Verification and Validation of Post Market Design Change

[shiptowns]

Hello,

My question is about V&V of parts that get iterated past revision A, how does one maintain traceability?

We have a part in stock that is rev B. R&D is proposing changes to part and ordered the parts. These parts were not accepted through the receiving process instead were delivered straight to R&D , however, R&D would like to use these parts for V&V. If parts pass, they would like to revise documents to rev C. How does one maintain traceability and compliance and control and accept these V&V results from redline parts?

Thank you

 

[Ronen E]

The use of the term "V&V" is detrimental in this case IMO.

In verification, R&D can source whatevr parts they like, as long as the prototype is representative of the documented design that they verify. No problems here (assuming they have proper internal traceability to what they did).

For validation, test units need to come off the "real" production process, or otherwise be justified as closely representing it. If you can retro-clear the parts used for building such units, according to your "normal" process, you might be able to get away with it. Otherwise, the validation may be questioned down the line.

Cheers,
Ronen.

 

[Bev D]

this depends on your regulatory agency - if any.
Ronen is correct that typically 'prototype' parts are not used for validation.
the general exception to this is when the 'prototypes' are built on the same production line, materials, operators and methods as will be used for full scale production. then if the parts all pass your internal QC requirements they may be shipped (generally referred to as 'concurrent validation') Another alternative depending on your regulatory agency - is that the parts be withheld from shipment until the change is formally approved. if you have no regulatory agency you only need to meet your internal requirements and/or industry norms.

as for control I use SAP controls for non-approved parts and a physical 'NCR' tag that identifies the parts. a written deviation is used to introduce the parts and then release them upon approval. or scrap them if they fail V&V.