Principle 4: Establish a Monitoring System

Statement

Monitoring is the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.

How is this stage achieved?

The monitoring system describes the methods by which the business is able to confirm that all CCPs are operating within the defined critical limit.

Monitoring actions must be able to detect a loss of control at the CCP and provide rapid results.  This should be in time to allow corrective action to be taken, to regain control of the process whilst the product is still under your control.

Examples:    On–line  time, temperature.

                     Off-line – Salt, pH, Aw, total solids.

Generally microbiological testing is not considered to be suitable as a monitoring activity because the results are not quick, even with the most rapid methods results are not instant.  Microbiological testing is useful as a verification activity (see principle 6).

Continuous Monitoring Systems       e.g. process temperatures recorded on thermograph.

Discontinuous Monitoring System    e.g. sample collection and analysis such as  pH.

Samples must be representative of the bulk product.

When choosing a monitoring system the person/s responsible must ensure that the results obtained are directly relevant to the CCP and any limitations are fully understood and documented.

All monitoring equipment must be calibrated and working correctly.

Documentation and Records

Record who is to carry out each monitoring activity (specify job title or name).  Ensure they are competent to do this and that their training is appropriate to the task being performed.  There should be a detailed description of precisely how to carry out the monitoring.  They must have the knowledge and authority to take the prescribed corrective action if the critical limit is not achieved.  Records of training and competency assessment should be maintained.

Document what control parameter (i.e. temperature, flow, pH) is to be assessed, how the monitoring is going to be carried out and the frequency at which it is to be performed.  For the frequency state if it is continuous of discontinuous. If discontinuous state exactly how often the monitoring will be performed.  Ensure that this is adequate to confirm control.  Monitoring systems should be supported by specifications, procedures and work instructions.

Monitoring records should include the date and time the activity was carried out and actual result.

All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and, where possible, by another nominated person that is responsible for reviewing the monitoring results  (typically this would be a Manager).

 

Review

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