Product Design Safety Evaluations
Aligned with FSSC 22000 – ISO-Based Food Safety Management System (FSMS)
(Supports ISO 22000:2018 Clause 8.5.1 – Control of Product and Process Design)
Requirement Overview
Under FSSC 22000, organizations are expected to control the design and development of products and processes to ensure they are safe, legal, and meet customer expectations. This aligns with ISO 22000:2018 Clause 8.5.1, which requires that changes in products or processes be planned, validated, and controlled to prevent adverse effects on food safety.
A product design safety evaluation is a proactive approach to identifying potential hazards or risks during the development of new or modified food products, ingredients, packaging, or production methods. It supports regulatory compliance, consumer protection, and continuous improvement.
Key Compliance Objectives
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✓ Evaluate food safety risks for new or modified products before market release
✓ Ensure products meet applicable legal, regulatory, and customer requirements
✓ Assess risks related to intended use, misuse, allergens, and consumer interaction
✓ Document and retain safety review and approval records
Step-by-Step Compliance Implementation
1. Establish a Product Safety Evaluation Process
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Process Elements:
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• Appoint qualified personnel from R&D, QA, and regulatory teams
• Create a formal product safety evaluation procedure linked to FSMS
• Integrate safety reviews into product development stage-gates
Evidence to Maintain:
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• Documented SOP for product design and safety review
• Process maps outlining approval flow
• Assigned roles and responsibilities for evaluation
- • Appoint qualified personnel from R&D, QA, and regulatory teams • Create a formal product safety evaluation procedure linked to FSMS • Integrate safety reviews into product development stage-gates
- • Documented SOP for product design and safety review • Process maps outlining approval flow • Assigned roles and responsibilities for evaluation
2. Conduct Risk-Based Safety Assessments
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Assessment Criteria Should Include:
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• Intended use, preparation, and end-consumer groups
• Ingredient safety (e.g., allergens, toxins, raw materials)
• Process-related hazards (e.g., cross-contamination, CCPs)
• Labelling accuracy, shelf-life validation, and packaging safety
• Compliance with applicable legislation (e.g., FDA, EU, Codex, FSMA)
Evidence to Maintain:
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• Risk assessment checklists and reports
• Material Safety Data Sheets (MSDS)
• Allergen risk analysis and packaging compatibility assessments
- • Intended use, preparation, and end-consumer groups • Ingredient safety (e.g., allergens, toxins, raw materials) • Process-related hazards (e.g., cross-contamination, CCPs) • Labelling accuracy, shelf-life validation, and packaging safety • Compliance with applicable legislation (e.g., FDA, EU, Codex, FSMA)
- • Risk assessment checklists and reports • Material Safety Data Sheets (MSDS) • Allergen risk analysis and packaging compatibility assessments
3. Approve Product for Market Release
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Approval Requirements:
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• Sign-off by QA, food safety team, or authorized manager
• Verification of hazard controls and process validation
• Documentation confirming legal and regulatory compliance
Evidence to Maintain:
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• Signed design safety evaluation forms
• Change control and validation logs
• Certificates of compliance, product specifications, and testing reports
- • Sign-off by QA, food safety team, or authorized manager • Verification of hazard controls and process validation • Documentation confirming legal and regulatory compliance
- • Signed design safety evaluation forms • Change control and validation logs • Certificates of compliance, product specifications, and testing reports
4. Reassess Upon Change or Trigger Events
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Trigger Events:
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• Product design changes or reformulation
• New supplier, raw material, or process changes
• Recalls, complaints, or regulatory findings
• Updates in relevant food laws or standards
Evidence to Maintain:
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• Updated safety evaluations and risk assessments
• Records of internal reviews tied to change control
• Reports from investigations related to consumer safety
- • Product design changes or reformulation • New supplier, raw material, or process changes • Recalls, complaints, or regulatory findings • Updates in relevant food laws or standards
- • Updated safety evaluations and risk assessments • Records of internal reviews tied to change control • Reports from investigations related to consumer safety
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented design safety evaluation | Create a formal procedure and link it to FSMS clause 8.5.1 |
| Generic or incomplete risk assessments | Tailor evaluations to specific product risks and legal markets |
| Missing proof of compliance | Retain up-to-date records of testing and legal certifications |
| No reassessment after significant change | Use your change control process to trigger design reviews |