Single Version of Truth – Beyond Productivity

Whether you are a pharmaceutical, medical device or consumer packaged goods manufacturer, a traceability infrastructure that uses the latest technologies can help improve your time to market, manufacturing processes and compliance.

Welcome to the age of the smart industrial plant. This is where operations technology (OT) and IT converge; digital technology connects people, processes and things into a single, seamless unified infrastructure; and data helps us identify new, exciting opportunities. While more manufacturing companies are adopting new data-enabling technologies, becoming a true, smart manufacturing operation requires one essential element: end-to-end traceability.

As the requirements for industry regulations and costs of warranty and refund programs continue to evolve, manufacturers can differentiate themselves by taking advantage of direct and indirect benefits provided by a traceability system: improving processes, controlling the supply chain, minimizing defect risk, navigating regulatory challenges and improving customer service levels.

With a traceability infrastructure, you can gather insight-rich data that helps improve manufacturing processes, compliance and supply chain management.

Why do smart plants need track-and-trace capabilities?

Large and middle-sized manufacturers are facing mounting challenges. For example, product recalls are on the rise. The recall process in the food manufacturing industry is a highly expensive one, averaging more than $10 million in costs to cover activities such as communicating the recall across the supply chain, retrieving and handling the recalled product, investigating the event and implementing corrective actions to prevent reoccurrence.

Also, counterfeit and diverted goods costs companies $500 billion in U.S. trade, according to the World Customs Organization. And simultaneously, organizations are struggling to improve continually operational efficiencies to stay profitable and competitive.

Without complete end-to-end traceability, it can be difficult to stay ahead of the competition, meet deadlines, keep customers happy and comply with regulations.

As an essential part of Industry 4.0, complete traceability still ranks among the technologies industry companies are slow to adopt. However, the trend is pushing toward more companies embracing it.

In a study of manufacturing companies, LNS Research found that while only 23 percent had the processes and software in place to enable end-to-end traceability, around 60 percent stated they plan to have these processes and software in the next year. This suggests manufacturers recognize the importance of product traceability.

Discrete part traceability

There are different ways to approach traceability. Discrete part traceability — the use of individual component-level marks — is typically the most effective at enabling end-to-end traceability, because each part can be linked within a final assembly.

A number of popular methods can create these discrete part-traceability marks. Direct part marking is the best method to verify readable marks are permanent and durable. Other indirect methods, such as ink jet printing and labeling, are commonly used because they offer low initial costs.

Among direct part-marking equipment, laser and pin (or dot peen) marking systems are the most popular, capable of creating permanent marks quickly on a variety of materials. Direct part marking with laser or dot-peen equipment can create durable barcodes that connect the part to a database, allowing it to be tracked through plant-level operations to final assembly, and then traced for the life of that product.

To succeed at end-to-end traceability with discrete part marking, it is important to mark components at the soonest possible moment in the manufacturing process. This lets you see the entire lifecycle of each part and maximize the value of your data, so you can spot production issues or trends and make proactive improvements.

Digitization improves time-to-market

Speed to market is an increasing concern for biotech and pharma manufacturers as product moves further along the pipeline from discovery through clinical trials. As the saying goes, ‘time is of the essence’ – this is particularly relevant in the highly competitive life sciences industry.

Laboratory data is essential to commercial production. Consequently, making lab or pilot plant data easily accessible to digital automation systems is critical. A modern DCS that can scale from user-friendly, software systems that are right-sized for labs to completely integrated plant-floor solutions can help.

Basing digital transformation on a scalable, modern DCS delivers significant benefits – in both the lab and on the production floor. A modern DCS can use analytics tools to convert raw data into actionable information that can impact operational and equipment efficiency from the lab through production.

For example, the system can analyze thousands of data points in a lab to quickly uncover correlations and causations that may otherwise remain hidden. On the plant floor, the modern DCS can deliver batch and equipment analytics to help keep systems running optimally.

Most critically, a modern DCS provides an end-to-end manufacturing solution that lays the foundation for electronic batch records (EBR), validation and regulatory compliance.

Data integrity and compliance

The move to an EBR system has been beneficial for most biopharmaceutical producers. By replacing paper-based workflows with computer-based workflows, they have reduced the risk of human error and sped up compliance processes.

However, EBR systems can do far more than digitize paper-based workflows and recordkeeping.

When integrated into a scalable manufacturing execution system (MES), EBRs become more dynamic and can support your operations in new ways. This is especially true as you move your operations toward a Connected Enterprise, in which your production and business systems are fully connected and can share information seamlessly.

When an MES with EBRs is brought into a connected ecosystem, it can begin to access enterprise-wide information, deliver role-based instruction to workers, and provide exception-based reporting. This can help speed up your time-to-market, cut costs in multiple areas, and ease or even improve your demonstrated compliance.

An MES that offers modern and dynamic EBRs can help accelerate time-to-market in multiple ways. In the words of one pharma producer, “An EBR solution is the GPS of manufacturing operations. It guides the user to the desired destination, finds the shortest trip, alerts one to dangers, and feeds them back in real time.”

Quality Assurance (QA) teams can use an EBR’s review-by-exception functionality to spot deviations much faster than scanning every record line by line to find them. This can speed up documentation review times and reduce how long a product must sit in a warehouse waiting for release. It also can improve batch accuracy and consistency.

In addition, real-time information access creates opportunities to speed up processes throughout the production cycle. For example, gauge data can be collected automatically versus requiring a worker to physically walk to each gauge and record their readings. The ability to collect and review process information also allows you to identify and mitigate unnecessary tasks, such as redundant material checks.

Furthermore, the time savings only become greater in a Connected Enterprise. The ability to connect your EBR system to mobile devices. For example, it can give workers faster and more convenient access to information anywhere on the plant floor.

Serialization for end-to-end supply chain

Whether you are a pharmaceutical, medical device or Consumer Packaged Goods manufacturer you are now required to track and trace products across the supply chain. In fact, a number of countries around the world are in the process of rolling out serialization-based anti-counterfeiting regulations. These include the European Union's Falsified Medicines Directive, the United States' Drug Supply Chain Security Act and China's electronic drug supervision code requirement.

Serialization uses a numeric or alphanumeric code known as a unique identification (UID) to realize full track-and-trace capabilities of a product throughout the supply chain, from its manufacturing origin through distribution channels and down to the point of sale. Production, transportation and point-of-sale event information are recorded and stored in a central database. This allows a product to be authenticated as legitimate through something as simple as a quick barcode scan, and permits the complete product event history to be reviewed or audited should an issue arise.

While serialization regulations vary by country or region, some general requirements that pharmaceutical manufacturers are expected to comply with include:

• The ability to generate, acquire and manage a UID for each saleable item.
• Linking package-level serial numbers in parent/child data relationships (for example, pallets to cases, cases to cartons or cartons to saleable items).
• Storage of UID information in a secure database that can be shared with trading partners.
• Validation that serialization data matches the physical product received.
• Confirmation that products have complete and accurate documentation.

While some manufacturers may opt to develop their own customized serialization system in an effort to harmonize the system with their existing equipment and processes – there are some significant limitations with this approach. It can lead to support issues, parts shortages and knowledge-transfer problems in the long term. The time and effort needed to design, test and commission a custom system can also be costly and disruptive to operations.

Pharmaceutical manufacturers should instead consider basing their system on a modular and scalable off-the-shelf control and information platform that can be easily integrated into their existing lines. Specifically, by tapping a software platform that also offers MES and EBR capabilities, a serialization system can help address global serialization requirements, including necessary data capabilities and high-speed device management of serialization components – all while minimizing production interruptions or validation burdens.

Additionally, a serialization system that uses an Electronic Product Code Information Services (EPCIS)-certified, cloud-based server can provide centralized UID generation, management and storage, as well as achieve interoperability with manufacturing and business systems. The cloud-based server is the central communications hub for supply chain partners and provides mobile connectivity, so product authentication can flow all the way down to the consumer level via tablets or smartphones.

Team up with technology

The Industrial Internet of Things (IIoT) continues to advance at a rapid rate. Pharmaceutical companies are transforming the industry by using smart, connected devices, analytics, and machine learning to improve drug manufacturing processes and deliver better patient outcomes.

Pharmaceutical companies have also dramatically increased the use of smart technology and automation in their production facilities to improve drug quality and speed innovation. And many have streamlined operations with modern MES and EBR systems.

But as the number of intelligent devices has proliferated, manufacturers have struggled to use the Big Data generated across the plant floor and beyond in truly transformative ways.

Now, thanks to advanced industrial connectivity, data aggregation and automated analytics capabilities, manufacturers can exact more value from more disparate data sources faster than ever before.

Leveraging a secure IIoT infrastructure, the latest capabilities can quickly connect all data that’s important on an asset or a line – and immediately monitor performance as well as make predictions about that performance.

Choosing technologies that give your workers better visibility to process parameters in real time is one way to improve workflows. For many biopharmaceutical companies, the next step is engaging in other digital tools that help workers use data and analytics in smarter, more impactful ways.

Specifically, augmented reality (AR) can be a game-changer that not only enhances workforce management, but also improves quality, yield and time-to-market.

In fact, more companies are beginning to use AR to support operator-driven activities. For example, here’s one-way AR can dramatically improve situational awareness in your cleanroom. Using a mobile device and AR app, your operator can focus on a piece of equipment and view critical parameters superimposed on the machine. No HMI required.

This same technology that makes monitoring equipment easier can also provide maintenance workers with detailed, visual and interactive instructions – at the site of repair.

But how do you decide what digital technologies can best enable the workers in your plant? A good place to start is with the workforce challenges you understand best. Chances are, you don’t need complex analytics to determine what those challenges are – you probably encounter them every day.

Then, focus on deploying AR or other technologies that offer the best opportunity for short-term wins that deliver a measurable return. And that can scale across multiple applications and plants to establish a smart industrial plant.