Guest Blog: The Importance of Validating Product Inspection Equipment
We’re delighted to welcome our first guest blogger, Robert Rogers.
Here Robert explains the importance of validating product inspection equipment to ensure food safety and quality…
Globally-recognized programs, governmental legislation and even individual customer requirements all have a focus on food safety where validation is a critical component. However, although the requirement for validation is clear, limited guidance is provided, particularly when it comes to validating foreign material process control systems like metal detectors or x-ray systems.
Codex Alimentarius defines validation as “Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome”. So basically we need to prove that implementing the metal detector or x-ray system will control the physical contamination hazard to an acceptable level.
One method would be a challenge study which involves running samples and validating the outcome. Once you’ve determined what you define as “an acceptable level”, you’ll need to establish the sample size. The number of samples should be statistically significant, as well as practical. While one sample may not be enough, 10,000 samples may not be practical. A statistician may therefore be a useful resource during the validation development process.
When the system’s installed and operating correctly, it’s best to start with validating the sensitivity or range of sensitivity. The best way to do this is to pass a certain number of “good” products through the system and determine the highest sensitivity that can be run without causing false rejects. The next step is to pass a certain number of “test packs” with the contamination samples and determine the lowest sensitivity that can be run while still detecting the desired contaminant. You’ll need to consider variations in the product such as temperature, texture and moisture, and their effect on the sensitivity, as well as contamination location.
It’s also important to validate the operation to prove that when the contamination is detected proper rejection occurs. This can be done by placing the contamination in different locations, as well as producing successive detection events to ensure proper operation. Again such tests should be performed to a statistically significant and practical number. Included in the operational validation, don’t forget to validate any fail safe type options such as air fail systems.
Documenting these validation challenge studies will give you and auditors confidence that the metal detector or x-ray system, when properly implemented, will be able to control the contamination to the acceptable level.
Robert is Senior Advisor Food Safety and Regulation at Mettler-Toledo Product Inspection Division in Tampa, Florida. Having worked for Mettler-Toledo for over 20 years, Robert has gained his experience by excelling in several positions within the organization, including in field service, training and product testing. In his current role, Robert provides subject matter expertise in foreign material detection and prevention strategies. He also assists in the development of food safety management programs, focusing on foreign body prevention and other product integrity and safety programs.
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