FDA Inspection — Quality System Architecture Explanation

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

Purpose of This Explanation

This document provides a concise explanation of how Sawgrass Nutra Labs has structured its Quality Management System (QMS) to meet the requirements of 21 CFR Part 111, with specific focus on:

• Quality Control authority
• Quality Assurance execution
• Process Family governance
• SOP and Work Instruction inheritance

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

Quality Unit Structure

Sawgrass Nutra Labs operates under a single, independent Quality Unit, referred to internally as Quality Control Operations (QCO).

In accordance with 21 CFR 111 Subpart F, the Quality Unit retains non-delegable responsibility and authority for all quality-impacting decisions.

This includes, but is not limited to:

• Approval or rejection of components, in-process materials, and finished products
• Review and approval of batch production and control records
• Approval of deviations, investigations, and CAPA
• Authorization of reprocessing, rework, or disposition activities
• Final product release decisions

The Quality Unit operates independently from Manufacturing, Packaging, Warehouse, and Supply Chain functions.

Separation of Governance, Control, and Execution

The QMS is intentionally structured into distinct layers to ensure independence, consistency, and regulatory compliance:

• QMS Governance: Defines enterprise-wide rules, escalation paths, documentation controls, risk management, audits, and management review.
• Quality Control (QC): Defines acceptance criteria, control limits, decision rules, and quality requirements.
• Quality Assurance (QA): Executes QC-defined requirements through approved SOPs, Work Instructions (WINs), and records under QMS governance.

Execution of activities does not transfer Quality Control decision authority.

Process Family Pack Model

Operational controls are organized into Process Family Packs (e.g., Warehouse, Production, Packaging).

Each Family Pack is a controlled SOP bundle that includes:

• WHAT-level SOP requirements
• HOW-level Work Instructions (WINs)
• Defined Auditable Artifacts (records)

Family Packs inherit Quality Control authority explicitly and do not redefine or dilute Quality Unit decision rights.

Quality Control Authority Inheritance

Every Process Family Pack includes a Quality Control Authority & Governance Inheritance statement establishing that:

• Quality Control responsibility and authority are retained by the Quality Unit
• Execution by non-Quality personnel does not constitute decision-making authority
• All quality-impacting approvals, releases, and dispositions remain under Quality control
• In the event of conflict, Quality Control authority prevails

Execution by Non-Quality Functions

Certain quality-governed activities (e.g., receiving checks, environmental monitoring, material handling) may be executed by trained personnel outside the Quality Unit.

For regulatory purposes:

• These personnel act as agents of the Quality Unit
• Acceptance criteria, escalation, investigation, and disposition remain governed by Quality procedures
• No non-Quality function is authorized to independently approve, release, or disposition product

This execution model is consistent with FDA expectations and industry practice.

Records and Evidence

Execution of activities generates controlled Auditable Artifacts that:

• Comply with ALCOA+ data integrity principles
• Are reviewed under Quality-governed processes
• Support traceability, investigations, and batch release decisions

Records demonstrate execution; authority remains with the Quality Unit.

Summary for FDA Investigators

• There is one independent Quality Unit
• Quality Control authority is not delegated
• SOPs and WINs inherit Quality authority through controlled Family Packs
• Execution does not equal decision-making
• This structure complies with 21 CFR Part 111

If asked, “Who makes the quality decision?” — the answer is always: Quality Control.

This document is an inspection-support explanation and does not replace controlled QMS governance, SOPs, or records.