Nonconformance vs. Nonconformity - I cannot find major and minor, either!

My firm's QMS has, for those offices registered, not yet migrated to the 2K standard. I haven't yet purchased the new standard, so I'm working off of the DIS, and what I have read about the standard here and elsewhere.

I don't see the term nonconformance in the text of the standard. I find conformance, conformity, and nonconformity. I realize the terms are sometimes used interchangeably, but to my ear, nonconformance is more of a state, or collective term, nonconformity, more appropriate to describe an instance. Please excuse my prejudice that to discuss a subject clearly, the terms used require clear definitions.

Similarly, I cannot find major and minor nonconformance or nonconformity in the standard. I remember reading somewhere online that these categories were something KPMG more or less arbitrarily came up with.

A quick search of the archives here turned up the rule that 5 to 7 minors = a major in in old standard, which I guess at this point would be the old, old standard.

Can anyone help me connect the dots? My firm's corrective action system uses the major and minor nonconformance scheme, which does not seem to have any basis in the standard.

Rex

[Marc]

-> I don't see the term nonconformance in the text of the
-> standard. I find conformance, conformity, and
-> nonconformity.

It's semantics. And differences in American English vs Queens English a bit. In addition, there is a difference between a system nonconformance and a part nonconformance. And it can get worse if you think in terms of defects vs defectives. So - we have system nonconformities and part/product nonconformities.

A nonconformity is a nonconformance. The difference is that the word nonconformance is not even found in an english dictionary. But:

Nonconformity:
Pronunciation - nan kEn for mih ti
Definition 1. refusal or failure to conform, esp. to societal customs, values, or the like.
Definition 2. lack of compliance or adherence, as to a standard, specification, regulation, or the like.

This is why the standard uses the term nonconformity I think. This is not to say nonconformance is not a word, but I have yet to find it in a dictionary.

-> to my ear, nonconformance is more of a state, or
-> collective term, nonconformity, more appropriate to
-> describe an instance. Please excuse my prejudice that to
-> discuss a subject clearly, the terms used require clear
-> definitions

Life is full of little inconsistencies. This is just one.

See This Thread

KPMG did not start major and minor findings. It is from the original ISO. Not from the ISO 9001 document but it was part of the original registration scheme.

There are documents available to registrars that are not available to you or me. I forget the main document name or who authored it. The number 67 or 65 rings a bell. Anyway, the idea was and is to provide some classification of findings.

There is a third 'finding'. It was originally called an 'observation' which was typically the opinion of an auditor on how you could improve something. This is often called an 'opportunity for improvement' as well. But - it is nothing less than an opinion and as we all know, opinions are like a__holes - everyone has at least one.

-> A quick search of the archives here turned up the rule
-> that 5 to 7 minors = a major in in old standard, which I
-> guess at this point would be the old, old standard.

This was a very early 'rule of thumb - 5 to 7 minors in any one 'category' or element was a major. It did not really make sense as in companies of 5000+ employees one expects to find more minors than in a company of 100 employees. Registrars each seem to come up with their own thresholds these days.

Maybe someone working for a registrar can shed some light here.

Thanks, Marc.

If the major/minor scheme disappeared from the standard at least two revisions ago, why does it linger in many companies' corrective action and audit systems?

I don't see anything about majors and minors in the 1994 standard some of our offices are registered to, but the criteria that is advertised for passing a registration or surveilance audit is "no major nonconformances". This is with a registrar who's auditing to the standard, and the passing grade is based on an undefined (in the standard) category of an undefined (in the standard) deviation. I don't get it.

If I'm the customer for the registrar's service and my requirement is to be audited against the standard, and the registrar is using criteria that have no basis in the standard, how is that meeting my requirement?

Self declaration is looking better and better to me.

Always a pleasure visiting here,

Rex

[Marc]

Major and Minor were never in ISO 9001. That was and is part of the registrars' documentation. I don't know that you have to use it internally - there is no requirement for you to. But the convention is to use them to classify what is 'serious' and what is not. It's sorta like you don't do a corrective action every time there is the slightest nonconformance - you'd be doing corrective action reports all the time.

You 'don't get it' because it is not a stated requirement of ISO 9001. That does not mean it is not part of the REGISTRAR'S requirements.

Just out of curiosity, is there a specific reason you object to major and minor classifications? I have for a long time objected to 'observation' (aka opportunity for improvement) as some auditors use them as a hammer to some degree (and I'm not convinced auditors are always qualified to say what is 'an opportunity for improvement). But major and minor never bugged me.

I don't have a problem with registrars using the major and minor breakdown, and most have it pretty well defined. But to have a major/minor scheme for an internal CA system seems confusing. If I were to audit such a system, I'd look carefully at the definitions being used and how and who is judging severity. The next question that comes to mind is how do they differ in being taken care of within the system.

IMO, don't get wrapped up in majors and minors in internal systems. It either works or it doesn't; if it doesn't work, fix it.

Before I get lambasted for promoting CA's for every little thing, keep in mind that many fixes are quick and not worth writing up. Discretion is key. But if a CA is warrented for a problem, it's past the point of being minor.

[Marc]

I don't see it as a big deal internally whether you use the two or not. The important part is how you decide what, if any, corrective action has to be taken when a nonconformity is identified.

It just seems like excess baggage to me.

I'm working with a QMS developed at another office in my company, that features these, I guess through parroting what the registrar has to say when they come to town. I want to understand where it comes from and decide if I think it's a good idea, before mounting a challenge to an entrenched system.

My take on its use is that things rarely get labelled major, because that's equivalent to a confession that the certificate should be pulled. If not used, why have it, other than to give the registrar something else to ding you over?

Rex

I also do not care for the major minor thing, but in spite of not wanting the registrar to see "majors, someone who doesn't know where a procedure is-has an obsolete copy in their possession-displays ignorance to what's in a procedure in their domain, has to get a major. That's not even close to minor. We just have to follow up with a very strong CAR, including and up to disciplinary action. A registrar then knows you are serious about your certification.(registration)(accreditation)whatever!
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