Material Hazard Management
Aligned with BRCGS Packaging Materials Issue 6 – Clause 3.5.1
Requirement Overview
BRCGS Packaging Materials Issue 6 – Clause 3.5.1.1 requires:
“The company shall have a documented procedure for the assessment of hazards posed to the product by raw materials, including primary packaging and other materials used in manufacturing. This assessment shall form part of the supplier approval and ongoing verification process.”
Material hazard management is a critical element in ensuring the safety, legality, and quality of packaging products. Risk assessments must consider all materials used, their sources, and their potential to introduce contamination, including chemical, physical, microbiological, or allergenic hazards.
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 assess hazards associated with raw and packaging materials
✓ Maintain a risk-based supplier evaluation and approval system
✓ Implement controls for high-risk materials and suppliers
✓ Ensure documented traceability and verification records are up-to-date
Step-by-Step Compliance Implementation
1. Create a Material Hazard Risk Assessment Procedure
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Required Actions:
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• List all raw materials, components, and packaging materials
• Assess potential hazards for each (e.g., migration risks, foreign body, contamination)
• Assign risk ratings and justification
Evidence to Maintain:
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• Risk assessment matrix or worksheet
• Criteria for classification of risk (low, medium, high)
• Reviewed and approved procedure for risk assessment
- • List all raw materials, components, and packaging materials • Assess potential hazards for each (e.g., migration risks, foreign body, contamination) • Assign risk ratings and justification
- • Risk assessment matrix or worksheet • Criteria for classification of risk (low, medium, high) • Reviewed and approved procedure for risk assessment
2. Integrate Risk Assessment into Supplier Approval
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Integration Includes:
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• Linking material hazard ratings to supplier risk level
• Requiring additional controls or testing for high-risk items
• Aligning supplier audits and COAs with risk level
Evidence to Maintain:
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• Supplier approval forms referencing material risk
• Certificates of Analysis (COAs) or compliance declarations
• Audit reports for high-risk material suppliers
- • Linking material hazard ratings to supplier risk level • Requiring additional controls or testing for high-risk items • Aligning supplier audits and COAs with risk level
- • Supplier approval forms referencing material risk • Certificates of Analysis (COAs) or compliance declarations • Audit reports for high-risk material suppliers
3. Implement Hazard Controls and Specifications
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Control Methods May Include:
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• Incoming material inspection and sampling
• Material specifications with safety parameters
• Supplier testing requirements and traceability systems
Evidence to Maintain:
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• Material specifications signed by both parties
• Receiving inspection logs and rejection records
• Test reports, third-party analysis results
- • Incoming material inspection and sampling • Material specifications with safety parameters • Supplier testing requirements and traceability systems
- • Material specifications signed by both parties • Receiving inspection logs and rejection records • Test reports, third-party analysis results
4. Conduct Ongoing Verification and Review
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Verification Includes:
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• Scheduled re-assessment of materials and hazards
• Monitoring supplier performance and material complaints
• Adjusting risk ratings based on new data or incidents
Evidence to Maintain:
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• Annual material risk review documentation
• Complaint trend analysis and CAPA records
• Updated risk ratings and supplier statuses
- • Scheduled re-assessment of materials and hazards • Monitoring supplier performance and material complaints • Adjusting risk ratings based on new data or incidents
- • Annual material risk review documentation • Complaint trend analysis and CAPA records • Updated risk ratings and supplier statuses
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented material risk assessment | Create and implement a material hazard evaluation procedure |
| Hazards not linked to supplier approval | Integrate risk into supplier assessment and verification steps |
| Outdated or missing specifications | Review and update material specs regularly |
| No follow-up after risk changes | Schedule regular reviews and revise controls based on trends |