Bridging process with the IT people

For many manufacturing enterprises, serious investment in plant-wide information systems has only recently become a corporate-led priority. But it is now clear that no manufacturer can expect to survive - much less thrive - without a coherent manufacturing IT strategy.

In the pharmaceuticals industry the original impetus for the adoption of information technology at the production operations level came from regulatory pressure. This helped establish systems to increase the accuracy, reliability and speed of retrieving product genealogy for batch or assembly operations (EBR/DHR), as well as validating process rigour (CFR21 part 11).

The return on investment for a well-executed manufacturing IT strategy has since become clear. Digitising manual and paper-based processes has introduced new levels of consistency, visibility and reliability to production operations and led to an institutionalisation of business rules as well as knowledge and skills. The ability to view system-generated control charts that show processes working comfortably within prescribed operating limits adds another level of consistency; previous paper-based processes are often riddled with batch record errors, causing manufacturing teams to regularly grapple with manufacturing deviations.

Pharmaceutical manufacturers used to plan for this inefficiency, scheduling 90 batches to make 80. In the post-digitised world the confidence interval for producing "golden" batches is closer to one percent. Productivity is another aspect of consistency, as industry learns to "lean out" waste and unnecessary inventory.

So, manufacturing IT is finally being viewed as a strategic asset, one that impacts the business's ability to respond quickly and efficiently to change, to support corporate initiatives and to execute on innovation. This means bringing an enterprise perspective to the game - and gaining a better understanding of the strategic implications that a more connected enterprise infers.

For some pharmaceutical manufacturers, this has created the impetus for organisational, process and policy convergence of corporate IT and manufacturing departments. It is vital that both perspectives have input to technology investments, architectures and policies that meet mission-critical requirements and still scale on a global basis. It's also critical to involve senior management at the highest levels.

Executive sponsorship and change management are the common threads within successful manufacturing IT strategies. The control concepts at the heart of such systems (such as adjusting for product potency, process verification, or digital signatures) represent strategic risk management opportunities that warrant senior management visibility and support.

Let's face it, these two cultures and perspectives have traditionally been at opposite ends of the spectrum. While they exist in the same enterprise and are already somewhat dependent on each other, neither, typically, has a good handle on what the other does, nor do they speak the same business "language".

Crossing this chasm can be a challenge, but one well worth the effort. Production operations are the heart of a manufacturing enterprise, but it's the ability to circulate that information among business and production systems that helps companies react faster and enjoy stronger control over desired outcomes.

Manufacturing management at Wyeth worked closely with IT to understand how IT infrastructure can support mission-critical production systems, and provided answers to 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? 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. They should focus on articulating operational requirements, and depend on IT to architect the data infrastructure.

On the other hand, our IT brethren must understand what high-availability means to manufacturing. What are the critical manufacturing parameters, and 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?

Production data is an asset that requires a lot of care and feeding for it to work. A common discussion today revolves around master data management (MDM) that must reflect the assigned roles and responsibilities of the people and systems involved in the production process. How do you draw the lines that define where MES, ERP, LIMS and other strategic systems begin and end?

MDM guides how plant and enterprise systems should interact. This becomes increasingly important as business or supply chain systems such as ERP are interfaced into execution, quality or other plant-level production management systems for planning and reporting purposes. A well thought-out and agreed set of data standards establishes a pragmatic foundation for systems interface requirements that then drives integration priorities.

By developing enterprise-wide translation tables of process, asset and product descriptions and hierarchies, Wyeth dramatically reduced its need for investment in integration middleware, and avoided the addition of new potential failure points associated with increasing the complexity of its production systems.

One of the most controversial and hotly debated aspects of systems-related responsibilities today is the line between ERP and MES systems. Formally documenting where systems of record reside and developing a plan for functional responsibility helps clarify and resolve these issues. Evaluating the capabilities of strategic systems will quickly show whether ERP can or cannot perform efficiently as an MES system, or whether an MES can or cannot perform planning, such as a finite scheduling and/or warehouse management.


Users must not fall prey to the siren song of sub-optimising one strategic system because of capital investment in another. While every manufacturing environment has its own unique characteristics and requirements, Wyeth's experience provides one example of a successful approach to dividing up systems "turf" (see below). At Wyeth, it was found to be easier to define these roles and responsibilities for its strategic/enterprise systems once it had appointed system owners or champions and moved away from a management-by- committee format. Essentially, this created a place for the "buck to stop" for each strategic/enterprise system.

How Wyeth Pharmaceuticals divides its manufacturing IT "Turf"

ERP: MRP processes, Bill of material, Final usage decision, Inventory control, Order genealogy, Production order generation 

MES: Manufacturing process control, Master batch record, Log books, Process data retention 

LIMS: Lab results, Stability studies, Retains, Material potency, Batch disposition recommendation based on lab results

Like many other industries, pharmaceutical manufacturers are impacted by the emergence of a truly global economy and its disruptive influence on business and supply chain models. For example, there has recently been a flurry of consumer product contamination issues that point out the need for better visibility across supply chain networks. Expectations are changing. Customers, partners, suppliers and even the government expect more when it comes to the velocity, ease and accuracy of business processes.

The result in practical terms is that pharmaceutical manufacturing operations are being managed as strategic business assets with all that confers, including investment in the appropriate technologies to create a"closed-loop" information architecture on an enterprise scale. The implications include a rejection of the traditionally insular view associated with developing and deploying plant-level information systems.

Bringing production operations into the digital age is not an easy task, but the journey is exciting and offers the key to the long-term success of process companies.