ISO 9001:2000 Process Approach - What is it? Is it 'Real'?

[M Greenaway]

I actually laughed out loud to that last post - great stuff.

Seriously though in the maze of 'good advice' it is difficult to know who is telling the 'truth', especially when at the back of your mind is the fear of losing your ISO cert (rightly or wrongly it is important) if you screw up.

I would rather cite in defence during a third party assessment my rationale for taking a certian approach was based on what TC176 recommended. Would certainly carry more weight than saying 'well thats what John Seddon recommended' - of course this is based again on the desire to retain certification (sadly).

 

[Marc]

Any Thing new?

Any new views with respect to the Process Approach?

Just asking.... :thedeal:

This was a pretty hot thread a year ago!

 

[ccochran]

Process approach

Howdy, folks:

I definitely agree with Marc on this. Despite all the hoo-ha about the process approach in ISO 9001:2000, there really aren't any radical requirements related to processes in the standard. Basically, these are the process highlights:

*** The standard writers attempted to organize the requirements in a process approach style. Big deal.

*** The organization must identify the processes needed for the system and their sequence and interaction (4.1 a & b);

*** The organization's quality manual must include a description of the sequence and interaction of processes within the system (4.2.2 c);

*** Product realization processes must be planned. [If this isn't already happening, then the organization is in deep trouble] (7.1)

*** Monitor and, where applicable, measure the processes that you identified. When the processes don't achieve planned results, take corrective action. (8.2.3)

Those are the highlights. There are other mentions of processes, but these are the requirements that require some kind of real action, in my opinion. It's not much.

True "process orientation" is much more than making a few high-level flowcharts. It is truly aligning your organization around the natural business processes that exist (...as opposed to aligning your organization around functional departmental boundaries).

When you get bored, take a look at this article of mine from Quality Digest (May, 2003): http://www.qualitydigest.com/may03/articles/05_article.shtml. It is by no means the last word of process orientation, but it attacks it from an angle that makes sense to me. I'd enjoy hearing your comments on the article, or anything else I've blabbered about.

Talk to you soon,
CC

~~~~~~~~~~~~~~~~~~~~~~~~~~~
Craig Cochran
Center for International Standards & Quality
Georgia Institute of Technology
[email protected]

 

[M Greenaway]

The change is only radical to the ISO9001:1994 standard, and to those quality professionals who grew up with it.

Most business leaders would see nothing radical in the process approach itself.

 

[energy]

Absolutely

The change is only radical to the ISO9001:1994 standard, and to those quality professionals who grew up with it.

Most business leaders would see nothing radical in the process approach itself.

True. I'm one of those. Not just because of ISO. Mil-Q-9856, Mil-I-45208 and associated "standards" were never fashioned with "Processes" in mind. It's very difficult to make that transition when you do not think about "processes". We just look at "things"! If you say that most Business Leaders, past and present, would see nothing radical in the process approach then that explains why I'm a follower.

 

[Randy Stewart]

Good Points All

True "process orientation" is much more than making a few high-level flowcharts. It is truly aligning your organization around the natural business processes that exist (...as opposed to aligning your organization around functional departmental boundaries).

This is the most difficult task we have found, especially when dealing with specific skill sets (metal model maker, welder, etc.).
It seems that by segregating individuals by skills, expertise, department function, etc. it promotes "departmental personalities".

 

[Icy Mountain]

Do it right!

I found some old stuff on The Vanguard Standard while looking for help on whether my CFO can be the Mgt. Rep. (why not!). Anyway, I probably fall somewhere between a strict interpretation of 9k2k and Seddon's systems thinking. The CEO of the company I registered to 9k94 would have had me drawn and quartered if I had reorganized his company into 20 sections. We worked carefully with a good (i.e. knowledgable in the standard and trained as a lead auditor) consultant to fit the 20 sections of the standard around our existing practices. We wrote a nice regurgitative (I like that even if it's not a word) manual and pointed to the process maps that defined how we ran our business. Where we were not doing "shalls" we added them to our overall business process. The CEO of my present company is much more systems oriented but the ISO9k2k process map still doesn't define the whole of our business sytem. 9k2k is just a foundation. Our competetion would kill us if that's all we did. We have a system model that gives us and edge and we will fit the 9k2k/TS2 requirements inside of that to satisfy the customer's requirement for a registered system.

 

[Icy Mountain]

>You have to look at your company and decide what you need and where. Then the auditor asks you about your rationalization(s).

In these forums you can get the most precise detail because you can post more and more details of your specific company and processes for people to consider and comment on.

Or - more to the point but isn't free - get a consultant to come in and take a look and talk to you about your situation. An assessment by a good consultant is typically worth the money.

Marc is not just plugging his own services here.
I had to come back and make sure everyone understands and is ready for this:
If you deviate from a strict, literal, exact regurgitation of these standards, you must be fully informed about, trained in, and understand fully, the standard or you will get a full-on-auditor-slammin'. You must be ready with intelligent answers that directly address your assessor's questions about how you meet the shalls. If you are taking a novel approach to registration (say: a 5 page quality manual, 2 dozen process maps, and your entire executive team as "mgmt. rep."), you can and will register if you cover all the shalls. I suggest you implement a no-nonsense, systems approach that fits your business, assisted by a good consultant (like Marc), and don't go anywhere near a registration audit without them, unless you are 100% confident that your brain has fully absorbed their approach. Been there/done that/got the battle scars and parchment.

 

[Mike Smith]

If you do not deviate from a strict, literal, exact regurgitation of the standard, you still must be fully informed, trained and fully understand the standard or you will still get a full slammin from the auditor. You still must have intelligent answers if you regurgitate the standard in the manual. I guess what i`m trying to say is just because you have a manual that regurgitates the standard does not mean that you understand and are fully prepared for the audit. They are auditing the processes, not the manual. We took the "novel approach" and are scheduled for the TS2 audit in December. We did not regurgitate the standard, just made sure we had all the shalls answered with our procedures, process maps, quality manual, etc. Now, you have me worried that this is the wrong approach. But, I would still be worried even if we had decided against the novel approach. Besides, its too late to turn back now.

 

[Greg B]

We took the "novel approach" and are scheduled for the TS2 audit in December. We did not regurgitate the standard, just made sure we had all the shalls answered with our procedures, process maps, quality manual, etc. Now, you have me worried that this is the wrong approach. But, I would still be worried even if we had decided against the novel approach. Besides, its too late to turn back now.

Mike,

Don't worry IMHO I think you have taken the correct approach. You have writen a system, that I assume, is user friendly for your organisation. Case closed. I passed 9K2K last year and we are now revamping the entire system to more along the lines of what you have stated. We used to have a procedure for every clause - this is being replaced by a procedure for each process. We are not too worried about the shalls (in a written sense). If it is not documented but everyone understands it then that is good enough for us. What I mean is that if an auditor asks 'How do you continually improve?' we won't be able to show a procedure on continual improvement but we can tell him how we have suggestion systems, certain agenda items in minutes, reviews of processes etc.
Have you thought about training people to answer the questions rather than writing volumes of information? eg: the above scenario requires people to be able to understand that they are actually continually improving and how they do that otherwise when asked how they do it - they generally would not know (we are training them to understand the clauses) We are not trying to skirt the system just make it better for us. Hope this makes sense.

Greg B