8.5.1.1 Control Plan - questioning audit NC

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 lengthy post. Would appreciate any thoughts on this. Revising PFMEA/CP every time we issue a TPM is not practical nor is is value added.

 

I agree completely with Andy. The process you have described (issuing a TPM) is a 'standard' one in industry, and (partially) is in place to prevent useless and repetitive document revisions (revise to add the 100% inspection, then revise AGAIN to remove it once the CA is completed). As Andy said, it appears that auditors are grasping at straws to try and find SOMETHING to write up.

 

Absolutely not! This is definitely a case where an auditor can't find anything, so they have to nit pick. You probably had grounds to appear and/or challenge the auditor, but sometimes you almost feel if you challenge them during the audit, it could cause them to dig deeper and find something a little more severe. If you had proof that you reviewed the APQP and decided updates weren't necessary, that's part of the review process. I don't know why the auditor would suggest more work, especially in an age where companies are encouraged to be more efficient and productive and this is obviously counter-productive.

 

It's understandable that you're facing a practical challenge in managing temporary process changes and their impact on control plans, particularly when it comes to compliance with audit standards like IATF 16949. The auditor's perspective emphasizes the importance of control and documentation in quality management systems. While there's no one-size-fits-all solution, here are some considerations and suggestions:

1. Risk Assessment: The first step should be a risk assessment for any temporary process change. Assess the potential impact on product quality, safety, and compliance. Based on this, decide whether an immediate update to control plans is necessary.
   
   
2. Documentation: Ensure that your temporary process memos (TPMs) include clear and detailed information about the change and its expected duration. This should include any impact on control plans, PFMEAs, or work instructions.
   
   
3. Change Impact Assessment: Whenever a TPM is issued, your process engineer should evaluate the need for control plan updates. If the change is likely to become permanent, it's best to plan control plan revisions in advance.
   
   
4. Scheduled Reviews: Consider periodic reviews of TPMs to determine if any of the temporary changes have indeed become permanent. This can be part of your management review process.
   
   
5. Control Plan Revisions: When it's evident that a temporary change is becoming permanent, make timely revisions to your control plan. The key is to ensure that the control plan accurately reflects the current state of your processes.
   
   
6. Practicality vs. Compliance: Engage with the auditor to discuss the practicality of revising control plans for very short-term changes, especially if they are highly frequent and have minimal impact on product quality. Seek their guidance on how to address these situations while ensuring compliance.
   
   
7. Continuous Improvement: Use these situations as an opportunity for continuous improvement. If temporary changes are becoming frequent, it might be worth investigating why they are occurring so often and whether there are systemic issues that need addressing.
   
   
8. Training: Ensure that employees involved in the process understand the importance of control plan revisions and how to make these updates efficiently.
   
   
9. Consultation: If in doubt, consult with industry peers or experts who have experience in handling similar audit findings and compliance challenges.
   

The key is to balance compliance with practicality and efficiency. It's about ensuring that your quality management system remains effective while not burdening your organization with excessive paperwork and administrative work for short-lived changes. The input of the auditor is valuable, and a constructive dialogue with them can often lead to a mutually acceptable approach.

 

I too have used TPM to manage and control temporary process changes, and was questioned once about it.

When I discussed with my auditor (who was actually an intelligent and reasonable person) I pointed out the exact wording of the standard; Shall review control plans, and update AS REQUIRED......

We agreed that the intent of this requirement was to prevent errors and missed changes in the process, and that the TPM process (which was clearly written, well documented, and immediately available to the operator) was sufficient to meet this need, and that no update to the control plan was required within the time allowed on the TPM.

 

You have a system in place to prevent non-value-add, repetitive, document changes. All while controlling the process. If one were to revise the CP for a temp change, you would improve nothing and open the door to document control findings for years to come.