This document provides a narrative explanation of the structure, intent, and interaction of the Sawgrass Nutra Labs Quality Management System (QMS). It is designed to orient employees, auditors, and leadership to how the QMS is organized and audited.
This document does NOT establish requirements, controls, or procedures. It explains how the QMS is constructed and navigated.
The QMS Architecture & Overview exists to explain:
It supports—but does not replace—the Quality Policy, Governance Charter, Governance Foundation, Operating Model, or Quality Manual.
The Sawgrass Nutra Labs QMS is organized using an inheritance-based architecture in which each layer has a distinct purpose. The separation of layers is intended to prevent overlap and support clear audit boundaries.
Defines leadership commitment, Quality Unit independence, and the purpose of the QMS. Narrative and principle-based.
Defines mandatory enterprise governance rules, authorities, data integrity expectations, supplier governance, and document architecture.
Maps regulatory requirements (21 CFR 111, 21 CFR 11, NSF/ANSI 455-2) to internal governance and controls. Contains mappings only.
Defines process families, organizational structure, system architecture, RACIs, and workflow interactions.
Explains how governance rules are implemented across the system and how process families interact to meet requirements.
Defines step-by-step execution of activities.
Provides objective evidence that activities were executed as required.
Each QMS layer is audited according to its defined purpose. Auditors must not expect content that belongs in a different layer.
This QMS Architecture & Overview provides the narrative clarity that binds the entire Quality Management System together. It ensures that every document, process, and record exists in the correct layer with the correct purpose—supporting a compliant, auditable, and durable QMS.