Corrective & Preventive Actions (CAPA)
Aligned with FSSC 22000 – ISO 22000:2018 Clause 10.1 & ISO/TS 22002-1:2009 Clause 2.4
Requirement Overview
Under FSSC 22000, organizations must establish an effective system for identifying nonconformities, determining root causes, and taking corrective and preventive actions to eliminate the causes of actual or potential issues.
Relevant Standards:
• ISO 22000:2018 Clause 10.1 – Nonconformity and corrective action
• ISO/TS 22002-1:2009 Clause 2.4 – Corrective and preventive action
CAPA is a critical component of a food safety management system, supporting continuous improvement, regulatory compliance, and risk reduction.
Step-by-Step Compliance Implementation
1. Identify the Non-Conformity
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Examples Include:
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• Deviations from CCP limits or operational parameters
• Customer complaints or returns
• Internal audit or inspection failures
• Failed verification activities or lab results
Evidence to Maintain:
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• Non-conformance reports (NCRs)
• Supporting data (photos, test results, logs)
• Initial risk/impact assessments
- • Deviations from CCP limits or operational parameters • Customer complaints or returns • Internal audit or inspection failures • Failed verification activities or lab results
- • Non-conformance reports (NCRs) • Supporting data (photos, test results, logs) • Initial risk/impact assessments
2. Contain and Control
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Containment Actions:
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• Isolate or hold affected products
• Notify relevant departments, suppliers, or customers
• Suspend production if needed to prevent further issues
Evidence to Maintain:
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• Hold tags or quarantine records
• Notification and communication logs
• Product traceability and batch details
- • Isolate or hold affected products • Notify relevant departments, suppliers, or customers • Suspend production if needed to prevent further issues
- • Hold tags or quarantine records • Notification and communication logs • Product traceability and batch details
3. Investigate Root Cause
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Common Tools:
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• 5 Whys
• Fishbone (Ishikawa) Diagram
• Cause-and-effect analysis
Evidence to Maintain:
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• Completed root cause forms
• Meeting notes from cross-functional investigations
• Records of interviews or supporting observations
- • 5 Whys • Fishbone (Ishikawa) Diagram • Cause-and-effect analysis
- • Completed root cause forms • Meeting notes from cross-functional investigations • Records of interviews or supporting observations
4. Implement Corrective and Preventive Actions
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• Corrective Actions: Address the immediate problem
• Preventive Actions: Address the root cause to avoid recurrence
Evidence to Maintain:
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• CAPA log with assigned actions, timelines, and owners
• Updated SOPs, process changes, or job aids
• Completed training and communication records
- • Corrective Actions: Address the immediate problem • Preventive Actions: Address the root cause to avoid recurrence
- • CAPA log with assigned actions, timelines, and owners • Updated SOPs, process changes, or job aids • Completed training and communication records
5. Verify Effectiveness
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Verification Techniques:
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• Follow-up audits or process checks
• Trend analysis of similar issues
• Retesting or reinspection of product or processes
Evidence to Maintain:
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• Verification checklists
• Signed-off effectiveness reviews
• Post-CAPA performance data or test results
- • Follow-up audits or process checks • Trend analysis of similar issues • Retesting or reinspection of product or processes
- • Verification checklists • Signed-off effectiveness reviews • Post-CAPA performance data or test results
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No clear root cause identified | Use structured tools (e.g. 5 Whys), involve multi-disciplinary team |
| Only short-term fixes applied | Implement preventive measures to prevent recurrence |
| No verification of effectiveness | Conduct follow-up audits and trend analysis |
| Poor documentation or incomplete logs | Standardize forms, assign responsibilities, and track status |