Root Cause Analysis & CAPA

What you'll learn

• Explain the purpose of Root Cause Analysis and CAPA
• Differentiate deviations, nonconformities, immediate causes, contributing factors and root causes
• Define problems clearly and establish appropriate investigation scope
• Collect, evaluate and document objective investigation evidence
• Apply the Five Whys technique to explore causal pathways
• Use Fishbone Analysis to organise and investigate potential causes
• Use Pareto Analysis to prioritise recurring problems and improvement opportunities
• Recognise human factors and system weaknesses that can contribute to errors
• Differentiate corrections, corrective actions and preventive actions
• Design SMART CAPA actions that are specific, measurable, achievable, relevant and time-bound
• Apply risk-based prioritisation to CAPA management
• Control CAPA implementation through ownership, documentation and change control
• Plan and perform effectiveness checks and make evidence-based CAPA closure decisions