When does design transfer take place?

J

Julie O

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

IMO, biocompatibility testing and pivotal clinical trials should use final "production" units, not "prototypes." Otherwise, the data may not be applicable to the final product.
 
J

Julie O

"Design Transfer" - in the regulatory (FDA) sense

In the "regulatory sense," design transfer occurs when the appropriate parties sign off on approval to begin production with the current set of design outputs.

The processes that lead to this magic moment can also be referred to as "design transfer activities," I think, but the actual transfer occurs with approval to start production.

My 2.
 

Ronen E

Problem Solver
Moderator
IMO, biocompatibility testing and pivotal clinical trials should use final "production" units, not "prototypes." Otherwise, the data may not be applicable to the final product.

The question is what exactly "final" means. The FDA allows use of equivalents for purposes such as design validation, suggesting that the untis don't have to be identical to the "final product".
 

Candi1024

Quite Involved in Discussions
IMO, biocompatibility testing and pivotal clinical trials should use final "production" units, not "prototypes." Otherwise, the data may not be applicable to the final product.

We does those tests with equivalents. That testing may bring some change to the product, and until they pass those tests they aren't in full production yet. So that is before the actual final transfer. Once they pass those tests, the transfer takes place.
 

mihzago

Trusted Information Resource
I appreciate the disagreement.

Let's look at the source of the "regulatory FDA sense". The definition of the design transfer states that: "Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications."

There's absolutely nothing about it being a gate event, or a "relatively short event", or that it is gating other design control elements.
Not even the FDA guidance on Design Controls states anything about the timing of activities.

Many companies however create a gate event as part of their product development process often called "Design Transfer", which is this magic moment when the design engineering team throws everything over to the manufacturing team. This may be a "final" (we all know nothing is final) check that all specifications and outputs have been completed and approved, which is fine. This gate however will rarely if ever be complete prior to design validation or process validation because design validation will often provide input into production. At the same time there may be problems discovered during process validation, pilot run or initial production runs that will require modifications and additional verification or validation.


I also found additional insight regarding the question about the relationship between validation and design transfer, and the use devices that are not final production units for the purposes of verification and validation. Question #81 in the "pre-amble":
"... Certain aspects of design validation can be accomplished during the design verification, but design verification is not a substitute for design validation. Design validation should be performed under defined operating conditions and on the initial production units, lots, or batches, or their equivalents to ensure proper overall design control and proper design transfer. When equivalent devices are used in the final design validation, the manufacturer must document in detail how the device was manufactured and how the manufacturing is similar to and possibly different from initial production. Where there are differences, the manufacturer must justify why design validation results are valid for the production units, lots, or batches."
 
U

Uberbert

Ronen ? Would you mind if I borrowed your definition of design transfer? It is the best and clearest I have seen.
 
U

Uberbert

After numerous re-readings of the standard and the guidance and conversations with folks who have actually done numerous design transfers for medical devices, I would say Ronen and Scott are spot on. Ronen?s example and definition are very good. I also agree that the FDA?s intent is serial production. The explanation of design transfer starts with ?Production specifications must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities.? (emphasis mine)


Scott?s differentiating between ?transfer to manufacturing? and design transfer further helps clarify the issue. To add just a touch, my understanding of design transfer had been that it was the process of transferring from design to manufacturing. While that is an important process, it is not what the FDA refers to as design transfer.
 
U

Uberbert

There's absolutely nothing about it being a gate event, or a "relatively short event", or that it is gating other design control elements.
Not even the FDA guidance on Design Controls states anything about the timing of activities.
I will respectfully disagree that there is nothing about design transfer being a relatively short event. Quoting the guidance:
No design team can anticipate all factors bearing on the success of the design, but procedures for design transfer should address at least the following basic elements.

  • First, the design and development procedures should include a qualitative assessment of the completeness and adequacy of the production specifications.
  • Second, the procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved.
  • Third, the procedures should ensure that only approved specifications are used to manufacture production devices.
The first item in the preceding list may be addressed during design transfer. The second and third elements are among the basic principles of document control and configuration management.

The key phrase is "qualitative assessment of the completeness and adequacy of the production specifications" which to me sounds a lot like a design review which is a discrete event. I am not sure why they did not just say a design review was required.

I will concede that the other text implies an on going process but I must also defer to my co-workers who have done design transfer and indicate it is more of an event than a process.
 

mihzago

Trusted Information Resource
I also agree that the definitions are very good.

However, I'll continue to argue the timing.

The key phrase you quoted" qualitative assessment of the completeness and adequacy of the production specifications" says nothing about timing. "Qualitative assessment" does not refer to timing; rather it indicates a systematic and complete review, not how long it takes.
Why can't I review this over a series of meetings/reviews. If you have 25 pieces of manufacturing equipment, 100 drawings of your product, 30 assembly and test specifications, software used in production and other things, how can you review all that in a single event? You can't.


Again, please do not confuse the "Design Transfer" (one of the Design Control elements defined by the FDA), with a product development gate of "transfer to production" as defined by your company.
You can state that the transfer to production is a point in time when all "Design Transfer" activities are completed e.g. all device and production specifications signed off and the first device that comes out of the line can be distributed to a customer.

Your co-workers may be referring to this Design Transfer review during which they simply check if all specs and documents were signed off, but I can guarantee they do not review all of those documents during that review.
 
Top Bottom