CAPA Management – 4 Essentials of a Successful Root Cause Analysis Process

It is often said that the “heartbeat” of the quality system is the Corrective and Preventive Action (CAPA) management process. Therefore, the changes that are made to the CAPA management process is crucial in improving business processes, meeting customer expectations and correcting defects. An effective CAPA process helps your team in understanding and analyzing the root cause of every issue that you face. Here we provide you with some easy tips and tricks to improve your root cause analysis process and keeping difficult issues from reoccurring.

Know the limitations and benefits of your analysis method

One of the most crucial part of having a successful investigation is to have a good CAPA root cause analysis technique. Some of the root cause analysis technique like the 5 Why Analysis, statistical methods, FMEA and Fishbone (Cause & Effect) Diagrams are all good and valid. However, you need to keep in mind the limitations and benefits of these methods in your process of investigation.

5 Why Analysis and all the other analysis methods have their own limitations and benefits; therefore, it is essential for you to analyze which method is the most appropriate for the issues at hand and make sure that your team is ready to carry it forward.

Focus on your goal

You need to keep your end goal in mind, establish a CAPA plan, and should understand that the goal of root cause analysis is not just to solve the issue that is at hand, but also to learn why the problem occurred and what things should be kept in mind to prevent the problem of repeating. The root cause need to be precise and should be something that can change with action. The reason behind why causes like “operator error” are usually not seen as true root causes is that “operator errors” cannot be rectified. Usually there is an underlying process which contributes to the operator error. The key to understanding the true root cause and for recommending the best preventive action is to identify the process.

Try doing it with a Team – not alone

It is preferable if you do the root cause analysis as a team to make it a creative process and oftentimes it enables you identify the error or cause from an unexpected part, and that is where a team approach will prove to be more valuable. Even though most of root cause analysis methods can be done by an individual or a single person, you may add value by receiving suggestions and advice from other team members in your organization.

Try using it for positive analysis

One interesting thing that you can do is to try and analyze the positive things that is happening in your organizations. You can do a root cause analysis on it and use the same technique, which is used to find the root cause of a problem—to analyze why certain departments or processes are performing exceptionally well. This will provide you with an opportunity for regular improvements and help to improve the quality of your outcome.

Join expert speaker Danielle DeLucy, MS, to get deeper insights on CAPA system maintenance, root cause analysis, documentation and planning in this webinar titledProper CAPA Management and Root Cause Analysis.”

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