Human Error Investigation Program - Effective Implementation

Human error is a primary contributor to quality and production losses across various industries. While complete elimination of human error may be challenging, many performance problems can be effectively prevented. The journey begins at the design stage, where crucial variables such as procedures, training, and workplace environment can be optimized to reduce the likelihood of errors. Understanding human behavior, the psychology of error, and identifying system weaknesses are essential steps toward improvement and resolution.

Join our webinar to explore practical approaches and models designed to tackle human performance issues in GMP-related environments. Discover a specific methodology that enables correction, prevention, and avoidance of recurring issues. Gain access to valuable tools that can be implemented immediately following the event, including techniques to classify human error categories, identify near root causes, and analyze underlying reasons behind such events. Stay informed about the latest trends in human error issues across the industry.

Why You Should Attend:

This webinar is a vital resource for professionals working in GMP-regulated manufacturing facilities, including pharmaceuticals, medical devices, biologics, food and nutrition, and any organization where employee activities carry the potential for mistakes. Don't miss this opportunity to address human performance challenges, enhance operational efficiency, and foster a culture of excellence.

Learning Objectives:

• Error Reduction System
• HES Tools
• Cognitive load tool
• Definition of Human Factors Categories (HFC)
• Importance of each HFC
• Learn the Human Error Risk Multipliers
• Recommendations for each HFC
• Implementing the program
• Metrics and KPI’s

Areas Covered In The Session:

• Human Error as the Root Cause
• What is Human Error
• How is Human Error controlled?
• Root Cause Determination
• 6 step method for error prevention
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Training managers and coordinators
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Plant Engineers
• Process excellence/improvement professionals
• Industrial/process engineers
• Compliance officers
• General/corporate counsel

Course Director: DR. GINETTE COLLAZO ‎

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. She 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.