Corrective action and root cause

Step 10 asks for corrective actions. A corrective action is any action taken when a deviation occurs in order to re-establish control, segregate and determine the disposition of the affected product, if any, and prevent or minimise reoccurrence of the deviation.

Codex says specific written corrective actions should be developed for each CCP. Write them so that they work at 3am with a new supervisor. Say who decides, what they do first, how the product is identified and held, and who can release it.

Work out what is affected. When limits are monitored continuously and a deviation occurs, any product being made at that time is potentially unsafe. When monitoring was not continuous, the business should determine what product may have been impacted. In practice, this usually means everything since the last good check.

Actions should include segregating the affected product and analysing its safety. Then decide. The product may be reprocessed, diverted to another use, or destroyed. Some deviations leave no option. Contamination with Staphylococcus enterotoxin, for example, may mean the product must be destroyed. External experts may be needed to assess safe use.

Keep decisions about product free from commercial pressure. 'It is only two degrees over' is a dangerous sentence. A critical limit was set because crossing it probably means unsafe food. Only a named person with the right knowledge should release held product, and the reasons should be recorded.

Codex says a root cause analysis should be conducted where possible. A simple method is to keep asking why. In our example, a tray failed its cooling limit. Why? The blast chiller was overloaded. Why? Two batches were made together. Why? The production plan changed for a large order. Why was capacity not considered? Nobody links the plan to chiller capacity. The fix is a capacity rule in production planning. Retraining the operator would have fixed nothing. A root cause analysis can also limit or expand the amount of product that is affected.

Document the details, including the cause of the deviation and what happened to the product. Corrective actions should be reviewed from time to time, to identify trends and make sure they are effective. Retraining may be part of the answer for some deviations, but it should not be the automatic one.

If unsafe food has left your control, Article 19 of Regulation (EC) 178/2002 applies. The operator must immediately start to withdraw it and inform the competent authorities. If it may have reached consumers, the operator must tell them why it is being withdrawn and, if necessary, recall it. Practise this before you need it. A plan is only useful if your traceability can tell you which batches went where, and quickly.