2019 - Introduction to Root Cause Investigation for CAPA

What is CAPA vs Correction
FDA and ISO (13485) Requirements
CAPA’s Criticality in Quality Systems
Steps in a CAPA Process
Quality Data Sources for CAPA
Risk Management as Part of CAPA
What is a Root Cause Analysis (RCA)/Investigation
Challenges Associated to RCA
Difference between a direct cause, a contributing cause and a true root cause
Six Steps in Problem Solving
Steps to Follow If the Root Cause is Not Clearly Known
Tools Used for RCA/Investigation
Examples of Three of These Tools and When to Use Them