Pfmea (Process FMEA) at Process Audit

S

stevenlee

#1
Dear all,

I have a question with the PFMEA.Does the in process audit must be analysis in PFMEA ?? can we have that as a process?

Thanks,
Steven
 
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Miner

Forum Moderator
Staff member
Admin
#2
Re: Pfmea at process audit

Are you asking whether the in-process 'quality' audit should be included as an item in the PFMEA?

If so, quality audits are typically looked at as one of the controls for the other process items. If there is some chance that the audit could have a detrimental impact on the quality, include it. Otherwise, the only failure modes typically associated with inspection are:

  • Reject a good product
  • Accept a bad product
  • Fail to follow procedure for nonconforming product
 

Jim Wynne

Staff member
Admin
#3
Re: Pfmea at process audit

Are you asking whether the in-process 'quality' audit should be included as an item in the PFMEA?

If so, quality audits are typically looked at as one of the controls for the other process items. If there is some chance that the audit could have a detrimental impact on the quality, include it. Otherwise, the only failure modes typically associated with inspection are:

  • Reject a good product
  • Accept a bad product
  • Fail to follow procedure for nonconforming product
I'd add one more item to the list--failure to properly identify inspection status when the inspection is finished.
 
G

gholland

#5
Your risk control measures have to be verified to be effective. If they are not effective or you don't verify them then you can't use them to reduce your RPN numbers. The inspection itself isn't part of your 'process' that you are evaluating but you do need to run some sort of verification that your in process inspection is effective in detecting the failure you are looking for. This verification would be referenced in the pFMEA.
 
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