How to Write SOP’s for Human Error Reduction

Product Id IQW19A0126
Speaker Ginette Collazo
Level Intermediate
Duration 90 Mins
  • Description
  • Why should you attend
  • Areas covered
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Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as understand exactly where the instructions weaknesses are so that procedures can be human engineered, improved and fixed.

Procedures are essential for both execution and audits. These should be written for users without missing relevant information for regulators. Usually, procedures have weaknesses that harm productivity, quality, and regulatory standing. We will discuss from content development to formats designed for human error reduction due to procedures.

  • SOP writing outline
  • Content development
  • The rationale for procedure use
  • Regulatory compliance background 
  • Universal purpose of procedures
  • The Human Perspective
  • Human Error as a root cause 
  • The thinking and reading process
  • Common mistakes and causes
  • How to create and maintain a procedure
  • Goals of a procedure
  • Good Procedure Writing practices (Terminology, Formats, layouts, mixed cases, steps content, familiar words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions" 
  • Procedure styles
  • Use of electronic information networks for procedure access
  • QA/QC directors and managers 
  • Process improvement/excellence professionals 
  • Training leaders and managers 
  • Plant engineering
  • Compliance officers 
  • Regulatory professionals 
  • Executive management
  • Manufacturing operations directors 
  • Human factors professionals

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.

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