Should a Registrar write a NC on something that was found during the Internal Audit

[Coury Ferguson]

Should the Certification Body (CB)/Registrar write a NC for something that was found during the Internal Audit Process?

For example: The Internal Audit process identified that Root Cause was not being addressed on the Internal Corrective Actions Requests. (There was another Corrective Action issued for this through the internal corrective action process.)

The Auditor, from the CB, while performing an Assessment, writes the exact finding up at a Minor NC. Now bear with me here...the time frame to answer the Corrective Action has not been exceeded

Should this be allowed?

I have added a Poll to see what everyone feels about this, and please provide your comments.

 

[Jen Kirley]

Re: Should the Registrar write a NC on something that was found during the Internal A

I used to tell people that an open action resulting from internal audit would make that problem off limits in a registration audit. However, when taking a Lead Auditor course for TS 16949, I was told that isn't supposed to be the case.

What it could (cautionary use of the word could here) do for you, however, is help defend you against an accusation of not having a process to notice the problem, or ignoring a process - as negligence is generally considered in a regulatory situation such as an OSHA investigation.

What it might also do is help ensure a nonconformance is classified as minor instead of major. The purpose of recording this kind of nonconformance in a registration audit is to make it something to follow up on in the next audit, to ensure the problem has been effectively addressed.

 

[John Nabors - 2009]

Re: Should the Registrar write a NC on something that was found during the Internal A

In my opinion, no. As long as you are still within deadline to address the internal corrective action, you are in conformance. Unfortunately, I'm not as smart as I think I am, so someone else here can probably provide a better answer.

Regards -John

 

[Coury Ferguson]

Re: Should the Registrar write a NC on something that was found during the Internal A

I used to tell people that an open action resulting from internal audit would make that problem off limits in a registration audit. However, when taking a Lead Auditor course for TS 16949, I was told that isn't supposed to be the case.

What it could (cautionary use of the word could here) do for you, however, is help defend you against an accusation of not having a process to notice the problem, or ignoring a process - as negligence is generally considered in a regulatory situation such as an OSHA investigation.

What it might also do is help ensure a nonconformance is classified as minor instead of major.

Well, in this situation, there is no Regulatory (FDA, FAA or such) Requirements.

Wouldn't this also show that the Internal Audit Process is effective in identifying the problem, and are taking the appropriate action to determine the Root Cause?

 

[GStough]

Re: Should the Registrar write a NC on something that was found during the Internal A

Coury,

I voted "no", although perhaps the auditor could have noted it as an opportunity for improvement (OFI) instead.

So, now you will have to open a CAR for something that already has a CAR open (from the internal audit)...

 

[Jen Kirley]

Re: Should the Registrar write a NC on something that was found during the Internal A

Well, in this situation, there is no Regulatory (FDA, FAA or such) Requirements.

Wouldn't this also show that the Internal Audit Process is effective in identifying the problem, and are taking the appropriate action to determine the Root Cause?

Yes, I would have made a positive comment about having found the problem internally. Nonetheless, as it was presented to me in the RABQSA course: if a nonconformance is noted in an audit and it has not yet been corrected, it should be recorded.

Based on that I would do the same in an internal audit, mainly to show the audit did notice the issue and it can be followed up on to assured it is resolved.

This is assuming there was a pattern of the nonconformance occurring. If it was a one-or-two time event, I might just make an observation on an internal audit, but the 3rd party audit (for TS) doesn't allow for observations. According to the training course I went to, if there's a noted nonconformance to requirements, the only choice is to write a major or minor.

 

[Coury Ferguson]

Re: Should the Registrar write a NC on something that was found during the Internal A

Coury,

I voted "no", although perhaps the auditor could have noted it as an opportunity for improvement (OFI) instead.

So, now you will have to open a CAR for something that already has a CAR open (from the internal audit)...

Good points Gidget.

Now it falls under the "Double Jeopardy" scenario in my opinion. Like getting two parking tickets while you are parked in the same spot that the original ticket was issued, minutes later.

Now there is two Corrective Action created for the same thing.

 

[John Nabors - 2009]

Re: Should the Registrar write a NC on something that was found during the Internal A

Yes, I would have made a positive comment about having found the problem internally. Nonetheless, as it was presented to me in the RABQSA course: if a nonconformance is noted in an audit and it has not yet been corrected, it should be recorded.

Based on that I would do the same in an internal audit, mainly to show the audit did notice the issue and it can be followed up on to assured it is resolved.

This is assuming there was a pattern of the nonconformance occurring. If it was a one-or-two time event, I might just make an observation on an internal audit, but the 3rd party audit (for TS) doesn't allow for observations. According to the training course I went to, if there's a noted nonconformance to requirements, the only choice is to write a major or minor.

I didn't see in Coury's OP that this was a TS 16949 audit. Did I miss something?

And if I did, this is just the kind of crap that makes me glad I'm out of automotive.

 

[Coury Ferguson]

Re: Should the Registrar write a NC on something that was found during the Internal A

Yes, I would have made a positive comment about having found the problem internally. Nonetheless, as it was presented to me in the RABQSA course: if a nonconformance is noted in an audit and it has not yet been corrected, it should be recorded.

This is assuming there was a pattern of the nonconformance occurring. If it was a one-or-two time event, I might just make an observation on an internal audit, but the 3rd party audit (for TS) doesn't allow for observations. According to the training course I went to, if there's a noted nonconformance to requirements, the only choice is to write a major or minor.

The TS16949 is not the standard, it is AS9100 (I should had said this in the original post.)

Let's take this one step further: How would you explain this to Management, when their thought pattern would be something like this..."Why do internal audits if the same thing will be identified during the assessment" which would cause some concern on why have the internal audit process, even though the standard requires it. It would undermine the purpose of the Internal Audit process, in my opinion.

 

[Phil Fields]

Re: Should the Registrar write a NC on something that was found during the Internal A

I voted yes.
The audit is a slice in time, what the auditor finds the auditor finds. The external audit needs to be look at as an improvement process, not how many Findings are written up.
Also the CAR being opened is an easy one to answer, since it is already being addressed. The response to the registrar should indicate that this is being addressed in CAR XXX from Internal Audit ABC.

Phil