Root cause Analysis and CAPA
Jim Hewlett is Professor of Biology at Finger Lakes Community College ( FLCC) and the Hub director for the Upstate New York Hub of NBC2.
The tools associated with Root Cause Analysis (RCA) are used in conducting in-depth investigations of failures in processes, policies, and procedures. Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. These valuable tools identify the root causes of failures and help professionals with the creation of Corrective Action and Preventative Action (CAPA) plans so that these failures can be avoided in the future. In this workshop, participants will be introduced to the basics of RCA and apply RCA tools to real-world case studies.