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  Major Nonconformity definition

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Author Topic:   Major Nonconformity definition
Kevin Tan
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Registered: Aug 1999

posted 08 August 1999 04:16 AM     Click Here to See the Profile for Kevin Tan     Edit/Delete Message   Reply w/Quote
Hello, this is my first posting to this forum.

I would like to ask for some help in interpreting the definition of a "major" non-conformity in QS9000 audit. There are 3 definitions given, i.e.

a) the absence or total breakdown of a system to meet a QS 9000 requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major.

b) Any noncompliance that would result in a probable shipment of a nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.

c) A noncompliance that judgement and experience indicate is likely to either result in the failure of the quality system or materially reduce its ability to assure controlled processes and products.

I have problem in interpreting the 2nd and 3rd definition. In particular, the term 'probable', 'may', 'judgement and experience' (whose?) can be quite subjective. It appears to have given the auditors a lot of freedom and discretion in raising a major.

Can anyone offer an insight into this?
Thanks.

Kevin

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Lassitude
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posted 09 August 1999 08:41 AM     Click Here to See the Profile for Lassitude   Click Here to Email Lassitude     Edit/Delete Message   Reply w/Quote
Take a read of Elsmar.com/mvsm.html and then come back and ask more questions.

Yes - it is somewhat subjective. And there is also the issue of a number of minors (it used to be 5 - now there is no 'standard' threshold that I'm aware of) minors makes a major.

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Debra Woodford
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Posts: 11
From:Muskegon Mi.
Registered: Jul 1999

posted 10 August 1999 09:49 AM     Click Here to See the Profile for Debra Woodford   Click Here to Email Debra Woodford     Edit/Delete Message   Reply w/Quote
I am of the understanding that a Major NC is just what you described in 1. A major breakdown or nonexsistance of a QS9000 requierment, and yes minors can add to a major that is where the "Opinion" if you will of the Registra. My experience is the overall impression your auditor gets of your system in general will determine major or minor, however, a NC is a NC, and even an observation in my opinion should be addressed with corrective action.

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Kevin Mader
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From:Seymour, CT USA
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posted 10 August 1999 11:25 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Major or minor? Which shall it be? Hmmmm...

Severity of the issue (what is the risk involved and what could reasonably occur if unaddressed) or frequency of the issue (mountains out of mole hills). I believe the Customer expectations need (standards, requirments, guidelines) to drive your actions here. What do they expect? Some are outlined in the QS requirements. Others may be contractually driven.

At any rate, the key word is "reasonable". Is it reasonable to assume that your systems will never produce rejects? Probably not. What levels are acceptable (again, what does the customer expect)? What is the process capability?

As far as issuing a CA request for minors, probably not a bad idea provided caution is exercised. You wouldn't want to create mountains out of mole-hills (some level of nonconformance is expected).

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barb butrym
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posted 11 August 1999 03:56 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
Since there is no way to address every possibility, some grey areas MUST exist...the auditor has the experience to make the call...IF you have chosen your registrar wisely, you will have that confidence in the auditor as well....You also have the right to rebutt and argue your point. If you can provide evidence to the contrary, you are encouraged and welcome to do so...If you do not feel comfortable doing that then perhaps you have chosen the wrong registrar. The registrars I work with are open to such discussions, and will explian the reasoning behind any upgrades to a Major NC......

You are correct in that there is no majic number of minors to add up to a Major...If anyone tells you there is its rubbish...or registrar dependant...It is an auditor comfort level. And the new rules say that any nonconformance must be closed (hard evidence reviewed) before recommending registration...not simply the Majors

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Kevin Tan
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Registered: Aug 1999

posted 13 August 1999 04:36 AM     Click Here to See the Profile for Kevin Tan     Edit/Delete Message   Reply w/Quote
Hi,
I would just like to thank each of you contributors who responded to my enquiry. Although, it still gives me an uneasy feeling that there is too much discretion placed on the registrar's auditors to be `reasonable'.
Regards,
Kevin

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Marc Smith
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From:West Chester, OH, USA
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posted 14 August 1999 12:54 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I just did an internal audit for a client which I have had an association with since February this year. When I first went there, I laughed. It was registered by UL and I thought "UL was paid off." I can better understand the auditor's point in some sense when they 'let slide' certain things.

Key Word = Risk Factor

They are improving. Significantly improving. I found myself asking myself whether I wanted to go beyond offering an observation rather than a 'finding' or 'observation'. In speaking with the quality manager I know there was full understanding of the system deficiencies. I had to come down to risk. Most I noted as observations because I believe the risk factor was low.

Comments?

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barb butrym
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posted 14 August 1999 07:53 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
you are right Marc.....risk is a key factor. As a consultant I too have seen the "my, God, they bought the cert" places too, but since I have been doing more registration audits lately, I have to ask, does it work for them? So often we have preconcieved notions of what needs to be, and have gained more respect for the auditors...or perhaps I see more competent auditors? there are still some nasty things going on....for sure....but a client needs to have a good relationship with the registrar so that decisions can benefit the company. When registration hangs in the balance, the auditor needs to be objective...I can tell you those minor/major/observation decisions do not come lightly to any auditor worth his salt.

As I train more and more lead auditors, I see the toughest part of the course is the case studies where the delegate must make the decisions and write up a N/C. They argue their point as if thier life depends on it. The class always splits...and in the end it has to boil down to evidence, and if it meets the intent of the standard. from there I can see if a delegate will make a good auditor or not....typically the class gives off a few that rise above the rest, but most struggle until they gain more experience.

[This message has been edited by barb butrym (edited 14 August 1999).]

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Marc Smith
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posted 14 August 1999 05:39 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Decisions in the ISO arena are a lot easier to make than those in the QS arena.

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Kevin Mader
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From:Seymour, CT USA
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posted 16 August 1999 10:40 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Marc,

I have to agree. Lately I have found myself talking about 'risk' more than ever. I attribute this to training other folks in my organization how to objectively assess risk. To often a lack of knowledge on the risk involved usually results in wasted effort or bad decisions.

Regards,

Kevin

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