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Design Transfer - How do you guys control the design transfer process?

#1
Hi
I am starting to look into my firms procedure for design transfer. How do you guys control the design transfer process - with a checklist, Design Transfer reviews etc? Hope for some knowledge sharing.Thank you.
 

somashekar

Staff member
Super Moderator
#4
Hi
I am starting to look into my firms procedure for design transfer. How do you guys control the design transfer process - with a checklist, Design Transfer reviews etc? Hope for some knowledge sharing.Thank you.
Just a comprehensive checklist should do. There is no review here as you have already completed all the reviews due, to arrive at the transferring stage. Its just you letting go and the others taking charge to use the provided outputs to make or buy in volume.
 

yodon

Staff member
Super Moderator
#5
Its just you letting go and the others taking charge to use the provided outputs to make or buy in volume.
Not sure if it was intended but this sounds too much like design just throwing the drawings over the wall and letting manufacturing run. The transfer process needs to be a fully cooperative effort between design and manufacturing to ensure the product can be reliably produced.

I actually have design transfer as one of the required design reviews, using the checklist as the driver. 13485:2016 requires that results and conclusions of the transfer be recorded and I use the review minutes to do so.
 

somashekar

Staff member
Super Moderator
#6
Not sure if it was intended but this sounds too much like design just throwing the drawings over the wall and letting manufacturing run. The transfer process needs to be a fully cooperative effort between design and manufacturing to ensure the product can be reliably produced.

I actually have design transfer as one of the required design reviews, using the checklist as the driver. 13485:2016 requires that results and conclusions of the transfer be recorded and I use the review minutes to do so.
The word 'Transfer' does not show up in the ISO 9001. Hence obviously its from the ISO 13485 reference this thread seems to have been opened. With full agreement to the said transfer process, the intent of my response was not throwing over. Several throwing over (Reviews, verification Validation) must have happened prior to coming to the design transfer phase, which are part of the design iterations. At the transfer phase a systematic procedure and records are deemed essential so that complex design outputs are all covered in the transfer and two things are avoided., Incorrect outputs and Incomplete outputs. An other major thing which is avoided is the need for design changes immediately after transfer.
 

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