QC-REQ-IDX Governance Index • Decision Accountability & Regulatory Anchors
Operations execute GMP work, QA administers QMS workflows (evidence routing, traceability, and record control), and the Quality Unit (QU) provides independent final authority. Under 21 CFR Part 111, required quality control operations must be defined, controlled, and evidenced — and the decision points below are non-delegable Quality Unit decisions.
Delegation of execution does not constitute delegation of decision authority. The Quality Unit retains full responsibility for evaluation, approval, and disposition of all regulated quality decisions.
QU Direct Execution Required indicates activities that must be physically performed or directly executed by the Quality Unit and cannot be fully delegated due to the need for independent evaluation, final disposition, or regulatory accountability.
| Decision Point | QU Execution Required | Regulatory Anchor |
|---|---|---|
| Upstream Controls (Specifications, Methods, Suppliers) | ||
| Specifications approval | No | 21 CFR 111.70, 111.73 |
| Test methods & examination approval | No | 21 CFR 111.75, 111.320 |
| Supplier qualification & COA reliance approval | No | 21 CFR 111.75 |
| System & Manufacturing Setup | ||
| Calibration & system control approval | No | 21 CFR 111.117 |
| MMR approval | No | 21 CFR 111.205, 111.210 |
| Production & Disposition Control | ||
| Material review & disposition | Yes | 21 CFR 111.113 |
| Batch record review & final release | Yes | 21 CFR 111.113 |
| Reprocessing / rework approval | Yes | 21 CFR 111.103 |
| Quality System Decision Controls | ||
| Investigation conclusions & CAPA approval | Yes | 21 CFR 111.113, 111.140 |
| Complaint evaluation | Yes | 21 CFR 111.560 |
| Returned product disposition | Yes | 21 CFR 111.535 |
| Records & Governance | ||
| Record retention & control | No | 21 CFR 111.605 |
Non-delegation All decisions listed above must be made, documented, and attributable to the Quality Unit.
Execution principle Activities may be delegated; however, execution involving regulatory judgment must be performed under direct Quality Unit control.
Scope This index defines decision authority and execution boundaries. Delegable execution activities are defined in the corresponding document.