Documentation for items used for Design Verification

Chef100

Starting to get Involved
#1
Hi all
I have been challenged in my company regarding the documentation needed for prototypes used for Design verification testing. What documentation is needed? Do you need full traceability to materials, process etc? Do you need to show that items are produced with the same raw materials specs as the approved output specs?
 
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shimonv

Trusted Information Resource
#2
This is a very broad question. You ought to have a Design Control procedure that identified the deliverables for each phase in the product life cycle.
In a nutshell, design verification and validation are done on initial production units. So, you have to have a certain level of documentation; not necessarily final but sufficient to demonstrate (with traceability) that you verified the design of the product which you intend to put in the market.

Shimon
 

yodon

Staff member
Super Moderator
#3
design verification and validation are done on initial production units.
Can't say that I completely agree with that statement (which is a bit shocking since I don't think I've ever disagreed with an @shimonv post!). Nothing in the standard about design verification mentions what must be used and in design validation, "representative product" must be used.

I will agree that you want to have sufficient documentation for what you did use. You need to be able to justify why the results are applicable to production units. As an example, we do a lot of electro-mechanical design work. Verifying software requirements often has to be done in a debug environment. We have the software under design controls so unless there are changes, we can justify applicability. Similarly, some electrical requirements may require testing hooked up to scopes but we have a complete board BOM to demonstrate why it's relevant. We sometimes package everything in prototype shells ("skins") - may be the same material as production but maybe 3D printed or machined rather than molded. We can justify using those in design validation (even though not production) because we can assert equivalence.

I will agree with @shimonv that it's a broad question and so what you use for verification and/or validation needs to be carefully considered and part of your plan. Be prepared to support your conclusions that V&V results are representative of the final product.
 

shimonv

Trusted Information Resource
#4
Can't say that I completely agree with that statement (which is a bit shocking since I don't think I've ever disagreed with an @shimonv post!). Nothing in the standard about design verification mentions what must be used and in design validation, "representative product" must be used.
Hi Yodon,
Thank you for the compliment! And I humbly admit that you are correct; the regulation does not dictate what must be used for design verification, but for design validation a "representative product" a.k.a "initial production unit" must be used.

The opening statement of Chef100 was:
"I have been challenged in my company regarding the documentation needed for prototypes used for Design verification testing."

I think we can agree about the intentions of such questions, and this kicked me into defensive mode. In my response I shifted from verification to verification and validation, which is kind of what you did in the end of your post: "Be prepared to support your conclusions that V&V results are representative of the final product." :)

It's a great forum!

Cheers!
Shimon
 

indubioush

Quite Involved in Discussions
#5
I agree with what has been said but just want to add clarification. The design verification stage is where change control must be implemented. Regardless of how you document the specific design used for verification, you need to be able to show that every change you make after design verification does not affect the results of verification testing. (Or if previous testing is affected, you repeat the test.) To be able to document those changes adequately, you need to have documented what the design or process was in the first place. This is a roundabout way of saying what Yodon said before.

In my opinion, it is best practice to have a simple history record that is used for recording relevant prototype information.
 
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