The Leader in Quality Life Science Training

Human Error Prevention (HEP) - Risk Factors and Strategies

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Course Brochure

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Course Description

Edwards Deming, the famous pioneering leader of Toyota in the mid-1900’s, widely regarded as the Father of Modern Quality, said: “85% of the reasons for failure are deficiencies in the systems and process rather than the employee.” Many studies place that number at 95%. This course challenges traditional thinking on what causes, and how to prevent, errors and deviations, and helps transform organizations from looking for people’s errors, to finding system flaws and harnessing people for solutions. HEP is a well-researched, well documented field adopted by many industries (e.g. aerospace, nuclear) decades ago. This highly interactive course provides practical tools and strategies for preventing deviations, rather than writing and closing them faster. It focuses on practical application without the need for costly equipment/facility changes, software, validation, or even change control in most cases.

 

The course includes an overview of key definitions, importance, human error causes, and myths vs. facts across industries to provide strong foundational knowledge and background. It then focuses on the many risk factors present in the biopharm/device industry, and goes through the top causes of, and strategies for preventing, human errors in this fast-paced, error prone environment. The course then focuses on specific application and practical HEP tools and implementation best practices to help attendees apply the learning at their firms.

 

This interactive course includes audience questions and polling, activities and exercises to help participants apply and retain the knowledge.

Who Should Attend

This comprehensive 15-hour course will be valuable to all personnel working in a GMP manufacturing environment, including Manufacturing, Quality Control, Quality Assurance, Quality Systems, Supply Chain, and Facilities and Engineering employees. It will benefit individual contributors, supervisors, area managers, and leadership decision makers, especially those involved in front line operations, deviation management, investigators, continuous improvement, and operational excellence.

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  • Learning Objectives

    At the end of the course, attendees will be able to:

    • Explain how system defects have caused major errors across many industries.
    • Describe The Bad Apple Theory.
    • Explain the ‘New View’ of human error.
    • Describe regulatory expectations for root causes & CAPAs.
    • Name the key job factors that influence performance.
    • List several risk factors that make biopharm and related industries error prone.
    • Explain why operator error is typically not a root cause and how blaming people for errors does little to prevent them.
    • Identify tools and best practices for determining underlying root causes.
    • Apply learning from session to identify potential causes and solutions other than human error.
    • Identify key strategies for preventing human errors.
    • Identify the top causes of, and key strategies for, preventing human errors.
    • Explain how each of the following strategies helps prevent errors:
    • Cite real-world examples of these strategies in practice
    • Apply key human error prevention tools in your daily job.

    The goal is to ensure all attendees walk away with practical, actionable best practices and foundational knowledge that they can bring back to their firms, whether as continuous improvement practitioners, change agents, or HEP champions and change agents to help improve their programs and processes and reduce deviations and errors, improve right-first-time (RFT), and drive compliance and productivity.

  • Agenda

    First Day


    Welcome

    • Course Overview
    • Logistics

    Human Error Overview

    • Importance of and key concepts regarding true root causes of ‘human errors.’
    • Review of high-profile tragedies across multiple industries and their true causes.
    • How industry has often tried to correct ‘human errors’ in the past.
    • Why do errors occur when everyone is for quality?
    • Our (BioPharm/Device) Error Prone Industry

    Regulatory Expectations

    • cGMP (FDA, EMA)
    • Guidance documents

    Job Performance Factors

    • Bad Apple Theory
    • Performance wheel
    • Biopharm risk factors
    • Biopharm common causes of error
    • Investigations and Root Cause Analysis

    Second Day


    Strategies for Prevention

    • Understanding human behavior
    • Positive attitude toward error  
    • Blame-free culture  
    • Simplification
    • User-centered design
    • Strong quality systems 
    • Removing risk factors
    • Education, not training
    • Responsibility & accountability

    Real World Application

    • Key examples from industry
    • You Try It!

    Third Day


    Review

    • Review prevention strategies using polling/quiz/game

    Tools

    • Pre-Job Brief
    • Gemba Walk
    • Value Stories
    • Visual SOPs
    • Deviation Management
    • Leadership Best Practices

    Final Activity – Apply the Tools

    • Divide into teams
    • Assign HEP tool to each team
    • Break out and develop the tool and implementation strategy
    • Discuss results as a class

    Summary/Q&A/Wrap-Up

    • Activity 
    • Highlight key points from session
    • Q&A
    • Encourage attendees to be change agents, and apply learning

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.

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