How To Write SOPs For Human Error Reduction

Human error is the primary cause of quality and production losses in many industries. Although human error is unlikely to 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 and understand precisely where the instruction's weaknesses are so that procedures can be human-engineered, improved, and fixed.

Why You Should Attend

Procedures account for more than 40% of human error events in manufacturing. The majority of regulatory citations are also related to procedures. 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 content development and formats designed for human error reduction due to procedures.

Areas Covered

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.
• Use of AI to write procedures

Who Should Attend?

• 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

Speaker(s)

Ginette Collazo

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, International GMP Conference, among others.

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