When does design transfer take place?

[Uberbert]

In searching this forum, I found threads on the “what” and “how” of design transfer but not so much on when. Conversations with quality engineers have suggested my perspective is off base.


As I read the standard and guidance, design transfer should occur before design verification and certainly before design validation. As a design engineer, 14 years ago I helped set up a quality system at a design engineering firm. We had a design transfer process and form that we used almost every time we released drawings to make an injection mold. I am helping set up another system again and wanted to confirm that strategy.


I think my argument can be summed up this way.
1. the definition of design validation indicates that there are device specifications to validate, therefore device specifications come before validation
2. the output of design transfer is production specifications, therefore design transfer comes before production specifications
3. Given 1 and 2 and assuming “device specifications" and "production specifications" are equivalent, design transfer comes before validation.


Other perspectives I have seen are (1) that design transfer occurs after design validation is complete and (2) is intended to ensure that the DMR is complete and adequate. My argument above refutes the (1) and regarding (2), neither the standard nor the guidance say anything about DMR in the design transfer section.


Finally, assuming design transfer occurs before design validation, I think the FDA chose poorly in listing it in the standard after design verification and design validation.


If I am off base or missing something, please explain.

 

[mihzago]

Design Transfer is not a single point in time, but rather a set of tasks and activities that may start as early as the definition of requirements (design inputs), and end when the device is released for actual production.

Design transfer does not have to happen before Design Validation, because nothing says it has to. The regulations states "initial production units ... or their equivalents".
Frequently the design validation will have an input into the production process (e.g. process validation) and vice versa, a transfer activity such as pilot run (or another activity) may require changes that impact Design Validation.

 

[normzone]

 

[Uberbert]

Mizhago,

We agree on many, but not all, points. I think my 3 point argument indicates that design transfer must to occur, or at least start, before design validation. In other words, how can manufacturing provide production units or their equivalents to quality for design validation if design has not "transferred" a device design to manufacturing?

Bert

 

[Julie O]

I think design transfer is the process of providing manufacturing with the information it needs to manufacture a new design. If there is information available at the inputs stage that they will find useful, and you pass it along at that stage, you have begun design transfer. The transfer ends whenever they have enough information to start production. This does not have to be production of the final product. It could be production of units needed for validation. Depending on how the validation works out, this might not be the design that will be manufactured for marketing. In that case, additional transfer activities (usually of design modifications) will occur between validation and market production.

 

[Ronen E]

Regulatorily, "Design Transfer" is not the transfer act itself but the (culminating) act of methodically making sure that the design is correctly translated into production specifications. For instance, a plastic part design may be represented by a drawing with some informative comments, while that drawing is not yet sufficient for mass production through injection molding (IM). The production specifications may (should) include, among other things, the IM process parameter settings. In Design Transfer, the manufacturer ascertains that the IM process has been properly fine-tuned for mass production and that the results have been documented in a formal and binding way, to guarantee good parts production. Of course, this is just one aspect of production specifications - I highlighted it as an example of the difference between "pure" design and production specifications.

The language in 21 CFR 820.30(g) (Design Validation) suggests that for these regulations "Production" refers to serial ("marketing") production, rather than to prototype / R&D style production; hence IMO Design Transfer refers to the formalization / setting of specifications related to mass-, commercial production. Informing those responsible for making units for Design Verification, Design Validation, Process Validation etc. (e.g. manufacturing staff) of the design / product requirements which are necessary for delivering test units would fall under the scope of these steps in the Design Control process (Design Verification, Design Validation etc.); not under Design Transfer in the regulatory sense.

 

[Scott A. Bednar]

The transfer to manufacturing (not design transfer) is a long drawn out process that builds over the life of the project. As the design evolves, manufacturing documentation is developed and processes are optimized until the design is frozen. The processes are validated and formal design verification is completed. The next run of product may be considered production and these units are used for validation testing and in some cases summative usability studies. Once all of the boxes are checked and the manufacturing engineer accepts the package, I consider that point in time design transfer. This scenario follows the layout of the standard and is typical of a sterile disposable development cycle.

 

[J0anne]

Design transfer is critical to product quality and it takes place when production specifications/working drawings are transferred from the design specifications.820.30 (h)

 

[mihzago]

I think I should clarify my response in earlier post on May-11; in the sentence "Design transfer does not have to happen before Design Validation ..." , the word "happen" should be replaced with "complete". So to reiterate, the design transfer has started, but is not necessarily complete prior to design validation.


There seems to be a common theme in all of the responses, which is also in line with my opinion, that the "Design Transfer" is not a distinct gate or a phase but rather a set of tasks and activities that progress throughout the project and may start as early as project initiation. It ends when Production team has all the necessary information to begin manufacturing devices that can be sold to the public.

 

[Ronen E]

"Design Transfer" is not a distinct gate or a phase but rather a set of tasks and activities that progress throughout the project and may start as early as project initiation. It ends when Production team has all the necessary information to begin manufacturing devices that can be sold to the public.

I respectfully disagree.

While I agree that the transfer of information from the design team to the manufacturing team, covering specifications that enable commercial production, is a long process that may start very early in the project, "Design Transfer" - in the regulatory (FDA) sense - IS sort of a gate event, in the sense that it should be relatively short end decisive; it requires a certain input to begin (design freeze, or the successful completion of design & process validation) and when successful/complete it allows the NPI process to proceed to commercial production. As I noted above, Design Transfer in the regulatory sense is the act of ensuring (checking, verifying) that the actual transfer work product is complete and adequate.