What Makes a Smart Doc Smart?

Posted on 14. Apr, 2009 by in Documentation & Training, Prima Communications Blog

I’m sure we can all take a tedious text procedure and make it look better by reformatting, adding graphics, or using white space better. Does that make it a smart doc? I don’t think so.

Smart docs require some planning and a lot of thought because they aren’t single pretty documents but a system of documentation that works together, is easy to use, and is rigorously logical. True smart docs can’t be developed in a silo but must be developed with the other documents in the system.

For instance, smart docs don’t repeat information in multiple places unless absolutely necessary. Information goes in the one most logical place. This sometimes requires some thinking about what that most logical place is and sometimes sparks some debate (which can be very healthy and lead to a better solution).

Smart docs also put similar information in similar documents. If information on how to operate a cartoner is in a reference manual, then information on how to operate a labeler is in a reference manual. If setup information is in a checklist on Line 2, then setup information is in a checklist for Line 6. This consistent documentation makes it easier for operators to find the information they need.

It’s not enough to have pretty documents. You need a system of smart docs.

What’s behind the motto “Whatever It Takes”?

Posted on 09. Jan, 2009 by in FAQs, Prima Communications Blog

We selected that company motto to convey our intense customer-service focus, and it guides our service offerings.

For example, if a company needs validation documents, they may also need a documentation-management system, equipment manuals captured electronically, protocols executed, procedures and training developed, and / or the project managed. We handle all aspects, doing Whatever It Takes to validate the process, product, equipment, or facility. While there’s certainly no job too big, there’s also no job too small. We’ve assembled manuals, hand-addressed mailings for increased readership, organized meetings to train organizations on document control…and then taught the course. For our clients—and our employees—we strive to do Whatever It Takes.

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.