QMS Reporting Interpretation — CAPA Table

Purpose

The CAPA Table provides a consolidated, record-level view of Corrective and Preventive Action (CAPA) records to support Quality Control Operations (QCO) oversight, status visibility, and navigation to authoritative CAPA records.

What This Tab Shows

• Individual CAPA records with key identifying attributes
• Current lifecycle status of each CAPA
• Associated event category, domain, and initiation context

Each row represents a single CAPA record maintained within the QMS.

Intended Use

• Provide visibility into open and closed CAPAs
• Support QCO oversight of CAPA progression and backlog
• Enable navigation to individual CAPA records for detailed review

Limitations

• Does not assess CAPA effectiveness or adequacy
• Does not evaluate root cause quality or investigation depth
• Does not establish acceptance criteria or closure approval
• Does not authorize or require action

Record Drill-Down and Traceability

This table provides direct links to individual CAPA records. Each CAPA record contains the complete required documentation, including investigation details, action plans, approvals, and formal disposition.

• Status transitions are controlled within the CAPA workflow
• Effectiveness review and closure approval are documented in the record
• The CAPA record remains the authoritative source of truth

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

Decision Authority

Interpretation of CAPA status and any resulting quality decisions remain the sole responsibility of the Quality Control Officer (QCO). Quality Assurance (QA) supports CAPA execution but does not independently approve, close, or disposition CAPAs.

Related Reporting Tabs

• Trend Graph: Visual, aggregated quality trends
• Trend Table: Status-based summary by reporting period
• Quality Events Table: Event sources driving CAPA initiation
• QMS – Change Control: Changes resulting from CAPA outcomes