WIN Execution Guide — Recall Management

Non-Authoritative Execution Guide Notice
This WIN Execution Guide is non-authoritative and supports execution of controls defined in the QA Family Pack. Authority for recall intent, classification, regulatory thresholds, approval, and change control resides solely with the QA Family Pack and the Quality Management System (QMS).

Purpose

To support consistent execution of recall-related activities, ensuring potential or confirmed recall events are properly documented, escalated, supported, and tracked under formal QA governance.

Scope

This WIN Execution Guide applies to QA-supported recall activities, including recall initiation support, traceability verification, execution tracking, and documentation supporting recall decision-making and closure.

This Execution Guide does not define recall classification, recall class, regulatory notification criteria, or release authority. All recall decisions are governed by the QA Family Pack and executed under the authority of the Quality Control Officer (QCO).

Decision Authority

QA personnel and BPOs support recall execution and documentation but do not independently initiate, classify, or close recalls.

Family Pack Anchor

Section 6 — Auditable Artifacts (AA)

AA-QA-RECALL — Recall Record

This artifact documents recall initiation, scope, execution status, reconciliation, effectiveness checks, and formal closure.

Minimum evidentiary expectations include:

Recall trigger and initiation rationale
Affected product, lots, and quantities
Distribution traceability and customer lists
Execution and reconciliation records
Effectiveness verification and closure authorization

Auditor focus: confirmation that recalls are controlled, traceable, and formally authorized.

Section 7 — WIN (Control Requirements)

WIN-QA-RECALL

Governs the quality execution framework supporting recall activities.

Ensure recall events are documented and tracked.
Support traceability and reconciliation.
Escalate information to the QCO for decision-making.
Maintain auditable recall records.

Control outcome: recall activities are controlled, traceable, and governed under formal quality authority.

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 — Receive Recall Trigger Information

Receive recall trigger from complaints, deviations, regulatory inquiries, supplier notifications, or internal findings.
Document trigger source and timing.
Escalate immediately to the QCO.

Step 2 — Identify Affected Product and Lots

Compile product, lot, and quantity information.
Confirm manufacturing, packaging, and distribution status.
Ensure traceability completeness.

Step 3 — Support Distribution Traceability

Generate customer, distributor, and shipment lists.
Verify accuracy of distribution data.
Identify gaps or uncertainties and escalate.

Step 4 — Support Recall Execution Tracking

Track product returns, corrections, or field actions.
Document quantities recovered, corrected, or remaining.
Maintain reconciliation records.

Step 5 — Support Effectiveness Checks

Verify response rates and product accountability.
Document effectiveness check outcomes.
Escalate unresolved gaps to the QCO.

Step 6 — Document Recall Closure

Ensure all recall documentation is complete.
Record QCO closure authorization.
Link recall to CAPA, management review, or regulatory correspondence as required.