Quality Control Laboratory (QCL)

1. Purpose & Enterprise Role

The Quality Control Laboratory (QCL) Process Family governs WHAT-level controls related to sampling, organoleptic evaluation, identity testing, and laboratory data management for materials tested internally or by qualified external laboratories.

QCL ensures that components, in-process materials, packaging, labels, and finished products are properly sampled, protected, identified, tested, and documented prior to use or release.

QCL does not make final product release or disposition decisions (QA) and does not perform in-process execution checks (QC-IPC). It provides verified laboratory and sampling evidence supporting downstream quality decisions.

2. Position Within the Business Process Architecture

QCL functions as a Quality Control Process Family operating under QA governance and independent oversight. QCL interfaces with Production, Warehouse, Procurement, and external laboratories to ensure integrity of sampling, testing, and data flows.

• Executes laboratory and sampling controls defined in QCL SOPs and WINs
• Operates independently from manufacturing and packaging execution
• Supports QA release and disposition decisions with verified data
• Maintains chain-of-custody and laboratory data integrity

3. Scope of QCL Oversight

QCL oversight applies to all laboratory-related activities that impact material identity, suitability, and compliance with specifications.

QCL Oversight Domains

• Representative sampling of components, WIP, and finished goods
• Organoleptic evaluation and internal identity verification
• Management of samples sent to external laboratories
• Chain-of-custody controls and documentation
• Review and verification of external laboratory results and COAs
• Laboratory data integrity and record lifecycle management

QCL activities generate GMP laboratory records that form part of the official quality evidence supporting QA decisions.

4. Governance & Decision Authority

QCL holds authority to perform sampling, testing, documentation, and data review activities but does not hold final authority for product release, rejection, or specification approval.

• Authority to perform and document laboratory and sampling activities
• Authority to escalate atypical results, OOS, or data integrity concerns
• No authority for final release or disposition decisions
• All escalations and final decisions route through QA

5. Risk Classification & Control Model

QCL is classified as HIGH RISK due to its direct impact on identity confirmation, test validity, data integrity, and regulatory compliance.

• Non-representative or improper sampling
• Invalid or incorrect identity testing
• Compromised chain-of-custody
• Acceptance of invalid or incomplete external lab results
• Laboratory data integrity failures
• Inadequate documentation supporting test results

6. Evidence, Records & Outputs

QCL produces auditable laboratory evidence demonstrating compliance with sampling, testing, and data integrity requirements.

• Sampling records and chain-of-custody documentation
• Organoleptic and identity testing records
• External laboratory submission and result records
• COA verification and laboratory data review records
• OOS and investigation support documentation

7. QCL Deliverables, Authority & Required Evidence

The QCL Process Family produces laboratory and sampling deliverables defined and governed by the QCL Process Family Pack.

Each deliverable is defined by a single authoritative SOP and supported by contemporaneous auditable artifacts demonstrating execution, review, and escalation.

1. Representative sampling and chain-of-custody governance
   Authoritative source: QCL Process Family Pack
   System of Record (SoR): TBD
2. Organoleptic evaluation and internal identity testing
   Authoritative source: QCL Process Family Pack
   System of Record (SoR): TBD
3. External laboratory coordination and result verification
   Authoritative source: QCL Process Family Pack
   System of Record (SoR): TBD
4. Laboratory data integrity and record lifecycle management
   Authoritative source: QCL Process Family Pack
   System of Record (SoR): TBD
5. OOS and investigation support for laboratory data
   Authoritative source: QCL Process Family Pack
   System of Record (SoR): TBD

Systems of Record identified above support execution and evidence capture only. They do not define QCL requirements, scope, or decision authority, which remain governed by the QCL Process Family Pack and associated SOPs.

The deliverables listed above represent the complete set of QCL Process Family deliverables as defined in the QCL Process Family Pack. No additional QCL deliverables exist outside this controlled scope.