Slide 202 of 262
The document mapping effort is extremely important.
It MUST include communication with corporate not only in regard to Quality Systems Manual inconsistencies, but at all documentation levels where there is a system, team and/or documentation interface requirement.
It must be detailed and precise. All inconsistencies must be addressed!
After you map your documentation (Verification), you have to Validate your documentation.
You Validate your document(s) by stepping through the actual process in step with the associated document.
Each step must exist and must be in the order of the documents’ procession.
Mapping internal documents is:
Verify internal reference documents exist and that the names and numbers ‘make sense’
Verify that the link subject matter makes sense and that requirements flow down
Find where the document fits in the ISO 9001 line item matrix
Examine matrix for redundancy