PKG – Packaging Business Process
The Packaging (PKG) business process governs the controlled labeling, packaging, and final presentation of manufactured product to ensure correct identity, labeling accuracy, traceability, and readiness for distribution.
Packaging Operating Model
The Packaging Operating Model below illustrates how manufactured product and approved packaging components are combined, labeled, inspected, and documented to produce correctly identified and traceable finished goods.
Manufactured product released from Production
Approved labels and packaging components
Packaging instructions / work order
Line clearance, label verification, and component setup
Application of labels, packaging, and assembly per approved instructions
Label checks, reconciliation, inspections, and monitoring
Contemporaneous documentation of packaging activities and outcomes
Labeled and packaged finished goods
Executed packaging batch record
Statused output for Warehousing or Distribution
Packaging activities are initiated only after receipt of manufactured product and approved labeling components. Packaging is a batch-bound process and requires strict reconciliation of all labels and components.
Process Interfaces & Boundaries
- Upstream: Production (PROD) – manufacture and transfer of product for packaging
- Downstream: Warehousing (WH) or Distribution – receipt of labeled finished goods
- Governance: QMS defines labeling and documentation controls; Packaging executes approved instructions
Quality Control Requirements Executed During Packaging
Packaging is classified as a QC-Executing Domain. Packaging activities execute defined Quality Control Requirements in accordance with the Quality Control Requirements Index (QC-REQ-IDX) under the authority of Quality Control Operations (QCO).
- QC-ENV-003 – Packaging Environmental Conditions: Packaging maintains defined environmental controls necessary to preserve product integrity during labeling and packaging operations.
- QC-MAT-005 – Packaging Component Quality: Packaging verifies and controls packaging components to prevent mix-ups, mislabeling, or use of non-conforming materials.
- QC-IPC-002 – In-Process Acceptance Criteria: Packaging executes and documents in-process inspection and acceptance criteria during packaging activities.
Final lot disposition and release decisions remain governed by the applicable QC-DISP requirements. Packaging executes defined in-process controls but does not independently determine final product disposition outside established authority.
Deviations, labeling discrepancies, or reconciliation failures identified during Packaging activities are documented and escalated through the Quality Event process in accordance with the enterprise Quality System.