Section 1 — Family Summary

The Quality Control Operations (QCO) Family Pack defines the authority, independence, and decision rights required to satisfy the Quality Control requirements of 21 CFR Part 111 Subpart F.

QCO represents the operational embodiment of the Quality Unit (QU) as established in the L00 Quality Charter. It exists solely to define who holds final quality authority and how that authority is applied across the Quality Management System (QMS).

This Family Pack does not define execution activities, testing, sampling, procedures, workflows, or records. It establishes decision authority only.

Risk Tier Classification: CRITICAL.
Failure to preserve Quality Control authority compromises batch disposition, regulatory compliance, and enterprise inspection outcomes.

Section 2 — Purpose, Scope & Regulatory Basis

2.1 Purpose

The purpose of this Family Pack is to:

• Define non-delegable Quality Control authority
• Establish independence from Operations, Commercial, and Schedule pressure
• Clarify execution versus decision boundaries
• Prevent dilution, fragmentation, or override of quality decisions

2.2 Scope

This Family Pack applies to all quality-impacting decisions, including:

• Acceptance or rejection of materials, components, and finished products
• Batch disposition and product release
• Approval of deviations, investigations, and CAPA
• Authorization of rework, reprocessing, salvage, or destruction
• Invalidation or rejection of data, results, or records

2.3 Regulatory Basis

21 CFR Part 111 Subpart F requires manufacturers to establish Quality Control Operations with authority over quality-related decisions. Regulatory intent emphasizes authority and independence, not organizational structure or job titles.

QCO fulfills this requirement by governing quality decision authority across all execution domains within the QMS.

Section 3 — Quality Control Authority Model

Quality Control Operations (QCO) holds the highest and final authority for quality-related decisions within Sawgrass Nutra Labs.

3.1 Non-Delegable Authorities

• Final acceptance or rejection of materials, labels, packaging, and products
• Batch disposition and product release
• Approval of deviations, investigations, and CAPA
• Authorization of rework, reprocessing, salvage, or destruction
• Invalidation or rejection of data or results
• Authority to stop operations when quality requirements are not met

These authorities are non-delegable and shall not be overridden by Operations, Management, cost, schedule, or commercial considerations.

3.2 Role-Agnostic Authority

QCO authority is applied by designation and qualification, not by department name or headcount. Individuals exercising QCO authority do so as agents of the Quality Unit under controlled assignment.

Section 4 — Execution Authorization & Split-Duty Framework

QCO may authorize the execution of quality-controlled activities. Authorization permits data generation and verification only and does not transfer Quality Control authority, judgment, or decision rights.

4.1 Authorized Execution Roles

• Quality Assurance (QA) executes and administers the Quality Management System under QMS governance and QCO authority.
• Operational personnel may execute limited verification activities only when acceptance criteria are predefined, objective, and non-interpretive.

Execution authority is limited to performing activities exactly as defined. Execution roles may not interpret results, apply discretionary judgment, or determine disposition outcomes.

4.2 Split Operational Duty (SOD)

• Individuals may not verify work they personally executed
• Verification must follow predefined acceptance criteria
• Any result outside limits requires immediate escalation to QCO
• No execution role may approve release, disposition, deviations, or CAPA

4.3 Prohibited Delegation

• Product release authority may not be delegated outside QCO
• Disposition authority may not be delegated to executing personnel
• Deviation or CAPA approval may not be delegated
• Operational or commercial roles may not influence quality decisions

Definition of Limited Execution

For the purposes of the Quality Management System, limited execution is explicitly defined as the performance of predefined, objective verification or measurement activities using documented acceptance criteria, without interpretation, discretion, or decision-making authority.

• Limited execution permits data generation and direct comparison to documented limits only.
• Limited execution does not permit interpretation of results, evaluation of acceptability, or continuation decisions following failure.
• Limited execution does not confer authority to approve, reject, release, rework, or disposition material or product.
• Any result outside predefined acceptance criteria requires immediate escalation to Quality Control Operations.

Activities requiring judgment, interpretation, trending, risk evaluation, or disposition determination are not considered limited execution and are reserved exclusively for Quality Control Operations.

Section 5 — Escalation, Non-Override & Stop Authority

QCO retains unconditional authority to halt execution, prevent release, or require escalation when quality risk is identified.

5.1 Mandatory Escalation Triggers

• Out-of-specification or out-of-trend results
• Deviation from approved procedures
• Data integrity concerns
• Unapproved changes or undocumented actions

5.2 Non-Override Rule

Quality Control decisions shall not be bypassed, reversed, or implemented through alternate pathways. Any attempt to override QCO authority constitutes a systemic compliance failure.

5.3 Quality Event, Change Control & CAPA Reporting Authority

All Quality Events, Change Controls, and CAPA are subject to the non-delegable authority of Quality Control Operations (QCO).

• QCO retains final authority to determine classification, escalation, investigation scope, and disposition of quality events.
• QCO retains final authority to approve, reject, or require modification of Change Control and CAPA actions.
• No operational, commercial, or scheduling role may suppress, delay, reclassify, or close a quality event outside QCO authority.

The reporting packages, workflows, records, and documentation used to initiate and manage Quality Events, Change Control, and CAPA are defined and executed under Quality Assurance (QA) Family Packs and controlled procedures.

This document does not define reporting mechanisms or record formats. It defines authority only.

Section 6 — Governance Inheritance & Precedence

This Family Pack implements and enforces the authority model defined in the L00 Quality Charter. It does not redefine, replace, or supersede the Charter.

• All SOPs, WINs, and records inherit QCO authority
• Execution does not confer decision authority
• Conflicts resolve in favor of QCO authority

Section 7 — Explicit Exclusions

This Family Pack intentionally excludes:

• Procedures or Work Instructions
• Sampling or testing methods
• Record templates or Auditable Artifacts
• Execution workflows

Evidence of execution is governed by QA and operational Family Packs. This document defines authority only.

This document is an authoritative QCO Family Pack. It establishes Quality Control authority, execution boundaries, and governance precedence across the Sawgrass Nutra Labs QMS.