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Quality Manual Organization and Structure including Numbering

Is Your Company's 'Quality' Manual....

  • Organized and numbered like ISO 9001.

    Votes: 39 60.0%
  • Organized, but NOT numbered like ISO 9001

    Votes: 17 26.2%
  • We 'Rolled Our Own' (Please comment how so in a Reply)

    Votes: 9 13.8%

  • Total voters
    65

Marc

Captain Nice
Staff member
Admin
#41
My Rant of the Week:

I find David's post consistent with my 'signature' here where I clearly state: One size does NOT fit all. To me, every client, every company, is an individual.

There is no doubt that the size is a factor (only one of many). Not to mention complexity of the operation(s) and processes. The manual I shared with you was for a company of about 12 souls - total - manufacturing, office folks, and the company owner. It was 'tailored' (more than most because of the small size of the company) so that they did not have to write a bunch of procedures which they did not have before they went throuh implementation and do not need. It was akin to the 'old' Quality Plans because the company only does one thing - mix chemicals in their 3 'vats'. There was a reason for putting many of the things they do, as well as defining many responsibilities, right into the manual - no need for another document. Other than specific work instructions (individual batch mixture procedures, for example) the company only had about 8 to 10 procedures (flow charts) total. In addition, their whole 'systems manual' (10 point Arial font) was 33 pages, which included index, quality policy, etc., etc. When you only do one thing and you're that small a company, no matter how you do it it's going to look like a product specific plan - they unload tanker, pump into vat, mix, drain into drums or totes and ship. No heating, no chilling, nothing but mixing. Easier and more simple than baking a cake. Just a bigger bowl and a bigger mixer. Every day, week in, week out - for almost 50 years now that's all they have done.

Nor do they have the weight behind them (size factor), should a disagreement arise, to want to take a chance on an idiot auditor. Working with Motorola, we had a lot of leeway on many issues that involved "...showing them the words..." that this small company would have had a harder time arguing about. Heck - we had heated arguments several times over "...where the words are..." even implementing at Motorola (I will grant you that was QS-9000, not ISO 9001).

1994-95 was the turning point for me in turning to a 'copy the manual' approach. It was when auditors started the word game. Or at least 1994-95 was when I was first stung by the "...I don't see those exact words..." writeups. It was not enough to say "...We didn't write anything about identification and traceability because it's not relevant in what we do..." Nor was it enough, for example, in addressing 4.3.2 (the 1994 version) to not somewhere state list item B "...any differences between the contract or accepted order requirements and those in the tender are resolved...." The company could both explain and show where and how they did this, but the company was written up because they did not specifically state those words somewhere. I particularly remember that writeup because the company owner went ballistic saying, amongst other things, that's since they do it and can prove they do it, why are the exact words from the standard necessary? He asked where it says a company has to repeat every word the standard contains. The owner genuinely realized at that time that the document (ISO 9001:1994) and registration was not just the BS he had thought all along, but worse. Audits could end up as little more than pissing matches.
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The manual I reviewed from David was essentially the answer to a somewhat recent question: Can your quality manual consist of a list of references, a flow chart of your main system(s) and none of the verbiage at all from the ISO 9001 document? I must distill that to what it is - a List of Reference Documents approach which includes a column as to which clause of the standard the document satisfies. The list simply follows the numbering scheme of the standard. It is no more than a list of references - pointers to documents. In fact, if I had shared the document matrix with you from the small company whose manual I shared with you, you would see it looks much like your quality manual! You can see it, however, by downloading the 'example' matrix above. It's what that 'study in simplicity' was drawn from some years ago. And none of it has changed due to the 2000 revision. They only had to change their systems manual. Documents are already categorized, as well. Add the few extras like an org chart, basic flow of processes, quality policy, etc. and you could not say there is a difference between your quality manual and their document matrix other than that they put the 'compliance' words in their system manual rather than in supporting documentation.

I do agree with the approach where it's practical and appropriate. :agree: It's quite simple: It's a Cross-Reference Matrix. I personally feel it is the most logical approach. But I don't look at it as sgnificantly different. 'The Words' have to be somewhere and they are obviously in the supporting (referenced) documentation when you do a 'systems manual' from a list (cross-reference matrix) appproach. Where you put the words, in my opinion, isn't relevant. What is relevant is that they are someplace. Whether you take the time to write them in the 'systems manual' or in the supporting documentation, you're still taking the time to write it. This said, it will soon be known if the revised standard will change the way auditors audit. It's supposed to, but I haven't seen it succeed.

Often times it's simply a matter of an auditor not seeing the 'right' words. That's why I take the 'copy the standard' approach. It has not been a problem when an auditor says "...I see you say you do it, now show me and explain...". It HAS been a problem with an auditor saying (and this is the stuff I just love): "...I can see you are doing it and your explaination is fine - you obviously comply except you don't specifically state that you do that. Now, if you'd just add xxxxxxxx to your procedures or in your manual or somewhere we'll be in business..."

I have for years argued the 'intent' issue. Many people say "...intent, hell! If it says do it then you do it!..." Were that it was that simple. It goes further than that (in part) because issues of verbiage continue to pop up. I can hear the rumbling now from some auditors: "...Well, that's not the way I audit!..." That may be the case, but I can't be assured that every time an auditor visits a client for a registration or surveillance audit that you will be their auditor. I have to prepare my clients for 'worst case' idiot auditors. And I teach my clients to be ready to fight an auditor's interpretation if they believe it's a 'bad' interpretation. To do this it is, of course, requsite that they themselves understand the standard, what it is asking (requiring) and can relate it to their business. This is the reason I for many years argued against 'part time' quality people (consultants on contract for a day or a few days a month, really) even in small companies. I expected my clients to not need me any more after their registration audit. I believe it was discussed in a thread here where I was soundly thrashed by a bunch of folks saying "...we're too small to need a full time quality person..." That's when my 'enlightenment' came and I now explain this option to potential clients. This also came up in a thread where a consultant advertised that they would serve as management representative through the audit and 'hand the system over' after the registration audit. I freaked out because my paradigm was my responsibility as a consultant was to teach the people what they needed to know - including the standard, what the words meant and how they applied to their company.

I will say that when one starts talking about a 'structured' approach I want to scream. I have never had a client (this is not to say unstructured companies are not out there) that did not have basic structures in place. The little company whose manual you reviewed was well structured long before ISO. In so far as how one structures one's systems manual - I see that as a minor thing. One looks at what one has and defines what is needed. Then an approach is determined based upon what exists and what is needed. With almost every client I have had (maybe by luck?), they had systems which were if not compliant, nearly so. All they needed was to understand the standard (and how it applied to them), tidy up some loose ends and provide something to tie everything together - the 'systems manual' did that.

The same for the new 'process approach' of ISO 9001. The reorganization of the standard confuses more than clarifies. Process Approach and Structured Approach should both be in Bullshit Bingo! squares. Buzzwords. We're talking business basics 101 now. Of course, I also think the word Quality should be in one of the squares...

To end my diatribe - I want to cite two examples of how stupid some auditors are for those of you out there thinking I'm overboard on making first assumption that a client will get an idiot auditor.

Case 1:

An auditor comes in and writes a client up for something that a previous auditor (in most cases several previous auditors) went over (yes - in detail) and said was fine and met the requirements. Now we have a 'smart auditor' who really knows his/her stuff (obviously the other auditors didn't) and - all of a sudden their system is not compliant.

Case 2:

I had a client who registered back about 1997. They went along fine for several years. Of course there were the usual "...well, the other auditor was wrong..." incidents, but one day the company owner called me laughing his :ca: off. The auditor tried to cite them for ineffective internal audit system (a major finding) because for the last 2 rounds there had been no findings at all. I was in the middle because they contract their internal audits to me. So - why was he laughing? He stopped the audit and all went to the conference room. They got the registrar's representative on the telephone. The company owner explained the citation for an ineffective internal audit system based upon no findings. The owner explained that for the prior two years the registrar's auditors (visiting at 6 month intervals) came up with no findings. He explained that if the auditor was correct - that a lack of findings is evidence that the internal audit system was not effective - that it followed that since the registrar's auditors had no findings in their previous 5 visits that the registrar was obviously sending unqualified auditors and he wanted his money back all the way to, and including, the registration fees.

Of course, the 'finding' was dropped. It was decided that - gee, well, maybe no findings means that everyone is doing their jobs and doing them correctly. Personally, I wish he had kicked the auditor out the door and sued the registrar. While I won't name the registrar because of my link to clients which use them, I will say they are a major player in the registration game and have been for years.

Hope for the best, but prepare for the worst. YOU may get the Auditor from Hell!

> So (in summary) I guess the size of the company and
> maturity of the management system both play a significant
> part in determing QMS structure.

In addition to a few other factors. In summary, I agree :agree: with you 100% :thedeal:

One last thought: Enron and Mr. Lay. I wonder if Enron was registered.
 
N

Neelanshu Varma

#42
ISO9001:1994 QMS Architecture

I had come across the attached article and had downloaded it from the net - hope you all will find it interesting. It is related to QMS architecture.

Though the article is focussed on SO9001:1994 standards and software industry, IMHO most of it is applicable in the current context and applies to other industries as well.
 

Attachments

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Neelanshu Varma

#43
These guidelines by ISO Technical Comittee clarify many of the issues that have been raised related to Flowcharting and Manual structure.

*** DEAD LINK REMOVED ***
 

Tom W

Living the Dream...
#45
Marc - when we wrote the manual we loosly followed the ISO / QS numbering. Since then we have revised here and there, and one of the changes I made was to align with QS numbering as close as possible in the level 1. I find this easier during audits and even internally when we do training involving the requirements.

I am currently looking to convert to TS, but am not sure if I should wait for 2002 version or go with 1999 version that I now have.
 
A

Aaron Lupo

#46
Here is a copy of a QM that I wrote for 9K2K you are welcome to download it and use it as your own (provided you make the necessary changes to fit your business). I would appreciate any feedback.

:)
 

Attachments

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noboxwine

#47
Quality Manual- Regurg of the standard ?

--From a New Guy. Great forum. A lot of knowledge about this crazy mixed up world of COMPLIANCE.
--Of the 3 or 4 QMS manuals I've been a part of writing, I honestly can't remember too many times any format added a lot value to improvement of the organization. It's been more efficient for me to regurg the standard for 3rd party compliance.
--Then, spend the extra time on developing visual, user friendly, colorful, flow chart type Process Instructions that will make a positive impact almost every time.:thedeal:
 

gpainter

Quite Involved in Discussions
#48
Most tier 1 QM add no value that I have seen. Mostly a selling tool. The new standard helps in this area and I am glad to see that most companies converting to the 00 standard are in fact downsizing the QM.
 
N

noboxwine

#49
Yes ! Isn't it interesting that the new standard is ever hinging upon actions resulting in bottom line improvments and satisfaction; As opposed to just a selling tool. There's hope for all us Quality Types, yet. It's about time !:agree:
 
D

David Mullins

#50
Re: Quality Manual- Regurg of the standard ?

Originally posted by noboxwine
It's been more efficient for me to regurg the standard for 3rd party compliance.

--Then, spend the extra time on developing visual, user friendly, colorful, flow chart type Process Instructions that will make a positive impact almost every time.
and
Originally posted by noboxwine
Isn't it interesting that the new standard is ever hinging upon actions resulting in bottom line improvments and satisfaction; As opposed to just a selling tool
Whilst I find the comments in slight conflict, and I'm sure they weren't intended that way, I would like to give noboxwine a job.
I'll write a Quality Manual which regurgitates the standard, and s/he can front senior management, middle management, fornt line management and the staff to explain how the primary document of the system should be ignored by them, as it's standard related crap that is inconsequential to the actual implementation and operation of the management system. No Personal Protective Equipment will be provided.

PS: It's OK to put wine in a box, that way you know which stuff not to drink.
 
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