Serialization, where automation and IT collide
Serialization can help prevent counterfeits but requires that automation and IT work together. Counterfeits are everywhere, from watches on the street corner to apparent high-end clothing sold from the back of trucks. Counterfeits hurt manufacturers’ profits and can harm their reputation, but when counterfeits invade food, pharmaceutical, and mechanical device markets, they also can affect health and safety. Most people are aware of the dangers of counterfeit drugs causing the deaths of thousands, and in some countries counterfeit medicines can be more common than real medicines.
Death by counterfeit
According to the World Health Organization’s estimates, 10%-15% of the world’s drug supply and probably about 1% of the U.S. supply is counterfeit. Food counterfeiting in China has resulted in multiple deaths due to contaminated ingredients with prosecutions for criminal offenses. In July 2013 French authorities reported seizing 100 tons of fish, seafood, and frog legs whose origin was incorrectly labeled; 1.2 tons of fake truffle shavings; 1100 pounds of inedible pastries; false Parmesan cheese from America and Egypt; and liquor from a Dutch company falsely marketed as tequila. In Britain fake vodka was found to contain bleach and high levels of methanol, and engine oil was found in olive oil.
Mechanical device counterfeits can also be deadly when they are used in automobiles, trucks, ships, airplanes, turbines, and rotating machinery. Substandard materials in counterfeit mechanical devices can fail, often with catastrophic consequences. For example, the Automotive Component Manufacturers Association of India has reported that up to 20% of all road accidents that occur in India are due to counterfeit auto parts.
Considering the health and safety risks due to counterfeiting, it is no wonder that serialization is becoming either a regulatory requirement or a tool to reduce liability risk. Serialization is defined as the labeling of each salable unit with a globally unique identification (ID) so that the unit can be tracked through the supply chain and counterfeits can be identified. The unique IDs are semi-random; a counterfeiter cannot simply pick numbers that are similar to real IDs. Serialization on food products is usually applied to the packaging, but some foods, such as eggs and fruit, are actually individually labeled. Pharmaceutical serialization is used to label the packages with printed labels or laser encoding for medical devices. Mechanical device serialization is often applied directly to the mechanical devices, such as laser encoding seen on bearings, gaskets, and tires, or metal labels applied directly to large devices.
Serialization is an IT project because the business must assign and record the unique IDs and make them available to regulatory authorities and supply chain partners. Serialization is also an automation project because the unique IDs are attached to devices at the back end of production lines or the front end of packaging lines. Serialization projects are where automation and IT are forced to work together.
Many companies are implementing serialization as an IT project with little or no concern for how the IDs will actually be applied to the devices. They consider serialization as just a printing problem. Enterprise resource planning (ERP) vendors, such as SAP and Oracle, provide serialization systems that can be used to create unique, semi-random IDs; associate the IDs with specific production sites, products, and material lots; and share the information with supply chain partners. A typical implementation will periodically assign a set of numbers to a product and download the numbers to a shop floor system. When production and packaging is complete, the shop floor system will send back the specific lot numbers and product IDs assigned to the serialization IDs. The shop floor systems will also send back the lists of unused and scrapped IDs, because it is important to track the scrapped IDs so they cannot be used in counterfeit products.
Usually the IT department hands off the serialization project when the IDs are sent to the shop floor systems, but that is often where automations problems occur. Implementing serialization in production or packaging is not just slapping a new label on a box, but it usually involves physical integration of the existing automated production or packaging line with the labeling and verification equipment. When IDs are applied, they must also be checked, so vision systems must be added to the lines after the labeling operation. The labeling and verification systems must be integrated into the overall control system and integrated with the ERP systems to obtain IDs.
Usually there is an MES (manufacturing execution system) that receives the IDs from the ERP system and makes them available to each production or packaging line’s labeling and verification system. The MES then also collects the used and unused IDs and periodically sends these back up to the ERP system. Automation is involved in the physical integration of the systems and with the IT integration, and because many existing systems are validated, it often requires revalidation of the updated system.
Automation and IT collide in serialization projects when companies consider them to be only IT projects, without allocating time and effort to the shop floor part of the project. If the IT organization or management thinks that serialization is just adding printers in production lines, then the project will end up late and over budget. If your company has a serialization project, or is starting one, make sure the manufacturing IT and automation groups are involved early in the project. Every production line may require a unique automation solution, with different labeling and verification devices and technologies. Only with automation and IT working together will your serialization project be a success and protect your customers.
– Dennis Brandl is president of BR&L Consulting in Cary, N.C. His firm focuses on manufacturing IT. Edited by Mark T. Hoske, content manager, CFE Media, Control Engineering and Plant Engineering, email@example.com.
This posted version contains more information than the January 2014 print / digital edition issue of Control Engineering.
At www.controleng.com, search Brandl for more on related topics.
See other articles at www.controleng.com/archives.
See other Manufacturing IT articles.