Process Control – Product Changeover Controls
Process Control – Product Changeover Controls
Requirement Overview
BRCGS Food Safety Issue 9 emphasizes the importance of maintaining strict process control during product changeovers, particularly when switching between allergenic and non-allergenic products, or between products of different specifications.
Clause 5.3.7: “The site shall have a documented procedure for product changeovers to ensure effective line clearance and removal of product, packaging, and labels from previous production runs.”
Clause 6.3.6: “Procedures shall be in place to ensure that the correct product is in the correct packaging with the correct date code and label.”
Effective changeover controls protect against allergen cross-contact, label mix-ups, contamination, and regulatory non-conformance.
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
-
✓ Prevent product mislabeling, cross-contact, and contamination
✓ Ensure allergen and non-allergen segregation during transitions
✓ Maintain traceability and batch integrity
✓ Validate cleanliness of lines, equipment, and packaging areas
Step-by-Step Compliance Implementation
1. Develop a Documented Changeover Procedure
-
Procedure Must Include:
-
• Step-by-step instructions for equipment cleaning and clearance
• Removal of previous product, packaging, and labels
• Line release and re-verification before new run
• Allergen-specific control measures if applicable
Evidence to Maintain:
-
• Product changeover SOP
• Visual line clearance checklist
• Approval logs from QA or line supervisors
- • Step-by-step instructions for equipment cleaning and clearance • Removal of previous product, packaging, and labels • Line release and re-verification before new run • Allergen-specific control measures if applicable
- • Product changeover SOP • Visual line clearance checklist • Approval logs from QA or line supervisors
2. Conduct Pre-Changeover Risk Assessments
-
Assessment Focus:
-
• Product compatibility (e.g., allergens, flavors, cleaning needs)
• Risk of label confusion or residual carry-over
• Type of cleaning required (dry clean vs. wet clean)
Evidence to Maintain:
-
• Pre-changeover risk assessment forms
• Allergen risk evaluations
• Cleaning validation records
- • Product compatibility (e.g., allergens, flavors, cleaning needs) • Risk of label confusion or residual carry-over • Type of cleaning required (dry clean vs. wet clean)
- • Pre-changeover risk assessment forms • Allergen risk evaluations • Cleaning validation records
3. Execute Changeover with Line Clearance
-
Required Activities:
-
• Physical removal of product, wrappers, inserts, labels
• Clean equipment and contact surfaces
• Inspect and verify clearance with QA sign-off
Evidence to Maintain:
-
• Completed line clearance checklist
• Photos (if required by procedure)
• QA line release sign-off forms
- • Physical removal of product, wrappers, inserts, labels • Clean equipment and contact surfaces • Inspect and verify clearance with QA sign-off
- • Completed line clearance checklist • Photos (if required by procedure) • QA line release sign-off forms
4. Verify and Document Line Readiness
-
Verification Includes:
-
• Correct product and packaging materials present
• Label verification (product name, date code, allergen info)
• Re-calibration of critical control points if applicable
Evidence to Maintain:
-
• Label verification log
• Equipment re-calibration record
• Start-up batch documentation
- • Correct product and packaging materials present • Label verification (product name, date code, allergen info) • Re-calibration of critical control points if applicable
- • Label verification log • Equipment re-calibration record • 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 physical inspection |
| No documentation of allergen switchover | Include allergen-specific changeover records and cleaning validation |
| Labeling errors during changeover | Implement dual verification (e.g., operator + QA) for labels |
| Incomplete line clearance documentation | Standardize and require sign-off for every line release |