Human Error Reduction in GMP Related Environments

• OVERVIEW

This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

• LEARNING OBJECTIVES

• Understand human error: factors and causes
• Understand the importance: regulatory and business
• Define the process to manage Human Error deviations
• Identify Root Causes associated to human error deviations
• Learn how to measure human error rates at your site
• Identify what I can do to support human reliability

• WHY SHOULD YOU ATTEND

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior can be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed.

This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss human error categories, near root causes and root causes for these events. We will discuss latest trends in human error issues in the industry.

• AREAS COVERED

• Background on human error phenomena
• Importance of human error prevention/reduction
• Training and human error
• Facts about human error
• Human error as the root cause
• What is human error
• How is human error controlled?
• Common mistakes: Memory failures, overconfidence, we believe we are above average, visual detection, vigilance effectiveness
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

• WHO WILL BENEFIT?

• Training managers and coordinators
• Operations
• Manufacturing
• Plant engineering
• QA/QC staff
• Process excellence/improvement professionals
• Industrial/process engineers
• Compliance officers
• Regulatory/legislative affairs professionals
• General/corporate counsel