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:

• Ensures readability of instructions, making them user-friendly, which will provide consistent interpretation among different staff (direct user, reviewer, approver, auditor, agency inspector, etc.)
• Provides the required foundation to establish a successfully proven, risk-based method for achieving procedural adherence
• Reduces internally driven revisions to instructional documents
• Provides a critical component for organizational control to produce quality products from validated processes
• Decreases deviation rate
• Produces efficiency gains of 25% to 30%, based on 18,000 data points
• Saves significant amounts of the cost associated with "waste" as defined by Six Sigma and Lean Manufacturing; depending on processes and profit margins, cost savings can be as much as billions of dollars saved annually

• Learn what human factoring is defined to be as formally defined by science
• What the foundation is that human factoring provides to create well written instructional documents
• What the relationship of human factoring is to the method to achieve procedural adherence
• What the method to achieve procedural adherence is and its relationship to human factoring(further seminars needed for significant understanding for developing and implementing the method within an organization
• Perform a human factoring analysis of instructional documents
• Prioritization options to select existing documents for human factoring analysis
• Know how what is needed and how to incorporate human factoring into creating new instructions and a document management system
• Know if your human factoring analysis of an instructional document was effective

• Improve audit inspection outcome
• Reduce variability in human interpretation of instructions, leading to deviations
• Increase organization efficiency
• Save money, up to potentially billions of dollars annually

• Human factors
• Top ten FDA audit findings
• 21 Code of Federal Regulations (CFR) Part 210 and 21 Code of Federal Regulations (CFR) Part 211
• Readability/usability of instructional documents, such as standard operating procedures (SOP) and batch records and master batch record/production batch record (MBR/PBR)
• Systematic monitoring of effective human factoring analysis of instructional documents by other quality systems
• Document management system

• Leadership Role (regardless of level within an organization)
• Instructional document author, reviewer, approver
• Document management staff
• Continuous improvement role
• Auditor role
• Manufacturing operation/production staff
• Training staff
• Safety staff

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.