Continuous Improvement Governance Specification
This specification defines the Quality Unit–approved governance requirements ensuring systematic identification, prioritization, implementation, and oversight of continuous improvement activities impacting GMP quality systems.
Authoritative Quality Control specification defining continuous improvement governance and decision authority. This document does not define improvement methodologies, project tools, or execution frameworks.
1. Purpose
To establish Quality Unit–approved governance requirements ensuring that continuous improvement initiatives enhance product quality, process robustness, and compliance without introducing uncontrolled change or regulatory risk.
2. Scope
This specification applies to planned improvement activities derived from performance monitoring, trend analysis, investigations, audits, risk reviews, management review, and quality metrics.
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Laboratory Operations
- Production (PROD)
- Packaging (PKG)
- Warehouse Operations (WH)
- Engineering & Facilities
- Information Technology (IT)
- Regulatory Affairs
3. Ownership & Governance
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
- QC-REQ-IDX Reference: QC-CI-001
Continuous improvement governance requirements defined in this specification shall not be used to bypass or weaken formal change control or validation requirements.
4. Continuous Improvement Governance Requirements
| Governance Element | Requirement | Applicability |
|---|---|---|
| Improvement Identification | Improvement opportunities shall be identified through systematic review of quality performance data and trends. | All quality systems |
| Prioritization | Improvement initiatives shall be prioritized based on risk, impact, and strategic quality objectives. | All improvement initiatives |
| Controlled Implementation | Improvements impacting GMP controls shall be implemented through approved change control. | GMP-impacting improvements |
| Effectiveness Evaluation | Implemented improvements shall be evaluated to confirm sustained benefit and absence of adverse impact. | All implemented improvements |
| Management Oversight | Continuous improvement activities shall be subject to periodic management review and oversight. | Quality system |
Continuous improvement shall be deliberate, data-driven, and aligned with Quality Unit governance.
5. Decision Logic
- Improvement initiatives aligned with governance requirements may be approved and implemented.
- Improvements introducing uncontrolled risk shall not proceed.
- Ineffective improvements require reevaluation or modification.
- Final determinations regarding improvement suitability reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Proposed improvements bypass change control
- Improvement initiatives introduce quality or compliance risk
- Lack of evidence demonstrating improvement effectiveness
- Disagreement regarding improvement prioritization or governance
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Continuous improvement plans and tracking records
- Performance metrics and trend analyses
- Change control records supporting improvements
- Effectiveness review documentation
- Management review outputs