Document ID: WIN-QA-SAMPLING-EG
Version: 1.0
Last Updated: 2026-01-23
WIN Execution Guide — Sampling Program Oversight
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 sampling requirements, acceptance
criteria, approval, and change control resides solely with the QA Family Pack
and the Quality Management System (QMS).
Purpose
To support consistent QA oversight of sampling activities by ensuring sampling
plans, execution evidence, and traceability meet approved requirements prior to
testing, disposition, or release.
Scope
This WIN Execution Guide applies to QA-supported sampling oversight activities
across Receiving, Production, Packaging, Warehouse, Stability, and External
Testing programs.
- Verification of approved sampling plans
- Confirmation of sampling authorization and traceability
- Review of sampling documentation and chain-of-custody
- Escalation of sampling deviations or gaps
- Support for quality disposition decisions
This Execution Guide does not define sampling techniques, quantities,
methods, or test procedures. Those requirements are governed by QC rules,
validated methods, and approved operational instructions.
Decision Authority
The Quality Control Officer (QCO) is the sole authority for:
- Approval of sampling program adequacy
- Acceptance of sampling deviations or justifications
- Escalation to investigation, CAPA, or rejection
QA personnel perform verification and escalation support but do not approve
sampling exceptions or deviations independently.
Family Pack Anchor
Section 6 — Auditable Artifacts (AA)
AA-QA-SAMPLING — Sampling Program Record
This artifact documents approved sampling plans, execution evidence, and QA
oversight supporting sampling activities.
Minimum evidentiary expectations include:
- Approved sampling plan reference
- Sample identity, lot, and status
- Chain-of-custody documentation
- Verification of authorized sampling
- Escalations or deviations (if applicable)
Auditor focus: confirmation that sampling is planned, authorized, traceable, and
governed.
Section 7 — WIN (Control Requirements)
WIN-QA-SAMPLING
Governs QA oversight and verification of sampling activities.
- Verify approved sampling plans are in place.
- Confirm sampling authorization and traceability.
- Escalate deviations or unauthorized sampling.
Control outcome: samples submitted for testing are representative, authorized,
and traceable.
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 Sampling Plan Authorization
- Confirm an approved sampling plan exists for the material or activity.
- Verify plan version and applicability.
- Sampling without an approved plan is escalated.
Step 2 — Verify Sample Identity & Status
- Confirm sample identity, lot, and material status.
- Verify sample is authorized for collection.
- Unauthorized or misidentified samples are escalated.
Step 3 — Review Chain-of-Custody Documentation
- Verify chain-of-custody completeness and continuity.
- Confirm date, time, personnel, and handoffs.
- Gaps or inconsistencies trigger escalation.
Step 4 — Verify Sample Handling & Transfer
- Confirm samples were transferred per approved controls.
- Verify documentation supports sample integrity.
- Handling deviations are escalated.
Step 5 — Prepare Evidence for Quality Review
- Compile sampling records and references.
- Ensure traceability to testing or disposition.
- Submit evidence package for QCO review if required.
Authority Reminder
This WIN Execution Guide is non-authoritative and exists solely to support
execution. Sampling acceptance, exceptions, and escalation decisions are
rendered by the QCO under the QA Family Pack.
Consistency Assessment (Non-Authoritative)
Based on the provided text, the execution steps align with the intent and control
framework defined in the QA Family Pack. No conflicts identified.