ISO 22000

Data dervied from the monitoring of operational Prerequisite Programmes and critical control points must evaluated by designated persons with sufficient knowledge and authority to initiate corrective actions.

Corrective actions must be initiated when critical limits are exceeded or when there is a lack of conformity with operational prerequisite programmes.

The food organization must establish and maintain PROCEDURES that specify appropriate actions to identify and eliminate the cause of nonconformities, to prevent recurrence and to bring the process/system back into control after nonconformity is found. The actions include:
- nonconformity review (includes customer complaints)
- review of trends in monitoring results to detect the development of out of control situations
- determining the cause of nonconformities
- evaluation of the need for action to ensure nonconformities don't recur
- determining and implementing needed actions
- recording results of corrective actions
- reviewing corrective actions taken to ensure effectiveness

Records of corrective action are made.

7.10.3.1 General
The food organization handles nonconforming products by implementing action that prevents the nonconforming product from entering the food chain. Unless the:
- hazard is reduced to acceptable levels
- hazard will be reduced to acceptable levels before entering the food chain
- product meets the acceptable levels despite the nonconformity

Nonconforming product is held until evaluation.

Customers receiving nonconforming product are notified to initiate withdrawal.

Controls/responses/authorization for dealing with potentially unsafe food products must be documented.

7.10.3.2 Evaluation for release
Product is released when:
- evidence that control measures have been effective
- evidence shows that the combined effect of the control measures comply with the performance intended
- results of sampling, analysis and/or other verification activities demonstrate that the affected lot of product complies with the identified acceptable levels for the food safety hazard(s) concerned

7.10.3.3 Disposition of nonconforming products
Unacceptable product is handled as follows:
- reprocessing or further processing
- destruction and/or disposal as waste

Timely withdrawal of unsafe food product lots are completed by authorized personnel (appointed by top management) through a DOCUMENTED PROCEDURE that details:
- notification of relevant interested parties
- handling the food products
- further steps to be taken

Withdrawn food product is securely held until:
- its destruction
- used for purposes other than originally intended
- determined to be safe for the same or other intended use
- reprocessed in a way that makes it safe

Records of the cause, extent and result of a food product withdrawal are reported to top management and used for management review.

Mock or practice withdrawal programmes are implemented to verify and record the effectiveness of the procedures.

iso 22000