Design and Development Process vs. Product

C

carolk79

#1
Hello,

Here is my situation. I have just been through my reregistration audit for ISO 9001:2000. We have design of product excluded from our certificate this time which was originally on the certificate. My president and registrar change the scope without informing me. A week before the audit I received an updated audit plan with the change on it. I tried to change what I could but it wasn't enough. So anyways, I received a minor nonconformance for not updating documentation due to the change in scope.

I understand in our procedures and work instructions what I need and don't but the standard is giving me troubles.

Can I exclude all of 7.3?????? If so where does process design fall. Will I need to keep some of 7.3 to allow for process design????

I am just so confused.


Please Help
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Hi Carol,

The basic rule is: if your organization is responsible for the design of the PRODUCT, then you can not claim exception to 7.3 and be certifiable to ISO 9001:2000. Check examples 2 and 3 HERE
 

Douglas E. Purdy

Quite Involved in Discussions
#3
Sidney Vianna said:
Hi Carol,

The basic rule is: if your organization is responsible for the design of the PRODUCT, then you can not claim exception to 7.3 and be certifiable to ISO 9001:2000. Check examples 2 and 3 HERE
Sidney,

Thanks for the update on this Guidance Document. I believe it was you that brought these to our attention earlier this year. I did not know that this document had been revised. How do you keep up with these changes? Do these documents hold any weight (authority) in the certification / registration system yet?

Doug
 
C

carolk79

#5
Thanks

We do not design product at our facility.

But my auditor said I have to have design of process. My only problem is I don't know where this requirement is or how to meet this requirement.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Very Simple!

carolk79 said:
We do not design product at our facility.

But my auditor said I have to have design of process. My only problem is I don't know where this requirement is or how to meet this requirement.
It is very simple. You challenge his/her assertion. Provided that we are talking ISO 9001 (that's my assumption since we are in the ISO 9000 Forum, and not TS-16949), have you auditor read paragraph 7.3 of ISO 9001:2000

7.3.1 Design and development planning
The organization shall plan and control the design and development of product..


It should be clear after that.
If s/he insists that you have to apply 7.3 to the product realization PROCESSES, then, you calmly, tactfully and diplomaticaly asks:
Dear auditor, could you please help me out finding this requirement in the Standard?

And don't ever feel afraid to elevate this to someone at the Certification Body's office. Auditors will make bad calls (I've done it) from time to time, and someone at the CB technical staff should clear the issue.

Hope this helps.
 

RoxaneB

Super Moderator
Super Moderator
#7
I'm with Sidney on this one, Carol. :) My organization has excluded ALL of 7.3 because, while we may design the PROCESS we do not design the PRODUCT.

Our Product specifications are provided from other sources. We simply design our processes to ensure we can provide the product. :)

For what's it worth, Carol, it took me some time to wrap my head around this whole PROCESS/PRODUCT design issue. :eek:
 
#8
carolk79 said:
We do not design product at our facility.

But my auditor said I have to have design of process. My only problem is I don't know where this requirement is or how to meet this requirement.
It sounds to me like you have a TS auditor. In TS, you cannot exclude process design. But, then again, TS puts a focus on the requirement that is not present in 9K.

With that stated, it might not be a bad idea to look at process design. There is a good possiblity that doing so will uncover problems (actual and potential).
 
C

carolk79

#9
You guys are great

Thanks this helps me a lot but I still have one more question???

Let me help you understand.

We are a fiberglass shop. What we do is regular production parts and, what we call "projects" "Projects" are one of two thing: 1)our customer provides use with a plug, or reversed mold, and we build a mold from there design.
2) Customer provides use with a print and/or drawing and we have to build a plug and a mold.

Now when we receive a RFQ on a mold we go through the following process:
After quote is accepted:
1)Create a timeline indicating person responsible, description of duties, date
and time of each process, and completion date. This is then submitted to
the customer.
2)When this is accepted by the customer, the work,including prints, drawing,
timeline, and a project Log is sent to production.
3)When requested by the customer, design reveiws are done periodically to
ensure that the customer design is feasible and meets requirements. At
the reviews, the customer comes to our shop and reviews progress and
initiates any changes that may need to be made.
4)After the mold is complete, a prototype is made from the mold.
5)The prototype is then sent to the customer for approval. If approved, the
customer will pay the remaining balance and we will begin produstion per
purchase order.
6)If not approved, customer will return the part with neccessary corrections
Changes will then be made and another prototype built and sent.

Now that you know all this information here is my question:

If I exclude design from my scope, what do I do with all this info????
Does this merely fall under product realization???
Could changes in design, specified by customer, be Engineers Changes???
 
Last edited by a moderator:

Paul Simpson

Trusted Information Resource
#10
Your choice

carolk79 said:
Hello,

My president and registrar change the scope without informing me. A week before the audit I received an updated audit plan with the change on it.

Can I exclude all of 7.3?????? If so where does process design fall. Will I need to keep some of 7.3 to allow for process design????
The problem is if you elect to include process design (as it sounds like your president has) then all elements of 7.3 come into play. The note 2 under 7.1 planning clearly allows you to apply the principles of design control to your own product realization processes - but it is your choice!
 
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