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4 Tips for Documenting a Quality System Exception

Patrick Kahl of Abbott Vascular explains how to properly document a quality system exception.

Patrick Kahl
Patrick Kahl, Abbott Vascular

Writing a nonconformance report isn't exactly one of the highlights of the job. But it's a critical task that, if done poorly or incorrectly, can pose regulatory and technical risks to the business. Patrick Kahl, quality systems analyst and project coordinator at Abbott Vascular, provided attendees at MEDevice San Diego this week with the following best practices to avoid an audit finding and other complications.

1. Tell a story that is clear, concise, and complete. Get to the point quickly and state the facts accurately, efficiently, and succinctly, Kahl advises. The goal should be for readers to have all the facts in front of them, presented in a clear manner, and not feel the need to dig deeper, according to Kahl. Engineers should make sure to explain exactly what was wrong and what happened in addition to citing the specific quality requirements. 

"Trust me, from an engineer's standpoint: More is never better. When you have to read through 20, 30, 40, or 500 of these for a year-end report for FDA, you don't want to have to read through three paragraphs of introduction to get to what the problem actually was." The quality exception, he says, should be explicitly stated at the beginning of the problem statement to facilitate easier review, trending, and tracking. Supporting evidence should follow.

2. Include bracketing information. When writing a nonconformance report, engineers need to assess what else could be impacted by the problem, such as other lots, departments, or sites, according to Kahl. He recommends that engineers demonstrate that they went through the exercise of considering the potential effects or consequences. However, Kahl notes that doing so can be effectively communicated in just a few sentences; a novel on the subject isn't necessary.

3. Be objective. It's imperative to write the true story, not a fairytale, Kahl cautions. "Everyone that I know of wants to impress and keep management happy. But you've got to make sure you put things the way they truly are," he says. "Sometimes the truth is ugly and not very comfortable. But it has to be there."

Engineers also need to make sure that they don't speculate; only the facts should be presented. Kahl adds that writing with an agenda or slanting investigations to pet theories can create more significant problems. In fact, Kahl recalls a report that included the comment: "The supervisor said this could be a really bad thing."

"If I was an auditor, I would eat that [statement] for lunch," he says. "There was nothing after that; it just kind of hung out there all by itself. Include all of the pertinent information to tell the story and no more." 

4. Don't procrastinate. Exceptions need to have timelines, Kahl says, but processes do need to have allowances for extensions in case something happens. "These things need to be spelled out in your procedures and then you have to hold to them," he states. "If you need an extension, then you need to justify it." Furthermore, follow up is essential or engineers will find themselves back at square one.

 —Shana Leonard, group editorial director, medical content
[email protected]

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