FDA Inspection — Quality System Architecture Explanation

Organization: Sawgrass Nutra Labs (SNL)
Regulatory Scope: 21 CFR Part 111 (Dietary Supplements)

Purpose

This document explains how SNL structures its Quality architecture in alignment with 21 CFR Part 111 and reflects the layered model presented in the Quality System Architecture diagram.

This document is informational only and does not establish or modify controlled procedures, specifications, or governance requirements.

1. Quality Unit (QU) — Final Authority Layer

SNL’s Quality Unit (QU) holds independent final quality authority.

The QU is an independent quality authority function responsible for required regulatory quality decisions and oversight, separate from operational GMP execution.

In accordance with 21 CFR 111 Subpart F, the QU holds final, non-delegable authority for quality-impacting regulatory decisions.

• Approval or rejection of components and in-process materials
• Batch record review and disposition
• Approval of deviations, investigations, and CAPA
• Authorization of rework, reprocessing, or material disposition
• Final product release decisions

The QU provides independent oversight across all GMP operations.

2. Authority Applied Using QC and QMS

Quality Controls (QC – Control Framework)

At SNL, Quality Controls (QC) represent the defined regulatory control framework — not an organizational department or function.

QC refers to the defined decision rules and acceptance criteria (the “rules layer”) that specify what decisions must occur and what criteria apply.

QC defines rules that govern quality, including:

• Acceptance criteria and specifications
• Sampling and testing requirements
• Environmental and facility controls
• In-process and analytical controls
• Stability and lifecycle requirements
• Disposition and release decision rules
• Data integrity and record requirements

Quality Management System (QMS – Governance Framework)

The Quality Management System (QMS) provides the structured governance framework through which QC rules are implemented, controlled, and monitored for effectiveness.

• Supplier qualification and approved supplier list
• Material status control (quarantine / released / rejected)
• Deviation, CAPA, and Change Management processes
• Records management and data integrity (21 CFR 111 Subpart P • ALCOA+)
• Audit and system effectiveness oversight

QMS governs both operational GMP execution and quality system processes.

3. Operational Execution Layer

GMP activities are executed by Operations within defined Process Families:

• Warehousing (WH)
• Production (PROD)
• Packaging (PKG)
• Sanitation (SAN)

Operations execute GMP activities under QMS governance. Execution does not transfer Quality decision authority.

4. Quality System Process Families (Administered by QA under QU Authority)

Quality system processes are administered by Quality Assurance (QA) under QU authority.

QA does not execute GMP operations.

QA administers and executes the quality system process families under QU authority, including:

• Deviation Lifecycle Management
• Quality Event Management
• CAPA Management
• Change Management
• Audit Management
• Training & Qualification

These processes enable independent oversight, escalation, and lifecycle control of quality events.

Execution vs. Authority

• Operations execute GMP activities.
• QA administers and executes the quality system processes.
• QA oversight is independent of Operations execution.
• QC defines the decision rules and acceptance criteria.
• QMS governs the system structure and effectiveness oversight.
• Final authority remains with the QU.

Summary for FDA Investigators

• There is one independent Quality Unit with final quality authority.
• Quality Controls represent the rules framework, not an organization.
• The QMS governs both operations and quality system processes.
• QA administers and executes the quality system under QU authority.
• Execution does not equal decision-making authority.
• This structure complies with 21 CFR Part 111.

If asked, “Who makes the quality decision?” — the answer is: The QU, applying defined QC decision rules within the QMS.

This document is inspection-support material and does not replace controlled QMS procedures, specifications, or records.