Mock Recall Performance – Timed Trace Tests

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

Updated October 2025 • Recall & Traceability • QA, Supply Chain, Regulatory, Operations

Mock recalls are timed drills that prove your ability to identify, locate, and control affected product—fast—using documented genealogy, distribution records, and contact reach. They are not “paper exercises.” A credible drill traverses end‑to‑end traceability, from source lots to customers, across MES, WMS, labeling, shipping (ASN / Pack & Ship), and event exchange (EPCIS). If you cannot produce a time‑stamped list of affected GTIN/lot/SSCC with customer destinations and on‑hand status, you don’t have recall readiness—you have hope.

“In a real recall, minutes matter. Either your systems return the truth on demand or you’re writing apologies to regulators and customers.”

1) Objective & Mandate

Mock recall drills verify that processes, people, and systems can reconstruct product genealogy and act (quarantine, notify, retrieve) inside regulatory and customer tolerance. Food manufacturers map KDEs and critical tracking events; pharma/device must demonstrate GMP/GDP controls and, where applicable, alignment with identity frameworks like DSCSA/UDI (identity ≠ quantity).

2) Scope Scenarios—Drill What Hurts

• Upstream contamination: Single supplier lot used across multiple SKUs/batches.
• In‑process deviation: Affected intermediate lot propagated into sub‑lots; test your MES genealogy.
• Downstream distribution: Mixed pallets, cross‑dock, third‑party DCs; validate ASN alignment and SSCC scans.
• Label/claim error: Wrong artwork or date code; triggers label verification/barcode validation checks.
• Cold chain excursion: Temperature log breach; ensure GDP custody and disposition control.

3) Data You Must Have—No Exceptions

• Identity: GTIN, Lot (AI 10), expiry where relevant, and SSCC for cases/pallets; correct GS1 AIs.
• Events: Receive, transform, pack, aggregate, ship, de‑aggregate—modeled and shareable via EPCIS.
• Locations & status: On‑hand in WMS with Hold/Release enforcement; shipped with customer IDs and quantities.
• Integrity: Immutable audit trails, meaningful e‑signatures (Part 11/Annex 11), and Data Integrity controls.

4) Drill Protocol—How to Run a Timed Trace Test

1. Trigger & timer on: Select a seed lot/SKU; declare scope and start time.
2. Freeze risk: Place related inventory on system Quarantine/Hold (WMS).
3. Trace back & forward: From seed lot, reconstruct inputs/uses (back) and shipments (forward) using eBMR/MES genealogy and WMS/EPCIS aggregation.
4. Build the lists: (a) On‑hand by site/bin/status; (b) Shipped by customer/PO/ASN; (c) Work‑in‑process.
5. Communicate: Issue internal stop‑ship; stage external notices; verify contact reach.
6. Stop timer & package evidence: Save queries, reports, labels, and event extracts. Debrief with gaps and CAPA.

5) Evidence Package—What QA Needs on File

• Timestamped drill charter, scope, and SLA.
• Trace outputs (CSV/PDF) listing GTIN/lot/SSCC, quantities, locations, customers.
• System screenshots or exports proving audit trails, label scans (GS1‑128), and barcode validation grades.
• EPCIS event bundle for aggregation/ship/receive, plus ASN reconciliation.
• Communication log: who was notified, when, and how; responses.
• Post‑drill CAPA with owners and due dates.
• Record retention mapped to archival policy.

6) Success Criteria & SLAs

• Time to first answer: Initial impacted‑scope list (seed lot → all children/shipments) within SLA.
• Completeness: ≥99% units accounted (on‑hand + shipped) with no ambiguous lots.
• Accuracy: Zero false lots/customers; zero label identity mismatches.
• Control: All impacted on‑hand inventory placed on Hold within the window.
• KDE coverage: All required KDEs available and consistent across sources.

7) Metrics That Matter

• T1 (trace): Seed lot → full impacted list (min).
• T2 (control): Time to place 100% on‑hand units on Hold.
• T3 (notify): Time to contact 95% of affected customers; proof of receipt.
• Event completeness: % cases/pallets with valid SSCC scans at ship/receive; % shipments with ASN match.
• Data quality: Duplicate/invalid AI rates; label grade pass rate.
• Closure: % drills closed with CAPA effectiveness verified.

8) Failure Modes—Reality Check

• Mixed‑lot cases with no parent→child links—recall math collapses.
• “Off‑system” picks or spreadsheets—violates Data Integrity and breaks audit trails.
• Wrong or missing GTIN/lot encodings; stale customer master.
• ASNs not reconciled to receipts; SSCC not scanned at dock.
• MES/WMS silos—no single query to bridge eBMR genealogy and shipment history.
• People untrained; no training matrix or call tree.
• No internal audit follow‑through; drills become theater.

9) System Design—Make Tracing Instant

• eBMR/MES: Record transformations with device‑fed data, signatures, and audit trails.
• WMS: Enforce scan at receive/pick/ship; status control by lot/SSCC; location topology clean.
• EPCIS: Persist aggregation/ship/receive events for cross‑party tracing.
• Labels: Correct GS1‑128 content; inline verification and validation.
• Security: Role‑based access management so drills don’t devolve into “admin only” heroics.
• Governance: QRM and Change Control for data model/label/flow changes.

10) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform unifies eBMR genealogy, WMS status, and EPCIS event history so mock recalls become queries, not archaeology.

V5 MES. V5 MES captures lot transformations with signatures and device data, enabling true end‑to‑end back/forward tracing.

V5 WMS. V5 WMS enforces scan discipline, Hold/Release, SSCC aggregation, and ASN handshake so distribution data align.

V5 QMS. V5 QMS schedules drills, logs results, drives CAPA, and preserves evidence under Document Control with audit trails.

Bottom line: V5 turns recall drills from a disruptive scramble into a repeatable, timed routine—and it exposes weak links before regulators or customers do.

11) FAQ

Q1. How often should we run mock recalls?
At least annually per site/SKU family, plus after major system/label/partner changes. Rotate scenarios so you test suppliers, intermediates, and finished goods.

Q2. What’s the difference between trace tests and full recall simulations?
Trace tests time the data retrieval piece (lists, locations, customers). Full simulations add governance, external communications, and reverse logistics trials.

Q3. Do DSCSA/UDI solve recall readiness?
No. They control identity. You still need genealogy, status control, shipping evidence, and the ability to place product on Hold and notify customers fast.

Q4. What regulators expect on timing?
Expectations vary by jurisdiction and program. Design SLAs that beat typical regulator windows and prove you can retrieve required KDEs and distribution records on demand.

Q5. What if our systems can’t query across MES and WMS?
Then your recall posture is weak. Bridge with an event layer (EPCIS) and standard identifiers (GTIN/Lot/SSCC), or upgrade the stack.

Q6. How do we prove the drill wasn’t staged?
Timestamp everything, capture live queries, preserve audit trails, and include raw event/scan exports in the evidence pack.

Related Reading
• Core: Recall Readiness | End‑to‑End Traceability | Batch Genealogy
• Identity & Events: GS1 GTIN | Lot (AI 10) | SSCC | EPCIS | ASN
• Execution & Control: MES | WMS | Hold/Release | Label Verification | Barcode Validation
• Governance & Integrity: Data Integrity | Audit Trail | 21 CFR Part 11 | Annex 11 | QRM | Change Control