Corrective & Preventive Actions (CAPA)
Aligned with BRCGS Food Safety Issue 9 – Clause 3.7
Requirement Overview
BRCGS Food Safety Issue 9 requires that sites implement effective systems for identifying non-conformities, investigating root causes, and taking corrective and preventive actions to prevent recurrence.
Clause 3.7.1: “The company shall have a documented procedure for handling non-conforming products or processes. This shall include root cause analysis and actions to prevent recurrence.”
A proactive CAPA process not only ensures compliance and audit readiness—it also drives continuous improvement and minimizes risk across operations.
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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✓ Identify and isolate non-conforming products or processes
✓ Conduct thorough root cause analysis
✓ Implement corrective and preventive actions to avoid recurrence
✓ Monitor effectiveness and document all CAPA steps
Step-by-Step Compliance Implementation
1. Identify the Non-Conformity
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Examples May Include:
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• Deviation from process control limits
• Customer complaints or returns
• Audit or inspection findings
• Failed verification or testing results
Evidence to Maintain:
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• Non-conformance reports
• Photos, test results, or logs
• Initial impact assessment
- • Deviation from process control limits • Customer complaints or returns • Audit or inspection findings • Failed verification or testing results
- • Non-conformance reports • Photos, test results, or logs • Initial impact assessment
2. Contain and Control
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Containment Activities:
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• Quarantine affected product or area
• Notify relevant departments or customers
• Stop production if necessary
Evidence to Maintain:
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• Quarantine logs or hold tags
• Notification records
• Batch or product traceability
- • Quarantine affected product or area • Notify relevant departments or customers • Stop production if necessary
- • Quarantine logs or hold tags • Notification records • Batch or product traceability
3. Investigate Root Cause
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Analysis Tools May Include:
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• 5 Whys
• Fishbone (Ishikawa) diagram
• Cause and effect matrix
Evidence to Maintain:
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• Completed root cause analysis forms
• Investigation meeting notes
• Input from cross-functional teams
- • 5 Whys • Fishbone (Ishikawa) diagram • Cause and effect matrix
- • Completed root cause analysis forms • Investigation meeting notes • Input from cross-functional teams
4. Implement Corrective and Preventive Actions
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Corrective Action: Immediate fix to address the issue
Preventive Action: Systemic fix to prevent recurrence
Evidence to Maintain:
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• CAPA form with actions, responsibility, and due dates
• Updated SOPs or training records
• Photos or logs of completed fixes
- • CAPA form with actions, responsibility, and due dates • Updated SOPs or training records • Photos or logs of completed fixes
5. Verify Effectiveness
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Verification Activities:
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• Follow-up audits or inspections
• Trend analysis and performance reviews
• Staff interviews or retesting
Evidence to Maintain:
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• Verification checklists
• Effectiveness review sign-offs
• Re-training records (if applicable)
- • Follow-up audits or inspections • Trend analysis and performance reviews • Staff interviews or retesting
- • Verification checklists • Effectiveness review sign-offs • Re-training records (if applicable)
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No root cause identified | Use structured tools (e.g., 5 Whys) and involve relevant staff |
| Only corrective action taken | Include preventive steps to address systemic risks |
| No follow-up or effectiveness check | Document verification and review after CAPA completion |
| Incomplete documentation or signatures | Use standard CAPA templates with assigned responsibilities |