Vigilance Procedure

The Vigilance Procedure provides instruction on classifying incidents to determine reportability and instruction on overall reporting process. The Vigilance Procedure Includes a Vigilance Decision Tree.

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Vigilance Procedure

The Vigilance Procedure provides instruction on requirements for reporting on serious incidents and field safety corrective actions. The Vigilance Procedure Includes vigilance decision tree and related forms.

Vigilance Procedure - Overview

The Vigilance Procedure, and applicable decision trees, will determine if the incident meets the three basic reporting criteria in order for an incident to be classified as reportable and provides instruction on how to report a reportable incident.