This query is more related to decision on raising Non conformance. Though I am putting if for ISO14001, I believe this query might be applicable to other QMS too.

During ISO 14001 Audit, it is found that some practice is just being implemented, whereas it should have been done earlier since it was released.

E.g. Some SOP was released 3 months back, but people have started really using it as per the operating norms or procedures just recently, a few days before the audit.

Does this qualify for non-conformance?

This query is more related to decision on raising Non conformance. Though I am putting if for ISO14001, I believe this query might be applicable to other QMS too.

During ISO 14001 Audit, it is found that some practice is just being implemented, whereas it should have been done earlier since it was released.

E.g. Some SOP was released 3 months back, but people have started really using it as per the operating norms or procedures just recently, a few days before the audit.

Does this qualify for non-conformance?

One thing to consider is the risk of the delayed implementation to the organization and the stakeholders. I mean, if the procedure was on something simple like how to separate recycled material, I don't see much risk to the organization and probably wouldn't raise much concern over this matter.

If the procedure focuses on a more significant process like handling hazardous material, I'd raise a concern.

I would also raise a concern if this was not the first time there has been a delay.

Additionally, I would ask if the original nonconconformance was closed out stating that everything was implemented and now you've discovered that it wasn't. That would be cause for concern.

How you procedure really depends on the nature of the original nonconformance.

:yes: I agree with rcbeyette,
If the procedure you defined is not affecting any process seriously,the auditor may himselfe decide whether it is a minor NC or the major one.
In your comment you have mentioned that some procedures ,i would like to know how many procedures you have left out .
If you get more than 6 minor NC's of same type that itself becomes a major NC & it may affect
Preetham

:yes: I agree with rcbeyette,
If the procedure you defined is not affecting any process seriously,the auditor may himselfe decide whether it is a minor NC or the major one.
In your comment you have mentioned that some procedures ,i would like to know how many procedures you have left out .
If you get more than 6 minor NC's of same type that itself becomes a major NC & it may affect
Preetham

Okay...I have to ask. How did you come with the number 6 as the trigger of a minor becoming a major?

During our internal audit process my senior has mentioned this.is it ok:confused:

of minors make a major, especially not 6.............:mg:

In fact, in my experience/opinion, internal auditors should not 'grade' their findings in this way. It's an external audit practice which should not be copied by internal auditors. It gives management the wrong impression of the findings and can lead to all sorts of problems......:caution:

Andy

Had you came across such situations ,where during external audit the increased no's of minor NC's has made the auditor to put it as major NC.

Preetham, for external auditors to do just that. It is supposed to indicate that there are systemmic issues, rather than simply 'local' or 'isolated' issues.

Have you not had experience of external audits before?

Andy

I had one external audit experience thats all.but i am still not clarified with the no of minor NC issue:(

at which minor non-confomities become major. It is dependent on many factors (or combination of):
The size and complexity of the organization
The complexity of the documented management system
The significance of the 'content' of the 'minors'
The nature of the criteria being audited
The impact of the minors on the customer or regulatory compliance

and possibly more things I've not mentioned here.......

Anyone got others?

Andy

at which minor non-confomities become major. It is dependent on many factors (or combination of):
The size and complexity of the organization
The complexity of the documented management system
The significance of the 'content' of the 'minors'
The nature of the criteria being audited
The impact of the minors on the customer or regulatory compliance

and possibly more things I've not mentioned here.......

Anyone got others?

Andy

FWIW, although I haven't been directly involved in the registration game for a while, I recall when doing a QS9000 thing with a former employer, and Entela as the registrar, there was a policy of three minors in one element = major.

... I recall when doing a QS9000 thing with a former employer, and Entela as the registrar, there was a policy of three minors in one element = major.
I recall the same thing at a past job at a QS9000 registered company. PJR was the registrar.

I think we've gone a little off topic from the original post and if this is going to spark a good discussion, perhaps we should split it to create a new thread?

While I think the idea of using a number to help to determine if a minor should be escalated up to a major is a nice tool for people new to the world of auditing, it should be taught with one additional rule...auditing is not black and white all of the time.

Past history - in other words previous similiar nonconformances - could be grounds to automatically make one incident a major.

My recent round of auditing refresher training highlighted the following guidelines for a major and minor:

A minor is a failure to comply with the requirements but is not likely to result in the failure of the management system or impede the organization's ability to assure controlled processes. It could be:

a failure in some part of the organization's documented management system relative to the requirements
a single, observed lapse in one item of the organization's management system


A major is the absence or total breakdown of a system to meet a requirement. A number of minor nonconformities against one requirement can represent a total breakdown resulting in a major nonconformance being issues...but that number is a judgement call and should take several factors (previously mentioned in this thread) into consideration. A major could also be the discovery of the failure to put corrective/preventive action in place where a noncompliance is discovered (note...noncompliance is different than a nonconformance).

I think we've gone a little off topic from the original post and if this is going to spark a good discussion, perhaps we should split it to create a new thread?.Roxane, you are correct. Please remember, before splitting the thread, that this is issue has been discussed several times. A good thread on that discussion is http://elsmar.com/Forums/showthread.php?t=7330

This was more of general query as this has been my experience.
Auditee will understand the scope of audit after the audit plan is released and will try to do ‘patchwork’ just in time before the audit so that he can say “Yes it’s just been implemented or it is under progress!!”

But certainly as you have indicated the impact needs to be evaluated.

FWIW, although I haven't been directly involved in the registration game for a while, I recall when doing a QS9000 thing with a former employer, and Entela as the registrar, there was a policy of three minors in one element = major.
Excuse me while I throw my hands up in horror! I thought the old "x minors = 1 major" garbage had been well and truly landfilled by now. Any auditor who can put a figure against the number of minors should be taken out and given a good talking to.

The significance of the major is that the system is not effectively implemented or has broken down. If there are a number of minors against one area (geographical / clause of the standard / department / process) then the lead assessor's judgement has to take into account the seriousness of individual N / Cs and the proportion of compliant and non compliant activities before they can judge if the system is working or not.

Just as an example at my first lead audit (too many years ago) the team raised a total of around 90 n/cs including around 30 against document control. No majors raised - certification recommended as there was no pattern to the n/cs.

The assessment was over 15 days and the company employed around 3000 people.

Excuse me while I throw my hands up in horror! I thought the old "x minors = 1 major" garbage had been well and truly landfilled by now.
It is - Jim and I were both citing the old QS9000 standard - replaced by TS16949 which (I think?) does not state this.

It is - Jim and I were both citing the old QS9000 standard - replaced by TS16949 which (I think?) does not state this.

Thanks, Cari. You don't happen to have a reference to this. I was working with QS in the early days and don't remember it. I must confess to not being in with TS (another story aired elsewhere on the cove) but if it is gone then thank heavens for that - it was always bull***t and hopefully nobody uses this arbitrary judgement any more.

Thanks, Cari. You don't happen to have a reference to this. I was working with QS in the early days and don't remember it. I must confess to not being in with TS (another story aired elsewhere on the cove) but if it is gone then thank heavens for that - it was always bull***t and hopefully nobody uses this arbitrary judgement any more.

I don't think it was actually a part of QS9000, per se. I think it was a CB thing. As I said, I know that Entela used it as a criterion, which was not to suggest that it might be a current requirement. I think it was a lame attempt at providing an "objective" breakpoint.

I don't think it was actually a part of QS9000, per se. I think it was a CB thing. As I said, I know that Entela used it as a criterion, which was not to suggest that it might be a current requirement. I think it was a lame attempt at providing an "objective" breakpoint.You are correct. And it did not apply only to QS-9000, but all Quality Standards. If I am not mistaken, this all started when the RAB (at that time) started questioning registrars recommending organizations for certification, while the audit report showed a "high number" of minor NCs found during the certification audit. In the case of the registrar I work for the policy was if you have more than X number of "minor" findings against the same clause of the Standard, and the lead auditor does not believe it constitutes a system break down (major), s/he would have to document in the audit report, the rationale/reasoning behind the decision NOT to elevate the collective minors into a major.

http://elsmar.com/Forums/showthread.php?p=63781&highlight=complexity#post63781

You are correct. And it did not apply only to QS-9000, but all Quality Standards. If I am not mistaken, this all started when the RAB (at that time) started questioning registrars recommending organizations for certification, while the audit report showed a "high number" of minor NCs found during the certification audit. In the case of the registrar I work for the policy was if you have more than X number of "minor" findings against the same clause of the Standard, and the lead auditor does not believe it constitutes a system break down (major), s/he would have to document in the audit report, the rationale/reasoning behind the decision NOT to elevate the collective minors into a major.
Seems a reasonable requirement. We have a review process for all initial and reassessments. Any query about the quantity and / or nature of non compliances is taken up with the lead auditor following review. If the auditor adds any notes to justify their decision that would be included in the review - same idea, different application.