Leveraging Bar Codes and RFID for Track-and-Trace Efficiency
It’s up to you to develop systems that utilize bar code and RFID data.
Debbie Murphy, Global Practice Leader, Life Sciences
A lot is expected from bar codes and radio frequency identification (RFID) when it comes to information capacity, security, and efficient identification. Regulators and retailers hope to defend products against diversion and counterfeiting, make electronic pedigrees practical, and prevent medication errors.
But bar codes and RFID do none of these things alone. The technologies simply provide accurate information. Until we all focus our attention on how we can exchange precise, real-time information in our operations, the potential of bar codes and RFID will remain unfulfilled.
RFID and bar codes make it practical to capture and share new types of information in new ways.
For instance, even though FDA’s labeling rule was intended to lead patient safety programs in hospitals, there are opportunities for manufacturers, wholesalers, and distributors to produce lots with unit codes. For example, encoding lot numbers along with the unit-of-use code and marrying them in a database to specific shipments would provide a new level of visibility. Marrying lot codes to electronic records created by production-line control software would enable manufacturers to conduct highly targeted recalls, like this: “We are recalling 50-mg tablets of Drug X, lot number 0123456789, made on March 19, 2003, between 8 a.m. and 1 p.m., on production line 2 at our Anytown, Any State, facility. These products were shipped to Acme Drug Distributors warehouses in Memphis, TN, and Columbus, OH. No other products are affected.”
RFID tagging can take traceability even further. The electronic product code (EPC) system from EPCglobal can provide a secure, unique, and unalterable serial number for each item that is tagged. This represents a powerful new form of information for the industry. A product’s National Drug Code (NDC) number and a unique EPC serial number can be encoded on a single tag.
Generation 2 standard EPC tags also have additional, rewritable memory, which could be used to encode transaction histories, lot codes, expiration dates, and other information to support additional applications. Multiple EPC tags can be read simultaneously. For example, all tagged outer packs contained within a case could be read with a single pass by a reader, which makes it practical to capture and use the information.
An RFID-based electronic pedigree system would work by applying an RFID label to pallets or cases. The chip within the label would be encoded with a serial number that uniquely identifies the items. It could also be encoded with a customer number or other details about the organization to which the product is being shipped. During shipping operations, the RFID tag would be read and the shipper’s inventory records updated, associating the items with a specific customer order. A date-and-time stamp would be applied to the scan to create a chain-of-custody record that is accurate to the minute. This powerful application would require a data warehouse to store transaction data.
The receiving organization could read the RFID label to record receipt and update its own inventory records. Organizations could compare the date that items were shipped to the date that they were received to see whether there were any unusual delays in the process that could suggest the shipment was diverted.
The RFID tag could also protect against counterfeiting. Relabelers, wholesalers, distributors, pharmacies, and hospitals could authenticate incoming shipments with portable readers to ensure no piracy or substitution occurred while the shipment was in transit. Manufacturers could conduct surprise audits of distribution facilities to determine whether and where counterfeit goods enter the supply chain.
Product authentication, pedigree requirements, inventory management, returns, and recalls can only be handled as efficiently as an organization’s information systems allow. It’s up to you to create systems that collect this powerful information.