How to Simplify FDA Traceability Data Capture using LPN Barcodes

The FDA now regulates over 22% of all products sold in the USA. A key part of many regulations is to track and trace materials in their supply chains. This is so that, in the event of products being contaminated or defective, such as to cause harm to people or animals, the cognizant health authority can quickly and effectively recall all the defective products, as well as defective precursor materials, so as to minimize harm.

At the core of many of these traceability mandates is the requirement to track the transformation of materials in the manufacturing process. This is because, while it is relatively easy to track materials through the supply chain when they are in boxes or other containers, most of the defects occur in the processing or manufacturing steps where input materials are transformed into output materials.

When materials are received, their containers may have a variety of barcodes, such as a UPC or GTIN barcode, a lot number barcode, a PTI (produce traceability initiative) combination GTIN and Lot Number barcode, an SGTIN barcode with GTIN and serial number (with possibly a lot Number and expiration date), an SSCC (serialized shipping container code) barcode, or possibly no barcode at all.

Or even worse: FedEx, UPC, USPS, or Amazon and other shipper tracking barcodes, which generally are not useful in traceability data recording, at least within the four walls of a manufacturing plant.

Other needed tracking and traceability information is then contained in shipping manifests, on bills of lading, printed on packaging, or sent electronically in the forms of ASNs (advanced shipment notices) and/or EPCIS (Electronic Product Code Information Services) files, or in the form of PDF documents and Emails.

In an FDA regulated manufacturing process, the contents of each container of raw materials, or each separate serialized item, input to the manufacturing process, typically has to be QC (quality control) inspected after receipt and then recorded as input into the making of each batch of products by the people on the production floor.

As part of this traceability recording, we have to record the item/part number for the contents of each container of material (based on its unique UPC or GTIN code), who made it, the lot number and serial number (if appropriate), expiration date, where it came from (including country of origin), whether it has passed QC inspection, as well as possibly other application specific parameters such as size, color, strength, and purity.

It is near impossible, given the plethora of different sources of the information that are needed to be recorded, for the people on the manufacturing/processing floor to sort all this out, at the time they make each batch of the product, at least not without seriously having a negative impact on production throughput and also making many mistakes.

In this white paper the author suggests using LPN (license plate number) barcodes as a way of solving this dilemma and bringing order to this mayhem.

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How to Simplify FDA Traceability Data Capture using LPN Barcodes