How do manufacturers keep up with a constantly changing “tsunami” of regulatory requirements?

In our latest Pulling the Digital Thread panel, four experts from different industries came together to discuss their tactics for responding to the varied, complex, and often country-specific regulations they must apply throughout their product lifecycles.

According to the speakers, organizations must move past a static, checkbox approach to compliance to succeed in today’s fast-paced and consumer-driven world. Instead, they must embed compliance controls throughout the product lifecycle processes, working towards a continuous, agile approach that easily adapts to regulatory and product changes. This approach assumes compliance will always change and implements controls for pivoting with these changes throughout the product lifecycle.

Here are four ways organizations can begin to make this shift and how the speakers believe that AI will come into play to support these changes.

1. Approach compliance from a systems perspective

David Segel, global business head of Digital Thread and Connected Digital Enterprise (CDE) at Tata Consultancy Services, emphasized the importance of seeing compliance as an ongoing business process alongside the rest of the product lifecycle — not just static boxes to check. It’s all about assessing compliance with a systems thinking approach throughout the lifecycle rather than rushing to fulfill one-off compliance regulations as they arise.

He said, “We [create] connectivity between the physical designs and the compliance data in order to make assessments correctly. The accuracy and fidelity of these assessments are key. And if you can automate this assessment…that’s an advantage as well.”

Segel sees AI as a critical enabler for breaking down risk assessment requirements and applying these requirements to the right places in the product lifecycle.

2. Build a Digital Thread for compliance visibility

To properly manage compliance in a dynamic environment, teams must centralize their product data in a single location. This is where the concept of a digital thread — linking product data gathered from across the product lifecycle and its associated manufacturing systems — comes into the picture. By pulling real-time knowledge on each product’s manufacturing steps, requirements, materials, and other key data, teams can better understand their current compliance status and quickly adjust to future changes.

According to Louis Hendriks, founder and initiator of Global Value Web, building out a digital thread with centralized data is key for compliance, as it allows you visibility into everything.

Essentially, as you build your digital thread, you can identify gaps in compliance data and work to fill these gaps as needed. This approach works well because a digital thread is data-centric, not document-centric.

Hendriks compares document-centric processes to the legend of the “blind men and the elephant,” where each person touches part of the proverbial elephant but does not fully perceive the 70,000 to 100,000 different muscles in the elephant’s trunk.1 Data-centric processes, on the other hand, provide a full view of the entire lifecycle and, therefore, shed light on any gaps in compliance. As more companies work towards this complete, data-centric picture, Hendriks anticipates that organizations can use AI technology to pinpoint and fill these process gaps.

3. Deliver the right data to the right people

Another key aspect of meeting compliance across your organization is delivering actionable information to the right people. Marcellus Menges, vice president of Global R&D at SICK Sensor Intelligence, says it’s important to narrow down the long lists of requirements and only act on the ones that apply to your organization’s industry and product.

He said, “The huge challenge is, ‘How deep do I have to dig into details?’ Because if I do it on too detailed a level, it will kill my processes. If you hand over thousands of requirements for one part, there’s a designer who has to design the part, and… will not know where to start.”

Menges sees a strong use case for applying AI to the digital thread to parse through these numerous requirements and highlight the ones that truly matter to your business and use case.

4. Share compliance data with key stakeholders

Organizations need to consider data interoperability to achieve a more agile approach to compliance. Key stakeholders such as supply chain partners and auditors will need to see data on both the finished product and the process involved. It’s important to document the process details in an easily shareable way with outside resources.

As I said, “In compliance management, the process itself has to be documented so that outside authorities can verify it. So not only do you need to be able to trace the data, but also how that data is being applied to figure out if you’re compliant or not.”

I see a use case in leveraging AI to recognize quantitative goals buried in the regulatory text as written parameters… then aggregate individual values across all related elements within the product structure to track degrees of compliance constantly.

Learn more about AI and compliance in the Digital Thread

The capabilities of AI-driven compliance tools will only continue to grow, and the organizations that can adopt them first will see a significant competitive advantage. However, the first step to embracing this type of technology is to consolidate and operationalize product and process data across the product lifecycle in a digital thread.

You can watch the full Bring the Power of Data and AI to Managing Compliance presentation on demand to explore the world of compliance using a digital thread approach.