When to perform Process FMEA?

  • Thread starter vikash_futrue - 2011
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vikash_futrue - 2011

#1
Shall we need to do process FMEA after Prototype or after productionization?
 
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Marc

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#4
There are different types of FMEAs. This might help a bit: FMEA Basics.

FMEAs are a Risk Analysis tool. FMEAs are not a specific ISO 9001 requirement. They are an automotive requirement. Risk analysis is also a requirement in other areas such as medical devices and aerospace.
 
S

sstafford

#6
when doing a process fmea, are failure modes, corrective modes suppose to be completed for the end result of the product? Or what it does for the manufacturing process?
 
T

tomvehoski

#7
when doing a process fmea, are failure modes, corrective modes suppose to be completed for the end result of the product? Or what it does for the manufacturing process?
Both, IMO.

If the failure causes your next machine to crash and results in a huge repair bill and late shipments, that is a risk you should address on the FMEA.

If the failure causes a bad part to be made and shipped, that affects your customer and should be addressed on your FMEA. This is often the difficult one, as you don't always know what the intended use of the part is.
 
M

mcammaert

#8
There are different types of FMEAs. This might help a bit: .

FMEAs are a Risk Analysis tool. FMEAs are not a specific ISO 9001 requirement. They are an automotive requirement. Risk analysis is also a requirement in other areas such as medical devices and aerospace.
Dear Marc,

Does ISO 9001 require similar documents as a PFMEA or are Risk analysis not important at all for ISO 9001?

Best regards!
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
Risk analysis isn't part of ISO 9001 presently but is in the upcoming 2015 version. As far as I know it does not specify a specific risk analysis method.

Others here will correct me if I'm wrong.
 
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