Management of Nonconforming Products
Aligned with FSSC 22000 – ISO 22000:2018 Clauses 8.9 & 8.9.2: Control of Product and Process Nonconformities
Also Relevant: ISO/TS 22002-1:2009 – Clause 18: Verification of PRPs
Requirement Overview
FSSC 22000 requires organizations to establish documented procedures for identifying, controlling, and disposing of nonconforming products to prevent their unintended use or release.
Key Standard References:
• ISO 22000:2018 Clause 8.9 – Control of product and process nonconformities, including disposition and authorization.
• ISO 22000:2018 Clause 8.9.2 – Corrections and corrective actions for nonconforming product handling.
• ISO/TS 22002-1 Clause 18 – Verification that PRPs are effective in preventing contamination.
Proper nonconforming product management safeguards food safety, ensures compliance with statutory and customer requirements, and protects brand integrity.
Key Compliance Objectives
Step-by-Step Compliance Implementation
1. Establish a Documented Nonconformance Procedure
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Procedure Must Include:
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• Definitions of nonconformance (e.g., contamination, specification deviation, labeling error)
• Assigned responsibilities for identification, evaluation, and decision-making
• Documented workflow for reporting and investigation
Evidence to Maintain:
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• Approved nonconformance SOP
• Process flow diagrams or decision trees
•List of authorized personnel for disposition decisions
- • Definitions of nonconformance (e.g., contamination, specification deviation, labeling error) • Assigned responsibilities for identification, evaluation, and decision-making • Documented workflow for reporting and investigation
- • Approved nonconformance SOP • Process flow diagrams or decision trees •List of authorized personnel for disposition decisions
2. Identify and Segregate Nonconforming Product
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Control Measures:
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• Clearly label or tag product as "Hold", "Reject", or "Quarantine"
• Store physically separate from conforming product, or use digital quarantine in ERP/WMS
• Restrict movement, handling, or dispatch until formally released
Evidence to Maintain:
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• Hold/quarantine logs (manual or electronic))
• Photos or label samples as proof of segregation
• Access restriction procedures
- • Clearly label or tag product as "Hold", "Reject", or "Quarantine" • Store physically separate from conforming product, or use digital quarantine in ERP/WMS • Restrict movement, handling, or dispatch until formally released
- • Hold/quarantine logs (manual or electronic)) • Photos or label samples as proof of segregation • Access restriction procedures
3. Determine Disposition and Take Action
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Disposition Options Include:
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• Controlled rework or reprocessing under verified conditions
• Downgrading for alternative use
• Disposal or destruction with traceable documentation
• Return to supplier with full justification
Evidence to Maintain:
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• Disposition decision log signed by authorized personnel
• Records of rework, destruction, or return
• Supplier notification forms where applicable
- • Controlled rework or reprocessing under verified conditions • Downgrading for alternative use • Disposal or destruction with traceable documentation • Return to supplier with full justification
- • Disposition decision log signed by authorized personnel • Records of rework, destruction, or return • Supplier notification forms where applicable
4. Conduct Root Cause Analysis (RCA) and Corrective Action
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Corrective Measures:
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• Investigate the underlying cause of nonconformance
• Implement corrective and preventive actions (CAPA)
• Review training, supplier performance, or process controls
Evidence to Maintain:
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• Completed nonconformance reports
• RCA and CAPA records with verification of closure
• Trend analysis data to detect recurring issues
- • Investigate the underlying cause of nonconformance • Implement corrective and preventive actions (CAPA) • Review training, supplier performance, or process controls
- • Completed nonconformance reports • RCA and CAPA records with verification of closure • Trend analysis data to detect recurring issues
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented nonconformance procedure | Create and approve an SOP with clear roles and decision criteria |
| Product not labeled during hold | Train staff to tag and record all quarantined materials |
| Missing root cause investigation | Implement formal RCA and CAPA documentation process |
| Reworked product not validated | Establish risk assessment and verification before re-release |