Human Error Investigations, Root Cause Determination and CAPA Effectiveness

Many variables, from procedures to training to workplace environment, affect human behavior. You need to understand human behavior and the psychology of error in order to implement a process dedicated to investigating and fixing human errors.

This training program will offer attendees an understanding of human error, its factors, and its causes. The program will also identify the regulatory and business importance of human error prevention and define the process of managing human error deviations.

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 weaknesses of the system are, so they can be improved and/or fixed. This course will offer practical approaches to address human performance issues in GMP-related environments by using a specific methodology to correct, prevent, and avoid re-occurrence of these issues.

• Understand human error: factors and causes
• Understand the importance of regulatory and business
• Define the process to manage human error deviations
• Identify the root causes associated with human error deviations
• Identify what I can do to support human reliability

• 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

Human error investigations and CAPA are essential elements in an organization's risk management framework. By focusing on thorough root cause analysis and implementing effective CAPA, organizations can significantly reduce the incidence of human error and enhance operational efficiency. The key to long-term success lies in continuously monitoring CAPA effectiveness and being proactive in addressing not just immediate issues, but also the broader system that enables human errors.