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

Last month, we had our Internal Quality Audit and as an Audit Team Leader, the final decision whether a certain nonconformance will be raised as major or minor noncompliance is in my hand, I had a hard time classifying them. What I did is that I just follow the definition of Major and minor and that's it, i come up with my decision. Question: If a certain noncompliance has been repeated over and over again during the audit, can I raise it as major? If during the audit, the auditee will say that there procedure is on-process of revising, will its still be a noncompliance/
Can you help me with this, i jsut need some sample cases on when to give major or minor noncompliance...

Thank you for reading my mail, hope to receive a reply from you guys...

You bring up a situation that, in all probability, occurs far too often. I myself have experienced the "we are currently revising our procedure" syndrome in different organizations I have been affiliated with.

As far as deciding the weight assigned to a nonconformance, it is hard to go wrong by following the definition of Major vs. Minor like you did. One thing you might think about though, in order to gain higher echelon management attention to the problem, is to cite the repeated discrepancy in the form of a Major nonconformance against element 4.14 Corrective and Preventive Action. I know several Registered Lead Auditors from different Registrars that do this and was taught that very way myself while attending a Lead Auditor Course.

The frequency and situation surrounding the repeated noncompliance is only something you know about within your organization but, if there appears to really be a systemic problem there - you are within your rights to do what I just described. Good luck to you.

Are there any more thoughts out there on the subject?

Yes - multiple minors can (and should) add up to a major as that indicates the 'system is broken'. In the old ISO days 5 to 7 minors made a major.

Now days it's real flexible, however, and it is not a part of the written standard.

Also see http://Elsmar.com/level2/m-vs-m.html

[This message has been edited by Marc Smith (edited 24 July 2001).]

Hey...its Internal.....you make the rules. Define it and do it. Thats what makes Internal and 3rd party so different..is it serious for the company as you see it? Then Its a major. Does it need to carry weight to get attention....then its a major !!!!

What makes the difference?
A nonconformance is a nonconformance, is a nonconformance.
Even from a third party, if I get a major I have to evaluate and make corrections; If I get a minor I have to evaluate and make corrections ; If I receive an observation or an opportunity for improvement (new verbage) I still have to evaluate and make corrections (if not it will result in a major or minor the next time)

Point being, all nonconformances need to be fixed and processes need to be continuously improved. (Value Added)
Discussing what is or what isn't. (Non-value Added)

thank you guys for the advice, i do appreciate that

Difference between a Major & Minor finding

I have to relate to our Internal Auditors the difference between a major and minor finding in our internal audits. I suspect that all our findings are minor since our company has been registared for 4 years now. Is there somewhere that find an explanation?
mooser

I'm sure you'll get much better answers than this but we've always said that a Major is one of three things:

1. A non-existent or broken down system that's required by the standards.

2. A situation that might reasonably cause the customer to get bad product.

3. What should be a minor but has happened before and never seems to get fixed.

This is the way I learned it from a variety of consultants and ISO trainers. Hope it's helpful. I've never seen an 'official' definition and don't even know if Major and Minor distinctions are recognized by ISO.

Alf


[This message has been edited by Alf Gulford (edited 15 August 2001).]

Alf....thats a good explaination. A difficcult decision for internal auditors.

I have stopped calling them major/minor until the auditors are seasoned.....they are all "findings" the decision is made by the mgt Rep or audit coordinator to keep it consistent. the IA writes up a summary of findings as part of the report, it is presented at a 'psuedo closing meeting' the area owners take responsibility, and discuss root cause and CA right there.......Then the CAR is issued if needed. Minutes are kept, for the audit file and follow up may be assigned. This is a new approach, has some bugs, not all my clients will be able to make the change...but for those who have its been great. I have also added 'continuous improvement' opportunities here.

This is how we've defined/explained to our auditors:
9.1 Nonconformities
9.1.4 Nonconformities must be objective, traceable, and complete.
9.1.5 Identify nonconformity classification:
9.1.5.1 MAJOR – Quality system does not comply with ISO standard.
9.1.5.2 MINOR – Implementationis not consistent with quality documentation or implemented system is not effective.
9.1.5.3 OBSERVATION – In the opinion of the auditor, improvement would be beneficial to avoid future noncompliance (QA and/or Plant Manager to decide if preventive action should be initiated).

Our previous determination of 'observations' being derived from a management system type review rather than quality system of course needs to be revamped for the y2k rev.