7.3.6 Design and Development Validation

[dickw]

We are full turnkey PCB supplier for the electronics industry. As a PCB design house, we are involved in the design and test of PCB's, specifically design planning, development, design review, and design test (verification) etc. The products are not our (we are designing PCB for third parties), it could be claimed that we d not have the capability to demonstrate a customer's product works in the field under certain conditions.

Is 7.3.6 Design and development Validation as permissible exclusion?
What is the argument for its inclusion?
If we do not exclude 7.3.6 is there associated product liability risks?

 

[David Hartman]

We are full turnkey PCB supplier for the electronics industry. As a PCB design house, we are involved in the design and test of PCB's, specifically design planning, development, design review, and design test (verification) etc. The products are not our (we are designing PCB for third parties), it could be claimed that we d not have the capability to demonstrate a customer's product works in the field under certain conditions.

Is 7.3.6 Design and development Validation as permissible exclusion?
What is the argument for its inclusion?
If we do not exclude 7.3.6 is there associated product liability risks?

At a previous employer I ran into this very situation. Rightly or wrongly (it did pass an ISO audit) what we chose to do was to include a statement in our documented procedure to the effect that "design validation is the responsibility of the customer".

 

[howste]

I think David has the right answer. The customer is responsible for the design of the finished product that the PCB goes into, so they need to validate the function of the completed assembly.

There may be some things that you can validate at the board level, but probably not all. I suppose you could at least validate that the board and components function as needed at the appropriate voltages that the customer will be using. Or given certain inputs, the board will give the desired outputs. Or is that just verification?

 

[Icy Mountain]

You can do it!

dickw,
If you were supplying PCBs to me, I would expect your validation to be a 100% shorts and opens test of the board based on my netlist. I may have some other critical characteristics depending on the PCB but most would be standard listing on the drawing (e.g.material: 0.062 epoxy/glass (fr-4) with finished copper weight of 4 oz/sq ft, all holes must be plated thru 0.001 minimum.)
Can't you sample test/validate these characteristics for the PCB using coupons?
Your product isn't the end result PCB assembly, so I wouldn't think you are responsible for validating that.

 

[edward.gibbs]

Don't you have First Article Tests?

I would consider FAT to to be design validation - assuming that it is a well designed procedure that verifies the product meets the design requirements.

Remember - you get to define the validation to take place (7.3.1). All 7.3.6 says is you need to do what you said you would do.

Ed Gibbs