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  • Scott replied to the topic CAPAs: Proactive vs Reactive in the forum Process Validation and Process Risk 7 years, 11 months ago

    From a business standpoint, you would want to open less CAPAs. In manufacturing of medical devices most CAPAs tend to be reactive since they are usually opened after an Event, Non Conformance, SCAR (Supplier Issue), or Customer Compliant. CAPAs, to some extent, demonstrate that your company is attempting to make necessary changes to comply with codes and standards and to fix certain processes. However, opening too many CAPAs can demonstrate that there is a lot to be desired about the processes that are already in place.

    To your point and to comply with FDA code FDA 21 CFR 820.100, a strong Quality System must have a well established and systematic approach to opening and closing CAPAs. In addition, it important to track the trend of the amount of Events, NCs, and SCARs your company is opening on a year by year basis. Ideally, you would like to see less and less CAPAs opened for these reasons.