Achieving Compliant Manufacturing Excellence through Real-time Performance Management

ARC WHITEPAPER
SEPTEMBER 2007
Achieving Compliant Manufacturing Excellence through Real-time Performance Management and Continuous Improvement
Executive Summary .....................................................................3
Manufacturing Excellence in Regulated Industries ............................5
Today's Compliance Challenges .....................................................6
Additional Challenges ...................................................................8
Real-time Performance Management ........................................... 10
Synchronized Manufacturing Operations ....................................... 15
Realizing Manufacturing Excellence .............................................. 17
Summary ................................................................................. 19



THOUGHT LEADERS FOR MANUFACTURING & SUPPLY CHAIN ARC Whitepaper . September 2007
Greg Gorbach About the Author: Greg Gorbach: As ARC?s Vice President, Collaborative Manufacturing and Architecture, Greg Gorbach is a thought leader in Collaborative Manufacturing and provides clients in a number of manufacturing vertical markets with strategic advice in dealing with boundary-crossing business processes. Greg's primary areas of focus are Collaborative Manufacturing, Oper-ations Management, Business Process Management, Manufacturing Performance Services, and the synchronization of plant systems with CRM, ERP, PLM, Supply Chain and other business systems. He brings over twenty years of hands-on experience to ARC, with direct experience within manufacturing organizations, as well as extensive ex-perience with suppliers to manufacturers.

This paper was commissioned by SAP. For additional information about SAP products and services, please contact SAP at: www.sap.com

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Executive Summary
Life Sciences manufacturers are feeling new pressure on their operations from many directions. Dynamic market needs, increased compliance re-quirements, more distributed manufacturing operations, rapid product innovation, Lean manufacturing, and the approaching transition to new IT technology all manifest themselves on the plant floor and throughout the en-terprise - and often lead to pleas for new technology solutions. Compliance management, integration, and data utilization are key issues to address in order to improve responsiveness and performance.
Many manufacturing companies recognize that improving corporate perfor-mance demands better synchronization with the plant floor. At the same time, moving to a risk-based approach to compliance may require new sys-tems and improved data visibility. For too long, manufacturing has been isolated. Most of the important production data has not been easily accessible, and is therefore not very useful in improving performance. Today, however, feasible solutions are available to drive excellence in manufacturing performance through better manufacturing intel-ligence and integration.
Real-time Performance Management (RPM) solutions acquire manufac-Fig 1: Value Network Dynamics Drive Manufacturing turing data in real-time, establish Performance Requirements; Better Integration and Data Utilization Enable Manufacturing Excellence and the operating context for that data, Optimal Real-time Performance and ensure that it is stored in a manner that makes it accessible at later times for a variety of uses. RPM facilitates the visibility of this real-time manufacturing data to users throughout the enterprise, and includes tools for enhanced decision support and role-based display of performance against operating metrics. Event-based triggers notify all who should be informed when important or unforeseen events take place. These solutions help com-panies achieve a higher level of manufacturing excellence by allowing them to better leverage their detailed manufacturing information.
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