FMEA recommended actions column - What to do after actions are complete?

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Andrews

We have a doubt in FMEA . There are two school of thoughts we have come across regarding the method of addressing completed recommended actions.One school of thought says keep the recommended actions in the "recommended actions" column itself as a record of all actions taken from the inception of the product and record the actions taken in the "actions taken" column.Second school of thought says that we have to transport the actions completed into the "current process controls prevention" or "current process controls detection" column.

Which is correct? Reason I am asking is because we follow the 1st approach but got an NCR in our preassessment audit
 
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Andrews said:
We have a doubt in FMEA . There are two school of thoughts we have come across regarding the method of addressing completed recommended actions.One school of thought says keep the recommended actions in the "recommended actions" column itself as a record of all actions taken from the inception of the product and record the actions taken in the "actions taken" column.Second school of thought says that we have to transport the actions completed into the "current process controls prevention" or "current process controls detection" column.

Which is correct? Reason I am asking is because we follow the 1st approach but got an NCR in our preassessment audit
Based on the information you've provided, there is no basis for an NCR that I can see. When recommended actions are completed, the RPN is recalculated and the actions taken are institutionalized. Anyone looking at the PFMEA document can see what happened, and so long as the appropriate changes have been made to the control plan, there shouldn't be a problem. I think it's a good idea to leave things as they are on the right side of the form as a record, as you suggest. FMEAs for similar processes can incorporate the changes as current controls.
 
I agree, in the original FMEA the changes should remain to show that you have reacted.
The next auditor will say "show me how you reacted to ....." and you will not have any thing to show :confused:
 
Bill Ryan said:
You might also look HERE for a few other "insights".
Bill,
The link given by you presents the second school of thought. We do not know which has to be followed.Does the AIAG give any guidance on this.
 
Andrews said:
Bill,
The link given by you presents the second school of thought. We do not know which has to be followed.Does the AIAG give any guidance on this.
Neither "has" to be followed. The auditor in this case is wrong because he's essentially expressing an opinion that has no basis in the standard (no "shall," in other words). As I said in an earlier post, the important thing is that the control plan (and inspection instructions, if any) are updated to reflect the actions taken. "Current" process controls is generally construed to mean current at the time the PFMEA is originally documented.
 
JSW05 said:
The auditor in this case is wrong because he's essentially expressing an opinion that has no basis in the standard (no "shall," in other words). i

There is no shall in the standard. But this looks like the auditors own shall because the heading in the FMEA says "current control".
 
Hi,

I agree with everyone else that in this particular FMEA, you should keep the actions taken in the columns to demonstrate what you have done!

The auditor is wrong! However, you should be taking your actions taken and implementing them in a lessons learned document or database. This is so that if similar processes are used again, you can ensure that the corrective actions taken here are carried over to the similar process. In this later process these actions would be Current Controls/Detections.

Hope this makes a bit of sense. Remember, OEM's and auditors love records that you have learned from your mistakes and that you have evidence of this!
 
Andrews said:
Bill,
The link given by you presents the second school of thought. We do not know which has to be followed.Does the AIAG give any guidance on this.


The purpose for FMEAs is to evaluate the processes, determine risks, and take additional actions to control these risks. If no further actions are taken, then the FMEA did not "improve" the process, because it did not effect any changes. It would only catalog the process as it exists.

So, if we take additional actions for higher RPNs, as the FMEA book recommends, the extended columns are the appropriate place to record the changes for that FMEA, and recal the new RPNs, to demonstrate how they improved the process. They become "current" controls on the next FMEA that would build off this one.

The "Lessons Learned" record is also a valuable document that should be utilized more. If there are lessons learned from this analysis, some of them may be beneficial to record in that document as well. That is your prerogative. But the two documents are different, and do not take the place of each other. The FMEA goes to the customer. The Lessons Learned tends to stay in the building.
 
Andrews said:
Bill,
The link given by you presents the second school of thought. We do not know which has to be followed.Does the AIAG give any guidance on this.

The link also reflects a systematic approach of review & update to the PFMEA, which is "supposed" to be a living document. IMHO the natural extension of the living document would involve the review & update which would include completed actions being institutionalized as 'current controls'.
 
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