Quality Control (QC) Governance Framework

This document defines the Quality Unit–owned governance framework for Quality Control (QC). QC establishes the authoritative acceptance criteria, control limits, and decision rules used to determine conformance, suitability, and disposition across the enterprise.

Quality Control does not perform operational execution, testing, or sampling. QC defines what must be met and supports independent Quality Unit decision-making under the Quality Management System (QMS).

Key Principle:
QC is a rule-defining and decision-authority construct, not an execution function.

1. Quality Control Role & Authority

Quality Control exists as a governance layer within the QMS. It defines the enterprise-level criteria and logic used by the Quality Unit to evaluate product quality, process performance, and material suitability.

QC operates independently from operational execution and does not own or perform manufacturing, laboratory testing, or material handling activities. Those activities are executed by Business Domains and Quality Assurance in accordance with QC-defined requirements.

Defines acceptance criteria and control limits
Defines decision rules for conformance and nonconformance
Supports independent Quality Unit decisions
Remains organizationally and functionally independent from execution

2. QC Requirement Authority

Quality Control requirement authority is exercised through the Quality Control Requirements Index (QC-REQ-IDX).

QC-REQ-IDX defines which document types are authorized to contain Quality Control acceptance criteria, limits, and decision logic. Documents not listed in QC-REQ-IDX are not valid sources of QC requirements.

Authoritative QC requirements are maintained in the Authoritative Quality Specifications Library and referenced by Quality Assurance procedures and Business Domain execution documents.

3. QC Decision & Disposition Authority

The Quality Unit, operating through Quality Control Operations (QCO), retains independent, non-delegable authority for quality-impacting decisions based on reviewed evidence and QC-defined criteria.

Material acceptance, rejection, or disposition
Product release or non-release decisions
Approval or rejection of rework or reprocessing
Final quality determinations independent of operations

Quality Assurance may execute review activities and recommend outcomes; however, final quality decisions remain under Quality Unit authority.

4. QC Risk Profile & Escalation Model

Quality Control is classified as CRITICAL RISK due to its direct impact on product quality, regulatory compliance, and patient safety.

QC-defined escalation thresholds require Quality Unit review when:

Acceptance criteria or control limits are exceeded
Repeated excursions or adverse trends are identified
Data integrity concerns are present
Unapproved or uncontrolled changes impact quality requirements

QCO (Quality Unit Authority)
 ├── QMS (governance)
 ├── QC  (acceptance criteria & decision rules)
 └── QA  (execution & evidence generation)

Governance Notice:
This document provides an orientation-level description of Quality Control governance, authority, and decision frameworks within the Sawgrass Nutra Labs Quality Management System. Authoritative Quality Control requirements are defined exclusively through QC-approved specifications and governed under the QMS.