Section 418(g) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility maintain records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act.
Section 418(h) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act.
2. Monitoring, Verification, and Their Relationship
Proposed SEC 504.3 would define "monitor" to mean "to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification." Monitoring is essential to managing food safety because it facilitates tracking of the operation (i.e., the "process, point, or procedure" that is being controlled). This provides ongoing information about whether the process, point, or procedure is under control (i.e., operating according to plan), and can provide information about shifts away from control. If monitoring indicates that there is a trend towards loss of control, a facility can take action to bring the process back into control before a deviation from a maximum or minimum value (critical limit) occurs. For example, if the minimum oven temperature needed to ensure pathogen elimination during baking of a particular size pet treat is 300 [degrees] F for a specific time and the procedure for baking pet treats calls for an operating temperature of 375 [degrees] F, monitoring would detect that the temperature in the oven was dropping and enable the facility to identify and fix the problem with the temperature before the temperature drops to 300 [degrees] F. In addition, monitoring is used to determine when a deviation occurs at a critical control point (i.e., exceeding or not meeting a critical limit), indicating there is loss of control. In the previous example, there would be loss of control if the temperature drops to 299 [degrees] F. When a deviation occurs, an appropriate corrective action must be taken, e.g., stop the baking process until the temperature in the oven can be maintained above 300 [degrees] F and reprocess the pet treats that were not baked at the appropriate temperature. Also, monitoring provides written documentation for use in verification. For example, if the facility monitors the temperature of the oven continuously, using a temperature recording device, the output of the temperature recording device is available during the verification activity of review of records. Under this approach, monitoring is directed to evaluating implementation of the preventive controls, and the written documentation of the monitoring is then used in verification.
Proposed SEC 507.3 would define "verification" to mean those "activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan." One aspect of verification, as proposed, is the initial validation of a food safety plan to determine that the plan is scientifically and technically sound, that all hazards have been identified, and that if the food safety plan is properly implemented these hazards will be effectively controlled. Another aspect of verification is evaluating whether the facility's food safety system is functioning according to the food safety plan. Both of these aspects are directed at the effectiveness of a preventive control; they establish that the preventive control is scientifically valid for controlling the hazard and verify that the preventive control is accomplishing its intended purpose. Examples of verification activities include review of monitoring records and review of records for deviations and corrective actions. The Agency discusses verification activities in more detail during its discussion of proposed SEC 507.45 (Verification) in section X.G.
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