Corrective Actions
Aligned with HACCP Principles – Principle: Establish Corrective Actions
Requirement Overview
Per HACCP guidelines (Codex Alimentarius and 21 CFR 117.135), facilities must establish predefined corrective actions for deviations from critical limits at each Critical Control Point (CCP). These actions must ensure that unsafe products do not reach the market and that the root cause of the deviation is addressed to prevent recurrence.
Corrective actions are essential to protect consumer health, ensure regulatory compliance, and maintain food safety integrity.
Note: Corrective actions must be documented, verified, and subject to review during audits.
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 affected product from entering commerce
✓ Identify and correct the cause of deviation
✓ Document all actions taken, including disposition of product
✓ Review and adjust HACCP plan or SOPs if necessary
Step-by-Step Compliance Implementation
1. Define Corrective Actions for Each CCP
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Each CCP must have:
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• A clear statement of what to do if a critical limit is not met
• Roles and responsibilities for executing the corrective action
• Procedures for holding or disposing of affected product
Evidence to Maintain:
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• HACCP plan with corrective actions table
• Training records for staff assigned to CCPs
• Product hold logs and deviation records
- • A clear statement of what to do if a critical limit is not met • Roles and responsibilities for executing the corrective action • Procedures for holding or disposing of affected product
- • HACCP plan with corrective actions table • Training records for staff assigned to CCPs • Product hold logs and deviation records
2. Identify and Address the Root Cause
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Root Cause Analysis Includes:
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• Investigating the source of the failure (equipment, procedure, personnel, etc.)
• Determining if the issue is isolated or systemic
• Recording findings and recommending action
Evidence to Maintain:
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• Root cause investigation form
• Maintenance or retraining logs
• Corrective action verification records
- • Investigating the source of the failure (equipment, procedure, personnel, etc.) • Determining if the issue is isolated or systemic • Recording findings and recommending action
- • Root cause investigation form • Maintenance or retraining logs • Corrective action verification records
3. Disposition of Affected Product
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Possible Actions:
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• Rework, reprocess, or relabel
• Downgrade or discard
• Hold for further testing or evaluation
Evidence to Maintain:
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• Product disposition forms
• QA approvals and lot tracking records
• Communication with regulatory authorities (if required)
- • Rework, reprocess, or relabel • Downgrade or discard • Hold for further testing or evaluation
- • Product disposition forms • QA approvals and lot tracking records • Communication with regulatory authorities (if required)
4. Documentation and Verification
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Corrective Action Records Should Include:
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• Date and time of deviation
• Details of deviation and affected product
• Action taken and personnel involved
• Signature of responsible party and verification reviewer
Evidence to Maintain:
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• Completed corrective action log or form
• Verification signature and date
• Updated procedures or training records if applicable
- • Date and time of deviation • Details of deviation and affected product • Action taken and personnel involved • Signature of responsible party and verification reviewer
- • Completed corrective action log or form • Verification signature and date • Updated procedures or training records if applicable
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No corrective action defined for a CCP | Add clear, written response steps to HACCP plan |
| Incomplete documentation of deviations | Ensure full corrective action logs are filled and signed |
| Repeated deviations without review | Conduct a root cause analysis and adjust SOPs or equipment |
| Affected product not properly managed | Improve hold and disposition procedures with documentation |