Quality Manual Organization and Structure including Numbering

I was still on the upper level stuff. Here's how I was looking at it. If you have (2) defined the process, then you have established the resources required, and, if you have (4) established linkages then you have determined where the inputs are coming from and where the outputs are going to. By no means was this meant to define the only parts or portions of a process. This is basic stuff. I agree with you that resources and "WELL" defined inputs and outputs are needed. To show our interrelationships between process I don't think you need to get that deep for your QM (IMHO). That's all.

Mike

In a corporation our size I believe process mapping is a very useful tool in identifying and understanding how processes that have evolved over a number of years, from various peoples tinkering from their own perspective, actaully operate. From this useful data we can then look at re-designing our processes so that they are more effective and efficient.

But true that in smaller companies it could be unnecessary.

A person, at least a dense one like me, sure could get corn-fused about what really is required in actually documenting one's processes -- for the satisfaction of an auditor that is, as you can always ask your internal customer if the detail is enough or not.

Tarheel said "We broke our flow down into the major departments such as sales, purchasing, manufacturing depts, etc. Then I listed what some possible inputs and outputs would be. Our auditor said that was suffiecient to satisfy the standard."

If I understand gpainter correctly, (perhaps I do not) all one needs to do is transfer an exact copy of Figure 1 from section 0.2 of ISO 9001 to your QM to be in compliance with the minimum requirements of the standard, but I don't see how that would explain anything about "our" processes to anyone.

Other posts I've seen show process flows using fancy flowcharting/graphics programs that have tons of detail and great complexity.

So.... Do you need to show all processes, or just "top level" ones? What are "top level" processes? Do you show all possible inputs and outputs or just "some" or "major" ones?

Let's say your small company bakes cakes. You send out flyers and have a web site for marketing but also get some word-of-mouth advertising; take orders by phone, internet, or occasionally someone stops by your shop to order; you purchase cake mixes, eggs, oil, and icing based on orders; mix-up the batter; bake the cake; icing the cake - sometimes adding special decorations or writing; and finally deliver the cake.

I can see very complex flow diagrams with lots of arrows everywhere for this simple business process flow description, or I can see basically the text I've written doing the job. But, what is needed?

Sorry in advance for asking

I think......

The standard only requires the top level 'model' that you describe, such as that shown in the standard itself or the many derivatives posted to this forum. I believe this is only mandated for external audit purposes.

Proper process mapping is a specific tool that serves another purpose, which perhaps we dont want to be dragged into discussing here.

.....I think

I'd NEVER do anything that ISO 9001 seems to say - or an auditor suggests - unless I was convinced that it's in the best interests of the organization in question.

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On the other hand I guess that, once we have a decent process description, we might as well use that and not do something special for the 'quality manual'

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My loudest approval on this Jim. I don't have a QM either and the only Quality Procedures we have is in the "Quality" Department (which is planned to be phased out over the next 3 years). It has taken a long time but with the help of our operations group we are starting to knock down the barriers between Quality and the Manufacturing or Business environments. IMHO the first step is in the nomenclature, we start the division there and it follows the whole system through. But we have had this discussion before.

I just want to add one more point here. If you come from a inspection background, how often did you see someone submit a part to be told if it is good? Not for to tell them they were wrong but more like - here's the part, tell me if it's good or not. Anyway, this use to get to me so when I go through audits I go in with the attitude that we have the greatest system in the world and it is up to the auditor to "PROVE" to me that I'm wrong. This goes beyond their individual opinions and such. Just like I have to show them evidence, they have to show me evidence.

The last 3 external audits I have done, this wasn't the case. In 2 instances the systems were good, but you could tell no one "believed" in them. It was like auditing with multiple guess records and procedures. If they passed or not isn't the point I'm trying to make. Don't set up a system just to fulfill the requirements. If people can't grasp it, it's going to fail. Human nature states that what I don't understand, I fear. And what I fear I destroy.

M Greenaway said:

I think......

The standard only requires the top level 'model' that you describe, such as that shown in the standard itself or the many derivatives posted to this forum. I believe this is only mandated for external audit purposes.
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Martin -- If so, that is one screwy requirement. As an outsider how would I know anything about your processes by looking at that generic "Figure 1"?

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Proper process mapping is a specific tool that serves another purpose, which perhaps we dont want to be dragged into discussing here.

.....I think

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Nah, drag us into discussing it. I think I know what you'll say, but go ahead, I may be missing some points.

I'd NEVER do anything that ISO 9001 seems to say - or an auditor suggests - unless I was convinced that it's in the best interests of the organization in question.

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This really scares me. I think this is about the fourth time in as many days that I agreed with Jim. Either he is coming around, or I am coming around, or we are just both communicating better.

My personal recommendation is you take Jim’s quote and post it on the top of every monitor in the place. It is YOUR system and it needs to work for YOU, not the registrar!

I have been beat up quite badly on occasion when I say that process mapping is not required. The standard requires you to know and understand your processes. You must identify them and describe their interaction. Process mapping is one good way to do that. I have seen companies that have approached this like filling out an FMEA. “Just put something down for the auditor.” This does nothing for the organization and for the auditor.

Many different ways to handle including: transfer of figure 1,using a process wheel, using the cross reference in the appendex of the 00 standard, if you have a reference section to each procedure that would also show it(as you reference other related procedures), flow diagrams,etc. Would like to here from a registered company on how they took care of it???

I thought 9000:1994 had some vague/open to interpretation sections in it - and I still do -- but compared to 2000 it seems positively clear. Some of that may be familiarity, some of it may just be the way my brain is wired, but I'm convinced that part of it is that 2000 really does has more ambiguity in it than 1994. Then again, maybe I'm just nuts!

Mike if there is anything to be clear on is this:

It is YOUR system and it needs to work for YOU, not the registrar!

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If you are getting registered just to register, don't waste your money. The standard is a guideline only, yes there are a few things it says you must do, but it doesn't tell you how. That is up to you. Going back to the small business that bakes cakes - the standard may tell you that the cake needs to be packaged and the ingredients need to be approved (so you don't give anyone a type of disease) but it won't tell you the amount to use. That's yours to figure out.