This document defines the governance, authority, independence, and accountability of the Quality Unit (QU) within the Sawgrass Nutra Labs Quality Management System (QMS).
This document establishes authority and governance. It does NOT define procedures, work instructions, or execution details.
The purpose of this document is to:
This document supports compliance with 21 CFR Part 111, including Subpart F (Quality Control).
21 CFR Part 111 requires dietary supplement manufacturers to establish and maintain Quality Control Operations with authority over quality-related decisions affecting components, in-process materials, packaging, labels, and finished dietary supplement products.
Regulations emphasize required authority and independence rather than organizational titles or department size.
The Quality Unit fulfills this regulatory intent by governing Quality Control Operations and the Quality Management System.
The Quality Unit (QU) is the highest authority for quality governance within Sawgrass Nutra Labs.
Quality Unit authority is non-delegable and may not be overridden by Operations, Management, schedule, or cost considerations.
Quality Control Operations (QCO) are the quality control functions required under 21 CFR Part 111 Subpart F.
The Quality Unit governs Quality Control Operations by:
Quality Control Operations operate under written procedures approved and governed by the Quality Unit.
The Sawgrass Nutra Labs Quality Management System (QMS) provides the structural and governance framework through which quality authority, accountability, and oversight are defined and maintained.
The QMS establishes:
Quality Control Operations perform the regulated quality control functions required under 21 CFR Part 111 Subpart F, including:
QCO operates under the authority and oversight of the Quality Unit.
Quality Assurance functions as the administrative and execution vehicle for quality systems.
QA may perform Quality Control Operations activities, provided that:
Quality Control authority is not divided between QMS, QCO, or QA.
The QMS defines governance. QCO performs regulated quality control functions. QA supports execution under Quality Unit oversight.
Quality Unit decisions shall not be overridden, bypassed, or influenced by Operations, Management, or Commercial interests.
Management is responsible for ensuring that the Quality Unit is adequately resourced, trained, and empowered to:
This document establishes governance and authority.
In the event of conflict between this document and lower-level procedures or work instructions, the authority defined herein shall prevail.
This document does not replace SOPs or specifications, but defines the authority under which they are approved and executed.
This Quality Unit Governance & Authority document ensures that quality authority within Sawgrass Nutra Labs is:
It forms the foundation for a compliant, durable, and inspection-ready Quality Management System.