Why Don’t Companies Make Documentation a Priority?

Posted on 05. Jan, 2009 by in Documentation & Training, Prima Communications Blog

The last time I surfed the FDA site to check on recent 483s (those nasty and all-too-frequent warning letters), about two-thirds were documentation-related. Either companies did not have procedures in place, did not follow the procedures they had, or had insufficient procedures.

Anyone who works in an FDA-regulated environment is used to documentation. It’s everywhere and covers almost any activity you can think of, yet companies don’t generally focus on ways to make their documentation better. Most companies treat documentation as something that just has to be done—and thereby miss the opportunity to make their employees’ jobs easier, boost first-time quality, and optimize processes.

How do I know most companies don’t make documentation a priority? There are three primary clues:

  1. The sheer number of audit findings related to documentation. I think most companies generally do a good job on their principal task, whether that is making car parts or implantable hips. Documentation, however, is often ineffective, redundant, and contradictory.
  2. The poor quality of most documentation. As a contractor I see many companies’ procedures, and generally I find many more bad procedures than good ones.
  3. The fact that most companies don’t use documentation professionals. Most companies will have whoever is responsible for a task develop the procedure for that task. There are many problems with this method, not least of which is if the person responsible for the procedure writes it, he or she may leave out steps that seem obvious or feel automatic. Also, most engineers, quality professionals, and managers are not writers by trade and don’t have the passion for effective documentation that a technical writer has, or perhaps the skills to integrate pictures and diagrams to clarify concepts.

Good documentation begins when you know what the documentation is for. Often an initial process map is useful in uncovering the true process and decision points that need to be documented. Once you know what you are going to document and why, you can begin to design documents that will clearly guide users. In some cases highly graphical lean documents may be more appropriate than standard text-based procedures.

In other cases maybe the only documentation needed is a few lines of instruction on a form or log instead of a separate procedure. In almost every case though, before a new procedure is developed or an existing one modified, the documentation set needs to be examined holistically to ensure things are not contradictory. And, in almost every case a good technical writer can improve a company’s documentation and help avoid one—or more—of those unwelcome 483s.