Permissible Exclusions in Section 7 - Design control requirements - No design

W

wajnberg

#1
Hi guys,
This is the first time I start a new topic, although I´ve been following all discussions particularly in the ISO 9X forum, where I´m more interested.
I would like to hear from you on the permissible exclusions (clause 1.2 of ISO/DIS 9000:2000, particularly where design/development is concerned.
To my knowledge, many companies registered to IS0 9002:1994 in order to avoid compliance with the requirements of design/development of IS0 9001:1994. In situations where IS0 9001 was not a contractual requirement, it was reasonable to understand that companies would opt towards IS0 9002.

When IS0 9002 is removed those companies will have to comply with IS0 9001, which includes requirements for design/development.
My questions are:

Will these companies be able to justify exclusion of design/development requirements?

Let us now imagine a company registered to IS0 9002 in Brazil, subsidiary of a large multinational group, manufacturing products with the technology obtained from a non registered American manufacturer from the same group. It´s reasonable to expect that as years went by, the brazilian subsidiary has also adapted and even made some minor developments on similar products, more adequate to the brazilian market and conditions. This situation has been happening with products in the market for years.

How will such situation be handled by the registrars?

In a recent article for Quality Digest, it is stated that “The intention is primarily to allow exclusion of design control requirements where there are no design activities”. I hope that is right.

What are your views?
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
I'm going to first point you to this discussion thread: Design - Widget vs. Service Organization Product

There will be much debate about this. I do not agree wholly with “The intention is primarily to allow exclusion of design control requirements where there are no design activities”. I believe that just about every company does some type of design - even service organizations. The problem is many people don't associate the word design with anything except 'widget' design. But, as the other thread points out there are aspects of what a service company does which are clearly design (in my opinion).

This, by the way, was recently e-mailed to me: I am presently adapting the design aspect of ISO to programme development. However, the resulting detail it requires the programme co-ordinator to think about makes them very reluctant to embrace the concept. Imagine asking them

What is the purpose of your programme
What are the input to your programme
Why did you select these inputs
How do you know they are valid inputs
How do you assess the need to change the inputs
How do you know the programme works


A secondary thought here - you can exclude many aspects of a business from the defined registration scope. Many want to make thisw a 'moral' issue as much as anything else. I remain non-judgmental - if you want to exclude something from your registration scope that's your business. Your customers requiring registration will make the decision on whether what is in the scope is sufficient or not. I have seen companies exclude specific production lines from their registratyion scope. I'm not saying this is a good idea, but I refuse to moralize on this one.
 
W

wajnberg

#3
Marc,
I didn´t refer to the other forum because I thought the discussion on that topic was more related to service organisations. I am concerned about all manufacturing organisations that are certified to ISO 9002,and are actually making product development to different and variable extents. It will be very difficult for registrars to define the starting point from which the design/development requirements of the Standard need to be applied. Therefore, as You said, maybe the best thing to do is to let certified customers decide about the issue.
But, let´s imagine that we have customers certified to ISO 9002 who want to start working towards the new Standard. How should we handle this matter? Maybe the best for the time being is wait until things get more clear. Don´t you think so?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
It will be very difficult for registrars to define the starting point from which the design/development requirements of the Standard need to be applied.
Registrars don't. You do. You determine / identify what you do, when you start, etc. remember, each project will differ somewhat.

I think you're taking this a bit too hard. You look at your organization and the interfaces you have. You look at section 7 and (in addition) you see what you do and do not do. Maybe you just get prints and build to them. just as with ISO9002 you justify what you do and do not do.
But, let´s imagine that we have customers certified to ISO 9002 who want to start working towards the new Standard.
I worked with a company in the fall - winter 1998-99. They registered to the 1994 version in June 1999. But - the quality manual I wrote for them was to the draft of the time. Yup - they'll have to upgrade the manual a bit, but for all intents and purposes they are compliant to ISO9001:2000. And 2 of my current clients are working on the year 2000 version.

I don't believe there's too awful much clarity to come. As I have looked thru the proposed changes I simply don't see that big a change all in all. My opinion of the doomsayers is that they compare top the Y2K doomsayers: Instead of a lot of "You wait and see!" you're getting "But it might radically change!" and "It's so drastic changing will be a serious problem." I'm sorry, I don't buy it.

My opinion? Don't be afraid. Start upgrades now.
 
F

Frankie

#5
I' going to write a manual based on DIS for a 9001:1994 certification, but I'm not sure the registar is going to like it, I've been told that many registars until now recommend to mantain 9001:1994 structure, and add in a separate section the new requirements of DIS... I don't agree with this, but I don't know what to do.......
What's your opinion about that?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Originally posted by Frankie:

I' going to write a manual based on DIS for a 9001:1994 certification, but I'm not sure the registar is going to like it, I've been told that many registars until now recommend to mantain 9001:1994 structure, and add in a separate section the new requirements of DIS... I don't agree with this, but I don't know what to do.......
What's your opinion about that?
My opinion is make a matrix. I doubt a registrar cares how you structure your documentation. What they do want is a clear way to see where you meet the spec.

A number of my clients have kept their existing documentation structures and those structures were in place well before ISO9000 was a part of their 'plan'.

See Doc_map_B.pdf and Doc_Matrix.pdf in This Directory

The question is, if you decide to have a separate quality manual (which most companies do), how do you structure that. My current clients are structuring their systems manual after the 2000 DIS - which I suggest is appropriate.

Do what you want - the registrar doesn't care.
 
F

Francesco

#7
Marc is right, the matrix is a good idea, expecially for small organizations. I've done it for my last client, It's very similar to the example Doc_Matrix.pdf,in addiction it includes the distribution list: doing this way you can remove from all the procedures that matrix, and in case of add/remove someone from the distribution list of one or more procedures, you are not compelled to make a revision of every document, but only of the main matrix.

Returning to the registars, don't care them, Frankie, simply meet the requirements and go straight your way.
 
W

wajnberg

#8
Frankie,
I´m also working on a matrix for the System Quality Manual. And to get my work done more quickly, I downloaded document hb150 from Standards Australia. It costs something like US$ 17.00, I think, but I found it very useful, because it shows very clearly all the changes between the 1994 and the 2000 versions.Take a look at it. May be you´ll find it useful too.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Permissible Exclusions

From: ISO Standards Discussion
Date: Thu, 10 Aug 2000 11:12:01 -0500
Subject: Re: Permissible Exclusions /../Trudeau/Arbuckle/Salinger

From: rudy.salinger dowcorning.com

Although ISO 9001:2000 would say "purchasing" cannot be excluded from the Quality System scope, it should be possible to address this requirement with minimal effort. The process which you would have to "establish, document, implement, and maintain" might be as simple as a statement in the top level documentation (Quality Manual) that "no materials or services that affect product quality are purchased. All other purchases are at the discretion of the employee requiring them." But you will have to be sure the exclusion of "services" as well as materials is valid, otherwise you will indeed have to put up a process.

The justification for this approach is the statement in ISO 9001:2000 that "The type and extent of control shall be dependent upon the effect on subsequent realization processes and their output."

This is my opinion, but it should be verified with the firm's registrar.

Rudy Salinger

> From: "Donald Arbuckle"
> Let me see if I understand this...

> If my company does not purchase anything (all parts, equipment, facilities,
> etc. are provided by the customer) other than laser paper for office use,
> pens/pencils, etc, then in order to meet the requirements of the standard
> and become compliant/registered, I must still establish, document, implement
> and maintain a purchasing process?? Doesn't this conflict with the
> requirements in 4.1 a), "identify the processes needed for the quality
> management system"?
> [I have other examples, but all reflect the same point...]

> I look forward to the technical specification that makes this perfectly clear...

>> From: "Trudeau, Pat"
>> John:
>> I have talked to a TAG team member personally about this and the only
>> exclusions are servicing and design. The team is in process of writing a technical
>> specification on the permissible exclusions right now that will make everything
>> crystal clear. You can also call ASQ directly and talk to Patty Kopp in standards
>> who will verify this.

**************************

From: ISO Standards Discussion
Date: Thu, 10 Aug 2000 11:13:45 -0500
Subject: Re: Permissible Exclusions /../Trudeau/Hartman

From: dhartman

Pat Trudeau stated, "I have talked to a TAG team member personally about this and the only exclusions are servicing and design."

In fact at this year's ASQ Annual Quality Congress Charles Cianfrani stated that the reason that 7.6 Control of Measuring and Monitoring Devices was placed in Section 7 was to allow service organizations the ability to take exception to it (since Section 7 is the only section where exceptions can be taken).

This would lead me to believe that it was "intended" (at least by some members of the TAG) to allow for exceptions to be taken to any/all portions of Section 7.0, as appropriate for your organization.

David Hartman

***************************

From: ISO Standards Discussion
Date: Thu, 10 Aug 2000 11:28:58 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Kozenko

From: Write9000

Don Arbuckle writes:
> If my company does not purchase anything (all parts, equipment, facilities,
> etc. are provided by the customer) other than laser paper for office use,
> pens/pencils, etc, then in order to meet the requirements of the standard
> and become compliant/registered, I must still establish, document, implement
> and maintain a purchasing process?? Doesn't this conflict with the
> requirements in 4.1 a), "identify the processes needed for the quality
> management system"?

Don and List:

I'm not saying "do this or else" because it's not appropriate for every firm, but here's a case where the answer to your inquiry is "Yep, you need Purchasing Procedures in all cases..."

I stayed late one evening (when my kids were young, no less ;o) to manually "baby-sit" the high-speed copy machine while we (as in, me and the machine ;o) ran 20 copies of a report due to the client, earlier that morning.

INDIRECTLY, the purchase of a bargain brand of copier paper had resulted in a mechanical incompatibility. Or in other words, the cheap paper didn't work worth a squat in the high speed copier.

The administrator who bought the paper thought he was doing great things because he saved the company a boatload of money. He wasn't reprimanded too much, because his intentions were sincere and there were no written procedures for purchasing. (Sincerity didn't matter, but the lack of Procedures did.)

Now, some firms can quickly attack the "Direct" impact on quality factors and stop there, and everything is fine. For those firms (and per your Post question), no Purchasing procedure would be required.

There might be other firms where a similar "quality attack" needs to happen on "Indirect" and perhaps even "Consequential" impacts on quality (especially Human Resources decisions and policies) because the more visionary your quality thinking becomes, the more apt you are to include these latter two in the root cause analysis of today's quality problems and in the justification for Preventive Actions against tomorrow's.

David M. Kozenko

****************************

From: ISO Standards Discussion
Date: Thu, 10 Aug 2000 11:31:23 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Miller

From: Ray.Miller (Ray)

All modern quality systems require procedures for documentation, training, purchasing, and contract review. If your employment agency or creative trade genuinely purchases no supplies or any materials, your H.R. process is therefor your purchasing process. If you contract your labor, your contract review procedures are your purchasing procedures.

The concept of a viable enterprise without a purchasing system is perhaps attractive, but will never actually work in the real world. The money leaves somewhere, somehow, and somebody gets it. Where does it go? How much? How often? With purchasing controls, you can answer all these questions.

--Ray
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#10
From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:13:30 -0500
Subject: Re: Permissible Exclusions /../Salinger/Arbuckle

From: "Donald Arbuckle"

Perhaps in my attempt to be clever (and somewhat facetious) my point got missed. I'll be more direct.

I cannot believe that the writers of the standard are truly saying that only Design and Servicing are permissible exclusions. If so, then why not say that, rather than leaving permissible exclusions open all of section 7. Mr. Hartman's post seems to support the idea that any part of section 7 can be excluded. That also appears to be the meaning of the statement in 1.2 Permissible Exclusions that reads, "These exclusions are limited to those requirements within clause 7..." I am in great disbelief that they meant anything other than what they said.

That said, if we "address" a requirement by stating in the Quality Manual that we do not do that work, isn't that the same as saying it under "permissible exclusions"? If not, what's the difference? If so, what's the beef?

Bottom line ... I have no question about the meaning of the Permissible Exclusions clause. It says that if a requirement in clause 7 is not applicable and does not affect the organization's ability to provide conforming product, then it does not have to be addressed further. It is excluded from the QMS.

Oh, by the way, I do have clients who have been successfully registered who do not do purchasing, others that do no packaging, others that do no inspections, and the list goes on. Each one has been registered without incident or question because of the nature of the organization's product, and/or customer requirements and/or applicable regulatory requirements. For real!

This should start a lively discussion...

Donald A. Arbuckle

*************************

From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:39:08 -0500
Subject: Re: Permissible Exclusions /../Trudeau/Robinson

From: Ralph Robinson
>
> Pat Trudeau stated, "I have talked to a TAG team member personally
> about this and the only exclusions are servicing and design."
>

A recent discussion with our Manager, Regulatory and Quality Systems, and her subsequent enquiry of our ISO registrar has yielded quite a different scenario.

According to our Registrar, _all_ of Section 7 of ISO 9001:2000 is
subject to exclusion if your organization can show that those elements
do not exist. Based on this information I'd say that the following could
potentially be excluded in a ISO 9001:2000 registration:
1. Customer-Related Processes (highly unlikely as everyone has
customers)
2. Design and Development (definitely possible)
3. Purchasing (highly unlikely, but possible)
4. Production and Service Operations (VERY doubtful for production
operations, but possible for service operations)
5. Control of Measuring and Monitoring Devices (same as #4)

If you look at the possibilities realistically, then the person Pat Trudeau talked to might be, in fact, correct, even though the possibility to exclude something might actually exist.

I think one of the key elements that we all need before we can make educated assessments of how this new standard will impact our organizations is the final Transition Guideline document. Hopefully that will answer some of our questions. Failing that, I hope that ISO 9004:2000 provides some clarity.

Ralph E. Robinson

> From: rudy.salinger dowcorning.com
> Although ISO 9001:2000 would say "purchasing" cannot be excluded from the
> Quality System scope, it should be possible to address this requirement with
> minimal effort. The process which you would have to "establish, document,
> implement, and maintain" might be as simple as a statement in the top level
> documentation (Quality Manual) that "no materials or services that affect
> product quality are purchased. All other purchases are at the discretion of
> the employee requiring them." But you will have to be sure the exclusion of
> "services" as well as materials is valid, otherwise you will indeed have to
> put up a process.
> The justification for this approach is the statement in ISO 9001:2000 that
> "The type and extent of control shall be dependent upon the effect on
> subsequent realization processes and their output."
> This is my opinion, but it should be verified with the firm's registrar.
>

****************************

From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:13:47 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Kozenko/Hankwitz

From: "Hankwitz, John"

David M. Kozenko makes a good point. But beware of over doing things. Does a procedure REALLY need to be written as a result of this incident? I would think normal day-to-day feedback would be adequate.

I heard that one company actually wrote procedures for making coffee, and posted them by each coffee maker. The logic was that visiting customers were provided coffee on occasion, and they wanted to make sure they wouldn't get a nonconforming mouthful. Good Grief!

Most often, a basic "New Employee Training" program will take care of most of these petty situations. Reserve procedure writing for those things that can't be effectively handled through training.

John Hankwitz

> David M. Kozenko writes:
> I'm not saying "do this or else" because it's not appropriate
> for every firm, but here's a case where the answer to your
> inquiry is "Yep, you need Purchasing Procedures in all cases..."
>
> I stayed late one evening (when my kids were young, no less
> ;o) to manually "baby-sit" the high-speed copy machine
> while we (as in, me and the machine ;o) ran 20 copies of a
> report due to the client, earlier that morning.
> (snip)

****************************

From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:34:23 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Schoffman

From: ASchoffm

<< From: "Donald Arbuckle"
Let me see if I understand this... If my company does not purchase anything (all parts, equipment, facilities, etc. are provided by the customer) other than laser paper for office use, pens/pencils, etc, then in order to meet the requirements of the standard and become compliant/registered, I must still establish, document, implement and maintain a purchasing process?? Doesn't this conflict with the requirements in 4.1 a), "identify the processes needed for the quality management system"? >>

Don, I believe you have hit on the weakness of the Permissible Exclusions clause. I believe the real intent was to differentiate 9001:2000 from the 9002:1994 standard which permitted companies with design systems that affect quality to obtain certification to an ISO standard (9002) without including their design function.

As in the past, where a clause does not apply to a particular organization, they can exclude it by simply stating that it does not apply to them. The registration auditor determines whether this is valid. This is especially true in service organizations where calibration of test equipment, packaging and delivery, servicing, etc. will not apply.

It seems to me, therefore, that there should have been no permissible exclusion clause at all - just the general rule that if a functions affects the quality process, it must be included in the quality system. If not, as in your example, a simple statement to that effect would be sufficient.

Alan Schoffman
 
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