Design as a Purchased Element in QMS

[Pancho]

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.

I really don't think design should be excluded from the scope of the QMS in such case. From your description, the manufacturer is buying the design to incorporate it into their product. Design is definitely an input required to make the product. As with all other inputs, you should plan and control it.

But planning and controlling design as an outsourced process may be quite simple. Perhaps all that you have to do is qualify your supplier. Do they design the same types of parts for others? Are they registered engineers? Do they provide you with a warranty? Can you have a third party review the design?

For example, your plan for design might be that you will only buy the design from registered engineers that have more than 5 years of experience designing similar products and carry $1M of professional liability insurance. And you might control the design by having a second engineer peer-review it (verification), and/or by testing a few parts (validation).

If failure of the product is inconsequential, then the controls could be very minimal indeed. But your manufacturer is likely to be controlling design in some way already or else NCs would be popping up everywhere. So I'd suggest you document what is being done, and improve from there.

 

[somashekar]

Pancho, I really appreciate your view.

As with all other inputs, you should plan and control it.

It is just that the manufacturer has a design pack for which he has paid a good price, and his competency is in making per that design in volumes, and there is a customer who just wants what he does. I see an Input but no more about any controls.

But planning and controlling design as an outsourced process may be quite simple.

I agree

Perhaps all that you have to do is qualify your supplier.

Yes, he is qualified under the purchasing evaluation and selection process. In fact he is the one who is encouraging production as he cannot do that.

Do they design the same types of parts for others?

He has a design that can be used and parts produced. He can sell the same to any other if someone is willing to pay the price.

Are they registered engineers?

No. There is no need or a necessity for any registration.

Do they provide you with a warranty?

The customer has satisfied himself with the part the designer has designed and validated, and is willing to buy in volume continuously. A business opportunity is open.

Can you have a third party review the design?

Not needed, see above. No money too for such expenditure.

 

[Pancho]

Ok, that clears the situation up a bit more, thanks. But there is still a choice to be made since your case seems to straddle the line.

If the client is looking to purchase a product manufactured to his preferred design, and given that there is a large volume, then it might be best to make clear, in the contract or purchase order, that the design is excluded from the scope of supply. If all the manufacturer's clients are like this, then the design could indeed be excluded from the QMS.

But if the responsibility for design is not clearly with the customer, and the customer (or the law) could construe it to be with the manufacturer, then the manufacturer should make sure that he has a quality design through appropriate planning and control.

 

[somashekar]

If the client is looking to purchase a product manufactured to his preferred design, and given that there is a large volume, then it might be best to make clear, in the contract or purchase order, that the design is excluded from the scope of supply.

I am not touching the PO, (There is no contract in this case)
The PO is placed by the customer on the manufacturer to just supply the part.
In reality the manufacturer has no design competency and is not demonstrated in his QMS. The customer and the manufacturer know very well who is the brainchild of the product.
The designer has said pay me $$$ and then call it your own design if you want. The manufacturer is clear and is not inclined to own the design. The designer has agreed to help going further, and where felt necessary he will charge for the service. The business is smooth going.

 

[somashekar]

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.

Jim.
Before the auditor or CB, I have a case where the manufacturer is so convinced that design and development is a big NO NO.
This is the way the business is going about and very well. Not at all a grey area for the one who is managing the QMS.
How can auditor or anyone else thrust design and say outsourcing design and then say go control it. The business scenario is clear.
I wish Jim and other CB people throw more light...

 

[Big Jim]

Jim.
Before the auditor or CB, I have a case where the manufacturer is so convinced that design and development is a big NO NO.
This is the way the business is going about and very well. Not at all a grey area for the one who is managing the QMS.
How can auditor or anyone else thrust design and say outsourcing design and then say go control it. The business scenario is clear.
I wish Jim and other CB people throw more light...

It appears that you are straddling the line between design and no design. That is why I suggested you talk to your CB. From my perspective, which may or may not be of much value, it is sometimes hard to differentiate between outsourcing and purchasing. I'm not equipped to answer that question, but your CB should be.

 

[somashekar]

It appears that you are straddling the line between design and no design. That is why I suggested you talk to your CB. From my perspective, which may or may not be of much value, it is sometimes hard to differentiate between outsourcing and purchasing. I'm not equipped to answer that question, but your CB should be.

I am with no design and I want to appear as well with no design.

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

Taking from this, outsourcing always has a purchase element.
Outsourcing has authority for that process with you and you have some competency built within.
Outsourcing is an activity due to lack of resources in a company OR is due to a MAKE or BUY decision. Both men and machine constitute resources. While machine can be totally non existant, a certain competency must be built in the company with due authority to accept the outsourced process delivery outputs. Only then there is a meaning for "control over such process"

 

[Pancho]

I am not touching the PO, (There is no contract in this case)
The PO is placed by the customer on the manufacturer to just supply the part.
In reality the manufacturer has no design competency and is not demonstrated in his QMS. The customer and the manufacturer know very well who is the brainchild of the product.
The designer has said pay me $$$ and then call it your own design if you want. The manufacturer is clear and is not inclined to own the design. The designer has agreed to help going further, and where felt necessary he will charge for the service. The business is smooth going.

The purchase order IS a contract. There is ALWAYS a contract.

Sorry to be so insistent, and this is probably not what you or the manufacturer want to hear, but if your contract (read PO) doesn't clear up that the design is not the manufacturer's responsibility, and the manufacturer is purchasing the design as an input for the product, then the manufacturer IS responsible for the design.

The above is true regardless of the business going smooth, or you wanting to be "no design", or what your QMS or the CB says, or the "brainchild", or the manufacturers lack of competency in design.

My thinking is that there is a major NC in the contract review procedure. Your manufacturer is accepting a PO with terms that he cannot possibly fulfill because he "won't touch the PO".

Yes, you should indeed exclude design from the QMS scope, but then you should also always negotiate away PO (read contract) terms that impute design responsibility. That needs to go into your manufacturers SOP as CA, and into the present order as a correction.

 

[somashekar]

but if your contract (read PO) doesn't clear up that the design is not the manufacturer's responsibility, and the manufacturer is purchasing the design as an input for the product, then the manufacturer IS responsible for the design.

Why would / should a PO for a product touch upon the design of that product, even in the PO terms perhaps printed overleaf.
The PO is a techno commercial document., and the correct reference of the product (code / part number etc) is all that is technical about it. The rest including warranty information etc are nothing connected to the product design.

My thinking is that there is a major NC in the contract review procedure.

The PO is the customer document and spells nothing about design or design ownership. The manufacturer accepts the PO and the contract is done. He is able to meet the PO requirements.

 

[Big Jim]

I am with no design and I want to appear as well with no design.

Taking from this, outsourcing always has a purchase element.
Outsourcing has authority for that process with you and you have some competency built within.
Outsourcing is an activity due to lack of resources in a company OR is due to a MAKE or BUY decision. Both men and machine constitute resources. While machine can be totally non existant, a certain competency must be built in the company with due authority to accept the outsourced process delivery outputs. Only then there is a meaning for "control over such process"

I have no prejudice on one side or the other. I just don't know.

I can think of a few cases where companies acquire designs and are not design companies. One of them is a bolt manufacturer. They make bolts to MIL specifications that they can easily acquire. In their case, they do not need to purchase the design so to speak, but they do pay a fee to copy the specs off from a web site.

Another is a boot manufacture where they claim that boot making is an art that was developed centuries ago and they continue to follow that craft.

Again, this is a discussion you need to have with your CB. In the end they will be the ones to make the final decision anyway.