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QS9000 paragraph 4.2
Cited in the AIAG APQP Manual
CFR 1910.119999999 lists the process FMEA as one of about 6 methods to evaluate hazards
Example: ICI Explosives - Hazardous Operability Studies
One of several methods that should be used to verify a new design (21CFR Part 820). Inspector’s check list questions cover use of the Design FMEA.
Requires Preventative Actions. The utilization of FMEAs is one continuous improvement tool which can satisfy the requirement (ISO9001, Section 4.14)
Can be used to evaluate potential hazards and their accompanying risks.
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