Quality Manual Organization and Structure including Numbering

Stew,

I agree with what you said. But, my point is several intelligent folks here apparently cannot agree on what the "average" ISO auditor (if there is such a thing) will require to give you the certificate or what the true intent of the standard is in this area.

Let's say my cake baking biz from the previous page works great without needing to formally document the sequence and interaction of the processes in a flowchart, diagram, text doc or anything else. It is a 3-4 person Mom and Pop shop. They don't need this documentation to run their biz but let's say they DO need the ISO cert in order to keep their top customer, who just made ISO certification mandatory regardless of previously demonstrated excellent performance by the bakery. This does happen in the real world, unfortunately.

So this cake shop owner just wants to do the minimum required in this instance, regarding this requirement, to get the cert as this doc. will probably never get looked-at again. So, what is the minimum required to meet the standard? Just re-print Figure 1 from section 0.2 of 9001? Or make a complex diagram showing all processes and all possible combinations and permutations of interactions? I don't know if we can get a consensus on that.

I guess in the real-world you gotta go by trial-and-error with your registrar.

They call it Doc Review!

Mike I understand what you're getting at. I'll say it again, if the registrar doesn't like it, challenge it. They're human (I know sometimes it is hard to tell), they make mistakes too. Make them prove you are not in compliance, question the decision. Going back to your example again: I know mom & pop never go on vacation without shutting down, but if they were going to pass the business on to someone so they can retire, I bet the recipes are written down somewhere. And that by showing the order in which the ingredients were added (without quantities) and showing that I mixed the batter before I put it in the oven, I would have a flow that would pass an audit. It would probably take me an afternoon to have my stuff ready for the auditor, and that is from scratch!
Don't make it more difficult than it really is.

They don't need this documentation to run their biz but let's say they DO need the ISO cert in order to keep their top customer, who just made ISO certification mandatory regardless of previously demonstrated excellent performance by the bakery.

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Real world top customers also de-source you no matter what certification you hold. And they will keep you even if you don't hold a cert.

Stew,

You could be my auditor any day.

Are you saying that work instructions that specify the sequence of operations could serve to satisfy 4.1 (a) and (b) provided there were WI's for each "major process"??? So if Mom and Pop's bakery baked cakes on one line and pies on another, and had a WI for each, they'd be covered?

You couldn't afford me!

Basically, yes. How much deeper would you have to go??? We're not talking brain surgery. There may be some type of documentation required like a "born on date" but I think you're getting the intent. Step back and look at your business system, there is a logical flow to how things should be. ISO isn't asking you to do more than put it on paper so it can be verified. If you don't have anything documented it is abitrary. ISO, QS, TS standards do not prohibit the use of reason! I said reason not common sense - but that's another thread.
You don't have to have the big dog & pony show to get certified, if the company has been in business (especially mom & pops) for any time at all, they probably have about 95% of the things needed for certification. As you develop the system and document it remember to keep it simple. Float the evidence to the surface so it is easy to see, don't bury it under a bunch of bells and whistles. One thing I would suggest, get another set of eyes to look at what you've done. It doesn't have to be a consultant but should be someone with some experience. See if they can tell where you are going with your system. If it is a small shop sometimes you get to close and can't see the forest for the trees. Believe me, it's not that difficult.

I like the active link idea. A nice change to the restated standard manuals

Stew got me to thinking...out loud here...

In the cross-reference table of 9001-2000, section 4.1 of 9001-2000 is equated to section 4.2.1 of 9001-1994 and that section applies to including or referencing your quality system procedures in the quality manual and outlining the structure of your documentation (the old doc. pyramid most people used). So, if you are currently 9001-1994 certified or compliant, and have good documentation of your processes via 2nd and 3rd tier docs (procedures, work instructions, SOP's, etc.), and this WORKS for your company (you produce good product and make customers happy), why can that not be considered a "proper and complete process description", Jim? Do I give my company more value by drawing that stuff out in a Visio flow diagram? Have I violated the word or intent of the standard? I'm not sure I have.

I don’t mean to be argumentative, but I’m really trying to understand this part of the “standard” better and also understand why Jim is so against “procedures” as “process descriptions”.

Jim said: “One clue that I may be right is that ISO 9000 defines a procedure and a process as being two different things.”

Well, yeah, but I’m sure they define a “flow DIAGRAM” (diagram is your word) and a “process” as being two different things, but the former can be used to describe the latter (and many very detailed and fine examples have been posted in the Cove) just as a procedure (maybe?) can be used to describe a process. So, I guess I missed your point on this one.

Jim said: “It includes this diagram, which reminds us that a process description includes key factors not normally associated with documented procedures: inputs, outputs, resource requirements and performance measures”

Maybe I’m weird (go ahead, I left myself open on that one) but many of MY documented procedures (what I call Tier 2 and 3 docs under 9001-1994) do contain these factors, I think, but may not contain every spatula or measuring cup. For example, in greatly abbreviated fashion, back to the bakery example: “ Preheat the Maytag oven to 375 degrees. Mix the oil, eggs, and Pillsbury cake mix as per the instructions on the box using the Waring blender. Pour the cake mix into the 13” x 15” Chef’s Choice pan, making sure it is ¾ to 7/8 of the way full, Verify the oven is fully preheated; put the cake in the oven; set the timer for 35 minutes. After the timer goes off, put a toothpick in the center of the cake and pull it out – if it is dry remove the cake from the oven, if not dry bake for 3 more minutes and repeat. After the cake cools, remove and taste a small piece from the underside to verify moistness and flavor.” Didn’t this “work instruction” or “procedure” cover all the factors you mention?

Some folks, if I understood them correctly, feel reprinting a generic diagram like Figure 1 from section 0.2 in your QM serves the needs of 4.1 a and b when that doesn’t tell me a darn thing compared to a “procedure”, but it is a “diagram”. Stew says keep it simple, which fits me to a “T” in more ways than one, and use procedures. Some people do really fancy and exquisitely detailed Visio “diagrams”. Maybe they are ALL right as long as it: 1) Meets the company’s needs and allows them to make customers happy and 2) Meets the requirements of 9001-2000. ????

Help me here ya’ll, if there is any helping me. Any opinions welcome. And, I promise not to change the rules every time someone gives an answer!!!!

Look Out

the fact that a company has been in business a while bears no relation at all to their ability to document their processes

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I was referring to mom and pop shops being able to define how things worked.

significant distinction between a process description and a documented procedure

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I may be throwing a wrench into the mix but your above quote is correct. However, it is not necessarily what 4.1 a & b is calling for (IMHO). Identify needed processes, identify their applicability to your organization and determine the interaction throughout. Personally I perfer process flow charts when I audit. It gives me a better feel for what is happening rather than reading a procedures. I won't say that I "require" one over the other.

The PDCA diagram gives us a process flow and shows interaction. I think we all will agree to applicability. Can you take it farther, sure. 4.1 a & b doesn't call for a process flow, nor does it call for a procedure. It calls out for them to be "documented".

I won't tell you that you are wrong Jim. But what you seem to be saying, if I understand you, is that only by deep documentation will you be able to satisfy this requirement. I just can't see it that way using the bakery example we have been using.

I have some very "deep" flow charts and process descriptions for some of our processes (digital scanning dies, cut package development for the NC Mills, etc.) but the operations that require training or acquired skills, have little. I'm not going to make a die designer to have a procedure that covers die design in detail. I'm paying him for his skill level and if he needs that in depth process description then he is in the wrong business or I'm paying him way too much.

That's my spin on it. I understand that we need to have defined processes, and that they have to make sense to our auditor/registrar in order for them to understand the system.

Jim,

I know you like a challenge and you left yourself open to one. Let's test your ability to satisfy 4.1 a and b in clear, simple, "complete and extremely useful" AND ISO compliant format. (Sounds like another thread.....). The business is the hypothetical bakery we've discussed, the product lines are cakes on line 1 and pies on line 2 but you only need to do cakes.

You said you think you could describe all the processes of most businesses on just 1 page, so this Mom and Pop shop should be duck soup. I can't wait to see it. Maybe you will help hundreds of folks here. So, do you accept the challenge?

Jim,

Sure, I'll play -- after all I issued the challenge.

From a previous post, here is how Mom and I run our business:

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 guess I should add I either get paid on the spot or for big customers issue an invoice at delivery and give them net 15 terms.

Does that give you all the needed info?

P.S. -- Don't just facillitate here -- do the work! Consultants...jeesh.