In some cases, critical limits have already been established in regulatory requirements, scientific literature, or expert consultation. You can establish critical limits which are different than regulatory requirements, however they must be based on sound scientific data and assure they result in a safe and unadulterated product. Principle 4 - Establish Monitoring Procedures Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring will allow you to track trends, identify deviations, and provide a record for verification. For each critical limit, you must determine the method and frequency of monitoring.
Continuous monitoring is ideal, but non-continuous monitoring is acceptable.
The frequency must be sufficient to represent the days production and should not exceed an acceptable risk level if a deviation is found and product is retained back to the last acceptable check. In most cases, monitoring will be continuous or in 30 to 60 minute intervals. It is imperative to clearly identify the individual responsible for monitoring, train thoroughly on process requirements, and assure they understand the importance and purpose of monitoring. A deviation is a failure to meet a critical limit. Corrective Actions include the procedures to be followed when a deviation occurs.