Product Design Safety Evaluations
Aligned with BRCGS for Consumer Products – Section 5.1 (Product Design and Safety Assessment)
Requirement Overview
BRCGS for Consumer Products requires that all new or modified products undergo formal safety assessments as part of the design and development process. This includes evaluating the product’s intended use, foreseeable misuse, regulatory compliance, and consumer safety risks.
“A documented safety assessment of the finished product shall be carried out to ensure the product is safe and fit for its intended use and complies with applicable legislation in the intended markets.”
This process ensures that your company identifies and mitigates safety risks before the product reaches the consumer, helping to prevent recalls, liability, and brand damage.
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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✓ Evaluate the safety of new or modified products during design
✓ Ensure products meet regulatory and legal requirements
✓ Assess foreseeable misuse and consumer interaction risks
✓ Document the evaluation and retain approval records
Step-by-Step Compliance Implementation
1. Establish a Product Safety Evaluation Process
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Key Components:
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• Assign qualified personnel (R&D, regulatory, safety officer)
• Define the safety evaluation workflow
• Link safety review to the product development stage-gates
Evidence to Maintain:
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• Product design and safety assessment SOP
• Defined roles and responsibilities
• Documented safety review process map
- • Assign qualified personnel (R&D, regulatory, safety officer) • Define the safety evaluation workflow • Link safety review to the product development stage-gates
- • Product design and safety assessment SOP • Defined roles and responsibilities • Documented safety review process map
2. Conduct Risk-Based Safety Assessments
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Assessment Criteria:
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• Intended use and consumer demographics
• Materials and chemical composition (e.g., allergens, toxins)
• Functional, physical, and mechanical hazards
• Packaging safety and labelling accuracy
• Compliance with applicable legislation (e.g., EU REACH, FDA, CPSIA)
Evidence to Maintain:
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• Completed safety evaluation forms or checklists
• Material safety data sheets (MSDS)
• Risk assessment reports for functional and misuse risks
- • Intended use and consumer demographics • Materials and chemical composition (e.g., allergens, toxins) • Functional, physical, and mechanical hazards • Packaging safety and labelling accuracy • Compliance with applicable legislation (e.g., EU REACH, FDA, CPSIA)
- • Completed safety evaluation forms or checklists • Material safety data sheets (MSDS) • Risk assessment reports for functional and misuse risks
3. Approve Product for Market Release
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Approval Requirements:
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• Formal sign-off from technical, regulatory, or quality manager
• Documentation of decision-making for design revisions
• Confirmation of regulatory and legal compliance
Evidence to Maintain:
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• Signed product safety approval form
• Documented non-conformities and change logs
• Regulatory compliance certificates or test reports
- • Formal sign-off from technical, regulatory, or quality manager • Documentation of decision-making for design revisions • Confirmation of regulatory and legal compliance
- • Signed product safety approval form • Documented non-conformities and change logs • Regulatory compliance certificates or test reports
4. Reassess When Design or Use Changes
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Trigger Events Include:
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• Design modification or reformulation
• Change in raw materials or components
• Consumer complaints or safety incidents
• Regulatory updates
Evidence to Maintain:
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• Updated design safety assessment
• Investigation reports for consumer feedback
• Change control records
- • Design modification or reformulation • Change in raw materials or components • Consumer complaints or safety incidents • Regulatory updates
- • Updated design safety assessment • Investigation reports for consumer feedback • Change control records
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented product safety evaluation | Establish a formal product safety assessment SOP |
| Risk assessments too generic | Tailor assessments to product-specific and market-specific risks |
| Missing regulatory verification | Keep updated records of legal requirements and safety test reports |
| No reassessment after design change | Use change control procedures to trigger reassessments |