Human error is known to be the primary cause of quality and production
losses in many industries. Although it is unlikely that human error will
ever be 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 essential to understand human behavior and
the psychology of error as well as understand exactly where the
weaknesses of the system are so that they can be improved and/or fixed.
This
course offers practical approaches and models to address human
performance issues in GMP related environments by using a particular
methodology to correct, prevent and avoid reoccurrence of these matters.
Why you should attend
This
training would provide tools that can be implemented and used after
this event. These include 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.
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
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
Ginette Collazo, Ph. D. is an
Industrial-Organizational Psychologist with 20 years of experience that
specializes in Engineering Psychology and Human Reliability, disciplines
that study the interaction between human behavior and productivity. She
has held positions leading training and human reliability programs in
the Pharmaceutical and Medical Device Manufacturing Industry.
Nine
years ago, Dr. Collazo established Human Error Solutions (HES), a
Florida based boutique consulting firm, where she has been able to
position herself as one of the few Human Error Reduction Experts in the
world. HES, led by Dr. Collazo, developed a unique methodology for human
error investigations, cause determination, CA-PA development and
effectiveness that has been implemented and proven amongst different
industries globally. This scientific method has been applied in critical
quality situations and workplace accidents.
Ginette Collazo, Ph.
D. is the author of the book Human Error: Root Cause Determination
Model, published in 2008. She is also a speaker at significant events
like Interphex, FDAnews Annual Conference, Global Conference on Process
Safety, International Conference on Applied Human Factors and
Ergonomics, and of course, Pharmaceutical Industry Association.
- 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
