Question: Analyze the problem and determine its cause (Root Cause Analysis) The investigation step will help you to analyze the problem and determine how and why

Analyze the problem and determine its cause (Root Cause Analysis)

The investigation step will help you to analyze the problem and determine how and why it happened. All the gathered information must be documented and organized as part of the CAPA process.

There are established analysis techniques that can be used to determine root causes, such as failure mode and effects analysis (FMEA), the 5 Whys or Fishbone diagrams.

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