Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
Learn to find true root causes with the 5 Whys, fishbone diagrams and Pareto analysis, turn them into a CAPA plan, and prove the fix worked with effectiveness checks.
Speaker
Meredith Crabtree
Quality consultant · 25+ years in regulated industries
Overview
A corrective action is only as good as the root cause analysis behind it. When the real cause is missed, the fix treats a symptom and the same deviation comes back.
This 90-minute root cause analysis and CAPA training walks through a systematic approach you can use on your next investigation. You'll apply three proven methods, the 5 Whys, the fishbone (Ishikawa) diagram and Pareto analysis, to real-world examples, then turn your findings into a corrective and preventive action (CAPA) plan with clear actions and owners.
The session finishes with effectiveness checks: how to decide what to measure, when to check, and how to show that the problem is truly solved before you close the CAPA.
Why attend: Strong root cause analysis and CAPA skills help you solve problems for good instead of fixing the same issue again and again. This training gives you a repeatable method to find underlying causes, build targeted corrective and preventive action plans, and check that each solution actually worked. It suits anyone who investigates deviations, nonconformances or complaints and wants a clear, defensible process that drives continuous improvement across the organization.
What’s covered
- Why root cause analysis, CAPA and effectiveness checks matter
- What root cause analysis is and what it is for
- The benefits of a structured root cause analysis
- Core methods: the 5 Whys, the fishbone (Ishikawa) diagram and Pareto analysis
- Real-life root cause analysis examples
- The step-by-step process
- Gathering data and information
- Analyzing data to find potential root causes
- Prioritizing and validating root causes
- What CAPA is and why it matters
- The difference between corrective and preventive actions
- How to develop an effective CAPA plan
- Case studies of CAPA in practice
- The purpose of effectiveness checks
- Methods and tools for checking effectiveness
- Criteria for judging whether a solution worked
- Documenting and communicating the results
- A case study that needs root cause analysis, a CAPA plan and effectiveness check criteria
- Working through the analysis and plan together
- Presenting and discussing the findings
Who should attend
What you get
About the speaker
Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree, and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.
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