Today, let's explore the management components contained in §117.140 of Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food.
The written management components are intended to ensure the effectiveness of your preventive controls. They must take into account the nature of the preventive control and its role, and importance in your facility’s food safety system.
Proposed §117.140(a) would require that the owner, operator, or agent in charge of a facility establish and implement written procedures, including the frequency with which they are to be performed, for monitoring preventive controls. What written procedures might we expect to see? We can divide procedures into three basic areas: monitoring, corrective actions/corrections, and verification.
Written monitoring procedures must specify a monitoring frequency that is adequate to ensure consistent performance. Documented records are subject to verification activities that are conducted from someone other than the person who completed the record. Exception records must also be included in the monitoring procedures.
Corrective actions and corrections
Preventive control violations must be identified, recorded, and corrected. The affected product must be evaluated for food safety hazards to prevent unsafe food from entering commerce. The written procedures must include the action taken to prevent the likelihood that the PC violation will reoccur.
A number of verification activities are included in the rule to ensure that the food safety plan is being carried out correctly. Some of the verification activities that FSMA requires include: implementing monitoring as written, making appropriate decisions about corrective actions, effectively minimizing or preventing identified hazards, and reanalyzing the food safety plan when preventive controls are not effective, significant changes in plant operations occur, new potential hazards are identified, or plant incidents reveal additional food safety hazards. Another important verification activities is that all record reviews are completed by or overseen by a Preventive Control Qualified Individual (PCQI).
Other verification activities that are required as appropriate include:
- Calibration of devices
- Application of the supply chain program
- Product testing for pathogens, indicator organisms, or other hazards
- Environmental monitoring (e.g. ready-to-eat (RTE) products)
- Validation of preventive controls
The integration and management of food safety plans that contain plant preventive controls, supply chain program controls, or require environmental testing for RTE product can be complex. We will break these up into future Tip of the Week segments for better understanding.
Next week, we will review the requirements for environmental verification and corrective action activities for RTE products when the presence of pathogens or appropriate indicator organisms are identified.