There is a common theme when working for a manufacturing company: get it done, and get it done right. The non-device / product related items, such as documentation, that are involved in the manufacturing process are often left on the back burner because of this. In my opinion, it is this documentation that is most necessary in the product lifecycle.

Every touch point of the product will come back to one question: why? Why does the product behave this way? What are the exceptions of software behaviors? Software is working on the next generation of a product by the time reports come in from product use, and their attention is no longer focused on that previous back burner item. It’s imperative, however, to properly and extensively document software before it hits the field. Whether healthcare, where FDA audits are required, or manufacturing, where industry audits are required, it comes down to one simple question: is the device / product working as it is supposed to.

When it is time to answer this question I’ve seen software teams point fingers and say, “That’s not our job”, “The software isn’t supposed to be used for this purpose”, and “It’s in the manual”. This vicious circle of shifting responsibility and haphazardly patching code to meet the next version release date only increases problems down the line, so take the time now and do the job right.

As product life cycle management continues to fall into the hands of freshman data teams these teams must know how to respond and how to support the product. In order to do that we need to understand how the device works, plain and simple. So, software, this is me sincerely asking, “Please, please document how your device is designed to operate”.