Improving the Flow of Information per S95 Standard

While in Asia last week, I had the opportunity to catch a presentation by Bob Lenich, Director of Emerson’s Data Management Services. With the announcement last year of Emerson’s acquisition of Decision Management International and the Compliance Suite manufacturing execution system software, Bob has been busy integrating the organizations.

The Compliance Suite software is being used by many process manufacturers, especially in highly regulated industries such as Life Sciences–Pharmaceutical and Biotech manufacturers. The starting point for applying manufacturing execution system software is the data model defined by the ISA-95 (S95) standard. The S95 standard describes the architecture of information flow between the plant floor, the automation system, the manufacturing execution level and the enterprise resource planning levels. Getting these workflow activities and the flow of information between them right is what defines highly efficient, customer-responsive manufacturers.

Bob described the place to start as understand the challenges of improving quality, improving throughput and/or increasing process availability/uptime as a few examples of what can drive process manufacturers to look at improving the flow of information around the organization. You have to understand the problems and needs in order to improve things.

As an example, in the area of quality, typical issues are to reduce deviations. These can be caused by ensuring the right material is available to add at the right time or eliminating manual error in calculations. Also, much time and effort currently spent just doing all the paperwork and paper work tracking required to meet today’s regulatory needs. Converting from paper to paperless systems can eliminate all of these problems

In addition to eliminating problems, reducing these deviations also improves throughput by reducing batch variability, reducing batch cycle time and reducing the overall batch release time as there aren’t as many problems to address.

Solving these problems requires addressing a mixture of automated and manual processes. Bob noted that the best way to address these issues should begin with a look at the current workflow, to understand where efficiencies can be gained.

The workflow should look at equipment, people, materials, documents and existing information to develop the business justifications and information architecture to address the areas of inefficiencies. Once a good benchmark is established, improvements can be made and the results quantified.

There many opportunities to do this and Compliance Suite is a great tool to use for enforcing these changes. Bob stressed that these changes are typically strategic in nature for the process manufacturer and require the upfront planning and design work to focus the efforts to the areas of greatest efficiency gains and continuing to prioritize the areas of improved data management and flow over time.

Posted Tuesday, January 22nd, 2008 under Life Sciences & Medical.

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