HACCP Plan — FlaxSeedsPro Processing Facility¶
Document No.: FSP-HACCP-001
Revision: 01
Effective Date: 2026-07-20
Approved By: Food Safety Team Leader
1. HACCP Team and Roles¶
| Name | Position | Role on HACCP Team | Responsibilities |
|---|---|---|---|
| Alice Chen | Food Safety Manager | Team Leader | Oversees plan development, validation, verification, and updates |
| Bob Martinez | Production Manager | Team Member | Process flow validation, CCP monitoring oversight, corrective actions |
| Carol Singh | Quality Assurance Supervisor | HACCP Coordinator | Hazard analysis, critical limit setting, record review, CCP verification |
| David Osei | Maintenance Engineer | Team Member | Equipment-related hazard assessment, preventive maintenance scheduling |
| Elena Rossi | Supply Chain Manager | Team Member | Supplier approval, raw material hazard assessment, receiving/storage PRPs |
| Frank Nakamura | Sanitation Lead | Team Member | Cleaning/sanitation procedures, allergen cross-contact control |
| Grace Kim | Training Coordinator | Team Member | HACCP training delivery, competency records, SOP updates |
Responsibilities of the HACCP Team: - Conduct hazard analysis using Codex Alimentarius methodology - Determine CCPs via Codex decision tree - Establish critical limits, monitoring procedures, corrective actions - Validate critical limits with scientific evidence - Review and update the HACCP plan annually or upon process/equipment change - Maintain records per document control procedure
2. Product Descriptions¶
2.1 Product Overview¶
| Attribute | Whole Brown Flaxseeds | Whole Golden Flaxseeds | Milled Flaxseed (Brown) | Milled Flaxseed (Golden) | Cold-Pressed Flaxseed Oil |
|---|---|---|---|---|---|
| Composition | 100% whole brown flaxseeds (Linum usitatissimum) | 100% whole golden flaxseeds | 100% ground brown flaxseeds, no additives | 100% ground golden flaxseeds, no additives | 100% expeller-pressed flaxseed oil, natural tocopherols added as antioxidant |
| Packaging | 25 kg multi-wall paper bags with PE liner | 25 kg multi-wall paper bags with PE liner | 25 kg laminated foil bags, nitrogen-flushed | 25 kg laminated foil bags, nitrogen-flushed | 20 L HDPE jerry cans, nitrogen-purged headspace |
| Storage | Cool, dry (<25°C, <65% RH), away from direct sunlight | Cool, dry (<25°C, <65% RH), away from direct sunlight | Cool, dry (<25°C, <65% RH), sealed | Cool, dry (<25°C, <65% RH), sealed | Cool, dark (15–20°C), sealed, protected from light |
| Shelf Life | 12 months from production | 12 months from production | 9 months from production | 9 months from production | 12 months from production |
| Intended Use | Ingredient for B2B food manufacturing (bakery, cereals, nutritional bars, smoothies, animal feed) | Ingredient for B2B food manufacturing (bakery, cereals, nutritional bars, smoothies) | Ingredient for B2B food manufacturing (bakery, beverages, nutritional blends) | Ingredient for B2B food manufacturing (bakery, beverages, nutritional blends) | Ingredient for B2B food manufacturing (dressings, supplements, nutraceuticals) |
| Target Consumers | General population (not for infants <6 months due to choking hazard for whole seeds) | General population (not for infants <6 months) | General population | General population | General population |
| Distribution | Ambient, food-grade containers, sealed trucks | Ambient, food-grade containers, sealed trucks | Ambient, food-grade containers, sealed trucks | Ambient, food-grade containers, sealed trucks | Ambient, food-grade containers, sealed trucks |
2.2 Intended Use Statement¶
All products are intended exclusively as food ingredients for B2B manufacturing. They are not packaged for direct retail sale to consumers. End users are licensed food processing facilities that incorporate flaxseed products as ingredients in their own finished goods (bakery items, cereals, nutritional bars, beverages, dressings, supplements, and animal feed). Products are not intended for direct consumption without further processing by the customer.
3. Process Flow Diagrams¶
3.1 Route A — Whole Brown Flaxseeds¶
[Raw Brown Flaxseeds Receiving]
|
[Pre-Cleaning (Magnet + Aspirator)]
|
[Gravity Separation / Destoning]
|
[Optical Sorting (Colour Sorter)]
|
[Grading (Sieve Classification)]
|
[Metal Detection (Reject Gate)]
|
[Packaging into 25 kg bags]
|
[Metal Detection (Final Check)]
|
[Palletizing & Stretch Wrapping]
|
[Cold Storage (Ambient Holding)]
|
[Dispatch]
3.2 Route B — Whole Golden Flaxseeds¶
[Raw Golden Flaxseeds Receiving]
|
[Pre-Cleaning (Magnet + Aspirator)]
|
[Gravity Separation / Destoning]
|
[Optical Sorting (Colour Sorter)]
|
[Grading (Sieve Classification)]
|
[Metal Detection (Reject Gate)]
|
[Packaging into 25 kg bags]
|
[Metal Detection (Final Check)]
|
[Palletizing & Stretch Wrapping]
|
[Cold Storage (Ambient Holding)]
|
[Dispatch]
3.3 Route C — Milled Brown Flaxseed¶
[Whole Brown Flaxseeds (from Route A stock)]
|
[Metal Detection (Pre-Grind Check)]
|
[Grinding (Hammer Mill, < 40°C)]
|
[Sieving (250 µm screen)]
|
[Metal Detection (Post-Grind)]
|
[Nitrogen Flush & Packaging (25 kg foil bags)]
|
[Metal Detection (Final Check)]
|
[Palletizing & Stretch Wrapping]
|
[Cold Storage (Ambient Holding)]
|
[Dispatch]
3.4 Route D — Milled Golden Flaxseed¶
[Whole Golden Flaxseeds (from Route B stock)]
|
[Metal Detection (Pre-Grind Check)]
|
[Grinding (Hammer Mill, < 40°C)]
|
[Sieving (250 µm screen)]
|
[Metal Detection (Post-Grind)]
|
[Nitrogen Flush & Packaging (25 kg foil bags)]
|
[Metal Detection (Final Check)]
|
[Palletizing & Stretch Wrapping]
|
[Cold Storage (Ambient Holding)]
|
[Dispatch]
3.5 Route E — Cold-Pressed Flaxseed Oil¶
[Whole Brown or Golden Flaxseeds (from Route A/B stock)]
|
[Metal Detection (Pre-Press Check)]
|
[Conditioning (Screw Heater, 35–40°C)]
|
[Screw Expeller (Cold Press, < 45°C)]
|
[Primary Filtration (Vibrating Screen, 150 µm)]
|
[Polish Filtration (Plate & Frame, 50 µm)]
|
[Metal Detection]
|
[Nitrogen Purge & Filling (20 L HDPE jerry cans)]
|
[Capping & Tamper-Evident Sealing]
|
[Labeling & Dating]
|
[Palletizing]
|
[Finished Product Storage (15–20°C, dark)]
|
[Dispatch]
4. Hazard Analysis Worksheet (Codex Format)¶
| Process Step | Hazard Category | Hazard Description | Source | Likelihood | Severity | Risk | Preventive Measure | Control Type |
|---|---|---|---|---|---|---|---|---|
| Receiving (Raw Seeds) | B | Salmonella, E. coli O157, Cronobacter | Contaminated soil, bird droppings, irrigation water | Medium | High | High | Supplier approval program, COA review, third-party lab testing per lot | PRP (Supplier Control) |
| Receiving (Raw Seeds) | C | Mycotoxins (aflatoxin, ochratoxin A) | Fungal growth during harvest/storage under poor conditions | Low | High | Medium | Supplier guarantee, COA for mycotoxins, visual inspection for mould | PRP (Supplier Control) |
| Receiving (Raw Seeds) | P | Foreign material (stones, metal, glass, plastic, wood) | Harvesting practices, transport contamination | Medium | Medium | Medium | Pre-cleaning step, supplier quality agreement | PRP (Supplier Control) |
| Pre-Cleaning (Magnet + Aspirator) | P | Incomplete removal of ferrous metal, light chaff | Magnet saturation, airflow imbalance | Low | Medium | Low | Daily magnet cleaning, airflow calibration weekly | OPRP |
| Gravity Separation / Destoning | P | Stones, heavy debris not removed | Screen wear, airflow misalignment | Low | Medium | Low | Weekly equipment inspection, preventive maintenance | OPRP |
| Optical Sorting | P | Foreign material, discoloured seeds not ejected | Camera lens dirt, compressed-air nozzle blockage | Low | Medium | Low | Daily lens cleaning, nozzle function test each shift | OPRP |
| Metal Detection (Reject Gate) | P | Ferrous and non-ferrous metal fragments | Equipment wear, broken machinery parts | Medium | High | High | CCP 1: Metal detector with reject verification | CCP |
| Grinding (Hammer Mill) | P | Metal fragments from mill wear | Worn hammers, screen breakage | Medium | High | High | Post-grind metal detection, preventive maintenance schedule | CCP (covered by CCP 1 downstream) |
| Grinding (Hammer Mill) | B | Microbial growth due to heat generation | Mill temperature > 50°C enabling mesophile growth | Low | High | Medium | Mill temperature monitoring ≤ 40°C, sanitation schedule | OPRP |
| Sieving (250 µm) | P | Oversized particles, screen breakage → metal contamination | Screen fatigue | Low | Medium | Low | Daily screen integrity check, monthly replacement schedule | OPRP |
| Nitrogen Flush & Packaging | C | Oxidative rancidity (lipid oxidation) — chemical | Inadequate oxygen removal, poor seal integrity | Medium | Low | Medium | Verify O₂ < 2% in headspace, seal integrity test each run | OPRP |
| Cold Press (Expeller) | B | Pathogen survival (Salmonella, E. coli) | Inadequate press temperature, cross-contamination | Low | High | Medium | Press temperature < 45°C maintained; raw material testing; sanitation | PRP (Sanitation) |
| Cold Press (Expeller) | P | Metal fragments from screw/wear parts | Expeller screw wear, barrel scoring | Low | High | Medium | Post-filtration metal detection, annual screw replacement | CCP (covered by CCP 2) |
| Filtration (Polish, 50 µm) | P | Metal fragments not removed | Filter media bypass, housing gasket failure | Low | Medium | Low | Daily pressure differential monitoring, PM schedule | OPRP |
| Metal Detection (Final Check) | P | Ferrous and non-ferrous metal fragments | Any upstream equipment failure | Medium | High | High | CCP 2: Final product metal detection with reject verification | CCP |
| Labeling | A | Allergen mislabeling — undeclared allergen | Wrong label applied, label content error | Low | High | High | Label verification SOP, barcode scanning, visual check each pallet | OPRP |
Legend: B = Biological, C = Chemical, P = Physical, A = Allergen
5. CCP Determination Using Codex Decision Tree¶
CCP 1 — Metal Detection (Whole Seed Routes, Post-Grading)¶
| Decision Tree Question | Answer | Rationale |
|---|---|---|
| Q1: Does this step control a hazard? | Yes | Metal detection is designed to detect and reject ferrous and non-ferrous metal fragments |
| Q2: Is the hazard reduced to an acceptable level? | Yes | Detection with reject gate removes ≥ 99.5% of ferrous ≥ 1.0 mm and non-ferrous ≥ 1.5 mm spheres |
| Q3: Could contamination occur at or exceed acceptable levels? | Yes | Equipment wear, broken machinery parts can introduce metal at any time |
| Q4: Will a subsequent step eliminate the hazard? | No | For whole seed routes, there is no subsequent metal detection of equal sensitivity (final check is after packaging) |
| Conclusion | CCP | — |
CCP 2 — Metal Detection (Final Check, All Routes, Post-Packaging)¶
| Decision Tree Question | Answer | Rationale |
|---|---|---|
| Q1: Does this step control a hazard? | Yes | Final metal detector checks packaged product before dispatch |
| Q2: Is the hazard reduced to an acceptable level? | Yes | Detection sensitivity: Fe ≥ 1.0 mm, non-Fe ≥ 1.5 mm, SS ≥ 2.0 mm spheres |
| Q3: Could contamination occur at or exceed acceptable levels? | Yes | Post-packaging metal contamination from closure/sealing equipment or environmental sources |
| Q4: Will a subsequent step eliminate the hazard? | No | This is the final step before dispatch |
| Conclusion | CCP | — |
6. CCP Summary Table¶
| CCP | Process Step | Hazard | Critical Limit | Monitoring Method | Frequency | Responsible | Corrective Action | Verification | Records |
|---|---|---|---|---|---|---|---|---|---|
| CCP 1 | Metal Detection (Whole Seed Routes, Post-Grading) | Metal fragments (Fe, non-Fe, SS) | Fe ≥ 1.0 mm sphere → reject; non-Fe ≥ 1.5 mm sphere → reject; SS ≥ 2.0 mm sphere → reject | Calibrated test wand (Fe, non-Fe, SS) passed through active detector; verify reject gate activates | Every hour of production | Production Operator | 1. Segregate all product since last acceptable calibration check. 2. Re-run through detector. 3. Document in metal detection log. 4. Notify QA Supervisor. | 1. Daily QA review of metal detection logs. 2. Weekly functional test with NIST-traceable test pieces. 3. Annual calibration by certified technician. | Metal Detection Log (FSP-MDL-001), Corrective Action Report (FSP-CAR-001) |
| CCP 2 | Metal Detection (Final Check, All Routes) | Metal fragments (Fe, non-Fe, SS) | Fe ≥ 1.0 mm sphere → reject; non-Fe ≥ 1.5 mm sphere → reject; SS ≥ 2.0 mm sphere → reject | Calibrated test wand passed through active detector on conveyor; verify reject gate activates and alarm sounds | Every 30 minutes of production | Packaging Operator | 1. Stop production line. 2. Segregate and hold all product since last acceptable check. 3. Re-run through detector. 4. Investigate source. 5. Notify QA. 6. Do not release held product until QA clearance. | 1. Daily QA review of logs. 2. Monthly sensitivity validation with certified test pieces. 3. Annual third-party calibration. | Metal Detection Log (FSP-MDL-002), Corrective Action Report (FSP-CAR-001) |
7. Validation of Critical Limits¶
| CCP | Critical Limit | Scientific Basis | Reference |
|---|---|---|---|
| CCP 1 & CCP 2 | Fe ≥ 1.0 mm, non-Fe ≥ 1.5 mm, SS ≥ 2.0 mm | These limits align with Codex General Standard for Contaminants and Toxins in Food (CXS 193-1995) and FDA Health Hazard Evaluation for metal fragments: Fe ≥ 1.0 mm poses risk of oral injury; SS ≥ 2.0 mm is the industry benchmark for food safety detection. Balances detection sensitivity with false-reject rate acceptable for production throughput. | 1. FDA Health Hazard Evaluation Board (1988-present) — Metal-in-Food guidelines. 2. Codex CXS 193-1995. 3. Campden BRI Guideline 79: Metal Detection in Food. 4. BRCGS Global Standard for Food Safety Issue 9 — clause 5.4.1. |
8. Verification Procedures¶
| Verification Activity | Frequency | Responsible | Records |
|---|---|---|---|
| Review of CCP monitoring records | Daily | QA Supervisor | QA Daily Review Log |
| Review of corrective action reports | Weekly | Food Safety Manager | CAR Review Log |
| In-process CCP validation (metal detector sensitivity) | Monthly | QA Technician | Sensitivity Validation Report |
| Internal HACCP audit (full plan review) | Semi-annually | Internal Audit Team | Internal Audit Report |
| External third-party HACCP audit | Annually | Certified Third-Party | Third-Party Audit Report |
| Re-validation of critical limits | Annually or upon equipment change | HACCP Team | Validation Report |
| Review of customer complaints related to foreign material | Monthly | QA Supervisor | Complaint Trend Report |
| Calibration of metal detection equipment | Annually (external) | Certified Calibration Lab | Calibration Certificate |
9. Document Control and Record Keeping¶
| Requirement | Procedure |
|---|---|
| Document identification | Each document assigned unique ID (FSP-XXX-###) with revision number and date |
| Document approval | All HACCP documents signed and dated by Food Safety Manager before issue |
| Document changes | Change request submitted to HACCP Team; re-approval required; obsolete versions archived |
| Record retention | All HACCP records retained for minimum of 5 years (or product shelf life + 2 years, whichever is longer) |
| Record format | Paper logs maintained in designated binders; digital copies scanned to secure network drive daily |
| Access control | Paper records stored in QA office (locked); digital records in password-protected shared folder |
| Training records | HACCP training records maintained per FSP-TRN-001 for each operator assigned to CCP monitoring |
10. HACCP Plan Revision History¶
| Revision | Date | Description of Change | Author | Approved By |
|---|---|---|---|---|
| 00 | 2026-06-15 | Draft version for review | C. Singh | A. Chen |
| 01 | 2026-07-20 | Updated CCP decision tree rationale, added Route E oil process | A. Chen | A. Chen |
This HACCP plan is developed in accordance with Codex Alimentarius CAC/RCP 1-1969 Rev. 4 (2003), the U.S. FDA Juice HACCP principles (21 CFR Part 120) adapted for dry ingredient processing, and BRCGS Global Standard for Food Safety Issue 9 requirements.