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How do you structure your QA (QMS) Manual? A Historical Discussion

barb butrym

Quite Involved in Discussions
#21
I hate it, as an auditor when i see a quality manual written verbatum. its shallow and meaningless.....and obviously created just to meet the standard as quickly and painlessly as possible and shows me there may be a lack of real commitment and i must look closely elsewhere (strictly my opinion). that said, obviously it is easier to audit to, especially for doc review...but then I never was one to take the easy road.
 

Marc

Captain Nice
Staff member
Admin
#23
Originally posted by barb butrym:

I hate it, as an auditor when i see a quality manual written verbatum. its shallow and meaningless.....and obviously created just to meet the standard as quickly and painlessly as possible and shows me there may be a lack of real commitment and i must look closely elsewhere (strictly my opinion).
A 'quality manual' is bunk. I totally disagree that "...its shallow and meaningless...". Please, please tell me. What do you expect of a 'quality' manual? Why is it important beyond serving as a skeleton to hang things on?

I personally look for a brief, 'by the book' manual "...with references...". The references are where the meat is.

When I see a manual which is little more than a repeat of the standard, I see a company which realizes the limited significance of a quality manual to begin with. I see a company which doesn't waste time and money on bull. I remember the arguement from years ago. It was the old "...make your quality manual special. Make it YOUR manual, not just a document you have because of an ISO requirement...." That was bunk then and it's bunk now. I've seen companies spend months and thousands of dollars on a 'manual' which should take no more than a day or two to 'tailor' and put refernces in. Now THAT is crazy, if not simply stupid.

A one page manual? Yup - I'm for it. But - as I have stated in numerous threads in these forums over the years, I stick with the 'copy of the standard' version to avoid 'missing something' which may just be a word or two. I first saw that happen in 1994 and have never let it happen again.

One page manuals? If the system is correctly structured and procedures are appropriately written to address requirements - not a problem. I'd go with a simple matrix referencing the ISO paragraph (requirement) to the appropriate company procedure.

Unfortunately, excessive, overly complex documentation is the 'norm' when companies undertake ISO. They don't know 'when to stop'. That's specifically why many of the changes from the 1994 version address documentation requirements.

One page has my vote. I propose a 7 or 8 point font.

[This message has been edited by Marc Smith (edited 22 August 2001).]
 
D

David Mullins

#24
I should have said that I support the theory of a one page manual. My reality has been that by the time you kick in a matrix, a flowchart, introductory and marketing-type statements (for customers who request a copy of your QManual with tenders), then referencing policies and procedures it ends up more like 7 or 8 pages.

This excludes all the traditional standard re-written stuff. So I'd have to use about a 2 point font!



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H

HFowler

#25
The idea of a 1 page Quality Manual is probably an exaggeration. I raise the question in this forum because I am interested in developing a FIRST TIME Quality Management System for our company that is VERY, VERY SIMPLIFIED, easily understood and maintained.

What I really want to do is start with ONLY what's required by ISO 9001:2000 and ONLY add to it as required by other statutory and regulatory agencies. I want to use charts as much as possible and keep the amount of documentation to a minimum.

Over time, as people become more "quality literate", then we can build on the basic framework without over complicating or losing sight of the core requirements.

I would be very interested in hearing from anyone that has taken, or considered this approach. (Especially the use of flowcharts to replace text procedures).
 
I
#26
A "small" QM was discussed 3 weeks ago in http://Elsmar.com/ubb/Forum15/HTML/000303.html
and I repeat some my words: ".. it was last July in Kyoto during ISO/TC 176 meeting. It was an Open Forum and we discussed one ( among all others) suggestion “Is it a real need in documented Quality Manual”? The answer was “yes”, but the descending importance of QM became clear."
As for registrars: their real interest in QM is in OrgChart ( to prepare an Audit Plan) and in Procedures Matrix ( to define a scope of Adequacy Audit). I understand them. Many QMs look like "brothers and sisters".
As for Sales: I think that an illustrative, not tiresome Quality Comics, written in a friendly easy manner is more attractive than an ordinary QM. Does your client really want to know what do you do with "identification and traceability"?
I hope we'll see in future such pleasant QMs. They should provoke staff to read other Quality documents. ISO 9000 isn't an amusing book. Let us do it so.
 
A

Alf Gulford

#27
I skimmed the forum and don't think I'm repeating much here.

What happened to the philosophy that a Quality Manual is a 'roadmap' for the organization? I know that the first thing any registrar does (at least those that I've dealt with) is to use the Quality Manual to get a sense of how we operate and what procedures we have to cover our processes. We also refer to it fairly often internally to communicate and re-enforce the 'right' way.

And I know Quality Manuals are used as a sales tool. We've requested them from suppliers as part of the qualification process and had ours requested (especially internationally) as part of the contract-letting process.

I know we may be talking from two entirely different perspectives but I want to recognize the value of the document beyond what's required for registration.

Alf
 

Marc

Captain Nice
Staff member
Admin
#29
> What happened to the philosophy that a Quality Manual is a
> 'roadmap' for the organization?

Well, there are a lot of interpretations of just what a quality manual is. That is a valid interpretation. But so many different companies and so many different industries make it a moot issue. The question becomes a matter of over all content - not how you deliver it. Quality manuals were, years ago, rare and there was a quality manual 'philosophy' at the time but I don't think there is any more.

The same effect, so to speak, can be seen in procedures. I remember back in 1995-6 when I set up a company with all level 2's in flow charts. The auditors came in and freaked out. I can still remember the guy saying "...These aren't procedures!..." The auditor's paradigm was the old rigid, text format. In fact, there was recently an interesting thread in the ISO ListServe I may copy here about documentation. Question: What must a procedure contain? A header? A footer? Revision level (what if we do revision by date instead of by 'level')? Authored by? Revised by? Revision date? Distribution list? Do you have to have a hard copy with an ink signature?

All these questions I could appreciate as I broke my 'quality' teeth in military manufacturing before personal computers were on every desk. There was a very structured, expected format for procedures. Most companies had, for all intents and purposes, similar procedures (at lease those involved in military manufacturing). Back in those days every company of any size had a specific department where all they did was type, distribute, retrieve obsolete and control procedures. Personal computers have changed all that.

Documentation has evolved significantly in the last 20 years. I'm sure some will stick with a 'quality manual philosophy'. When I work with a client I'm concerned about total, overall content. What is where. Is everything present and accounted for? This is the main reason I push every client to have a cross-reference (matrix) where they track the requirements (in this case ISO) line item by line item to the document in their system which fulfills the requirement. For me it's a simple issue as, when you look closely, if you're just starting this is called a Gap Analysis. A detailed Gap Analysis I must admit - not just a 'Does the system Exist?' Gap Analysis. But this is the way I start and track an implementation. Call it a Gap Analysis. Call it a Check List. Call it what ever you want. I can say auditors love them and they make audits a snap. They reduce confusion. They ask how you comply with section X, paragraph Y, letter A you just look at the matrix and go right to where that line item is addressed within the company's doumentation system.

That said, the two ISO 9001:2000 audits I have gone through have differed from the 'old days'. There were the same issues of "...show me where you address this..." but in addition continuous improvement and such were discussed more and in length. In large part, in my opinion, it almost approached consulting - which I discussed in another thread. In my opinion most of it is more verbal gymnastics. In my opinion it does not diminish the value of a cross-reference matrix.

Back to the Quality manual issue... Look at how your over all documentation system(s) are structured and decide what is right for your company. I have had smaller companies where their level 2's were all part of their quality manual - and all were flow charts. It was right for them, their size, their company. It would not work for many companies but for this one it did.

I think the structured quality manual idea, including having an ISO 'guideline' on quality manuals, is a fine and dandy idea. I'm also happy it's a guideline and not a requirement. Do what's right for your company and your internal systems.

Philosophy..... I remember taking a course or two with a name like that whilst in college back in the early 1970's.... :cool:
 
V

venkat

#30
Qa Manual ISo 9000:2000

You have mentioned that copy verbatim of the clauses 1 to 8.5 of the standard. If I not mistaken does it refer to ISO 10013 or any other standard

Can you please clarify.

I also would request viewers to post a model manual compliant to ISO 9000:2000 to post in this site. for different companies viz. manufacturing, software, hospital, service, textiles etc
 
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