Costco X-Ray Exemptions

Costco’s requirements:

In short, Costco is requiring you to use the best method available to remove the contaminants that are either common to your industry or which you have encountered in your product. Sometimes this method is a metal detector, sometimes a screen, sometimes an optical sorter. But because most products end up packaged and you can’t screen or visually inspect packaged goods, the solution is most commonly x-ray because it’s usually the best option; and that’s why it’s known as the x-ray requirement.
For an explanation of when x-ray or metal detection is superior than the other, go here.

Risks Specific To Your Process

There are various uncommon risks that may be specific to your process or which Costco is unaware of, and they know this. For example, we often x-ray milk, egg nog, creams, and mayonnaise because stainless gets in them from screeners—the very thing Costco is expecting to prevent contaminants. Sadly, we’ve also had to x-ray whole muscle meat for bird shot on multiple occasions. So if you have an exemption but know you’re prone to a risk Costco is unaware of, they still consider it your responsibility to address.

Ultimately, just ask yourself what kind of contaminants you’ve found in your product, identify any high-risk sources, and see what problems other producers like you have had problems with. Then send us your product with samples of contaminants if you have them, or just tell us what they are. We will then either tell you which method is best or generate your exemption report for Costco. We usually need to test regardless because letters of exemption must be accompanied by proof.

Here’s the applicable excerpt from the latest Safety Audit Expectations document in Costco’s own words:

"All manufacturing operations must have a foreign material detection system (metal detection, x-ray, sieves, optical sorter etc.) installed, selecting the most effective solutions available for their products and processes. Suppliers must justify their choice with documented scientific and technical evidence that proves the system’s effectiveness in reducing contamination, citing sources like expert recommendations, scientific literature, regulatory guidance, and validation studies:

Shell Eggs, whole raw agricultural commodities, whole roasted coffee beans, whole muscle meats, whole or portioned in shell crab; whole lobster tails, whole eviscerated fish, hand portioned fish fillets and peeled/de-headed shrimp, and packaging products will be exempt from the foreign material device requirement. The operation will need to maintain current good manufacturing practices and prerequisite programs to mitigate foreign material contamination.

Operations that utilize a physical barrier (e.g. screen, filter, sieve) that's appropriately sized and placed just prior to packaging will be exempt from the foreign material device requirement. The operation will need to conduct integrity checks at a defined frequency, and maintain current good manufacturing practices and prerequisite programs to mitigate foreign material contamination."

 

Special Cases

Finally, they allow exemptions with a report showing it’s not practical. This will be the case when your product is not able to be x-rayed, or x-ray does not screen for contaminants as well as another method.

X-Ray Is Impractical

There have been instances of product being too hot to x-ray (because manual handling was also required) or too large and dense to x-ray, like huge containers of pickles we came across. If your product has a lot of salt in it and is in a large package, it probably fits this exemption.

Some product is too close to the density of the contaminant you’re trying to find, such as looking for thin plastic film in salad kits. Some products are prone to risk of aluminum shards, but are too close to aluminum’s density to be able to pick them out.

Another Inspection Method Is Better

The article we referenced at the start expounds on this, but sometimes metal detectors will be better than x-ray. These instances usually involve

•  Foil: if the possible foil contamination will be flat (not balled up) metal detectors will find that foil more easily.
•  Thin wire: if a thin wire is oriented perpendicular to an x-ray machine’s detector, it could slip by.
•  Aluminum: metal detectors would be the solution to the example in the previous section.

The down-side to each method having its own strength is that if multiple contaminants pose a threat, and they're both specific to one solution, you may need both. For example, if you're looking for stainless (which x-ray is much better at) and foil (which metal detection is much better at), you could need both a metal detector and x-ray machine. The instances are rare but they do happen.

Contaminant specs. are not named by Costco because what is practical varies, but it will depend on the threat posed by the contaminant. Bone fragments will never break a tooth, but at a few mm it can jab into your gum. Stainless, however, can break a tooth down to around 0.8mm. Ultimately they just don't want recalls.

When it comes to choosing between metal detection or x-ray, Costco is going to want to know first, if you have any non-metal risks. Second, they'll want to know what your current metal dection spec. is, what you've found with it, and whether having x-ray would have improved detectability.

Letters of Exemption

We can test your product with metal detection and x-ray and provide a Performance Comparion Sheet. And if neither will be practical or effective, we will prepare an exemption report for Costco detailing why.

Costco Traceability Requirements

All the details with exact verbiage from Costco are on this page, but essentially Costco will require you to perform traceability audits unless you have an automated system in place that you’ve tested. The traceability function of our control & analytics software takes care of this, which we can integrate with your process system and existing software.