Writing Standard Operating Procedures (SOPs) for Human Error Reduction

Ginette Collazo, Ph.D.

Course description

Poorly written SOPs are responsible for over 40% of human error events in manufacturing and are the leading cause of regulatory citations. Well-crafted procedures are critical for both successful execution and regulatory compliance. Proper procedures need to be clear, user-friendly, and include all necessary information for regulators. However, many procedures are flawed, leading to decreased productivity, compromised quality, and poor regulatory outcomes.

This accredited 90-minute course will explore how to develop and format procedures that minimize human error and improve overall performance.

While it cannot be completely eradicated, many human performance problems are preventable. Errors often begin in the design phase, and effective procedures are key to ensuring human reliability. To reduce error rates, it’s important to understand both human behavior and the psychology behind mistakes, as well as identify weaknesses in current procedures. This course will teach how to re-engineer, improve, and humanize procedures to enhance productivity and compliance.

Upon completion of this course, you will be able to:

• Identify the key components of effective Standard Operating Procedures (SOPs) aimed at minimizing human error.
• Explain the value of well-written SOPs in ensuring regulatory compliance and enhancing operational efficiency.
• Determine common mistakes and their cause in existing SOPs.
• Evaluate the effectiveness of SOPs to ensure continuous improvement.
• Use good procedure-writing practices to draft or revise an SOP.

COURSE OUTLINE

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
• Procedure styles
• Use of electronic information networks for procedure access.
• Use of AI to write procedures