Integrating Enterprise and Plant IT Functions

The same changes in information technologies that have transformed the way we live have affected manufacturing systems. In all areas of manufacturing and pharmaceutical companies particularly, adopting new information technologies has become serious business. Collaboration, real-time, agility and visibility are words used to describe the desired end results and how production and business processes should work. For as long as these systems have been available, the reality for many manufacturers is that serious investment in plant-wide information systems has only recently become a corporate-led priority. In fact, using the terms manufacturing and IT in the same sentence was rare, and putting them in the same room was even more exceptional. However no manufacturer can expect to survive, much less thrive, without a coherent manufacturing IT strategy.

This convergence of manufacturing and IT can present wonderful opportunities as well as acute challenges for organizations. As with any new technology, early adopters blaze the trail that others follow. The pharmaceutical industry’s adoption of information technology at the production operations level, while still in early stages, can be viewed as a highly relevant precursor by organizations seeking to achieve world-class performance. In our industry, the original drivers came from regulatory bodies. Bringing manufacturing into compliance with government quality expectations helped drive the adoption of systems that increased the accuracy, reliability and speed of retrieving product genealogy for batch or assembly operations (EBR/DHR) as well as validating process rigor (21 CFR part 11). Ironically, the same mandates that drove improvement in our industry may hinder additional advancements due to the validation costs associated with changes in production-related processes.

Nonetheless, the return on investment for a well-executed manufacturing IT strategy has been well documented by many independent sources. Digitizing manual and paper-based processes introduces new levels of consistency, visibility, and reliability to production operations. Automation supports the institutionalization of business rules and tribal knowledge. This is the equivalent to transforming the art of production into a science that can be measured, evaluated and consistently improved. One caveat, however: when you initiate a transition with a workforce from paper batch records to electronic ones, training and change management play critical roles in that process. Don’t assume that everyone on the shop floor has a computer skills. Conduct a basic computer skills assessment as a first step and follow up with the proper level of remedial training.

One of the most basic things that regulatory bodies look for is consistent process control. For example, in the past it was typical that certain process operators could manufacture specific problematic batches better than others. Codifying those key operator’s experiences as best practices within a software application establishes a new level of reliability. When process consistency is established, production cycle times begin to decline because operators do not have to grapple with manufacturing deviations caused by batch record errors characteristic of paper-based systems. In our pre-digitized world, we planned for this inefficiency, scheduling 90 batches to make 80. In the post-digitized world our confidence interval for producing “golden” batches is closer to 1%. Productivity gains are yet another aspect of consistency as we lean out waste and unnecessary inventory.

Justifying system investments

Increased productivity, consistency, and reliability are success measures cited to justify investment in plant-wide information technology. Once that happens, manufacturing IT becomes a strategic asset, one that impacts the business’ ability to respond quickly and efficiently to change, support corporate initiatives, and execute innovation efforts.

When these things begin to happen, it gives you an enterprise perspective, and a better understanding of the strategic implications a more connected enterprise supports. For some pharmaceutical manufacturers, this has created the impetus for organizational, process, and policy convergence of corporate information technology and manufacturing departments. It’s vital that both groups bring their perspectives and have input to technology investments, architectures and policies that meet mission critical requirements. Support and sponsorship from the top along with effective change management are critical to a successful manufacturing IT strategy and implementation. The control concepts at the heart of such systems represent strategic risk management opportunities that warrant senior management visibility and support.

Synergies or competition?

The enterprise level and manufacturing have two cultures, each with its own needs and perspectives. While they exist in the same enterprise and are dependent on each other, neither typically has a good handle on what the other does, nor do they speak the same language. Crossing the chasm between can be a challenge, but one well worth the effort. Improving the flow of information in your company is analogous to a healthy heart and circulatory system. Production operations are at the center of a manufacturing enterprise, but it’s your ability to circulate that information reliably, accurately, and efficiently among business and production systems that helps you react faster and enjoy stronger control over desired outcomes.

One of the most immediate benefits of blending IT and manufacturing perspectives is a shared vision for what’s possible. Consider that most manufacturing teams are so focused on getting product out the door that they typically don’t have time to research new manufacturing techniques and/or technologies via seminars and conferences. Our IT department at Wyeth has helped manufacturing management understand how IT infrastructure can support mission-critical production systems, and answered an array of questions:

What is a segmented network, and why is it important;

What are the pros and cons of wired versus wireless access points;

What’s a SAN;

What data is being backed up and how often;

Are you conducting stress testing or disaster recovery planning; and,

How long will it take to recover?

These are just a few of the technology “gotchas” that manufacturing teams need to understand to create effective and scalable support for an IT-intensive production system. Focus your efforts on articulating operational requirements, and depend on IT to design your infrastructure architecture.

At the same time, we need to teach IT brothers and sisters what is critical to manufacturing:

What high-availability means;

What are critical manufacturing parameters;

How must that data be managed, collected and protected;

How is this data being used; and,

Where in the process is data being entered, stored and retrieved?

Of course, these are just a few of the areas that the IT professional needs to know to help create an effective manufacturing IT strategy. Convergence creates value by heightening each group’s understanding of the other. By establishing common ground, we enable more productive discussion of technology issues, opportunities, and benefits.

Your company’s production data is an asset that requires a lot of care and feeding for it to work effectively for you. One of the more common discussions today revolves around master data management (MDM). This is a complex topic that needs to reflect the assigned roles and responsibilities of both the people and systems involved in your production process. How do you draw the lines that define where MES, ERP (enterprise resource planning), LIMS (laboratory information management system), and other strategic systems begin and end? The discussion may start out as simply philosophical but can quickly become emotionally charged. Nonetheless, it’s critical that you work through the process and reach consensus. These kinds of turf battles ultimately help organizations synchronize business needs and desired systems capabilities. The outcome helps determine your system’s landscape, and have a direct impact on your ability create agile, responsive manufacturing that supports your ability to innovate and compete effectively in today’s global economy.

Master data management is an essential element in your manufacturing IT strategy that helps guide how plant and enterprise systems should interact. This becomes increasingly important as business or supply chain systems interface with execution, quality, or other plant-level production management systems. As your enterprise-wide system landscape architecture unfolds, the need for data management governance becomes paramount. Plant-level decisions that you might have considered very simple increase in complexity when considered from an enterprise standpoint. For example units of measure or product short-text descriptions have broader effects than you might have ever realized. Governance can help guide such decisions and help eliminate points of failure. A well thought-out and agreed upon set of data standards establishes a utilitarian foundation for system interface requirements that will drive integration priorities. Developing enterprise-wide translation tables of process, asset and product descriptions and hierarchies, helped Wyeth dramatically reduce its need for additional investment in integration middleware and avoided the addition of new potential failure points.

One of the most controversial and hotly debated aspects of systems-related responsibilities today is the process of drawing lines between enterprise resource planning and manufacturing execution systems. Documenting where systems of records reside, and developing a plan for functional responsibility helps resolve these issues. Evaluating the capabilities of your strategic systems will show quickly whether ERP can perform efficiently as an MES system or whether your MES can perform planning, finite scheduling, or warehouse management. Don’t fall prey to the siren song of sub-optimizing one system because of a capital investment in another. While every manufacturing environment has unique characteristics and requirements, our experience provides one example of a successful approach to dividing up systems “turf”:

ERP — MRP processes, bill of material, final usage decision, inventory control, order genealogy, production order generation;

MES — manufacturing process control, batch records, log books, process data retention; and

LIMS — lab results, stability studies, retains, material potency, batch disposition recommendation based on lab results.

At Wyeth, we found that it was easier to define these roles and responsibilities for our strategic/enterprise systems once we appointed system owners or champions and moved away from a management by committee format. This created a place for the “buck to stop” for each strategic/enterprise system. This approach doesn’t discourage debate, however after the dust settles it ensures that a clear line of authority exists for making a decision on the direction and vision for a given strategic/enterprise system. We recognize that changing business needs may dictate a review of these lines of demarcation, so these system owners or champions meet on a periodic basis to challenge the status quo.

While accommodating change has always been a factor in manufacturing, the scale and scope of change today is unlike any experienced before. Like many other industries, pharmaceutical manufacturers are experiencing the impact of macro trends that are changing the landscape in significant ways. The emergence of a truly global economy and its disruptive influence on business and supply chain models has far reaching implications. For example, the recent flurry of consumer product contamination issues points out the need for better visibility across supply chain networks. Expectations are changing. Our customers, partners, suppliers, and even the government expect more when it comes to the velocity, ease, and accuracy of our business processes. Moreover, automation technology is changing so rapidly that companies able to apply it wisely in their business processes can realize a true competitive edge in the market.

The result in practical terms is that pharmaceutical manufacturing operations are being managed as a strategic business asset. That approach includes investment in the appropriate technologies to create a “closed-loop” information architecture on an enterprise scale. The implications of that change are many, including rejection of traditionally insular views associated with developing and deploying plant-level information systems held by some manufacturing management teams. Just as no world-class company would consider deploying a home-grown ERP application today, the systems that manage your manufacturing process should governed, deployed and maintained with similar system. We recognize that changing business needs may dictate a review of these lines of demarcation, so these system owners or champions meet on a periodic basis to challenge the status quo.

While accommodating change has always been a factor in manufacturing, the scale and scope of change today is unlike any experienced before. Like many other industries, pharmaceutical manufacturers are experiencing the impact of macro trends that are changing the landscape in significant ways. The emergence of a truly global economy and its disruptive influence on business and supply chain models has far reaching implications. For example, the recent flurry of consumer product contamination issues points out the need for better visibility across supply chain networks. Expectations are changing. Our customers, partners, suppliers, and even the government expect more when it comes to the velocity, ease, and accuracy of our business processes. Moreover, automation technology is changing so rapidly that companies able to apply it wisely in their business processes can realize a true competitive edge in the market.

The result in practical terms is that pharmaceutical manufacturing operations are being managed as a strategic business asset. That approach includes investment in the appropriate technologies to create a “closed-loop” information architecture on an enterprise scale. The implications of that change are many, including rejection of traditionally insular views associated with developing and deploying plant-level information systems held by some manufacturing management teams. Just as no world-class company would consider deploying a home-grown ERP application today, the systems that manage your manufacturing process should governed, deployed and maintained with similar IT rigor. Evaluate your software partners wisely for that elusive combination of domain expertise, market commitment, and resource depth. Wyeth’s partner of choice for plant-wide information software and automation control systems is Rockwell Automation, a choice based their alignment with our commercial-off-the-shelf (COTS) software philosophy, global support needs and scope of functionality. Bringing your production operations into the digital age is not an easy task, and certainly not one to take on without the help of trusted partners. But the journey is exciting and may be key to long-term success in the highly competitive, collaborative, and innovative world that some call “Manufacturing 2.0”.

Portions of this article appeared in the November 2007 issue of Innovations in Pharmaceutical Technology.

Author Information

Jim Ricigliano is director, process excellence, Wyeth Pharmaceuticals. Reach him at riciglij@wyeth.com . Matthew Bauer, is director of market development, Rockwell Automation. Reach him at mjbauer@ra.rockwell.com .

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