CAPA - The Process that It Follows

Of all the available processes associated with managing a quality and compliance management system, CAPA is the most prominent and effective one. In case of identifying a faulty event in the system, CAPA is generated and eventually becomes the most effective to prevent or identify the faulty event in the system.

The CAPA process includes application of collected information through a series of assignments, verification criteria, and list of related events. Aim of the CAPA action plan is ultimately introducing a process that will correct a faulty event, minimizing a risk and bring an overall change i n the company.

Checking the Effectiveness of CAPA

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CAPA is a risk assessment and mitigation tool and by implementing a repeat risk measure, CAPA is reassessed and risk level is recorded. In case, the implemented risk measure becomes able to reduce the risk and bring it down to acceptable parameters, it is effective. Similarly, when the risk is not reduced and or is slightly reduced but is not within an acceptable parameter, correction of the measure become important. Using risk mitigation as a measure of effectiveness is extremely valuable for ensuring the CAPA has actually solved the problem.

By using this method, CAPA process turns out to be a incessant improvement cycle which involves investigation and risk assessment processes as the inputs to the process and utilizing reporting and risk mitigation history as the controls for effectiveness.

DMAIC - Another Process of Measuring Effectiveness of CAPA

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Another dimension of checking effectiveness of CAPA is to implement DMAIC. With DMAIC (define, measure, analyze, improve, and control) process, as outlined by Six Sigma, the CAPA process takes action to analyze and improve the processes of risk mitigation and objectively determines the effectiveness of the process. Components of Six Sigma analyze the benefits of a DMAIC process applied to improving the CAPA and also ensure the effectiveness of the CAPA.

ComplianceOnline with its effort to bring the knowledge to the door step of your company have collaborated with many industry experts who has led many successful CAPA processes and have more than 20-30 years in various areas of expertise, to do knowledge delivery in the form of webinars easy to understand and easy to attend.

For a better understanding and effective implementation of CAPA, take advantage of these webinars available in the format of recordings or CDs and train your entire team interfacing with CAPA with below CAPA based webinars.

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ComplianceOnline Trainings

COURSE TITLE   CAPA Essentials - core principles and practices needed to implement an effective and efficient CAPA process This CAPA training will provide the core principles and practices needed to implement an effective and efficient CAPA process. More Info CAPA - Best Practices and Common Pitfalls for FDA Regulated Industries This CAPA session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with CAPA system in relation to Warning Letters and 483 citations. More Info Risk-Based CAPA Systems This Corrective and Preventive Action (CAPA) webinar will teach how the risk based approaches be implemented under CAPA. More Info Developing a Robust CAPA System In this webinar instructor will explain what are essential elements of CAPA system to meet current regulatory requirement and how to achieve it More Info Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation. More Info