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St. Jude Medical, Inc., St. Paul, Minnesota, is a global manufacturer and distributor of heart valves, pacemakers, defibrillators, and interventional cardiology products and services. St. Jude Medical's mechanical heart valve has been implanted in more than 800,000 patients worldwide.

The heart valve's working components are made of pyrolytic carbon, one of the hardest man-made materials. The manufacturing process developed by St. Jude Medical to produce pyrolytic carbon components consists of specialized manufacturing practices and proprietary technology and processes utilizing CNC machining, coating, materials testing, polishing and final finishing, plus numerous in-process quality assurance inspections.

A few years ago, the Heart Valve division at St. Jude Medical changed its Carbon Manufacturing operations from the traditional batch system to cellular manufacturing. It began incorporating demand-flow techniques and self-managed team strategies. Carbon Manufacturing made the move to team-based manufacturing because the company wanted to improve competitiveness by creating a sustainable improvement culture that would ensure ongoing quality and cost leadership.

I recently heard James Kwan, Plant Manager for Carbon Manufacturing, and several members of his operations team speak enthusiastically about the company's transition to cellular manufacturing. The company's cellular implementation plan focused on the following key factors:

• Organizing key operations into cell teams instead of departments;
• Developing self-managed work teams;
• Implementing continuous flow, instead of lot-size processing;
• Eliminating non-value-added work; and
• Improving communications across functional areas.

Once the implementation plan was developed, Carbon Manufacturing identified critical success strategies for its migration to cellular manufacturing:

1. Communication—ensuring understanding and buy-in of everyone involved in the transition process.

2. Orderly transfer of production capacity—procuring and installing equipment before it was required. This created a buffer capacity to ensure uninterrupted product flow.

3. Management of constraints—educating everyone on constraint management and performance measurement.

4. Training of key personnel—training all employees in socio/team skills to prepare them to work in the new environment.

5. Execution of the plan—leveraging internal and external resources to assure adequate support for all transition activities and standard business functions.

Obviously, as a manufacturer of heart valves, quality is of utmost importance. A transition quality assurance plan was developed in support of standard FDA/ISO quality system compliance activities:

• Assuring conformance to the company's quality systems;
• Designing constraints to be machines, not people;
• Enhancing quality via improved communication and reduced inventory; and
• Validating new equipment and process flow designs.

The first step was to communicate the vision and how it would impact people and day-to-day business. As Sue Clegg, a resource cell team member and trainer for final finishing and inspection stated, "We had to provide for team development, ownership and accountability. We also had to enable decision-making at appropriate levels, break down rank within the work teams, and improve communications."

Another step was to identify the bottleneck operations. As Dave Larson, CNC machinist, said, "We identified bottleneck areas in the new cellular layout and recognized the need to keep these bottleneck operations running all the time. Downtime on a bottleneck is lost capacity." Mr. Larson discovered that being busy all the time is not the most effective way to operate in the cellular environment, but constraint operations must be kept running.

St. Jude Medical's Carbon Manufacturing team members have worked hard to make the cellular manufacturing process a success. Everyone believes the new environment has brought the company to a new level of competitiveness and will help ensure that they can sustain long-term product quality and cost leadership.