The Human Error Tool Box – A Practical Approach

Human error remains a significant factor behind quality and production losses in various industries. While it can't be fully eliminated, many performance-related issues can be mitigated through targeted strategies. Often, these errors originate at the design phase and are influenced by factors such as procedures, training, and the workplace environment—elements that can be controlled to reduce the occurrence of human error.

This course provides a clear understanding of human behavior, the psychology of error, and how to identify system weaknesses that can be improved. Participants will learn practical techniques to address human performance challenges in GMP-compliant settings, using specific methods to correct, prevent, and avoid recurrence.

The session will emphasize the Human Error Phenomena, its causes, and prevention. You’ll also explore key tools like Root Cause Analysis (RCA), Cognitive Load Assessment, and others, focusing on how to track human error trends and apply crucial metrics to reduce incidents. This accredited course equips professionals with the knowledge to effectively manage human error and improve operational outcomes.

Why You Should Attend:

• Understand human error: factors and causes
• Understand the importance: regulatory and business
• Define the process to manage Human Error deviations
• Learn about human error measurement
• Learn about tools for measurement
• Establish Key Performance Indicators
• Define and measure human error rate, cognitive load, and CAPA effectiveness
• Identify what I can do to support human reliability

Areas Covered in the Session :

• Background on Human Error Phenomena and Measurement
• The importance of Human Error Prevention/reduction
• Quantitative and qualitative information gathering
• Why do we need tools for human error reduction programs
• Training as a tool and human error
• Facts about human error and training
• Human Error as the Root Cause: What to do and how to measure it
• Tools
• Prediction
• Root Cause Analysis
• Cognitive load assessment
• Systems available
• Human error rate
• Floor checklist
• Interview questions
• Human error rates and other metrics
• Trending and Tracking
• Metrics and Human Error
• KPI’s
• Human Error rate
• 1st-time pass rate
• Overall equipment effectiveness (OEE)
• Trending /Tracking

Who Should Attend:

• 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
• Executive management

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.