Process Control – Product Changeover Controls
Aligned with FSSC 22000 Requirements
Requirement Overview
FSSC 22000 places emphasis on establishing and implementing line start-up and change-over procedures to ensure that products—including packaging and labeling—consistently meet applicable customer and legal requirements. These procedures must include controls to remove materials from previous runs, such as packaging and labels, to maintain product integrity and prevent cross-contamination or mislabeling.
Effective changeover controls are critical to preventing allergen cross-contact, label mix-ups, contamination, and ensuring regulatory compliance.
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 product mislabeling, cross-contact, and contamination
✓ Maintain segregation between allergenic and non-allergenic products during transitions
✓ Ensure traceability and preservation of batch integrity
✓ Validate cleanliness of lines, equipment, and packaging areas
Step-by-Step Compliance Implementation
1. Develop a Documented Changeover Procedure
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Procedure Must Include:
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• Step-by-step instructions for equipment cleaning and line clearance
• Removal of previous product, packaging, and labels
• Line re-verification and release before new production begins
• Allergen-specific controls when applicable
Evidence to Maintain:
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• Product changeover SOP
• Visual line-clearance checklist
• QA or line-supervisor approval logs
- • Step-by-step instructions for equipment cleaning and line clearance • Removal of previous product, packaging, and labels • Line re-verification and release before new production begins • Allergen-specific controls when applicable
- • Product changeover SOP • Visual line-clearance checklist • QA or line-supervisor approval logs
2. Conduct Pre-Changeover Risk Assessments
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Assessment Focus On:
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• Product compatibility (e.g., allergens, flavors, cleaning requirements)
• Risk of label confusion or residual contamination
• Appropriate cleaning method (e.g., dry vs wet cleaning)
Evidence to Maintain:
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• Pre-changeover risk assessment forms
• Allergen risk evaluation records
• Cleaning validation documentation
- • Product compatibility (e.g., allergens, flavors, cleaning requirements) • Risk of label confusion or residual contamination • Appropriate cleaning method (e.g., dry vs wet cleaning)
- • Pre-changeover risk assessment forms • Allergen risk evaluation records • Cleaning validation documentation
3. Execute Changeover with Line Clearance
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Required Activities:
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• Remove all previous product materials, wrappers, inserts, labels
• Clean equipment and contact surfaces according to SOP
• Inspect and verify clearance; require QA line-release sign-off
Evidence to Maintain:
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• Completed line-clearance checklist
• Photographic evidence (if required)
• QA line-release form or sign-off
- • Remove all previous product materials, wrappers, inserts, labels • Clean equipment and contact surfaces according to SOP • Inspect and verify clearance; require QA line-release sign-off
- • Completed line-clearance checklist • Photographic evidence (if required) • QA line-release form or sign-off
4. Verify and Document Line Readiness
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Verification Includes:
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• Confirm correct product and packaging materials are in place
• Check labels (product name, date code, allergen info) for accuracy
• Re-calibrate critical control points if needed before production start
Evidence to Maintain:
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• Label verification log
• Equipment re-calibration records
• Start-up batch documentation
- • Confirm correct product and packaging materials are in place • Check labels (product name, date code, allergen info) for accuracy • Re-calibrate critical control points if needed before production start
- • Label verification log • Equipment re-calibration records • Start-up batch documentation
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| Residual product or labels from prior run | Strengthen line-clearance checklist and include physical inspection step |
| No documentation of allergen switchover | Add allergen-specific cleaning records and validation to procedures |
| Labeling errors during changeover | Implement dual verification (operator + QA) for label accuracy |
| Incomplete line clearance documentation | Standardize and mandate sign-off for line readiness |