fd94a4ef4396a22d492d9d81a60f384d9006267115cc77cd26b3e79589027be3
draft
contextual
prescribed

All Global CAPAs mandate a multi-disciplinary investigation team and require specific tools such as 5 Whys and Ishikawa Diagram for root cause analysis so that comprehensive investigations are conducted.

Supporting contexts

Rationale

All Global CAPAs mandate a multi-disciplinary investigation team. The following tools are REQUIRED for all Global investigations: 1. 5 Whys: To be used for initial drill-down into mechanical or procedural failures. 2. Ishikawa (Fishbone) Diagram: Mandatory for all Global CAPAs. Barrier Analysis: Evaluation of the 'Swiss Cheese Model' of failure to identify which quality gates were breached.

legacy import — synthesised from supporting_context_primary

Effective from: 4/28/2026, 12:55:03 PM

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