By Larry Hall
As anyone involved in this effort already knows, incorporating item-level serialization in the pharma supply chain is a huge undertaking. It will take years of strategic analysis, program management and project management.But as we move towards this “New Supply Chain,” there are a few fundamental concepts we’ve already learned. Here are seven things you need to know as you modify your supply chain to support serialization, traceability and authentication.
1. Every saleable item must be captured
Every saleable item will have a unique serial number (SN), and this SN needs to be captured. This is essential for fundamental supply chain processes such as order processing and receiving.
The capture can be a direct scan of a saleable product, or a scan of an aggregated product carrier from which individual unique SNs can be derived. Since this data can be in the form of 1/2D bar codes or RFID tags, realistically you must prepare to handle a combination of all three. Sophisticated multi-modal devices such as those from Motorola allow you to do this with one device.
2. Aggregation is required
It is not possible or practical to scan each saleable item all the time. Therefore, aggregation of serial numbers into specific carriers will be required to optimize supply chain practices.
Examples of aggregation carriers include blister packs, cases, totes, pallets and overpack containers. You should plan on these aggregated carriers being defined not only in the manufacturing setting, but all throughout the supply chain.
For example, one of our clients uses multiple types of aggregation carriers at its distribution centers in Turkey. Serialized barcode labels on pallets, full cases and overpack containers are scanned during the shipping process to verify the accuracy of shipped items at the product or lot level against customer shipment orders. Visibility to exceptions is provided to operators in real time at the point of scanning, and the distribution center can ship the serialized carriers without requiring operators to scan each saleable item.
3. You need trust and accountability in your supply chain
In order for aggregated items to be captured and the contents assumed, there needs to be trust and accountability in the supply chain. Periodic audits to verify the aggregations should be required. A traceability audit should be available at all times.
The trust needs to validate that the aggregations are accurate, captured and labeled without error.
4. Serialization hierarchies must be maintained
A trusted data source for serialization hierarchies is required. There has been much debate about who will own this data and were it will reside, but everyone agrees that this data must be maintained.
5. Remote printers enable serialized aggregations
Remote printers will be required to tag (and re-tag) aggregated carriers as they are processed in the supply chain. We’ve seen an increased need for these printers to be portable and remote so that assets can be re-tagged anywhere in the supply chain.
We recently discovered while working with a pharmaceutical manufacturing client that the aggregation of serialized eaches/units and cases to parent containers, and the associated serialization of the parent containers, may occur at numerous and varied locations throughout the client’s distribution centers. Mobile RFID printers deployed as a component of the comprehensive track and trace solution allow this client to dynamically aggregate and serialize parent containers with serialized RFID and barcode labels, printed at the exact location where aggregation takes place.
6. Edge devices will be required
When serialized materials are handled and processed, new “intelligent” devices will be needed to capture and process transactions without error and to keep the serialization hierarchies in constant sync. In addition, the devices need to be mobile in order to optimize supply chain practices.
Our clients utilize a variety of edge devices depending upon their unique manufacturing and distribution supply chain requirements. These include a combination of handheld computers, wearable terminals, fixed and mobile RFID and barcode printers, dock door portals, exit portals, conveyor line tunnels, touch screen terminals, RFID enabled shelves and serialized tag “replacement hospitals.” You should be able to have the edge device you need to fit your supply chain practices.
7. Exception processing is a must
Exception processing support will be required from the “intelligent” edge devices to deal with anomalies in the serialized or aggregated product. In this “new supply chain,” exceptions must be flagged as they occur. It is the ability to flag exceptions and remove anomalistic product that will ultimately provide the increases in patient safety.
For example, a manufacturer uses our serialized receiving module to verify that serialized items possess valid serial numbers, and that the serial numbers reside in a status appropriate for being received. Serial number hierarchies are validated and automatically rebuilt systematically as required, based on the physical product that is received. Visibility to exceptions is provided to operators in real time at the point of receipt, to enable routing the product in question to hold/quarantine areas.
No doubt we will discover a few more fundamental concepts as we continue to define and build “the New Supply Chain” based on serialization, traceability and authentication. Keeping these seven in mind will provide a good, solid foundation from which to start.
Do you have any to add to the list? Please let me know.
About ROC IT Solutions
ROC IT Solutions enables serialized data capture, label printing and tag management for receiving, picking, shipping, returns, deactivation, aggregation and de-aggregation of pharmaceutical products. Our solutions streamline serialization at all points in the supply chain, from manufacturers to wholesalers, distributors and retailers. Through more accurate and efficient supply chain serialization, ROC IT Solutions’ track and trace software helps companies protect revenues, combat counterfeiting and diversion, and ensure consumer safety.
ROC IT serialization software enables “intelligent edge data capture,” allowing companies to capture and process data for serialized assets at the edge of the supply chain, where materials handling takes place. By reducing data capture errors and providing real-time decision making at the point of materials handling, our solutions enable serialized product tracking without bottlenecks or bandwidth issues. Our unique distributed architecture enables agile and scalable solutions that are easily deployed and maintained to support any ERP, EPCIS / Serial Number Management, track-and-trace, Auto-ID or other application, as well as interoperability with any device for barcode and RFID data capture, using GS1 standards. Learn more at http://www.rocitsolutions.com.