NSF/ANSI 455-2 Auditor Briefing
Document Control
Document ID: QMS-AUD-BRIEF
Document Type: Auditor Orientation / Audit Aid
QMS Classification: Informational (Non-Governance)
Version: 1.0
Effective Date: ____________________
Owner: Quality Unit
Organization: Sawgrass Nutra Labs (SNL)
Manufacturing Scope: Dry-process dietary supplements
Applicable Standards: NSF/ANSI 455-2, 21 CFR Part 111, 21 CFR Part 11
Purpose of This Briefing
This document is provided to orient auditors to the structure, intent, and audit boundaries of the Sawgrass Nutra Labs Quality Management System (QMS). It is an informational aid intended to support an efficient, risk-based audit.
This briefing does not establish governance requirements, operational controls, procedural obligations, or records.
QMS Architecture Overview
The Sawgrass QMS is organized as a layered hierarchy. Each layer has a distinct purpose and audit scope. Content is intentionally segregated to prevent duplication, contradiction, or interpretive drift.
| Layer | Name | Primary Purpose | Audit Focus |
|---|---|---|---|
| L00 | Quality Charter | WHY the QMS exists | Leadership commitment, quality intent, QU independence |
| L0 | Governance Foundation | WHAT rules are mandatory | Governance controls, authority, data integrity expectations |
| L0-X | Regulatory Crosswalk | Requirement mapping | Accuracy and completeness of mappings |
| L1 | Operating Model | STRUCTURAL HOW | Process families, roles, organizational architecture |
| L2 | Quality Manual | SYSTEM HOW | System implementation and integration |
| L3 / L4 | Procedures & Records | Execution & proof | Sampled during implementation review |
Traceability rule: L3 → L2 → L1 → L0 → L00 No layer may override or contradict the layer above it.
Common auditor question:
“NSF/ANSI 455-2 requirements are centrally interpreted and mapped
in the Regulatory Crosswalk. Process Family Packs identify participating SOPs,
while completeness and audit criteria are governed at the system level.
Accuracy is validated through SOP approval, internal audit sampling,
and change control.”
Quality Unit (QU) Authority
- The Quality Unit operates independently from Operations and Supply Chain.
- QU holds non-delegable authority for batch release and disposition.
- QU approves deviations, investigations, CAPA, and change control.
- QU governs supplier qualification and outsourced activity oversight.
- QU approves L0–L2 controlled documents.
- QU governs data integrity and 21 CFR Part 11 compliance.
No operational role may override Quality Unit decisions related to quality, compliance, or data integrity.
Primary Audit Contact: Quality Unit Leader
This document is an informational audit-orientation aid and is not a controlled QMS governance or procedural document.