Process Control: Start-Up & Changeover Procedures
Aligned with BRCGS Food Safety Issue 9 – Clause 5.3 and Clause 6.1
Requirement Overview
BRCGS Food Safety Issue 9 emphasizes the importance of process control to ensure product integrity and food safety. Clause 5.3 requires that processes be controlled to meet product specifications, while Clause 6.1 mandates hygiene and product protection during start-up, shutdown, and changeover activities.
Clause 5.3.1: “The company shall operate procedures to ensure that product formulation and manufacturing processes meet the specified requirements…”
Clause 6.1.1: “There shall be documented and implemented procedures to ensure product safety, legality and quality during start-up, shut-down and product changeover.”
Start-up and changeover procedures help prevent contamination, incorrect product formulation, and allergen cross-contact, especially in high-risk or high-care environments.
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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✓ Prevent contamination and ensure clean equipment at start-up
✓ Avoid cross-contact between different product types or allergens
✓ Maintain process integrity during line transitions
✓ Document all checks and verifications for traceability
Step-by-Step Compliance Implementation
1. Develop and Document Start-Up & Changeover Procedures
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Key Elements to Include:
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• Equipment inspection and sanitation confirmation
• Line clearance verification (previous product, tools, materials)
• Product formulation or packaging material checks
• Pre-operational verification and release
Evidence to Maintain:
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• Start-up and changeover SOPs
• Cleaning records and verification logs
• Line clearance and pre-op checklists
- • Equipment inspection and sanitation confirmation • Line clearance verification (previous product, tools, materials) • Product formulation or packaging material checks • Pre-operational verification and release
- • Start-up and changeover SOPs • Cleaning records and verification logs • Line clearance and pre-op checklists
2. Assign Roles and Train Personnel
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Responsibilities Include:
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• QA/Production verifying line readiness
• Operators confirming material and formulation setup
• Maintenance team inspecting equipment readiness
Evidence to Maintain:
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• Training records specific to changeover protocols
• Job descriptions outlining responsibilities
• Verification sign-off sheets
- • QA/Production verifying line readiness • Operators confirming material and formulation setup • Maintenance team inspecting equipment readiness
- • Training records specific to changeover protocols • Job descriptions outlining responsibilities • Verification sign-off sheets
3. Execute and Verify Changeover Controls
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Activities Include:
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• Removal of old product, labels, and packaging
• Inspection of conveyors, hoppers, and dosing equipment
• Allergen control and cleaning validation, if applicable
• Trial product inspection or initial product hold
Evidence to Maintain:
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• Completed changeover logs with time/date/operator
• QA verification reports
• Hold-and-release forms for first production runs
- • Removal of old product, labels, and packaging • Inspection of conveyors, hoppers, and dosing equipment • Allergen control and cleaning validation, if applicable • Trial product inspection or initial product hold
- • Completed changeover logs with time/date/operator • QA verification reports • Hold-and-release forms for first production runs
4. Monitor, Review, and Improve
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Ongoing Activities:
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• Regular internal audits of changeover compliance
• Review of incidents or product non-conformances linked to start-up or changeovers
• Improvements based on audit findings or customer complaints
Evidence to Maintain:
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• Internal audit reports
• Root cause analysis of non-conformances
• Updated SOPs and training documentation
- • Regular internal audits of changeover compliance • Review of incidents or product non-conformances linked to start-up or changeovers • Improvements based on audit findings or customer complaints
- • Internal audit reports • Root cause analysis of non-conformances • Updated SOPs and training documentation
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| Incomplete or undocumented changeovers | Use standardized checklists and verification logs |
| Cross-contact or mislabeling post-changeover | Strengthen allergen validation and label checks |
| No verification of equipment cleanliness | Implement documented visual and ATP inspections |
| No formal training on procedures | Provide documented role-based training and re-certification |