Here we go again, folks. Your company has developed and implemented a world-class food safety program. You speak at conferences about how your team worked to develop and implement a food safety program that other companies dream about having at their manufacturing facilities.
Surprise! You have to recall not just one day of production but weeks of production. How can such a massive failure happen? All employees have been thoroughly trained and records are reviewed and verified every day.
Your failure was due to a hazard that your food safety program was designed to prevent from happening. A new hazard analysis is conducted to determine how the hazard was introduced into the process after the last preventive measure but without success.
You cannot start new production until you determine the root cause of the failure.
You restart your investigation with the basics and immediately find issues with the preventive control equipment either in the laboratory or within the process. The pH meter was standardized incorrectly or the standard solutions were incorrect. Perhaps, your solution for acidity titration was incorrect. The pressure gauge on your process was out of calibration. Your temperature probe had been damaged after calibration, but what about your offline temperature cross-checks? Your diversion valve diverted too slow or there was bleed through. Your dud detector stops detecting duds. Valves to your retort bleed through into the retort creating cold spots in your retort. So Surprise! You have a recall and the “what the hell!?” moment.
So, should a failure of the preventive control equipment be considered a hazard that potentially may occur? Should you specifically risk assess that hazard within your food safety program? Are the supplier recommendations for recalibration good enough? Seems that everyone likes to use annually as a good frequency. What are these frequencies based upon? Do you have a pressure testing scheme for your valves or are they on an annual schedule to replace or just when they with not open or close? Has your preventive maintenance program been cost reduced for incremental savings? Not all preventive control equipment is identified as preventive control equipment. Those associated key pieces of equipment that may affect the operation of the preventive measures need to be considered as well.
Or do you continue to collect certificates of calibration or just double check the calibration records? When do you decide to take a deeper dive into food safety?