Ingredients for Success

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 processesshould 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 the pharma 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 (21CFR part 11).

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 of the most basic things that regulatory bodies look for is consistent process control, which allows production cycle times to decline because operators do not have to grapple with manufacturing deviations caused by batch record errors characteristic of paperbased systems. In Wyeth’s 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 one percent. Productivity gains are yet another aspect of consistency as we lean out waste and unnecessary inventory.

Synergy or competition?
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.

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.

However, the enterprise level and manufacturing have two cultures, each with its own needs and perspectives. While they exist in the same company 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.

Production operations may be at the center of a manufacturing enterprise, but it’s the ability to circulate that information reliably, accurately, and efficiently among business and production systems that helps faster reactions 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. At Wyeth, the IT department has helped manufacturing management understand how IT infrastructure can support mission-critical production systems.

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

Convergence creates value by heightening each group’s understanding of the other and enabling more productive discussion of technology issues, opportunities, and benefits.

Data driven
Company production data is an asset that requires a lot of care and feeding for it to work effectively. One of the more common discussions today revolves around “master data management” (MDM), which should be an essential element in the manufacturing IT strategy, guiding 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 the enterprise-wide system landscape architecture unfolds, the need for data management governance becomes paramount. Plant-level decisions increase in complexity when considered from an enterprise standpoint. For example, units of measure or product short-text descriptions have broader effects than might be 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 has helped Wyeth dramatically reduce its need for additional investment in integration middlewareand avoided the addition of new potential failure points.

Drawing lines
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 to work through the process and reach consensus.

Documenting where systems of records reside, and developing a plan for functional responsibility helps resolve these issues. Evaluating respective capabilities will show quickly whether ERP can perform efficiently as an MES system or whether your MES can perform planning, finite scheduling, or warehouse management.

While every manufacturing environment has unique characteristics and requirements, our experience at Wyeth 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

• LIMS – lab results, stability studies, retains, material potency, batch disposition recommendation based on lab results

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.

High expectations
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.

Our customers, partners, suppliers, and even the government expect more when it comes to the velocity, ease, and accuracy of 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.

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.

Bringing 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.

All Round Solution

Schneider Electric (SE) and its subsidiary TAC recently collaborated to win and execute a major greenfield electrical distribution and building automation project for the Novartis pharmaceutical manufacturing plantin Singapore.

The scope of the project included electrical supply for the whole plant; building management; process automation; manufacturing execution system (MES), interface definition and integration with process packaged units for granulation, milling, compression, and coating; and IT and LAN infrastructure.

Pharmaceutical plants are ideal candidates for the level of integration performed by SE/TAC, as all systems are present across a typical facility. Process systems, building systems and CCTV systems can all operate on the same LAN backbone allowing for substantial savings in devices such as servers, operator workstations and cabling. A realistic estimate of the overall project cost savings is in the range of 10 to 15 percent.

According to Schneider, being appointed as the main Electrical and Automation (E&A) vendor resulted in substantial engineering cost savings, through factors such as having a single point of contact for the client (as compared to having to deal with multiple subcontractors directly), the ability to reduce the number of design interfaces through standardization of networks, protocols and interconnection practices; and a dramatic reduction in the number of engineers, designers and drafters as well as drawings and review cycles.

For such a strategy to be successful, it is imperative that the company selected as the electrical distribution and automation main vendor is involved early in the design process.

Schneider says that much of the engineering effort, project management experience and best practices used on this project can be directly reusable in future plant expansions and other similar projects for Novartis.

This will create a compound effect ensuring ongoing improvements in engineering development and project management efficiency at the same time as ensuring that consistently high quality standards are maintained.