Integrating the FMEA process with problem investigation/RCA process and PFMEA

MCJames

Registered
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My apologies as this isn't a response to your question, but why would you not need to update the fmea to add a new line item based on a lower severity complaint? X company is trying to add new line items to the fmea if they do not match the RPN but are lower severity (which is ALL the time). Sam process, failure mode, everything the same execpt the severity/RPN. I guess for tracking severity of risks? Does this make sense and if not why not?

Thanks for the replies! I should have been more clear in my flowchart. By "Increase in RPN based on complaint? -> No" what I meant to say is that if your estimate of occurrence is still correct (say 1 occurrence out of 1000), there would be no need to update the occurrence value on your FMEA.

I hadn't considered the other possibility that you brought up which is: what if it's an existing risk but a novel, less severe harm which actually lowers your RPN? In that case @elly12345 I would expect to update the FMEA accordingly. As it relates to the original thread, I suppose what our customer wants to see is clearer, more in-real-time documentation of this decision making.

@Jen Kirley Yes, we investigate all complaints with the goal of determining a root cause. It seems like you're clued in to exactly the issue we have with complaints like these though -- we're limited in the root cause analysis we can reasonably perform. To you question though, we have been able to trace at least one spike in infections to a particular hospital. In that case we were actually able to perform RCA and correct the problem (sales rep mishandling the device!).
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
@Jen Kirley Yes, we investigate all complaints with the goal of determining a root cause. It seems like you're clued in to exactly the issue we have with complaints like these though -- we're limited in the root cause analysis we can reasonably perform. To you question though, we have been able to trace at least one spike in infections to a particular hospital. In that case we were actually able to perform RCA and correct the problem (sales rep mishandling the device!).
That is a success story to me! It is (almost) exactly the type of question I had. And it would fit onto a line item in your FMEA. In fact, it would go a long way to be able to point out you do take end user behavior into account.

How did you address this person's mistake?
 
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