Principle 5: Establish a Corrective Action Plan

Statement

Document any action to be taken when the monitoring results  show that a CCP has deviated from the critical limit (indicating a loss of control).  In addition to this less stringent corrective actions may also be set for target levels.

How is this stage achieved?

You must decide upon and document specific corrective actions that are to be taken if monitoring results for a CCP show that there has been a failure to meet the critical limit.  The action to be taken must ensure that the CCP is brought back under control.

When deciding upon corrective actions for a CCP consider the following:

  1. What are you going to do straight away?

Think about the need to stop the process, quarantine the product, quick adjustments to equipment (e.g. increasing the temperature).  Possible actions if unacceptable operating practices are found.

  1. What are you going to do about affected product that has been produced since the last good check this may be in storage/despatch?  This does not include recalling the product because monitoring should be sufficient to capture the issue before the product has left site.

Think about the need to quarantine the product from the last good check i.e. product manufactured during out-of-control conditions, disposal of the product.

  1. What are you going to do to in the future?

Think about reworking the product if this is appropriate, carrying out an investigation (review cause and correction to prevent recurrence), disposal of the product.

  1. Consider who has the responsibility for the above, for instance who is authorised to dispose/rework the product or take the appropriate corrective action.

  1. Think about training and competency of personnel involved with any of the above.

Documentation and Records

Document the corrective action to be taken when a CCP exceeds its critical limit and who is responsible for this action/s or other actions such as disposal, rework.  Relevant records must be kept including training records and what happened to the batch of product that was affected by the corrective action.

In a well-organised system it should be possible to identify a procedure which contains the details of the corrective action and who has the authority to authorise the corrective action.

Review

A review of this principle should be scheduled and triggered if there are changes within the business (see Principle 6).