Root Cause Analysis (RCA)

This hands-on workshop equips quality, manufacturing, and operations professionals with a structured, evidence-based approach to root cause analysis (RCA) that satisfies ASQ methodology, ISO 9001/13485/14001 requirements, and GMP regulatory expectations (21 CFR, EU Annex 15, ICHQ10). Participants will learn why investigating past the symptoms of a problem to a documented root cause is both a quality best practice and a regulatory requirement, and how to apply four industry standard tools – Fishbone (Ishikawa) diagrams, 5 Whys, Pareto Analysis, and FMEA – individually and in combination to match investigation depth to risk.

Through instructor-led examples and team exercises, participants will practice building a fishbone diagram, running a 5 Whys chain, constructing a Pareto chart from defect data, and score a mini-FMEA to prioritize risk. The session closes with a walk through of a standardized, audit ready RCA template that participants take home for immediate use in their own investigations.

Key learning objectives and outcomes:

By the end of this session, participants will be able to:

• Navigate Regulatory Requirements: Explain how ASQ methodologies, ISO QMS standards (including medical device and environmental frameworks), and global GMP laws mandate and shape root cause investigations.
• Integrate RCA into the QMS: Master where root cause analysis sits as the critical trigger linking an initial event detection and immediate containment to downstream CAPA execution and standardized procedural changes.
• Categorize Variables using the 6Ms: Construct and facilitate functional Fishbone diagrams to partition complex problem variables into Manpower, Method, Machine, Material, Measurement, and Mother Nature buckets.
• Trace Verifiable Causal Chains: Apply the 5 Whys drilling technique to move past superficial worker error and surface underlying systemic or process gaps using objective evidence.
• Isolate the “Vital Few” Errors: Build and correctly interpret a Pareto Chart to isolate the ~20% of defect categories driving ~80% of total operational costs or frequency volumes.
• Quantify and Preempt Risk Profiles: Execute a proactive Failure Mode & Effects Analysis (FMEA) to mathematically score and rank process vulnerability via Risk Priority Numbers.

Who should attend:

• Quality Engineers and Technicians
• Manufacturing Supervisors, Leads, Inspectors
• CAPA owners
• Auditors
• Anyone responsible for investigating deviations, non-conformances, or customer complaints