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bb254 replied to the topic CAPAs: Proactive vs Reactive in the forum Process Validation and Process Risk 7 years, 1 month ago
From a medical device company perspective, it is better to have preventative CAPAs than reactive CAPAs. At my current employment, we have both preventative and reactive CAPAs. In recent meetings our manager began giving out multiple preventative CAPAs to balance out the number of reactive CAPAs that have been submitted. A preventative CAPA shows an auditor that the company is focused on improving their product or process before an error or complaint is made. Reactive CAPAs tell an auditor that a problem was brought to the attention of the company and this is how they fixed it. A preventative CAPA shows that the company is taking the initiative to avoid future issues. If you have a large amount of relative CAPAs in a company than that directly tells your auditor that something is wrong with the company’s standards. Relative CAPAs aren’t viewed as “a good thing” in terms of the medical device industry.