QMS Reporting Interpretation — Quality Events Table

Purpose

The Quality Events Table provides a consolidated, record-level view of quality events to support Quality Control Operations (QCO) oversight, visibility, and navigation to authoritative event records.

What This Tab Shows

• Individual quality event records with key identifying attributes
• Current lifecycle status of each quality event
• Event categorization, domain, and incident date information

Each row represents a single quality event record maintained within the QMS.

Intended Use

• Provide visibility into open and closed quality events
• Support QCO oversight of event status and progression
• Enable navigation to individual event records for detailed review

Limitations

• Does not evaluate investigation adequacy or root cause quality
• Does not assess severity, impact, or regulatory reportability
• Does not summarize investigation outcomes or effectiveness
• Does not authorize or require action

Record Drill-Down and Traceability

This table provides direct links to individual quality event records. Each event record contains the complete required data fields, including investigation details, approvals, and formal disposition.

• Status changes are controlled within the quality event workflow
• Disposition decisions are documented and approved within the event record
• The individual event record remains the authoritative source of truth

This table does not summarize, reinterpret, or override record-level data or decisions.

Decision Authority

Interpretation of quality event status and any resulting quality decisions remain the sole responsibility of the Quality Control Officer (QCO). Quality Assurance (QA) supports execution but does not independently disposition quality events.

Related Reporting Tabs

• Trend Graph: Visual, aggregated quality trends
• Trend Table: Status-based summary by reporting period
• QMS – CAPA: Corrective actions linked to quality events
• QMS – Change Control: Changes resulting from event outcomes