ROOT Cause Analysis vs. CAUSAL Analysis; What are the Benefits?
Speaker: Amy M. Peterson
GCT 300 117
Webinar Description :
Root Cause Analysis doesn’t provide a complete analysis for a deviation, which hampers the ability to determine effective CAPA and track data for adverse trends of all causes to deviations.
Objectives of the Presentation:
- Understand what the difference is between Root Cause Analysis and Causal Analysis
- Learn the benefits of Causal Analyses
- Understand how causal analysis helps determine
- EFFECTIVE CAPAs, prevent repeat deviations, and provide the ability to track and trend investigation data for adverse trends
Quality System: Investigations, Root Cause vs. Causal Analyses, Track and Trend Investigation Data to Determine Adverse Trends
Why you should attend
Attend to understand the difference in Root Cause Analysis and Causal Analysis; the significant benefits to discovering additional causes so they can be addressed in order to prevent repeat deviations.
Amy M. Peterson, MS has 18 years of quality assurance (QA) experience in the biotechnology / pharmaceutical industry. Her most recent years have been focused on bringing an understanding of how to take quality to the next level of robustness. She has extensive expertise: - MANAGING HUMAN ERROR - Designing robust QA systems, including the ehancement of a systems to MEASURE EFFECTIVE CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) - Designing quality systems which account for human system interaction, preventing human error from leading to a deviation (i.e., event, excursion, exception) that carries consequences. She adapted, implemented and evaluated an engineering and psychology based approach to managing human error in the industry with parallel success to the North America commerical nuclear industry where the approach was developed by academics and industry experts; now proven successful for over 20+ years. RESULTS ACHIEVED: > $100,000 MILLIONs saved in just one facility (approximately 1200 employees) Multiple company awards > 80% REDUCTION in deviation rates (deviations per batch) Trained/mentored by a collegeage with 25+ years of experience working in North Americal commercial nuclear. MENTOR is a: - Senior Reactor Operator (SRO) - Nuclear Regulatory Commission (NRC) Certified expert in Human Error Management This specialized expertise with it’s application to CAPA effectiveness has tremendous benefits for all high risk industiries to provide error free services.