Observation - Potential Nonconformity - How to address this Audit Finding?

K

Ka Pilo

#1
Quality manual should be reviewed and modified on the aspect of cross referencing table between quality manual and ISO 9001 requirements
Is this a valid audit finding? (The category of finding: Obesrvation - Potential Nonconformity)

Any tips on how to address this?

Many thanks in advance!
 
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Wes Bucey

Quite Involved in Discussions
#2
Re: Seeking tips on how to address this audit finding?

Is this a valid audit finding? (The category of finding: Obesrvation - Potential Nonconformity)

Any tips on how to address this?

Many thanks in advance!
I'm not happy with the terminology of "should," but this is essentially an "opportunity for improvement," not a "finding." The auditor will be unable to show a "shall" in any Standard to support this comment as a finding in need of corrective action.

When in doubt on ANY comment by an auditor, one of the surest methods of shaking out "mission creep" is to merely say,
"SHOW ME THE SHALL!"
 

somashekar

Staff member
Super Moderator
#3
Is this a valid audit finding? (The category of finding: Obesrvation - Potential Nonconformity)

Any tips on how to address this?

Many thanks in advance!
Is this an internal audit finding or a CB audit finding ... ?
I feel with a valid example of a wrong or missing detail in the cross referencing table in your quality manual, this is a simple and a valid finding. However even if this is an observation, still a valid wrong or missing reference must have been found.
With no feelers nothing or everything can be looked as a potential NC
 

qusys

Trusted Information Resource
#4
Is this a valid audit finding? (The category of finding: Obesrvation - Potential Nonconformity)

Any tips on how to address this?

Many thanks in advance!
Agree with the other exper covers,no finding.
if it is a registrar observation, it remembers to me something like request in ISO TS readiness review where you shall demonstrate that you have addressed all ISO TS clauses in your QSM.
The easiest way to do is to provide a table in quality manual where there are the clauses of the standard for each your QMS identified processes, a sort of cross reference.
Hope this helps:bigwave:
 

Big Jim

Super Moderator
#5
Is this a valid audit finding? (The category of finding: Obesrvation - Potential Nonconformity)

Any tips on how to address this?

Many thanks in advance!
This is not a legitimate finding. There is no such requirement in ISO 9001:2008. You don't need to do anything about it. If you wish, you can reply for your own records that you can find no requirement to do so.

That said, you might find it useful to cross reference your quality manual in such a manner. It may make it easier to look things up in the standard when you choose to modify the quality manual. In that spirit, it could be a legitimate observation, but certainly not a potential nonconformity.

I wonder if the auditor got carried away with his characterization of an observation and labeled it in a manner that some observations may have fit out of habit.
 

Big Jim

Super Moderator
#7
I think there is. Either the below is a requirement or I misinterpret it.
That's not what he wrote it up for.

". . . cross referencing table between quality manual and ISO 9001 requirements."

What he wrote it up for is a requirement of AS9100B that was not carried over to AS9100C. It is not part of ISO 9001:2008.
 

Wes Bucey

Quite Involved in Discussions
#9
"
Is this a valid audit finding? (The category of finding: Obesrvation - Potential Nonconformity)
Quality manual should be reviewed and modified on the aspect of cross referencing table between quality manual and ISO 9001 requirements
Any tips on how to address this?

Many thanks in advance!
Is this an internal audit finding or a CB audit finding ... ?
I feel with a valid example of a wrong or missing detail in the cross referencing table in your quality manual, this is a simple and a valid finding. However even if this is an observation, still a valid wrong or missing reference must have been found.
With no feelers nothing or everything can be looked as a potential NC
Where is the SHALL for a cross-referencing table? Cross-referencing tables are primarily for the convenience of lazy auditors. Many organizations have become enablers of lazy auditors for one primary reason - appease the auditor so he will get out early with no "findings" (because the organization wants to save money in not having to lose employee time explaining things to a lazy auditor who seems incapable of being anything other than being a Kwality Kop. The shame is there are so many good and great auditors out there that the few lazy auditors have given organizations a monetary incentive to bloat the quality manual adding extraneous and superfluous "comparison grids" or to slavishly include stuff they copy from quality manuals of corporations a thousand times larger than theirs, needlessly mandating "management review meetings" even though the Standard only calls for "management review" - which can usually be done with a "desk review" by a responsible manager, especially in small shops where the owner, manager, and janitor are all the same person. "Mission creep" is the greatest time and money waster, NOT the Standard or strict compliance to the Standard. Employees have no requirement to know or reference the Standard. The job of the employee is to follow the organization's quality manual to serve the interest of the organization in serving the interests of its customers. This pandering to the occasional lazy 3rd party auditor is one of the reasons so many organizations feel compelled to reproduce the entire Standard in their quality manuals, restructuring their preferred business operation plan to EXACTLY mirror the Standard, not for the ease of operation, but to simply make life easier for an auditor.


This is not a legitimate finding. There is no such requirement in ISO 9001:2008. You don't need to do anything about it. If you wish, you can reply for your own records that you can find no requirement to do so.

That said, you might find it useful to cross reference your quality manual in such a manner. It may make it easier to look things up in the standard when you choose to modify the quality manual. In that spirit, it could be a legitimate observation, but certainly not a potential nonconformity.

I wonder if the auditor got carried away with his characterization of an observation and labeled it in a manner that some observations may have fit out of habit.
This whole thread would probably NOT have arisen if the auditor had used "could" instead of "should," but then MY question in the closing meeting would have been,"How would that change benefit my organization?"

I think there is. Either the below is a requirement or I misinterpret it.
If you had interpreted it that way in the first place, then the observation wouldn't have been written, because you would have implemented it. What's happened is that this auditor has made you second-guess yourself and in so doing, you adopted HIS misinterpretation.

That is something a consultant would suggest but not from a good 3rd-party auditor IMHO.
Ah, there you have it - this would not have arisen with a GOOD 3rd party auditor!

I'm not so sure a good consultant would have suggested it except as the "safe prophylactic" against this sort of misinformed auditor on a BIG mission creep. I'm ashamed to admit I made my documentation overly "idiot proof" during my aerospace sojourn in 2000/2002 to :ca: against FAA inspectors who sometimes (not often) would quibble over whether a punctuation should be a semicolon (;) or a comma (,) and question why we had not included a zip code with a supplier's address. The sad part is that I was in awe of these FAA guys who all seemed to hold multi-engine aircraft pilot's certifications and absolutely knew their beans when it came to interpreting complex engineering drawings. These weren't stupid men, but they were absolute slaves of bureaucracy.
 
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