Templates and records · ISO 22000 · Clause 8.5.3
ISO 22000 validation of control measures template
Before relying on a heat treatment or a metal detector, you have to prove that it works. It is the record most often missing at audits and the one that carries most weight.
In one sentence
Validation of control measures demonstrates, before they are applied, that each measure — or combination of measures — chosen for a CCP or an OPRP is capable of bringing the hazard to its acceptable level, and clause 8.5.3 of ISO 22000 requires the validation methodology and the evidence obtained to be retained.
- Where the standard requires it
- ISO 22000 · Clause 8.5.3 Clauses are cited using the numbering of ISO 22000:2018, the current edition. ISO is preparing a third edition that may renumber them; when it is published it will have its own transition period.
- Type of information
- Mandatory record Methodology and evidence to be retained (8.5.3)
- Who fills it in
- The food safety team Often with support from a laboratory or an external expert, whose competence must be on record
- When
- Before applying the measure and after every change A new recipe, pack format, piece of equipment or line load requires revalidation
- How long it is kept
- Set by the organisation ISO 22000 only sets a minimum for traceability (8.3: the shelf life of the product). Covering the shelf life plus the three-year certification cycle lets you show the history at recertification.
What the standard requires
What ISO 22000 demands and what it leaves to your judgement
The food safety team validates that the chosen control measures achieve the intended control of the significant hazard. This is done before they are implemented in the plan and after any change that could affect them.
When validation shows that the measure is not sufficient, it must be modified or combined with others and reassessed. The standard does not impose a method: in-house studies, challenge tests, published scientific data, official guidance or historical process data are acceptable sources if they are justified.
Validating is not verifying: validation asks whether the measure can work; verification (8.8) asks whether it is being applied and working day to day.
Structure
Fields the template should include
- Control measure validated and the hazard it targets
- CCP or OPRP it belongs to
- Objective: acceptable level to be achieved
- Validation method and reference sources
- Study conditions: product, format, equipment, load, worst case
- Results obtained
- Conclusion: valid, valid with conditions or not valid
- Parameters carried into the plan: critical limit or action criterion
- When it must be revalidated
- Person responsible and date
Example
Example: validation of the pumpkin soup heat treatment
Company, people and figures are fictitious: the example only shows what a properly completed record looks like.
| Field | Content |
|---|---|
| Measure | Heat treatment in kettle · CCP-1 |
| Objective | Reduction of vegetative pathogens to the acceptable level set in the hazard analysis |
| Method | Heat penetration study with probes at the kettle's cold spot, with reference to the scientific literature on Listeria |
| Worst case | Maximum load of 400 kg, starting product at 4 °C, highest viscosity in the range |
| Results | Three trials: the cold spot exceeds the target temperature for the set time in all three |
| Conclusion | Valid for loads of up to 400 kg |
| Carried into the plan | Critical limit for temperature and time at the core of the product, with continuous recording |
| Revalidation | If the kettle, the base recipe or the maximum load changes |
| Responsible | Food safety team leader · 9 January 2026 |
At the audit
Mistakes auditors commonly flag
- The equipment manufacturer's data sheet is presented as validation of the company's own process.
- The study does not consider the worst case: maximum load, coldest product, largest format.
- Validation is confused with verification and only the daily temperature log is provided.
- A change in recipe or format does not lead to revalidation.
- OPRPs are left unvalidated because "they are not CCPs".
In Kimobox
How this record is kept in Kimobox
- 1Validation is a record linked to the control measure and to the CCP or OPRP in the plan.
- 2Studies and laboratory reports are attached with their date and version.
- 3A process change handled as a planned change flags the validations that need repeating.
Frequently asked questions
What people ask us before getting started
Do OPRPs also have to be validated?
Yes. Clause 8.5.3 applies to the control measures chosen for significant hazards, whether they are categorised as CCPs or OPRPs.
Is a published study enough?
It can be, if the study conditions are comparable to those in the plant. If the product, equipment or format differ, you must justify why the data still apply or supplement them with your own trials.
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