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What should the QMS Auditor do if a Major Nonconformity is found during an Audit?

D

D.Salman

#1
Dear all,
What should the QMS auditor do If a major nonconformity is found during the audit?
Many thanks in advance.
 
#2
Re: Major nonconformity

Dear all,
What should the QMS auditor do If a major nonconformity is found during the audit?
Many thanks in advance.
Are you sure it's a major? Tell us what you found and why it's a major and we can better help to understand your course of action.
 

NikkiQSM

Quite Involved in Discussions
#4
Re: Major nonconformity

Dear all,
What should the QMS auditor do If a major nonconformity is found during the audit?
Many thanks in advance.
If it's an internal audit you are conducting for your own company, you should issue a corrective action. Investigate why there is a Major, why it was missed, and what needs to be done to correct it. Involve Management Council if need be. Conduct re-training once the issue has been corrected and validate that your CA was effective.

If you are conducting an audit on a supplier, issue your finding to the supplier and have them conduct what is listed above. Request "proof" that the CA has been conducted and that it is effective.
 

RoxaneB

Super Moderator
Super Moderator
#5
Re: Major nonconformity

Are you sure it's a major? Tell us what you found and why it's a major and we can better help to understand your course of action.
Maybe the OP is the recipient of the finding and not the issuer.

I have experienced one major nonconformance during an external audit (on the receiving end). First off, I never, EVER, want to experience that again! Secondly, they stopped the audit and contacted their home office for guidance. They were concerned if the audit could proceed beyond that point. Thankfully, we quickly assessed the situation and were able to fix it (correction) and start the process of corrective action during the audit. All of was "forgiven".

From an internal audit perspective, I have stopped a few audits based on major findings. In some cases, the audit resumed the following business day...with a lot of caution and eyes on everything. Either way, I immediately connected with senior leadership in the area, outlined the situation and explained why the audit was being stopped. The details of the stoppages were included in the report, even if it did resume the next day.
 
#6
Re: Major nonconformity

Dear all,
What should the QMS auditor do If a major nonconformity is found during the audit?
Many thanks in advance.
Write the ncn with the statement, the violeted clause of the standard, reporting the evidences to support it.:bigwave:
 

Randy

Super Moderator
#7
What should the auditor do? Simple, follow the procedures that guide their conduct when such a situation happens. This is a no brainer
 

Helmut Jilling

Auditor / Consultant
#8
Re: Major nonconformity

...I have experienced one major nonconformance during an external audit (on the receiving end). First off, I never, EVER, want to experience that again! Secondly, they stopped the audit and contacted their home office for guidance. They were concerned if the audit could proceed beyond that point. Thankfully, we quickly assessed the situation and were able to fix it (correction) and start the process of corrective action during the audit. All of was "forgiven".

...
There are a lot of things in this post that trouble me. Primarily:

* Stopping an external audit for 1 major? Kind of defeats the purpose.

* Fixing it and forgiving it? VERY wrong.

That CB was not following the rules at all...
 
#9
Re: Major nonconformity

Maybe the OP is the recipient of the finding and not the issuer.

I have experienced one major nonconformance during an external audit (on the receiving end). First off, I never, EVER, want to experience that again! Secondly, they stopped the audit and contacted their home office for guidance. They were concerned if the audit could proceed beyond that point. Thankfully, we quickly assessed the situation and were able to fix it (correction) and start the process of corrective action during the audit. All of was "forgiven".

From an internal audit perspective, I have stopped a few audits based on major findings. In some cases, the audit resumed the following business day...with a lot of caution and eyes on everything. Either way, I immediately connected with senior leadership in the area, outlined the situation and explained why the audit was being stopped. The details of the stoppages were included in the report, even if it did resume the next day.
I agree with Helmut! This is deeply disturbing that any CB would go through this - call the office? What? They didn't know what to do?

However, that aside, I was still questioning the "major" from any point of view. Shouldn't the thing be viewed the same. I mean, if there's objective evidence, Roxanne, both sides should see it the same way...
 

RoxaneB

Super Moderator
Super Moderator
#10
Re: Major nonconformity

There are a lot of things in this post that trouble me. Primarily:

* Stopping an external audit for 1 major? Kind of defeats the purpose.

* Fixing it and forgiving it? VERY wrong.

That CB was not following the rules at all...
In the external auditors' "defense" (please note the use of ""), this was an audit to the first version of ISO 9001 many years ago. Perhaps the experience of the external auditors was not much. I was responsible for ensuring manufacturing was up to par, but not the whole organization, so I don't know what went into the CB selection.

The Major was a missing traveller document. They were following the product line and unfortunately, the bus frame selected was missing all of its documentation for requirements we were to meet at our site as well as the requirements for our US facility to meet.

The "fix" was that we found the missing documentation and we started investigating immeidately why it went missing in the first place. Our travellers were placed in loose folders that rested on the frames and were subject to being misplaced, lost and/or destroyed along the production line.

This was a registration audit so it was to last several days, considering the size and scope of our organization. They continued with the audit while we started to address the issue regarding our documentation. Thankfully, the frame happened to travel to the US location at the same time as us, all documentation intact and with it.

Still, I swore I would never go through that experience again of having an audit stopped.

And, for what it is worth, I also swore I would never EVER deal with that Registrar again. ;)
 
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