QC-REQ-IDX Orientation
This page provides orientation and explanatory context for the Quality Control Requirements Index (QC-REQ-IDX). It is intended to support inspections, audits, and onboarding of Quality leadership by explaining how Quality Control requirements are structured and governed.
This page is explanatory only. It does not define requirements, acceptance criteria, or procedures and is not a controlled GMP specification.
1. What Is the QC-REQ-IDX?
The QC-REQ-IDX is a master index of Quality Control requirements. Each entry in the index links to a single authoritative Quality Control specification that defines acceptance criteria and decision authority for a specific quality domain.
The QC-REQ-IDX does not replace SOPs, records, or systems. Instead, it provides a structured map of what must be true for quality decisions to be made.
2. What a QC-REQ Represents
Each QC-REQ ID represents a discrete Quality Control requirement governed by the Quality Unit.
- Each QC-REQ links to one authoritative specification
- The specification defines acceptance criteria and decision logic
- Procedures and systems implement the requirement
- Records provide evidence of compliance
QC-REQs are intentionally written at a governance level to ensure clarity of authority and consistency across operations.
3. Relationship Between Specifications, SOPs, and Records
The Quality Control documentation hierarchy is structured as follows:
- Specifications define requirements, acceptance criteria, and decision authority
- SOPs and procedures define how requirements are operationally implemented
- Records and data provide evidence that requirements were met
Specifications do not describe execution steps, and SOPs do not redefine requirements.
5. Change and Continuous Improvement
QC-REQ specifications are subject to formal change control. Changes are evaluated for impact and risk, supported by appropriate validation or verification, and reviewed for effectiveness.
Continuous improvement activities are governed to ensure that enhancements do not introduce uncontrolled risk or erode compliance.
6. How This Page Is Used During Inspection
This orientation page may be referenced to provide context on how Quality Control requirements are organized and governed. Inspectors may then select specific QC-REQs, specifications, SOPs, or records for detailed review.