Verification is one step to help ensure the food safety system is working to prevent, control or significantly reduce public health hazards. Verification includes validating the steps to ensure the process will work, and secondly includes the evaluation activities that verify the system continue to work. Verification activities are clearly defined in the FSMA and the Preventive Controls Rule, as well as in current regulated HACCP requirements.
Here is an example of how to apply the required verification steps — as outlined in the FDA’s proposed Preventive Control rule – to test metal detector failure.
In this scenario the product is a 40 pound bag of dry powdered milk. The qualified individual determined during the hazard analysis that metal is a significant physical hazard. The preventive control is the finished product metal detector, but there are other programs that help prevent metal from entering the product stream, such as the facility and premise preventive maintenance program.
Corrective Action – Product Control
During production, a quality technician was performing a metal detector check as designated by the preventive control (or HACCP CCP). The quality technician reported a failure of a prescribed test wand, or a failure to meet a preventive control parameter. All the product was placed on hold from the last good metal detector check, which is required to be performed every 2 hours, per the requirements for a corrective action for that control step. (Generally, industry best practice is to hold all the product for that day/lot of production until there is an investigation performed, even if the preventive control states “from the last good metal detector check” – just as precaution.) This failure of a routine monitoring step would initiate the prescribed corrective action.
Another step in the prescribed corrective action is to ensure that all product from the last good metal detector check is evaluated for safety by being required to be rerun through a functioning metal detector.
Corrective Actions – Metal Detector
Based on the new proposed PC rule, what would be an example of a functioning metal detector? Since documentation is foundational to FSMA compliance, how would you prove that a metal detector is truly effective?
- It is a metal detector that has been validated to ensure the hazard is detected, or the food safety risk associated with the size of the metal detected in the specific product matrices is adequately controlled by eliminating failing product from reaching the consumer.
- The equipment manufacturer is generally the best resource to assist in validation of their detection device and the specific product matrices.
- The metal detector has been calibrated. Generally metal detection calibration is performed annually by the equipment manufacturer.
- Keep in mind, this calibration record will require a verification by the qualified individual.
- The metal detector is subject to ongoing verification of monitoring activities.
Once tested and found functional, the product can be re-run through the metal detector. It is important to remember to document, document, document, because if it is not documented the corrective action to ensure product safety did not happen.
For more details on verification, risks, and food safety solutions, read the entire White Paper written in cooperation with The Acheson Group: Verification: Can Your Food Safety Plan Meet the Rigors of FSMA’s Proposed Preventive Controls?