A Systems Approach to Root Cause Analysis and CAPA Investigations

Abstract: Problem solving is critical to successfully maintaining and improving pharmaceutical and biotech processes. Processes are dynamic and as predicted by the 2ndlaw of thermodynamics will deteriorate over time if left alone. Federal Regulation Title 21 requires that an organization’s quality system include a process for Corrective and Preventive Action (CAPA). Central to an effective CAPA system is the identification of root causes of problems. Systematic approaches for problem solutions have been called for but few have appeared. Problem solutions tend to be handled individually. The frequent result is root causes are not identified and the problems reoccur. A systematic approach based on process and systems thinking and the DMAIC problem solving, and improvement framework is presented, discussed and illustrated. The focus is on getting to root cause and putting permanent fixes in place so that he problems do not occur again. The concepts and methods involved illustrated with pharmaceutical and biotech case studies and examples.

Compliance • Investigations • Quality • Tools