Lack of 3rd Shift Internal Audit - Major or Minor NC (Nonconformance)?

[Peters]

Lack of 3rd shift internal audit - major or minor NC?
We had discussion with General Manager in the end of our audit. Company internal audits were only on 1st and 2nd shift. Our (auditors) opinion was it's major nonconformity because it's clear, well-defined requirement in ISO/TS 16949. And deviation was evident. General Manager said "it wasn't total breakdown of a system to meet ISO/TS 16949 requirement". Well... maybe...
What do you think about this?

 

[Stijloor]

Lack of 3rd shift internal audit - major or minor NC?
We had discussion with General Manager in the end of our audit. Company internal audits were only on 1st and 2nd shift. Our (auditors) opinion was it's major nonconformity because it's clear, well-defined requirement in ISO/TS 16949. And deviation was evident. General Manager said "it wasn't total breakdown of a system to meet ISO/TS 16949 requirement". Well... maybe...
What do you think about this?

Peters,

A minor in my book. If you had not performed any audits, that would be a major.

(BTW, grading nonconformities as a result of an internal audit is not required.)

Stijloor.

 

[Chris Ford]

Peters,

A minor in my book. If you had not performed any audits, that would be a major.

(BTW, grading nonconformities as a result of an internal audit is not required.)

Stijloor.

That's a very good point, Stijloor. In many cases, like the one we're talking about here, it can become very subjective. I think grading (i.e. prioritizing) is a good idea, but the grading system needs to be very quantitative.

As an auditor, I've asked audit managers about their logic and rationale when assigning a criticality level to an audit finding. It really opens the door for an auditor to ask a lot of questions and can even bring under scrutiny the audit results in general.

So to answer the OP's question, it's impossible to come to any conclusion without seeing how your procedure defines the assignment of these ratings. What's your procedural definition of a major and a minor nonconformity? Does the procedure outline a process for determining the criticality level?

If you're asking what an auditor might say... I definitely would not suggest that a failure to audit one shift is a major nonconformity, either.

 

[Big Jim]

I would also agree that it is a nonconformance. As to the severity of it, more information would be needed but I'm also inclined to think it would be a minor.

The only major on internal auditing that I have written was for a company that specified they would audit their entire quality management system at least once a year, had determined they had nine processes, had started two of them (without completing them) eighteen months ago, not even started the remaining seven. As you can see, that was pretty much a "no-brainer" major. A full and total breakdown of their internal audit program.

You are nowhere near that.

 

[AndyN]

I think we need a further piece of the puzzle before we can reach a decision and most auditors stop at simply rating their NC in the hope it will be seen as having some importance.

The part that's missing is what's going on on third shift and is it effective? Now, if there's a production shift (not just maintenance, let's say) and there's been performance issues - higher non-conformities, lower yield, late delivery (or shortages), customer concerns which were generated from this shift etc. and the internal audits could have helped to identify what was causing this, then it's more like a significant finding.........
If, however, there isn't any issues with the 3rd shift's performance, it would be less significant......

 

[Peters]

Do you remember Minor NC definition in Rules?

Part of this definition:
"It may be one of the following:
-A failure in some part of the client's quality management system relative to ISO/TS 16949
-A single observed lapse in following one item of a company's quality management system"

Does this situation fit with this definition?

 

[Sidney Vianna]

The part that's missing is what's going on on third shift and is it effective? Now, if there's a production shift (not just maintenance, let's say) and there's been performance issues - higher non-conformities, lower yield, late delivery (or shortages), customer concerns which were generated from this shift etc. and the internal audits could have helped to identify what was causing this, then it's more like a significant finding.........
If, however, there isn't any issues with the 3rd shift's performance, it would be less significant......

Andy, thanks for bringing critical thinking into this discussion. That is EXACTLY what an auditor who wants to add value to the organization should be concerned with. Too many quality professionals, including some of our counterparts want "black/white" criteria to categorize an NC, when, in reality they come in all shades of gray. Real auditing requires analytical skills and a desire to evaluate situations using risk assessment approaches.

This kind of enquiring mind is what we need to promote audits to a higher level. What are the implications of not having an internal audit of the 3rd shift? It depends, like you pointed out. Well done.

 

[Stijloor]

<snip>Too many quality professionals, including some of our counterparts want "black/white" criteria to categorize an NC, when, in reality they come in all shades of gray.

Sidney,

It's in the "shades of gray" where subjectivity rules and auditors get lost.
Subjectivity can lead to "opinions" and that's when an audit can become a blasting success or too often a (miserable) failure.

Stijloor.

 

[Chris Ford]

Sidney,

It's in the "shades of gray" where subjectivity rules and auditors get lost.
Subjectivity can lead to "opinions" and that's when an audit can become a blasting success or too often a (miserable) failure.

Stijloor.

Exactly. Rating the nonconformity helps in prioritizing them in the final report, but you don't really need a rating system in order to prioritize the final report. I've worked for several companies that believed it was absolutely necessary to give nonconformities some sort of rating score. My only recommendation if a rating system is used, is to assure that the rating system is quantitative.

For internal audits, they're all nonconformities and they all need to be addressed. So, rating them doesn't have a whole lot of benefit, in my opinion.

 

[Sidney Vianna]

It's in the "shades of gray" where subjectivity rules and auditors get lost.
Subjectivity can lead to "opinions" and that's when an audit can become a blasting success or too often a (miserable) failure..

Either we like it or not, life, business, auditing, etc. is, for the most part, full of variables and sprinkled with a few attributes here and there. People who try to live their lives via a checklist mentality with yes/no boxes have a hard time coping with reality.

When it comes to management system auditing, the vast majority of situations auditors are confronted with is a "degree of conformance". Auditing requires the ability to judge complex situations. While criteria is always necessary to guide our work, all attempts to develop all encompassing and prescriptive rules and criteria that, designed to cover all possible scenarios, are destined to fail.

That is exactly why we have documents such as ISO 19011, which provides guidance on how management system auditors should perform. That is why auditors need to be COMPETENT. They need to assess the situations within the context and risks involved.

Let me offer a simple scenario. Most people would say that a single instance of an obsolete document identified, out of 235 documents checked, during an audit, would lead to a either a non-consequential "observation" or minor non-conformity, isn't it? The problem is not systemic, would most people argue.

Well, what if the single piece of obsolete document observed during the audit is the FINAL INSPECTION AND TEST criteria? And, from the previous revision to the current, the actual accept/reject numbers have changed. In other words, we could be accepting defective products by using this obsolete specification, which would bring risks from the customers perspective, or we could be rejecting perfectly good products, which would be detrimental to the organization's bottom line.

Either way, one single piece of outdated document can have dire implications. So, would you categorize that situation as an observation, minor or major NC?

Real auditing is not easy. It does require a lot of things, such as analytical skills. Because subjectivity abounds everywhere we go. And we have to deal with it.