ISO 22000

7.4.2.1
All food safety hazards that are reasonably expected to occur in relation to the type of product, type of process and actual processing facilities must be identified and recorded. The identification shall be based on:
- the preliminary information and data collected
- experience
- external information including, to the extent possible, epidemiological and other historical data
- information from the food chain on food safety hazards that may be of relevance for the safety of the end products, intermediate products and the food at consumption

The step(s)(from raw materials, processing and distribution) at which each food safety hazard may be introduced must be indicated.

7.4.2.2
When identifying the hazards, consideration must be given to:
- the steps preceding and following the specified operation
- the process equipment, utilities/services and surroundings
- the preceding and following links in the food chain

7.4.2.3
For each of the food safety hazards identified, the acceptable level of the food safety hazard in the end product must be determined whenever possible. The determined level shall take into account established statutory and regulatory requirements, customer food safety requirements, the intended use by the customer
and other relevant data. The justification for, and the result of, the determination must be recorded.

iso 22000

A hazard assessment must be conducted to determine, for each food safety hazard identified, whether its elimination or reduction to acceptable levels is essential to the production of a safe food, and whether its control is needed to enable the defined acceptable levels to be met. Each food safety hazard must be evaluated according to the possible severity of adverse health effects and the likelihood of their occurrence. The methodology used must be described, and the results of the food safety hazard assessment recorded.

iso 22000

Based on the hazard assessment, an appropriate combination of control measures must be selected that is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable levels. In this selection, each of the control measures must be reviewed with respect to its effectiveness against the identified food safety hazards. The control measures selected must be categorized as to whether they need to be managed through operational prerequisite programmes or by the HACCP plan.

The selection and categorization must be performed using a logical approach that includes assessments with regard to the following:
- its effect on identified food safety hazards relative to the strictness applied;
- its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable immediate corrections)
- its place within the system relative to other control measures
- the likelihood of failure in the functioning of a control measure or significant processing variability
- the severity of the consequence(s) in the case of failure in its functioning
- whether the control measure is specifically established and applied to eliminate or significantly reduce the level of hazard(s)
- synergistic effects (i.e. interaction that occurs between two or more measures resulting in their combined effect being higher than the sum of their individual effects)

Control measures categorized as belonging to the HACCP plan shall be implemented.
Otherwise control measures must be implemented as operational prerequisite programmes. The methodology and parameters used for this categorization must be described in documents, and the results of the assessment recorded.

Control measures

iso 22000

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iso 22000

Each of the operational prerequiste programmes must be documented and include all of the following information:
- food safety hazards to be controlled by the programme
- control measures
- monitoring procedures that demonstrate operational prerequisite programmes are implemented
- corrections and corrective actions to be taken if monitoring shows that the operational prerequisite programmes are not in control
- responsibilities and authorities
- records of monitoring


Interpretation from the International Register of Certificated Auditors:
Establishing the operational prerequisite programmes (PRPs)
One of the outputs of the hazard analysis is the determination of operational PRPs. This sets up prevention and control measures which deal with food safety risk levels somewhat below those which need to be included in the HACCP plan. Auditors should examine the decision making process at the hazard analysis stage as well as how the necessary control and monitoring activities for operational PRPs are determined.

iso 22000