Enabling Bidirectional Traceability with Digital Threads: Safeguarding Quality and Compliance

Ensuring compliance and mitigating risk with end-to-end traceability

This is the second article in Michael Finocchiaro’s Digital Thread and Aras Innovator® series. The first post, Working Concurrently and Collaborating Seamlessly with Digital Threads, focused on how digital threads enable collaboration between teams in real-time, improving cross-functional efficiency. Today’s post will explore how digital threads integrate disparate data models across various systems to provide a single source of truth.

“Bidirectional traceability is a game-changer for compliance in sectors like aerospace and automotive. It not only safeguards quality but also ensures that regulatory requirements are met without delays, protecting the company from costly recalls or legal risks.”
—Peter Bilello, president, CIMdata

In highly regulated industries like aerospace, automotive, and medical devices, compliance and quality management are not just operational concerns—they are critical factors that can make or break a company. As the products produced by these industries grow increasingly complex, traceability is mission-critical. The ability to track changes and ensure compliance at every stage of development, from initial design to production and maintenance, is essential for mitigating risks, providing quality, and avoiding costly product recalls.

The digital thread is one of the most powerful tools companies can leverage to achieve this level of oversight. By integrating data across systems and providing a continuous flow of information, digital threads enable bidirectional traceability, meaning that companies can trace product changes both upstream (back to design) and downstream (through production, delivery, and maintenance). Aras Innovator, a robust PLM platform, offers end-to-end traceability capabilities through its digital thread technology. It provides organizations with the tools to maintain compliance and quality across the product lifecycle.

In this blog, we will explore how bidirectional traceability enabled by digital threads helps companies safeguard quality, manage compliance, and mitigate risks. We’ll also dive into specific use cases from highly regulated industries, such as aerospace and medical devices, to highlight the tangible benefits of adopting this approach.

The importance of traceability in regulated industries

As stated earlier, traceability is more than a best practice—it’s often a requirement for regulated industries. Government agencies such as the US FAA (Federal Aviation Administration), FDA (Food and Drug Administration), and international standards organizations such as ISO (International Organization for Standardization) mandate strict adherence to quality management processes. Companies must prove compliance at every stage of product development to bring products to market.

Without proper traceability, organizations face many challenges:

1. Compliance risks: Companies must maintain detailed records of all product changes to demonstrate adherence to regulations. Incomplete or inaccurate records can lead to non-compliance, resulting in fines, sanctions, or product recalls.
2. Quality control: Without the ability to trace changes across the product lifecycle, it becomes difficult to identify the root cause of defects. This can lead to recurring quality issues, increased rework, and dissatisfied customers.
3. Risk of recalls: If a product fails in the field, companies must be able to quickly identify and address the issue. In cases where traceability is poor, it may be impossible to pinpoint the specific batch or component that caused the failure, resulting in costly recalls.
4. Root cause analysis: When repetitive issues occur, a lack of traceability can inhibit the manufacturing and engineering processes from finding the design flaws that lead to failures. Companies cannot implement a closed-loop development system without adequate traceability.

For example, in the medical device industry, traceability is essential for ensuring that every device meets strict regulatory standards. A small change in material composition, manufacturing processes, or packaging could compromise patient safety. In such an environment, the ability to trace every decision and modification made during the design and production of a device is crucial to maintaining compliance and preventing costly recalls. In the case of manufacturing errors or inspection failures, the customer needs to move back along the digital thread towards engineering to correct any design errors leading to the failures as soon as possible.

How Aras PLM enables bidirectional traceability with digital threads

“With increasing regulatory scrutiny, manufacturers need more than just traceability—they need a dynamic, bidirectional approach. Digital threads allow organizations to track and verify every part of the product lifecycle, reducing compliance risks and ensuring consistent quality control.”
— Michelle Boucher, vice president of research, Engineering.com

Bidirectional traceability refers to the ability to track a product’s lifecycle both upstream and downstream—from design specifications to production, testing, and service, and vice versa. This capability allows companies to understand not only what changes were made but also the rationale behind those changes, who approved them, and how they impacted the overall product.

Aras Innovator uses digital threads to provide a comprehensive traceability framework that integrates data across the product lifecycle. Here’s how it enables bidirectional traceability:

1. Seamless data integration with low-code API management: Aras Innovator connects disparate systems—such as ERP, CAD, and manufacturing execution systems (MES)—into a unified data model. This ensures that every change made during the design, production, or service phase is recorded, providing a complete and accurate product history. This integration makes it possible to trace decisions and modifications across departments, supply chains, and external partners.
2. Comprehensive change management:With Aras Innovator’s robust change management capabilities, companies can track every revision made to a product—who made the change, when it was made, and why it was necessary. By maintaining this detailed history, companies can trace any product defect or failure to its origin, allowing for quick resolution and minimizing disruption.
3. Impact and sustainability analysis: Bidirectional traceability enables impact analysis, which helps companies assess the potential effects of changes before they are implemented. For example, if a new material is introduced during production, Aras Innovator can trace how that change affects downstream processes, such as supply chain logistics or maintenance schedules. Conversely, companies can trace upstream to see how a design flaw might impact quality control in manufacturing.
4. Regulatory compliance documentation: Aras Innovator automatically generates the documentation required for regulatory compliance by maintaining a continuous digital thread. This includes detailed reports on product changes, approvals, testing results, the new European Digital Product Passport, and audit trails, all of which can be easily accessed to demonstrate compliance with regulatory bodies.

From an architectural perspective, Aras Innovator provides a robust framework for creating bi-directional digital threads that enhance connectivity and traceability across various items, such as part-part or requirement-part relationships. This flexibility allows digital threads to be modeled to support bi-directional, upstream, or downstream data flows, enabling seamless integration between related items across the product lifecycle. Throughout the design lifecycle, the digital threads dynamically adapt, referencing the latest revisions before a release and linking to specific revisions post-release, preserving historical accuracy and enabling reliable traceability. Additionally, these digital threads carry their lifecycles, accommodating effectivity criteria tied to particular dates, manufacturing sites, or supply chain events. This lifecycle orientation further empowers Aras Innovator to automate critical tasks, such as initiating review processes or prompting supplier interactions based on the thread’s current state, facilitating efficient and responsive collaboration across the enterprise.

Another example of how Aras implements a bidirectional digital thread is when MBOMs and work instructions are pushed along the digital thread from the Aras Innovator PLM system to the production ERP and MES systems on the factory floor. At the same time, the pricing, supplier, and Engineering Change Orders move from the downstream ERP and procurement systems up the digital thread to the Aras PLM solution. This helps lower overall product or manufacturing costs, avoid supply chain disruptions, and ensure that issues or compliance problems found during the manufacturing process are resolved in engineering to improve overall quality and safety.

Enabling bidirectional traceability at Kawasaki Robotics with Aras Innovator

Problem statement

Kawasaki Robotics faced several challenges that led them to seek a new PLM solution:

1. Data fragmentation: The company’s systems for managing design BOMs, workflows, and production data were outdated and lacked the ability to handle 3D CAD data efficiently. This resulted in difficulty sharing data across teams and ensuring traceability from design to production.
2. Inconsistent data handling: As Kawasaki Robotics shifted towards 3D CAD for engineering processes, managing this data on file servers led to inconsistencies and security concerns. The need for a centralized system became critical as the complexity of their products increased.
3. Limited collaboration and transparency: The existing systems could not provide the visibility needed for global collaboration, limiting the ability to track product configurations and manage technical documentation effectively. This hindered communication and slowed down the development process.

How Aras Innovator enabled bidirectional traceability

Kawasaki Robotics addressed traceability challenges by implementing Aras Innovator in two phases, integrating their 3D CAD, BOM management, and workflow systems to establish a digital thread across the product lifecycle.

Centralized 3D CAD and BOM management

Aras Innovator unified 3D CAD and BOM data, linking design changes directly to production workflows. This streamlined product configuration management, ensuring all teams accessed accurate, up-to-date information.

Enhanced traceability and compliance

The digital thread enabled Kawasaki Robotics to track upstream and downstream product changes, from design to manufacturing and service, which was essential for managing complex robotic systems and meeting regulatory standards.

Secure, global collaboration

Integrating Aras Innovator across locations allowed real-time, secure collaboration while controlling data access. Using 3D PDFs further improved data sharing without requiring additional 3D CAD software.

Technical Document Management

Aras Innovator’s document management streamlined production documentation workflows in phase two, reducing errors and enhancing process visibility.

Kawasaki Robotics’ adoption of Aras Innovator transformed its data management, documentation, and global traceability. The implementation offered a flexible, scalable solution to ensure end-to-end traceability, improve efficiency, and maintain compliance across the product lifecycle for organizations in complex, regulated industries like robotics.

To learn more, read Kawasaki Robotics Builds Global Platform for Enterprise Engineering.