For Medical Devices

What's Wrong? Why Do We Have Repeat Investigations?
by Nathan Conover, Sr. Partner, Pathwise

Repeat CAPA investigations are arguably one of the largest areas of concern for quality managers today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as 30% of all open investigations- or 1 in every 3. What's going wrong? Why is this happening to so many of us?

This scenario often results in the investigator identifying a "quick fix" solution to the symptom that never addresses the root cause of the underlying issue.

There are many reasons this phenomenon occurs; the majority of which are occurring because of mistakes taking place in the initial steps of the investigation process. As a best practice, investigators are asked to scope out exactly what the problem is and outline it in a problem statement. Far too often this step is done improperly or rushed, and the problem is not captured with a true scope and specifications. For example, problem statements that describe the issue using simple descriptors, such as "failed assay" or "improper installation," lack rich information and can be interpreted in many different ways. Without a clear and concise description of the problem, it is difficult for the investigator to determine the underlying issue--or even--to know where to begin searching.

When the problem statement is mislabeled, the symptoms of the problem and not the problem itself tend to be treated. This scenario often results in the investigator identifying a "quick fix" solution to the symptom that never addresses the root cause of the underlying issue. In this case, the investigation will have a corrective action that eliminates the symptoms of the problem for a short time, but the problem ends up resurfacing with a new set of symptoms. Therefore, it is beneficial to spend time up front in clearly identifying what the scope and specifics of the problem truly are.

The second area that can cause repeat investigations is incomplete effectiveness checking. In many cases, once the effectiveness checking process begins, it is not carried through all the way to the end. Once it is noticed that the problem is going away and/or that complaint rates are decreasing then the CAPA is subsequently closed. This is an example of inadequate measurements for effectiveness checking. Effectiveness checking should show a formal plan to measure the elimination of the underlying problem to ensure that it will not reoccur.

To prevent a future occurrence of a problem that should already have been addressed, it is recommended that companies implement a formal process for effectiveness checking, making sure that proper verification and validation takes place. Ongoing monitoring of the situation should also occur until closure. If an incorrect root cause was identified or an incorrect corrective action was implemented, a strong, well-maintained effectiveness checking plan would be able to catch it.

By addressing and developing a formal problem scoping and effectiveness checking plan, quality managers should see a decrease in repeat investigations and an overall improvement of their CAPA system.

Nathan Conover, a Sr. Partner for Pathwise, has spent nearly a decade working with the Medical Device and Life Science Industry. He regularly presents and consults with large to medium size organizations around the world on how to improve quality and how to stay in compliance with FDA and ISO standards and regulations. He is a faculty member of the Parental Drug Association (PDA), American Association of Medical Instrumentation (AAMI), and IVT.

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