Boston Professional Events List

2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, reduce, and prevent to improve results.

May 10, 2018 - 08:00 AM - May 11, 04:00 PM
New Brunswick

ZIP: 08816
Phone: 347 282-5400

Ticket Price: Seminar One Registration $ 1295 | Special Group Discount Register for Four attendees $ 3995


Small mistakes can lead to big disasters—just ask the scientists and engineers who worked on the Mars Climate Orbiter: a $327.6-million USD spacecraft that was destroyed because of a failure to properly convert between units of measurement.

Any manufacturer who’s had to shut down an entire production line because someone misread a label or forgot to “carry the one” can sympathize. In fact, according to a new study from Vanson Bourne, manufacturers know the pain of unplanned downtime due to human error better than anyone.

An interactive workshop presented by Ginette M. Collazo & WCS 

Dr. Ginette Collazo — a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors by 50 percent or more —  will conduct a one-of-a-kind workshop that teaches quality managers and manufacturing excellence professionals how to reduce errors and improve quality metrics.Dr. Collazo recently worked with a drug manufacturer that had a baseline rate of 4.7 errors per thousand units manufactured.  But with effective human error reduction strategies, the error rate was reduced to 1.9.

A 60% reduction achieved in just 10 months

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 to address human performance issues in GMP related environments by using a specific methodology to investigate, correct, prevent and avoid re-occurrence of these issues.

Areas Covered

•    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

Who will 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

Learning Objectives

Ginette Collazo has recently developed new tools to measure, explain and predict human error from both process and cognitive load perspectives. And she’ll demonstrate her newly created tools for improving systems and processes, staff training and reducing human error:

•        Process-related prediction tool: This tool allows organizations to identify cracks and concerns that are based on their organizational processes.  80% of mistakes are caused by problems within these systemic areas:

        o Procedures

        o Human factors engineering

        o Training

        o Communication

        o Supervision

•         Cognitive load assessment tool: Only 20% of mistakes occur due to human frailties.  This tool examines best practices for restructuring training and processes to improve workers’ ability to perform as expected.  The tool focuses on workers’:

        o Individual performance

        o Memory

        o Attention

        o Problem solving

        o Calculating

        o Reasoning

        o And decision makingm



Course Outline:

DAY ONE (08:00 AM to 04:30 PM)


8:00 a.m. – 8:30 a.m. Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m. Understanding the Basics of Human Error On The Manufacturing Floor

        • How human errors intersect with manufacturing regulations

        • Examples of applicable GMP requirements and what the FDA expects companies to be complying with

        • A review of other industry standards that apply to manufacturing

        • What GMP investigators look for during inspections and the most common violations found in Form 483s and Warning Letters

        • The various types of human errors commonly found on manufacturing floor

10:00 a.m. – 10:15 a.m. Break

10:15 a.m. – 12:00 p.m. Human Error In Context — What Are the Factors That Drive Human Errors?

        • The taxonomy of human error; how and why drug and device companies need to focus on this in their investigation processes

        • The role of operational controls and their role in reducing human errors

        • Simple procedures that prevent 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

12:00 p.m. – 1:00 p.m. Lunch

1:00 p.m. – 2:30 p.m. Internal vs. External Factors

        • How our biology affects our thinking process and individual performance  

        • Understanding the latest on cognitive load and attention, memory, and decision-making errors 

        • How our senses control how we react — it’s more important that 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

2:30 p.m. – 4:30 p.m. Corrective and Preventive Action (CAPA) — #1 Manufacturing Compliance Problem

        • How to develop corrective actions that make sense 

        • 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 

        • Human error detection and recovery rate 

        • Assuring the regulators your CAPA program is effective and you’ve adequately focused on human error



DAY TWO (08:30 AM to 04:00 PM)


8:30 a.m. – 10:00 a.m. Human Error Reduction Techniques

        • Discussion of insights from Day 1

        • 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.

10:00 a.m. – 10:15 a.m. Break 

10:15 a.m. – 12:00 p.m. Human Error Investigation 

        • Human error investigation process defined from beginning to end

        • How to gather data in the human error investigation process

        • Important steps for effective human error investigations

        • How to report issues to make sure management listens 

12:00 p.m. – 1:00 p.m. Lunch

1:00 p.m. – 2:30 p.m. Root Cause Analysis Tools 

        • 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

2:30 p.m. – 2:45 p.m. Break 

2:45 p.m. – 3:45 p.m. Metrics and Human Error

        • KPI’s

        • Human error rate

        • 1st time pass rate

        • Overall equipment effectiveness (OEE)

        • Trending 

        • Tracking 

3:45 p.m. – 4:00 p.m. Review and Key Insights 

4:00 p.m. Adjourn Workshop 



Speaker Details

Ginette M. CollazoPh.D, President, Ginette M. Collazo, Inc.


Dr. 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.

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.

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.

Event Categories
Keywords: assessment , climate, communication , craft, design , environment, learn, Learning , Management


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