Design Changes - Updating the Design and Development File

[Turquoise202]

Hi everyone,

I would like to know which parts of the design and development file need to be updated following a significant design change to an existing device, which has already undergone design transfer.

Obviously the change has to be documented, verified, validated, reviewed and approved. But do the Design Input and Design Output parts of the file need to be updated accordingly?
Or is it enough that the description of the change and the affected documents are recorded in the change form?

Would truly appreciate your reply.

 

[Jen Kirley]

Is this a change of feature?

What are the inputs of the file?

What are the outputs? Besides drawings and/or other specifications, approvals, communications and anything else that is part of this process.

 

[somashekar]

Hi everyone,

I would like to know which parts of the design and development file need to be updated following a significant design change to an existing device, which has already undergone design transfer.

Obviously the change has to be documented, verified, validated, reviewed and approved. But do the Design Input and Design Output parts of the file need to be updated accordingly?
Or is it enough that the description of the change and the affected documents are recorded in the change form?

Would truly appreciate your reply.

Such a change as you mention must have triggered from some input. Relevant outputs must have been changed accordingly. All that changing are in between. These are the starts and finishes of the change cycle. If these are not recorded, you are delinked.

 

[Turquoise202]

Thank you both for your replies. I am actually not asking this following a specific planned change rather than as a general question for the purpose of writing design control and change control SOPs.

 

[somashekar]

Thank you both for your replies. I am actually not asking this following a specific planned change rather than as a general question for the purpose of writing design control and change control SOPs.

Such a change control SOP must begin with review of the design inputs with a view to add new inputs or modify existing inputs. Thereon the activities can flow to get to the new design outputs that meet the changed new design inputs.

 

[yodon]

It would also be a good idea to assess the impact of the change on the Risk Analysis and any Usability aspects.

Since you indicate it's an existing device, it would also be a good idea to assess any impact on the existing product. If this is, for example, a change to improve safety, you might need to take actions for product already distributed and in inventory.