Navigating Complexity and Compliance in the Process Industries

From Expanding Universes to Expanding Digital Threads: Navigating Complexity and Compliance in the Process Industries

Einstein’s equations suggested the universe should not be static, but should be expanding, just like your digital thread.  Okay, so Einstein didn’t say that last part. I added it to see if you were paying attention. Even if he didn’t say it, no truer point can be expressed about your digital thread than it needs to be so dynamic it can continuously expand and capture new data points as they become relevant.

As product complexity increases, it is continuously changing and creating new business processes. These changes, along with new and demanding compliance requirements are generating the need for more data points in your company’s digital thread.  In turn, new data points generate more relationships between the data points. Ultimately, it takes a very flexible digital thread solution to not only capture and manage the information, but to ensure the connections of the data are accurate and up to date so the context of the information can be fully understood and utilized.

Where is product and process complexity coming from?

Increasing product complexity comes from several areas and different reasons.  For example, the addition of software driven components and their electronics to manage software within a product has added a new dimension to developing and maintaining a product. It was always a challenge to ensure the compatibility of interdependent parts and sub-systems with other parts and sub-systems produced by different suppliers.  Imagine the increased complexity of guaranteeing every software version resident within the parts are also complaint with each other.

An example of increased product complexity impacting process industries like food & beverage, consumer packaged goods (CPG), and pharmaceuticals stems from regional regulations driving companies to develop multiple formula variations for the same product to comply with local regulations. While this may not be a new challenge, these product variations produce and contextualize additional data throughout the development process.

Furthermore, the coordination between product lifecycle management (PLM), enterprise resource planning (ERP), and manufacturing systems requires additional sophistication across systems creating more complex integrations. Having traceability from the manufacturing process all the way back to requirements in the ideation phase is frequently necessary to satisfy many new regulations.  Keeping the digital thread accurate and up to date with different formulas, recipes, materials, and other relationships is critical for the on-going successful delivery of the product.

A breakdown in compliance and an opportunity for digital thread expansion

In the recent article, FAA Investigating How Questionable Titanium Got Into Boeing and Airbus Jets, the author explained how some recently manufactured Boeing and Airbus jets had components made from titanium that were sold using fake documentation. The fake documentation supposedly verified the material’s authenticity but now raises concerns about the structural integrity of those airliners.

The development of an airliner is a good example of a hybrid process that combines both process and discrete manufacturing, driving increased complexity and regulatory compliance. As a first step, raw materials are processed into parts using recipes to then be used as part of the mechanical design of the aircraft.

In the case described here, the supplier of fuselages for Boeing and wings for Airbus is “trying to determine where the titanium came from, whether it meets proper standards despite its phony documentation, and whether the parts made from the material are structurally sound enough to hold up through the projected life spans of the jets.”

Compliance challenges like this represent the strongest examples of why companies need to expand their digital thread beyond discrete product development and manufacturing and include the processes that acquire and process raw materials into the product.

Once the issue was uncovered, the digital thread would allow users to navigate the product data to answer critical questions like the ones listed above. I am sure there were many other questions their digital thread would be called upon to answer during the investigation including when the titanium in question came into their supply chain, where it was used, and where it originated from.

Even if the data points were readily available, the relationships between the data would also be needed to fill in the context as well as provide the necessary traceability. With today’s complicated supply chain strategies, these questions may not be easily answered – even with a digital thread. The Boeing/Airbus case demonstrates the difficulty of tracing the problem.

“The issue appears to date to 2019 when a Turkish material supplier, Turkish Aerospace Industries, purchased a batch of titanium from a supplier in China, according to the people familiar with the issue. The Turkish company then sold that titanium to several companies that make aircraft parts, and those parts made their way to Spirit, which used them in Boeing and Airbus planes.

In December 2023, an Italian company that bought the titanium from Turkish Aerospace Industries noticed that the material looked different from what the company typically received. The company, Titanium International Group, also found that the certificates that came with the titanium seemed inauthentic.”

Ultimately the senior vice president for global quality at Spirit summed it up by stating:

“Our quality management process relies on the traceability of the raw materials all the way from the mills,” Mr. Brown said. “There has been a loss of traceability in that process and a documentation challenge.”

A compliance breakdown in a beverage company presents an opportunity to assess impact with the digital thread

Another example of a compliance breakdown in a process industry can be found in the publication, Supporting Many Forms of Compliance with Aras Innovator. In the commentary, CIMdata discusses a situation where a beverage company they worked with “had a supplier change that turned finished, ready-to-ship product into scrap. The new supplier did not have a Kosher certification for its ingredient, but the product it went into was certified Kosher. The beverage company realized the problem only after the product was manufactured and ready for shipment. Once the issue was identified, the product could not be sold and had to be scrapped.”

Luckily the company caught the issue early enough to avoid affecting any customers or requiring a recall. If the beverage did get sold to the public, having a digital thread would help them determine the impact of the issue.  Come to think of it, the company in question might have been able to avoid the whole issue if AI-driven preventative analytics were in place to identify the issue earlier by using the data in the digital thread, but that’s a blog for another day.

How PLM helps the process industry’s digital thread strategy

In the recently published eBook Managing the Digital Thread in Process Manufacturing with PLM, Tech-Clarity’s President Jim Brown explores the role of PLM for the Process Manufacturing Digital Thread.

In the eBook, Jim states that his research found two-thirds of manufacturers indicated their product digital thread is important – or critical – to their company’s overall success and profitability. Additionally, his surveys also show that product digital thread delivers significant business value including improved quality, time to market, engineering efficiency, innovation, and compliance.

That said, Jim recognizes that “the solutions that serve as the backbone of the digital thread, PLM, are not typically suited to industries driven by formulas and recipes as opposed to discrete bills of material (BOMs)”.

The eBook offers a lot of critical information and suggestions to process manufacturers using or potentially using PLM to drive their digital thread strategy beyond the current  discrete manufacturing focus of today’s PLM solutions. One of Jim’s recommendations for adopting the right PLM solutions includes,

“There are system architectures, however, that are better suited to adaptability. Low-code systems provide the flexibility to change data models and processes. This flexibility allows them to support digital thread models that weren’t originally designed into the PLM system while more closely meeting a company’s unique needs. A low-code approach could allow existing PLM capabilities to be modified, or cloned and modified, to support process industry needs without changing the core underlying system”.

This eBook is a must read for professionals developing a long-term digital thread strategy for their process manufacturing organizations like food & beverage, (CPG), chemical processing, and pharmaceuticals.

Learn more about digital thread for process manufacturing

There are many factors driving today’s investments in digital thread technology. Process industries have specific challenges adopting traditional PLM solutions to solve this issue due to the uniqueness of their business processes. Regardless of the issues, the need to have the product data contextualized in a searchable, digital technology is required in today’s system landscape.

As mentioned earlier in the blog, I recommend reading Tech-Clarity’s eBook, Managing the Digital Thread in Process Manufacturing with PLM to learn more about the opportunities and issues facing process manufacturers when developing their digital thread strategy around a PLM solution. Other excellent resources include the  webinar, Bring the Power of Data and AI to Managing Compliance and an interview with Aras CTO Rob McAveney where he demonstrates Aras’ digital thread. The demonstration includes a peek at Aras’ Manufacturing Process Planning (MPP) application, a simulation study, and 3D visualization all through the digital thread lens.