If you work in the GMP regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of the quality control unit.” and it states that “(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.” Human Error is NOT a root cause. Human errors start at the design stage. Many variables that affect human behavior can be controlled by procedures, training, workplace environment, and more importantly, MANAGEMENT SYSTEMS, reducing the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error and implement a process exclusively dedicated to investigating and “fixing” these problems. This course offers practical approaches and models to address human performance issues in GMP-related environments by using a particular methodology to correct, prevent and avoid the reoccurrence of these matters.
We need to be able to explain human behavior. Did the human fail because process weaknesses set them for failure? Do procedures provide all information and clearly indicate critical steps and warnings or cautions associated with steps? Do systems work for manufacturing, or is it the other way around? These are all tough questions to ask, but most importantly, to answer. This training would provide tools to implement and use after this event. These include practical tools. We will discuss human error categories, near root causes, and root causes for these events. We will discuss the latest trends in human error issues in the 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. 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.