In addition to the verification activities for CCPs and other preventive controls, strategies must be developed for scheduled reanalysis of the Food Safety Plan. Reanalysis is required at least every three (3) years or whenever there is a significant change in the product or process. Reanalysis is also required if information becomes available about a new hazard associated with the food (e.g., FDA issues an advisory notice) or if there is a failure with the system such as discovering an ineffective preventive control, an outbreak or similar situation. In addition, reanalysis is required when an unanticipated deviation occurs; i.e., a specific corrective action procedure has not been established. The preventive controls qualified individual is responsible for ensuring that this verification activity (reanalysis) is performed and they may contract with an independent third party to help conduct system‐wide verification activities.
Significant Changes May Include:
Significant changes in the product or process that may require reanalysis (and sometimes additional validation) include when an event or situation may alter the original conclusions. Examples include the following:
- Raw material changes, including a new supplier, may require reanalysis to determine if there is a potential for food safety related functional properties to be altered. For example, a new thickening agent may change the viscosity of a product, which could have an impact on heating characteristics for some products. Switching suppliers may also warrant review of the new supplier’s allergen controls to assure that a new hazard is not introduced. The process may require reanalysis.
- Product or process changes may warrant reanalysis. For example, reducing the level of salt, which can alter microbial growth patterns, may require evaluation for some products. Intended shelf life, process requirements and other elements of the system may require reanalysis. If a new allergen is introduced on a line, reanalysis of the procedures used to clean the system may be warranted to validate that surfaces can be adequately cleaned to remove allergens.
- Increasing production volumes that lead to extended run times may provide more time for microbial growth for some processes. The adequacy of sanitation to maintain sanitary conditions during this extended time may require reanalysis.
- Adverse findings during reviews or observation of recurring deviations may suggest that the original validation is no longer adequate. This may trigger reanalysis of the full system, including validation of elements of the process that are not performing in a reliable manner.
- Emerging scientific information on hazards or control measures may also trigger reanalysis efforts. For example, when E. coli O157:H7 first emerged as a foodborne pathogen, it was observed that it tolerates higher levels of acid than many other foodborne pathogens. Reanalysis of process lethality was needed.
- New distribution or consumer‐handling practices may also trigger reanalysis. For example, if an RTE product distributed to the general public though retail sales is subsequently marketed to infants, revalidation of controls to protect this more vulnerable population may be warranted.
Verification of your Food Safety Plan
Verifying that the Food Safety Plan is still applicable and relevant is the focus of reanalysis. This includes the hazard analysis. Reanalysis activities also include onsite observations and record reviews performed by the food safety team or other unbiased individuals not responsible for performing the monitoring activities. This is to verify that the Food Safety Plan is being followed and it may identify trends that need to be addressed. Reanalysis should occur at a frequency that ensures the Food Safety Plan is being followed continuously. This frequency depends on a number of conditions, such as the variability of the process and product. Activities that should be conducted during Food Safety Plan reanalysis include:
- Check the accuracy of the product description and flow diagram.
- Check for new guidance or scientific information related to critical limits or hazards that may require a change in the hazard analysis.
- Check that preventive controls are monitored as required by the Food Safety Plan.
- Check that processes are operating within established critical limits with few, if any, deviations.
- Check that appropriate corrective actions have been taken and verification activities have been completed.
- Check that records are completed accurately and at the time intervals required.
- Review consumer/customer complaints related to food safety.
- Check that corrective actions have been performed whenever monitoring indicated a deviation from critical limits.
- Check that equipment has been calibrated at the frequencies specified in the Food Safety Plan.
- Check that equipment has been maintained so that the process operates as originally designed.
- Check to be sure that all records are reviewed by a qualified person within 7 working days from the time they were created.
An independent third party audit can also be included in a system wide Food Safety plan verification. Third party auditors can provide an unbiased assessment to help determine if the plan is working properly. Experts may also need to be consulted to re‐validate a particular processing step; e.g., when reanalysis identifies new information on a hazard that was not addressed in initial validation studies.