Unverified Design – An Example
For those of us who travel routinely, one of the most sought-after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile devices and technology, access to a continuous power supply while on the move is a necessity. This is all too often realized when you get that annoying message on your smartphone that your battery is critically low and you need to connect your charger … and all available outlets in your immediate vicinity are taken by fellow travelers.
Fortunately, some airlines are recognizing this growing need and providing multi-outlet charging stations for their flying customers. I was fortunate enough to locate an unoccupied charging station on a recent trip only to discover that it was inoperable. I checked behind the unit and found that it was unplugged, as the outlet could not accept a fourth plug due to outlet and cord configurations (see photo … yes my phone had enough battery left to snap a picture!):
This situation could have been avoided with a simple design/specification verification of outlets and plugs before deploying the units to the terminals. So what does this have to do with software quality/system validation? This example hardly impacts any pharmaceutical product quality or patient safety. The fact is, similar situations often arise when reviewing validation plans and auditing system life cycle documentation.