FDA ( Food and Drug Administration) is an agency within the Department of Health and Human Services which is responsible for protecting the public health in USA. The project I was involved was strongly "validated" and had to be compliant with FDA regulations (21 CFR Part 11 - Electronic Records and Electronic Signatures).
How these affect testing?
Every single piece of test (usually test script) had to be formally reviewed and signed before and after execution by 3 persons. In total 6 signatures per each test script. My first feeling was that this project is really good tested. But soon I have realized several problems. This huge bureaucracy introduced many consequences for example very long loop between test idea (the moment of creating the script) and test execution (the moment when formally written test step were used for "testing").
Furthermore testers responsible for test scripts creation where seldom executing own test scripts. This approach was compliant with General Principles of Software Validation and guidance for Electronic Signatures Validation provided by FDA. But from my point with such enormous obligatory bureaucracy something which supposed to be "testing" becomes "checking" and regular office work. This 'heavy scripted testing' highlighted the problem of separation between the test creation and execution. Even though we’ve covered all written requirements with test scripts we didn’t go beyond this, we didn’t find out new informations about the product, we didn’t present more insights to stakeholders, we didn't use diversity of tester experiences and skills - simply we were not serving the project as we could do. In addition with huge amount of resources we were still struggling to meet deadlines, leaving people exhausted and unhappy.
Below simple example:
Imagine that there are two testers. Tester A covers requirement with 2 test scripts. One test script per positive and negative test case. Tester B executes those two test scripts. Execution occurs usually month from the moment of test script creation. What are the results of such approach? For example you will never hear statements like:
"Wait, let’s do this test first instead of that test" or
"Hey, I wonder what would happen if…", or
"Bag it, let’s just play around for a while"*
There was simply lack of exploratory testing. For every suggestion of change I heard we have to follow FDA rules and keep "scripting" requirements. This made me wonder, how on earth some government agency can know better than our company what is best for testing ? I went with this problem to Michael Bolton. I was lucky and he found a minute to discuss this with me:
What I learned from this coaching session:
1. There is no procedure and script for producing test scripts.
It means that to some extent, we all apply exploratory approach. When we create any test script we often combine our subjective knowledge about the program, our previous testing experience, and formal requirements. Rarely same approach works for each test script and we need to make decision what is best along the way which can be the argument the every scripted processes "come from" exploratory processes, and not the other way around. Michael also pointed out that "whatever benefit the script provides after you've done your exploration the real benefit came when you found problems "during" the exploration" and I agree with this. From my experience I can say that often more problem are found during test script creation ("exploration") than while actual test script execution
2. There is no single statement in FDA guidance that we have to apply scripted testing to achieve validation and verification.
I have reviewed FDA guidance and regulations and indeed I couldn’t find a word that test scripts are the must. They mention about the evidences, which can be gathered with any approach to testing.
He also suggested to read the principle of the least burdensome approach. This document is not directly related to testing but we can read there few interesting statements for example :
"(...) FDA is an agency committed to fostering innovation and ensuring timely public access to beneficial new products. A least burdensome approach should be used in almost all regulatory activities. Application of the least burdensome principles to premarket requirements will help to reduce regulatory burden and save Agency and industry resources (...)"
I see above as suggestion for well-balanced approach in every aspect of project validated under FDA regulations. For example: why can't we be more flexible, let’s have enough evidences of executed scripted tests while on the other hand give testers freedom to explore the product so they can use their experience and unique testing mind in best possible way.
3. What can we change ?
- Think in terms of reference, inference, conference, and experience. Think in terms of keeping the design activities closely linked to execution. Instead of telling people what steps to follow, provide them with a motivation or a risk or an information mission.
- For the less experienced or less skillful testers, supervise them and coach them. Train them.
- Now, when there are specific things that need to be checked, specific procedures that MUST be followed - specify those.
- Provide them with guidewords for the sorts of problems that you want them to focus on.
- Another thing to get them to do: keep notes of your observations, questions, concerns, confusions. Talk about them after the testing session, or get help during it.
- If someone wants to know /exactly/ what you did, consider this: screen recorder (eg. http://www.bbsoftware.co.uk/BBTestAssistant.aspx )
Alek
*(I borrowed above quotes from Micahel Bolton)
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