How to implement an effective Human Error Investigation Program

Human error is a leading cause of quality and production losses in many industries. It will never disappear completely, but many human performance problems can be prevented, because errors often start at the design stage, in procedures, training and the work environment.

This 90-minute human error investigation program training gives practical approaches and models for GMP-related environments. You'll learn what human error is, how it is controlled, how to determine root and near-root causes, and a 6-step method for preventing errors and avoiding repeats.

The session also covers an error reduction system and tools, a cognitive load tool, human factors categories and their risk multipliers, measuring error rates, trending, tracking and prediction, CAPA effectiveness, implementation steps, metrics and KPIs, and current trends in human error issues.

• Define human error and explain how it is controlled
• Determine near-root and root causes of human error events
• Apply the 6-step method for error prevention
• Use human factors categories, risk multipliers and the cognitive load tool
• Measure, trend and predict human error rates
• Implement a program with metrics, KPIs and effective CAPAs

• Human error as the root cause
• What human error is and how it is controlled
• Human error categories, near-root causes and root cause determination
• The 6-step method for error prevention
• The error reduction system, tools and cognitive load tool
• Human factors categories (HFC), their importance and recommendations for each
• Human error risk multipliers
• Human error rates and measurement
• Trending, tracking and prediction
• CAPA effectiveness
• Implementing the program, metrics and KPIs
• Current trends in human error issues

Reducing human error means understanding human behavior and the psychology of error, and knowing exactly where your system is weak. This training gives you practical tools you can put to use straight after the session.

It suits training managers and coordinators, operations, manufacturing and plant engineering staff, QA/QC, process improvement professionals, industrial and process engineers, compliance officers, regulatory affairs professionals and corporate counsel.

• Training managers and coordinators
• Operations
• Manufacturing
• Plant engineering
• QA/QC staff
• Process excellence/improvement professionals
• Industrial/process engineers
• Compliance officers
• Regulatory/legislative affairs professionals
• General/corporate counsel

Ginette Collazo, Ph.D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.