As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end where human error investigations should begin. Human error is about explaining human behavior. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented.
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 offers 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.
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. FDAnews has called her a “veteran of helping drug, biologic and device firms reduce manufacturing errors,” and the Caribbean Business describes her as “ the missing link in modern business.” Today her Error Reduction System has been implemented in all types of industries worldwide.