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From the end of September to the beginning of November 2020, there were at least five issues related to possible foreign matter contamination in food, including three FDA recalls for various brands of popcorn and two USDA public health alerts. Additionally, the presence of foreign material accounted for five FDA recalls in July, and, 69.6% of USDA pounds recalled during the second quarter of 2020 were due to foreign material, according to the Stericycle Expert Solutions Recall Index.

With recalls continuing to occur on a near-daily basis, some of these statistics may not seem highly significant, until you consider that the October USDA public health alert for ready-to-eat (RTE) meat and poultry bowl products was due to concerns that the products may be contaminated with glass. (In this case, no recall was requested because it is believed that the products were no longer available for consumers to purchase.) A consumer having swallowed the glass could have led to intense physical harm for that consumer — and significant impact on the company which distributed the product.

While no food facility intends for its product to be distributed with foreign objects in it, it is not always easy to detect foreign matter in a food.

Why are foreign objects such an issue? According to Detectapro Products President Paul Gaertner, foreign object contamination in the final product can create any number of negative impacts against the processor. If a foreign object is detected on the line, it might be something as simple as discarding the affected product and continuing with production. However, he said, “Simplicity may come at a price. How many pounds of product are discarded due to the finding of the foreign object, and how long does the line stay out of production before it can begin again?”

If the foreign object is not detected and ends up in the final packaging, it can create the need for a recall, he added. “A recall is very expensive and a real logistical nightmare for the retailer involved in handling the return of the recalled product.” This also can lead to bad press for the processor which is not immediately quantitative; litigation against the processor; and long-term financial and public relations impacts that can be quite costly.

“Foreign objects pose a significant risk,” added Detectamet Group Marketing Manager Robert Lockwood. “The most significant and immediate risk is to the end consumer, a member of the general public, who might consume contaminated produce that could therefore cause a risk to their health.” As a consequence of this, the reputation of the food manufacturer, and their operating procedures, are likely to be called into question, he said, “Not to mention the costly product recall procedure that the processor will have to carry out to reclaim that produce.”

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How Should a Facility Address a Foreign Object Customer Complaint? In its Guideline for Industry Response to Customer Complaints, the USDA Food Safety and Inspection Service (FSIS) includes information on substantiation of a customer complaint — including that of foreign objects. While written for the meat and poultry plants under USDA jurisdiction, the guidance is just as applicable for FDA-regulated facilities. Following are excerpts from the guideline specifically related to addressing customer complaints of foreign objects, with some minor additions to focus the guidance to all facilities regardless of food produced:

  1. An establishment should develop criteria and a mechanism for determining the validity of any customer complaint. The establishment should start by verifying whether the product is under the jurisdiction of USDA FSIS or FDA.
  2. Verify the establishment where the product was produced. Products are often similar and may be produced at multiple locations, so the establishment should verify that the product was produced at that location and, if not, notify the corporate office or customer if the product is not produced by that company.
  3. Develop criteria to determine that no tampering of the product occurred after shipment from the producing establishment.
  4. Determine what evidence, if any, the customer has of the adulteration and misbranding. This could be photographs, video, or a sample of the foreign material. An image or a sample of the product can show the condition of the product, while an image or sample of any physical adulteration such as foreign material provides information that can be used to start the investigation into the cause of the adulteration. The purchase location also may be helpful to identify distribution channels that may have contributed to the adulteration or misbranding.
  5. Facilitate the substantiation of complaints as soon as possible when there is the potential that adulterated product is in the hands of household consumers.

When the establishment determines that hands-on examination of the product, label, or any other material is important in determining if adulterated product has been produced, delays in the shipment of the identified foreign object, product, or label should be avoided. The recommended best practice is to perform an initial substantiation and investigation using immediately available photographic or video evidence and take appropriate action based on that evidence, then follow up with additional actions, as warranted, once the physical material, product, or label are made available for a hands-on examination.

The establishment should identify the specific establishment employee(s) (name or title) who will receive notification of the complaint and are responsible for the initial substantiation. Since complaints may occur on weekends, applicable contact information should be included in the program. FSIS and FDA each have additional requirements for official notification, however best practice is to notify the applicable agency as soon as an establishment begins investigating a complaint, as everyone benefits if a recall can be prevented by early notification and halting distribution.

If the customer complaint claim is determined to be not valid, the establishment should maintain documentation to support how that decision was made. Such documentation could be used to support why the establishment did not take any actions related to the product, especially if new evidence, which does substantiate the initial claim, is identified in the future.

Why is it so difficult to control foreign objects in food? “Controlling foreign objects in food can be difficult indeed,” Gaertner said. In-house quality programs such as six sigma and adhering to GFSI-certification guidelines are aimed at every level of production, and on-site detectable production tools and products allow detection systems to pick up certain types of foreign objects.

But beyond that, he said, “Every shift must be diligent in calibrating detection systems. A company can put in place the correct quality plan, but these plans are only as good as the personnel implementing them.”

Using utensils and equipment that are detectable when passed through a metal detector or x-ray inspection system helps to minimize the risk of foreign matter contamination. This can provide peace of mind, Lockwood said, “that the risk of foreign matter contamination has been appreciably reduced, and that if a contaminant is detected, the specific product affected can be removed from the production line before it reaches the consumer.”

“Implement quality practices and maintain the practices,” Gaertner added. “Use metal and x-ray detectable products anywhere and everywhere you can on the processing floor.”

The author is owner of LJ Writing Services and a member of the QA Advisory Board.