This is the third in a series of blog postings in which we present a top-ten list of common errors encountered in the context of medical projects. Of course, such a ranking depends on personal observations and individual experience – and hence has a subjective outcome. Please feel invited to tell us about your perspective in the comments section!
Documentation is an important aspect in medical projects. This holds for all sorts of disciplines – e.g., requirements engineering, system analysis, architecture and design, development, testing, deployment, configuration management, build/test environment, and project management. Even when a medical device has been on the market for decades, for example, the producer/distributor must be able to reenact why and how something was achieved during development or maintenance.
As mentioned in the previous post, a typical reaction to legal requirements is overfulfilling: Out of fear of maneuvering themselves into a tenuous position via insufficient documentation, people readily produce much more paperwork than formally required. How much more, you ask? Let me put it this way: You wouldn’t believe! We’re not talking about a 100-page architecture document here. We’re talking about individual module test specifications, for instance, having thousands and thousands of pages.
However, there is more to observe in practice than just excessive documentation: completely inhomogeneous amounts of documentation. In the worst case, projects produce mountains of worthless paperwork for some of the aforementioned disciplines while simply forgetting about others.
On a side note, this anti-pattern of asymmetrical effort can be found in many forms. A rather typical example that comes to mind is tool validation: Yes, you should validate the tools used in the creation of your medical software (such as your unit-test framework or your code coverage analyzer). But no, this does not imply that you should invest three man-months and produce epical documentation for a simple tool.
Coming up next: #7, The 100% Confusion. See you there!