Gain insight into the techniques behind Root Cause Analysis (RCA) and learn how to plan and implement effective Corrective and Preventive Actions (CAPA) to ensure continuous quality improvement.
All errors indicate some form of quality deficiency in the quality system, such as deviations, complaints, or recalls. Authorities expect companies to identify and correct these quality deficiencies that occur in a busy work environment. With RCA, you gain an understanding of the fundamental causes of a problem, which is crucial to determine and implement effective corrective and preventive actions (CAPA).
In this course, we employ a structured approach where you learn to clearly identify and describe the problem. This may involve documenting incidents, deviations, or quality issues that need investigation. Once the problem is identified, an RCA is conducted to find the root causes. The goal is to understand why the problem occurred to prevent reoccurrence. The course will give examples of how to conduct an RCA using systematic tools.
Based on the RCA results, a CAPA plan is developed. We will go through how such a plan can look and why it is important to manage the different actions. A CAPA plan outlines the actions needed to correct the problem and the actions needed to prevent a problem to occur and implementing the identified actions may involve changes in processes, procedures, employee training, system adjustments, etc.
After implementing CAPAs, it is important to monitor and evaluate the effectiveness of the actions to ensure the problem is resolved and does not reoccur. This may include ongoing monitoring, audits, and process reviews. The course combines theoretical presentations, case studies, and knowledge sharing.
This course can also be conducted on-site at the company - see here.
Course Instructors:
Mette Maria Juul Sørensen, Education Consultant, Pharmakon
Louise Schou Petersen, Education Consultant, Pharmakon
