Quality System Regulation: Reflecting on CAPA Procedures

Our training program (QSRCP) Quality System Regulation (QSR) Certified Compliance Professional™ is designed to demystify the complex regulatory policies of the FDA for Quality System Regulation, a process with some many moving parts that pharmaceutical and medical device manufacturers find themselves in a maze of stumbling blocks. Non-compliance is costly in terms of time and money, and quality system regulation touches every stage of development.

Our training program can help you jump these hurdles, but before you begin the course, here are two questions that you can ask yourself about current operations and procedures to get a better grip on how you approach quality system regulation. In particular, let’s look at CAPA or corrective and preventive action:

Why do we have CAPA procedures in place?

If your knee-jerk reaction is “to comply with the FDA regulations” you may need to rethink your answer. CAPA is not just about cutting through red tape; it’s about delivering the best product to consumers, creating efficiencies in your processes and steering clear of roadblocks. But few companies are focused on the real reasons for CAPA. In fact, reporting from 2016 indicated that between the period of 2010-2016, the FDA issued the most Form 483s for inadequate CAPA procedures than any other type of violation. If your bar for quality system regulation and CAPA is low, it’s time to raise it for the health of your business.

Can you reframe how you approach CAPA closures?

If your current quality system regulation process focuses on the timeline of a CAPA closure, you’re aiming at the wrong target. CAPA is about find the root cause of a problem, not about completing a task on a deadline. While keeping a closure investigation on target is certainly important, and deadline are a help, the goal here is to find where the problem started and prevent it from happening again, regardless of the time spent. After all, solving the problem will prevent it from cropping up in the future, and that’s the real time metric your company should focus on.

Source:

https://incompliancemag.com/article/a-guide-to-medical-device-corrective-action-and-preventative-action-capa/

https://www.qualitydigest.com/inside/management-article/five-common-mistakes-companies-make-capa-062018.html