Produce Traceability Initiative (PTI) – Case Labeling

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

Updated October 2025 • Labeling & Traceability • PTI, GS1, WMS/MES, Food Safety

PTI case labeling defines the minimum identity and data carriers required to trace fresh produce at the case level across growers, packers, shippers, distributors, and retailers. It is not optional hygiene; it’s the backbone of credible recalls and speed‑to‑quarantine. Practically, PTI means a human‑readable case label plus a GS1‑128 barcode encoding the produce GTIN, lot/batch, and key dates—tied into systems that actually use those scans. The discipline aligns with EPCIS event exchange and FSMA 204 traceability expectations, and it only works if execution is enforced in WMS/MES.

“If your cases don’t scan GTIN + Lot at ship and receive, you don’t have PTI—you have labels that look compliant.”

1) Purpose & Mandate—What PTI Case Labels Solve

PTI case labels standardize identity so that produce can be traced quickly across trading partners. The goal is simple: from any seed lot, reconstruct the forward path to distribution and the backward path to source within hours, not days. That only happens if every case has a reliable GTIN and Lot, printed and scanned under control, and if aggregation to pallets is preserved via SSCC.

2) Core Elements—Human Readable + GS1‑128

A usable PTI label has both: (1) clear text (commodity/variety/size, pack date, grower/shipper) and (2) a GS1‑128 encoding the data that systems consume. Don’t bury the lot in text; encode it with the proper Application Identifiers so scanners and WMS can act on it automatically.

3) Data Model—Which GS1 AIs Belong

• Identity: GTIN (AI 01), Lot/Batch (AI 10).
• Dates: Production/pack (AI 11/13). Add expiry/use‑by (AI 15/17) where required.
• Quantity: Count per case (AI 37). Use weight AIs (e.g., 310x/320x) only if trading on weight.
• Logistics: For pallets, SSCC (AI 00); link cases→pallet via aggregation events (EPCIS).

4) Label Design & Validation—Make Scans Bulletproof

Design labels that print clean at line speed and pass barcode validation grades. Keep quiet zones, font sizes, and placement consistent. Label verification should be at‑line, with rejects kicked out automatically. Validate templates and printers under Part 11/Annex 11 expectations—no uncontrolled edits.

5) Master Data—GTIN Discipline and Governance

PTI collapses without clean master data. Assign GTINs per commodity/variety/size/pack configuration and retire them correctly. Control AI usage centrally. If you re‑pack or private‑label, manage owner/brand GTIN rules and keep attribute changes under Change Control.

6) Execution at Pack—From Harvest to Case

Capture the seed lot/field/block and transformation into the finished case in MES. Print the PTI label only after identity is known; never pre‑print generic lots. Lock in line clearance, dual verification on changeovers, and device‑fed dates and counts—no hand‑typed lot strings.

7) Ship & Receive—No Scan, No Move

At shipping, scan every case and pallet. Build and transmit an ASN with GTIN/Lot and SSCC. At receiving, reconcile scans to the ASN in the WMS; exceptions go to Quarantine/Hold. Anything that bypasses scan discipline is invisible in a recall.

8) Status Control & Rotation—FEFO Wins

Use FEFO (or FIFO where dates aren’t applicable) driven by the dates on the case label. Enforce directed picks (Directed Picking) and prevent ship of Unreleased or Held lots with WMS interlocks.

9) Aggregation & Events—EPCIS or It Didn’t Happen

Record aggregation (case→pallet) and shipping events. Persist them as EPCIS so partners can trace cross‑company. If you can’t emit/consume events, you will hand‑build recall lists while product keeps moving.

10) Distribution & Handover—Dock Discipline

At Dock Loading, verify pallet SSCC and sampled case labels before handover. Ensure Pack & Ship documents reflect the same GTIN/Lot counts as scans. DCs should reject non‑scannable labels—period.

11) Risk Management—Design Out Label Errors

Use PFMEA thinking to target failure points: wrong GTIN, stale lot, date roll, printer swaps, mixed‑lot pallets. Embed controls in the process: machine‑verified templates, prevented manual lot entry, staged approvals for new GTINs, and routine internal audits on label evidence and scan rates.

12) Changes—Templates, GTINs, and Customers

Every template or GTIN change runs through documented MOC/Change Control. Re‑OQ printers and scanners after firmware updates. If a retailer mandates different AI sets or case text, treat it as a controlled rollout—no mixed artwork on the floor.

13) Deviations & CAPA—When Labels Go Wrong

Mislabels and unscannables are deviations. Contain immediately (block shipment, relabel in quarantine), investigate root cause, and issue CAPA that fixes system causes—not just reprints. Chronic failures belong in supplier quality or printer maintenance programs.

14) People & Culture—Scan or Stop

Train operators that “no scan, no move” is non‑negotiable. Build a training matrix for label roles and certify on real printers/scanners. Reward teams for catching label errors pre‑ship; penalize work‑arounds that bypass scans.

15) PTI Metrics—Proof You’re in Control

• Scan coverage: % cases scanned at pack/ship/receive.
• Label quality: verification grade pass rate; scan exceptions per 1,000 cases.
• ASN match: % receipts matching ASNs (GTIN/Lot/SSCC).
• Recall drill speed: minutes to list impacted cases/customers from a seed lot.
• Rotation integrity: FEFO pick compliance; aged stock escapes.
• Change velocity: on‑time template/GTIN updates without incident.

Tie these to business outcomes—chargebacks avoided, waste reduction, and speed‑to‑quarantine—to prove PTI is more than a sticker cost.

16) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform drives PTI from template approval to scan enforcement. Configuration is versioned; evidence is attributable; and cross‑module events (identity, status, signatures) are queryable for recall drills.

V5 QMS. In the V5 QMS, control label templates via approval workflow, manage deviations/CAPA, and govern GTIN/AI rules under Document Control.

V5 MES. The V5 MES prints PTI labels at pack with device‑fed lots/dates, captures transformations into the eBMR, and enforces line clearance and dual verification.

V5 WMS. The V5 WMS enforces scan‑to‑move, SSCC aggregation, ASN reconciliation, and Hold/Release—turning PTI rules into barcode‑enforced behaviors.

Bottom line: With V5, PTI becomes system behavior: right label, right scan, right data—every case, every time.

17) FAQ

Q1. What must be on a PTI case label?
Human‑readable commodity/variety/size and a GS1‑128 encoding GTIN (AI 01), Lot (AI 10), and production/pack date (AI 11/13). Add quantity (AI 37) and expiry/use‑by (AI 15/17) when applicable.

Q2. Do we need pallet labels too?
Yes. Use an SSCC (AI 00) on each pallet and preserve case→pallet aggregation. Without SSCC, cross‑dock and DC flows break traceability.

Q3. How do PTI labels interact with ASNs?
ASNs should carry the same GTIN/Lot/SSCC counts you scanned at ship. Receivers scan and reconcile; mismatches go to Quarantine/Hold until resolved.

Q4. Can operators type lots when printers fail?
No. Manual entry invites error and kills recall credibility. Use redundant printers and controlled reprint workflows under QMS oversight.

Q5. What about mixed‑lot cases?
Avoid them. If unavoidable, create a new handling unit ID, document composition in genealogy, and route through MRB with relabeling and label verification.

Q6. How do we prove PTI works?
Run timed trace drills. From a seed lot, produce within SLA a list of impacted cases/customers using scans, EPCIS events, and ASN matches—then fix whatever slowed you down.

Q7. Do customers allow alternate AI sets?
Some do, some don’t. Standardize internally on core AIs and treat customer‑specific variants as controlled changes with testing and training before rollout.

Related Reading
• Labels & AIs: GS1‑128 Case Label | GTIN | GS1 AIs | Lot (AI 10) | Barcode Validation | Label Verification
• Identity & Events: SSCC | EPCIS | ASN | End‑to‑End Traceability | Batch Genealogy
• Execution & Control: WMS | MES | Directed Picking | FEFO | FIFO | Pack & Ship