This webinar will cover how to conduct a human factors analysis of instructional documents, which is a critical task to perform for existing documents. The concepts from this session can be incorporated into the creation of new instructional documents also. Technical writing without human factoring expertise is not sufficient for authoring "well" written instructions that can and will be followed by multiple staff within an organization and working within different environments. The Code of Federal Regulations (CFR) requires written procedures, follow written procedures but does not tell how to accomplish the best-written procedures or what process to put in place so procedures are always followed during task performance. Why am I confident that human factoring an instructional document is critical to FDA regulated industry?
Human factoring instructional documents are the way FDA regulated industry will eliminate "inadequate written procedures," "No written procedure exist" and "written procedure not followed" from continuing to consistently be in the FDA top ten audit findings. North America Commercial Nuclear industry, along with collaboration from the Institute of Nuclear Power of Operations (INPO) and the Nuclear Regulatory Commission (NRC) successfully developed a scientific-based method that takes into account risk and human error/operation modes for creating well written instructional documents. These documents define a process for how to use instructional documents so they are followed, which is integrated into the document management process. This method has been successful for 20+ years. Human factoring instructional documents are critical for multiple reasons, all which provide efficiency, significant cost savings, and play a key role in providing quality products to consumers around the world:
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, Ginette 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 is also 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, Pharmaceutical Industry Association, and International GMP Conference.