IT, Automation and Drug Manufacturing: Just Grow Up!

The three groups are still disconnected at many drug companies today, as we learned in a very informal survey and touched on in a very brief article recently (click here to read , with insights from Gawayne Mahboubian-Jones (PRODUCT, not Process Development Manager as identified in the article, at Optimal Automation LLP....we need some PAT for editorial processes, it seems) Jacobs Engineering's Scott Sommer and Conformia's Anjali Kataria. Rockwell Automation's recent White Paper analyzed the situation with the memorable title "Come Together." Charlie Gifford, who established the ISA 95 integration best practices working group, has a more to-the-point suggestion: "Grow Up!" He describes the situation that exists at many drug manufacturing facilities in a recent column and addresses them in his new blog, "Hitchhiking Through Manufacturing." One recent post asks why end user groups aren't more involved in developing standards. This leaves "their best interests" to vendors, and, as Scott Sommer will reveal at Interphex, they aren't always being served. Of course, few people have the time or the inclination to get involved, but, it could be that, if they work for pharma companies, they may not even know what 88 and 95 are, if they're like 30+% of respondents to our survey last year, or, if they're like the similarly sized chunk of respondents who found that they weren't important). Below, an excerpt from the full op-ed. (Does it remind you of anything you're seeing at your workplace?) This is all by way of introduction to today’s subject—the bloody war zone in manufacturing operations management (MOM) systems. These applications sit between corporate IT (top management and the folks who crunch the financial and planning numbers) and process control systems (performing the role of diplomat, facilitator and translator for the plant’s workflow. They translate operations data into triggers and alerts, and business process and financial metrics). In the other direction, MOM systems translate enterprise work orders and planning into product definitions for detailed scheduling, work dispatching, work execution and process control. The product definition in this case is manufacturing workflow in the form of discrete routes and batch recipes. This MOM bidirectional translation is much harder and expensive than it needs to be because of culture and system language differences. The language gap between the financial side and plant process side of the business is so wide that it is the #1 barrier to successful globalization and transitioning to adaptable manufacturing for North American manufacturers. The cultural problem cannot be solved until the language barrier is addressed. The problem is plants have been and are viewed as cost centers by businesses, which consequently cause finance and planners to run plants in a bare-bones manner—a bad practice, since, as the manufacturing form must adapt to global pull make-to-order supply chains, no money is invested in plants unless it’s less than 12 months to ROI. Furthermore, most plants currently run disparate/stand-alone operations IT or paper systems in production, quality, inventory and maintenance, all of which apply distinct languages in their systems, requiring paper-based workflow transactions between departments. That makes for lots of paper calling one item by many names—not to mention much non-value added work and error creation. No common language exists even at the plant level. So when the business folks, who speak the language of accounting ledgers and material planning, want information exchange from these disparate systems, the Sandbox War ensues. The folks on the business side say, “Give me real-time visibility to work order and financial activity-based costing in my language. (I pay the bills!)” Then the plant person says (not so loudly), “I will only give you visibility to my operations in a black-box format because corporate IT people have no clue about our daily firefights, and we do not need their uninformed opinions.” Neither side realizes how large and complex job it is to integrate and translate between the plant and business in real-time. So the walls go up, and turf and ego wars erupt, leading to bad compromises with which no one is happy... Both sides must now grow up and work together, since the 21st-century plant and its role have changed dramatically. The plant is now the dynamic, adaptable asset in a global distributed supply-chain network. Real-time visibility of capacity and capabilities are essential to global competitiveness. The plant is now in a pull, not push, role in the global supply chain. More products are make-to-order, not make-to-stock. Manufacturing systems must be built to support adaptable business and workflow processes. To do this, we must make the business case to corporate IT, business and plant management that they have apply the manufacturing operation standards such as ISA-88/95, OMAC, OAGIS, MIMOSA and OPC across the enterprise in a simple form to lower the life cost of integrated systems and make those systems adaptable to business process. This business case has not been make at the CIO and CFO level of most American manufacturers, as it has been in Europe and Asia. Common manufacturing language is the barrier to 21st-century success for American manufacturing...
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  • <p>Self-assessment characteristics are provided to help evaluate success with each of the core distinguishing characteristics.-<a href="">Dr. Naveed Fazlani</a> </p>


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