Causes of a bad qualification strategy
Sometimes we encounter with bad strategies of qualification and several reasons could be the origin of it. Honestly, in most of the cases, although a bad strategy has been detected, there is no time to change it even if the project has already started.
As a result, the qualification is not fully covered (real risks not covered) and verifications are focused on some aspects with low critically from GxP perspective.
Which could be the reason for a bad qualification strategy?
To decide the qualification strategy, it is necessary to know relevant information about the project, like the scope, phases, who will support and built the system (training needed).
Sometimes IT departments are waiting for QA departments to conclude and negotiate what should be the testing and deliverables QA expects. How many times can you hear between both what is necessary to cover and what it is not? IT Teams usually says, QA does not understand the technology therefore they cannot request something profitable. Also, QA usually delegates what to cover to IT departments decisions because they are not sure what to request indeed. It seems like a jumble sale negotiating each step.
It is important to remember that the qualification strategy is a part of the methodology and it works like a black box. Also, if the project scope has changed, or something is not understood in initial phase, there is a possibility to change the strategy although it is a great cost. It is a must to change the qualification strategy if someone detects any incongruence or misalignment. Some changes in the scope not only affects to IT departments, qualification strategy may be affected.
In addition, the qualification is the way to demonstrate the compliance of the requirements, but it is not the way to discuss about what should be the deliverables and effort committed.
How to approach a successfully qualification:
- Understanding the scope, phases and requirements well defined.
- Also, to have processes and procedures that help to determine standard deliverables for each phase and not to expect the qualification as a negotiation of deliverables.
- People trained although they were external contractors.
- IT departments always should provide an IT service with warranty even if the qualification is not requesting anything. Not expecting what to do.