How to Write Procedures to Avoid Human Errors

Poorly written procedures are a common source of human error. SOPs matter both when work is carried out and when it is audited, so they must be written for the people who use them while still giving regulators everything they expect to see.

This 90-minute SOP writing training covers how to develop procedure content and choose formats designed to reduce errors. You'll look at the human side of procedures, including how people think and read, why they sometimes refuse to use procedures, and the common mistakes and weaknesses that hurt productivity, quality and compliance.

The session then sets out good writing practices, procedure styles, document hierarchy and how to create, maintain and give access to procedures.

• Explain why procedures matter for execution and audits
• Identify why people refuse to use procedures
• Choose the best formats and content elements for SOPs
• Describe document hierarchy and the types of procedures based on their use
• Recognize common human errors and deviations linked to procedures
• Explain how reading and writing processes affect procedure use

• SOP writing outline
• Content development
• The rationale for using procedures
• Regulatory compliance background
• The universal purpose and goals of procedures
• The human perspective and human error as a root cause
• The thinking and reading process
• Common mistakes and their causes
• How to create and maintain a procedure
• Good writing practices: terminology, formats, layouts, mixed case, step content, common words, references, branching, conditional steps, and precautions, warnings and cautions
• Procedure styles
• Using electronic information networks for procedure access

Human error drives quality and production losses in many industries. It may never be eliminated, but many performance problems can be prevented, and errors often start at the design stage. Procedures play a big part in human reliability.

Understanding the psychology of error and where instructions fall short lets you human-engineer and fix your SOPs. The session suits QA/QC, training, compliance, regulatory, engineering, manufacturing and human factors professionals.

• QA/QC directors and managers
• Process improvement/excellence professionals
• Training directors and managers
• Plant engineering
• Compliance officers
• Regulatory professionals
• Executive management
• Manufacturing operations directors
• Human factors professionals

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, and of course, Pharmaceutical Industry Association.