Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f)

[gxzn008]

In QSR 820.30 design control (f) there written: "including identification of design, method, the date", I am not sure the meaning of the "identification of design", how to understand this sentence?

Thanks.

[Jim Wynne]

The whole of 820.30 is here.

The complete sentence you're referring to is:

The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

"Identification of the design," I would think, pertains to the the thing being verified. There must be some form of identification of the design as a whole in order to be able to keep records straight. If there are requirements for such identification I don't know what they are, but there has to be some form of identification (a number, a name, e.g.).

[Ronen E]

In Reply to Parent Post by Jim Wynne

The whole of 820.30 is here.

The complete sentence you're referring to is:

The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

"Identification of the design," I would think, pertains to the the thing being verified. There must be some form of identification of the design as a whole in order to be able to keep records straight. If there are requirements for such identification I don't know what they are, but there has to be some form of identification (a number, a name, e.g.).

The design verification must specify what version of the device (or design output) has been verified. If you have a proper, elaborated, all-level-revision-controlled BOM, identifying the top-level revision should pretty much suffice. If the whereabouts of the detailed design documentation (drawings etc.) are not obvious or orderly covered somewhere else in the QMS, they should be specified too, so they can be reasonably accessed for review.

Cheers,
Ronen.