Understanding DFMEA and PFMEA - Supplier Related

#1
Hello,
New here and looking for some advice regarding a requiest I have had.

I understand that the requirements to perform failure mode analysis are part of the standard for the QMS.
The DFMEA can be performed by the team designing the product and that I understand. The part I am struggeling with is with the manufacturing. If I use a factory that is "apparently" IATF 16949 certified to assemble my design to what level to they have to perform PFMEA and is there any example template that they would use ?

I have been in contact with them and they quite rightly state:
"As we understand, failure could be caused by many many reasons, e.g. Design, components, assembly, environment... What we can do is only provide original components and professional assembly, we can not provide FMEA for the entire project."

Some help to understand what I should expect to have as an acceptable level of service for 16949 compliance.

Thanks
Marc
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
I won’t comment on the requirement as I am not an expert in 16949.
However, I am proficient at FMEAs. The ‘causes’ you say that your supplier mentioned are NOT what is asked for in an FMEA. These are just general aggregated categories of causes. IF this is their approach to the possible causes then their FMEA is basically worthless and they are just ‘checking the box’ anyway. The intent of FMEA is to list the specific - and actionable - potential causes to failure modes. The NEXT STEP is to characterize the process to understand if the potential causes are controlling or dominant factors in the process output and to understand what the tolerances should be on those factors - and other control mechanisms - to guarantee that the output of the process will meet the requirements.
 

Jim Wynne

Staff member
Admin
#3
Hello,
If I use a factory that is "apparently" IATF 16949 certified to assemble my design to what level to they have to perform PFMEA and is there any example template that they would use ?
What do you mean that the "factory...is apparently IATF certified..."? Are they registered/certified or not?
 

Miner

Forum Moderator
Staff member
Admin
#6
This supplier should be able to fully complete a Process FMEA. This should include any potential failure modes associated with assembly such as missing, misplaced, wrong orientation, upside down, wrong component, wrong sequence, etc.
 
#7
This supplier should be able to fully complete a Process FMEA. This should include any potential failure modes associated with assembly such as missing, misplaced, wrong orientation, upside down, wrong component, wrong sequence, etc.
My thoughts exactly. If they can't do that then they aren't complying with 16949.
 
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