Changing FMEA template to include Detection Ranking for the PFMEA

M

malshar2

#1
I have a question regarding changing the FMEA template to include detection ranking for the PFMEA. I was told that we're not allowed to change the template (I'm not sure the reason). Please let me know if you have any ideas. Thanks!
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
there is no 'law' against it. earlier versions of FMEA had detection ratings adn employed them in the calculation of the 'RPN' value. current modern thinking dismisses the RPN and detection and ratings forvarious reasons mainly becasue the RPN canbe quite misleading in allowing high severity and high occurence items go un-mitigated. This can result in high yield loss putting delivery at risk, high reqork increasing cost and the possibility of escape to the field (very few detection schemes are really foolproof). since occurence and detection are mostly opinion based - rather than data based - The RPN has resulted in 'manipuation' of the values to get an RPN that doesn't require action. I have even seen severity - which should be fairly strighforward - be 'negotiated' with detrimental effects.

Your Customer may not want you to add Detection back in. Some industry guidelines have also dismissed detection 'requiring' the use of only severity and occurence and the 'classification' of a failure mode instead of the RPN. You might want to consult your Customer and/or industry standards...
 

SHernandez

Team Lead II - Biomedical innovation
#3
Hi,

All templates and training I can find online pFMEA have "Detection". I understand the previous comment regarding the subjectivity of detection and the modern thinking. I couldn't find guidance for medical device industry stating if we have to put the "detection" or if we can only have severity and occurrence.

Where should I look for that guidance?
Thank you in advance
 
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