Serialization, Track & Trace for Enhanced Supply Chains
Serialization, Tracking & Tracing
In today’s fast-paced global marketplace, there is a pressing need for businesses to ensure secure, compliant and efficient movement of goods across their end-to-end supply chain. Serialization, tracking and tracing are foundational solutions that address common regulatory compliance and visibility challenges. In this article, learn how to transform current supply chain processes to streamline operations and deliver safe, quality products.
Supply Chain Traceability Challenges
- Complex regulations
- Data management
- Product lifecycle visibility
- Supply chain disruptions
- Counterfeit products
Common Business Drivers
Compliance
The World Health Organization (WHO) has estimated that 10% of global pharmaceutical commerce involves counterfeit drugs. In Europe alone, it is estimated that the Pharmaceuticals & Life Sciences industry lost €9.6 billion in sales due to counterfeits during the period of 2012-2016, which represents 3.9% of total sales.
Biotechnology and drug developers, food manufacturers, wholesalers and many other industrial stakeholders are vital to the health of the global population. However, these businesses often operate under strict regulations to ensure the safety and quality of goods at each level, from raw material to consumer distribution. Any disruption in a supply chain can have unforeseen ripple effects across their enterprise operations.
End-to-end traceability is the basis for enhanced consumer protection from falsified or damaged products. With the knowledge about the physical location of a particular product within a supply chain at any point in time, businesses can successfully detect counterfeiting incidents, minimize the delivery of damaged goods and reduce product diversion.
The regulatory landscape is always changing and expanding into new industries, such as Medical Device Manufacturing, Food, Beverage & Tobacco, Electronics, Batteries & Semiconductors, Agribusiness & Chemicals, and Automotive & Industrial Machinery. All organizations selling products in these regulated markets should expect requirements to continuously evolve, especially for safety and sustainability initiatives. Digital tracking and tracing solutions provide the information required to report and show compliance while reducing errors through serialization. The illustration featured below breaks down the many facets of regulatory compliance reporting.
Aggregation
Aggregation is the capture of a data hierarchy, such as serialized packs, bundles, shipping cases and pallets, in a single, more manageable repository. Given this process provides access to real-time data on each level of supply chain operations, aggregation benefits include improving inventory management, decommissioning useless systems, streamlining recall processes and reaching compliance.
Serialization and aggregation, from ingredients sourcing to products being placed in consumer hands, involves various legacy manufacturing and Enterprise Resource Management (ERP) systems. The entire process requires rigorous control, governance mechanisms and standard guidelines for product serialization, which are constantly evolving and increasing in complexity.
Emerging Compliance Regulations
- GS1 Standard: These standards are the most widely used and designed to improve the efficiency, safety and visibility of supply chains across physical and digital channels. GS1 barcodes can identify, capture and share key information about products, locations, assets and more. Global Trade Item Numbers (GTIN) can be used by companies to uniquely identify trade items. The GTIN can be encoded in a barcode or an EPC/RFID tag.
- DSCSA: The U.S. FDA Drug Supply Chain Security Act (DSCSA) outlines steps to build an electronic system to identify and trace certain prescription drugs when distributed in the United States. The goal is to protect consumers from exposure to drugs that are counterfeit, stolen or contaminated. The DSCSA includes product verification through the ability to scan or enter into the system the four product identifiers – the GTIN, serial number, lot number and expiration date. This information can be sent to the manufacturer repository, and the repository can confirm the product is verified.
- FMD: The EU Falsified Medicines Directive (FMD) is a set of rules to protect consumers from fake medicines in the European Union (EU). It includes anti-tampering security on packaging and tracking of medicines using a unique identifier that must be encoded in a two-dimensional barcode printed on each sales unit.
- FMSA: The U.S. FDA wrote its Food Modernization Safety Act (FMSA) regulation to prevent foodborne illnesses. Seven rules have been outlined and tied to specific actions at each point in the global supply chain to reduce contamination. Among others, it comprises standards for growing, harvesting, packing and storing produce, and it defines transportation requirements, supplier verifications and third-party certifications.
- Chestny ZNAK: The Chestny ZNAK is a national track and trace system created by the Center for Research in Perspective Technologies which requires mandatory marking of consumer goods sold in Russia based on barcodes. The system's purpose is to protect customers from fake goods by ensuring their authenticity and quality. Several pilot projects have been started in the last years and all defined industries must be tracked at the unit level. Digitization and automation of these serialization regulations include printing 2D codes on products and human-readable text, cross-checking the 2D code and text, sending that information to a database for comparison, checking the quality of the 2D code and uploading the GTIN serial number, lot number and expiration date to a corporate or government repository.
Overcome Supply Chain Disruptions with Value-Based Tracking
Anti-Counterfeiting and Diversions
Digital supply chain solutions enable companies to record historical data of product movement, time spent at each stage and packaging information. Many industries apply this technology intending to protect their brands, product integrity and consumers from the effects of counterfeiting and possible damage during diversions. A full tracking and tracing approach involves the implementation of both serialization and aggregation solutions into packaging lines and enterprise IT systems.
Recalls
How do industrial enterprises efficiently recall products, and how can they reduce warranty claims? Imagine a contaminated ingredient that has been processed into a ready-made meal and the company needs to determine where the critical ingredient was sent, sold, used and processed. Finding the right answers without end-to-end traceability of the products across the supply chain can substantially slow down the recall process. With serialization and traceability solutions in place, businesses can identify unique parts, items and ingredients, as well as their progress across each stage of production, how they are added into multi-level assemblies and how they move across highly distributed supply chains. A faster recall response helps protect customers and organizations from producing and distributing counterfeit, contaminated or damaged items.
Warranty Validations and Return Verifications
One in six people in the U.S. get sick from contaminated food every 12 months. Manufacturers have an important role to play in preventing foodborne illnesses through responsibilities outlined in the Food Safety Modernization Act (FSMA). There have been several cases where a contaminated product damaged consumer trust due to items not being traced during a global recall. Without visibility of where products have been used or created, there is no way to react proactively before the issue becomes larger and gains more public awareness. Cases like this feature the importance of traceability across all industries.
Overall, digital traceability solutions can identify counterfeit goods and provide recall insights, batch-management verification, warranty validation, aggregated logistics and a management system for goods returned from the market.
Benefits Beyond Compliance
Regulatory compliance is the primary driver for the deployment of serialization solutions, however, there is a high value beyond compliance. This extra value includes:
Supply Chain Visibility
Connecting the entire value chain with a tracking and tracing system unlocks data that enables not only regulatory compliance but full visibility into the control of inventory, shipping and third-party logistics performance. While improving process inefficiencies, businesses can also improve waste/scrap management and overall supply chain performance.
Data Sharing for Improved Product Safety
Through the combination of tracking and tracing solutions with blockchain information, decentralized systems enable data sharing across the entire network from producers to consumers. This improves material provenance and traceability from batch origin to finished products. Material provenance, sometimes referred to as batch genealogy, provides traceable accountability in products that are sold by showing the origin and life cycle of items from raw materials or ingredients through delivery. Batch genealogy captures the relationship between a selected batch and all batches, process orders, production orders, stock transfers and subcontract purchase orders that have issued or received material from the selected batch or its related batches. The information is also used to verify authenticity and confirm certain practices relating to sustainability, safety and fair trade. Data collected can also trigger customized product issue alerts that allow partners to make critical, time-sensitive decisions and integrate into backend systems for reporting and analysis.
Effective Team Collaboration
Increased transparency through a single system used for information sharing and tracking can have a significant impact on the entire value chain. The quality and availability of data is influenced by accuracy, timeliness, credibility and inter-organizational relationships. It is necessary to provide real-time insights with integrated information to all involved value chain partners through the product cycle. This data must be available at every level of the process from the created purchase order and in-transit tracking to arrival confirmation.
Secured Brand Reputation
Another dimension of serialization that technology benefits is its effects on your business and customers by introducing standardized information and process simplification. In the end, tracking and tracing systems help companies stay ahead of competition while ensuring brand protection through delivering consistent product quality on time. Contributing to a secure supply chain also provides value by reducing inefficiencies that can impact cost and time. By giving consumers transparent access to the origin and current location of an ordered product within the supply chain, trust is created and businesses can showcase sustainable Diversity, Equity and Inclusion (DEI) practices.
Features of Digital Supply Chain (Tracking & Tracing) Solutions
- Serialize and aggregate items/products/batches
- Trace, verify and access item/product/batch genealogy
- Monitor and obtain real-time insights into supply chain activities and events
- Manage, access and exchange serialization data securely from a centralized database
- Label, re-label and repackage items/products/batches
- Manage product recalls and returns efficiently and effectively
- Report compliance data to government systems
- Identify potential problems or defects in products and processes
- Integrate third-party tools, systems and processes (ERP, Warehouse Management Systems, RFID/Barcode Scanners, etc.)
Engineering’s Expertise
As regulations for serialization and demands for product traceability grow in size and scope, so will the value of integrated technologies for tracking and tracing. Engineering Industries eXcellence has broad technical expertise, deep regulation knowledge and an innovative solution portfolio that makes us a power player in the arena of supply chain traceability and compliance. Our global team of Digital Supply Chain (Tracking & Tracing) experts has been delivering traceability projects to organizations worldwide for over a decade. By connecting the entire supply chain, our tracking and tracing solutions provide real-time visibility across global value chains, harmonizing product information from raw material to end-of-life.
