Regulatory Non-Conformance Documentation

Document Number Date Reported Reported By

Department

Process/Area Affected

Details of Non-Conformance

Description of Non-Conformance Date/Time Occurred Reference Regulation/Standard Severity / Classification Root Cause Analysis

Root Cause Method of Detection Immediate Actions Taken

Immediate Corrective Actions Personnel Responsible Date of Completion (Immediate Actions) Corrective and Preventive Actions

Corrective Action(s) Planned Preventive Action(s) Planned Assigned to Target Completion Date Verification and Closure

Verification of Effectiveness Verified By Date Verified