Is There Foreign Material in Your Finished Product?

Verification is one step to help ensure the food safety system is working to prevent, control or significantly reduce public health hazards. Verification activities are clearly defined in the FSMA and the Preventive Controls Rule, as well as in current regulated HACCP requirements. In previous articles we’ve discussed how to determine inherent risks during hazard analysis and test for metal detector failure.

In this article, we’ll share a process used to verify if foreign material was in a finished product. In this scenario, a cheese-filled sandwich cracker is the target. The qualified food safety individual determined during the hazard analysis that there was a significant physical hazard for metal due to a previous issue with the cheese filling supplier. The preventive controls are supplier control and metal detection.

Corrective Action – Product Control

The crackers were being rejected throughout the day at a high rate. The quality team investigated and found multiple small metal balls. Immediately, all of the product was put on hold for that production lot, which started after sanitation that morning. Placing product on hold is the first step in the prescribed corrective action.

Corrective Action – X-ray Machine or Metal Detector

The qualified individual was overseeing the corrective action process as required. It was discovered that the metal detector minimum sensitivity setting was very close to the size of the small metal balls found in the product.

In this case, to ensure product safety the facility’s qualified individual required that product be re-run through a detection device that has a lower sensitivity than the current in-line metal detector. So they called on the experts: the detection device providers.

Metal Detector Provider – A Resource for Corrective Action

In this case the metal balls were very close to the detection limit of the metal detector. What can a facility do in this instance? If they rerun the product and it all passes, does that make the product less of a food safety risk – no. Therefore, it may be appropriate to call in the experts. The X-ray machine and metal detector manufacturer can assist. The experts may be able to bring an X-ray machine to your site, to re-run the product at an increased sensitivity. We previously defined “functional metal detector” in the “Metal Detector Failure” to ensure the new special circumstance X-ray machine meets the food safety plan expectations. This process needs to be documented and all of this is overseen by a qualified individual.

Corrective Action – Prevent Re-occurrence

What are the steps to ensure this does not happen again? The root cause investigation revealed an older gear box was in poor condition and ball bearings had gotten into the product stream. The gear box was replaced prior to start up and the preventive maintenance schedule was updated with the manufacturer’s recommended settings. (We believe it a good practice to apply this corrective action elsewhere as a preventive action; on another line in the same facility or on a similar line in a sister facility.)

Reanalysis

The next question that can be asked is “Would this corrective action require a reanalysis of the food safety plan?” These bullets will walk through the thought process so far to help answer this question.

• The daily monitoring of the preventive control identified multiple product rejects and subsequent investigation revealed small ball bearings present in the finished product.
• Corrective action was initiated
• place product on hold;
• bring in a x-ray machine, verify the functionality per the food safety plan;
• re-run the product;
• root cause investigation revealed the issue and it was resolved.

This scenario would not require a reanalysis. The current hazard analysis identified metal as a significant hazard.

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?