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Module 6 of 8 · ISO 22000 · Clause 8 (8.5 to 8.9)

Hazard control and the HACCP/OPRP plan

The core of ISO 22000: analysing hazards, validating control measures, monitoring CCPs and OPRPs, verifying the whole and acting if a batch goes out of control.

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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

  1. 1Build the hazard analysis on the process map, step by step, with its assessment and category.
  2. 2Record CCP and OPRP monitoring from the line terminal, with the actual time and a correction opened on any deviation.
  3. 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.

See HACCP in Kimobox

ISO 22000 templates and records in this chapter