AS9100 Major for repeat.

[StebanGtz]

Hello everyone,

Last year, we received a nonconformance (NC) related to clause 8.4.2 because our receiving instructions did not include the material specification.

To address this, we updated the work instructions to include the material specification and trained the receiving team to verify that the material meets the correct specification.

During this year’s audit, the auditor followed up and asked the receiving team whether they inspect the raw material against the specification (specifically the composition of the raw material). In reality, our training focused on verifying that the material certificate matches the purchase order (PO). As a result, the auditor issued another minor NC under clause 8.4.2 and, additionally, a major NC under clause 10.2.1 for the effectiveness of our corrective action process.

This is the first time we’ve received a major NC related to the corrective action process, and we’re unsure how to respond. Do you have any suggestions or feedback on how to address this issue?

 

[Randy]

This is the first time we’ve received a major NC related to the corrective action process, and we’re unsure how to respond. Do you have any suggestions or feedback on how to address this issue?

If you feel it unfair or incorrect appeal it.

Here's what I see, did you actually verify the effectiveness of the CA, or did you do the basic leg/paper work and blow off making sure the CA had actually taken hold and was working as desired?

 

[Jtavo]

StebanGtz -

• did the audit team accept your response to the initial / original NC?
• did you verify the NC had been corrected?

- If so then this is a new Finding - even though the intent of the original finding may have been implied. They accepted your response to the original NC? If that's not what they meant then...?
- A Major Finding is systemic in nature. Do you have many examples where there has been failures to control and correct, or is it just the one?

 

[Bev D]

What was the exact text of the 3 findings? What requirement was cited? What exactly was your first corrective action and how did you verify effectiveness?

Specifically was the auditor looking for (1) the receiving personnel to verify that the certificate of analysis (?) which would have the suppliers material testing results to be within the material specifications and the receiving personnel were not doing this? OR (2) was the auditor looking to have receiving personnel actually retest the material?

 

[StebanGtz]

If you feel it unfair or incorrect appeal it.

Here's what I see, did you actually verify the effectiveness of the CA, or did you do the basic leg/paper work and blow off making sure the CA had actually taken hold and was working as desired?

We verify the effectiveness and everything was well. The receiving team was looking the CofC of the material and they were verifying that the spec was correct but not the composition.

 

[StebanGtz]

StebanGtz -

• did the audit team accept your response to the initial / original NC?
• did you verify the NC had been corrected?

- If so then this is a new Finding - even though the intent of the original finding may have been implied. They accepted your response to the original NC? If that's not what they meant then...?
- A Major Finding is systemic in nature. Do you have many examples where there has been failures to control and correct, or is it just the one?

Yes, he accepted the response for the initial / original NC. We added to the receiving instructions the specs of the materials the receiving team need to verify, but this time the auditor said that the intention was to verify everything, spec and composition.

Yes, after we added the list of specifications, everything was well, except for the composition issue.

No, this is the first time that we had a Major Finding, that's why I don't know how to address the issue an answer the finding.
Do you have any ideas?

 

[StebanGtz]

What was the exact text of the 3 findings? What requirement was cited? Waht exactly was your first corrective action and how did you verify effectiveness?

Specifically was the auditor looking for (1) the receiving personnel to verify that the certificate of analysis (?) which would have the suppliers material testing results to be within the material specifications and the receiving personnel were not doing this? OR (2) was the auditor looking to have receiving personnel actually retest the material?

The three findings were:
2024 Minor 8.4.2 Material properties not reviewed to the standard
2025 Minor 8.4.2 Material properties not reviewed to the standard
2025 Major 10.2.1 Repeat NC

and specifically, the auditor said during this audit, the intention of the last year finding was the receiving team need to verify the composition of the material vs the spec, not just review the spec on the CofC vs our requirement. So, on this case will be 1.

 

[ChrisM]

When you/the auditor states "verifying the composition of the material vs the spec", does this mean that he expects, for example, the percentage of iron, tin etc to be checked against the specification for that grade of material and not just accept the test result figure on a Mill Cert?
Personally I think that would be unreasonable - if your inspection staff know what a Mill Cert is, know how to read the grade of material referenced on it and how to determine the relevant P/O requirement specification, that should be sufficient.
However I have come across instances where you would be required to send off a coupon for analysis to independently verify that the grade is correct, irrespective of the presence of a Mill Cert; is this what your auditor is getting to - that you do not verify the material grade but take it "as written" from the certificate?

 

[Bev D]

Exactly what I wanted to know…plus what is the exact wording of the requirement for this?

I suspect the real causal mechanism here is that the OP doesn’t understand the real requirement and what it means

 

[John Predmore]

FYI, AS9100 has bold-text requirements that expand ISO 9001 8.4.2, including the note:
"When external provider test reports are utilized to verify externally provided products, the organization shall implement a process to evaluate the data in the test reports to confirm that the product meets requirements. When a customer or organization has identified raw material as a significant operational risk (e.g., critical items), the organization shall implement a process to validate the accuracy of test reports."