Inbound Logistics | March 2024

Gateway to Delays Thousands of Porsche, Bentley, and Audi finished vehicles were reportedly impounded at several U.S. ports in mid-February 2024 due to allegations that the vehicles were manufactured using Chinese subcomponents called gateways that breach U.S. anti-forced labor laws under the Uyghur Forced Labor Prevention Act (UFLPA). As automakers struggle to find parts that are in compliance with UFLPA, they face backlogs that will likely extend the current expected delivery delays, putting revenue and reputation at risk. Jena Santoro, senior manager of intelligence solutions at Everstream Analytics, which has been tracking this situation, shares some key points: 1,000 Porsche sports cars and SUVs, several hundred Bentleys, and several thousand Audis were impacted. • A vehicle gateway is a crucial component in modern automotive manufacturing as it facilitates communication and data exchange between different networks or systems within the vehicle. Without it, a vehicle’s electronic control units operate independently and much less effectively. More importantly, gateways also fortify against cybersecurity issues, and are critical in the development of autonomous vehicles that rely on advanced data exchange and safety protocols. Though the vehicle manufacturers are now working diligently to replace the parts with those that are in compliance with U.S. laws, delivery delays to dealerships, and therefore to customers, are expected at least until the end of March. Depending on the complexity of the vehicle concerned, the part can be replaced within between 30 minutes to several hours. The issue, however, is identifying alternate sources of reliable product that will not be found in violation of the UFLPA, and procuring them quickly. Luckily, the landscape for global automotive central gateway manufacturing is highly competitive and not as centralized regionally like some other automotive components, such as semiconductors. In this case, the supplier found in violation of forced labor was farther down the sub-tier automotive supply chain. As such, it will take time to verify that alternate product suppliers do not have the same vulnerabilities in their extended networks. As seized vehicles mount at U.S. ports of entry, automakers will

visibility of a drug as it moves throughout the supply chain,” says Andre Caprio, director of business development, pharmaceutical and health care at Covectra, a company in Westborough, Massachusetts that provides serialization, tracking, and tracing solutions. When the new requirements take effect, each case, vial, or other sellable unit will carry a two-dimensional barcode with data such as the product’s name and dosage, a lot number, expiration date, and a unique serial number. Each entity in the supply chain must capture that data and store it for at least six years. Say, for example, that manufacturer Pfizer ships a product to a distributor. “Pfizer sends an electronic file that says, ‘I’m shipping 10 units of this particular product. Here are the serial numbers,” Caprio says. Receiving the product and data, the distributor verifies that they match. “As they push that product downstream, they need to send the same information to the downstream partner, which needs to receive and store that data as well,” he adds. Most companies in the drug supply chain are still working to comply with the new requirements, Caprio says. One key step is to implement a DSCSA compliance technology solution from Covectra or another provider. The company also needs to collaborate with its suppliers and customers, creating links that will allow them to share data. Even before choosing a solution, a company should reach out to the Healthcare Distribution Alliance (HDA), an industry organization that includes panels for pharmacies as well as distributors. “The HDA is the best neutral resource for a company to get insight on DSCSA,” says Caprio. Companies may also get valuable advice from peer organizations. 4. SEC Climate Disclosure Since March 2022, the U.S. Securities and Exchange Commission (SEC) has been preparing to release a new set of rules that will require publicly traded companies to report how they are

be faced with backlogs that will likely extend the current expected delivery delays.

3. Drug Supply Chain Security Act

products at the lot level. But starting in November 2024, they will need to use electronic systems to collect, store, and share their data, and each product will need to carry a unique serial number at the lowest unit of sale. Congress designed the DSCA to prevent drug counterfeiting and theft and to make it easier to recall drugs when necessary. “It allows the supply chain to have

Since 2013, the Drug Supply Chain Security Act (DSCA) has required all parties from manufacturers to pharmacists to track and trace prescription drugs and certain prescription medical devices throughout the entire supply chain. Currently, companies can use paper- based systems and capture data on

28 Inbound Logistics • March 2024

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