Should a Quality Policy have Revision Control?

[AndyN]

I believe it is, and always has been, acceptable to take verbal statements - 'statements of fact', to be 'objective evidence, if given by a person in authority, i.e the process owner.......

Indeed, with less emphasis by the ISO 9001 requirements on documentation, management may be the only source of evidence!

 

[JaneB]

Thank you Randy and Andy for bringing some basic sense to the whole question.

Please, people who are recommending all kinds of convoluted and bureaucratic methods, do first read exactly what the Standard says. Then think about what you're recommending, how long your method takes to do and maintain, whether it's worth all that time or not, and if not whether there are easier and better ways of achieving the outcomes required - eg, as Helmut suggests!!.

The Standard does not, as Randy says, mandate either a revision number, a revision date or a signature! The phrases 'revision number' or 'signature' do not appear. That's why Randy 'challenges' his students (lucky students to get that challenege, along with no doubt Randy's unique sense of humour and good sense).

Yes, they are common ways of achieving requirements, but they are not, repeat not, The Only Ways. If for some reason they are embedded in your consciousness, it might be wise to again read what it actually says (versus what you've been taught, told or believe it does).

And again, how many different quality policies are there likely to be around at a time?? How many times is it usual and likely that someone's quality policy is reviewed? Most commonly the policy doesn't change very often. Review it by all means - should take little time (eg, is it still suitable? Yes. OK, then let's move on ... .)

Recently I came across a case where page containing policy had been revised but policy acually had not been revised; as a result date appearing in page containing policy was different from date appearing in the policy document displayed at various locations.

Uh huh... and was the content (ie, the text) of the policy any different? (What you write implies not). And what was the importance, the impact and the risk (if any) of having the date be different in two different places? I'd put this as a very, very minor point. There's infinitely more important issues for quality to focus on!

Do let us keep the focus on issues of importance, impact and risk, and not on such relatively minor and insignificant issues. It's just this kind of nitpickery "can't see the wood for the trees" that earns quality a bad rap in my opinion.

 

[Randy]

Wow! Those are some nice comments there Jane, especially from someone I've learned to respect.

Yeah, this is one of those subjects that really gets over-engineered to the point of not being recognizable in practice. It's so simple to do that folks feel compelled to complicate it so it "looks" right.



(Please don't take anything wrong from the Controversy Thread)

 

[JaneB]

Wow! Those are some nice comments there Jane, especially from someone I've learned to respect.

And me too, you, likewise Randy.

Plus I like your unique phraseology at times - I think it was the 'tell 'em to go hug a duck' one that made me laugh out loud.

PS, re. other, no problems.

 

[neelu]

Spirit of what Andy and Jane try to convey is appreciated. But to a novice who reads the comments in this thread, it would appear as though 'documentation control' is something that they talk about in trg. programs, but need not be worried about. And that may generate new protocols in QMS implementation! Whether you like it or not, you cannot wish away 'doc. control'. With nearly 20 years of experience in QMS behind me, I can say for sure that if an orgn. excelled in quality mgmt., it also had excellent doc. control system! I would ike to consider that a good documentation control system is the lifeline of a good QMS and any aberration in documentation control need to be attended to and not ignored as 'trivial' or 'not important'. Evidence of failure in documentation control is often symptomatic of larger problems.
Now auditors do gather oral evidence from process owners-isn't it a good practce to corroborate such evidence by checking records and/or observation?

 

[AndyN]

Neelu:

You are very correct in your comments! We often agree on such points, however, there can be an over reliance by (new) auditors on documentary evidence, when in many cases it's not required.

I've witnessed, in the past, CB auditors who have asked for 'sign-up' sheets to 'prove' the quality policy was communicated at a town hall meeting - in a plant of over 6,000 people!! I wonder, if everyone did sign off, how many times 'Mickey Mouse' or similar would appear!

If they did but realize, the 'proof' is found in the verbal evidence from interviewing people. But it's too easy to ask for paperwork, while sitting comfortably in someone's office instead of planning and understanding how a particular requirement can be verified!

I don't think anyone is advocating ignoring document controls, just challenging some of the paradigms which lead to bureacracy for which quality systems are (unjustly) criticized!

 

[BradM]

Man... is this the Randy and Jane Hour?? Are you two about to start a Morning talk show together??

Spirit of what Andy and Jane try to convey is appreciated. But to a novice who reads the comments in this thread, it would appear as though 'documentation control' is something that they talk about in trg. programs, but need not be worried about. And that may generate new protocols in QMS implementation! Whether you like it or not, you cannot wish away 'doc. control'. With nearly 20 years of experience in QMS behind me, I can say for sure that if an orgn. excelled in quality mgmt., it also had excellent doc. control system! I would ike to consider that a good documentation control system is the lifeline of a good QMS and any aberration in documentation control need to be attended to and not ignored as 'trivial' or 'not important'. Evidence of failure in documentation control is often symptomatic of larger problems.
Now auditors do gather oral evidence from process owners-isn't it a good practce to corroborate such evidence by checking records and/or observation?

Good observations. What these road-weary auditors are trying to do is undue many years of hearsay, suggestions and ideas that have become etched in stone as Law.

The QMS in each organization needs to fit their business needs. You need revision control, but that it does not need to be some convoluted, complex process that then creates other problems.

I had my own business for years and had a pretty good quality management system- Word documents, a couple of spreadsheets, and full revision control. It needs to be effective, not complex!

Hopefully what newbies can carry away from these threads is the empowerment to think on their own in regards to the standard, and their organizations fulfillment of it.

 

[JaneB]

Neelu, do please correct me if I'm wrong, but I do not recall writing anything that suggests document control should or could be 'wished away'.

It can't & shouldn't be - it's a mandatory part of the Standard for very good reason. And I do agree with your point about good systems for doc control being important.

Where we may possibly part company is that I don't think that all and every system for document control needs to be huge, cumbersome or complicated. I do think it's a 'horses for courses' thing (as is everything in the Standard IMO). Do you have that expression? It means something like 'things vary in different applications/places'.

In certain organisations, very, very tight systems of document control are not only advisable, but they're essential. Examples that come to mind are those where control must be exercised over drawings (eg, engineering drawings, architectural drawings, construction drawings) and IT specifications. I certainly do not want to be a passenger on an aeroplane that was built or contains components built or maintained by organisations with loose doc control systems. And I've seen the results in some businesses of not maintaining good control over drawings, for example: a nightmare!! Emergency instructions... procedures ... etc.

BUT in other organisations (and this is at times hard for some engineers/eng types in particular to grasp), there just isn't the same need for tight, tight, tight control. Many service businesses don't have any drawings, and may need only some procedures, forms & perhaps checklists. Their system can be less rigid, perhaps, because the risks are lower and the importance lower. But yes, of course they must still be able to satisfy the requirements for doc control.

9001 is not a specific one. Unlike the vast majority of Standards, it's a generic one. 14001 is another. They say what must be done, but not how. The how is up to the particular organisation.

And that is why the Standard does not mandate anything as specific as revision numbers or signatures. Indeed, it says, quite specifically, that a procedure 'shall establish the controls needed to...' In other words, the controls that the organisation determines are needed to achieve adequate control.

I urged - and will continue to urge - (as does Randy!) people to read the actual Standard itself. Yes, 4.2.3 on doc control. But I wish also more people would read, for example, the Introduction, eg such as it not being the intent of the Standard to insist on uniformity of structure or documentation, and that (0.1) the design and implementation of the system is influenced by various factors, which it then lists.

My message to newbies never has been, and never will be, 'don't bother re. doc ctrol, it's not important.' But if I come across posts that insist that things 'must' or 'should' be done in a certain way 'to meet 9001 requirements for doc control' that aren't correct, and that I know are incorrect, misleading and/or not terribly practical, I can't always remain silent. Because it can & should be done better.

I'm not sure I agree that doc control is the 'lifeline' of any system. Important yes, but I'd probably consider management planning and review more important. But I DO agree that failures there may be symptomatic of larger problems. But again, not always! Depends upon the actual system & context.

This whole discussion started with a question about whether a quality policy should have 'revision control' on it. I continue to maintain it was a quite trivial issue, and if that was 'all' an auditor could find, I'd be looking for a better auditor, if not registrar, who actually focussed on risk and importance, not such relatively trivial issues.

I want people to think, not just blindly accept anything anyone says.

 

[neelu]

Jane, thanks a lot for your erudite comments on my post. I do agree with most of the observations you have made; and about some, I would like to add/differ as follows:
1.'Horses for courses',certainly;clause 4.2 itself says documentation system should be compatible with the competency available in an orgn. But Jane, how many consultants put this dictum into practice? In my experience, best QMS has always been the one where a consultant has been a facilitator in its truest sense or one that put together by the orgn. itself. The quality of a product from a consultant is aways related to one's knowledge of the industrial sector cocerned, one's sensitivity to philosophy and culture of the orgn. and one's maturity in his profession.
2. Documentation system of an orgn. may be, by choice, simple or complicated; but whatever it may be, it should be consistent with what is written down in the mandatory procedure for documentation control.
3. Importance of quality policy and its control; I think, we must give it the pride of place the standard demands. It is the 'face of the orgn.' that is exposed to a customer very often; the very fact that quality policy appears under 'Management Responsibility' is a measure of its importance; its control should be consistent with whatever orgn.'s doc. control system demands and QP ideally is the 'foundation' or the 'source' of the QMS. I believe that QMS in an orgn. can be as good as as its top management and ideally, QP is a mirror of its orgn.al philosophy and culture. We (perhaps of the old school) used have exclusive workshops to develop the QP of the organization!
4. I still maintain,Jane, that documentation control system is the 'lifeline' of QMS. If an orgn. continues to ''maintain" its QMS effectively, one of the attributes would definitely be an effective documentation control system. Such a system can only ensure 'effective mgmt. review', 'review of quality objectives', 'CAPA processes' and ultimately 'continual improvement'.
I am sorry if I have gone off the track a wee bit from theme of the thread. I am a staunch believer in the philosophy and power of QMS. My only intention was to see that our comments do not imply dilution in its requirements and consequently cause QMS to be browbeaten!

 

[Randy]

1.'Horses for courses',certainly;clause 4.2 itself says documentation system should be compatible with the competency available in an orgn.

No it doesn't, you're making that up. 4.2. says "Documentation requirements" and that's it.

2. Documentation system of an orgn. may be, by choice, simple or complicated; but whatever it may be, it should be consistent with what is written down in the mandatory procedure for documentation control.

OK, so is this a new revelation you're sharing because this isn't news and nobody has stated otherwise

If an orgn. continues to ''maintain" its QMS effectively, one of the attributes would definitely be an effective documentation control system. Such a system can only ensure 'effective mgmt. review', 'review of quality objectives', 'CAPA processes' and ultimately 'continual improvement'.

Such a system can only help ensure that you can find a piece of paper when you need it. All the other you mentioned needs people that are committed to the process and document control won't make that dog hunt.

Also you're kind of on track with the policy being the face of the organization, too bad most organizations are ugly (your illustration, not mine)
The policy is a promise or a statement of intent made by top management on behalf of the orgaization (in reality the policy is an objective or goal) that the organization is going to use the management system for to help it achieve or fulfill...Kinda like soccer (or football depending on where you are). The policy is the goal line and the QMS is the team that has to work together to get the goal. No single player or system element can do it alone, it takes all the elements or players working effectively to make it happen.