Minor Nonconformance turning into a Major - Systemic failure throught an organization

[Randy]

OK guys here's the deal.....I'm currently conducting a Lead Auditor course and a question has come up that hasn't before.

We all know that minor n/c's can become a major if we find systemic failure throught an organizations system, for example lot's of obsolete documents being used or uncontrolled red line changes to procedures or lack of awareness of specific matters.

The question I have been asked is this....Suppose that an organization has had a number of N/C's identified in a variety of clauses/subclauses in the same element...like in an EMS N/C's are identified in 3 or 4 or more out of the 7 clauses in 4.4 Implementation and operation or numerous N/C's are identified in multiple clauses of Element 7 Product realization. Would or could situations like these be elevated to a Major against the entire Element Like 4.4 or 7?

I can't recall this ever being brought up before but it does make sense.

I'd like some quick feedback that I can sahre with my folks

Thanks

 

[Craig H.]

Randy:

There are those here with lots more experience, but I would like to take a shot.

The decision to make many minors a major would hinge on if the number of N/Cs is the result of a major systemic breakdown. If all of the N/Cs are related to just one part of a clause and limited to one area, but the other areas conform, then a major is not warranted (unless it is the second time the same multiple N/Cs have been found - then it is a C/A issue, too). If the N/Cs are many of the same type and spread throughout the system, then it may just be time to start thinking major.

JMHO, of course. I'm interested to see other's take on this. Good question.

Craig

 

[M Greenaway]

I would say that you must reach a point where so many minors must warrant an overall major, even if unrelated.

 

[D.Scott]

QSA defines a Major nonconformity as - "The absence or total breakdown of a system to meet a QS-9000 requirement. A number of minor nonconformities against one requirement which when combined can represent a total breakdown of the system and thus be considered a major nonconformity."
This is one of 3 definitions but is the only one relevent to the question. I think the key is that the minors would have to represent a TOTAL breakdown of the system. Let's say in document control an auditor found 5 procedures that one way or another were determined to be minor nonconformities. Although there were a large number, in a system with hundreds of procedures this may not signal that the system was in TOTAL breakdown. The "total" statement makes the decision to issue a major very subjective. It almost allows for the arguement that if one procedure was handled correctly, the breakdown can't be "total". I have heard auditors state that they could elevate it to a major but I have never seen it done. IMHO it would be very hard to defend a judgement of "TOTAL" breakdown.

Dave

 

[Randy]

I'm really looking for minors related or within a major element like 4.4 of EMS or 7 of QMS being elevated to a Major against the whole element for not meeting the requirements it.

 

[Sidney Vianna]

Randy,

From my perspective, the Lead Auditor has to consider not only the number of the NC's, but also the size and complexity of the organization being audited.

My assessment, as a lead auditor, at the end of an audit resulting in 17 minor non-conformities scattered through different sub-clauses of ISO 9001:2000 Section 7, for an organization with 4,500+ associates in 3 separate sites, dealing with complex aerospace products would be VERY different if I had the same number of 17 minor NC's after spending a couple of days in a small machine shop with 15 employees.

The second scenario would make me question how effectively implemented the system really was . . . .

In other words, the number of opportunities for discrepancies vs. the actual number of discrepancies is part of the big picture, in my evaluation.

Hope this helps.

 

[Sam]

OK guys here's the deal.....I'm currently conducting a Lead Auditor course and a question has come up that hasn't before..... Etc.

I would say yes based on the following,

From the TS2 Certification scheme:
A major nonconformity is one or more of:

- the absence of or a total breakdown of a system to meet an ISO/TS 16949-2002 requirement.
A number of minor nonconformaties against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.

- any noncompliance that would result in the probable shipment of nonconforming product. A condition that result in the failure or materially reduce
the usability of the products or processe for their intended purpose.

- a noncompliance that judgement and experience indicate is likely either to result in the failure of the quality management system or to reduce its ability to assure controlled processes and products.

 

[Randy]

Thanks for the input guys, but maybe I haven't been real clear.

What I was asked is this (I'll just use 14001 stuff but the same thought can apply to 9001 as well)...

It is understood and is not being disputed that numerous N/C's found across an organization/system in the same clause can be a Major but let's think on this information and big "what if" below....

During an audit if we identify where N/C's are apparent in a variety of elements such as:

*Unauthorized changes to documents being made (4.4.5)

*Emergency drills not performed as planned (especially when there have not been any actual incidents) (4.4.7)

*Personnel not aware of their individual responsibilities (4.4.1 and/or 4.4.2)

*No record on the decision to communicate significant aspects externally (4.4.3), so on and so forth.......

(You know a bunch of minor N/C's that can commonly be found that on their own aren't really drop dead serious issues and only require some c/a to be applied.)

Could a variety of these that are contained within a single major element of the standard (4.4 Implementation & operation in this case) actually be elevated to a Major N/C for the non fulfillment of that complete element (4.4)?

 

[JRKH]

I would say No

What would you write the NC against based on the findings you outline above?

Your statement earlier of a number of minors against a large section of the standard is the key for me. Section 7 in ISO9k2k for instance covers virtually every area of a company's processes.

The fact that you are only finding minor non-conformances in the various areas indicates that you are also finding conformities within those areas/caluses. Otherwise you would already have you Major. Therefore the standard has been implemented.

I certainly think that others have made good points in regards to company size and general attitude (culture) within the company. If these minors are all accompanied by poor attitudes on the part of the auditees then you have concern with the company commitment and communication.

Overall, I don't see how the minors you describe above could add up to a major.

James

 

[Randy]

Yeah, I know where you're coming from. We are only talking fictional, what if situations here. I told my students that I would present this premise to the best folks around for discussion and also to show how the Cove operates and can be used for help.