measure and record results against specified critical characteristics."
Work Instructions
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Work instructions document specific tasks performed to meet the procedural requirement. Example: "Each hour, the operator will measure the length of feature X on five sample parts and plot the results on the chart for that feature. Recorded results must show a minimum 99.7 percent pass rate within tolerance in each hour."
Coordination of Procedures and Work Instructions
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Audits of procedures and work instructions will identify potential disconnects between the two documents. They must be synchronized. The greatest detail of work performed is dedicated to work instructions.
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Resources
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