Notification of Change (NOC) – Supplier Change Notice

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Supplier Quality & Risk • QMS, MES, WMS, Traceability

Notification of Change (NOC)—also called a Supplier Change Notice—is the formal process by which a supplier informs a manufacturer of material changes that can affect form, fit, function, safety, quality, or regulatory status of goods and services. In regulated and brand-critical industries, NOC is the difference between controlled adaptation and blind disruption. A proper NOC program ties supplier declarations to your Management of Change (MOC), routes them through impact assessment across MMR/MBR, artwork, and compliance files, and enforces “hard gate stops” in execution so an unapproved change cannot hit the line. Without this backbone, you will eventually run the wrong grade, wrong spec, or wrong label and then spend weeks unpicking genealogy to recall product you never should have made.

“If a supplier can change your product without your system knowing, you don’t have supply— you have surprise.”

1) What Counts as a Supplier Change?

“Change” is broader than most teams think. It includes formulation tweaks in a raw, alternate sources for critical precursors, shifts in manufacturing site or country of origin, process parameter updates that alter impurity profiles, packaging material or label content revisions, shelf-life or storage condition changes, testing method substitutions, and even ERP or labeling software migrations that could impact identity, traceability, or print accuracy. Any movement that could influence product quality, safety, efficacy, labeling, or regulatory status is in scope. Mature suppliers classify changes, provide proposed effective dates, include objective evidence like new CoAs and validation summaries, and respect customer notice periods. Immature ones ship first and email later. Your controls must assume the latter and prevent use of material that violates your approved master data until the NOC is assessed, accepted, and implemented under Change Control.

2) NOC vs. MOC—Two Sides of the Same Gate

A supplier NOC is an external trigger; your internal MOC is the decision engine. The minute an NOC arrives, log it as an MOC record in the QMS, assign risk level, cross-reference impacted SKUs and BOM nodes, and pull the current MMR/MBR. If the proposed change alters identity or functional attributes, route to technical, quality, regulatory, and operations for impact analysis. Align effective dates with inventory run-down plans governed by FEFO/FIFO and update incoming inspection and IPC plans. The output of MOC is not a memo; it is a set of enforced changes to masters, tests, labels, and gate logic in MES/WMS and, where applicable, commercial and labeling systems.

3) Document Control and Master Data—The Source of Truth

NOC cannot be managed by email. All supplier notifications, redlines, validation summaries, and agreements must sit under Document Control with versioning, approvals, and retention. Impacted masters—specifications, BOM, label artwork, test methods—must be revised through controlled workflows, linked to the NOC/MOC record, and rolled out with training and effective-date governance. When your MES pulls the MMR step or your WMS presents a pick list, there should be no ambiguity about which version is in force.

4) Hard Gate Stops in WMS and MES

The hallmark of a robust NOC program is the inability to accidentally use unapproved material. In WMS, NOC-flagged lots should land in a quarantine or evaluation status at Goods Receipt; Directed Picking must exclude them from reservations, and Dynamic Lot Allocation should only surface approved equivalents that meet FEFO rules. In MES, barcode scans should reconcile item/lot to the NOC disposition; attempts to use an “under review” lot should block the step, require a reason code, and, if permitted at all, demand dual verification with deviation reference. This is where many companies fail—they “communicate” the change but don’t enforce it. Communication without gate logic is theater.

5) Qualification, Testing, and Bridging Evidence

For moderate to high-risk changes, demand evidence beyond the supplier’s letter. That includes comparative testing against your component release specifications, first article or pilot runs, CPV trending for process drift, micro/tox substantiation where relevant, and stability or compatibility studies to protect shelf-life and packaging integrity. For equipment or software shifts at the supplier, request proportionate IQ/OQ/PQ or method comparability. Build these into your AQL sampling plans and incoming inspection instructions and store results with immutable audit trails to satisfy Part 11/Annex 11 expectations for electronic data integrity.

6) Labeling and Regulatory Implications

Supplier changes frequently ripple into labeling: new allergen disclosures, altered net content tolerances, updated UDI or GTINs, country of origin, or claims basis. The only safe pattern is print-from-source with mastered artwork under Document Control and label verification at packout. If the NOC alters claim support or identity, route through regulatory for listings/notifications updates (e.g., MoCRA product listings or medical device registrations) and hold shipments until approvals are in place. Do not rely on tribal knowledge; bind the requirement to the part in the system so the station simply cannot print the wrong file.

7) Genealogy and Recall Exposure

The business case for rigorous NOC control is recall math. If your WMS and MES cannot pinpoint which batches used which changed lots, you will recall broadly and expensively. With proper Lot Traceability, you can surgically identify impacted work orders, units, and customers and support a targeted field action. Link the NOC ID to every affected eBMR and shipping record so complaint handling and CAPA can immediately pivot on the change and prove containment.

8) Commercial Risk: Cost, Lead Time, and Dual Sourcing

Approved changes still have operational consequences: revalidation lead time, inventory write-downs of the superseded spec, and training for revised work instructions. Bake NOC cadence into S&OP and MRP so cut-in dates don’t collide with promotions or launches. Where risk is high, pre-qualify alternates and encode equivalence classes in Dynamic Lot Allocation, ensuring the system presents only approved, functionally equivalent choices to pickers and stations.

9) Data Integrity and System Requirements

NOC management is an electronic-records problem as much as a technical one. Systems must enforce unique users, e-signatures with meaning, time sync, and secure audit trails. Evidence—supplier letters, attachments, test results, decisions—must be attributable, legible, contemporaneous, original, and accurate (ALCOA+). If users can alter dispositions or masters without leaving a trace, your NOC process will not survive inspection. Validate critical workflows under proportionate CSV expectations.

10) Training and Change Adoption

An approved NOC is not “done” until the floor runs the new method. Push contextual training tied to roles and stations; require read-and-understand acknowledgements for revised SOPs; and gate execution in MES based on training status for high-risk steps. Measure adoption through first-pass yield and deviation rates in the first weeks after cut-in.

11) Common Failure Modes & How to Avoid Them

• “FYI only” culture. Supplier sends a note; operations proceed unchanged. Fix: convert every NOC to an MOC with enforced dispositions.
• Masters lag reality. Label/spec updated on paper but not in systems. Fix: one source of truth under Document Control feeding printers, WMS, and MES.
• Quarantine bypass. Evaluating lots “temporarily” used. Fix: status interlocks and Directed Picking that make the wrong action impossible.
• Evidence gaps. No bridging studies or method comparability. Fix: predefined qualification plans tied to risk and AQL.
• Downstream misalignment. Customer service and artwork teams uninformed. Fix: cross-functional MOC routing with effective-date governance and training requirements.
• Recall sprawl. Weak genealogy forces broad actions. Fix: end-to-end Traceability linking NOC IDs to batches and shipments.

12) Metrics That Prove Control

Track NOC to MOC conversion rate and cycle time, percentage of NOC-flagged lots blocked at receipt, first-pass qualification yield, incidents of quarantine bypass, label/artwork verification first-pass rate, post-cut-in deviation rate, CAPA recurrence tied to supplier changes, and time to update masters across systems. For each metric, define “red lines” that trigger automatic deviation and management review.

13) Implementation Roadmap

Start by mandating NOC clauses in supplier quality agreements with minimum notice periods and evidence expectations. Stand up a QMS workflow that converts NOCs into MOC with risk scoring and cross-functional routing. Connect QMS to Document Control so spec and artwork updates are one action, not three. Integrate WMS to place NOC lots in evaluation status at receipt and restrict picks and allocations. Integrate MES to block scan-in and require reason codes and dual verification if temporary use is permitted. Validate critical paths per CSV, train roles, and drill recall using an NOC scenario to prove your spine.

14) How This Fits with V5 (Module-by-Module)

V5 by SG Systems Global operationalizes NOC control with one backbone and three execution pillars. See the V5 Solution Overview for architecture; below is how each module converts supplier notices into enforced behavior on your floor:

V5 QMS — NOC Intake, MOC, and Governance. The V5 QMS provides a dedicated NOC workflow that ingests supplier notices (attachments, redlines, validation summaries) and converts them into MOC with risk scoring, approver routing, and effectiveness checks. It ties directly to Document Control so impacted specifications, test methods, and label artwork are revised with e-signatures and versioning. Deviations and CAPA link to the NOC ID to manage fallout, while audit trails and retention satisfy Part 11/Annex 11 expectations.

V5 WMS — Status Interlocks and Allocation Discipline. The V5 WMS automatically receives the NOC disposition and places inbound lots into Evaluation, Blocked, or Approved states at Goods Receipt. Directed Picking and Dynamic Lot Allocation ensure only approved, version-aligned lots surface to orders, respecting FEFO/FIFO. Attempts to pick an under-review lot are blocked with explicit error messaging and audit entries.

V5 MES — Scan-Time Blocking and eBMR Traceability. Within the V5 MES, each material scan reconciles to the NOC/MOC disposition before a step can proceed. If temporary use is authorized, the system requires reason codes, dual verification, and captures additional IPC readings. All actions land in the eBMR with timestamps, user IDs, and device status checks (e.g., calibration, line clearance). Packout binds label versions to the NOC so downstream field actions can be targeted.

One Spine, Measurable Control. Across modules, V5 provides unified dashboards for NOC cycle time, blocked-pick attempts, post-cut-in deviations, and recall drill performance—evidence that your supplier changes are controlled in practice, not just narrated on a slide.

15) FAQ

Q1. Which supplier changes must be notified?
Any change that can influence identity, performance, safety, labeling, or compliance—materials, process, site, software, packaging, shelf-life, or test methods. Codify this in your supplier quality agreement and link to your NOC workflow.

Q2. How long should notice periods be?
Risk-based. Critical materials often require 90–180 days with samples for qualification; lower-risk packaging may be shorter. The notice period must include time for bridging tests, MMR/MBR updates, training, and inventory run-down under FEFO.

Q3. Can we ever use changed material before approval?
Only under a controlled deviation with risk assessment, temporary specifications, and additional IPC checks. Enforce dual verification at the station and capture rationale in the eBMR.

Q4. What documents must be updated after NOC approval?
Specifications, test methods, BOM, MMR/MBR, label artwork, inspection plans, training materials, and supplier files—each under Document Control with e-signatures.

Q5. How do we prove control to auditors?
Show an end-to-end NOC case: supplier notice → MOC record and risk assessment → master updates and training → WMS status blocks and MES scan-time interlocks → qualification results → targeted genealogy for impacted lots. The absence of blocked-pick attempts is not proof—captured blocks with audit trails are.

Related Reading
• Governance & Records: QMS | MOC | Document Control | Change Control | Audit Trail (GxP)
• Materials & Warehousing: WMS | Goods Receipt | Directed Picking | Dynamic Lot Allocation | FEFO
• Execution & Release: MES | eBMR | IPC | Hold / Release | CoA
• Risk & Qualification: AQL | First Article Inspection | IQ/OQ/PQ | CPV
• Compliance Backbone: 21 CFR Part 11 | Annex 11 | ALCOA+ | Lot Traceability