ISO 22000 - (Section 7 - Planning and realization of safe products)

7.10. Control of nonconformity

7.10.1 Corrections

The organization shall ensure that when critical limits for CCP(s) are exceeded (see 7.6.5), or there is a loss of control of operational PRP(s), the products affected are identified and controlled with regard to their use and release.

A documented procedure shall be established and maintained defining

  1. the identification and assessment of affected end products to determine their proper handling (see 7.10.3), and
  2. a review of the corrections carried out.

Products manufactured under conditions where critical limits have been exceeded are potentially unsafe products and shall be handled in accordance with 7.10.3. Products manufactured under conditions where operational PRP(s) have not been conformed with shall be evaluated with respect to the cause(s) of the nonconformity and to the consequences thereof in terms of food safety and shall, where necessary, be handled in accordance with 7.10.3. The evaluation shall be recorded.

All corrections shall be approved by the responsible person(s), and shall be recorded together with information on the nature of the nonconformity, its cause(s) and consequence(s), including information needed for traceability purposes related to the nonconforming lots.

7.10.2 Corrective actions

Data derived from the monitoring of operational PRPs and CCPs shall be evaluated by designated person(s) with sufficient knowledge (see 6.2) and authority (see 5.4) to initiate corrective actions.

Corrective actions shall be initiated when critical limits are exceeded (see 7.6.5) or when there is a lack of conformity with operational PRP(s).

The organization shall establish and maintain documented procedures that specify appropriate actions to identify and eliminate the cause of detected nonconformities, to prevent recurrence, and to bring the process or system back into control after nonconformity is encountered. These actions include

  1. reviewing nonconformities (including customer complaints),
  2. reviewing trends in monitoring results that may indicate development towards loss of control,
  3. determining the cause(s) of nonconformities,
  4. evaluating the need for action to ensure that nonconformities do not recur,
  5. determining and implementing the actions needed,
  6. recording the results of corrective actions taken, and
  7. reviewing corrective actions taken to ensure that they are effective.

Corrective actions shall be recorded.

7.10.3 Handling of potentially unsafe products General

The organization shall handle nonconforming products by taking action(s) to prevent the nonconforming product from entering the food chain unless it is possible to ensure that

  1. the food safety hazard(s) of concern has(ve) been reduced to the defined acceptable levels,
  2. the food safety hazard(s) of concern will be reduced to identified acceptable levels (see 7.4.2) prior to entering into the food chain, or
  3. the product still meets the defined acceptable level(s) of the food safety hazard(s) of concern despite the nonconformity.>

All lots of product that may have been affected by a nonconforming situation shall be held under control of the organization until they have been evaluated.

If products that have left the control of the organization are subsequently determined to be unsafe, the organization shall notify relevant interested parties and initiate a withdrawal (see 7.10.4).

NOTE The term "withdrawal" includes recall.

The controls and related responses and authorization for dealing with potentially unsafe products shall be documented. Evaluation for release

Each lot of product affected by the nonconformity shall only be released as safe when any of the following conditions apply:

  1. evidence other than the monitoring system demonstrates that the control measures have been effective;
  2. evidence shows that the combined effect of the control measures for that particular product complies with the performance intended (i.e. identified acceptable levels as identified in accordance with 7.4.2);
  3. the 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. Disposition of nonconforming products

Following evaluation, if the lot of product is not acceptable for release it shall be handled by one of the following activities:

  1. reprocessing or further processing within or outside the organization to ensure that the food safety hazard is eliminated or reduced to acceptable levels;
  2. destruction and/or disposal as waste.

7.10.4 Withdrawals

To enable and facilitate the complete and timely withdrawal of lots of end products which have been identified as unsafe

  1. top management shall appoint personnel having the authority to initiate a withdrawal and personnel responsible for executing the withdrawal, and
  2. the organization shall establish and maintain a documented procedure for
    1. notification to relevant interested parties (e.g. statutory and regulatory authorities, customers and/or consumers),
    2. handling of withdrawn products as well as affected lots of the products still in stock, and
    3. the sequence of actions to be taken.

Withdrawn products shall be secured or held under supervision until they are destroyed, used for purposes other than originally intended, determined to be safe for the same (or other) intended use, or reprocessed in a manner to ensure they become safe.

The cause, extent and result of a withdrawal shall be recorded and reported to top management as input to the management review (see 5.8.2).

The organization shall verify and record the effectiveness of the withdrawal programme through the use of appropriate techniques (e.g. mock withdrawal or practice withdrawal).