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GM/VP softgrading internal audit finding - need feedback from an audit guru!

sandra2014

Starting to get Involved
#1
Hello,
I need a question answered by an auditing guru- we a a contract manufacturer, that performs our QMS internal audits under AS9100D, ISO 13485:2016, ISO 9001:2015 QMS guidelines. One of the auditors noted a nonconformance finding, but our GM/VP overruled this nonconformance finding and directed it to be changed to an opportunity for improvement. This was noted and signed on the final report by the GM/VP. I searched all the applicable AS9100D, ISO 13485:2016, ISO 9001:2015 stds, but the requirements do not specifically state that this is a violation. Please direct me to the specific clause that would deem this unacceptable? Any advice is greatly appreciated!
 

GStough

Staff member
Super Moderator
#2
Hi sandra2014,

I'm no "auditing guru" but I'm curious. Has the GM/VP attended any kind of auditor training? Was he one of the auditors who identified/observed the nonconformance and have first-hand knowledge of the scenario? Does the GM/VP have direct responsibility for the area where the NC was detected? Your answers to these questions would be helpful in directing you to the specific clause(s) to determine whether his actions are acceptable.

:)
 

sandra2014

Starting to get Involved
#3
Hello, The GM/VP technically has responsibility for all of the QMS, he is also our management rep. He also has a Quality Assurance background. Specifically the finding was related to a uncontrolled redline change on our traveler made by one of our account managers. our engineering dept was not notified of this redline, they are a required signatory for any changes to controlled documentation. Also, this was brought up by an external auditor their finding was: ISO 13485:2016 measurement analysis and improvement-internal audit clause 8.2.4 'internal auditor independence not maintained' findings may be overturned by management even if there is misalignment with the internal auditor. Please advise.
Thx,
 
Last edited:

Ninja

Looking for Reality
Trusted
#4
Hello,
I need a question answered by an auditing guru- we a a contract manufacturer, that performs our QMS internal audits under AS9100D, ISO 13485:2016, ISO 9001:2015 QMS guidelines. One of the auditors noted a nonconformance finding, but our GM/VP overruled this nonconformance finding and directed it to be changed to an opportunity for improvement. This was noted and signed on the final report by the GM/VP. I searched all the applicable AS9100D, ISO 13485:2016, ISO 9001:2015 stds, but the requirements do not specifically state that this is a violation. Please direct me to the specific clause that would deem this unacceptable? Any advice is greatly appreciated!
Also, some more specifics about the NC found might be a bit helpful...
 

sandra2014

Starting to get Involved
#5
Also, some more specifics about the NC found might be a bit helpful...
Hello, The GM/VP technically has responsibility for all of the QMS, he is also our management rep. He also has a Quality Assurance background. Specifically the finding was related to a uncontrolled redline change on our traveler made by one of our account managers. our engineering dept was not notified of this redline, they are a required signatory for any changes to controlled documentation. Also, this was brought up by an external auditor their finding was: ISO 13485:2016 measurement analysis and improvement-internal audit clause 8.2.4 'internal auditor independence not maintained' findings may be overturned by management even if there is misalignment with the internal auditor. Please advise.
Thx,
 

Ninja

Looking for Reality
Trusted
#6
Specifically the finding was related to a uncontrolled redline change on our traveler made by one of our account managers. our engineering dept was not notified of this redline, they are a required signatory for any changes to controlled documentation.
So you have a procedure to follow, and it was not followed, with no approval from the governing party...I don't see how this is an OFI any more than shipping the wrong product to a customer.

Also, this was brought up by an external auditor their finding was: ISO 13485:2016 measurement analysis and improvement-internal audit clause 8.2.4 'internal auditor independence not maintained' findings may be overturned by management even if there is misalignment with the internal auditor. Please advise.
Thx,
How in the world would this "overturning" ever make it in front of an external auditor? That's silly. Any "overturning" would be done on a draft of the audit report, prior to it being issued...since it was "overturned" by the person in charge of the QMS. If you got a third party finding on this, I would consider it a self-inflicted wound.

If the external auditor wrote it up because it was a NC that was softballed for image maintenance...there's the answer to your OP question right there...and I would agree with the finding.

I've been a VP...stuff like that does cross your mind at times...but it is still inappropriate given the information shared so far.
 

mikegospo

Starting to get Involved
#7
As an auditor, I would review the finding and make a determination as to whether it actually is a nonconformance or not. If it is and it was "overturned" it could then become a finding the audit performed by the registrar. Internal audits in many cases document findings which are not true nonconformances, typically this is just based on inexperience, misunderstanding the requirements or how the evidence was presented. Perhaps the auditee did not understand what the auditor was looking for. I would recommend that all audit reports for internal audits be reviewed for these issues. As long as the "overturning" is justified there would be no problem with this.
 

tony s

Information Seeker
Trusted
#8
If there's a clear evidence violating an established requirement which resulted to raising a nonconformity, this cannot be converted into an opportunity for improvement. NC is defined as a "non-fulfillment of a requirement" and cannot be "downgraded" into an OFI.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
Hello, The GM/VP technically has responsibility for all of the QMS, he is also our management rep. He also has a Quality Assurance background. Specifically the finding was related to a uncontrolled redline change on our traveler made by one of our account managers. our engineering dept was not notified of this redline, they are a required signatory for any changes to controlled documentation. Also, this was brought up by an external auditor their finding was: ISO 13485:2016 measurement analysis and improvement-internal audit clause 8.2.4 'internal auditor independence not maintained' findings may be overturned by management even if there is misalignment with the internal auditor. Please advise.
Thx,
I am a self declared audit guru :D The GM is soft grading the finding. For what reason, we could only speculate. But, whatever the reason, he is undermining the work of the internal auditors and allowing a nonconforming situation to exist. With the OFI classification, no formal corrective action would be required.
 
#10
I don't think we can say anything until we know what the "uncontrolled redline" was. If it was simply administrative, then no harm, no foul. If was a process alteration, I would be more concerned.
 
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