Some departments don't have Quality Objectives - Non Conformity?

[Hodgepodge]

Not all quality manuals are a regurgitation of the standard. Fact is there is a lot of discussion in the Cove about how the QM should not be a regurgitation of the standard. Quality Manuals should be understandable and usable by those actually using them. After all, not many people refer to manufacturing as “Product Realization”. I suppose the ISO-babble should be understood by some in a company, but it certainly does not need to be understood by all.

This being said, process owners and managers may change process definitions, requirements for documentation and/or records. When this happens they may be making changes that meet the requirements of their quality manual but may not be including enough of what is required by the standard. It is easy to imagine…someone is making changes to processes or procedures…they see a requirement for something they have always thought was a waste of time…they say to themselves, “Why do we need to do that?” and then proceed to eliminate something that was originally written in to a procedure to meet the standard even though it is not a delineated requirement of the company’s quality manual (this is almost a good reason for having a regurgitation-style quality manual, oh no! :mg.

Yes, I suppose the review of changes prior to approval and implementation of process changes ought to catch glitches such as the one I describe above. Regardless of the fact that auditing to the requirements of the standard is a requirement of ISO 9001, having another set of eyes look at your work is usually a good idea. The internal audit is a good way of doing that.

 

[Big Jim]

perhaps, but...
This has come up before, and will probably come up again, but "interpret" doesn't mean "to make up one's own definitions." The ISO requirements can't be applied without interpretation--understanding the meaning of the requirements. Look at the first and eighth definitions here.

Thank you Jim.

From that definition I would certainly agree that auditors may need to intrepret.

"to explain something; give an explanation."

Some of the other definitions may be a bit dicey though.

 

[Big Jim]

Jim, you clearly have your views on many topics. They don't agree with mine - we've taken differing stances on many topics and I know well enough that whatever I post, you have a different viewpoint. My position has long been that, for example, just because a course teaches internal auditors to 'interpret' the standard doesn't mean it was the effective thing to do! As I've posted many, many times before here, we read daily about people who can't relate their audit findings in a manner that management understand. Where did the training stand on that? Do we expect management to know the words of ISO? I hope not!

Furthermore, the course content requirements of accredited auditor courses, hasn't changed in eons, based as it was on second party techniques. Where's the improvement in that? I could go on.

I've had too many experiences of ineffective audits, to agree with your approach, Jim. I can't imagine what yours has been, but we won't see eye to eye, clearly!

Perhaps it is time to de-mystify the standard when it is being taught. Like Randy says, "it ain't rocket science". It really isn't that complex.

 

[JaneB]

Perhaps it is time to de-mystify the standard when it is being taught.

I see many, many courses already saying or claiming they demystify the Standard, present it in simple/plain/etc English, so I think this is already done or tried. But in any case, any such course is inherently an attempt to interpret ie, explain the Standard, no?

It's 'not that complex', no. But it does take some experience and thought to learn to understand and apply it well. I imagine most people with some experience with it, whether as manager, consultant, auditor or whatever, would concur.

It's a generic Standard, not a specific one as most are. Thus, still subject to some interpretation and almost certainly always will be.

But let's be clear about what is meant by 'interpretation'. As Jim already pointed out, that does not mean making up one's own definitions, or inserting meanings into it which are not there. It does mean coming to an understanding of the intent, meaning and practical application of particular sections/clauses/subclauses in a particular instance or instances.

 

[JaneB]

The intent during internal audit is to raise max number of NC to keep the QMS healthy and to prevent any major NC arising during external audit.

Heavens, no! I disagree strongly with your stated aim to raise the 'maximum' number of NCs and the bit about preventing any major NC during external audit. I'm not sure where you have got this from, but it isn't from the Standard!
Clause 8.2.2 clearly states the aim of internal audit is:

to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.

Doing that well would certainly result in a healthy and effective system, as well as few/zero issues at any external audit. But the latter is virtually a byproduct of having a healthy internal audit program (as it should be) rather than a primary aim.

 

[Big Jim]

I see many, many courses already saying or claiming they demystify the Standard, present it in simple/plain/etc English, so I think this is already done or tried. But in any case, any such course is inherently an attempt to interpret ie, explain the Standard, no?

It's 'not that complex', no. But it does take some experience and thought to learn to understand and apply it well. I imagine most people with some experience with it, whether as manager, consultant, auditor or whatever, would concur.

It's a generic Standard, not a specific one as most are. Thus, still subject to some interpretation and almost certainly always will be.

But let's be clear about what is meant by 'interpretation'. As Jim already pointed out, that does not mean making up one's own definitions, or inserting meanings into it which are not there. It does mean coming to an understanding of the intent, meaning and practical application of particular sections/clauses/subclauses in a particular instance or instances.

If it is being taught as AndyN seems to express so that once a consultant sets up a manual no one in the company dares look at the standard, it sounds like some mysticism has been mixed in. It is that sense that I'm expressing de-mystification.

 

[JaneB]

because the department manager cant be ***** to create them

having a wee bit of trouble getting everyone on board the quality system train

And there, alas, is the heart of the issue. Andy's advice on this is sound. The outward sign of this is just a symptom (ie, departments not having objectives). The issue to address is the underlying one: people aren't all on board with the system. Where's the management on this?

 

[JaneB]

If it is being taught as AndyN seems to express so that once a consultant sets up a manual no one in the company dares look at the standard, it sounds like some mysticism has been mixed in. It is that sense that I'm expressing de-mystification.

This is simply illogical.

The premise is dubious (you are concluding a meaning and attributing it to AndyN - it isn't the same meaning I drew from what he wrote). And the inference you draw is a non sequitur.

 

[Big Jim]

This is simply illogical.

The premise is dubious (you are concluding a meaning and attributing it to AndyN - it isn't the same meaning I drew from what he wrote). And the inference you draw is a non sequitur.

From AndyN:

"Emphatically, No! Let me explain:

"The ISO standard is the reference/requirement for the design of the quality management system. Once the system is designed and meets the relevant requirements, it's implemented and the auditors verify that implementation. If they discover an implementation issue, they will report it and it will automatically become a non-conformity to the standard, won't it?

"To audit to the design, once the system is built is like checking a house for building regs. after the owner moves in and lives there! Too darned late!

"We read here, daily, about internal auditors who get all wound around the axle about what ISO says, then management don't understand, or take corrective actions and on and on - in the main because they have been taught, at a Lead Auditor course, to audit to the standard - and that's all they know!"

That was his response to my question as to shouldn't internal audits be performed against both the standard and the organizations procedures.

I later commented that perhaps it would be useful to de-mystify the standard when it was taught since his approach was that the standard was too mis-understandable for internal auditors to explain to top management to which Jane B responded that de-mystification doesn't work.

This looks logical to me. The standard isn't that hard to understand. It isn't rocket science. The solution isn't to remove the use of the standard by internal auditors. It is to help the entire organization better understand it.

Perhaps you feel differently, but I don't think you do based on the quote at the bottom of your signature:

"Fools ignore complexity. Pragmatists suffer it. Some can avoid it. Geniuses remove it." ~ Alan Perlis

 

[JaneB]

I later commented that perhaps it would be useful to de-mystify the standard when it was taught since his approach was that the standard was too mis-understandable for internal auditors to explain to top management to which Jane B responded that de-mystification doesn't work.

Er... sorry, Jim, but I have to disagree with your post, and I don't think this is an accurate summary.

I also think topic-wise, we've wandered way off beam and now appear to be somewhere along a bypath (if not multiple bypaths) and arguing various differeng not entirely clear points.

Return to thread topic, anyone?