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.
Quality System Document Hierarchy
The hierarchy of documents in a Quality System is 1.) QSM (Quality System Manual); 2.) Procedures; 3.) Work Instructions; and 4.) Forms / Records.
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.”
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 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
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.