Product Design & Development
Aligned with FSSC 22000
Requirement Overview
FSSC 22000 requires that all products introduced, reformulated, or changed must go through a formal product design and development process to ensure that food safety, legality, quality, and customer requirements are maintained.
A structured design and development process ensures that risks are assessed, controlled, and communicated before launch. This applies to new products, packaging, process changes, and ingredient substitutions.
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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✓ Ensure all new or modified products are safe, legal, and meet customer requirements
✓ Assess food safety risks related to formulation, packaging, and shelf life
✓ Conduct trials and validations before commercial production
✓ Document each stage of development with traceable records
Step-by-Step Compliance Implementation
1. Establish a Product Development Procedure
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Key Elements to Define:
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• Triggers for initiating product development (e.g., new recipe, reformulation, customer request)
• Roles and responsibilities of the development team
• Stage-gate process for development, testing, and approval
Evidence to Maintain:
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• Product development SOP
• Cross-functional team assignments
• Documented product development workflow
- • Triggers for initiating product development (e.g., new recipe, reformulation, customer request) • Roles and responsibilities of the development team • Stage-gate process for development, testing, and approval
- • Product development SOP • Cross-functional team assignments • Documented product development workflow
2. Conduct Product Risk Assessment
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Evaluation Criteria Include:
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• Ingredient hazards (e.g., allergens, chemical residues, microbiological risks)
• Process-related hazards (e.g., thermal processing, kill steps)
• Intended use and possible misuse by consumers
• Shelf life and labeling impact
Evidence to Maintain:
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• HACCP review or new hazard analysis
• Allergen assessment forms
• Risk evaluation report
- • Ingredient hazards (e.g., allergens, chemical residues, microbiological risks) • Process-related hazards (e.g., thermal processing, kill steps) • Intended use and possible misuse by consumers • Shelf life and labeling impact
- • HACCP review or new hazard analysis • Allergen assessment forms • Risk evaluation report
3. Validate Process and Packaging Suitability
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Activities to Perform:
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• Trial runs at pilot or production scale
• Packaging material compatibility and integrity tests
• Label and artwork review against regulatory and customer requirements
Evidence to Maintain:
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• Trial reports and production trial logs
• Packaging validation test results
• Approved label and artwork records
- • Trial runs at pilot or production scale • Packaging material compatibility and integrity tests • Label and artwork review against regulatory and customer requirements
- • Trial reports and production trial logs • Packaging validation test results • Approved label and artwork records
4. Review and Approve Before Launch
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Actions Include:
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• Final review by QA, food safety, and senior management
• Documented sign-off before the first commercial run
• Internal training and updated SOPs to reflect new product
Evidence to Maintain:
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• Signed approval documentation
• Updated product specification
• Training logs for affected staff
- • Final review by QA, food safety, and senior management • Documented sign-off before the first commercial run • Internal training and updated SOPs to reflect new product
- • Signed approval documentation • Updated product specification • Training logs for affected staff
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented development procedure | Create and implement a formal product development SOP |
| Incomplete risk assessments | Include allergen, HACCP, and regulatory reviews for all new products |
| Launch without final approvals | Require multi-department sign-off before commercial production |
| Unvalidated shelf life or packaging | Conduct stability and compatibility testing prior to launch |
