Human Error Investigations, Root Cause Determination and CAPA Effectiveness
Objectives of the Presentation
- 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
- Identify what I can do to support human reliability
Why Should you Attend
Human error is known to be the major cause for 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 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.
- 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
- CAPA effectiveness