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, supervision, 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 for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Why should you Attend:
This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss why supervision is so important in reducing and preventing human error. Supervision approaches, near root causes and root causes for supervision related errors, and will address the main 5 elements to assure an error free environment.
• Background on Human Error Phenomena
• What is Human Error
• Importance of Human Error Prevention/reduction
• Supervision and human error
• Facts about human error caused by supervisors and how to avoid it
• When operator error is the Root Cause?
• How is Human Error controlled by supervision?
• Common mistakes: Memory failures, Overconfidence, Visual Detection, and Vigilance Effectiveness and how supervision can help improve these
• Types of error
• Human error rates and measurement
• Trending and tracking
• CAPA Effectiveness
• Understand human error: factors and causes
• Understand the importance of supervision in creating a high reliable group for both regulatory and business compliance
• Discuss issues related to supervision and how to avoid traps that will allow errors to occur
• Identify Root Causes and CAPA associated to supervision.
• Learn how to measure human error rates at your department and keep track of metrics
• Identify what I can do to support human reliability at the site
Who will Benefit
- Supervisors, Managers and Directors
- Plant Engineering
- QA/QC Staff
- Process Excellence/Improvement Professionals
- Industrial/Process Engineers
- Compliance Officers
- Regulatory/Legislative Affairs Professionals
- General/Corporate Counsel
Industries who can attend
This 90 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Ginette M. Collazo
Ginette M. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, 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.