Design as a Purchased Element in QMS

somashekar

Leader
Admin
Can someone give me known examples where the QMS of a company has excluded design and development, purchased a design from an individual and manufactured per the design and market it to someone else.
Design is not outsourced, as the individual who sold the design is not one to be controlled in any way. He sells his design and commits to support when necessary.
 

Pancho

wikineer
Super Moderator
Can someone give me known examples where the QMS of a company has excluded design and development, purchased a design from an individual and manufactured per the design and market it to someone else.
Design is not outsourced, as the individual who sold the design is not one to be controlled in any way. He sells his design and commits to support when necessary.

I think whether design can be excluded depends on the contract between the manufacturer and their clients. Do the clients know that the design responsibility is by a third party, or that they are responsible for the design? If there is a design NC, is it clear to those customers that they have to go back to the designer, or that they themselves have that responsibility?

It is not clear from the post what the answer is in your case, but if the answer to either of those questions is "no", then the manufacturer better control the design as an outsourced service and not exclude it from their QMS.
 
Last edited:

somashekar

Leader
Admin
I think whether design can be excluded depends on the contract between the manufacturer and their clients. Do the clients know that the design responsibility is by a third party, or that they are responsible for the design? If there is a design NC, is it clear to those customers that they have to go back to the designer, or that they themselves have that responsibility?

It is not clear from the post what the answer is in your case, but if the answer to either of those questions is "no", then the manufacturer better control the design as an outsourced service and not exclude it from their QMS.
There is no any contract between manufacturer and their client. The client wants this product as offered and so is buying. Client has no interest to know about who the design owner is. The client has evaluated the product and then want it the way it is. So I do not see a design NC issue after purchasing the product.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
This is probably a question for your registrar.
It is a nice idea to ask the registrar how a situation like this should be handled, but as a CB auditor I wouldn't want to confront it for the first time during an audit and I commend somashekar for raising it here. In an increasingly global economy I think we will confront ambiguities like this more as we go along, and I think the Cove is a great place to air the question because I want to see what everyone else says. :cool:
 

Big Jim

Admin
It is a nice idea to ask the registrar how a situation like this should be handled, but as a CB auditor I wouldn't want to confront it for the first time during an audit and I commend somashekar for raising it here. In an increasingly global economy I think we will confront ambiguities like this more as we go along, and I think the Cove is a great place to air the question because I want to see what everyone else says. :cool:

I certainly never meant that the question should wait until an auditor appears for the registration audit.

The topic seems to fall into a somewhat grey area, and thus the suggestion to talk with his registrar. It is a topic that should be settled very early.

It will be interesting to see what others have to say, but in the end, the registrar will have the last say.
 

Pancho

wikineer
Super Moderator
There is no any contract between manufacturer and their client.

That there is no written contract is a bit worrying to me, particularly if, as you mentioned initially, the product does require some design that was provided by others. There is always an implied contract in any buy-sell transaction, even if such contract is not written. And the terms of implied contracts under English law and its derivatives are usually favorable to the buyer.

In the US, the default contract terms are provided by the Uniform Commercial Code. These include expressed warranties and implied warranties (such as merchantability, and fitness for purpose), unless specifically disclaimed and agreed-to in writing.

Of course, in other countries the default expressed and implied warranties may be different. But even ISO 9001 (?7.2.1b and c) requires compliance with fitness for purpose and whatever else applies by local law. So if design or development were an input purchased by the manufacturer to incorporate into the product, then I'm still thinking that it should be planned and controlled.

The client wants this product as offered and so is buying. Client has no interest to know about who the design owner is. The client has evaluated the product and then want it the way it is. So I do not see a design NC issue after purchasing the product.

Cases where design input could be excluded from the scope of the QMS might include those where the design is provided by the client, or raw commodities, or where there is a contract that the goods are sold "as-is". As I said, without the specific written agreement in this last case, I'd still be worried. But if in your jurisdiction "buyer beware" is still the norm, then perhaps my worry is unfounded.

I haven't seen examples of QMSs with design exclusions for cases like the one that you mention, but why would they be different from other QMSs with design exclusions? Wouldn't a simple sentence in the quality manual excluding section 7.3 of the standard suffice, while the QMS is, in regards to every other clause, the same?
 

harry

Trusted Information Resource
I was involved with manufacturing of electrical cables once. Customers order by quoting local or internal standards such as JIS or VDE and we manufacture according to the respective product standards/specification. No design is involved - all we need to do is to have product certification for the respective product. Also, product certification is based on manufacturing process, control and testing and approval of the final product.
 

somashekar

Leader
Admin
I haven't seen examples of QMSs with design exclusions for cases like the one that you mention, but why would they be different from other QMSs with design exclusions? Wouldn't a simple sentence in the quality manual excluding section 7.3 of the standard suffice, while the QMS is, in regards to every other clause, the same?
Yes, this is my view. I always believe that the QMS must match the business and business realities. However talking about design, I have mostly seen design and development, as owned (D&D scope included) or customer provided (D&D scope excluded, with customer justification), while in real business, the design is purchased out and controls mentioned are just paper controls (for auditor)
I do not like this.
So if the design is bought out it must stand excluded no matter what the CB / auditor opinions about this. The company may even pay to get some design modifications if the design owner agrees to do. This is not a control means. The design owner is an independent individual and will not agree to any of your controls that you put out for the sake of the scope inclusion and QMS certification.
 

qusys

Trusted Information Resource
Can someone give me known examples where the QMS of a company has excluded design and development, purchased a design from an individual and manufactured per the design and market it to someone else.
Design is not outsourced, as the individual who sold the design is not one to be controlled in any way. He sells his design and commits to support when necessary.

But in this case should manufacturing give inputs to D & D? It is always the contrary and you can apply the so called "foundry model". In the post, are you saying that the customer speaks manufacturing entity to have a product, but I think that the customer requirement should be transmitted and agreed with desing function... It is very difficult to me to imagine the scenario you are depicting and I have never had experience in these terms.
 
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