How to write SOP's that Avoid Human Error

Why Should You Attend:

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 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 from content development to formats designed for human error reduction due to procedures.

Areas Covered in the Webinar:

• SOP writing 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.

Who Will Benefit:

• 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

Ginette M Collazo
Organizational Psychologist, Ginette M Collazo Inc

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.

Frequently Asked Questions:

1. If you have an associated checklist, would you recommend one long checklist for an activity or breaking it down into multiple shorter checklists?
2. Is it recommended to avoid use of words such as 'should' and to say 'must' instead Also, do you recommend use of flow diagrams, photos etc.?
3. When to include as separate work instruction (how much detail to include)?
4. What is the ideal level of sub steps? (e.g. 1.2.1 Three levels?)
5. Do you make a distinction between appendices and references?
6. Is this only for the draft document or also for the final procedure?

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