Poll: Should auditors promote the process approach?

[ISO 9001 Guy]

Let's see if I got it right now: The element-by-element approach is one in which the organization writes its process documents in a way that simply reflects what the Standard says; the documents don't describe the processes themselves really, and make no attempt to show how everything works together to ensure customer satisfaction. "Canned" documentation kits make it so easy to do this - just add the organization's name in the space provided. We in the Cove have warned people against this practice too many times to count.

How close did I come to what you have been trying to say, ISO 9001 Guy?

That's pretty close. Part of it, anyway. Sorry if I wasn't being clear.

 

[ISO 9001 Guy]

I asked for specifics on what you, the auditor, would accept as objective evidence your client is using the process approach, and this thread contains almost complete theory.

Jennifer, please allow me to help you answer your question.

What are the characteristics of a controlled process? (You began to mention some earlier.)

 

[ISO 9001 Guy]

I think it's unfortunate that we even need to discuss a question like the original one, because the process approach should be promoted from within the organization, not from without.

The guidance in question is directed at CBs and auditors, isn't it? That's why the question.

 

[Jen Kirley]

The guidance in question is directed at CBs and auditors, isn't it? That's why the question.

No one here is disagreeing that guidance is being directed at CBs and auditors. The disagreement is in how it should be carried out without losing impartiality.

 

[Jim Wynne]

Jennifer, please allow me to help you answer your question.

What are the characteristics of a controlled process? (You began to mention some earlier.)

Not answering for Jennifer, of course, but a controlled process is one in which:

• Input and output requirements have been explicitly defined;
• The method of processing has been explicitly defined, including any exceptions that might be permissible and,
• the performance of the process is acceptably predictable.

 

[ISO 9001 Guy]

Not answering for Jennifer, of course, but a controlled process is one in which:

• Input and output requirements have been explicitly defined;
• The method of processing has been explicitly defined, including any exceptions that might be permissible and,
• the performance of the process is acceptably predictable.

It's a start. But let's work a little harder on that, please. Is there guidance available anywhere to describe common characteristics of a controlled process? Beyond the definition involving "input" "process" "output"?


"Method" is an important one, as you suggest.

Anyone want to chime in here? Help us out? As a group effort, this could be fun--really!

(I'm looking for a reference document or something from ISO, not that we need it, but it will be useful to associate our results with those of the guidance. If you know what I'm talking about, please say so. Bear in mind that the guidance is usually so very sensible, we should be able to naturally arrive at the "official" principles ourselves. Going through this exercise helps us understand ISO language and how it applies to what we do.)

 

[Jim Wynne]

Let's work a little harder on that, Jim. Is there guidance available anywhere to describe common characteristics of a controlled process? Beyond the definition involving "input" "process" "output"?

I don't need to work a little harder; you asked a question and I gave an answer. Shall we agree to disagree (again ) or if you feel that the answer is inadequate, would you rather teach me something?

 

[ISO 9001 Guy]

I don't need to work a little harder; you asked a question and I gave an answer. Shall we agree to disagree (again ) or if you feel that the answer is inadequate, would you rather teach me something?

I adjusted the question, trying to give us a starting point.

I hope others will chime in. This could be fun.

 

[ISO 9001 Guy]

No one here is disagreeing that guidance is being directed at CBs and auditors. The disagreement is in how it should be carried out without losing impartiality.

It is, isn't it! Good sign!

 

[Paul Simpson]

When discussing ISO 9001 issues, it's useful to use the definitions in ISO 9000:2005. That way, everyone is talking the "language of the standard." When discussing quality management systems, the ISO 9000:2005 definitions for process and system are very important. And procedure. And (quality) management system.

OK. I can live with it - not a very elegant definition of "system": "set of interrelated or interacting elements." but then it was developed by a committee.

i'd still say a six sigma process meets that definition - wouldn't you?