Equipment & Facility Design for Risk Zones
Aligned with BRCGS Food Safety Issue 9 – Clauses 4.3 & 4.4
(High Care, High Risk, Ambient High Care Zones)
Requirement Overview
BRCGS Food Safety Issue 9 requires manufacturers to implement zoned production areas where the design, layout, and equipment used are appropriate for the product risk level and effectively control cross-contamination.
Clause 4.3.1: “Premises shall be designed, constructed and maintained to prevent contamination and facilitate hygiene operations appropriate to the nature of the product and production process.”
Clause 4.4.1: “The design and layout of equipment shall ensure that it is fit for purpose, permits cleaning and maintenance, and does not pose a risk of product contamination.”
These requirements are particularly critical in High Risk, High Care, and Ambient High Care zones, where vulnerable products must be protected from environmental and cross-contamination risks.
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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✓ Design facilities and equipment appropriate to the designated risk zone
✓ Control personnel and material movement to prevent contamination
✓ Ensure effective cleanability and segregation in all risk areas
✓ Maintain physical and procedural barriers between risk zones
Step-by-Step Compliance Implementation
1. Identify and Map Production Risk Zones
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Risk Zone Types Defined:
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• High Risk: Chilled RTE products with a high risk of pathogen growth
• High Care: Chilled RTE products with lower risk (e.g., no direct contamination risk post-processing)
• Ambient High Care: Shelf-stable RTE products at risk from environmental contamination
Evidence to Maintain:
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• Production risk zone classification map
• Zoning justification records
• Risk-based layout diagrams
- • High Risk: Chilled RTE products with a high risk of pathogen growth • High Care: Chilled RTE products with lower risk (e.g., no direct contamination risk post-processing) • Ambient High Care: Shelf-stable RTE products at risk from environmental contamination
- • Production risk zone classification map • Zoning justification records • Risk-based layout diagrams
2. Design Facilities to Match Zoning Requirements
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Facility Design Considerations:
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• Separate air handling units and positive air pressure in High Risk zones
• Physical barriers or walls between areas
• Temperature control systems and restricted access points
• Floor and drain design to prevent cross-zone contamination
Evidence to Maintain:
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• HVAC system design specs
• Floor plan with zoning details and flow direction
• Barrier and access control documentation
- • Separate air handling units and positive air pressure in High Risk zones • Physical barriers or walls between areas • Temperature control systems and restricted access points • Floor and drain design to prevent cross-zone contamination
- • HVAC system design specs • Floor plan with zoning details and flow direction • Barrier and access control documentation
3. Select Equipment Suitable for the Risk Zone
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Key Features to Include:
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• Hygienic design (e.g., smooth welds, no hollow frames)
• Easy to dismantle and clean
• Dedicated tools for each risk zone
• Resistant to corrosion and water ingress in washdown areas
Evidence to Maintain:
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• Equipment specs and approval records
• Cleaning validation reports
• Equipment zoning matrix or color-coding policy
- • Hygienic design (e.g., smooth welds, no hollow frames) • Easy to dismantle and clean • Dedicated tools for each risk zone • Resistant to corrosion and water ingress in washdown areas
- • Equipment specs and approval records • Cleaning validation reports • Equipment zoning matrix or color-coding policy
4. Control Personnel, Product, and Waste Flows
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Flow Controls Must Include:
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• Controlled staff entry with hygiene stations and changing rooms
• Separated raw and finished product routes
• Controlled waste removal from High Risk areas
• Color-coded PPE and utensils to prevent cross-use
Evidence to Maintain:
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• Personnel flow diagrams
• PPE zoning policy
• Waste management SOPs and logs
- • Controlled staff entry with hygiene stations and changing rooms • Separated raw and finished product routes • Controlled waste removal from High Risk areas • Color-coded PPE and utensils to prevent cross-use
- • Personnel flow diagrams • PPE zoning policy • Waste management SOPs and logs
5. Validate and Monitor Risk Control Measures
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Ongoing Control Activities:
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• Environmental monitoring program (EMP) for risk zones
• Routine hygiene validation and swabbing
• Internal audits of zoning effectiveness
• Periodic airflow and pressure verification
Evidence to Maintain:
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• EMP records
• Zoning audits and corrective actions
• Pressure differential readings and HVAC service logs
- • Environmental monitoring program (EMP) for risk zones • Routine hygiene validation and swabbing • Internal audits of zoning effectiveness • Periodic airflow and pressure verification
- • EMP records • Zoning audits and corrective actions • Pressure differential readings and HVAC service logs
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented risk zone classification | Define and justify zone designations with supporting rationale |
| Inadequate segregation or air control | Upgrade physical or airflow barriers between risk zones |
| Equipment not fit for high care use | Replace or modify to meet hygienic design standards |
| Poor personnel or product flow control | Redesign routes and retrain staff on zoning policies |