How to Conduct a Human Factor Analysis of Instructional Documents, Particularly Master Batch Records (MBR) and Standard Operating Procedures (SOP)

Duration: 90 Minutes
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.
Human Factor Analysis
Product ID: 501574
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
Areas Covered
  • Human Factors
  • 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
Who can Benefit
  • Leadership Role (regardless of level within organization)
  • Instructional Document Author, Reviewer, Approver
  • Document Management Staff
  • Continuous Improvement Role
  • Auditor Role
  • Manufacturing Operation / Production Staff
  • Training Staff
  • Safety Staff
Topic Background
Human factors defined by various organizations, including the FDA
To provide background perspective, consider the following Human Factor definitions (source of definition provided):

Human Factors and Ergonomics Society (HFES)
1)The following definition was developed by the Human Factors and Ergonomics Society (HFES) (found in older HFES literature)
  • Human Factors is concerned with the application of what we know about people, their abilities, characteristics, and limitations to the design of equipment they use, environments in which they function, and jobs they perform.(http://www.hfes.org/web/AboutHFES/ethics.html)
National Aeronautics and Space Administration (NASA)
2)The following definition was developed by NASA
  • Ergonomics is the scientific study of human work conditions, especially the interaction between man and machine. Ergonomics is a term taken from the Greek work "ergon," meaning work, and "nomos," meaning natural laws. The goal of ergonomics is to made work more comfortable and to improve both health and productivity. It is an interdisciplinary science of designing the job, products, and place to fit the worker. Psychology, industrial engineering, computer science, biomechanics, and safety engineering all play a role in ergonomics.(http://media.nasaexplores.com/lessons/02-048/9-12_1.pdf)
Food and Drug Administration (FDA)
3)Human factors (HF) is the study of how people use technology. It involves the interaction of human abilities, expectations, and limitations, with work environments and system design. The term "human factors engineering" (HFE) refers to the application of human factors principles to the design of devices and systems. It is often interchanged with the terms "human engineering," "usability engineering," or "ergonomics."

The goal of HFE is to design devices that users accept willingly and operate safely in realistic conditions. In medical applications, HFE helps improve human performance and reduce the risks associated with use error.

In many cases, HFE focuses on the device user interface (also called the UI or the man-machine interface). The user interface includes all components and accessories necessary to operate and properly maintain the device, including the controls, displays, software, logic of operation, labels, and instructions.(http://www.fda.gov/cdrh/humanfactors/whatis.html)

NOTE: Additional definitions and information can be located at: http://www.hfes.org/Web/EducationalResources/HFEdefinitionsmain.html
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Instructor Profile:
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, 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, Pharmaceutical Industry Association, and International GMP Conference.
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