WIN Execution Guide — Reserve Samples

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 reserve sample requirements, disposition, use, and destruction resides solely with the QA Family Pack and the Quality Control Officer (QCO).

Purpose

To support consistent QA execution of reserve sample controls by ensuring finished goods reserve samples are properly identified, secured, maintained, accessed, and tracked in compliance with regulatory and quality system requirements.

Scope

This WIN Execution Guide applies to QA-supported reserve sample activities for finished goods, including:

This Execution Guide does not define reserve quantity requirements, testing methodology, or authorization to destroy or release reserve samples. Those decisions are governed by the QA Family Pack and executed under QCO authority.

Decision Authority

QA personnel execute verification, tracking, and escalation activities in support of QCO decision-making.

Family Pack Anchor

Section 6 — Auditable Artifacts (AA)

AA-QA-RESERVE — Reserve Sample Record

This artifact documents reserve sample identification, storage, access, and lifecycle status.

Minimum evidentiary expectations include:

Product, lot, and quantity retained
Date of reserve sample collection
Storage location and conditions
Access history and authorization
Final disposition and rationale

Auditor focus: confirmation that reserve samples are maintained, secured, and controlled throughout the product lifecycle.

Section 7 — WIN (Control Requirements)

WIN-QA-RESERVE

Governs QA oversight and execution of reserve sample controls.

Verify reserve samples are collected and labeled correctly.
Ensure secure storage under controlled conditions.
Track access, usage, and status changes.
Escalate deviations and support QCO disposition.

Control outcome: reserve samples remain intact, traceable, and available to support investigations, stability, or regulatory review.

Authority Statement:
The AA and WIN above are authoritative and maintained under formal change control within the QA Family Pack. This Execution Guide supports execution only.

BPO-Owned Execution Zone — WIN Execution Guide

Step 1 — Verify Reserve Sample Collection

Confirm reserve samples were collected per approved batch and release records.
Verify product name, lot number, quantity, and collection date.
Any missing or incorrect reserve samples are escalated via a QMS Quality Event.

Step 2 — Verify Labeling & Identification

Confirm reserve sample labels are legible, complete, and durable.
Ensure labels match batch records and system records.
Label discrepancies are documented and escalated.

Step 3 — Verify Storage & Environmental Controls

Confirm reserve samples are stored in designated, secured locations.
Verify storage conditions align with product requirements.
Environmental excursions are escalated through the QMS.

Step 4 — Control Access to Reserve Samples

Ensure reserve samples are not accessed without documented authorization.
Requests for reserve sample use are routed to the QCO.
Unauthorized access triggers immediate escalation.

Step 5 — Support Authorized Use or Investigation

Document QCO-approved reserve sample access or removal.
Maintain traceability to investigation, stability, or regulatory activity.
Ensure partial use or depletion is accurately recorded.

Step 6 — Maintain Reserve Sample Lifecycle Records

Ensure reserve sample records remain current and complete.
Track remaining quantities and retention timelines.
Support QCO-authorized destruction at end of retention period.

WIN Execution Guide — Reserve Sample Management