In this article about testing contaminant detection and production inspection devices, Sesotec food safety experts explain the importance of validation, verification and monitoring and their role in ensuring the effectiveness of a foreign material control program.
For food manufactures and processors, product inspection and contaminant detection devices are an important part of an effective foreign material control program. In order to ensure the safety of their products, food industry businesses rely upon detection technology – often metal detectors and x-ray inspection systems – to identify physical contaminants and remove defective products from the production flow.
But just as production processes vary tremendously according to a plant’s products and scale, contaminant detection devices also differ. In order to safeguard consumer health, international food safety standards require that companies validate, verify and monitor their contaminant detection technology on an ongoing basis..
Validation, verification, monitoring: what they mean and how they differ
Validation, verification and monitoring are three distinct phases of testing product inspection devices. Each phase relates to a different period in a device’s lifecycle and uses different criteria to evaluate the effectiveness of the device within a given process.
Depending on the global food safety and quality standards applied, specific requirements for each phase of testing inspection devices may vary slightly. In this piece, we refer to the requirements laid out in IFS Food Version 7..
1. Validation: can my device achieve the intended outcomes? In testing contaminant detection technology, validation refers to the initial processes of qualifying whether a device can adequately fulfill the specific, documented requirements of its intended use..
Validation takes place before a food company purchases and/or implements a contaminant detection system. According to IFS Food V7, validation requires “the provision of objective evidence.” This evidence takes the form of specific criteria, such as the probability of detection (POD) and the false rejection rate (FRR), which are determined and documented before testing begins.
For instance, after assessing the foreign body risks present in their process, a company may determine they require a metal detector that can detect metallic particles of a certain size with a POD no lower than 99.998% and a FRR no higher than 0.001%. Factors such as packaging, product effect and production line speed should also be taken into account. These metal detector sensitivity criteria are then documented and different metal detection devices are tested accordingly. Only the devices that perform according to these standards will pass the validation phase..
2. Verification: is my device performing as expected? After a contaminant detection device has been implemented, verification refers to scheduled, periodic testing procedures designed to ensure the device continues to function as expected.
To be compliant with IFS Food V7, verification should take place annually and include a series of thorough control tests, training sessions for personnel and the complete documentation thereof. Beyond detection sensitivity, the verification process should also include controls to ensure the device is reliably separating defective and/or contaminated products from the production flow.
As it only happens once annually, IFS Food V7 stipulates that the verification process should involve tests and documentation that are more exhaustive than the regular monitoring protocols detailed in the next section..
3. Monitoring: is my process under control? In regard to foreign material controls, monitoring refers to frequent, ongoing performance tests designed to assess whether any changes have taken place since the last test that could impact the performance of an inspection device.
Monitoring is a routine protocol carried out multiple times per shift, usually at the beginning and end of a shift and whenever a product or batch is changed over. According to IFS Food V7, monitoring consists of “a planned sequence of observations or measurements of control parameters.” Such observations and measurements include, among others:
ensuring the device is operating according to the correct settings
running a series of test pieces through the device to ensure they are rejected
ensuring the catch basin for rejected products has been emptied and nothing is obstructing the ejection chute
Monitoring processes must also be documented, though not with the same exhaustiveness required in the verification process.