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 course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Areas Covered in the Session
- Background on Human Error Phenomena and measurement
- Importance of Human Error Prevention/reduction
- Quantitative and qualitative information gathering
- Why do we need tools for human error reduction programs?
- Training as a tool and human error
- Facts about human error and training
- Human Error as the Root Cause: what to do and how to measure it
- Root Cause Analysis
- Cognitive load assessment
- Systems available
- Human error rate
- Floor checklist
- Interview questions
- Human error rates and other metrics
- Trending and tracking
- CAPA effectiveness
- Metrics and Human Error
- Human Error rate
- 1st time pass rate
- Overall equipment effectiveness (OEE
- Trending /Tracking
- Understand human error-factors and causes
- Understand the importance-regulatory and business
- Define the process to manage Human Error deviations
- Learn about human error measurement
- Learn about tools for measurement
- Establish Key Performance Indicators
- Define and measure human error rate,cognitive load, and CAPA effectiveness
- Identify what I can do to support human reliability
Who Will Benefit
- Training Managers and Coordinators
- Plant Engineering
- QA/QC Staff
- Process Excellence/Improvement Professionals
- Industrial/Process Engineers
- Compliance Officers
- Regulatory/Legislative Affairs Professionals
- General/Corporate Counsel
- Executive Management
Ginette Collazo PH.D, is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.