Design Transfer - How do you guys control the design transfer process?
- Thread starter Chef100
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@Ajit Basrur posted a related question, asking for a checklist in this thread: Looking for a Design Transfer Checklist
I attached a first cut at considerations. I'm hoping to get feedback on how useful that is. It's fairly, um, comprehensive.
I attached a first cut at considerations. I'm hoping to get feedback on how useful that is. It's fairly, um, comprehensive.
Don, your checklist is very comprehensive 
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.
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.
ragulkumar
Registered
Please share anyone's design transfer sop template I don't know how to make please help me
Did you do a search? Did you look at this thread?
ragulkumar
Registered
I saw but I need it for a sample template of sop on design tranfer
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