I agree with the posts above that state that it is important that medical device companies have both a proactive and reactive risk management system in place. Although I agree that being proactive and trying to prevent failures from happening is definitely preferred over having to deal with failures, it is inevitable that no matter how much due diligence is performed, something may happen to the product resulting in a complaint, ultimately resulting in a CAPA being initiated. I believe that this reactive risk management approach to investigate failures that occur, perform root cause investigation, and ultimately fix the problem and prevent it from happening again are every bit as important as the proactive risk management processes. If a company has a very good reactive risk management process, CAPA’s can be resolved quickly and this will prove to the FDA that your company speedily addresses complaints, performs a thorough investigation, and ultimately resolves the issues that the product was having.