Definition Major vs. Minor Nonconformance (Finding) - Internal Audit - Definition & Differences

E Wall

Just Me!
Trusted Information Resource
Yes. To us that goes to the Major definition - system does not comply to the standard.

However, I would caution that this may depend on how you have your audits set up. Are you auditing by department or by element/clause? If the minor findings are unrelated to an standard element/clause, then I would say no they are still minors.

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Eileen V. Wall
ISO Coordinator

EDIT ADDITION: Our registrar has also moved from the Major/Minor classification to 'Nonconformity', then description detail is included.

[This message has been edited by E Wall (edited 16 August 2001).]
 
E

energy

The new standard, 9001:2000 definitions only refer to audit findings. "Results of the evaluation of the collected evidence against audit criteria. Note Audit findings can indicate either conformity or nonconformity with audit criteria, or opportunities for improvement."
Like Barb, we report all "findings" to the Steering Committee(we are still in the startup mode). At that point, we decide to issue Corrective Action based upon the serious of it, as determined by the Committee. Major, minor, concerns are only heard of when you have auditor training. Like the origin of level 1 or Tier 1 document levels, not mentioned in the standard, the origin of major/minor may be buried somewhere in the older versions, or just used so much by everyone, it became "the way" you measure the seriousness of the finding. Of course, we have yet to select a Registrar, so we haven't heard their take on it. I will be querying them very hard on that topic because the seriousness of their findings may determine if we have to have them come back at extra cost due to so called "Major" findings. We have to know how it is measured, before we become a client. Not just, "it's a major" with no criteria. The rule of thumb is that if the finding can cause a breakdown in the Quality Mgt System, it was considered a "Major", for lack of a better word. Minors are just that, minor corrections or strong recommendations for improvement.
JMHO

energy

[This message has been edited by energy (edited 16 August 2001).]
 
A

Alf Gulford

I'll agree with Eileen that 3 or more could indicate a Major, with the caution that in a large company or very large department, three minor issues (e.g.; document control) out of thousands of possibilities may not warrent a Major. Lots of judgement and reasonableness, if that's a real word, involved.

By the way, Eileen, congratulations on being quoted in the new Quality Digest. Your knowledge and experience have been evident in this forum, it's nice to see you recognized in other publications too; and it's also just nice to see a name I actually recognize quoted once in awhile.

Alf
 

E Wall

Just Me!
Trusted Information Resource
Thank you Alf! Gotta watch my head don't swell :naughty: hehehehhehe

Having others appreciate my point of view seems pretty foreign after the battles I have been through at work the last few years (looooooooong story - I'm sure most have lived through or heard of similar so I won't bore you with the details).

I've only been involved with forums for the last few months and it has been such a benefit for me on so many levels. Also, it is also a great kick :D to be 'published' here and in QD.

To most I'm a babe in the woods (*grin* don't form any pictures now). I've really relied on a lot of the Cove 'regular's' posts to check myself against. The knowledge and talent in this place is astounding! I appreciate being among you all.

Eileen
 
D

David Mullins

Don't make the internal auditors job harder than it is already. Cripes, they're still trying to get comfortable with auditing, starting to think they shouldn't have taken it on, don't have time for it, etc, and you want them to delineate between major and minor NC's?
NO!
123
SAT/UNSAT/OBS
If it doesn't comply with documented or intended arrangments, it's a NONCOMPLIANCE. If the auditor is unable to substantiate the NONCONFORMANCE then it is an OBSERVATION.

If your internal auditors are seeing genuine MAJOR NONCONFORMITIES you're either just starting down the QMS path, or your system is shot - and you should have known this already!

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M

mooser

Your replies have been a graet help. I also read that the lead auditor would determine that 3 or more minor findings in one area to be a major finding. Is this also a standard practice?
 
M

mooser

Dave, you as well as the rest contributors, have helped me make the decision to determine myself, as lead auditor, the severity of the findings. I will have to change the present procedure that requires placing a major/minor to the findings by the auditor. The lead auditor ultimately has the final say anyway.
I am surprised that the Q10011 standard never talks about major/ minor findings only nonconformances. Is the Major/ Minor findings the development of Registars or one the National Accreditation Programs?
 
J

Jim Biz

Don't know how/when the Major/Minor thing got started (it's before my time - a rare commodity) :)

Anyway - I know how it continues to be used by our registrar.

Major - an observed minor that action has not been effectivley implemented for within 6 months - significant enough to have an effect on the operation of the management system

Minor - the "Opinion items" written because the auditor can not / will not buy off on an internal explaination of our system
(IE the procedure should say and/or - not and therefore it is unclear and can be easily addressed - or a finding that something was not "effectivley addressed" during internal audits etc).

The major difference between a Major and a minor finding is that MAJORS cost money..

We had one major finding a couple of years ago - our training program was not in the auditors opinion sufficient(sp?) for our needs - he wanted to see more detailed records and increased action taken.

Time passes - we replace the HR manager - next audit - the new Hr manager has not set up the records system to the point that it satisfies the auditor. MAJOR finding issued.

To clear the Major - nothing was done differently than any other minor with the exception that More evidence could be shown that the records system was now current and operational.

Everyones happy - 6 weeks later we get a bill - from the registrar claiming time spent to clear up the whole thing.

Our internal problem with Major/Minor is makjng decisions on what the difference should be in timely actions? Should a major be required to be cleaned up in a week - and a minor in 3-4 weeks?

Not sure any of this helps but that's our take on it anyway.

Regards
Jim
 
E

energy

David,

It's hard to get people away from the major/minor method, even though there is no method specified in the new standard (just company specific practices and opinions), because the Registrars continue to use these terms. It's a Machiavellian thing for lack of a better way. We will let our Auditors report all findings and Mgt will determine the CA. The registrar we select will have to justify his rating of nonconformances in a more specific way, other than their subjective terms. If it becomes obvious that all Registrars use this method, then "When in Rome do ..........."

energy

[This message has been edited by energy (edited 17 August 2001).]
 
A

Al Dyer

We effectively, use and have used in previous lives a simple pass/fail option for internal audits. Keeps it simple for the internal auditors and takes away the gray areas of decision making.

MHO

ASD...
 
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