Root Cause Analysis in Pharmaceutical Industry: 5 Whys, Fishbone, Examples & CAPA
Published by: Pharma Quality System Editorial Team • Editorial basis: 21 CFR 211.192, FDA OOS guidance and recent inspection findings, ICH Q9(R1) and Q10, and Health Canada GUI-0001 PROBLEM DEFINITION • EVIDENCE • 5 WHYS • FISHBONE • HYPOTHESIS TESTING • CAPA Root cause analysis in the pharmaceutical industry is a structured, evidence-based investigation process used to understand why a quality problem occurred, how far its impact extends, and what must change to prevent recurrence. Quick answer A strong pharmaceutical root cause analysis does more than name a person, machine, or event. It defines the problem precisely, preserves and reviews evidence, evaluates the full scope, develops scientifically plausible causes, tests those causes where possible, distinguishes root causes from contributing factors, and connects the conclusion to appropriate corrective and preventive action (CAPA) and effectiveness checks. ...