Root Cause Analysis (RCA)

« Back to Glossary Index

Root Cause Analysis (RCA) in pharmaceutical manufacturing is a methodical approach employed to pinpoint, investigate, and rectify the underlying causes or contributing factors of problems, failures, or deviations within manufacturing processes, systems, or operations. The primary goal of RCA is to unearth the root causes of issues rather than merely addressing the symptoms, thereby preventing future occurrences and enhancing overall process performance and quality. This involves the meticulous collection of data, conducting thorough investigations, applying analytical tools and methodologies, and implementing targeted corrective and preventive actions based on the findings to effectively tackle root causes and facilitate continuous improvement.

« Back to Glossary Index