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 is 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 that can be followed and a defined 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 is 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 required foundation to establish a successfully proven, risk-based method for achieving procedural adherence
- Reduces internal 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 cost associated with "waste" as define by Six Sigma and Lean Manufacturing; depending on processes and profit margins, cost savings can be as much as billions of dollars saved annually
Objectives of the Presentation:
- 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
Why Should you Attend:
- 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
- Top Ten FDA Audit Findings
- 21 Code of Federal Regulations (CFR) Part 210; 21 Code of Federal Regulations (CFR) Part 211
- Readability/Usability of Instructional Documents, such as standard operating procedures (SOP) and batch records; 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
Dr Ginette M. Collazo,
Owner - Industrial/Organizational Psychologist ,
Ginette M. Collazo, Inc.
Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.
Her work experience is from Bristol Myers Squibb, Johnson & Johnson, Schering Plough and Wyeth, holds specialized studies in Human Reliability, and has authored various publications on this topic. Her most recent publication is "Error Humano: C4c06 Modelo de Determinación de Raiz Causa", a book that describes success factors that reduce human errors. Having implemented Human Reliability programs in various industries, she understands firsthand what works and what doesn’t when trying to change a culture from an error tolerant environment to an error free learning organization.
Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people’s mistakes.
Ginette’s clients all over the world including Germany, Argentina, USA, Trinidad Tobago, Dominican Republic, Singapore, Europe, and more. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.
- Instructional Document Author, Reviewer, Approver
- Document Management Staff
- Continuous Improvement Role
- Auditor Role
- Manufacturing Operation / Production Staff
- Training Staff
- Safety Staff