Does anybody can share the idea about DFMEA, will you treat it as document or record?
Per my understanding, DFMEA is product based, which should be a record only, becaue design only for "new", not like PFMEA, which is manufacturing process based.
If you use a template or WI for your FMEA that would be considered a document. (The blank form)
The calculation of RPN #'s creating recommended actions and recording results are all evidence of activities preformed and therefore I would classify this as a record. This is especially obvious if you have a place for sign-off on the FMEA itself.
Actually, In general any document that has one or more signatures on it I consider a record when I'm auditing. Prior to activities being preformed with the document then it's 'just a document'
While actively assessing risks, driving corrective/preventive action/continual improvements and while linked to a control plan, it should be considered a controlled document. The test for the need for a controlled document would indicate that people may take incorrect action if they worked from an obsolete version of the FMEA document.
When all is complete and no more activity is occurring, an FMEA may become a record. However, FMEAs are typically considered a "living" document, so this may not occur until the product end-of-life.
Does anybody can share the idea about DFMEA, will you treat it as document or record?
Per my understanding, DFMEA is product based, which should be a record only, becaue design only for "new", not like PFMEA, which is manufacturing process based.
You'll get confused if you try to decide whether or not something is a document instead of whether or not a document needs to be controlled. In this instance, both D- and P- FMEA documents are subject to change, so some form of revision control is necessary.
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