Design and Development Process vs. Product

Q

qualitygoddess - 2010

#11
To Design or Not Design, That is the Question

carolk79 said:
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???
Ah, the slippery slope of design or no design..............

May I suggest you take a look at definitions in 9000-2000 to assist you? page 11, 3.4.3 gives an interesting definition for a "project". Then look below at 3.4.4 design and development. This clearly states that the design process transforms requirements into specified characteristics or a specification of a product, process or system. In the project steps you describe above, you are not creating a spec, you are creating a project (see Note 3 of a project).

This is not a perfect argument that you are not doing some aspects of design. After all, 9000-2000 is only a guidance doc. It gets tough when you try to justify the mold building and prototyping as something other than design. However, I think you can try to make the argument that these projects are simply part of the process to make production product. Your mold building, product reviews with the customer (don't call them design reviews), prototyping, etc. are all part of the process to produce the customer's designed part.

I can think of one instance where a client took this approach, and their registrar agreed. They did build simple molds for plastics processing, but everything was dictated by the customer, even down to the plastics used. I can think of another instance with a different registrar where this type of argument did not work. The client could exclude only validation. They built molds or sourced them for the customer. They had to develop a system for design planning, reviews, changes, and verifications.

All you can do is try. Good luck.

--QG
 
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