Document ID: WIN-QA-SHIP-RELEASE-EG
Version: 1.0
Last Updated: 2026-01-23
WIN Execution Guide — Shipment Release
Non-Authoritative Execution Guide Notice
This WIN Execution Guide is non-authoritative and supports execution of controls
defined in the applicable QA Family Pack. Authority for control intent,
requirements, approval, and change control resides solely with the QA Family Pack
and the Quality Management System (QMS).
Purpose
To support consistent execution of shipment release activities by ensuring that
only accurate, approved, and properly documented materials are released for outbound
distribution in compliance with quality and regulatory requirements.
Scope
This WIN Execution Guide applies to QA-supported shipment release activities,
including verification, evidence preparation, escalation, and documentation
supporting outbound distribution.
- Verification of shipment accuracy and material identity
- Confirmation of approved material status prior to shipment
- Preparation and review of required shipment documentation
- Escalation of discrepancies through the QMS Quality Event process
- Documentation supporting formal quality disposition
This Execution Guide does not define quality decision authority, disposition
criteria, or release approval rights. Those authorities are governed by the QA Family
Pack and exercised by the Quality Control Officer (QCO) or formally delegated QA
leadership.
Decision Authority
The Quality Control Officer (QCO) functions as the formal decision
authority for shipment release determinations governed under the QA Family Pack.
QA personnel may perform evidence review, verification, and preliminary assessment.
Final disposition, release authorization, rejection, or escalation decisions are
rendered exclusively by the QCO or formally delegated QA leadership as defined in the
QA Family Pack.
Family Pack Anchor
Section 6 — Auditable Artifacts (AA)
AA-QA-SHIP-RELEASE — Shipment Release Authorization
This artifact documents verification, review, and formal quality authorization of
outbound shipments.
Minimum evidentiary expectations include:
- Material identity, lot, and shipment details
- Confirmation of approved status prior to shipment
- Completed shipping documentation
- Quality disposition and authority attribution
- Date/time and responsible personnel
Auditor focus: confirmation that distribution occurs only after formal quality
authorization.
Section 7 — WIN (Control Requirements)
WIN-QA-SHIP-RELEASE
Governs the quality review and authorization framework for outbound shipment release.
- Verify shipment accuracy and material identity.
- Confirm approved status and documentation completeness.
- Escalate discrepancies through the Quality Event process.
- Support formal disposition by the QCO.
Control outcome: shipments are released only after verified compliance and formal
quality authorization.
Authority Statement:
The AA and WIN above are authoritative and maintained under formal change control
within the QA Family Pack. This Execution Guide reproduces them verbatim for
execution support only.
BPO-Owned Execution Zone — WIN Execution Guide
Step 1 — Verify Shipment Accuracy and Material Identity
- Verify shipment contents, material identity, lot numbers, and quantities against the shipping order.
- Confirm physical labels match system and shipping documentation.
- Any mismatch is stopped immediately and a QMS Quality Event is initiated.
Step 2 — Confirm Approved Material Status
- Verify all materials included in the shipment are in an approved or authorized-for-shipment status.
- Materials not meeting status requirements are not released and require escalation.
Step 3 — Review Shipment Documentation
- Confirm required documentation (packing list, bill of lading, certificates) is complete and accurate.
- Ensure documentation aligns with shipment contents and destination.
- Documentation gaps are addressed or escalated via a Quality Event.
Step 4 — Prepare Evidence for Quality Disposition
- Compile verified shipment data and documentation.
- Ensure traceability to materials, lots, and destination.
- Submit evidence package for QCO review.
Step 5 — QCO Disposition & Authorization
- The QCO reviews submitted evidence.
- The QCO renders formal disposition (release, hold, reject, or escalate).
- Disposition authority and rationale are documented in the AA.
Step 6 — Maintain Shipment Traceability
- Ensure shipment records are retained and accessible per record-retention requirements.
- Confirm linkage to batch, customer, and downstream distribution records.
- Traceability gaps are escalated via the QMS.
Authority Reminder
This WIN Execution Guide is non-authoritative and exists solely to support execution.
The QA Family Pack and QCO remain the sole sources of quality decision authority.
Consistency Assessment (Non-Authoritative)
Based on the provided text, the execution steps above are consistent with the intent
and control framework defined in the QA Family Pack. No conflicts identified.