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Inference: The importance of aggregation accuracy

Pedigree laws that mandate unit-level serialization, like the California pedigree law, require members of the supply chain to certify shipment and receipt using unit-level serial numbers.

For a drug manufacturer, those unit serial numbers are known on the packaging line, but the drug packages are typically packed into multi-unit cases and then stored in their distribution center, or that of a contract third-party logistics provider (3PL).

At some point, the distribution center must fulfill an order, typically to a wholesaler/distributor, but before the shipment can be made, the manufacturer is responsible for constructing a pedigree for all of the unit-level serial numbers of the units in the customer shipment.

How will the manufacturer know exactly which units have been collected for the shipment?  They are sealed inside of cases, and the unit-level serial numbers are not visible.  One option would be for the distribution center staff to cut open each case in the shipment, pull the units out, and scan each unit-level serial number on the drug packages, then put them all back into the cases and reseal them.  That’s obviously impractical.

A better option would be to use inference to “infer” which unit-level serial numbers are included in the shipment.  For that to work, the case-packing operation would need to include unique serial numbers on each case and then capture the unit-level serial numbers as they are being packed into the cases.  The unit-level serial numbers would then be associated with the case-level serial number.  This is known as unit-to-case “aggregation” information, and it may include unit-to-bundle and then bundle-to-case aggregation, and/or case-to-pallet aggregation as well.

Now, when the distribution center needs to know exactly which unit-level serial numbers to include on their customer’s pedigree, all they need to do is read the serial numbers on the cases included in the shipment, and then use the unit-to-case aggregation information in reverse.  That is, they would “infer” the units from the case serial numbers.

Further, when the manufacturer’s customer receives their shipment, they will need to confirm that they received a valid pedigree for all of the units included.  To do that, they too could open every case and scan every unit-level serial number.  But the better way is to use the same unit-to-case aggregation information in the same way that the manufacturer’s distribution center did by simply reading the case-level serial numbers (or the pallet-level serial numbers) and inferring those of the units.  To enable this approach, the manufacturer must pass the unit-to-case aggregation information for the shipment to their customer along with the e-pedigrees.

However, if the aggregation information is not accurate, due to inaccurate data capture, both the manufacturer’s and the customer’s use of inference will result in shipping and receiving of product that does not include a corresponding e-pedigree for one or more units.  This puts them both in violation of the law.  The number of units in the error will depend on what went wrong in the case-packing aggregation capture operation.

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