Corrective action should be taken by nominated persons whenever monitoring reveals that critical limits are not being achieved at critical control points.
How is this stage achieved?
Corrective actions are a set of planned actions that should be carried out by nominated persons. There are two types of corrective action:
- Corrective actions intended to prevent loss of control at a CCP: This may become apparent when monitoring at a critical control point identifies a failure to achieve target values but the critical limits have not yet been breached. Appropriate responses to this type of event may be an adjustment of the process to prevent loss of control and an investigation into why the target values were not achieved.
- Corrective actions to be taken when loss of control at a CCP has been identified. This will be the case when monitoring has identified that a critical limit has not been achieved and will require the following response:
- Restore control to the system
- Identify and place under control any affected product
- Investigate the cause of the loss of control
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 it would be helpful to consider the following:
- What are you going to do straight away? Think about the need to stop the process; quarantine the product; and make quick adjustments to relevant equipment or the process for example by increasing the process temperature or extending the process time.
- 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.
- 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.
- Allocate clear responsibility for the above, for instance who is authorised to dispose/rework the product or take the appropriate corrective action.
- Are all personnel trained and competent for performing the activities stated? 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, 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.
A review of this principle should be scheduled and triggered if there are changes within the business as outlined in Principle 6.