Major/Minor Nonconformity - Nonconformance from last audit found again

[mjflkitty]

Hi everyone!

Sorry I was not able to log in for so long. I was handling 2 audits at the same time.

Anyway, I realized that there was a confusion regarding declaring a nonconformity as Major and Minor. Because in our procedure we have identified what is major and minor.

But since the process we audited has again the same findings from the previous Internal Quality Audit. Meaning the minor NC they have before was again raised by auditors. Then we escalated it to be major emphasizing that the corrective action they did was not effective.

Am I right?

can anyone share thier thoughts on this?

I would also like to ask if we could eliminate major and minor nonconformity and just place nonconfomity, what is your opinion? what could be the benifits of removing the classification? one benefit i see is it eliminates confusion.


Thanks
kitty

 

[Claes Gefvenberg]

I would also like to ask if we could eliminate major and minor nonconformity and just place nonconfomity, what is your opinion? what could be the benifits of removing the classification? one benefit i see is it eliminates confusion

You certainly could, and I also happen to think that you should... See post #14 in the thread Major vs. Minor vs. Opportunity for Improvement - Product as well as Office Processes .You could also have a look at Internal Audit Findings - Major vs. Minor Finding - Defining the differences for further info.

/Claes

 

[Denis]

Hi
We only have non conformities and observations (for improvement of the QMS / best practice).

I find that trying to put non conformities into categories more difficult, and makes some ncr's more important to other area's of the business. Whilst making some ncr's more important it has the negative efeect of making the minor's less important.

I don't think there is an absolute method, each business culture will have a different take on classification.

 

[mjflkitty]

Minor into major NC

I would eliminate the classification of minor and major

But for the meantime,

Is it justifiable, since the auditors agreed to escalate the minor NC to major NC

first reason:
1. it was a minor findings before
2. since the root cause analysis was not evident
3. the corrective action was not effective to addressed the finding
4. reoccuance of the problem

what is your opinion?

 

[Denis]

This is what we do in our management of non conformity.

Whatever an auditor classes the non conformity as (major / minor etc) I more or less accept, if it is justifiable.

So, I don't really get to hung up on their classifications, as different people have different views on the importance of the same non conformity.

The important issue, is that it is a non conformity and therefore needs corrective action. The more important the ncr ( usually with regard to product quality) the timescale for effective corrective action becomes.


Therefore, the timescales for effective , verified action is the key for me.

Hope this helps.

 

[Randy]

The NC should be against your C/P Action process because it is obviously not working.

You should also do a for real root cause analysis of both the original fault and the C/P actions taken

 

[Caster]

.........since the process we audited has again the same findings from the previous Internal Quality Audit. Meaning the minor NC they have before was again raised by auditors. Then we escalated it to be major emphasizing that the corrective action they did was not effective.

Our registrar did this to us during a QS9000 assessment. He gave us a minor 6 months before, and found the exact same problem 6 months later. This time he made it a major and placed us on Probation.

Now that many months have passed and I have calmed down, I have to say he was correct. We did not do solid root cause anlaysis and did not put into place system wide and effective corrective action. Good on him!

It was "heck" to live through, but we are better for it.

 

[mjflkitty]

Major and Minor

Hi,

Thanks for the nice input. I already explained to the process owner that the corrective action they have was not sufficient. and the root cause analysis was not that through.

Example was: the document they issued was not updated. then the same findings was seen by the auditor. I explained to them that although updating the document was a minor NC before, now it is major because the corrective action of "updating the document" was not sufficient. they should have atleast consider why they were not able to update and review the document prior to issue.



I would like to ask for suggestions regarding if we eliminate the classification of minor and major NC. We prioritize NC as to major and minor, because we can't do everything at the same time. how can we demonstrate prioritization of NC as auditors besides labelling it as minor and major?

Thanks for everything

 

[celeo]

I would agree with virtually all the comment above. The purpose of grading is to distinguish between
a) A Non Conformance with a 2 month corrective action implementation deadline. These are generally matters that affect safety and efficacy of a device and/or regulatory compliance. (i.e. the law). Typically they also involve a systematic failure to follow procedure.
b) Minor non conformance (MNC) which must be addressed before the next audit is due (6 or 12 months). If there is a decision not to act on the MNC, then a written rationale must be given. If the MNC is not addressed in any way at all, then it will grow up to be a major non-conformance at the next audit.
c) Observations are opportunities for improvement which you may or may not do anything about. The choice is yours, but I would be inclined to think it wise to consider that the auditor, particularly external auditors, have seen many Q-systems and is offering good advice without being a consultant.

 

[RoxaneB]

I would eliminate the classification of minor and major

If this works for your organization (and others)...great! Just a note of caution on this, however...

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

In other words, if you sample 30 documents and only 1 is found to be lacking a proper Revision History, that is, to me, a Minor. I don't want to see root cause analysis on this. I just want the document fixed. These are, as I refer to them in meetings, quick WHAM!-BAM!-Let's-get-back-to-making-product kind of nonconformities.

But if, out of 30, 15 are incorrectly documented. Or, as is your situation mjflkitty, a recurrence of the situation (especially if this is with the same person/department/document), I would make it a Major. Why is the process not be followed? Training? Stubborn? Misunderstanding? Root cause analysis and a proper action plan (and verification) should prevent an additional recurrence of this situation.

If the issue is small and can be easily remedied, why not implement the easy solution? People will soon tire of the Management System (from my experience) if they are constantly using heavy, in-depth problem solving tools to resolve simple issues.

You mentioned in an earlier post that your documented process defined the difference between a Major and Minor. Would you care to share those definitions with us? If, perhaps, the definitions were more precise, your team would be more willing to accept the existence of Majors and Minors.

My organization, for example, as an NC Guidelines Matrix. We list every department, along with every known potential for an NC to occur. From that we show what situation would equal a Minor and quick problem resolution and which, if a Major, would entail root cause analysis.

For example, if <x tons of product had a stated discrepancy, we would do a Minor. If >x tons had the same discrepancy, we're doing root cause, etc.

As like Celeo, we also have Opportunities for Improvement.