Human Error Investigations Root Cause Determination and CAPA Effectiveness

This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.

• Understand human error: factors and causes
• Understand the importance: regulatory and business
• Define the process to manage human error deviations
• Identify the root causes associated with human error deviations
• Identify what I can do to support human reliability

• Background on human error phenomena
• Importance of human error prevention/reduction
• Training and human error
• Facts about human error
• Human error as the root cause
• What is human error
• How is human error controlled?
• Common mistakes: Memory failures, overconfidence, we believe we are above average, visual detection, vigilance effectiveness
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior can be manipulated reducing the likelihood of these occurrences.

To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are, so they can be improved and/or fixed. This course will offer practical approaches to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

• 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

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.