Preliminary steps to the analysis (8.5.1)
The food safety team gathers the starting information: characteristics of raw materials, ingredients and contact materials and of the end product, its intended use and reasonably foreseeable misuse, and flow diagrams confirmed on site. These are the Codex preliminary steps, required here as requirements.
Hazard analysis (8.5.2)
Biological, chemical and physical hazards — allergens included — that are reasonably expected to occur at each step are identified, and their acceptable level in the end product is determined. They are then assessed, considering the likelihood before control measures are applied and the severity of their effects, to decide which are significant.
For each significant hazard a control measure is chosen and categorised, using a systematic approach, as a CCP or an OPRP. That reasoning, not just its outcome, is what the auditor asks to see.
Validation of control measures (8.5.3)
Before the plan is applied, you must show that the chosen measure is capable of bringing the hazard to its acceptable level: heat penetration studies, microbiological challenge tests, published data or official guidance. The methodology and the evidence are retained.
Hazard control plan (8.5.4)
For each CCP, measurable critical limits; for each OPRP, measurable or observable action criteria. Both with their monitoring system — method, frequency, responsibility, records — and with the actions planned for when they are not met.
This is the big difference from a classic HACCP: OPRPs carry the same documentary rigour as CCPs, even though a failure is handled differently.
Updating, monitoring, verification and nonconformities (8.6 to 8.9)
PRPs and the plan are updated whenever something relevant changes. Monitoring and measuring equipment is calibrated or verified (8.7).
Verification (8.8) confirms that the PRPs and the plan are working and that hazard levels are within acceptable levels. It cannot be carried out by the same person who monitors that activity, and its results are analysed as a whole.
If a CCP goes outside its limit or an OPRP fails its criterion, corrections and corrective actions are applied (8.9.2 and 8.9.3), the affected product is handled as potentially unsafe and evaluated before release (8.9.4), and withdrawal is prepared and tested (8.9.5).
What an auditor usually asks for
- Hazard analysis by step with acceptable level and justification of significance
- Documented categorisation of each control measure as CCP or OPRP
- Evidence of validation of each measure before it is applied
- Control plan with critical limits, action criteria and monitoring
- Verification carried out by someone other than the person monitoring
- Records of potentially unsafe product with the release or disposition decision
How to cover hazard control in Kimobox
- 1Build the hazard analysis on the process map, step by step, with its assessment and category.
- 2Record CCP and OPRP monitoring from the line terminal, with the actual time and a correction opened on any deviation.
- 3Schedule verification with an owner other than the person monitoring, and review the results on a trend dashboard.
The auditor does not only ask why something is a CCP: they ask why another significant hazard is an OPRP and not a CCP.
ISO 22000 templates and records in this chapter
- ISO 22000 hazard analysis template · Mandatory record
- ISO 22000 validation of control measures template · Mandatory record
- ISO 22000 HACCP/OPRP plan (hazard control plan) template · Mandatory document
- ISO 22000 CCP and OPRP monitoring record template · Mandatory record
- ISO 22000 PRP and HACCP plan verification record template · Mandatory record
- ISO 22000 potentially unsafe product record · Mandatory record
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- ISO 22000:2018 — Food safety management systems. Requirements for any organization in the food chain ISO · 2018 ed. (2nd edition), published June 2018
- ISO 22000:2018/Amd 1:2024 — Climate action changes ISO · February 2024
- ISO/DIS 22000 — Draft revision of the standard (3rd edition) ISO · Under development
- ISO 22002-100:2025 — Prerequisite programmes on food safety. Part 100: requirements for the food, feed and packaging chain ISO · 29 July 2025
- ISO 22002-1:2025 — Prerequisite programmes on food safety. Part 1: food manufacturing ISO · 29 July 2025; replaces ISO/TS 22002-1:2009
- General Principles of Food Hygiene, CXC 1-1969 Codex Alimentarius (FAO/WHO) · 2020 revision
- Regulation (EC) No 852/2004 on the hygiene of foodstuffs EUR-Lex · 29 April 2004
- Regulation (EC) No 178/2002, Articles 18 and 19 (traceability and withdrawal) EUR-Lex · 28 January 2002