Traceability & Recall Program

Document Control

Field	Value
Document ID	FS-TRC-001
Version	3.0
Effective Date	2026-01-20
Owner	Traceability & Recall Coordinator
Approver	Food Safety Team Leader
Review Frequency	Annual

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1. Traceability System Description

1.1 Objective

The traceability system enables the company to trace any finished product one step back (to raw material supplier) and one step forward (to customer) within 4 hours of a request. This meets the requirements of: - EU Regulation (EC) 178/2002 (General Food Law — Article 18) - Codex Alimentarius CXG 60-2006 (Principles for Traceability) - BRCGS Food Safety Issue 9 (Clause 5.8) - FSSC 22000 (ISO 22000 — Clause 12.1)

1.2 Lot Numbering System

1.2.1 Raw Material Lot Numbers (Incoming)

RR-YYYYMMDD-SSSS
│  │         │
│  │         └── Supplier batch/serial number (last 4 digits)
│  └──────────── Receiving date (YYYYMMDD)
└─────────────── Material code (2-letter: FL=Flax, SE=Sesame, MU=Mustard,
                 CE=Celery, SO=Soy, PL=Packaging, AD=Additive)

Example: FL-20260715-1023 = Flaxseed received 15 July 2026, supplier batch ending 1023.

1.2.2 Production / In-Process Lot Numbers

PR-A-YYYYMMDD-HHMM-SSS
│ │           │    │
│ │           │    └── Sequential batch number (001–999)
│ │           └─────── Timestamp of first production (HHMM)
│ └─────────────────── Line designation (A, B, C)
└───────────────────── Prefix "PR" (Production)

Example: PR-A-20260715-0830-042 = Line A, 15 July 2026, started 08:30, batch 042.

1.2.3 Finished Product Lot Numbers

FP-CCYYMMDD-BB-PP
│  │        │  │
│  │        │  └── Pack configuration code (e.g., 01=25kg bag, 02=500g retail)
│  │        └───── Production batch sequence (01–99)
│  └────────────── Packaging date (CCYYMMDD)
└───────────────── Prefix "FP" (Finished Product)

Example: FP-20260715-42-01 = Finished product packed 15 July 2026, batch 42, 25 kg bag.

1.2.4 Customer / Pallet Labels

Each pallet label includes: - Finished product lot number - Pallet number (001–999 per lot) - Gross / net weight - Production date - Best-before / expiry date - Product description and SKU - Customer PO number (if applicable)

1.3 Traceability Chain: Raw Material → Process → Finished Product → Customer

Supplier ──→ Receiving ──→ Storage ──→ Production ──→ Packing ──→ Finished Goods ──→ Customer
    │            │            │             │              │             │               │
    │            │            │             │              │             │               │
    └──── LOT ───┘            │             │              │             │               │
         (RR-...)             │             │              │             │               │
                              │             │              │             │               │
                         Storage Lot    Production Lot ───┘         Finished Lot ────────┘
                         (internal)     (PR-...)                   (FP-...)           Despatch
                                                                                    Record

1.4 Data Recording Points

Traceability Point	Data Captured	System
Supplier delivery	Supplier name, lot, quantity, receipt date, COA	ERP (lot-enabled)
Raw material storage	Material lot, storage location, put-away date/time	WMS
Production issue	Material lot, quantity, production order, line, time	ERP / Production Log
Processing step	Time stamps, line parameters (temp, pressure, speed)	SCADA / Process Log
Rework addition	Rework lot, quantity, target product lot	Rework Log (FS-ALC-F04)
Packaging	Finished product lot, packaging material lot, label lot	ERP / Packaging Log
Finished goods storage	Pallet number, location, storage condition checks	WMS
Customer despatch	Customer name, despatch date, lot numbers, quantity, vehicle	ERP / Despatch Log

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2. One-Step-Back Tracing

2.1 Procedure

Upon request (mock recall or actual incident), the traceability team traces from a finished product lot back to all raw material lots used in production.

2.2 Steps

Step	Action	Time Target	Responsible
1	Identify finished product lot(s) in question	Immediate	Recall Coordinator
2	Retrieve production batch record for that product lot	15 min	QA / Production
3	Extract all raw material lots issued to that production order	15 min	QA
4	Retrieve receiving records for each raw material lot	15 min	Procurement / QA
5	Identify supplier, supplier lot number, quantity received, date	10 min	Procurement
6	Obtain supplier COA and allergen declaration for each lot	20 min	QA / Procurement
7	Compile traceability report (FS-TRC-F01)	15 min	Traceability Coordinator
8	Review and validate report	10 min	QA Manager
Total target		≤ 100 min

2.3 Data Sources

• ERP System: Production orders, material movements, goods receipt records.
• Paper Logs: Production batch record (signed), receiving log (signed).
• WMS: Storage locations, lot transfers.
• SCADA: Process parameters (for lot confirmation).

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3. One-Step-Forward Tracing

3.1 Procedure

From a specific raw material lot or finished product lot, identify all customers who received product containing that lot.

3.2 Steps

Step	Action	Time Target	Responsible
1	Identify subject lot (raw material or finished product)	Immediate	Recall Coordinator
2	Search ERP for all production orders using that raw material lot (if starting from raw material)	20 min	QA
3	Identify all finished product lots produced	15 min	QA
4	Search despatch records for all pallets / orders of those finished product lots	20 min	Logistics
5	Identify customers, quantities, despatch dates, delivery addresses	15 min	Logistics
6	Compile outbound traceability report (FS-TRC-F02)	15 min	QA
7	Review and validate report	10 min	QA Manager
Total target		≤ 95 min

3.3 Data Sources

• ERP: Sales orders, despatch notes, delivery notes.
• Logistics Records: Vehicle loading sheets, customer signature proof-of-delivery.
• WMS: Outbound pallet movements, picking records.

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4. Mock Recall Procedure

4.1 Requirement

A mock recall / traceability exercise must be completed at least once per calendar year. The exercise must be passed within 4 hours from initiation to completion.

4.2 Success Criteria

• Finished product → all raw materials: 100% traced within 4 hours.
• Raw material → all finished products → customers: 100% traced within 4 hours.
• Mass balance: documented yield reconciliation (inputs vs outputs within ±2%).
• No "dead ends" where traceability data is missing or unrecoverable.

4.3 Mock Recall Process

Phase	Activity	Timeline
Initiation	Food Safety Team Leader selects a random finished product lot from the past 6 months.	T = 0
Notification	Recall Coordinator is notified of the mock recall scope. Traceability team assembles.	T + 10 min
One-Step-Back	Trace raw material lots, supplier lots, receiving records.	T + 0 → T + 100 min
One-Step-Forward	Trace all customers, quantities, despatch dates.	T + 0 → T + 95 min (parallel)
Mass Balance	Compare raw material input quantity vs finished product output quantity + waste.	T + 100 → T + 180 min
Report Compilation	Complete traceability report forms (FS-TRC-F01, FS-TRC-F02).	T + 180 → T + 210 min
Review & Scoring	QA Manager reviews completeness, accuracy, time. Score assigned.	T + 210 → T + 240 min
Debrief	Team reviews findings, identifies gaps, assigns corrective actions.	T + 240 → T + 270 min

4.4 Scoring

Criterion	Weight	Target	Points
Time to complete	25%	< 4 hours	25 (pro-rated if > 4h)
Raw material trace completeness	30%	100% of lots traced	30
Customer trace completeness	30%	100% of customers traced	30
Mass balance accuracy	15%	Within ±2%	15
Total	100%	Pass ≥ 85%	100

4.5 Corrective Action on Failure

If the mock recall score is below 85% or exceeds 4 hours: 1. Root cause analysis within 5 working days. 2. Formal CAPA plan within 10 working days. 3. Gap closure within 30 days. 4. Repeat mock recall within 60 days covering the gap area.

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5. Recall Plan

5.1 Recall Team & Contact Tree

Role	Name (Primary)	Name (Deputy)	Responsibility
Recall Coordinator	Food Safety Team Leader	QA Manager	Overall recall management, decisions, regulatory liaison
Communications Lead	Marketing Director	Sales Director	Media, customer notifications, consumer enquiries
Logistics Lead	Logistics Manager	Warehouse Supervisor	Product location, physical retrieval, quarantine
Technical Lead	QA Manager	QA Supervisor	Investigation, root cause, corrective action
Legal Counsel	External Legal Advisor	—	Legal advice, liability assessment
Regulatory Affairs	Regulatory Manager	Food Safety Team Leader	Notify competent authorities (FSAI, FSS, RASFF, etc.)
Finance Lead	Finance Director	—	Cost tracking, insurance claims

5.2 Recall Decision Tree

1. Consumer complaint / test result / regulatory alert received
    │
    ├── Is the issue a food safety hazard? (physical, chemical, biological, allergen)
    │       │
    │       ├── YES ──> 2
    │       └── NO  ──> Monitor / routine CAPA (not a recall)
    │
2. Is the product already on the market?
    │
    ├── NO  ──> Withhold / destroy at facility (no recall needed)
    └── YES ──> 3
    │
3. Has product reached consumers?
    │
    ├── NO (still at distributor/retailer) ──> Trade recall (withdraw from trade)
    └── YES (consumer level) ──> Consumer recall (public notification required)
    │
4. Determine recall class:
    ├── Class I: Reasonable probability of serious adverse health consequences or death
    │            ──> Full public recall, RASFF alert, press release
    ├── Class II: May cause temporary / medically reversible health consequences
    │            ──> Trade recall, regulatory notification
    └── Class III: Not likely to cause adverse health consequences (e.g., labelling)
                 ──> Corrective action at trade level
    │
5. Authorise recall: Recall Coordinator + CEO
    │
6. Execute recall per communication plan.

5.3 Communication Tree

Recall Coordinator (activates tree)
    │
    ├── Regulatory Authorities
    │       └── FSAI / FSS / RASFF / Local EHOs
    │
    ├── Internal
    │       ├── CEO
    │       ├── Food Safety Team
    │       ├── QA Manager
    │       ├── Production Manager
    │       ├── Sales / Customer Service
    │       └── Legal Counsel
    │
    ├── External (Trade)
    │       ├── Distributors (phone + email)
    │       ├── Retailers (phone + email + formal recall notice)
    │       └── Food service operators (phone + email)
    │
    └── External (Consumer)
            └── Press release / website / social media / consumer helpline

5.4 Media / Press Release Template

A pre-approved press release template is maintained in the Recall Plan folder (FS-TRC-F03). Key elements: - Product name, pack size, lot codes, best-before dates - Reason for recall (clear description of hazard) - Actions consumers should take (do not consume, return to point of purchase for refund) - Consumer helpline number and operating hours - Date of issue and recall authority reference number

5.5 Regulatory Notification Timelines

Jurisdiction	Class I Notification	Class II Notification	Communication Channel
EU (RASFF)	Within 48 hours	Within 48 hours	RASFF portal + competent authority
UK (FSA)	Within 24 hours	Within 48 hours	Food Alert system
Ireland (FSAI)	Within 24 hours	Within 48 hours	FSAI portal
Codex (international)	Within 48 hours (INFOSAN)	Within 48 hours	INFOSAN network

5.6 Recall Effectiveness Check

• Target: ≥ 95% of affected product recovered.
• Methods: Customer confirmation (phone/email), returned stock count, distributor inventory reconciliation.
• Effectiveness check documented within 14 days of recall initiation.

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6. Product Identification (Lot Codes)

6.1 Lot Code Formats by Packaging

Packaging Type	Lot Code Location	Format	Example
25 kg woven polypropylene bag	Printed on label (side panel)	FP-CCYYMMDD-BB-PP	FP-20260715-42-01
500 g retail pouch	Printed on back panel (downward)	FP-CCYYMMDD-BB-PP	FP-20260715-42-02
1 kg bulk box	Printed on outer label	FP-CCYYMMDD-BB-PP	FP-20260715-42-03
20 L oil drum	Laser-printed on drum side	FP-CCYYMMDD-BB-PP	FP-20260715-42-04
Pallet label	A4 label on two adjacent sides	FP lot + pallet number	FP-20260715-42-01 / P001

6.2 Best-Before / Expiry Date Format

BBD: DD/MM/YYYY or EXP: MM/YYYY

6.3 Label Integrity Checks

• Labels checked for adhesion, print quality, and legibility at start of each production run and every 30 minutes during run.
• Label applicator verified with photo-eye sensor.
• Rejected labels (misprinted, smudged, missing data) logged and destroyed.

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7. Record Keeping Requirements

7.1 Retention Periods

Record Type	Minimum Retention
Raw material receiving records (including COAs)	5 years
Production batch records	5 years
Finished product despatch records	5 years
Customer / sales records	5 years
Traceability exercise results (mock recalls)	5 years
Recall / withdrawal records	10 years
Supplier approval records	Current + 3 years
Training records	Employment + 1 year
Calibration records	5 years
Environmental monitoring records	3 years

7.2 Record Format

• All records may be kept in electronic format (ERP, WMS, scanned documents) or hard copy.
• Electronic backups performed daily (off-site or cloud).
• Hard copy records stored in fireproof cabinet in QA Office.
• Access to records: Traceability Coordinator, QA Manager, Food Safety Team Leader, and authorised auditors.

7.3 Record Integrity

• Records must be legible, date-stamped, and signed (or electronic equivalent with audit trail).
• No erasures — corrections made by single line strike-through, initialled, and dated.
• Electronic records maintained in a validated, access-controlled system with full audit trail.

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8. Recall Simulation Scenarios & Results

8.1 Annual Simulation Plan

Year	Scenario	Scope	Date	Result	CAPA
2024	Undeclared sesame in 500g ground flax	Domestic retail customers	12/03/2024	95% in 3h 20min	—
2024	Foreign metal fragment in 25kg flax meal	1 international customer	18/09/2024	100% in 2h 45min	—
2025	Packaging mislabel (allergen not declared)	3 domestic distributors	22/04/2025	100% in 3h 10min	Need faster customer contact numbers
2025	Supplier gluten cross-contact in sesame seed	All customers (7)	10/11/2025	100% in 3h 50min	—

8.2 Upcoming Simulation Schedule

Quarter	Scenario Focus
Q1 2026	Raw material to customer — multiple raw material lots (complex trace)
Q2 2026	International customer + multi-country distributors
Q3 2026	Rework trace exercise (rework lot → multiple finished lots)
Q4 2026	Full recall simulation (including mock press release and regulatory notification)

8.3 Lessons Learned Log

ID	Finding	Root Cause	CAPA	Status	Closure Date
LL-2025-01	Customer contact numbers outdated by 6 months in ERP	No periodic review of customer contact data	Implement annual customer data verification	Closed	15/06/2025
LL-2025-02	Raw material COA paper filing took 25 min to retrieve	Off-site archiving of old records	Digitise all COAs for last 5 years; implement scanning at receiving	Closed	30/07/2025
LL-2025-03	SCADA time stamp discrepancy vs batch record by 8 min	Clock drift on SCADA terminal	Enable NTP sync on all SCADA terminals	In progress	—

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Appendices

• Appendix A: Traceability Report Form (One-Step-Back) — FS-TRC-F01
• Appendix B: Traceability Report Form (One-Step-Forward) — FS-TRC-F02
• Appendix C: Press Release Template — FS-TRC-F03
• Appendix D: Recall Contact Tree (pocket card)
• Appendix E: Lot Number Encoding Quick Reference Guide

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End of Document — FS-TRC-001