Industry 4.0

10.15.2025

Traceability in action: cross-industry use cases

Discover the cross-industry lessons of traceability, from 'farm to fork' in food to 'cradle-to-grave' part management in aerospace.

The principles of traceability are universal, but their application is tailored to the unique challenges and regulatory landscapes of specific industries. By examining blueprints from sectors where traceability is not just a best practice but a critical requirement for safety and compliance, manufacturers in any field can glean valuable lessons.

Automotive industry: a masterclass in precision and compliance

The automotive industry has long been a pioneer in traceability, driven by the immense complexity of its global supply chains, the paramount importance of vehicle safety, and the catastrophic financial and reputational costs of product recalls. The sector provides a masterclass in implementing precise, multi-layered traceability systems.

Use case #1: Quality control for critical components

For safety-critical components like airbags, brake systems, and engine parts, traceability is the foundation of quality control. The process begins by applying a permanent, unique identifier to each component, often a laser-etched 2D data matrix code that can withstand the rigours of the manufacturing process and the life of the vehicle.

As the component moves through the production line, this unique ID becomes the anchor for a rich digital record stored in the MES. Every critical process parameter is captured and linked to the part's ID:

  • the exact torque applied to a bolt;
  • the temperature profile of a heat treatment cycle;
  • the results of a non-destructive test (NDT); and
  • the dimensional measurements from a coordinate-measuring machine (CMM).

This creates a comprehensive 'birth history' or digital genealogy for every single critical part, providing an indisputable record of its quality.

Use case #2: Surgical recall management

The automotive industry has learned the hard way about the cost of imprecise traceability. The infamous Takata airbag recall, which began in 2013, ultimately affected over 67 million vehicles from numerous carmakers, driving the supplier into bankruptcy precisely because it was impossible to know exactly where all the faulty parts were.

Modern traceability systems are designed to prevent such a catastrophe. If a defect is discovered in a specific batch of brake sensors from a supplier, the manufacturer can use its integrated MES and ERP systems to execute a precise, surgical recall. The system can trace the faulty batch to the specific brake assemblies it was used in, and then identify the exact Vehicle Identification Numbers (VINs) of the cars that received those assemblies. This allows the company to recall only the few thousand affected vehicles, rather than an entire model year's production, saving billions of dollars and preserving brand trust.

Use case #3: Regulatory compliance (IATF 16949, ISO 26262)

The automotive industry is governed by rigorous quality and safety standards that explicitly mandate traceability.

  • IATF 16949 is the global Quality Management System (QMS) standard for the automotive supply chain. It requires organisations to have a robust traceability system that can identify product lots and their relation to manufacturing records, ensuring that nonconforming products can be contained.
  • ISO 26262 is the international standard for the functional safety of electrical and electronic systems in vehicles. It requires end-to-end traceability throughout the entire safety lifecycle, ensuring that every safety requirement is linked to design elements, implementation, and, crucially, verification and validation activities (often mapped using a V-model framework).

Traceability systems provide the auditable, documented evidence that is essential for demonstrating compliance with these standards. Furthermore, industry bodies like the Automotive Industry Action Group (AIAG) provide best-practice frameworks, such as the CQI-28 Traceability Guideline, to help suppliers implement effective systems.

Use case #4: Supply chain resilience and transparency

Recognising the vulnerability of their complex global supply chains, leading automotive players are collaborating on initiatives to create end-to-end visibility. Catena-X, for example, is an ecosystem for the automotive industry that aims to create a standardised, secure data network across the entire value chain. It uses concepts like digital twins (a virtual replica of a physical part) and a 'one-up, one-down' data sharing principle, where each participant only shares data with their direct supplier and customer.

This approach enables secure, end-to-end traceability without forcing any single company to expose its entire supply network, thus preserving data sovereignty and competitive relationships.

Lessons from food, beverage, and pharmaceuticals sectors

While the automotive industry focuses on mechanical precision and safety, the food, beverage, and pharmaceutical sectors are driven by the need to protect public health from contamination and counterfeit products. These industries rely on robust traceability systems, often underpinned by global standards, to ensure the integrity of their supply chains.

Use case #1: Safety and transparency from farm to fork

The foremost concern in the food industry is public safety. A single contamination event can lead to widespread illness, making rapid recall and source identification critical. The 2009 Salmonella outbreak linked to the Peanut Corporation of America, which resulted in nearly 4,000 different food items being recalled, serves as a stark reminder of the consequences of poor traceability.

The FDA Food Safety Modernization Act (FSMA) Rule 204 is a landmark regulation in the U.S. It establishes stringent traceability requirements for companies that manufacture, process, pack, or hold foods on the official Food Traceability List (FTL) – a list of high-risk foods like leafy greens, fresh-cut fruits, and certain seafood. The rule mandates the maintenance of records containing specific Key Data Elements (KDEs) associated with defined Critical Tracking Events (CTEs), such as harvesting, cooling, shipping, and receiving.

Companies are implementing traceability in various ways to meet these demands. Supermarket chains like Tesco use QR codes to provide consumers with farm-to-table information about their produce. Global brands like Nestlé have piloted blockchain technology to trace ingredients like milk from farms in New Zealand to factories in the Middle East. A comprehensive example is Chipotle Mexican Grill, which implemented a system using GS1 standards to trace ingredients from the farm to its restaurants, enabling rapid recall response and enhancing its 'Food with Integrity' mission.

Use case #2: Patient safety and the fight against counterfeits

The pharmaceutical industry's traceability efforts are driven by two critical needs: ensuring patient safety and combating the pervasive global threat of counterfeit drugs. Falsified medicines can be ineffective at best and lethal at worst, making supply chain integrity a matter of life and death.

In the United States, the Drug Supply Chain Security Act (DSCSA) mandates an electronic, interoperable system for tracing prescription drugs down to the individual package level. This process, known as serialisation, requires each saleable unit of a drug to have a unique product identifier. The European Union has similar requirements under its Falsified Medicines Directive (FMD).

Traceability in pharma extends across the product lifecycle. It is used to manage and document complex clinical trials, ensure proper drug administration by healthcare professionals (providing access to dosage and instructions), and facilitate post-market surveillance to monitor a drug's safety and efficacy after its release. A pilot program between Johnson & Johnson and AmerisourceBergen demonstrated how GS1 standards could be used to successfully implement an end-to-end traceability system to meet DSCSA requirements.

The primary hurdles in the pharmaceutical sector include navigating the complex and diverse web of global regulations, the high cost of implementing serialisation on high-speed packaging lines, integrating traceability systems with existing enterprise software, and securely managing the massive volumes of data generated.

The role of GS1 standards

A common thread running through these diverse industries is the critical role of GS1, a global standards organisation. GS1 provides the 'universal language' for traceability, ensuring that systems can communicate and interoperate across companies and borders. Key GS1 standards include:

  • Global Trade Item Number (GTIN): a unique identifier for products.
  • Global Location Number (GLN): a unique identifier for physical locations and legal entities.
  • Electronic Product Code Information Services (EPCIS): a standard for sharing traceability event data (the 'what, where, when, and why' of product movement).

These standards form the backbone of many regulatory compliance efforts, including FSMA and DSCSA, and are essential for achieving true supply chain interoperability.

High-stakes manufacturing of aerospace sector

In the aerospace industry, there is no margin for error. The operational environment is extreme, the systems are extraordinarily complex, and the consequences of a single component failure can be catastrophic. Consequently, traceability is not merely a quality control measure – it is a fundamental requirement for ensuring safety, reliability, and airworthiness.

Use case #1: Part lifecycle management and airworthiness

Unlike in many other industries, the lifecycle of an aerospace component extends far beyond its initial installation. Traceability in aerospace involves documenting the 'cradle-to-grave' history of every critical part. This comprehensive record includes:

  • Provenance: the origin of the raw materials and the identity of the original manufacturer.
  • Manufacturing history: detailed records of the production processes and quality checks performed.
  • Operational history: tracking of flight hours, cycles flown, and any significant events the part has experienced.
  • Maintenance, repair, and overhaul (MRO): a complete log of all maintenance activities, repairs, and modifications performed on the part throughout its service life.

This entire history is essential for proving a part's airworthiness – its fitness for safe flight. This documentation is often formalised on standardised certificates, such as the FAA Form 8130-3 in the United States and the EASA Form 1 in Europe, which must accompany the part throughout its life.

Use case #2: Counterfeit prevention

The aerospace supply chain is a prime target for counterfeiters and suppliers of unapproved parts. The introduction of a single fraudulent component, such as a brake pad or engine part from an uncertified source, can compromise the safety of an entire aircraft.

Robust traceability systems are the primary defence against this threat. Direct Part Marking (DPM), where a unique identifier like a 2D data matrix code is permanently etched or marked onto the component itself, is a common practice. This provides a durable, tamper-resistant identity for the part. By scanning these marks at every stage of the supply chain and MRO process, stakeholders can verify the authenticity and provenance of each component, ensuring that only certified, legitimate parts are installed.

Use case #3: Regulatory compliance (AS9100, FAA, and EASA)

The aerospace industry is governed by some of the world's most stringent regulatory frameworks.

  • AS9100: this is the internationally recognised Quality Management System (QMS) standard for the A&D industry. It is built upon the foundation of ISO 9001 but includes additional, more rigorous requirements specific to aerospace, particularly concerning product safety, risk management, and traceability. AS9100 mandates strict product traceability throughout the entire production process to ensure that the origin and history of every component can be identified in the event of a defect.
  • Regulatory authorities (FAA & EASA): government bodies like the Federal Aviation Administration (FAA) in the U.S. and the European Union Aviation Safety Agency (EASA) set the legally binding regulations for aircraft design, production, and maintenance. Traceability systems are essential for generating and maintaining the extensive documentation required to demonstrate compliance with these regulations during audits and certifications.

Aerospace traceability challenges

Despite its critical importance, implementing traceability in the aerospace sector is fraught with challenges. The supply chains are incredibly complex and global, often involving hundreds of suppliers across multiple tiers. Maintaining data integrity and interoperability between the disparate systems used by these various partners is a significant hurdle. The high cost and complexity of implementing robust systems can also be a barrier, especially for smaller suppliers.

Closing thoughts

Regardless of your industry, the question is no longer if traceability is necessary, but how robust your system needs to be. The challenges of global supply chains, rising consumer expectations, and stringent regulations will only intensify. Now is the time to evaluate your own operations. Are you equipped to provide the level of granular, real-time data that these leading sectors demand? Building a future-proof traceability system is a foundational step in creating a more resilient, efficient, and transparent manufacturing operation.

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