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It's Easy to Get into Trouble Because of CAPA

True and robust Corrective and Preventive Action (CAPA) systems are more than just a formal mechanism for tracking problems, says an FDA expert on quality systems. They must encompass a number of data sources, including complaint handling, nonperforming product mechanisms, Medical Device Reporting, corrections, removals, and recalls, said Jan Welch, a quality systems expert in CDRH's Office of Compliance. She spoke as part of an audioconference on implementing an effective CAPA system, held March 6.

March 10, 2008

2 Min Read
It's Easy to Get into Trouble Because of CAPA

True and robust Corrective and Preventive Action (CAPA) systems are more than just a formal mechanism for tracking problems, says an FDA expert on quality systems. They must encompass a number of data sources, including complaint handling, nonperforming product mechanisms, Medical Device Reporting, corrections, removals, and recalls, said Jan Welch, a quality systems expert in CDRH's Office of Compliance. She spoke as part of an audioconference on implementing an effective CAPA system, held March 6. It was sponsored by FOI Services and moderated by Nancy Singer, president of Compliance-Alliance Inc. and a member of MD&DI's Editorial Advisory Board. A lot of firms who have been cited by FDA have not gotten this message, she said. She did an analysis of FDA-483 observations issued in 2007 and found that 964 of the 3332, or 29%, issued had something to do with CAPA. Of these, 474 had to do with the actual CAPA system, 363 had to do with complaint handling, and 127 had to do with failure to document nonconforming product. Of the 474 citations having to do specifically with the CAPA system, 144 came from documentation problems, and 104 came from failure to establish or maintain a CAPA system at all. This happens too often with startup firms and firms that don't think they are making a medical device but really are, Welch said. Unfortunately, the numbers also indicate that CAPA problems are not easy to fix. During 2007, CDRH issued 74 warning letters for deficiencies related to the quality system or good manufacturing practices, and 62, or 84%, had something to do with CAPA, Welch said. This percentage has been consistent over the last few years, she said. One of the keys to improving this, Welch said, is not to be afraid of "feeding the CAPA system." Too many firms think FDA will react negatively if there are a lot of CAPA files, open, but this is not the case, she said. "FDA is not hung up on the numbers," she said. "It is interested in how you are handling CAPA files and what is being done with them." At the other extreme, it is not appropriate to designate every CAPA issue as a top priority. "It can't be," she said. "You have to use risk management tools and prioritize them, and document those decisions." What's important is that the firm show that progress is being made on all open CAPA files, she said.

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