Production Risk Zones & Segregation
Aligned with FSSC 22000 - High Risk • High Care • Ambient High Care
Requirement Overview
FSSC 22000 requires that the production of products in high-risk, high-care, or ambient high-care areas be managed to prevent contamination. Facilities must identify, segregate, and control these zones to protect product integrity, maintain hygiene standards, and prevent cross-contamination.
Premises and process flows must be designed, constructed, and maintained to effectively separate manufacturing zones and reduce contamination risks. Proper classification and segregation are critical for ready-to-eat (RTE) or high-sensitivity products.
Aligned with BRCGS for Storage & Distribution Issue 4 – Clause 4.3.1 & 4.3.3
Requirement Overview
BRCGS for Storage & Distribution requires that products moved via cross-docking are traceable and controlled at all times, even when they are not held in storage for extended periods.
Clause 4.3.1: “The company shall ensure that traceability is maintained at all stages, including during cross-docking operations.”
Clause 4.3.3: “Procedures shall be in place to ensure that all products handled, including those not stored on-site, remain under control and are not subject to contamination or substitution.”
Cross-docking operations must not compromise product traceability, safety, or integrity. Even with minimal handling and temporary presence, each product must be accurately identified, documented, and protected.
Key Compliance Objectives
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✓ Identify and validate risk zones based on product and process risk
✓ Implement physical and procedural segregation measures
✓ Control the movement of personnel, equipment, and air
✓ Maintain zoning maps, cleaning protocols, and verification records
Step-by-Step Compliance Implementation
1. Identify and Classify Risk Zones
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Zone Classifications:
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• High Risk – RTE products with high exposure risk (e.g., cooked meats)
• High Care – RTE products requiring protection from recontamination (e.g., sandwiches)
• Ambient High Care – Shelf-stable products requiring strict hygiene (e.g., flow-wrapped snacks)
Evidence to Maintain:
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• Risk zone assessment documentation
• Product classification and process flow diagrams
• Justification for each area’s risk level
- • High Risk – RTE products with high exposure risk (e.g., cooked meats) • High Care – RTE products requiring protection from recontamination (e.g., sandwiches) • Ambient High Care – Shelf-stable products requiring strict hygiene (e.g., flow-wrapped snacks)
- • Risk zone assessment documentation • Product classification and process flow diagrams • Justification for each area’s risk level
2. Design Effective Physical Segregation
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Segregation Measures Include:
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• Separate rooms, walls, barriers, or airlocks
• Positive air pressure in High Risk areas
• Controlled drainage flow from clean to dirty zones
Evidence to Maintain:
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• Facility zoning layouts with marked barriers
• Air pressure monitoring logs
• Maintenance records for doors, filters, and seals
- • Separate rooms, walls, barriers, or airlocks • Positive air pressure in High Risk areas • Controlled drainage flow from clean to dirty zones
- • Facility zoning layouts with marked barriers • Air pressure monitoring logs • Maintenance records for doors, filters, and seals
3. Implement Procedural Segregation Controls
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Key Controls:
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• Staff zoning with uniform color coding
• Dedicated tools, utensils, and PPE per zone
• Entry controls such as handwashing, boot wash, and changing areas
Evidence to Maintain:
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• SOPs for personnel and material movement
• Zone-specific equipment logs
• Uniform and hygiene compliance checks
- • Staff zoning with uniform color coding • Dedicated tools, utensils, and PPE per zone • Entry controls such as handwashing, boot wash, and changing areas
- • SOPs for personnel and material movement • Zone-specific equipment logs • Uniform and hygiene compliance checks
4. Validate and Monitor Risk Zone Effectiveness
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Verification Methods:
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• Environmental swabbing for relevant pathogens
• Internal audits and inspections
• Staff training assessments on zone protocols
Evidence to Maintain:
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• Microbial test results by zone
• Audit checklists and CAPAs
• Training attendance and evaluation records
- • Environmental swabbing for relevant pathogens • Internal audits and inspections • Staff training assessments on zone protocols
- • Microbial test results by zone • Audit checklists and CAPAs • Training attendance and evaluation records
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| Undefined or inconsistent zoning | Conduct a risk assessment and create zoning maps |
| Cross-use of utensils or PPE across zones | Implement color-coded equipment and strict segregation policies |
| Airflow issues in High Risk areas | Install pressure controls and maintain HVAC filters |
| No validation of hygiene effectiveness | Start routine environmental monitoring in each zone |