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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
#21
Going off topic is not a big thing around here as you know (it's one of my personal specialities...) - I really AM interested in ISO 13485 and thought a dedicated thread would be a good idea. I may be wrong - it may be relevant to this thread. Nothing to be sorry about. I apologise if was 'stern' sounding.

BTW - to start a New Topic (Thread) just go the the appropriate forum and click the Start New Topic button.
 
J

John The Auditor

#23
People,

As a 3rd party auditor please stop giving me the regurgitation of the manual.

I konw you dont meam\n it.

One of my favorite manual contain 60 linked flowchart - that's it.

Another is a 600 person project managment group whose total manual is about 30 pages. The rest of the system resides in a system called formware. These are forms that require certain valid inputs before a process can end or begin. All the deliverables from a process are defined. The whole system conains not one word of ISO speak
 

Marc

Captain Nice
Staff member
Admin
#24
Originally posted by John The Auditor

One of my favorite manual contain 60 linked flowchart - that's it.
I don't think that the issue is that simple, but I agree with you. The problem generally lies in that companies that have been in existence for a while already have procedures in place. In addition, my ISO 900x experiences - dating back over 10 years - is that many auditors will be going through the documentation and say "Well, what about line item x? Specifically where does it say that in your supporting procedure?" To me it was, early on, enough auditor bull - give the auditor something simple enough that everything is there and directly points the auditor to the appropriate documentation. And don't miss even 1 line item. I have since prepared my clients for, and expect (sorry :( ) a really stupid or pricky auditor. If we 'get a good one' - all the better. If we get a 'picky' one we're prepared.

I can't remember if it was in a thread here or in the ISO ListServe *** DEAD LINK REMOVED *** but there was a good discussion on whether you even need a quality manual. There was some good back and forth. I personally 'require' clients to have a quality manual because they are so simple to do and they serve as a directory - pointers if you will - to fulfillment of the requirements.

It also may be that you know what you're doing. The 'Call for Auditors' has brought every known type of soul out of the woodwork and into auditing. Just as it has in consulting, I will add, being a consultant. Everyone seems to have taken early retirement and is now an auditor or consultant. I have run into some of the stupidest auditors that the world has ever seen. Many (most?) simply do not accept the 'outline' idea.

A quality manual is so easy to do - and for most 'starters' ties everything together that I've never seen it as an issue. I'm in the middle of my third and 4th update to the 2000 version and have a simple, fill in the blanks manual. Take old manual, bring the pointers over. Check old manual for additions (they all have modifications to some degree specific to the company) and bring them over. A morning's job if you stick to it.

Do I agree with you? Yes. But I bet that to the largest % of auditors that would be like waving a red flag in front a bull. In part I say this because I went through something similar (auditor ignorance) with flow charts in 1995. The auditors came in and it took close to an hour of negotiations before the auditors would conceed that flow charts are, in fact, procedures. It was the first company that I did all the level IIs in flow charts. The auditors had never seen such a thing! Though converted and dated in1996, if you take a look at these old flow charts you can see some the originals. They have been posted there (here?) - free - for almost 6 years now to give people ideas about how to approach simplifying documentation.

This last June I finished up with a client who had everything on the intranet in chart fashion. It was really neat. Started with a top level 'company' flow chart - sorta like a tree and all the sub-processes were branches. Everythig was interlinked. No - no Mickeysoft bull and bugs - just a cheapie program (which is really, really nice, called SmartDraw). Systems flow charts were so linked that - click on a 'referenced Form' and it would open right up. I originally argued against it and its complexity, but they over ruled me and did it - and did one heck of a job. I still think they over did it, but it really is nice.

Again - I agree with you, but reality aften smacks us in the face when we're not prepared. I just wish I could remember where that thread on whether or not you need a quality manual is. If I run into it I'll come back to this thread and post the link.

> The whole system conains not one word of ISO speak

The only 'Iso Speak' is in the quality manual its self. Limiting it to that space can do wonders.

> Another is a 600 person project managment group whose
> total manual is about 30 pages.

If you're referring to the quality manual, the 'form' I use is about 21 pages, 10 point Ariel, includes the 'Figure 1 diagram, complete index, references, etc. I don't think that's too long.
 
J

Jim Biz

#25
Refreshing !!

As a 3rd party auditor please stop giving me the regurgitation of the manual. I konw you dont mean it.
John- a truley refreshing comment -
If I knew that YOU were going to audit our system - I would gladly "revert" to the style of our origional efforts back in 96.
(It was a "combination of" charts & COMPANY wording - on how we were intending to satisfy the standards language.)

I was told at the time that It was "not sufficient" and could not be effective because it "strayed" from the standards language itself. Our Auditors comment - I must see the standards reflected in your manual word for word - <u>mirror image</u>. (we even argued over minor wording differences - and vs and/or)

Well needless to say - I was at the time unanimous in my opinion - at that point even our local consultant was questioning my efforts although he understood what we had done - his position was we had "left ourselves open" to too many questions and arguments.

My management folks took a very strong line on this & cleaned up the issue thru the only channel they could control (that would be ME) ) -- told me to do "whatever was needed" to get through the registration - no need to stick to your guns at this point & have it be a cause for expensive 2nd or 3rd audits to obtain the registration - RIGHT?

Frankly - I can't POSITIVLEY - say our big gun mgr's "mean it" - but I can tell you "I mean it" and remind them "the standards require this-and/or that" every chance I get..
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#26
Question: what is the definition of “rolled our own”?

This is a long standing discussion, but I think an important one. I must admit that many of the Quality Manuals I review are reiterations of the ISO Standard. Some are purely canned products and for me, this says a lot about the organization using it.

Second Question: what does this group think the ‘masterpiece’ effort would look like?

Regards,

Kevin
 

Marc

Captain Nice
Staff member
Admin
#27
> I was told at the time that It was "not sufficient" and
> could not be effective because it "strayed" from the
> standards language itself. Our Auditors comment - I must
> see the standards reflected in your manual word for word -
> mirror image. (we even argued over minor wording
> differences - and vs and/or)

This is precisely why I require a manual and why I wrote what I did. I do learn from experience (well, sometimes I do and sometimes I don't - but this time I did) that it's not worth a pissing match over words - which is what audits sink to quite often. Verbal battles and interpretative BS.

> Question: what is the definition of "rolled our own"?
>
> This is a long standing discussion, but I think an
> important one. I must admit that many of the Quality
> Manuals I review are reiterations of the ISO Standard.
> Some are purely canned products and for me, this says a
> lot about the organization using it.

In my military manufacturing days - and again when I entered automotive - there were requirements for a quality manual and/or a product quality plan. Somewhere in the contract there would be one. This was before ISO 9001 was popular - well, in the case of my Mil experience before ISO was released. Customer quality manual and/or quality plan contents were usually dictated more by bullet points (minimum contents index). So - you could sorta write your own. You addressed issues like how you deal with nonconforming product - but you wrote it and auditors were not looking for verbiage as the ISO auditors often do. Their interest was that a system existed, was documented and followed. You can see this to some degree in ISO 9000:2000 where they list the concepts. Since we all have ISO 9000:2000 handy (don't we? :confused: ) take a look at Annex A Figure A.9 - Concepts relating to conformity. There are some concepts auditors would look for. But they didn't pick your ass hairs over verbiage like the ISO auditors so often do. This is where I first understood the term Meeting the Intent.

One thing to remember is prior to about 1990 not many companies even had such a thing as a quality manual per se.

To me, Roll You Own is where you describe your system as it exists and that certain fundamental concepts exist within the system (such as segregation of nonconforming product as an element of your nonconformance system) without resorting to ensuring every single word in a 'standard' is - somewhere - repeated.

> Second Question: what does this group think the
> 'masterpiece' effort would look like?

I prefer the 'Roll Your Own' for every system except the quality manual. And it will look like - what you do (specific to your company). The 'quality manual' has evolved into - well, a standard within its self.<hr>I should point out that even though I talk about a 'canned' manual which I use for implementations and upgrades, I expect certain tailoring in each company. That is to say, there is the standard - word for word - and you have your references. You always have to take a look at the company and at the manual and at the procedures as a whole. Typically there are some 'notes' or other additions or clarifications added here and there.
 
J

John The Auditor

#28
As a 3rd party auditor I can only make one comment to those of you who are tired of auditors who demand manuals that mimic the standard word for word, who reject procedures because they are not in the right format, etc.

FIRE THEM !!!!!!!!

You pay them a lot of money and if you are not getting value treat them like any other poor supplier - GET A NEW ONE!!!


Until people start to to take control of their ISO registrations and demand that narrow minded auditors are no longer welcome the problems will continue.

Another hint - find auditors who have a lot of busines experience - especially those that have had excellent sales careers - they know what customers want.

Avoid the person who has spent an eternity as an inside resource in quality - they can write a procedure that looks great - no one wnats to uses it though.

Remember accountability to a customer for a quality issue is not the same as accountability to your company for the customer and the revenue generated
 

Marc

Captain Nice
Staff member
Admin
#29
The easy answer is Fire Them!

You reach a point where you can't keep calling the registrar and telling them to "...send another auditor because this one wants us to ....". Or finding another registrar. It's an expensive, time consuming process. Hopefully a company will choose a 'good' registrar to begin with. But that in its self is not always the case.

Unfortunately - nearly all the auditors I have ever dealt with want to 'see the words'. For something so cheap and quick to do as a 'quality' manual (which I prefer clients call their 'systems' manual, it's simply not worth even going through the possibility of spending the time with a 'difficult' auditor. Anyone who wants to take a chance of getting an auditor such as you is welcome to take the chance. To me the odds are just not worth it and it's not a big deal.

> Until people start to to take control of their ISO
> registrations and demand that narrow minded auditors are
> no longer welcome the problems will continue.

I don't see it as a 'control' issue considering probably 80% (a guess) of the auditors out there don't think like you. It's line by line - by the book for them. My only true concern is an auditor's ability to see the requirements in light of the type, size, etc. of company they are auditing. For example, in an insurance company - what is nonconforming product and how do you deal with it? What does a corrective action system look like in an insurance company? It's these issues (like the auditor who did a writeup for use of whiteout citing legibility of quality records in the old 4.16 and one other clause I forget off hand) in a situation where whiteout wasn't a risk factor and the 'record' was not a defined quality record (which he decided should be - and demanded that "...next audit it will be one of your quality records..."). These are things which bring thoughts of changing registrars.

Me? I say sweat the big stuff. Don't worry about an issue of providing a quality manual which word for word repeats the standard.
 

JodiB

Still plugging along
#30
so happy to hear that!

Having worked for a registrar, I felt ashamed of myself for "taking the easy way out" and being "unimaginative" in creating a manual that follows the standard's numbering system, and being almost anal in making sure that I used all the key buzz words in each section. I did take a bit of literary license in saying some things but for the most part I just wanted to make sure that all the right words were there and couldn't be argued with.

At least this way, I feel somewhat confident that our manual will pass scrutiny and is one less thing for me to worry about.

It feels great knowing that the majority has done the same thing!

:confused: But now I have a question: Someone mentioned to me somewhere that I should consider having an appendix of approved procedures ( or attachment, or something) with the manual, as opposed to referring to the procedures within the sections. This was to allow me to add/ subtract, etc. the procedures without doing a revision of the manual.

The Organization Chart is something else that is supposed to be an attachment for the same reason.

My question is : are these pages rev'd individually then? Do I put some sort of rev level on them?

And in the page numbering of the manual (both on the page and as referenced in the Table of contents), are these attachment (or is it "appendix" ? ) pages listed consecutively or do they have a different numbering scheme? The org chart is inserted around page 8.

I have other things like a figure of the documentation pyramid, and a table of responsibilities for the QMS.

Any help is appreciated!:bigwave:
 
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