Root Cause Analysis

Kick-off: When it’s human

• Expectations on Humans
• Why human error could not be a root cause
• Blame culture vs. Root Cause
• Error Culture

Excerpt from FDA Warning Letter
“…the investigation failed to establish a root cause and your quality unit failed to ensure the implementation of adequate corrective actions to prevent future recurrence.”

Presentation and Workshop:
Using 5 Whys und Ishikawa

• Short Introduction of the methods
• Strengths and weaknesses of each method
• Typical mistakes in application
• Workshop: Real Life Examples and Experiences

Interactive Session: Comparative Analyses

• Identifying and documenting errors with worksheets
• The need for a systematic approach
• The key for success: comparison of occurred deviations with available facts

Bow-Tie Risk Management and Problem Solving Analysis

• Controls, connection and causality
• Risk velocity
• Preventive- detective and corrective controls
• The link to Fault Tree Analysis and Event Tree Analysis

Interactive Session: A3 Methodology

• What is a problem?
• The causes investigation; point of cause, direct cause and root cause
• The 8-steps, structure and methodology
• Deep Dive: Point of Cause Analysis
• Solving a murder case

Human Error Related Deviations

• The What
  - Top 10 Categories: FDA Warning letters (2021 -2022)
  - The Commonality
  - Undesirable behaviour…what is it?
• The How
  - The KAP Model
  - Factor in the Social Element
• The Recurrence
  - Human Error is NEVER a Root Cause
  - Blame it on the Culture

• Behavioural Root Cause Analysis Tool (3B Method)
• Theory behind 3B Method
  - Informative Construct (brain)
• - Motivational Construct (beating heart)
  - Perceived Barriers Construct (brick)
• Utilize the Solution
  - Sort the HErD - 3B Method
  - Practice in groups

RCA Completion

• How to document a Root Cause Analysis
• How to define the right actions based on the outcome

Deviation Management and CAPA

Principles and all relevant aspects to implement, improve and/ or work with a Deviation Management and CAPA System are topic of ECA’s Deviation Management and CAPA training course. For more information see www.gmp-compliance.org/ or send an e-mail to w.schmitt@concept-heidelberg.de.