ISO 22000 Requirements for an FSMS
This domain tests clause knowledge and your ability to map evidence to ISO 22000:2018 clauses 4–10. Expect scenario questions on hazard analysis, control plans, verification, emergency response and improvement.
Clause map
4 Context: scope and interested parties. 5 Leadership: policy, commitment and roles, including the food safety team leader. 6 Planning: risks and opportunities, objectives, changes. 7 Support: resources, competence, awareness, communication, documented information. 8 Operation: PRPs, traceability, emergency preparedness, hazard analysis, validation, hazard control plan, monitoring, corrections and corrective actions, unsafe product, recall, updating, verification. 9 Performance evaluation: monitoring and measurement, internal audit, management review. 10 Improvement: nonconformity and corrective action, continual improvement, update.
Hazard analysis sequence
Clause 8.5.1 requires hazard identification, acceptable levels, hazard assessment, and selection and categorization of control measures as PRP, OPRP or CCP. Validate control measures before implementation (8.5.2), then monitor them and verify after implementation (8.7).
Worked example: A spice processor identifies metal fragments. The hazard is physical, severity high and likelihood moderate. Metal detection has a critical limit (Fe 2.0 mm, non-Fe 2.5 mm, SS 3.0 mm), so it is a CCP, monitored every batch, validated with test pieces at start-up and verified weekly by QA. If the detector fails, product is held under 8.5.8, a correction is recorded, and a corrective action investigates the cause under 8.5.7. Reasoning: a measurable limit plus batch monitoring makes it a CCP; validation proves the measure works before use; verification confirms it remains effective.
Traps: mixing validation and verification; writing corrective action when a correction is meant; forgetting management review inputs; treating OPRP action criteria as critical limits; omitting recall testing; citing ISO 9001 clauses rather than ISO 22000:2018.