Ragnar said:
Hello! Looking for some help. During a recent audit the question came up with regards to the dock audit process appearing in the process flow dia. & control plan but not on the
FMEA. Are there potential failures associated with dock audits and should these be captured in the FMEA and assigned RPN's? Any infor would be greatly appreciated.
Thanks:
Respectfully:
Ragnar.
Basically, if you have a process operation step called out in your Process Flow Diagram, it needs to be listed as an operation/step in the
PFMEA and, consequently, the Control Plan. Whether you address Failure Modes at a particular step is another matter.
I agree with JSW05 that there are
Potential Failure Modes at any process step but I may not, necessarily, address one at a "transfer" operation (for example).
Regarding Dock audits - we don't address them as a process step except in a "Pre-Launch" mode where we audit each skid of product. Once in a "production" mode, the step is removed from the PFD, PFMEA and CP. If you think about it, one of the "Golden Rules" of the PFMEA is that you need to assume product entering your processing step is "correct" with the intention being you "prevent or catch/correct" nonconformities at the operation they are produced. In that vein of thought, the only "Failure Mode" for a Dock Audit would be something to the effect of "Inspector rejects acceptable product".