HOW TO DEPLOY ROOT CAUSE AND CAPA TO MINIMIZE HUMAN ERROR

Many variables, from procedures, to training to workplace environment, affect human behavior. You need to understand human behavior and the psychology of error in order to implement a process dedicated to investigating and fixing human errors.

Human Error Solutions’ CEO, Ginette Collazo, Ph.D., an industrial-organizational psychologist and one of the world’s few human error reduction experts, will discuss error categories, near root causes and root causes – along with the latest trends in human error issues.

She’ll present practical approaches and models to address human performance issues in good manufacturing practice (GMP) related environments by using a methodology to correct, prevent and avoid reoccurrence.

Areas Covered in the Session :

• Determine what is a causal factor of quality and compliance issues, as established in GMPs
• Gain better control over non-conformances by incorporating a failure investigation system and root cause analysis / risk management / human factors in our process, procedures and systems
• Understand the types of human error, including intentional and unintentional errors of omission and commission in FI and RCA
• Measure human error rates by using the root cause determination tool, and cognitive load tool
• Track human error and determine trends in quality and compliance by root cause coding structure
• Make predictions regarding potential non-conformances by diagnostic studies and root cause determination tool coding
• Determine CAPA effectiveness by event reoccurrence and root cause recurrence

While human error may never be eliminated completely, you will come away with an understanding of the psychology of error and how to incorporate root cause and CAPA to minimize human error.

Who Should Attend:

• Training managers and coordinators
• Operations Departments
• Manufacturing Departments
• Engineering Departments
• QA/QC Departments
• Process excellence/improvement/six sigma professionals
• Industrial/process engineers
• Compliance officers
• Regulatory Affairs Departments
• 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.