Design - Widget vs. Service - Exclusion? In Service operation design not addressed

P

pthareja

#21
heat treatment process design

dbzman said:
I work for a Heat Treating company and I have had this discussion with our Corporate Quality Manager. He insists that we do not do design. I say we do.

We are certifying to ISO9001:2000 this October and have plans on certifying to TS next year.

Ts does not let us get away with the design exclusion. Even though we are a service company we are defined as "Manufacturing" by the auto industry. I believe that if we "design" a heat treating process we fall under design in the standard.

Has anyone contacted IATF or any of the other "Experts" on this?

Mike W

:bonk:
thought provoking thread!

Now Suppose there is a change in product specifications, as a CA / PA. Due to new advancements, tightening Pollution control norms... or what ever. Six sigma necessitating narrower controls, aided by plc's....

that it needs a change. Will it not go as per clause 7.3 of ISO9K2K as, very well illustrated, in a post earlier?

I don't appreciate/ understand why do quality-management-system responsible operators ( all hierarchical levels) shirk/ get scared of 7.3 while their customer focus is reportedly always at a high ebb? The balancing act demands achieving process-comprension capability maturity?
 
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E

energy

#22
Short and sweet

Diana Cadwalader said:
My opinion is that there is absolutely no company who is exempt from Design.
All processes must be designed. Therefore, the design of the process is subject to the same rules. However, getting most folks to buy into this philosophy is an uphill battle.
Because I have created an Inspection Process, does that make me a designer? Because the Shop Foreman has developed a Material Handling Process, is he/she a designer? Everybody knows what "Design" is. You face an uphill battle because you are making your own rules. Sorry, but every time I see this argument, I want to scream. If what you say was true, there would have never been an option in the old or new ISO Standard to exclude it. :agree: :smokin:
 
E

energy

#24
I have to ask

Marc said:
Yes - the definition of design is 'evolving'.
Why do you think that is? I mean, some people just start creating the concept that ALL processes should be included in Design? What's the advantage? Make it harder to get registered? The ultimate conceptual design was when you decided to go into business. We should have to justify our "design" of everything we created to make our business profitable? If anything, it's proprietary. It's your idea and your niche. I've always thought that there are groups out there that start these radical ways of thinking to try to impress the rest of us morons who eventually bear the brunt of their "brainstorms". ;)
 

Douglas E. Purdy

Quite Involved in Discussions
#25
I am with Energy on Design & Development

Posted by Marc - 2 Days Ago at 03:56 AM
If nothing else, the 2000 version requires process design. This is where you are 'caught'... In QS and now TS process design has always been part of the show - APQP.
But I look beyond that and away from automotive (this being the ISO 9K forum).
I can understand where 'process design' would be a product for a 'service provision,' but I am having a hard time distinguishing where 'process design' ends and 'control of production provision' (7.5.1) begins for a manufacturer.

Here again I think the vocabulary of 9000 fails me in regards to the reading of 9001. In 7.3.1 the "organization shall plan and control the design and development of product." 9000 defines product as "a result of a process," but then defines Design and Development as "a set of processes that transforms requirements into specified characteristics or into specidfication of a product, process or system."

By that definition then the development of the Quality Management System itself would need to comply with 7.3.

Please help me understand?!

Thanks,
Doug
 

tony s

Information Seeker
Trusted Information Resource
#27
Re: I am with Energy on Design & Development

I can understand where 'process design' would be a product for a 'service provision,' but I am having a hard time distinguishing where 'process design' ends and 'control of production provision' (7.5.1) begins for a manufacturer.

Here again I think the vocabulary of 9000 fails me in regards to the reading of 9001. In 7.3.1 the "organization shall plan and control the design and development of product." 9000 defines product as "a result of a process," but then defines Design and Development as "a set of processes that transforms requirements into specified characteristics or into specidfication of a product, process or system."

By that definition then the development of the Quality Management System itself would need to comply with 7.3.

Please help me understand?!

Thanks,
Doug
Same here Doug. Try this one:

According to ISO 9001:2005 Section 3. Terms and definitions said:
A term in a definition or note which is defined elsewhere in this clause is indicated by boldface followed by its entry number in parentheses. Such a boldface term may be replaced in the definition by its complete definition. For example:

product (3.4.2) is defined as “result of a process (3.4.1)”;

process is defined as “set of interrelated or interacting activities which transforms inputs into outputs”.

If the term “process” is replaced by its definition, as follows:

product then becomes “result of a set of interrelated or interacting activities which transforms inputs into outputs”.
So if we replace terms in the ISO 9001 7.3.1 clause, which says:
The organization shall plan and control the design and development of product.
with definitions in ISO 9000:2005:
ISO 9000:2005 3.4.4 said:
design and development
set of processes that transforms requirements into specified characteristics or into the specification of a product
We can also say that ISO 9001 7.3.1 requires us to:

Plan and control the set of interrelated or interacting activities which transforms inputs into outputs that transforms requirements into specified characteristics or into the specification of a result of a process.

The result will have a colorful meaning, isn't it?:bigwave:

All the more for people whose vernacular is other than English.

tony s
 
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