Design
transfer is another critical phase of the design control of the medical
device. This is the phase of
transferring the design into manufacturing or production. The key is to ensure
the production specifications are being done right. This is to ensure that the
manufactured devices can be repeatedly and reliably produced within product and
process capabilities.
Therefore,
to achieve that, it is critical to have frequent consultation and intensive
interaction especially between design engineering and production engineering.
All
must be involved with design review meetings and activities from the beginning
to end. Intensive interaction is especially required when the device is new to
the production team.
Some
examples of production specification are as below:
·
Assembly
Drawings
·
Component
Procurement Specification
·
Computer-aided
Manufacturing (CAM) Programming Files
·
Digital
Data Files
·
Inspection
and Test Specification
·
Manufacturing
Instructions
·
Manufacturing
Jigs and Aids
·
Master
EPROM
·
Programmable
Device Files
·
Prototypes
·
Training
Materials
·
Workmanship
Standards
Another
key element is having a design and development procedure which include a
qualification assessment for the completeness and adequacy of the production
specifications.
Secondly,
the procedures shall ensure all documents and articles regarding production
specifications are reviewed and approved by respective team members.
Thirdly,
procedures should also ensure that only approved specifications are used in the
manufacturing of the medical devices.
I
found that it is very useful to have all the documents about production specification
into a formal ‘design transfer’ template. This template must contains all the
final version of all documents of the design transfer.
But,
unfortunately, I had encountered many medical device manufacturers failed to
have a seamless design transfer. For example, design engineering waited until
the last minute to transfer to production and expect the medical devices to be
produced perfectly. Therefore, it is critical that the manufacturing and
production department not to get involved at the last minute. You just cannot dump the whole design transfer
documentation to the production team last minute.
Reference
|
Criteria
|
21 CFR 820.30(h)
|
Each
manufacturer shall establish and maintain procedures to ensure that the
device design is correctly translated into production specifications.
|
Disclaimer:
Although
the author had exhaustively researched all sources to ensure the accuracy and
completeness of the information contained in this blog, but no warranty and
fitness is implied. I assumed no responsibility and implied warranty of any
kind for errors, inaccuracies, omission, or any inconsistency herein. No
liability is assumed for incidental or consequential damages in connection with
the use of the information contained herein. Readers should always use their
own judgment and review all related regulatory guidelines. Guidelines can
change over time.
