How to Perform a Compliant Human Error Investigation
Complimentary
Learning Level: Advanced
Time: 1100 - 1230 EDT
Session Length: 1.5 hour
Human error remains one of the leading causes of deviations, quality issues, and production losses in GMP-regulated environments. While often identified as the root cause, human error is rarely the actual root but rather a symptom of deeper systemic issues such as process design flaws, inadequate training, or environmental factors.
This webinar aims to equip participants with the tools and methodologies necessary to conduct effective human error investigations, going beyond surface-level analysis to uncover and address the true root causes of errors.
The presentation will provide a step-by-step framework for investigating human errors in compliance with FDA and other regulatory expectations. Key topics include data collection and analysis, root cause determination, utilizing the Root Cause Determination Tool, conducting effective interviews, and identifying contributing factors. The
session will also explore how to measure error rates, track trends, and ensure CAPA effectiveness, integrating these insights into a robust human error reduction program.
By the end of the webinar, participants will have a clear understanding of how to perform thorough human error investigations, ensuring compliance, preventing recurrence, and fostering a culture of continuous improvement. Attendees will leave with actionable strategies to enhance human reliability and drive operational excellence within their organizations.
Learning Objectives
Understand the Foundations of Human Error Investigations
Gain a clear understanding of the principles behind effective human error investigations, including the regulatory context, the psychology of error, and the critical distinction between symptoms and true root causes. This knowledge forms the foundation for conducting compliant and thorough investigations.
Learn Practical Investigation Tools and Techniques
Explore proven tools and methodologies, such as the Root Cause Determination Tool and effective data collection techniques. Participants will learn to analyze human error events, identify contributing factors, and conduct interviews that reveal actionable insights.
Develop and Measure Corrective and Preventive Actions (CAPA)
Discover how to design and implement CAPAs that address systemic issues and prevent recurrence. Participants will also learn how to measure human error rates, track trends, and evaluate CAPA effectiveness to ensure continuous improvement and regulatory compliance.
