Quality, Validation, and SDLCs

Discussion of software development methodologies – which is really the GMP, Quality approach, Waterfall or Agile? Many QA people will tell you that you need to follow some form of Waterfall method. Write up requirements, then a functional specification, then a design specification, and then you can begin coding. Only this method will ensure that you create a quality piece of software.

Now, the FDA has shifted their view on the subject, to some degree. This is most notable in some of their guidance documents on software validation, where they require that a company select an SDLC, without requiring a specific one. However, if you take the entirety of the text, you can still feel a call for the more traditional Waterfall approach. Perhaps this, as well as the general unwillingness of people in quality to change, is why.

What I would like to do, though, is get back to the fundamentals. Get back to exploring what quality is, what validation is to accomplish, in order to answer the question posed at the beginning of this entry. This will all be very simple, its just forgotten most of the time.

Quality is simply the fitness for use of a product. If it meets your needs, in terms of function, price, longevity, etc., then it is a quality product. Validation is simply a way of establishing that a product is quality product. We validate processes to establish that they produce products of acceptable quality. We validate software to establish that it meets the needs of the end user. It is interesting to note that there is an understanding that fitness for use does not necessarily mean conformance with requirements. Just because something meets documented requirements does not mean that it actually is fit for use. I imagine the infamous Tacoma Narrows bridge met its requirements. It was simply that someone forgot a key requirement that was the problem.

If, then, we need to ensure that software is fit for use, yet we can’t rely on software requirements as the arbiter of what fit means, where does that leave us? Traditional Waterfall methodology says that we must develop requirements, then build. While many accept that you can revisit requirement during the build phase, this practically does not happen very often. What if we missed something? What if there was a subtle need that we didn’t detect during a typical requirements gathering exercise? Usually, this problem is not detected until the product has been released. Then, it is too late. The end user can request changes, even complain, but then they are often accused of changing requirements, and the changes have to wait until some subsequent project.

This brings me to the subject of Agile programming. I suspect most people view this as a means to shortcut documentation and get the program out faster. While it is true that Agile may result in less meaningless documentation, and will likely produce software faster, these are results, not drivers of the process. The key driver of Agile is good software. This is enabled, in part, by much closer integration with the business during the process. It is dependent on extensive prototyping as a means of confirming understanding by both the customer and the developer, as to the actual needs the system is to fulfill. In other words, it is focused on developing a solid understanding of what will make the system fit for use. It does this, by placing a focus on business understanding, first and foremost.

So, if Agile produces software that better fits the needs of the business (vs. the stated requirements) that makes the software quality software, the process used to develop it, and the software itself, eminently validatable.

Leave a Reply

Your email address will not be published. Required fields are marked *