Represented in demonstration — Warning
Maintain release hold pending deviation assessment
- Owner
- QA Operations
- Evidence
- REL-DEMO-008 and QEV-DEMO-014
- Residual rationale
- Product impact remains unresolved; acceptance is unavailable.
Risk decision environment
Quality Risk
The rationale, effective controls and acceptance authority matter more than a decorative score.
Risk summary
High · unresolved risk — WarningCalibration uncertainty may affect laboratory evidence used in the BL-0726 disposition dossier.
- Affected object
- Equipment use, assay review and batch BL-0726
- Initial risk
- High
- Residual risk
- Not accepted
Effective controls
- Maintain release hold pending deviation assessment
- Review candidate affected equipment-use records
- Complete analytical evidence review
Decision rationale
Potential product impact and analytical evidence remain incomplete. Numeric scoring cannot substitute for that uncertainty.
Control ledger
Controls, evidence and residual rationale
Overdue — Critical attention
Review candidate affected equipment-use records
- Owner
- QA Investigations
- Evidence
- INV-DEMO-011
- Residual rationale
- The source record and candidate record set are not connected.
Awaiting evidence — Warning
Complete analytical evidence review
- Owner
- QA Materials
- Evidence
- MAT-DEMO-021
- Residual rationale
- Laboratory completion is not the same as a QA disposition.
Module scope and controlled ownership
Defined module areas
- Risk Assessments
- Risk Register
- Hazard Identification
- Risk Analysis
- Controls
- Residual Risk
- Risk Acceptance
- Periodic Review
- Linked Changes
- Linked Deviations
- Linked CAPAs
Sentinel ownership
- Quality-risk records
- Control definition
- Residual-risk review
- QA risk acceptance
Authority boundary
Risk method surfaces are defined. Calculation and risk-acceptance engines are not implemented.
Implementation stateDefined shell · non-authoritative
- Workflow, persistence, electronic signatures and compliant audit trails are not implemented.