We are using the pFMEA for co-relating with the process controls. Further, we are using FMEA process in handling complaints & deviation process (FMEA to drive the Root cause analysis process)
I request guidance/precautions from the experts:
On the steps of integrating the RCA-FMEA process with pFMEA process.
Whenever an incident occurs [complaint/NCR/Change control], the risk-perceptions of 'risks/effects' and 'failure modes' are updated.
The 'updating' could be revising the earlier existing RPN (of the effect/failure modes) in the pFMEA OR including new effects/failure modes...
On the contents/index of the annual review report on risk management.
Thanks in advance