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Root Cause Analysis for Drugs and Devices

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This management report provides a step-by-step guide to conducting an effective root cause analysis, from recognizing problems that need to be investigated to documenting the investigation so regulators can see you are on top of the situation. Along the way, you’ll learn about:

  • Gathering the right people to conduct the investigation;

  • Developing an accurate problem statement;

  • Identifying problems that should trigger CAPAs;

  • Various analytical tools that can help narrow the focus of your investigation, including:

    • Affinity diagrams;

    • Fishbone diagrams;

    • GANTT charts;

    • Trend analysis;

    • Pareto analysis; and more.

  • Documenting the effort in detail; and

  • Understanding regulators’ requirements and avoiding consequences, such as 483s and Warning Letters.

The report also includes root cause analysis templates readers can customize for their own investigations, including:

  • Is/Is Not table;

  • Possible Causes and Confirmed Facts lists; and

  • Contradiction Matrix.

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PDF Edition

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Table of Contents

  • Introduction
  • Why Perform Root Cause Analysis?
  • Initial Steps: Understanding the Problem
  • Next Steps: In Search of Confirmed Facts and Possible Causes
  • And More …

View the entire TOC

Who Will Benefit

  • Company Executives
  • Quality Managers
  • Regulatory Managers
  • Program Managers
  • Project Managers
  • Product Development Managers

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