When to verify and when to validate Design Changes

Aphel

Involved In Discussions
#1
Hello!

I am faced with the following situation.

Our design change procedure states that changes have to verified and validated, if necessary. The decision for verifying or validating a design change is up to the design change team.

Our procedure does not contain criteria, in what case a design change needs verification and in what cases a design change needs verifiaction and validation...

Do you have any criteria, decision trees,... defined in your design change procedure that adresses this issue?

Thanks a lot for any hint!

Best regards,
Aphel
 
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somashekar

Staff member
Super Moderator
#2
Hello!

I am faced with the following situation.

Our design change procedure states that changes have to verified and validated, if necessary. The decision for verifying or validating a design change is up to the design change team.

Our procedure does not contain criteria, in what case a design change needs verification and in what cases a design change needs verifiaction and validation...

Do you have any criteria, decision trees,... defined in your design change procedure that adresses this issue?

Thanks a lot for any hint!

Best regards,
Aphel
As the final design comes out after verification and validation, any change to that design will have to be verified and validated to the extent of the change made, before coming out.
A procedure with words like 'if necessary' or 'where necessary' is always at risk in application and leads to personal bias. Your procedure can address it as the extent of verification and validation can be decided by the design team, based on the extent of changes made, considering the effects on medical device effectiveness, performance, and safety. So the design change team will look into the design change significance and apply suitable verification and validation. If your medical device also carries a CE mark, they will decide on informing the notified body, based upon the significance of the design changes.
 
D

dap2452

#3
I know this is a fairly old thread but thought I'd add a thought or two. Internal audit (by me!) picked up this theme and I have to fix it. My plan is to add three fairly simple cues to the change note: for risk assessment, for the need for V&V (we call R&D tests 'design verification' and we call user approval - often given on their behalf by our Clinical Support colleagues - 'design validation') and for the need to advise various authorities [our NB, FDA, Health Canada etc). If of interest I'll post the format on here in a few weeks as long as you all promise not to laugh!
 
D

dap2452

#5
Silly me , I forgot to add the aide memoire we used at my last firm and I am publicising in my new one:

Verification : did we make the product right?
Validation : did we make the right product?
 
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