- Standard Operating Procedures (SOP)
SOPs are written and approved procedures for any process which requires critical design and control and for risk/fault/hazard/safety analysis.
Examples are:
- FMEA/Hazard analysis, critical testing for safety agencies.
- Change control for any document or process, which is critical to the development process (i.e. ECO, ECN, changes to the MRD, PRS etc…).
- The corporate development process including GPEP.
- Contingency plans for handling unknown risks, hazards, faults (in the process, as well as, the product and components).
- Quality Plans.
- Frozen Documents
If a document is closed to any unapproved changes (i.e. it is 'frozen') it must fall under the control of a formal mechanism that insures that no ad hoc changes are introduced into the product designs and processes. The sign shown here, when attached to any document, indicates that the document is frozen and is 'Read Only'.
- EXternal Requirements (EXR)
There will be documents which need to be referenced and used, but not generated by the project team, These documents, such as regulatory agency standards, legal documents, public competitor information, industry standards, etc. will need to be retained as required. By default, they are always frozen since they cannot be changed.
Examples are:
- Industry standards
- Calibration instructions for procured parts
- Market studies
All necessary and pertinent project and product documents should be maintained in one of two main controlled repositories. These repositories may be hard copy or electronic copy files; they allow a standard mechanism for document collection, maintenance and control. It is a good idea to assign a responsible 'keeper of the files'.
Each product will have the following two files.
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©1999, 2005, Richard M. (Dick) Haney
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