Document ID: OG-WIN-PROD-PREWEIGH-REC
Version: 1.0
Last Change Date: 2026-02-26
WIN Execution Guide — Material Pre-Weigh & Reconciliation
Non-Authoritative WIN Execution Guide Notice
This WIN Execution Guide supports execution of applicable Family Pack controls.
Authority for control intent and requirements remains solely with the
governing Family Pack. This document does not create, modify, or interpret controls.
Purpose
To support controlled pre-weighing, quantity verification, reconciliation,
and traceability of materials prior to batch addition.
Scope
Applies to all production material pre-weigh activities performed prior
to batch manufacturing addition, including reconciliation and controlled staging.
Section 6 — AA (Auditable Artifacts)
AA-PROD-PREWEIGH-REC — Material Pre-Weigh & Reconciliation Record
- Material identity, lot, and container traceability
- Batch authorization reference
- Target quantity versus actual quantity
- Scale/equipment ID and verification status
- Independent verification (where required by risk level)
- Reconciliation of remaining quantities and container balance
- Labeling and controlled staging confirmation
- Escalation linkage for quantity discrepancies or wrong-lot risk
Auditor focus: Quantity accuracy, traceability integrity, and reconciliation control prior to batch addition.
QC-REQ Anchor: QC-IPC-002, QC-REC-002
Section 7 — WIN (Work Instructions / Control Requirements)
WIN-PROD-PREWEIGH
- Verify material identity and batch authorization.
- Perform attributable weighing.
- Confirm scale suitability and verification status.
- Reconcile remaining quantities.
- Stage pre-weighed materials under controlled conditions.
Stop-Execution Condition:
- Wrong-lot identification risk
- Quantity discrepancy outside defined tolerance
- Scale malfunction or verification concern
- Traceability or labeling gap
Control outcome: Only verified lot and reconciled quantities advance to batch addition.
Process: Production (PROD)
Business Process Owner: Production BPO
Primary Systems / Forms: PREWEIGH-REC-01 (or equivalent weighing log)
BPO-Owned Execution Zone — Operational Step Sequence
Material pre-weigh is conducted under controlled conditions with
full traceability, quantity verification, and reconciliation prior to
release for batch addition.
Step 1 — Verify Material Identity and Batch Authorization
- Confirm material name, internal code, and lot match batch documentation.
- Verify authorized batch reference is current and approved.
- Ensure material status permits use in production.
Step 2 — Confirm Scale Suitability and Verification Status
- Confirm scale ID matches designated equipment.
- Verify calibration and verification status are current.
- Perform required pre-use verification checks.
- Do not proceed if scale functionality is in question.
Step 3 — Perform Attributable Weighing
- Weigh target quantity in accordance with batch requirement.
- Record target versus actual quantity.
- Ensure entries are contemporaneous and attributable.
- Obtain independent verification when required by risk level.
Step 4 — Reconcile Remaining Quantities
- Calculate and document remaining container balance.
- Verify reconciliation aligns with issued quantity.
- Investigate and escalate discrepancies outside defined tolerance.
Step 5 — Label and Stage Under Controlled Conditions
- Apply appropriate identification labels to pre-weighed containers.
- Ensure lot, batch, and quantity information are clearly visible.
- Stage materials in designated, segregated pre-weigh area.
- Maintain protection against contamination or mix-up.
Stop-Execution Principle
If wrong-lot risk, quantity discrepancy outside tolerance,
scale malfunction, or traceability gap is identified:
STOP — HOLD MATERIAL — ESCALATE — DOCUMENT
Authority Reminder
This document supports execution only and is non-authoritative.
The governing Family Pack remains the sole source of control intent and requirements.