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  • kak33 replied to the topic CAPAs: Proactive vs Reactive in the forum Process Validation and Process Risk 7 years, 1 month ago

    I think we can all agree that it is better to be proactive in MOST, if not all situations for the best interest of the business. I think it is also important to note that by definition one of the intentions of a CAPA is to prevent. I think it is up to the event owner/investigator and MRB to ensure that due diligence has been done to scope out the the preventative action plan and that potential ways the event could manifest in other branches of the business have been considered. It is commonly known that medical devices focus most of their CAPA efforts on correcting issues, rather than preventing them in the first place. This could ultimately lead to over use of the CAPA process.

    Additionally, I think that initiating CAPAs in response to internal audits and periodic reviews of processes is a very effective way to be proactive instead of reactive. My company deliberately has periodic audits scheduled to catch any gaps or issues before they can manifest in ugly ways.