Can this be a case for Design and Development Exclusion

[DrM2u]

I am still confused ... So far I am not sure what, if any, international standard we are talking about when we reference Clause 7.3. I am also not clear about what ATL is, whether it is a test laboratory or a regulatory agency's lab, and if the testing is part of the regularoty approval process or the design validation process.

Whatever the answers are, I will toss in the perspective of product and design liability. If the product fails while in use because of a faulty design and it causes significant damages then someone is liable all the way down to the design authority for the product. I am not sure how all the 'product certification' and/or regulatory agencies work in all countries but I seriously doubt that they assume full responsibility for the design of the product. Therefore the organization that designs the product (develops the product concept, makes or outsources the prototypes, verifies and/or validates the design, etc) retains some of not all responsibility for the design. Someone correct me on this.

What I am trying to say is to use the liability approach as one of the methods to determine if clause 7.3 from whatever standard you are dealing with is applicable or can be excluded. My gut feeling is that it is at least partially applicable. On the other hand, following the guidelines of 7.3 is a good business practice regardless of applicability.

 

[Andre Venter]

Hello Boris

If on the other hand there are manufacturer / customer / industry standards for a product or service and a customer just asks for one of these, there is no original thought involved, we select from a catalogue or make one up from a whole series of catalogue components then there is no design.

This is what our company does, so it seems the exclusion is a valid one, am I right ?

 

[Richard Pike]

If the product fails while in use because of a faulty design and it causes significant damages then someone is liable all the way down to the design of the product

Sorry - any legal team will find a 100 holes in that argument!

If my Customer wants a parachute with a 90% reliability - then ?

 

[DrM2u]

If on the other hand there are manufacturer / customer / industry standards for a product or service and a customer just asks for one of these, there is no original thought involved, we select from a catalogue or make one up from a whole series of catalogue components then there is no design.

If an organization manufactures a product based on an industry, national and/or international product DESIGN standard then there is no design responsibility because:
a. The design of the product is already established and
b. The organization has no control over the design of the product

A good example is the fasteners industry where many organizations manufacture bolts/screws based on certain standards.

On the other hand if an organization manufactures a product that has to meet certain fit and/or functional standards (i.e. CA, EEC, FDA, etc) then the organization still has control over the design of the product and the said standards are part of the design input (let's say clause 7.3.2). A few good examples are appliances and electronics.

Andre, since you know your situation the best, you have to decide if your organization is making 'screws' or 'microwave ovens'.

 

[DrM2u]

Sorry - any legal team will find a 100 holes in that argument!

If my Customer wants a parachute with a 90% reliability - then ?

Richard, you are misinterpreting my statement. I did not say anything about product reliability and I am not sure that anyone can 'argue' that no one is responsible for the design of the product unless it is designed by Mother Nature.

 

[Richard Pike]

You stated that design responsibility goes - all the way back - and the balance of your arguement is based on that statement.

This is in my opinion quite simply not the case and as I indicated there would be a 100 contradictions to that argument.

Lets put into perspective; If we supply direct, then any design activity is our responsibility. If we sub-contract the design element then its still our responsibility, agreed?

SO! If another organization sub contracts the design to us, but they have final approval over the design - i no longer have design control and therefore cannot be design responsible.

You cant have it both ways!

 

[DrM2u]

Richard, it comes down to who has authority over the design of the product.

 

[Paul Simpson]

Phew! I'm going to have to let this thread settle down a bit before I put my in. Just as I'm poised to respond another post comes in and I would have to change my response.

I'll just cover this:

Hello Boris

If on the other hand there are manufacturer / customer / industry standards for a product or service and a customer just asks for one of these, there is no original thought involved, we select from a catalogue or make one up from a whole series of catalogue components then there is no design.

This is what our company does, so it seems the exclusion is a valid one, am I right ?

Agreed! Short but sweet.

 

[Richard Pike]

Right; absolutely. Who has authority over the design -- not who provides the design service.

So I may design .. but do not have authority to sign of.. hence "design" does not apply to me.

Looks like we are in agreement?

 

[Big Jim]

Something that has not been explained is just what is your relationship with the entity that validates your design. Who are they? Without knowing how they fit into the equation you will continue to get differing opinions.