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Documentation Requirements, Corrective Action and Nonconforming Product

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Jamie Created:   Apr 05, 2020 Last commented:   Apr 06, 2020

Documentation Requirements, Corrective Action and Nonconforming Product

Revision D. We had an auditor tell us that "the standard requires us to document" items like counterfeit parts within the Nonconforming product process specifically (even though we already have it in another process) and human factors documented in the Corrective Actions process specifically. Both of which actually don't state that they need to be documented in the process, but instead need to be determined or ensured coverage (which would be seen in the completion of the process in its own inherently). I don't believe the auditor is accurate in his statement based on how the standard is written. Wanting to get another person's perspective on this.

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AS9100 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

AS9100 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Mark Hammar Apr 06, 2020

AS9100 Rev D does require that you have a documented procedure for nonconforming product, and corrective action. However, I agree with your assessment that the requirement does not dictate that “counterfeit product” be included in the procedure (although it needs to be controlled with the process). Again, although human factors need to be considered while determining the cause of nonconformities, the standard does not specify that this be in the document, just a document that defines the process.

That being said, it is common practice to include these things in the procedures, such as stating that human factors are considered in the determination of cause, but I agree the standard does not explicitly state what needs to be in the documented procedure.

I have always found that it can be very helpful when receiving a non-conformance from the certification auditor to ask the question “Exactly what requirement is not being met?” Including insisting on the word-for-word from the standard. They should be presenting their non-conformances in a “should be” and “as found” format so that you can clearly see what is not done. If they can’t quote a “should be” then it is likely not a non-conformance.

For more on what the certification body is responsible to do, see the whitepaper: What to expect at the Iso certification audit, https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit

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