4.6 Corrective action system

SCAR Standard (8D / 5-Why)

Required structure, evidence expectations, timelines, and what “root cause” must look like (mechanism + why not detected). Mandatory effectiveness verification, not just closure.

Effectiveness Verification and Recurrence Prevention

How SQ verifies: repeat audit point, capability evidence, incoming data trend, defect recurrence window, control plan update. Defines “reopen SCAR” triggers.