Production Risk Zones & Hygiene Controls
Aligned with FSSC 22000 (High Care, High Risk, Ambient High Care)
Requirement Overview
FSSC 22000 requires that facilities implement zoning controls to minimize the risk of contamination between different production areas. These zones are defined based on the vulnerability of the products and the risk of cross-contamination, with specific hygiene measures required for each.
Each zone must have appropriate physical separation, personnel flow controls, and hygiene protocols to protect ready-to-eat (RTE) or otherwise vulnerable 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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✓ Define and segregate hygiene zones based on product risk
✓ Implement hygiene and personnel controls appropriate to each zone
✓ Prevent cross-contamination between zones
✓ Document zoning rationale, maps, and hygiene procedures
Step-by-Step Compliance Implementation
1. Conduct a Zoning Risk Assessment
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Assessment Factors:
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• Type of product (RTE vs. raw)
• Process flow (open vs. closed systems)
• Microbiological risk of contamination
• Environmental controls (airflow, humidity, traffic patterns)
Evidence to Maintain:
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• Risk zoning assessment report
• Justification for zone classification (High Risk, High Care, etc.)
• Zoning map with clear boundaries
- • Type of product (RTE vs. raw) • Process flow (open vs. closed systems) • Microbiological risk of contamination • Environmental controls (airflow, humidity, traffic patterns)
- • Risk zoning assessment report • Justification for zone classification (High Risk, High Care, etc.) • Zoning map with clear boundaries
2. Define and Enforce Zoning Boundaries
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Control Methods Include:
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• Color-coded floor markings and signage
• Physical barriers and airlocks
• Entry/exit procedures and dedicated equipment
Evidence to Maintain:
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• Facility layout with zoning overlays
• Access control logs and zoning SOPs
• Photographic evidence of signage and barriers
- • Color-coded floor markings and signage • Physical barriers and airlocks • Entry/exit procedures and dedicated equipment
- • Facility layout with zoning overlays • Access control logs and zoning SOPs • Photographic evidence of signage and barriers
3. Implement Hygiene Controls Per Zone
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High Risk:
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• Strict segregation of raw and RTE areas
• Positive air pressure and HEPA filtration
• Dedicated clothing, footwear, and tools
• High-level handwashing and disinfection protocols
High Care:
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• Controlled entry with hygiene stations
• Temperature and air control
• Regular environmental swabbing
Ambient High Care:
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• Segregation from raw material areas
• Controlled personnel and equipment movement
• Focus on dry sanitation and allergen control
Evidence to Maintain:
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• Hygiene SOPs per zone
• Training logs for hygiene and gowning procedures
• Records of environmental monitoring and compliance checks
- • Strict segregation of raw and RTE areas • Positive air pressure and HEPA filtration • Dedicated clothing, footwear, and tools • High-level handwashing and disinfection protocols
- • Controlled entry with hygiene stations • Temperature and air control • Regular environmental swabbing
- • Segregation from raw material areas • Controlled personnel and equipment movement • Focus on dry sanitation and allergen control
- • Hygiene SOPs per zone • Training logs for hygiene and gowning procedures • Records of environmental monitoring and compliance checks
4. Control Movement Between Zones
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Movement Protocols:
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• Controlled personnel and material flow
• Gowning changes and hygiene checkpoints
• Disinfection of tools, trolleys, and containers
Evidence to Maintain:
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• Visitor and contractor logs with zone access records
• Cleaning and disinfection logs for cross-zone equipment
• Staff training acknowledgments on movement protocols
- • Controlled personnel and material flow • Gowning changes and hygiene checkpoints • Disinfection of tools, trolleys, and containers
- • Visitor and contractor logs with zone access records • Cleaning and disinfection logs for cross-zone equipment • Staff training acknowledgments on movement protocols
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No clear zoning boundaries | Use updated maps, signage, and physical barriers |
| Inconsistent hygiene controls between zones | Implement zone-specific SOPs and training |
| Shared tools or clothing across zones | Assign dedicated tools and PPE per zone |
| Inadequate staff awareness of zoning rules | Reinforce through induction and periodic refreshers |