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Discussion Thread Title: Design Verification - Managing Changes
Single Post View
Old 13th February 2018, 02:34 AM

Total Posts: 1
Please Help! Design Verification - Managing Changes

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!

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