Packaging Design Control
Aligned with BRCGS for Packaging Materials Issue 6 – Clause 3.3 Design and Development
Requirement Overview
BRCGS for Packaging Materials Issue 6, Clause 3.3, requires that companies control the design and development of packaging materials to ensure product safety, legality, and functional suitability.
Clause 3.3.1: “The company shall have a procedure to manage the design and development of products to ensure that product safety, legality, and quality are maintained.”
Design controls help prevent contamination risks, compatibility issues, and regulatory non-compliance throughout the product lifecycle.
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 packaging materials are safe, legal, and fit for purpose
✓ Prevent design flaws that could compromise food safety or functionality
✓ Document the design, approval, and change management processes
✓ Align packaging specifications with customer, legal, and end-use requirements
Step-by-Step Compliance Implementation
1. Establish a Packaging Design Procedure
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Procedure Should Include:
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• Roles and responsibilities during design and development
• Verification of regulatory and customer requirements
• Risk assessment during material or format changes
Evidence to Maintain:
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• Documented design and development SOP
• Design control flowchart or checklist
• Assigned team roles and approval authorities
- • Roles and responsibilities during design and development • Verification of regulatory and customer requirements • Risk assessment during material or format changes
- • Documented design and development SOP • Design control flowchart or checklist • Assigned team roles and approval authorities
2. Define Design Inputs and Requirements
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Design Inputs May Include:
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• End-use conditions (e.g., food contact, temperature, shelf life)
• Customer specifications and legal requirements
• Environmental or mechanical stress factors
Evidence to Maintain:
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• Signed customer packaging specifications
• Food contact compliance declarations
• Regulatory requirement checklist
- • End-use conditions (e.g., food contact, temperature, shelf life) • Customer specifications and legal requirements • Environmental or mechanical stress factors
- • Signed customer packaging specifications • Food contact compliance declarations • Regulatory requirement checklist
3. Conduct Design Reviews and Risk Assessments
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Review Elements Should Cover:
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• Packaging integrity and compatibility with product
• Migration testing or compliance with applicable standards (e.g., EU 10/2011, FDA)
• Physical performance testing (e.g., seal strength, barrier properties)
Evidence to Maintain:
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• Completed risk assessments (e.g., HACCP for packaging)
• Validation and testing reports
• Design review meeting minutes
- • Packaging integrity and compatibility with product • Migration testing or compliance with applicable standards (e.g., EU 10/2011, FDA) • Physical performance testing (e.g., seal strength, barrier properties)
- • Completed risk assessments (e.g., HACCP for packaging) • Validation and testing reports • Design review meeting minutes
4. Approve and Control Final Designs
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Control Measures Include:
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• Approval of artwork, dielines, materials, and formats
• Controlled release of final packaging specs
• Version control and secure storage of packaging files
Evidence to Maintain:
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• Signed packaging approval forms
• Finalized and dated design specifications
• Document control log with version history
- • Approval of artwork, dielines, materials, and formats • Controlled release of final packaging specs • Version control and secure storage of packaging files
- • Signed packaging approval forms • Finalized and dated design specifications • Document control log with version history
5. Manage Design Changes
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Change Control Should Cover:
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• Triggers for re-evaluation (e.g., supplier changes, customer updates)
• Risk assessment and re-validation steps
• Customer notification and approval (if required)
Evidence to Maintain:
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• Design change request forms
• Updated risk assessments and testing data
• Notification logs and customer approvals
- • Triggers for re-evaluation (e.g., supplier changes, customer updates) • Risk assessment and re-validation steps • Customer notification and approval (if required)
- • Design change request forms • Updated risk assessments and testing data • Notification logs and customer approvals
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No design control procedure in place | Implement a documented and approved design process |
| Incomplete packaging specifications | Finalize and control all key spec documents with sign-offs |
| No risk assessment during redesigns | Perform and document material/functionality risk reviews |
| Design changes not documented | Establish and maintain a formal change control log |