Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let's examine two key distinguishing features of a good approach to CAPA management.
Risk as a FilterOnce the CAPA process is started, you are obligated to follow through, research cause, and find a corrective action to remedy the problem. Scarce resources are deployed to work on many events that may not carry a significant impact or risk for the company. Thus the FDA says "the level of study should be commensurate with the risk involved."
The FDA says "the level of study should be commensurate with the risk involved."
Far too many companies are not deploying good risk management as a mechanism to filter what should go to CAPA for corrective actions, what should simply be contained/mitigated, or perhaps what only needs observing for awhile.
My recent experience shows that an overly conservative approach to managing CAPA has overcome legitimate efforts to employ a trustworthy CAPA system. Nearly every day I look at organizational SOPs and work-forms that dictate the data entry and analysis of complaints, deviations, audit findings and the like that feed the CAPA process, only find no effective risk filter ahead of the CAPA system. To make matters worse, many of these forms have taken away the quality manager's "Command Central" operation, which used to direct the path of the inbound event.
The most common risk filter should consist of a simple matrix evaluating "impact" and "frequency." Typically four or five dimensions are established for each criterion, such as
Values can then be assigned to each descriptor and then placed in a simple two-dimensional chart. The Impact value examines safety, hazard, and harm; and Frequency examines size, occurrence, and increase. As quality management expert Dr. Joseph Juran used to put it, "the useful many vs. the critical few." Of course, more than a few events may ultimately disposition to CAPA but we certainly should not put events with minor impact and a low frequency of occurrence into the CAPA process. With resources scarce and investigators overworked, we need to first focus on those events that have significant impact.
Proper and Thorough Investigation is a Science, Not an ArtFar too many times we rely on our experience as a methodology for our investigations. Even if you have a great amount of knowledge and have seen nearly every problem before, you will likely not arrive at true cause if you rely only upon your expertise. Repeat problems and situations where you are stumped and can't find a testable answer prove that a better method is needed. Let's face it: new products are always being launched, technology constantly changes, and new people are removed or added to the mix. All of these demonstrate a need for a better investigational process. The best investigators are open-minded and superb questioners, versus experts who guess and revert to experimentation or trial and error. What makes this worse is that many forms used to capture the critical thinking and data entry are just a collection of blank boxes without any real coaching embedded to guide us through the investigation. Because of this, we often make too many mistakes and then have to rely more on disruptive experimentation that is invasive and costly just to prove we have a correct cause. This means a slower process for finding cause, using an ineffective method that is bound to yield the wrong answer.
Foolproof Investigations: A Proven Approach for Root Cause Analysis in a Regulated Environment (download white paper below) describes a new approach to investigating that brings much better success and less disruption. It focuses your deductive reasoning by asking key questions that lead you from one logical step to the next. You don't have to be an expert to solve many of the problems we encounter if we can improve our critical thinking skills. I have used this process to solve countless problems both big and small. Read it to see more of what I believe is the future of better investigations and let me know what you think.
Ken Peterson is a Quality Management Architect with a strong background in both life sciences and engineering. He has more than 25 years' experience in consulting and organizational change, quality management and product development. His responsibilities at MasterControl Inc. include enhancing the Quality Management System solution product offering and incorporating best practices for managing CAPA within the MasterControl client solution.
Currently Mr. Peterson is Chairman of the Board of Directors for Intermountain Biomedical Association (IBA) and on the Board of Advisors for the Utah Technology Council (UTC). He works closely with FDA and business to drive growth and build lasting partnerships. Contact him at firstname.lastname@example.org
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