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Discussion Thread Title: Design Verification - Managing Changes
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Old 13th February 2018, 01:20 PM
John Broomfield's Avatar
John Broomfield

Total Posts: 2,660
Lightbulb Re: Design Verification - Managing Changes

In Reply to Parent Post by jamesmiller View Post

Hello Folks,

Wanted to know your opinion on the following scenario

I am in the middle of a design verification and found our that there are two different issues

1. A test failed because the requirement was written wrongly, instead of raising an alarm at 10 seconds, it raised at 20 seconds - but the correct requirement is indeed 20 seconds.

Now in my root cause analysis and resolution, i have to change my requirement to say 20 seconds AND amend the protocol - do I need to rerun my test again ? If the answer is No, then my dates of protocol will be "later" than my dates of execution. Will this be viewed as "fix the spec" than fix the design ?

If I do this, is there a potential design control violation ?

2. Similar as above case, (for a completely different requirement) but this time my protocol was written wrongly and test HAS completed execution and failed, due to a incorrect protocol. Do I just amend the protocol and refer to old results ?

Common sense says, yes - but is there any violation of quality requirements from FDA/CE perspective ?

thank you in advance!

It seems to me that your design verifications have discovered a nonconformity in the spec writing process for which you need to take corrective action.

But the product design itself may fulfill the performance requirements, is that right?

Your design team's risk assessment should determine whether to proceed to design validation or to replan the design verification to start again.


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