Design in ISO9001 - R U Confounded?

[Marc]

A snippet from the ISO ListServe:

-----snippo-----

Subject: Re: Q: Design vs. R&D/..../Kottha/Deibler
Date: Thu, 22 Oct 1998 11:41:47 -0600
From: ISO Standards Discussion

From: Bill Deibler
Subject: Re: Q: Design vs. R&D/..../Kottha/Deibler

Listfolks,

I worked for a firm that is based in the UK and is now a part of the Fujitsu family, ICL (International Computers Ltd). By 1991, all manufacturing facilities in the UK were registered to 9001. We found it advantageous from a quality perspective to apply 4.4 Design Control, to the design of our manufacturing processes....it simply made us a better manufacturing organization.

At the time, ICL was Europe's largest computer manufacturer, and was well known for it's state-of-the-art manufacturing capabilities. Major players such as Sun Microsystems, were using ICL to manufacture their high-end workstations.

In contrast to what Jag has stated below, there are plenty of companies applying 4.4 Design Control to process design or service design.

BTW, I also was involved in implementations of 9001 that were company-wide. That is, 9001 was applied across the company. All organizations were included in the registration (including groups such as human resources, legal, accounting, MIS development, etc.)! BSi was offering a program called company-wide-registration which supported companies who wanted to apply 9001 to all internal organizations.

Now...I haven't had much time to follow this thread very much, but I haven't noticed whether the argument of R&D vs. Design has touched on the point I made on this list some years back...that the ISO vocabulary does not include the words Design or Production.

Is software development a purely design process or is it also a production process? Finding the answer to the question is even more muddled when considering the difference in the guidance offered in ISO 9000-3:1991 vs. ISO 9000-3:1997 which contradict each other. 9001's 4.9 Process control is mapped to the development process in 9000-3:1991, while 9000-3:1997 states that 4.9 applies to replication, delivery, and installation.

Another confounding fact, overlooked by the authors of 9000-3:1997 is that 9000-1:1994 states "The process of development, supply and maintenance for software is different from that of most other types of industrial products in that there is no distinct manufacturing phase. Software does not wear out and, consequently, quality activities during the design phase are of paramount importance to the final quality of the product". This statement is in line with the guidance given in 9000-3:1991.

This issue of undefined terms is referenced in Chapter 20 in Irwin Publishing's, ISO 9000 Handbook, 3rd Edition.

The thing is, 9001 4.4.2 adresses design and development planning. Software development methods often mix research/design/development together. Some of the latest methods for development embrace a build-a-little, test-a-little, incremental approach that embraces these often blurred phases.

This blurring of phases is not unique to software development, as hardware development organizations employ similar techniques.

Remember the D, in R&D stands for development, and ISO 9001 4.4 definitely applies to development.

....now research...the R in R&D....that's another topic for next time......

nuff said,
bill
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Bill Deibler

[Roger Eastin]

This is another good snipit. I think that including process design under 4.4 is an interesting concept, although the "General" paragraph of 4.4 states that this applies to products. QS9K is especially good here because between APQP and the additional QS9K verbage in 4.9 forces a closer look at how processes are "designed". ISO9K would do well to emphasize the process more in its spec.

[Marc]

Yeah - I guess I typically blurred the distinction due to automotive prejudice - process design is addressed through APQP and the related documents (Process Flow Diadram, PFMEA, Control Plan). I am well aware of ISO registration of colleges, service industries and such and just 'naturally' looked at design of their processes as applicable.

The definition of product includes service(s). From ISO/DIS 9001:2000:

--> ...3.1 - product - result of a process
--> NOTE 1 There are four agreed generic product categories:
--> - hardware,
--> - software,
--> - services,
--> - processed materials.

deibs@ssqc.com

[This message has been edited by Marc Smith (edited 21 January 2000).]

[Marc]

Any new thoughts on this?

[CarolX]

Originally Posted by deibler

The definition of product includes service(s). From ISO/DIS 9001:2000:

--> ...3.1 - product - result of a process
--> NOTE 1 There are four agreed generic product categories:
--> - hardware,
--> - software,
--> - services,
--> - processed materials.

[This message has been edited by Marc Smith (edited 21 January 2000).]

Looking for some thoughts on this.....The generic product categories????

We are not a "service" company....we provide "hardware". I have seen arguments before about "servicing the customer" , i.e. your standard stuff, like follow up visits, calls, etc. falling under the "servicing" requirements of the standard. I have seen some discussions go so far as to throwing this into a "design" function.....

CarolX