Quality Control Requirements – Domain Applicability Crosswalk

Document Type: Internal Applicability Crosswalk (QMS – Governance)

Authoritative Source: Quality Control Requirements Index (QC-REQ-IDX)

Owner: Quality Control Operations (QCO)

Applies To: All Business Domains performing or supporting GMP-relevant activities

Purpose:
Identifies Business Domains that execute or support Quality Control Requirements defined in QC-REQ-IDX. Establishes applicability and execution boundaries only. This document does not define, restate, or modify Quality Control requirements.

Authority Model:

Quality Control Operations (QCO) holds non-delegable authority for establishment, approval, and modification of Quality Control requirements and final disposition decisions.
Business Domains may execute Quality Control activities when trained and authorized under the Quality Management System.
Quality Assurance (QA) provides independent review and compliance oversight.

Domain Classification:

QC-Executing Domain – Performs Quality Control activities generating acceptance inputs.
QC-Enabling Domain – Generates data supporting Quality Control decisions.
QMS-Governed Domain – Subject to QMS controls; does not execute Quality Control requirements.

Domain Applicability Mapping

Marketing

Classification: QMS-Governed Domain

Sales

Classification: QMS-Governed Domain (Release-Restricted)

QC-REQ ID	Quality Control Requirement Title
QC-DISP-002	Release Decision Criteria

Procurement

Classification: QC-Enabling Domain

QC-REQ ID	Quality Control Requirement Title
QC-MAT-003	Supplier Qualification Status Impact
QC-CHG-002	Impact & Risk Assessment

Material Readiness

Classification: QC-Executing Domain

QC-REQ ID	Quality Control Requirement Title
QC-MAT-001	Component Identity Verification
QC-MAT-002	Component Purity & Contaminant Acceptance
QC-MAT-003	Supplier Qualification Status Impact
QC-SAMP-001	Sampling Plan Governance
QC-SAMP-002	Lot Acceptance Decision Criteria
QC-ANL-004	Outsourced Testing Governance
QC-DI-002	Record Completeness & Traceability
QC-DISP-001	Lot Disposition Authority

Warehouse

Classification: QC-Executing Domain

QC-REQ ID	Quality Control Requirement Title
QC-ENV-001	Warehouse Environmental Conditions
QC-ENV-004	Temperature-Controlled Storage
QC-ENV-005	Retained Sample Storage
QC-MAT-004	Material Storage & Handling Condition
QC-DISP-003	Rejection & Quarantine Governance

Manufacturing

Classification: QC-Executing Domain

QC-REQ ID	Quality Control Requirement Title
QC-ENV-002	Production Environmental Conditions
QC-IPC-002	In-Process Acceptance Criteria
QC-IPC-004	In-Process Deviation Response

Packaging

Classification: QC-Executing Domain

QC-REQ ID	Quality Control Requirement Title
QC-ENV-003	Packaging Environmental Conditions
QC-MAT-005	Packaging Component Quality
QC-IPC-002	In-Process Acceptance Criteria

Technical / Process Support Testing

Classification: QC-Enabling Domain

QC-REQ ID	Quality Control Requirement Title
QC-ANL-001	Analytical Method Suitability
QC-ANL-002	Instrument & System Suitability
QC-ANL-003	Measurement Uncertainty Impact
QC-IPC-001	Critical Process Parameter Governance
QC-IPC-003	Process Monitoring & Trending

Sanitation

Classification: QC-Enabling Domain

QC-REQ ID	Quality Control Requirement Title
QC-FAC-002	Facility Cleanliness
QC-FAC-003	Facility Drain Design & Maintenance
QC-UTIL-003	Wastewater & Drainage Systems

Maintenance

Classification: QC-Enabling Domain

QC-REQ ID	Quality Control Requirement Title
QC-UTIL-001	Compressed Air Quality
QC-UTIL-002	Water Quality Classification
QC-UTIL-004	Backflow & Cross-Connection Prevention
QC-CHG-003	Validation & Requalification Governance

Environmental Health & Safety

Classification: QC-Enabling Domain

QC-REQ ID	Quality Control Requirement Title
QC-FAC-001	GMP Area Classification & Zoning
QC-UTIL-003	Wastewater & Drainage Systems
QC-CHG-002	Impact & Risk Assessment

Information Technology

Classification: QC-Enabling Domain

QC-REQ ID	Quality Control Requirement Title
QC-DI-004	Electronic Record & System Governance
QC-CHG-003	Validation & Requalification Governance

Training & Learning

Classification: QMS-Governed / QC-Enabling Domain

QC-REQ ID	Quality Control Requirement Title
QC-CHG-004	Change Effectiveness Review