Operations Management COP E-Letters

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E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs). The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.

*COPs are now an ISPE Member-only benefit, therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue all E-Letter content and other valuable resources that will assist you in being more effective at your job.

October 2012

My Experience with Implementing OEE – Indentifying and Overcoming Barriers
Overall Equipment Effectiveness (OEE) is a very powerful Key Performance Indicator (KPI) that measures availability, performance, and quality and is also geared to measuring the effects of process improvement across all of those aspects of operations. Having said that, it is common to experience difficulties during the metric definition, implementation, analysis, and process improvement phases of the OEE program. An article provides one person’s experience in identifying and meeting those challenges. More. ( 263 KB)

Back to Basics:  Transforming the Pharmaceutical Supply Chain European Conference
This conference will provide insight into many of the critical-to-success factors in pharmaceutical supply chains. It will focus on how the industry can achieve world-class performance levels and transparency in the end-to-end networks - with a better understanding of how to deliver value to all stakeholders to which the pharmaceutical supply chain industry relates. More.

Bridging the Compliance and Operational Excellence Gap
At the 2012 ISPE Annual Meeting, find the best practices to drive performance of manufacturing operations using methods such as QbD and Operational Excellence. Education session 409 will follow a comprehensive, modern approach to managing and assuring quality, including technology, software and information management solutions for continuous process validation that ensures compliance with evolving regulatory expectations. More.

April 2012

Simulations for Improved Production Cycles Using a Lean Supply Chain Postponement Strategy
A supply chain postponement strategy is a valuable lean design concept for the biopharmaceutical industry that has applicability particularly because of the typical multi-stage production processes involved in the conversion of raw materials through to final customer fulfillment. An article discusses a case study focusing on postponement as a supply chain strategy and how to develop the design process and the benefit of using simulation to test a new design, including one such as postponement, prior to implementing it in practice. More.

ISPE’s Operations Management Community to Develop New Guide:  Seeks Input and Volunteers
In support of its mission to review all areas of operations management, which includes the integrated process flow from the supply of raw materials to final product distribution, ISPE’s Operations Management Community of Practice is engaged in producing the first ISPE guidance document, tentatively titled the Pharmaceutical Operations Management Guide, which will focus entirely on operations management. More.

Roche Diagnostics GmbH Wins 2012 Facility of the Year Award for Operational Excellence
Roche received the award for its “TP Expand” Project in Penzberg, Germany. The project was the result of an innovative and well engineered master plan featuring six independent projects and a GMP IT system known as DAMAS. The DAMAS system is the key component that enabled a high level of operational excellence at the Penzberg site. Look for an in depth case study on the center in the Facility of the Year Award Special Edition, a supplement to the upcoming Pharmaceutical Engineering May/June 2012 issue. More.

Volunteer Opportunities with the Operations Management Community
The Steering Committee of the Operations Management Community of Practice (COP) is looking for professionals for the following five Task Teams: Good Practice Guide, Performance Indicators, Improvement Tools, Operations Strategy, and Supply Chain. More.

January 2012

Applying Overall Equipment Effectiveness (OEE): Approaches and Supporting Technologies
An article identifies how to capture information necessary to measure and report OEE and the overall design/technology architecture needed to maintain the resulting system. The article is the third in a series on OEE and its application in pharmaceutical/biopharmaceutical manufacturing written by the Operations Management Community of Practice (COP). More. ( 18 KB)

Using OEE for Packaging Line Improvement
This new ISPE Knowledge Brief describes the concept of Overall Equipment Effectiveness (OEE), the metrics used in OEE, the basics of conducting an OEE study, and how to implement OEE improvement for operations associated with a primary or secondary packaging line located in a pharmaceutical area. More.

Volunteer Opportunities with the Operations Management Community
They “can’t offer fortune and glory, but perhaps a modicum of fame and the satisfaction of contributing to the industry.” The Steering Committee of the Operations Management Community of Practice (COP) is looking for professionals for the following five Task Teams: Good Practice Guide, Performance Indicators, Improvement Tools, Operations Strategy, and Supply Chain. More. ( 257 KB)


April 2011

Do You Walk the Talk When It Comes to Operational Excellence?
An article by Jim McKiernan compares two different experiences: a visit to a plant with a very low level of visual communication about its operational excellence program and a visit to a plant where safety, production targets, Overall Equipment Effectiveness (OEE), and other key measures are clearly visible at each line and consolidated at cell level. Read more ( 372 KB).

Overall Equipment Effectiveness (OEE) State of the Art in the Pharma Industry
There was considerable initial reluctance to adopt an OEE measure, which was not seen as readily translated from other industries to pharma. However, OEE is finding increasing acceptance in the pharma industry and many companies are now using it in all parts of their operations. An article by the Operations Management Community of Practice takes a look at the State of the Art of OEE. Read more ( 339 KB).

“Guerilla Transformation” – Change an Insurgency into a Movement
Joseph Paris, by discussing Game Theory and the Nash Equilibrium, illuminates why business transformation is unattainable without a disruptor – and why the purposeful engineering and introduction of such a disruptor is necessary for a Change Agent to be effective in a Continuous Improvement program. Read more.

New Risk-MaPP Resources: Blog and FAQs
ISPE published the Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) in September 2010. The Guide provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. The Guide has generated much discussion. In response to industry needs, ISPE has set up a blog and developed an FAQ document dedicated to the issues related to the Risk-MaPP Baseline Guide. Read more.


October 2010

OEE Basic Philosophy and Definitions
Regardless of where Overall Equipment Effectiveness (OEE) has been deployed, one thing all industries have in common in relation to OEE is lively discussion of how it should be defined. An article by the Operations Management Community of Practice provides OEE basic philosophy and definitions as part of a planned series of articles on OEE and its application in pharma/biopharma manufacturing. Read more ( 112 KB).

Operations Management COP Update
The Operations Management Community of Practice (COP) has more than 600 members, and the steering committee has organized itself into four task teams to address focus areas of interest to all of us. Read more.

What the Operations Management Community is Discussing Right Now
Innovation indexes and benchmarking are some topics on the Operations Management COP site that are in need of input. Read more.


April 2010

Improvement Tools for the Early 21st Century in Pharmaceutical Operations – Operational Excellence
An important part of the Operations Management Community of Practice will be to help members understand and share experiences in the use of appropriate improvement tools to ensure that technical operations continuously improve and achieve best in class levels of performance. Read more ( 16 KB).

PQLI Roadmap: Product Design, Development, and Realization, a Science- and Risk-Based Approach to Implementation – An Overview of ISPE’s First PQLI Guide
An article in the April/May issue of Pharmaceutical Engineering magazine provides the background and current status of ISPE’s Product Quality Lifecycle Implementation (PQLI®) initiative, including the development of an ISPE PQLI Guide Series. Read more.

ISPE GAMP Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach
This recently published Guide uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization. It collects and integrates information and knowledge from many disciplines and sources into a single comprehensive guideline. Read more.

What the Operations Management Community is Discussing Right Now
Cost reduction initiatives, innovative management tools box, and supply chain leadership continue to be hot topics of discussion on the Operations Management COP site. Read more.

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