Document ID: OG-WIN-PROD-MMR
Version: 1.0
Last Change Date: 2026-02-26
WIN Execution Guide — Master Manufacturing Record (MMR) Verification
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 verification and execution of the approved Master Manufacturing Record (MMR)
to ensure batch activities align strictly with authorized manufacturing instructions.
Scope
Applies to all Production personnel executing batch operations under an approved
Master Manufacturing Record. This execution guide governs version verification,
instruction alignment, and escalation of conflicts prior to and during batch execution.
Section 6 — AA (Auditable Artifacts)
AA-PROD-MMR-REC — Master Manufacturing Record Verification
- MMR identification and revision level
- Batch authorization reference
- Verification of current approved version
- Confirmation of alignment between execution steps and documented instructions
- Escalation reference if version conflict or instruction discrepancy identified
Auditor focus: Evidence that only current, approved MMRs are used for batch execution
and that undocumented deviations are not permitted.
QC-REQ Anchor: QC-IPC-002
Section 7 — WIN (Work Instructions / Control Requirements)
WIN-PROD-MMR
- Confirm use of current approved MMR version.
- Ensure execution aligns with documented instructions.
- Prohibit undocumented procedural deviations.
Stop-Execution Condition:
- Use of outdated or unauthorized MMR
- Instruction conflict identified
Control outcome: Batch execution aligns strictly with approved manufacturing instructions.
Process: Production (PROD)
Business Process Owner: Production BPO
Primary Systems / Forms: Approved MMR, AA-PROD-MMR-REC
BPO-Owned Execution Zone — Operational Step Sequence
MMR verification is performed prior to batch initiation and maintained
throughout execution to ensure alignment with approved manufacturing instructions.
Step 1 — Verify MMR Identification and Revision
- Confirm MMR ID matches the authorized batch number.
- Verify revision level corresponds to the current approved version.
- Confirm document status indicates approval within the controlled system.
Step 2 — Confirm Batch Authorization
- Verify batch record references the correct MMR ID and revision.
- Ensure issuance authorization is documented prior to execution.
- Confirm no superseding version has been released.
Step 3 — Align Execution with Documented Instructions
- Execute each manufacturing step as written in the approved MMR.
- Do not alter sequence, parameters, or materials without authorized evaluation.
- Document execution contemporaneously in the batch record.
Step 4 — Monitor for Instruction Conflicts
- Identify any discrepancies between equipment configuration, materials, or process parameters and documented instructions.
- Pause execution if ambiguity or conflict is identified.
- Escalate discrepancies to supervision and QA prior to continuation.
Stop-Execution Principle
If an outdated version, unauthorized document, or instruction conflict is identified:
STOP — HOLD EXECUTION — 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.