Deviation in Design verification

#1
Hi all
I am in the Medical Device business and we are internally having a discussion regarding deviations in Design Verification tests.
You can do Design Verification on prototype items but by that you also say that you have a risk of a deviation which is related to the manufacturing process. How do you guys handled this?
 

yodon

Staff member
Super Moderator
#2
Your production controls should eliminate the likelihood of introducing deviations. That should be the whole idea behind design transfer: ensure that you can build what was designed and include the controls (in process and final acceptance) along the way to confirm you AREN'T deviating.

Note that while verification can be done on prototypes, validation needs to be done using "representative" product (13485) / "initial production units, lots, or batches, or their equivalent" (820).
 
#3
Your production controls should eliminate the likelihood of introducing deviations. That should be the whole idea behind design transfer: ensure that you can build what was designed and include the controls (in process and final acceptance) along the way to confirm you AREN'T deviating.

Note that while verification can be done on prototypes, validation needs to be done using "representative" product (13485) / "initial production units, lots, or batches, or their equivalent" (820).
I of cause agree, but the nature of prototypes is that you haven't validated your production process etc at the time the prototypes are produced. Why do final design transfer and validation if the Design verification reveals problems that should be adressed by design changes.
 

yodon

Staff member
Super Moderator
#4
Maybe I'm misunderstanding. When you say "risk of a deviation which is related to the manufacturing process" are you talking about the manufacturing of the prototype or the manufacturing of final product?

The point I was trying to make is that once you work all the kinks out (prototyping, verifying, etc.) your production process controls are intended to reduce the risk of deviations in manufacturing.
 
#5
Maybe I'm misunderstanding. When you say "risk of a deviation which is related to the manufacturing process" are you talking about the manufacturing of the prototype or the manufacturing of final product?

The point I was trying to make is that once you work all the kinks out (prototyping, verifying, etc.) your production process controls are intended to reduce the risk of deviations in manufacturing.
I mean a risk of a deviation when you produce your prototypes for the DV.
 

yodon

Staff member
Super Moderator
#6
At least in my experience, prototypes intended for DV are made with a considerable amount of care and go through a fair amount of check-out and so deviations are pretty unlikely. I guess you could elevate your check-out process, considering where your risks for deviation are.
 

indubioush

Involved In Discussions
#7
What kind of deviation are you talking about? Does the product still meet its design specifications? If you are building a prototype device and your manufacturing process is still being defined, you just need to ensure that you obtain approval for using the device for the verification test.

You can change a manufacturing process without affecting the design. It is difficult to know the situation from your description though. Sometimes the product is so fully dependent on the manufacturing process that you would not want to do DV prior to having controlled production.

If you do a design verification test, and it fails, indicating that you need to redesign your product or process, you correct the design or process and then repeat the design verification test(s). The records of the design review and any actions need to be captured in your design history file.
 

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