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.

I believe is always beneficial to be proactive rather than reactive. In a reactive system you solve matters as they arise, this can lead to possible beneficial changes. However, solving matters before they become an issue will generally lead to optimization and aid any reactive changed needing to be made. According to the FDA Sec. 820.100 explains Corrective and preventive action; therefore as you said, a proactive system in place will lead to lesser issues and efficiency. Now in terms of CAPAs yes they are more of a reactive protocol, however, a higher number of them can have a negative implementation.

In agreement with the post above that it is more beneficial to be proactive than reactive. In the reactive approach, a root cause analysis is usually performed to answer 'why' a problem exists. However, with the proactive approach, different kinds of corrective actions will prevent the 'why' from happening again. We are usually more likely to address known problems rather than investing resources to prevent problems from happening in the first place. There definitely need to be systems installed to assess and identify issues before they become problems.

It is good to be proactive and reactive for medical devices. Medical devices may sometimes be used externally, but other times they will be implanted. From a business standpoint it would be more beneficial for a company to be proactive when it comes to medical devices. This will ensure a safer device. As a result of medical devices being used for body applications, it would make more sense to take a proactive approach. This way it will decrease the amount of possible issues that may arise after the device is in use. If the company is unable to perform a proactive method, then the reactive process should be used. The reactive approach gives a summary of all the issues that need to be attended and fixed. It is better to prevent potential problems before and during production then after is it used from a business perspective.

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.

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.

I very much agree with your statement. Internal audits are essential for keeping an up to date quality system. Implementing CAPA as a result of internal audits issues will help keep the company out of trouble. If for example, a remediation occurs: reactive measures will be taken (hiring and preparing, etc) however the preparation and executing might be smoother if there were planned the proactive cases. On the other hand, CAPA processes an proactive planning can prevent remediation in general.

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.

It is important to have preventative action in medical devices because once a negative effect happens, it has already been out on the market if it was not prevented and this could cost lives. Reactive action is important but it may have been too late for some patients. While it is not possible to anticipate every action that may be required in the future, preventative actions are essential to foresee at least the most common and most dangerous effects.