Effective Approach to Human Error Reduction

Ginette Collazo, Ph.D.

Course description

In GMP regulated industries, it is not enough to address human error deviations as an inconvenience; it is a regulatory requirement. The quality control unit is responsible for ensuring that errors are fully investigated and prevented as per the Code of Federal Regulations (21 CFR 211.22). However, human error is not a root cause but rather a result of various variables that affect human behavior, which can be controlled through design, procedures, training, and workplace environment. Understanding human behavior and the psychology of error is crucial, and implementing a dedicated process to investigate and resolve these issues is essential.

This accredited training course provides practical approaches and models to address human performance issues in GMP environments. We will discuss a methodology to correct, prevent, and avoid the recurrence of these issues, providing you with practical tools that can be implemented in your workplace. The course will cover human error categories, near root causes, root causes, and the latest trends in human error issues in the industry.

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

• Explain the psychology of error
• List the regulatory requirements in GMP environment for managing human performance deviations
• Describe Root Cause Analysis and Investigation
• Use Root Cause Determination tools
• Establish the Human Error Rate at your site
• List the steps to implementing the Human Error Reduction Program
• Use proper metrics and KPIs