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

7.6. Establishing the HACCP plan

7.6.1. HACCP plan

The HACCP plan shall be documented and shall include the following information for each identified critical control point (CCP):

  1. food safety hazard(s) to be controlled at the CCP (see 7.4.4);
  2. control measure(s) (see 7.4.4)
  3. critical limit(s) (see 7.6.3);
  4. monitoring procedure(s) (see 7.6.4);
  5. corrections and corrective action(s) to be taken if critical limits are exceeded (see 7.6.5);
  6. responsibilities and authorities;
  7. record(s) of monitoring.

7.6.2. Identification of critical control points (CCPs)

For each hazard that is to be controlled by the HACCP plan, CCP(s) shall be identified for the control measures identified (see 7.4.4).

7.6.3. Determination of critical limits for critical control points

Critical limits shall be determined for the monitoring established for each CCP.

Critical limits shall be established to ensure that the identified acceptable level of the food safety hazard in the end product (see 7.4.2) is not exceeded.

Critical limits shall be measurable.

The rationale for the chosen critical limits shall be documented.

Critical limits based on subjective data (such as visual inspection of product, process, handling, etc.) shall be supported by instructions or specifications and/or education and training.

7.6.4. System for the monitoring of critical control points

A monitoring system shall be established for each CCP to demonstrate that the CCP is in control. The system shall include all scheduled measurements or observations relative to the critical limit(s).

The monitoring system shall consist of relevant procedures, instructions and records that cover the following:

  1. measurements or observations that provide results within an adequate time frame;
  2. monitoring devices used;
  3. applicable calibration methods (see 8.3);
  4. monitoring frequency;
  5. responsibility and authority related to monitoring and evaluation of monitoring results;
  6. record requirements and methods.

The monitoring methods and frequency shall be capable of determining when the critical limits have been exceeded in time for the product to be isolated before it is used or consumed.

7.6.5. Actions when monitoring results exceed critical limits

Planned corrections and corrective actions to be taken when critical limits are exceeded shall be specified in the HACCP plan. The actions shall ensure that the cause of nonconformity is identified, that the parameter(s) controlled at the CCP is (are) brought back under control, and that recurrence is prevented (see 7.10.2).

Documented procedures shall be established and maintained for the appropriate handling of potentially unsafe products to ensure that they are not released until they have been evaluated (see 7.10.3).