8.5.1.1 Control Plan - question audit NC

Bob Sutton

Registered
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
 

Sidney Vianna

Post Responsibly
Leader
Admin
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
The 2 words that I highlighted, are key here. Common sense would support your position, in my opinion. A temporary mitigating activity should not be reflected in a control plan, that, for the most part, is supposed to cover the stable, volume production, "normal" conditions.

Good luck. And consider appealing the minor NC, for your own sanity and the CB auditor enlightenment.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
What @Sidney Vianna said.

Also, this 'non-conformance" seems so ridiculous as to make me wish we could see the actual nc statement as written by the auditor. Just to make sure we clearly understand. Would you mind providing it to us verbatim ?

Thank you.
Be well.
 

Hendor

Involved In Discussions
As you comment,

They seem to me more like internal containment activities, which are part of your corrective action process, while you identify your causes and implement appropriate actions; as mentioned in 10.2.3 (b)

You define the (TPM), you have its approval, and you have it documented. Up to this point it seems fine to me.
 

Johnnymo62

Haste Makes Waste
I consider it inappropriate to use your TPM to basically say keep 100% inspecting. If you had a separate additional 100% inspection then I think it's ok.

That being said I agree that you wouldn't change the control plan to add a containment activity while corrective actions are being developed.

I would expect the control plan to change for whatever corrective actions you put in place in addition to the ineffective 100% inspection.
 

Sebastian

Trusted Information Resource
Organization found implementation of additional inspection required.
Organization found revision of control plan not required.
I read definition of control plan and couldn't find, containment actions are not covered.
After complaint, parts are manufactured with additional inspection and go straight to customer.
It is normal process at this time.
 
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