G
gjkoenig
Hello,
We were recently audited by a new customer and were cited for not having a procedure for PFMEAs. We are a TS16949 company and generate PFMEAs during the Contract Review and include them in our PPAPs per AIAG. There is no separate procedure (SOP/WI) on PFMEA but the PFMEA Form is referenced in some of our existing SOPs. How is the PFMEA Process normally invoked/controlled in an organization? Do we need to create a separate SOP or Work Instruction in order to spell out the details from inception to monitoring or is it enough to just reference our PFMEA Form in the existing SOPs? I really do not want to create another "Procedure" if we are already covered somewhere else.
The SQE auditor also mentioned that because of having no procedure, we do not have clearly identified RPN numbers for each process that would trigger an action (corrective action). As a newbie to PFMEA, I was under the impression that it is not advisable to use threshold numbers but rather evaluate the process risks individually.
I would appreciate any comments.
gjkoenig
We were recently audited by a new customer and were cited for not having a procedure for PFMEAs. We are a TS16949 company and generate PFMEAs during the Contract Review and include them in our PPAPs per AIAG. There is no separate procedure (SOP/WI) on PFMEA but the PFMEA Form is referenced in some of our existing SOPs. How is the PFMEA Process normally invoked/controlled in an organization? Do we need to create a separate SOP or Work Instruction in order to spell out the details from inception to monitoring or is it enough to just reference our PFMEA Form in the existing SOPs? I really do not want to create another "Procedure" if we are already covered somewhere else.
The SQE auditor also mentioned that because of having no procedure, we do not have clearly identified RPN numbers for each process that would trigger an action (corrective action). As a newbie to PFMEA, I was under the impression that it is not advisable to use threshold numbers but rather evaluate the process risks individually.
I would appreciate any comments.
gjkoenig