The organization shall incorporate the use of a
documented Failure Mode and Effects Analysis
(FMEA) procedure and ensure the FMEA's are
updated to reflect current part quality status.
The FMEA shall be written for each part or part
family or they may be process-specific and written
for each process. In any case, they shall address
all process steps from part receipt to part shipment
and all key heat treat process parameters as
defined by the organization. A cross-functional
team shall be used in the development of the
FMEA. All special characteristics, as defined by
the organization and its customers, shall be
identified, defined, and addressed in the FMEA.