Two days workshop on
Human Error Reduction Model: How to Manage Human Performance Deviations in a Regulated Environment
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
Course Description
Dr. Ginette Collazo, a 15 year veteran in helping drug, biologic and device firms reduce manufacturing errors, will conduct a one-of-a-kind workshop that teaches quality managers and manufacturing excellence professionals how to reduce errors and improve quality metrics. Based on her ground-breaking research, Dr. Collazo explains how small improvements in both manufacturing systems and improved employee training can deliver big results.

Dr. Collazo will work with small groups and help form solutions that manufacturers can take back to their facilities.

Some of the interactive exercises include:
  • What's not working in the facilities: Participants will be split into groups and asked to describe the most common human errors within their facilities. The workshop will then reconvene and break-out; group leaders will describe what they uncovered. A list of the most common problems will be tallied to help focus the discussion.
  • CAPA: Determining when human error reduction is the key to a successful solution and FDA compliance. Split into small groups, each group will be asked to determine if a CAPA solution is effective and if human error prevention related provisions will satisfy the FDA.
  • Practices identifying which human error techniques are best applied to certain situations. For example, when is a human error really a human resources problem? This interactive exercise will help manufacturers know what to apply and when.
  • Brainstorming root causes for real cases. Using the situations identified in the first interactive exercise the group will apply applicable tools. Getting to the true root cause of an error is commonly described as the hardest part of reducing errors. We'll take manufacturer's toughest problems and send them home with detailed, written solutions.
Learning Objectives
  • How to understand the implications of human error events - how they affect product quality, business operations and regulatory compliance
  • Best practices for diagnosing your error tolerance, how to get an error reduction program started and how to measure its effectiveness
  • How to identify the relationship between CAPA and human reliability and performance expectations
  • Destructive human behavior factors and how to create the effective recommendations to modify them
  • 5 key elements of an effective human error CAPA system - strategies to address essential system safeguards that must be put in place to prevent and correct problems
  • How to unlock the mystery of root cause analysis and human error
  • How to understand key obstacles in existing practices - why correctives don't correct, and preventives don't prevent
  • Trending and tracking - how to assure that improvement is not by chance but by design
  • Insights into how to leap past hurdles and predict errors
Why Should you Attend
This Workshop explains how small improvements in both manufacturing systems and improved employee training can deliver big results. 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. In addition to Dr. Collazo's analysis of how and why errors occur, this workshop features multiple interactive exercises allowing you to work in small groups with your colleagues to tackle common manufacturing problems.

Who can Benefit
  • QA/QC directors and managers
  • Process improvement/excellence professionals
  • Training directors and managers
  • Manufacturing operations directors
  • Human factors professionals
  • Plant engineering
  • Compliance officers
  • Regulatory professionals
  • Executive management
Agenda

Day 1 (8:30 am – 9:00 am: Registration Process)

Understanding the Basics of Human Error on the Manufacturing Floor (8:30 a.m. – 10:00 a.m.)
  • How human errors intersect with manufacturing regulations
  • Examples of applicable FDA requirements and what the FDA expects companies to be complying with
  • A review of other industry standards that apply to drug and device manufacturing
  • What FDA investigators look for during inspections and the most common violations found in Form 483s and Warning Letters
  • Which violations tied to human errors and manufacturing are trending up
  • The various types of human errors commonly found on manufacturing floors
  • How we got here - why is human error reduction such an important topic
Break 10:00 a.m. – 10:15 a.m.

Human Error In Context - What Are the Factors That Drive Human Errors? (10:15 a.m. - 12:00 p.m.)
  • The taxonomy of human error; how and why drug and device companies need to focus on this in their investigation processes
  • Why administrative and management systems factor so prominently into deviations and non-conformances
  • The role of innovative operational controls and their role in reducing human errors
  • Simple procedures that prevent human error - how they should be described and presented to maximize human error reduction
  • Common examples of poor human factors engineering and workplace conditions that contribute to human error
  • When training is appropriate and when we should stop
  • Learn how common day-to-day communication gaps contribute to human error
  • How supervision can be one of the best human error reduction strategies at your site
  • When is individual performance responsible for human error and when does it become a root cause
  • How to address cognition, attention, and memory failures at your site
Lunch 12:00 p.m. - 1:00 p.m.

Internal vs. External Factors (1:00 p.m. – 2:30 p.m.)
  • How our biology affects our thinking process and individual performance
  • Understanding the latest on cognitive load and attention, memory, and decision making errors - how they commonly occur on the manufacturing floor
  • How our senses control how we react - it's more important than you think
  • Best practices for controlling human factors for optimum people performance
  • How to create an organizational environment that supports human error reduction initiatives -from senior management to floor level staff
  • Why our culture with regards to human error has to change; it's not an easy process but vitally necessary for drug and device companies
Break 2:30 p.m. – 2:45 p.m.

Corrective and Preventive Action (CAPA) (2:45 p.m. - 4:45 p.m.)
  • FDA's #1 Manufacturing Compliance Problem
  • How to develop corrective actions that make sense - what's working and not working
  • Creating preventive actions that truly prevent; how to stop errors that have not yet happened
  • Understanding the human error prediction process and tools
  • Prevention and human error control: proven ways to measure improvement and on-going trend analysis
  • When to use detection mechanisms instead of preventive mechanisms - the pros and cons of each
  • Human error detection and recovery rate - are you really uncovering all the errors within your facilities?
  • Assuring for the FDA your CAPA program is effective and you've adequately focused on human error
  • Interactive Exercise! When to do what?
Day 2 (9:00 am : Workshop Start)

Human Error Reduction Techniques (8:30 a.m. – 10:00 a.m.)
  • When is human error a human resources issue?
  • How and when to apply engineering controls to correct and prevent human error deviations
  • What to do when individual performance is the major contributor
  • Human error and documentation: From design, construction, change management and implementation
  • Additional Contributors for human errors will be discussed
Break 10:00 a.m.– 10:15 a.m.

Human Error Investigation (10:15 a.m. – 12:00 p.m.)
  • Human Error investigation process defined from beginning to end
  • How to gather data in the human error investigation process
  • How to perform an effective interview
  • Important steps for effective human error investigation
  • How to report issues to make sure management listens
Lunch 12:00 p.m. - 1:00 p.m.

Root Cause Analysis Tools (1:00 p.m. – 2:30 p.m.)
  • A brief review of common tools used in determining root cause
  • Hierarchy and use of the root cause determination tool for human error investigations
  • How to perform a cognitive load assessment
  • The interview process and interview techniques for human error root cause analysis
  • When and how to use the human error prediction tool
  • When to perform a Process vs. procedure analysis and why it is so important to do so before establishing procedure revision as a CAPA for human error
Break 2:30 p.m. – 2:45 p.m.

Metrics and Human Error (2:45 p.m. - 4:45 p.m.)
  • KPI's
  • Human Error rate
  • 1st time pass rate
  • Overall equipment effectiveness (OEE)
  • Trending /Tracking
























Dr. Ginette M. Collazo - Owner - Industrial/Organizational Psychologist at Ginette M. Collazo, Inc.


Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.

Her work experience is from Bristol Myers Squibb, Johnson & Johnson, Schering Plough and Wyeth, holds specialized studies in Human Reliability, and has authored various publications on this topic. Her most recent publication is "Error Humano: C4c06 Modelo de Determinación de Raiz Causa", a book that describes success factors that reduce human errors. Having implemented Human Reliability programs in various industries, she understands firsthand what works and what doesn’t when trying to change a culture from an error tolerant environment to an error free learning organization.

Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people’s mistakes.

Ginette’s clients all over the world including Germany, Argentina, USA, Trinidad Tobago, Dominican Republic, Singapore, Europe, and more. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.