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QMS Operational Procedure |
QOP-75-02 |
|
Section 7.5 | Section Revision: A | Revision Date: 7/12/2010 |
Work Instructions | ||
Approved By: Todd Gifford | Date: 7/12/2010 |
I PURPOSE
The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities for establishing work instructions and workmanship standards.
II APPLICATION
This procedure applies to all departments involved in Dee’s processes summarized in Description of Sequence and Interaction of Processes.
III DEFINITION
Work Instructions are electronic procedures instructing on how to carry out a process or perform a task. They can instruct on how to perform a particular task. Guidelines for identifying the need for work instructions are included in this procedure.
IV PROCEDURE
1. Identification of need
1.1 The need for work instructions and workmanship standards for a given process is determined on the basis of the following considerations:
Importance of the process
: Work instructions are desirable for processes that are critical to our operation.
Complexity of the process
: Work instructions are desirable for more complex processes.
History of quality problems: Work instructions may be developed for processes that have a history of quality problems, especially when these problems can be associated with the lack of adequate instructions.
1.2 The need for work instructions for other than order fulfillment processes is determined on the basis of the importance and complexity of the process or task; the level of education, experience and training of personnel; and the degree and depth of the instructions already provided in the quality manual and operational procedures.
2. Issue and authorization
2.1 Work instructions are normally issued by the President, Vice President of Operations, or Vice President of Sales. However, Quality Assurance or Production Supervisor may issue work instructions and workmanship standards, regardless of where they are used.
3. Format, control and distribution
3.1 Work instructions can be in the form of electronic procedures.
3.2 Irrespective of their format, work instructions are electronic and located with the electronic user forms they are associated with.
V ASSOCIATED DOCUMENTS
QOP-75-01 Operational Procedure: Operations Control
QOP-42-02 Operational Procedure: Control of Documents