Q: I have a question about FDA expectations for design transfer. What can we use as evidence to demonstrate we’ve met the QSR requirement that “design is correctly transferred”? Is a verification report for each work instruction enough?
A: Design transfer is much more than just writing work instructions. Design transfer encompasses the overall design and development of the manufacturing and production processes for making, packaging and labeling your product.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Design transfer encompasses the overall design and development of the manufacturing and production processes for making, packaging and labeling your product.[/pullquote]
Design transfer includes:
– Selection and approval of suppliers
– Development of all production processes for components, sub-assemblies and final assemblies
– Development of packaging and labeling processes
– Development of incoming, in-process and finished product acceptance activities and criteria
– Development of servicing and installation processes
– Validation of all production processes (after characterization)
– Validation of all automated testing tools and methods
– Validation of packaging and labeling processes
– Development of Device Master Record documents
– Determination of suitability of the facilities to be used for manufacturing, packaging and labeling
– Consideration of environmental and contamination controls
– Determination of process monitoring requirements, and
– Qualification of production tools, jigs or equipment.
So you can see, design transfer is not just a single step — it’s the sum of all the above requirements and the point at which you gain knowledge of the manufacturability and serviceability of your product. In addition, first article inspection is a key activity of design transfer, giving you an understanding of whether your suppliers or your manufacturing facilities can make products that truly meet your design intent.
Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator and co-editor of FDA’s Investigations Operations Manual) and instructor of EduQuest’s training class on Design Control for Medical Devices: Meeting FDA’s 21 CFR Part 820.30 Rules for Quality Design and Manufacturing.