FMEA Level of Detail - Is the registrar's auditor correct?

J

John McCarthy

#1
Hi there,

We've recently had a QS9000 pre-registration audit and one of the areas we were pulled up on was the level of detail on our FMEAs. We are an Electronics Manufacturing company (both Surface mount & Plated through hole PCB technology) and had tackled FMEAs purely from a process viewpoint i.e. we examined the process of assembling PCBs from SMT placement machines, reflow ovens through to manual assembly, solderwave, test etc. The auditor in question felt these were too lightweight and that we should be getting into alot more detail such as the effect of different processes on individual components on the PCB assemblies. Our problem is that we manufacture a vast number of different products for alot of customers who are not automotive (and don't require QS9000) and if we were to go into that detail on all our products, we'd spend the rest of our lives doing FMEAs. From your experience, is the auditor correct here or is he going over the top? I always felt with Process FMEAs that it was the manufacturing process that needed to be investigated.

Any feedback is much appreciated !!

John.


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Marc

Hunkered Down for the Duration
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#2
Originally posted by John McCarthy:
we were pulled up on was the level of detail on our FMEAs
I'd have to see your FMEAs, but I am not convinced your auditor can determine for you the level of detail 'required'. Did s/he write you up or what?
 
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