The life sciences production environment is constantly evolving – driven by the need to achieve a competitive edge, and deliver consistently high quality products.
Life sciences companies seeking to achieve world-class performance can view the pharmaceutical industry’s adoption of information technology at the production operations level, although still in the early stages, as a highly relevant precursor of changes to come. In our industry, the original impetus took the form of regulatory pressure. Mandated compliance with government quality expectations helped drive the adoption of systems that eased the pain and simultaneously increased the accuracy, reliability and speed of retrieving product genealogy for batch or assembly operations (EBR/DHR) as well as validating process rigor, Ironically, the same impetus for improvement in our industry may hinder additional advancements due to validation costs associated with changes in production-related processes.
Digitising manual and paper-based processes introduces new levels of consistency, visibility and reliability to operations. It institutionalises business rules and tribal knowledge. This transforms the art of production into a science that can be measured, evaluated and consistently improved upon. However, when you transition a workforce from paper batch to electronic records, training and change management play critical roles. Typically, everyone on the shop floor has varying degrees of computer skills. Initially conducting a basic computer skills assessment goes a long way in determining the readiness of your workforce so you can follow up with proper computer remediation training.
Payoff – tactical or strategic?
Demonstrating consistent process control has long since been a challenge issued by regulatory organisations to pharmaceutical manufacturing sites. The ability to view system generated control charts that show processes working comfortably within prescribed operating limits adds another level of consistency. Process consistency also has a direct impact on production cycle time. Paper-based processes are often riddled with batch record errors, causing manufacturing teams to grapple with manufacturing deviations. As a result, production is slowed or halted. In our pre-digitised world, we planned for this inefficiency, scheduling 80 batches to make 90. In the post-digitised world, our confidence interval for producing ‘golden’ batches is closer to 1%.
Production productivity, consistency and reliability are typical success measures when justifying an investment in plant-wide IT systems. Manufacturing IT is viewed as a strategic asset that impacts the businesses’ ability to respond quickly and efficiently to change, to support corporate initiatives and to execute innovation. This means bringing an enterprise perspective to your game, and gaining a better understanding of 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 for both perspectives to have input into technology investments, architectures and policies that meet mission-critical requirements and still scale on a global basis. It is also essential to involve senior management at the highest levels. Investing in enterprise-wide production and performance management applications, such as manufacturing execution systems (MES), is widely viewed as critical, but these systems introduce radical process change. Executive sponsorship and change management are common threads within successful manufacturing IT strategies. Control concepts at the heart of such systems represent strategic risk management opportunities that warrant senior management visibility and support.
Convergence creates synergies
Improving information flow in a manufacturing enterprise is similar to the impact of a healthy circulatory system on human performance. Production operations are the heart of a manufacturing enterprise, but it is the ability to reliably, accurately and efficiently circulate that information amongst business and production systems that helps them react faster and enjoy stronger control over desired outcomes. One of the most immediate benefits of blending IT and manufacturing perspectives is developing a shared vision for what is possible when creating a modern manufacturing IT architecture. Consider that most manufacturing teams are so focused on getting product out the door, that they do not have time to research new manufacturing techniques or technologies via seminars and conferences. This is where working closely with IT has added significant value at Wyeth. The IT team helped manufacturing management understand how IT infrastructure can support mission-critical production systems, and worked with us to answer an array of questions. What is a segmented network, and why is it important? What are the pros and cons are of wired versus wireless access points? What is 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. Our IT brethren must understand what high availability means to manufacturing. What are the critical manufacturing parameters, and how that data must 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 organisation’s understanding of the other’s area. By establishing common ground, we enable a more productive discussion of manufacturing technology issues, opportunities and benefits.
Drawing the ‘Turf’ lines
Master data management (MDM) is a complex topic that needs to reflect the assigned roles and responsibilities of both the people and systems involved in a production process. MDM is an essential element in manufacturing IT strategy that helps guide how plant and enterprise systems should interact. This becomes increasingly important as business or supply chain systems such as enterprise resource planning (ERP) are interfaced into execution, quality or other plant-level production management systems to aggregate and extract key production data for planning and reporting.
At Wyeth, we found that it was easier to define 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. It does not discourage debate, however 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 recognise 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.
Information is the next Industrial Revolution
Like many other industries, pharmaceutical manufacturers are experiencing the impact of macro trends that are significantly changing the manufacturing landscape. A recent flurry of consumer product contamination issues illustrates 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. Technology is changing so rapidly that companies that apply it wisely in their business processes can realise a true competitive edge.
Pharmaceutical manufacturing operations are being managed as a strategic business asset with all that it bestows, including investment in appropriate technologies to create closed-loop information architectures on an enterprise-wide scale. The implications are many, including rejecting the traditionally insular view associated with developing and deploying plant-level information systems that some manufacturing management teams hold.
Just as no world-class company would consider deploying a home grown ERP application today, the systems that manage your manufacturing process should be 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 on its alignment with Wyeth’s commercial off-the-shelf (COTS) software philosophy, global support needs and scope of functionality. Bringing production operations into the digital age is not easy, but the journey is exciting and rewarding. Do not take on the task without the help of qualified and trusted partners.
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