Incomplete nonconformance records

#1
I am conducting an AS9100D audit at a partnering sign. There are dozens of Nonconformance Records going back as far as 2016 that are still in a NEW state, have little to no nonconformance description and have not been updated. I’m thinking this is a finding in the nonconformance or records control arena but I’m looking for the best clause reference as I bet I will get push back. Inputs are greatly appreciated.
 
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n25philly

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#2
I would say a good starting point is to ask how they handle 10.2.1 h, take specific actions when timely and effective corrective actions are not achieved
 

John Predmore

Trusted Information Resource
#3
8.7.1 is the section on Control of Nonconforming Outputs (NC), but that is for the purpose of “preventing their unintended use or delivery.” Yet, your question indicates the problem you see is no action on NC product, years after being identified as NC.

It is clear the production process has created NC product, as evidenced by NC records you mentioned. How can the organization be confident they captured and contained ALL of the NC product ever created, and no NC product was inadvertently used or escaped? At a minimum, a proper investigation would give assurance how effective their inspection methods are in detecting and containing such NC product. More directly, what has the organization done to investigate the cause of the NC product and reduce or prevent recurrence?

If this is also your concern, refer to section 10.2 to write an audit finding. AS9100 section 10.2.1 goes beyond ISO9001 and requires “documented information that defines the nonconformity and corrective action management processes”. If years have passed with no records answering these questions, they are lacking documented evidence their 10.2.1 records are adequate and their 10.2.2 actions are effective.
 

Jen Kirley

Quality and Auditing Expert
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#4
Maybe I have brain fog (can't rule anything out a week post-Covid) but I do not see any mention of whether these NCs were issued in response to Nonconforming output or nonconforming product.

In either case, the fact is the Nonconformance process appears to be dysfunctional. There could be a lot of reasons, but overall the Nonconformance process is extremely important and needs to be treated as such.

I would not stop with this symptom. I would peel back some layers to understand why all of these NCs have been aging.

1. Has the process owner left and not been replaced by someone with knowledge and resources to manage it?
2. How are NCs tracked?
3. Were these NCs reported to Management Review? There is a subclause requiring it.
4. How are NCs reported to Management Review? See #2. There is also a tendency to just say things like "3 NCs issued" but no better information for top management.
5. Were the NCs decided to be unimportant or invalid, and just never got closed out?
6. Were these NCs acted on and this is just a record keeping issue? Still, there is a requirement to ensure there are no recurrences and that is pretty hard to do if there is no record of what happened with the NC, and the response etc.
7. How engaged is management in these nonconformances?

I would be very concerned if I received pushback over something like this. It is about more than a clause in the standard. Even if the NCs were small, there's a good chance the same dysfunction would occur for a bigger issue and that cannot be tolerated.
 
Last edited:

Sidney Vianna

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#5
In vehement agreement with Jen. Finding a “home” to write up a nonconformity against is so superficial. As an auditor you have to ascertain the underlying reason behind these incomplete instances of nonconforming product records. Is it just a lack of paperwork work discipline or an indication of complete disregard for the identification, containment, evaluation and disposition of out of spec products.
 
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