3. Files Reviewed
- L00 — Quality Charter :contentReference[oaicite:1]{index=1}
- L0 — Governance Foundation :contentReference[oaicite:2]{index=2}
- L0-REG — Regulatory Crosswalk :contentReference[oaicite:3]{index=3}
- Baseline Regulatory Completeness Certification :contentReference[oaicite:4]{index=4}
- L1 — Operating Model :contentReference[oaicite:5]{index=5}
- L2 — Quality Manual :contentReference[oaicite:6]{index=6}
- Family Pack 0 — Authorized SOP Universe :contentReference[oaicite:7]{index=7}
All mandatory files required by the audit instruction were present, controlled, and internally consistent.
5. Foundation QMS Control Assessments
5.1 Governance Authority (L00)
Governance intent, authority, QU independence, and enterprise scope are clearly established.
5.2 Governance Rules (L0)
Mandatory enterprise governance rules are complete, non-procedural, and aligned to regulatory frameworks.
5.3 Regulatory System-of-Record (L0-REG)
All applicable regulatory requirements are centralized, mapped, and frozen under change control.
5.4 Structural Implementation (L1)
Operating Model correctly implements governance structurally without procedural contamination.
5.5 System HOW (L2)
Quality Manual explains system-wide application of governance without task-level content.
6. Traceability Verification
Traceability path confirmed as:
L3 → L2 → L1 → L0 → L00
No reverse citation, no orphan governance, no SOP-level regulatory citation detected.
7. Audit Conclusion
FOUNDATION QMS STATUS:
The Sawgrass Nutra Labs Quality Management System is:
- Formally established
- Governance-complete
- Regulatorily traceable
- Metadata-controlled
- Audit-defensible at the foundation level
No findings, recommendations, or CAPA are issued by design.
This audit strictly validates system establishment and control.