Risk Controls in PFMEA

Quality Engineer

Starting to get Involved
Typical failure modes relating to inspection involve handling; failure to detect a defect is not a new failure mode it is an ineffective control.

Handling failure modes involve consideration of contamination, breakage, exposure to ESD, etc.

But I read on other discussion/forum that
1. accepting a bad part or rejecting a bad part
2. Missed inpsection etc.

are failure modes of the inspection processes?
 

Tidge

Trusted Information Resource
But I read on other discussion/forum that
1. accepting a bad part or rejecting a bad part
2. Missed inpsection etc.

are failure modes of the inspection processes?

If you are doing a process validation for a manufacturing process, inspection is a risk control for that (manufacturing) process. Inspection methods themselves are a separate process.
 

Onceuponatime

Starting to get Involved
Typical failure modes relating to inspection involve handling; failure to detect a defect is not a new failure mode it is an ineffective control.

Handling failure modes involve consideration of contamination, breakage, exposure to ESD, etc.

14971 already requires assessing risks stemming from risk controls. If inspection (risk control) results in additional risks 'contamination, breakage, exposure to ESD', your Risk Analysis needs to capture those as well.
 
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