Changing dFMEA


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I didn't see a thread for this, though it seems a very basic question. We are a medical device company compliant with FDA and 13485 going through the process of an engineering change which will be a mitigating factor to an existing risk identified in the dFMEA. There was a discussion about the proper way to add this mitigation. Do we have to rev the dFMEA to add it? I was assuming that any change to our released FMEAs would have to be processed through a formal revision. The ops manager thought that only changes to the information that contributes to the initial RPN would require it to go through the revision process so we could simply add this mitigation and the new P1, P2, etc resulting. I checked our SOP which was vague but seems to imply that this change would have to be an actual revision. None of us have come from a background that has given us any prior experience to compare to or draw knowledge from. Is there a hard and fast rule? A best/common practice? Is it simply a matter of whatever the company has decided and written into their own requirements?


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Is your DFMEA not approved and under change control? Yes, if we were in your situation, we'd rev the DFMEA (via whatever change authorization mechanism you use). Otherwise, I'm not clear how you (your ops manager) would identify the original version -v- the changed one.


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Yes, it is approved and under change control. Which is exactly why I was advocating to make the changes through our change process. Thank you for weighing in. I hate to argue a point too insistently when I don't feel I have enough knowledge to do so. As a side note, I realized after my initial post that I used the word "mitigation" which is now no longer the terminology embraced in 14971. Just wanted to head off the nitpickers :vfunny:


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It appears the hazard has not changed, only the mitigation. If the dFMEA hazard points to a verification, or validation, then the verification, or validation could be revised. The mapping from the hazard to the verification, or validation would be maintained, and the dFMEA would not need to be revised. If the RPN is changing, then the dFMEA would need to be revised. Note that if a mitigation is added, then the RPN could go down.
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