Current Control Periodic Document Reviews - Process Updates in the FMEA

A

afranchina

#1
Hi,
I have question about the current process update in the FMEA during the periodic document review.
If, for example, an action already taken has decreased the detection of a FM by introducing a more effective control, am I supposed to move this new control from the Action Results Section to the Current Control Section leaving the Action Result portion empty and available for further actions to be taken?
Thakns
 
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John Broomfield

Staff member
Super Moderator
#2
Re: Current Control Periodic Update - Process Updates in the FMEA

Hi,
I have question about the current process update in the FMEA during the periodic document review.
If, for example, an action already taken has decreased the detection of a FM by introducing a more effective control, am I supposed to move this new control from the Action Results Section to the Current Control Section leaving the Action Result portion empty and available for further actions to be taken?
Thakns
afranchina,

Updating the relevant FMEA(s) should be part of your documented procedure for preventive action.

Yes, when you have evidence that any of the risk assessment criteria (severity, detectability or frequency) have been altered by preventive action you should recalculate the RPN*.

Your FMEA should include a reference to the relevant PAR# so you have a record of the actions taken and the evidence of effectiveness.

If in doubt, wait for the cross-functional FMEA team to re-run their FMEA.

*The Risk Priority Number may also be changed by the discovery of any new information.

John
 
Last edited:

Jim Wynne

Staff member
Admin
#3
Re: Current Control Periodic Update - Process Updates in the FMEA

Hi,
I have question about the current process update in the FMEA during the periodic document review.
If, for example, an action already taken has decreased the detection of a FM by introducing a more effective control, am I supposed to move this new control from the Action Results Section to the Current Control Section leaving the Action Result portion empty and available for further actions to be taken?
Thakns
afranchina,

Updating the relevant FMEA(s) should be part of your documented procedure for preventive action.

Yes, when you have evidence that any of the risk assessment criteria (severity, detectability or frequency) have been altered by preventive action you should recalculate the RPN*. Your FMEA should include a reference to the relevant PAR# so you have a record of the actions taken and the evidence of effectiveness.

If in doubt, wait for the cross-functional FMEA team to re-run their FMEA.

*The Risk Priority Number may also be changed by the discovery of any new information.

John
I think the OP is not asking about whether the RPN should be recalculated, but whether the "Recommended Actions" should be moved out of the right side of the PFMEA form to the left side when actions are complete and the RPN is recalculated. The answer is generally "no," because leaving it on the right side provides a record. Those actions might be moved if the PFMEA is redone completely, but the fact that the new control(s) and new RPN are present make it self-evident that the previous controls were either augmented or superseded.
 
#4
Re: Current Control Periodic Update - Process Updates in the FMEA

It is quite possible that a second action could be initiated to reduce the RPN even farther. I have seen this handled two separate ways. One is to move the revised RPN to the left. If you do that, you will want to keep a copy of the original FMEA with the original RPN for historical purposes. The second way I have seen is to recreate the right side of the FMEA with a 2nd (or 3rd, or 4th, etc.) area for action. This will show continuous improvements as you go. It is fairly easy to do if you use a simple spreadsheet, but some canned FMEA programs might not allow you to expand.

In either case, you will have a record of what actions were taken to address the RPN and the resulting numerical change.

Hope that helps.
 
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