I want to add another wrinkle here. Obviously you can't have a "final" DMR until everything about the design is completed - inputs, outputs, verification and validations - of both process and design - though there is a bit of a "chicken and egg" challenge as to how to best manage those.
However, when you "complete the DMR" is very different than "when you design your manufacturing process." Yes, it is possible to just design away and when you complete DV, "toss" the product to manufacturing and let them design the manufacturing procedures. Or, it is equally possible for your design engineers to say "here is how we made them, just do this" at that point. Neither method seems to work very well and both increase the likelihood that you will be unable to consistently make good product to the existing design.
It is much better to design the manufacturing process in parallel to the product design, with give and take between designers as features and design decisions evolve. Sometimes, you can add tolerance to a design that makes the product much easier to build etc. In this methodology, your DMR is evolving the entire way, but "transfer" is much easier.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 16-Jan-2018 20:38
From: Marcelo Antunes
Subject: Timing of Manufacturing within Design Control
Manufacturing is after design transfer (design transfer is more or less the creation of the manufacturing process) and usually before design validation (design validation uses initial production units, lots, or batches - in this case manufacturing is before this - or their equivalents).
The DMR is the "cake recipe"for the manufacturing of the design. You need to have it after design verification (which confirms that the design output meets the design input requirements).
FDA clearance is after design validation (and process validation, which is another topic, is during design transfer and thus before design validation).
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Marcelo Antunes
Regulatory Strategy Consultant
SQR Consulting
Sao Paulo
Brazil
Original Message:
Sent: 12-Jan-2018 15:52
From: Anonymous Member
Subject: Timing of Manufacturing within Design Control
This message was posted by a user wishing to remain anonymous
Ladies and Gentlemen,
I am new to Quality & Regulatory, and I am having trouble reconciling when manufacturing of products should occur within the context of Design Input phase, Design Output phase, Design Transfer phase, and Design Validation phase. Do I need to have all my design inputs translated into design outputs, and have those outputs verified and validated before I create the Device Master Record? When should I file for FDA clearance after the Design Transfer phase, after the DMR is created or after process validation has occured? Help!