Reporting Package: 2026 – QMS Consolidated Reporting Package
Report Tab: Change Control Table
Owner: Quality Control Operations (QCO)
Version: 1.0
Last Updated: 2026-01-23
QMS Reporting Interpretation — Change Control Table
Non-Authoritative Interpretation Notice
This page provides interpretive context only. Authoritative requirements,
execution expectations, change approval, implementation authorization,
and release decisions are governed by approved SOPs, WINs, and the
Quality Management System (QMS).
Purpose
The Change Control Table provides a consolidated, record-level view of
controlled change records to support Quality Control Operations (QCO)
oversight, status visibility, and navigation to authoritative change records.
What This Tab Shows
- Individual change control records with key identifying attributes
- Current lifecycle status of each controlled change
- Associated change type, domain, and initiation context
Each row represents a single controlled change record maintained within the QMS.
Intended Use
- Provide visibility into open and closed change controls
- Support QCO oversight of change workflow progression
- Enable navigation to individual change records for detailed review
Limitations
- Does not evaluate change impact or risk classification
- Does not authorize implementation or release
- Does not assess effectiveness of implemented changes
- Does not replace review of individual change records
Record Drill-Down and Traceability
This table provides direct links to individual change control records. Each
change record contains the complete required documentation, including impact
assessment, approvals, implementation details, and formal disposition.
- Status transitions are controlled within the change control workflow
- Approval and release decisions are documented in the change record
- The individual change record remains the authoritative source of truth
This table does not summarize, reinterpret, or override change-level data or
decisions.
Decision Authority
Interpretation of change control 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
approve, release, or disposition controlled changes.
Related Reporting Tabs
- Trend Graph: Visual, aggregated quality trends
- Trend Table: Status-based summary by reporting period
- CAPA Table: Corrective actions driving or resulting from changes
- Quality Events Table: Events initiating change control
Governance Alignment
This interpretation supports consistent understanding of change control
reporting and aligns with the QCO authority model without creating procedural,
execution, or decision requirements.