Where are the rules for when a repeat minor nonconformance becomes a major?

[AndyN]

Which brings to the front: The definition of "similar".

Exactly!

 

[Marc]

Something I wrote in 1995 as I was "drafting" this website just before I paid for a domain name and went "live" on the internet about 6 January 1996 (from ISO 9000 / IATF 16949 - Who-What is Cayman Business Systems? - See: What Part do I Play?)

As an auditor once said to me:

"I am simply a Judge - interpreting and applying the ISO - QS Laws at the company interface level.

As the facilitator directing development, integration and implementation it is your responsibility to be a Teacher, Student, Guide, Navigator, Director and Choreographer, and to serve as a Lawyer - representing your client company. It is specifically your responsibility to challenge disputed 'gray' area interpretations, to argue and justify your client company's interpretation(s) of, and compliance with, (how they meet the intent of) the Law (ISO 9001 and/or QS 9000).

It is the responsibility of your client company management to ensure understanding of, and compliance with, internal systems and documentation - from ISO 9001 (or QS 9000) and the company Quality Systems manual to individual work instructions. It is a specific, necessary responsibility of your client company management to provide leadership and to be involved in the continuing process.

You can appeal my findings and decisions if you wish. There IS an appeals process (system).

And use lots of flow & organizational charts, and don't forget lots of tables of contents, matrices and various supporting databases... And there will be a quiz.... A big, long, expensive quiz.... And smaller quizzes about every 6 months..."

Well, that's not exactly what the guy said, but it better describes the reality.

Auditor opinions/interpretations have long been problematic at times, but they have to exist because, as I said in an earlier post in this thread, each scenario is typically unique. So, it becomes much like pornography: "I know it when I see it."

Similar? "I know it when I see it."

 

[qualprod]

Andy, if you look at Page 56, in the definition of a Major Nonconformity, it states that "A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity." A repeat, such as in your example, could be viewed as 2 nonconformities. But I might be "stretching" it.

What do others think?

But also it depends what kind of minor, it could be several minor in some processes , but would require more quantify in one type than in other to escalate it to major.

E.g. several non conformities to fill out some forms, or...several for not complying the actions to implement corrective actions, which , this last one, maybe is of more negative impact.

 

[Marc]

Good point @qualprod

 

[AndyN]

If we take the definition of a "major" from the rules, so far what I've seen raised to a major (by a couple of CB auditors) is laughable! A tiny sample (1 or 2 instances) when the total population was hundreds and, to rub salt into the wound, there was ZERO impact on product quality, deliverables to customers etc.

In my mind, at least, the wheels have come off this particular rule for some clients... How do you address a systematic failure which actually isn't?

 

[Marc]

I recall, back in the days of QS9000, a particular CB (Intertek or similar) had a contractual rules that 4 or more minors in one element of the standard made a major - but that was during the visit. It wasn't a "compounding" rule, as 5.11.5 of the rules implies.

True. That was a registrar specific "rule" way back when, even though there were some like that which a number of registrars shared to some degree.

How do you address a systemmatic failure

Systemic, I think - And precisely - How is a systemic failure defined...

 

[Marc]

<snip> A tiny sample (1 or 2 instances) when the total population was hundreds and, to rub salt into the wound, there was ZERO impact on product quality, deliverables to customers etc. <snip>

Sigh... Or the total population was thousands, or tens of thousands... At times like that I can just see, in my mind, @Statistical Steven and @Bev D cringe.

 

[Statistical Steven]

Sigh... Or the total population was thousands, or tens of thousands... At times like that I can just see, in my mind, @Statistical Steven and @Bev D cringe.

I cringe the most when the sample is selected from one part of the population. For example, we sample on day 1 of a 3 day process and expect no changes to the output over time

 

[Rameshwar25]

Some fifteen days back, when I was discussing this issue with one of IATF 16949 auditor (with veto power), he told me in such situations, minor nonconformity is converted into major, as Mr Ruiz told, as per 5.11.5 of rule book. This is also part of 5.11.5 that , a major non-conformity is raised against procedure on problem solving (corrective action procedure). Why that procedure could not effectively resolve minor nonconformity? Thus, now, there will be two major NCs.

 

[Marc]

In such situations, minor nonconformity is converted into major, as Mr Ruiz told, as per 5.11.5 of rule book

This is another time where I don't have the text so it would be good to know what "rule book" is being referred to, what 5.11.5 in it says, and to have example(s) of what the minor nonconformances are.