QC-REQ-IDX Governance Index • Execution vs Decision Authority
Certain GMP execution and administrative activities may be performed by QA or Operations; however, the Quality Unit (QU) retains full responsibility for oversight, review, approval, and final disposition decisions.
Delegation of execution does not constitute delegation of decision authority.
All delegated activities must be performed under defined procedures, with complete traceability, and are subject to Quality Unit review and approval where required under 21 CFR Part 111.
| Delegable Activity | Expectation (Execution Requirements + QU Oversight) |
|---|---|
| Batch record preparation & compilation | QA or Operations may prepare and compile BPRs, ensure completeness, and assemble supporting documentation. The Quality Unit performs final review and approval prior to release. |
| Evidence routing & QMS workflow administration | QA administers workflows, ensures traceability, routes records for review, and verifies completeness. The Quality Unit reviews and approves all required decision points. |
| Supplier documentation review & qualification support | QA may collect, review, and assemble supplier qualification documentation. The Quality Unit approves supplier qualification status and COA reliance decisions. |
| Deviation documentation & investigation support | QA or Operations may document deviations, perform investigations, and collect supporting data. The Quality Unit evaluates impact and makes final disposition decisions. |
| Drafting specifications, procedures, and records | QA or technical functions may draft controlled documents and specifications. The Quality Unit reviews and approves all GMP-critical documents prior to use. |
| Testing, inspection, and in-process monitoring | Operations or laboratory personnel may perform testing and monitoring activities per approved methods. The Quality Unit reviews results and determines acceptance and disposition where required. |
| Data collection & record generation | Personnel may generate and record GMP data in real time. The Quality Unit ensures data integrity, review, and approval in accordance with established procedures. |
Governance principle Delegated activities must be executed under controlled procedures with full traceability. The Quality Unit retains final authority and accountability for all regulated decisions.
Scope This document defines delegable execution activities and required oversight. Non-delegable decision authority is defined in the corresponding Quality Unit Decision Index.