In context to CAPA procedures, what does root cause analysis aim to improve?

Root cause analysis is a fundamental component of Corrective and Preventive Action (CAPA) procedures in the pharmaceutical industry, aimed primarily at identifying the underlying causes of issues or problems that arise during manufacturing or quality control processes. The objective of this analysis is to ensure that once a problem is identified, the organization can implement effective corrective actions that address the root cause rather than just treating the symptoms.

By focusing on the true underlying factors causing non-conformances or deviations, organizations can develop preventive measures that help to avoid similar issues in the future. This proactive approach leads to improved product quality, enhanced compliance with Good Manufacturing Practices (GMP), and, crucially, a reduction in the likelihood of recurrence of the same or similar issues.

While other areas such as profitability, supplier relationships, and employee engagement may be important for overall business success, they do not directly relate to the specific aim of root cause analysis within the CAPA framework. The primary focus of root cause analysis is on understanding and eliminating the sources of problems in processes to enhance quality and reliability in pharmaceutical production.