Implementing an Effective Human Error Reduction Program

In GMP-regulated industries, human error deviations are more than an inconvenience: the regulations require you to deal with them. This 90-minute human error reduction program training explains what that means and how to build a program that works.

21 CFR 211.22 gives the quality control unit authority to review production records to make sure errors have not occurred or, if they have, that they were fully investigated. European Commission guidance adds that when human error is suspected, you must make sure process, procedural or system problems weren't overlooked, take appropriate CAPAs and monitor their effectiveness under quality risk management.

The program presented combines qualitative and quantitative methods with practical tools for controlling, measuring and predicting human error.

• Explain what human error is and what GMP regulations require when it occurs
• Describe how human error is controlled through an error reduction system
• Implement a human error reduction program using a six-step process
• Measure human error rates and set metrics and KPIs
• Trend, track and predict human error events
• Evaluate the effectiveness of CAPAs for human error

• What human error is
• How human error is controlled
• The error reduction system
• The six-step method for error prevention and implementation
• Practical human error tools
• Implementing the program
• Human error rates and measurement
• Metrics and KPIs
• Trending and tracking
• Prediction
• CAPA effectiveness

Regulators expect human error to be investigated properly, not used as a default root cause. This training gives you steps you can implement at your own site, including practical tools, a six-step implementation process and ways to measure effectiveness so human reliability keeps improving.

It suits training managers, operations, manufacturing and plant engineering staff, QA/QC, process improvement and industrial engineers, compliance and regulatory professionals, and corporate counsel.

• 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.