Recording data during tests execution



  • We have a quality processes department who are responsible for processes in our organization to meet FDA standards. It seems though that they require more of us than is actually verified by FDA auditors. Unfortunately this department has a lot of political power so we pretty much have to do anything that they tell us.

    Anyway, one of the things they require us to do is to record a lot of stuff during the execution of tests. So for example if I test the performance of a calculator app, instead of having a test that looks like this:

    Action: Multiple 2342352345 by 131345356452 and measure the time it takes to perform the calculation Expected result: It took no more than 2 minutes

    The test would look like this:

    Action: Multiple 2342352345 by 131345356452 and record the time it takes to perform the calculation Expected result: Recorded time = ?

    Action: Verify (Pass/Fail).............................................................................................................. Expected result: It took no more than 2 minutes

    Action: Record a screenshot of the result and attach it to the test............................................. Expected result: Screenshot was recorded and attached.

    Can you explain why they require us to do that?



  • This is not necessarily the case, but I would suspect that your processes department has been bitten in the past by documentation not meeting FDA standards or by FDA auditors whose expectations are higher than the FDA standards. So they've effectively adopted a CYA approach ("cover your anatomy") and insist that absolutely everything that can be documented gets documented.

    That said, they do have valid reasons for their approach.

    The sample format you've supplied requires explicit documentation of the actual output. For the kinds of software that are subject to FDA standards and FDA auditing, that data could mean the difference between winning and losing an expensive lawsuit (or having people die because of a software glitch...). Whether your software is life-critical or not isn't relevant - it's still being held to that level of standard.

    The screenshot requirement is added evidence that the test was actually performed as specified. I know that sounds bad, but when faced with a mountain of repetitive manual tests, it's perfectly normal and human to not perform them precisely as written (particularly since in my experience the software updates faster than the tests can be updated to match so half the time it's impossible to perform the tests as written anyway).

    The short version is that your processes department is requiring both the tests and the evidence that the tests were performed so that they have the ability to prove to FDA auditors that everything is meeting standards whenever an issue arises.


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