Three Quality Management Tips to Avoid Death by CAPA - for Medical Devices Industry

Improve Your CAPA System with These Practical Suggestions

It's been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal corrective and preventive action (CAPA) system to monitor and manage the safety complaints associated with their products. Yet, managing a CAPA system remains a major challenge for many manufacturers.

A sound CAPA system organizes and evaluates complaints, nonconformances, and other deviations about products and services to improve patient safety. But the problem is: How do you properly evaluate complaints and identify those that need to enter into the CAPA system?

It is becoming all too common for companies to experience "death by CAPA", meaning they are putting so many issues and complaints into their CAPA system that they have difficulty focusing on those that could truly impact patient safety.

The evaluation of complaints and issues worthy of CAPA treatment and the decision making entailed in the process is often an obstacle for many firms. As K.A. Trautman wrote in The FDA and Worldwide Quality System Requirements Guidebook for Medical Device, the degree of CAPA taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encountered.

"[The] FDA cannot dictate in a regulation the degree of action that should be taken because each circumstance will be different, but FDA does expect the manufacturer to develop procedures for assessing the risk, the actions that need to be taken for different levels of risk, and how to correct or prevent the problem from recurring, depending on that risk assessment", Trautman wrote. Given the many challenges posed by the FDA's CAPA requirement, let's consider a few things that could help you improve your CAPA system.

1. Use a Risk-Based Filter. To make sound, defensible decisions on what should go into your CAPA system, consider employing a"risk-based filter".  Keep in mind that according to FDA regulation, once an item goes into CAPA, you must do a complete investigation in order to close it out. So it's very inefficient to escalate into CAPA problems that don't impact key criteria such as safety. It can actually distract you from the more serious problems. Nathan Conover, a colleague of mine at PathWise, offers an example he recently saw firsthand. "I was consulting with a company that produces drug-eluting stents. Now, if one of their stents turns out to be bent, that is a problem and it needs to go into CAPA. But this particular company was reporting a manufacturing cosmetic glitch on the bags the stents were packaged in, which had no bearing on the safety, performance, or the sterility of the device itself. That's not necessary for CAPA."

2. Use a Scoring System. PathWise suggests instituting a scoring system that categorizes complaints to assess their frequency of occurrence and their potential impact on patients, and use that to determine which complaints should be entered into the CAPA system. Just because a complaint doesn't go into the system, however, doesn't mean it can be ignored. According to the FDA, if a company doesn't enter a specific complaint into its CAPA system, it must demonstrate to the agency why it did not do so.

3. Get Advice From Experts. Putting all this into practical application can be more difficult than it seems. I have helped numerous clients set many "CAPA Gateways" into procedure, but it still is often difficult to decide exactly where to draw the line between inputs with moderate impact and those with minor impact. Obtaining advice from your medical device experts is key to determining the correct impact. Statisticians can also help with acceptable quality or frequency levels. Decision making will always be somewhat of an art more than science, but your rationale for determining the disposition of each CAPA input can provide a viable and defensible path forward for managing CAPA inputs to meet the criteria of both the FDA and your organization. Recent data collected by Jan Welch, consumer safety officer, Division of Enforcement A of the FDA's Center for Devices and Radiological Health , shows that in 2006, 79 Warning Letters were issued and of that 69 (87 percent) had CAPA deficiencies. Many of these were related to lack of effective investigation, ineffective corrective action, poor affectivity checks, and a variety of other reasons. Still, it all begins with working on the right inputs.The tips above are but a few things you can use to guide you in deciding when a correction will suffice, or if prevention is needed in addition to a corrective action.

About the Author
Ken Peterson started his career at Pfizer Inc. and has been a senior partner at PathWise Inc., a leading CAPA training and consulting provider, for the past 15 years. He is the chairman of the board of the Intermountain Biomedical Association. He is a frequent speaker for AAMI, PDA, ASQ, and other professional organizations.
Learn more about PathWise and its services, including a CAPA management workshop on Oct. 11-12, 2007, in Washington , D.C. : Read more about optimizing your CAPA process:


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