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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?