Quality Systems

Deviation Management & Root Cause Analysis

Deviation classification, root cause methods including 5 Whys and fishbone analysis, and why 'human error' alone never satisfies FDA.

What this course covers

This course covers what constitutes a reportable deviation and how severity classification works, root cause analysis methods including 5 Whys and fishbone or Ishikawa analysis, why 'human error' alone is never an acceptable standalone root cause under FDA expectations, and how a deviation investigation connects forward into CAPA and, when relevant, into an OOS investigation.

Who this course is for

QA staff who manage or review a site's deviation program
Investigators conducting root cause analysis
Anyone documenting or approving deviation records

What you'll learn

What constitutes a reportable deviation and how severity classification works
Root cause analysis methods including 5 Whys and fishbone or Ishikawa analysis
Why 'human error' alone is not an acceptable root cause under FDA expectations
How a deviation investigation connects to CAPA and, when relevant, to an OOS investigation
Documentation standards that hold up to inspection scrutiny

Why it matters

21 CFR 211.192 has been one of the most cited provisions in FDA drug inspections for years running, and a shallow deviation investigation is almost always the reason. Getting root cause analysis right is one of the highest-leverage skills in a quality system.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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