I'm hoping some of the highly knowledgeable and experienced members of this forum can offer some thoughts on a recent IATF audit finding.
Background:
We of course have PFMEAs/Control Plans and work instructions. On occasion, for a variety of reasons an immediate change is needed to an existing process. We issue what we call a temporary process memo (TPM) with a two week expiration date. If the change is to be permeant change we evaluate and revise appropriate documents (PFMEA/CP/WIs) prior to or by the expiration date of the TPM.
Example: We receive a customer complaint and part of the containment action includes adding an additional inspection to the process.
Audit finding:
The auditor found the situation that I used as an example. Customer complaint resulting in containment that included issuing a TPM for additional inspection for a two week period. In this case the added inspection did not become a permanent change.
The auditor issued a minor finding due to the fact that we were not in compliance with "8.5.1.1 Control Plan: The organization shall review control plans, and update as required, for any of the following: g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA)".
Specifically, he looked at the existing control plan and saw that we indicate 100% inspection as part of our control methods. He indicated that we should have revised the control plan to now say 200% visual inspection. When we explained that it was a temporary change he stated we should have revised the control plan when the temporary change started and go back and revise the control plan when the temporary change expires. TPMs are not that uncommon especially post launch on a new program or as part of complaint containment. Our TPM documentation does ask the question as to whether the PFMEA and/or Control Plan will require updating (meaning, is this temporary change going to be permanent). A process engineer is one of the TPM approvers and is the person that answers the question about whether we need to revise PFMEA/CP.
Sorry for the long post. Revising PFMEA/CP for every TPM is not practical for us or value added. Would greatly appreciate any thoughts. Thanks
Background:
We of course have PFMEAs/Control Plans and work instructions. On occasion, for a variety of reasons an immediate change is needed to an existing process. We issue what we call a temporary process memo (TPM) with a two week expiration date. If the change is to be permeant change we evaluate and revise appropriate documents (PFMEA/CP/WIs) prior to or by the expiration date of the TPM.
Example: We receive a customer complaint and part of the containment action includes adding an additional inspection to the process.
Audit finding:
The auditor found the situation that I used as an example. Customer complaint resulting in containment that included issuing a TPM for additional inspection for a two week period. In this case the added inspection did not become a permanent change.
The auditor issued a minor finding due to the fact that we were not in compliance with "8.5.1.1 Control Plan: The organization shall review control plans, and update as required, for any of the following: g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA)".
Specifically, he looked at the existing control plan and saw that we indicate 100% inspection as part of our control methods. He indicated that we should have revised the control plan to now say 200% visual inspection. When we explained that it was a temporary change he stated we should have revised the control plan when the temporary change started and go back and revise the control plan when the temporary change expires. TPMs are not that uncommon especially post launch on a new program or as part of complaint containment. Our TPM documentation does ask the question as to whether the PFMEA and/or Control Plan will require updating (meaning, is this temporary change going to be permanent). A process engineer is one of the TPM approvers and is the person that answers the question about whether we need to revise PFMEA/CP.
Sorry for the long post. Revising PFMEA/CP for every TPM is not practical for us or value added. Would greatly appreciate any thoughts. Thanks
