Outlining Implementation Strategies for Lean Manufacturing

Interphex2007, New York, NY (Apr. 24)-Compared with other industries such as the automotive industry, the pharmaceutical industry has been slow to adopt lean manufacturing. This situation, however, is changing. Faced with growing complexity in its supply chain from outsourcing and technology improvements, greater cost pressures from weakening product pipelines, and increasing regulatory standards, the pharmaceutical industry is looking to lean manufacturing as a way to mitigate these challenges.

The adoption of lean manufacturing requires an organizational change and commitment, said Dennis Constantinou, senior director, industry strategy and marketing, life sciences, Oracle Corporation (Costa Mesa, CA, www.oracle.com). Constantinou spoke at the “Implementing Lean Sigma in Pharmaceutical Manufacturing” session held at Interphex2007 Conference & Exhibition on Apr. 24. The session also featured input from Teva Pharmaceuticals USA (www.tevapharmusa.com), a subsidiary of the generic drug manufacturer Teva Pharmaceutical Industries Ltd. (Jerusalem, Israel, www.tevapharm.com), which recently implemented a lean manufacturing program.

In moving to lean manufacturing, a pharmaceutical company needs to evaluate current and future performance to shape operating and management systems. “When looking at operating systems, you must know your demand levels, create tactical plans, and standardize work charts and instructions,” said Constantinou. Key performance indicators, communication strategies, and a visible problem-resolution system are critical elements in an effective management system in a lean-manufacturing organization, he said. 

A company must incorporate the elements of lean manufacturing in its operations strategy, operations execution, operations information technology (IT), and operations organization, which includes building flexibility into those processes and systems, said Constantinou. “In looking at operations IT specifically, there are several imperatives to support pharmaceutical manufacturing challenges,” he said. These elements include:

• adapting to existing business processes such as IT solutions that map to defined value streams;

• building quality into manufacturing such as through on-line testing and providing near real-time feedback;

• controlling standard operating procedures such as through electronic documentation;

• demand-driven manufacturing; and

• compliance and security. 

Teva rolls out lean manufacturing
To illustrate the value of and process for lean manufacturing, Mike Randolph, senior director, manufacturing operations, and Jonathan Young, associate director of Lean and Six Sigma project management at Teva Pharmaceuticals USA outlined how Teva implemented lean manufacturing into the operations of its 195,000-ft2facility in Sellersville, Pennsylvania. The Sellersville site performs dosage-form manufacturing for solids, liquids, and crèmes and packaging. It also includes laboratory and research and development capabilities. Teva manufactures more than 100 molecules at the facility, producing more than 200 products.

Teva began the process for implementing lean manufacturing in 2001, outlined Randolph. The company has realized several gains in its manufacturing process, including a 31%-increase in commercial productivity, a 55%-decline in manufacturing incidents, and a 41% decrease in deviations.

To its implement it lean manufacturing program, Teva formed functional teams headed by coaches that were front-line supervisors that received specialized training. Teva worked with Everest Consulting Group, Inc. (Raleigh, NC, www.everestcg.com), which assisted Teva in implementing a Professional Coach Certification Program to train coaches. Teva now has roughly 74 coaches and 50 functional teams. The value of this team approach is to build stewardship over tasks and processes and to sustain the mindset of lean manufacturing in the organization. 

Teva also worked with The University of Michigan’s Tauber Manufacturing Institute (Ann Arbor, MI, www.tmi.umich.edu) as part of its lean-manufacturing implementation to address strategies for reducing cycle times and increasing capacity without major capital investment (1).

Young discussed several tools that Teva has used in implementing lean manufacturing. These include 5S, a system to reduce waste and optimize productivity through maintaining an orderly workplace and using visual cues to achieve more consistent operational results, and Kaizen, or rapid improvement processes, which focuses on improving productivity and achieving sustained continual improvement.

Teva also used cellular manufacturing or work cells, where work units are arranged in a sequence that supports a smooth flow of materials and components through the production process with minimal transport or delay. For Teva, this meant streamlining its solid-dosage manufacturing from five major units (dispensing, granulation, tableting, coating, and packaging) to three (granulation supply, finished-dosage form, and packaging). Although the functions did not change, reducing the number of steps or units allowed for cross-training, better utilization of labor and equipment, and the assignment of a business unit owner, who is the point person responsible for ensuring the flow of processes and product to subsequent units. 

1. “Decreasing Cycle Time, Increasing Capacity in a High Mix, Low Volume Constrained Batch Environment, Spotlight 2005, Tauber Manufacturing Institute, The University of Michigan School of Engineering and Business School, p. 30–31,  http://tmi.umich.edu/SpotlightBooklet2005.pdf, accessed Apr. 24, 2007.