Prima, Published

Posted on 27. May, 2009 by in Documentation & Training, Prima Communications Blog

Larry Elwell, Prima’s Director of Engineering Services, recently authored an article published in Medical Device & Diagnostic Industry magazine’s May 2009 issue. Larry’s article focuses on the documentation piece of quality system compliance and explains how well-developed documentation can be an asset during audits as well as for daily operations use.

Having been through a few audits myself, I can second Larry’s advice on how dedicating energy in document development can pay off during audits or certification evaluations. While your staff may be the experts on the information, having a professional writer assist in document development will not only ensure your documents are developed consistently and concisely, but with the years of experience our staff brings with us, will often enable us to lend additional insight and value.

Larry (or any of our other qualified, talented professionals) is available to discuss your unique documentation needs, audit plans, or how this year’s ISO requirements compare to last year’s.

Are Your Documents Useful?

Posted on 22. Apr, 2009 by in Documentation & Training, Prima Communications Blog

Let’s face it—most of us write documents for the wrong reasons.

Either a) someone told us to write it, b) there’s a regulation that says we need it, or c) something went wrong or was done incorrectly, so it was decided that a document should be created or modified to “fix” that problem.

Why are these reasons wrong, you ask? Because ideally, a document—a work instruction, a procedure, a manual, or yes, even a policy—should be written to inform and instruct. It should be written for the user, the reader, the operator—rather than the boss who said it needed to be written—or the FDA.

Writing for a wrong reason inevitably creates unwieldy, complicated, and redundant documents that are not useful. And the more convoluted the information, the more difficult it is to maintain that document set.

It’s a challenge to go back and undo what’s already in place. Most of us have inherited these cumbersome document sets, and reversing the trend of complex, often unnecessary documentation is not an easy task. But there is hope.

You can start by following these three simple steps:

  1. Write with the audience in mind—NOT the auditor. Not your boss.
  2. Say what needs to be said—nothing more, nothing less. This can be very difficult and ties directly to the first point. Too often we err on the side of including everything, but that is faulty in several respects.
  3. Use pictures or visuals.

You can’t easily change what’s already in place—though sometimes the effort required to do so is well worth it—but you can try to move the trend in the right direction.

Presentation Matters

Posted on 18. Mar, 2009 by in Documentation & Training, Prima Communications Blog

These two documents have the same information in them:

Which would you prefer to read? Which would you remember better? Which explains the process better?

Even very technical information can be presented in a visual and logical manner that makes it easy to use and understand.

I’ve been subcontracted to various companies where I’ve spent the first week(s) reading SOPs. The way most of those documents are written and presented is a remedy for insomnia. While I signed that I read them, comprehension of the material presented wasn’t all that great (and I’m an educated, fairly bright person!).

I’d be willing to bet that workers’ deviations from standard operating procedures often occur because of unclear, text-heavy documents.

Does Prima have experience in writing documentation to meet global standards?

Posted on 09. Jan, 2009 by in Documentation & Training, FAQs, Prima Communications Blog, Writing & Marketing

Yes. We’ve helped dozens of organizations gain certification to various standards, from ISO 9000:2000 to ISO 14000, the Malcolm Baldridge award to Six Sigma and Lean Sigma, and ISO 13485:2003 for medical devices.