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Traceability

This page aims to provide a comprehensive understanding of traceability in manufacturing, focusing on its fundamental principles and practical applications within the manufacturing industry.

Traceability or product traceability plays a pivotal role in modern manufacturing, enabling the meticulous tracking and monitoring of products and components throughout their lifecycle.
We will also cover specific OMRON solutions relevant to traceability in manufacturing:
  • Code Reading and RFID: Discover how code reading and RFID technology enhance traceability through efficient data capture.
  • Laser Marking: Learn how laser technology is used for permanent product marking ensuring reliable tracking and traceability for the lifetime of the product (cradle to grave).
  • Communication: Explore the importance of real-time data exchange in traceability processes.
  • Implementation: Gain insights into practical strategies for setting up robust traceability systems and ensuring data quality.
  • Code inspection: Discover how code inspection or barcode verification technology plays a crucial role in maintaining traceability by ensuring the readability and accuracy of product codes and labels.
 These topics will help you to better understand traceability in manufacturing. Let's get started

What is traceability?

The term "Traceability" is derived from the words "Trace" and "Ability." While its precise definition can vary slightly across industries like automotive, electronic components, food, and lifescience(pharmaceuticals), in the manufacturing industry, it is generally defined as follows:
Traceability is the ability to keep track of products and their ingredients as they move through the supply chain, for example from the farm to the consumer's plate. However, traceability can also be used in other industries like electronics, automotive and aerospace industries to track additional information related to the item being traced, such as the parts used, quality data, machines involved, and even the operators that handled them. It's important to note that while the product itself may be continuously tracked, the information associated with it can still be accessed without continuous tracking. For example, you can look up quality data for a product by its serial number when making a warranty claim, even if the serial number wasn't tracked throughout the entire supply chain. 
 
Simply put, traceability represents the capability to track and trace every aspect of the production process, from raw materials to final product delivery. It is the meticulous recording of information that enables manufacturers to have a comprehensive view of their product's history.

What is Serialization?

Serialization and Traceability are closely related concepts often used together, but they have distinct meanings. Serialization involves assigning a unique identifier to a product or item, typically in the form of a serial number. This unique identifier enables traceability at the individual item level.
Serialization Applications: Serialization finds applications in various industries. In pharmaceuticals, it's crucial for drug traceability and compliance with regulatory requirements. In electronics, it helps ensure product authenticity and quality control. The automotive industry uses serialization to track components, enhancing production control and facilitating recalls when necessary. For instance, when a mobile phone is serialized, each phone is assigned a unique serial number, allowing for tracking of specific components used in that particular phone. Without serialization, traceability is still feasible, but it typically operates at a higher level, such as tracking items in larger batches or lots.

Challenges

Implementing serialization can present challenges, such as managing vast amounts of unique identifiers, ensuring data accuracy, and coordinating with suppliers and partners in the supply chain. However, these challenges are often outweighed by the benefits in terms of precision and control.
 
Simply put, serialization is a powerful tool that enables careful tracking and tracing of individual items or components, enhancing traceability in various industries. While it may not always be necessary, its ability to provide fine-grained data is invaluable in situations where accuracy and precision are required, or mandated through legislation.

What is traceability in manufacturing?

In an era where consumer trust and product integrity are more important than ever, traceability in manufacturing has emerged as a cornerstone of industry excellence. But what exactly is traceability, and why does it carry such weight in the manufacturing world?
Traceability in production involves the ability to identify and track and trace material, components and items throughout the entire production and distribution chain. Traditionally, the use of manual(written) records limited the ability to keep traceability data and the scope of what could be traced. Barcode technology has given companies the capability to automatically identify products and components and to use electronic systems to store vast amounts of data associated with the product. The barcode serves as a unique identifier that allows a product to be traced back to its origins.
 

What is lot traceability in manufacturing?

Lot traceability in manufacturing refers to the ability to track and trace a specific group or "lot" of products or components throughout the production and distribution processes. It involves assigning a unique identifier, typically a lot number, to a batch of items that share common characteristics, such as production date, materials used, or location of manufacture. Lot traceability allows manufacturers to monitor and document the entire history and journey of that particular group of items, from the moment they are produced to their final destination.

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What is Track and Trace in Manufacturing?

In manufacturing, track and trace systems let companies follow and control their products or parts from creation to sale and beyond. They use barcodes or RFID tags, along with special software, to collect and analyze data about where items go and what happens to them.

Sometimes barcodes are directly marked onto a products in the form of a QR or Datamatrix code. In this case, the mark is called a direct part mark (DPM) and permanent for the lifetime of the product.  
 

So, what gets tracked?

It could be anything your company makes and sells, whether it's as simple as fast moving consumer goods or as complex as semiconductor parts or automotive components.
 
Traceability systems are crucial. They help manufacturers spot problems, manage their stock, comply with regulations, and prevent expensive product recalls. They can also give a clear view of how goods move from production to the customer, a vital part of a strong supply chain.

How is it used in the industry?

In the manufacturing industry, the growing importance of traceability cannot be overstated. It's crucial to have real-time knowledge of the whereabouts of components or products within the production line, as well as throughout the supply chain.

Various technologies and tools are employed to implement track and trace systems. Some of the technologies include:

  • Barcodes, QR codes, or RFID chips/tags
  • Labelling systems, laser markers, barcode verification systems
  • Real-Time Locating Systems (e.g., GPS)
  • Code readers and scanners, tablets, or smartphones
  • Software solutions

The trend finds applications across numerous areas, including:

  • Tracking progress in manufacturing and production processes
  • Ensuring the traceability of components
  • Locating tools, machinery, testing, and measuring equipment

What is Code Reading and RIFD?

The basis for traceability is identifying a part, and the most common way to do this is the barcode. Code reading refers to the process of scanning and interpreting various types of codes, such as 1D (one-dimensional), 2D (two-dimensional), whether they are printed on a label or applied as a direct part mark (DPM).
 
This machine-readable structure usually contains a unique identifier for a WIP part and uniquely identifies it every time it is scanned. 
You can think of barcodes as the glue connecting the physical world to the digital realm – each time a code is scanned, digital records are updated to reflect new information about the whereabouts and overall status of physical objects.

Barcode Types

1D codes, also known as linear barcodes, consist of a series of parallel lines and spaces of varying widths. They can encode a limited amount of information, typically a product identifier or a serial number. 
 
2D codes, on the other hand, can store significantly more data compared to 1D codes. They are composed of patterns of squares, dots, or other geometric shapes. Examples of 2D codes include QR codes and Data Matrix codes. 2D codes provide the ability to store additional information such as batch numbers, expiration dates and URLs or manufacturing details.  
 
DPM codes are directly marked on the surface of a product or component using methods like laser etching or dot peening. DPM codes are designed to remain readable in harsh environments and be permanently attached to the part or products.   
 
RFID technology provides unique identification capabilities with the ability to store as much information as 2D codes. In addition, RFID brings some unique advantages. It uses radio waves to wirelessly transmit data, allowing contactless identification, even in harsh environments, even without line of sight.  Some RFID tags can store much more data than even 2D codes and can be written in the process, serving as a local repository of production data, without the need for an online database.

Digimarc Barcodes: The Next Big Thing?

Digimarc is a machine-readable watermark that is imperceptible to humans, and built into the design- or artwork of a label, box or container. The Digimarc watermark can be applied to the entire surface of a product, keeping the appearance of the packaging or product intact. This opens up completely new possibilities, for example for better recycling of the packaging.
 
OMRON is currently collaborating with this technology to enhance its customers' efficiency and meet their specific needs. For information contact us.

Our solutions for Traceability in manufacturing

Explore our key applications and solutions that empower efficient traceability throughout the manufacturing process.
 
At OMRON, we excel in traceability solutions, from laser marking to verification, and from reading the codes to ensuring correct communication of traceability data. Our advanced technology ensures reliability and accuracy. Choose us to elevate traceability, streamline asset management, and enhance quality control in your manufacturing processes. We've got you covered, whether it's RFID or traditional code reading.
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RFID Asset Tracking

*Unique RFID tags for precise asset identification. *RFID tags can store additional asset data. *Tags attached to assets, data captured wirelessly, and real-time updates.

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Laser Marking

*Laser marking for durable, permanent, excellent quality codes. *Fiber laser markers with deep marking and 3D capabilities. *Benefits include marking on diverse materials and high-resolution markings.

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Code Quality Verification

*Ensuring reliable traceability with 100% code readability. *Solutions for compliance with ISO and GS1 standards. *Benefits include documented compliance, guaranteed readability and reduced downtime.

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Code Reading Challenges

*Overcoming challenges in reading codes in harsh environments. *Solutions with advanced decoding algorithms for reading even the poorest of quality codes. *Benefits include reading damaged codes and reliable reading in challenging conditions.

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Communication & Implementation

*Efficient data collection in traceability. *Cost-effective implementation with database and communication enabled controllers. *Support for SQL, MQTT, REST and OPC-UA

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What are the benefits of traceability in manufacturing?

Quality Control

Traceability ensures consistent product quality by tracking and monitoring each component's quality throughout production.

Product Safety

Industrial robots can operate 24/7 and increase the speed of manufacturing processes. The speed and dependability of robots ultimately reduces cycle time and maximizes throughput.

Regulatory and Legal Compliance

Helps companies comply with strict industry regulations, government and industry directives, avoiding legal penalties and fines.

Supply Chain Optimization

Traceability extends into the supply chain, enabling efficient inventory management and timely product delivery.

Brand Reputation

Builds trust with customers, partners, and regulators, enhancing a company's reputation.

Types of Traceability in Manufacturing

Traceability in production can be looked at from two main angles: supply chain traceability and internal traceability.

Internal Traceability: Imagine you have a specific area, like a single company or a factory. Inside that area, you want to keep track of how parts or products move around. For instance, if a car engine assembly plant buys parts like camshafts and pistons from suppliers and puts them together, they use internal traceability to keep a record of these parts' history and quality checks.

Chain Traceability: Now, think bigger. Chain traceability covers the entire journey of a product, from getting the raw materials and parts to making, distributing, and selling it. Manufacturers can track where their products have gone ("trace forward"), and customers can find out where the products they have come from ("trace back"). This helps manufacturers investigate issues and recall products if needed. It also gives consumers confidence in the products they choose, knowing they can trust their origin.

Trace Forward and Trace Backward Traceability

In traceability, 'trace forward' means following where products go using collected data. 'Trace back' means looking at past records. To have proper traceability, products are labeled at each step. Real traceability means you can always check where things are going and where they've been.

Manufacturing traceability and Industry 4.0

OMRON leads the way in manufacturing traceability solutions, offering a comprehensive suite of technologies and expertise. Our solutions encompass laser marking for durable product marking, code reading and RFID technology for efficient product identification, robust communication systems for real-time data capture, and practical implementation strategies to ensure data quality.
 
We understand the critical importance of traceability in enhancing product quality, safety, and ensuring compliance. By leveraging Industry 4.0 technologies, we enable manufacturers to achieve seamless tracking and traceability throughout their production processes. With OMRON, you can confidently navigate the evolving landscape of manufacturing traceability and stay ahead in an ever-advancing industry.

Ensuring Compliance and Quality Control

This powerful concept does more than just monitor, it provides an assurance of product quality. A robust traceability system ensures that any defects or issues can be quickly identified and rectified, guaranteeing that only the highest-quality products reach the market.

The importance of traceability transcends individual businesses, addressing industry-wide challenges. With globalization and the complexity of supply chains, traceability has become a critical solution necessary to safeguard against errors, contamination, and counterfeit goods - ensuring not just compliance with regulations but also securing a manufacturer's reputation and consumer trust.

Staying Compliant: Regulatory Compliance and Standards

Traceability in manufacturing is not just about keeping track of materials and products for efficiency and quality control. It's also a critical component in compliance with regulatory standards and ensuring adherence to various industry-specific regulations. Without reliable traceability systems, manufacturers risk facing legal penalties, operational disruptions, and damage to their reputation.
 

Exploring the Link Between Traceability, Regulatory Standards and Compliance

Regulatory bodies around the world impose stringent standards that manufacturers must comply with to ensure safety, quality, and ethical considerations in production. Traceability allows manufacturers to demonstrate conformity with these regulations by providing a transparent overview of their supply chains, production processes, and distribution networks.

The Role of Traceability in Meeting Industry-Specific Regulations

Different industries may be subject to varying regulatory requirements that dictate how traceability should be implemented. For instance, the pharmaceutical industry must adhere to the Drug Supply Chain Security Act (DSCSA) in the United States, the EU Falsified Medicines Directive (FMD) in Europe, while the food and beverage sector is regulated largely by the Food Safety Modernization Act (FSMA) in the U.S. 
 
Additionally, the medical industry follows regulations such as the EU Medical Device Regulation (MDR), EU In Vitro Diagnostic Regulation (IVDR), and the tobacco industry adheres to the EU Tobacco Product Directive (TPD). Traceability ensures that entities within these industries can promptly recall products, investigate issues, and establish accountability as required by these regulations.
 

Global Standards for Traceability and Their Implications on Manufacturing

There are several international standards that relate to traceability in manufacturing, such as the ISO 9001 Quality Management System and ISO 14001 Environmental Management System. These global standards set forth the best practices for traceability that manufacturers across the world can implement to streamline operations, improve quality, and maintain compliance in the global market.

In conclusion, effective traceability in manufacturing is indispensable for staying compliant with regulatory compliance and standards. It is not just about fulfilling a requirement but plays a vital role in safeguarding the interest of stakeholders, including customers, regulators, and the manufacturers themselves.

GS1 Global Traceability Standard

Additionally, it's worth mentioning the GS1 Global Traceability Standard, which serves as a global specification for traceability practices in various industries.
The GS1 Global Traceability Standard is a widely adopted framework for enhancing traceability in various industries worldwide. It emphasizes data accuracy, promotes interoperability, and provides unique product identification through Global Trade Item Numbers (GTINs). 
These standard covers both barcoding and RFID technologies, offering flexibility and compatibility. Adherence to GS1 standards enhances supply chain visibility, ensures compliance with regulations, and supports continuous improvement. GS1 provides resources and support for effective implementation, making it a valuable tool for modern manufacturing and supply chain management.

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