How to simplify process industry complexity with digital threads

Today’s products and the processes behind their production are becoming increasingly complex across nearly all industry verticals. This is certainly true for process manufacturers due to several changing factors such as evolving consumer expectations, new technological advances and a growing regulatory demand for more transparency and traceability. While many of these new developments are good for the overall quality and growth trajectory of products going to market, they also introduce new challenges for industry leaders.

To manage new levels of complexity, innovative process manufacturers have started to implement digital thread solutions to offset additional workload associated with increasing product variability and regionalization, disperse processes and data sources and fluctuating compliance demands. This is especially important in industries such as chemical, food and beverage, and pharmaceuticals, where even the smallest oversight in documentation can lead to major compliance issues. Digital threads allow for a comprehensive approach to tracking every element of process manufacturing.

Evolving challenges and complexities in process industries

Products are rarely simple, homogeneous assets. Instead, they consist of an intricate combination of components, subcomponents, recipes, ingredients, formulas, electronics, software, development processes and other elements. Each of these features contribute to the quality outcome of a product, and each can potentially cause erroneous defects, performance issues or other problems that directly impact consumers and compliance status.

Thus, it is important to constantly monitor each product component throughout its lifecycle to identify and address issues proactively. However, this is no small task. In many cases, individual components are developed by multiple companies or teams, often in different locations, before being integrated into the main product’s lifecycle at varying points in the process. While each third-party manufacturer may follow the agreed upon specifications, it is ultimately the company selling the finished product that is responsible for the quality of the completed product to the consumer. The process manufacturer must track and document key data points, including those related to third-party components, to ensure product quality and regulatory compliance. If best practices are not followed effectively, the overarching documentation process can introduce errors and can quickly become outdated if not properly maintained.

Complexities in highly regulated industries

Process industry data and lifecycle management is even more difficult in industries such as food and beverage, pharmaceuticals, chemical and others where more stringent and specific regulations apply to certain regions, product categories and classifications, and subcategories. Here are a few examples that illustrate these difficulties, especially when it comes to traceability:

A company that makes dairy-free packaged desserts may order ingredients from third parties and must ensure these ingredients are free from dairy contamination, while also performing other quality and quantity checks.
Pharmaceutical companies must develop, label, track and deliver several forms of a single drug to ensure that the right drug form is received by the right patients and appropriate pharmacies.
A global chemical company needs to document which product versions do and do not contain a certain chemical ingredient that has been banned by the European Union. From there, they work to ensure these products remain separated and clearly labeled as they are shipped to their planned markets.
A cosmetics manufacturer partners sourcing pigments from multiple suppliers must track when each vendor’s pigments enter production, especially if a quality problem with one of these pigments arises down the line.

In each of these scenarios, multiple overlapping yet unique data points must be tracked to maintain process standards, product quality and compliance. Process manufacturers must consider the context, relationships and interactions of each data point, as well as how deviations impact the end product. Tracking this data manually is incredibly challenging without the right monitoring and documentation tools in place.

The role of digital threads in process management

Digital threads provide an effective solution for ensuring data accuracy and compliance across different processes, assets and intersecting relationships. Acting as a dynamic data ledger for product data, digital threads capture information across every part of the product lifecycle, from research and development, ideation and requirements, design, product development, supply chain through manufacturing and beyond. Digital threads can expand and become quite complicated over time, but therein lies its key strength: It is designed to handle and structure high volumes of different data points, contexts and relationships simultaneously so they can be referred to, retrieved, cross-checked and relied upon for current and future product development needs.

In a process manufacturing environment where multiple data points can change, shift or emerge rapidly, a robust digital thread is key. Below is a case study that illustrates how modern process manufacturing issues may be avoided with a digital thread strategy.

Food and beverage case study

An example comes from a food and beverage manufacturing company, looking to produce a Kosher-certified beverage that relies on several third-party suppliers for its ingredients. Unfortunately, one of these suppliers provided an ingredient that did not have a Kosher certification, but this was only discovered after the product was ready to ship. As a result, the entire product batch had to be thrown out and could not be sold for its original purpose.

For this company, a digital thread could have helped them proactively organize and discover data about this third-party supplier, including whether or not they worked with Kosher-certified ingredients. Although they discovered the error before the product reached customers, a digital thread would still be invaluable if a product recall required further investigation into the issue. Whether that investigation was internal or led by an outside regulatory body, a digital thread would at least provide the documentation and evidence necessary to figure out where the problem first started.

Adapting to change with digital thread technology: Tips and strategies

Companies can successfully navigate the complexities of modern process landscapes by leveraging digital threads, but this requires a solid understanding of how digital threads function and a commitment to building a comprehensive data strategy. Here are some tips to keep in mind:

Collect data early and often: The earliest stages of product ideation and development are just as important to your digital thread as everything else, especially more stringent regulatory environments where traceability is paramount. Make sure data is collected and updated frequently.
Monitor and update datasets regularly: Digital threads require frequent maintenance and monitoring to stay accurate and effective. Depending on the type of cloud or hosting platform and other technologies you incorporate, this monitoring and update process can be automated for increased efficiency.
Leave room for data variability: When working with complex processes and data relationships, there is a high likelihood of having multiple similar recipes and formulas that are all valid and usable. Be sure to design your digital thread in such a way that multiple data points can be the “right answer,” but do not compromise your standards or quality assurance checkpoints to make this work.
Invest in scalable cloud technology: Cloud-based hosting solutions offer elasticity and scalability that can provide a helpful foundation for digital thread development and reconfiguration. If you’re not already operating in a cloud environment, consider investing in a cloud solution that is compatible with your industry’s unique compliance and performance requirements.
Evaluate low-code digital transformation opportunities: Leveraging low-code platforms as part of your digital thread strategy will provide the needed flexibility to evolve the design of the thread as fast as the business changes. Process manufacturers should look to low-code PLM solutions with a mature digital thread solution to provide the capabilities needed to stay ahead of changing compliance regulations across regions.
Leverage AI-powered predictive analytics: As AI technology continues to advance — especially AI-powered analytics and automation — it can optimize your data collection, management, and analysis processes in digital threads, helping you unlock deeper insights and improve efficiency.

By adopting a PLM platform that enables the creation of a digital thread and traceability, companies can simplify the complexity of process manufacturing while ensuring compliance and product quality.