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By Joan D'Amico
Continuous improvement initiatives can take drug manufacturing quality to the five sigma range, but moving up to the six sigma realm requires time and resources. The investment required may challenge any mid-sized enterprise’s cost-to-benefit ratio.
The drug encapsulation specialist Capsugel, an operating division of Pfizer, instituted a global Six Sigma program last year that struck a balance between implementation costs and potential savings and opportunities. While the company already had a continuous improvement program in place for 20 years, its management felt the need to go farther. Critical to the project’s success was minimizing the disruption of day-to-day workflow. This article will outline Capsugel’s approach and analyze the results seen thus far.
Any Six Sigma project on a global scale requires top-down management support and bottom-up grassroots involvement. A training program is needed that involves enough people so that the project can reach a critical mass.
Often companies create a whole new organizational structure for their Six Sigma work. They reassign employees full-time to the Six Sigma initiative, hiring people to cover the rest of their day-to-day workload. This approach may speed up the process, but makes it far more expensive than integrating Six Sigma into everyone’s daily workflow.
“We didn’t want to take on additional overhead in order to train a large group of Black Belts,” explains Blair Chalmers, Capsugel’s global Six Sigma manager, “so we trained smaller groups of engineers and assigned them to more complex projects involving interdependent variables, since these projects would require more robust Six Sigma methodologies.”
The company instituted week-long training sessions for key engineers involved in the program; after each session, these engineers would work on projects for a month, and then return for another week-long training session, an approach recommended by many Six Sigma experts.
Thus, Capsugel was able to train and build its Black Belt workforce gradually, and have them gain experience by working on solving major, chronic problems. Once the first group of six engineers completed training certification and project work, they moved on to other projects, and the next group of seven engineers went through the same initial training process and project work.
This approach paid off quickly, Chalmers says. “We were able to find solutions to problems that had plagued us for years without adding people or creating a new organization,” he explains. Engineers were able to keep up with the workload, and the company could reap the continuous improvement benefits immediately.
As part of its continuous improvement efforts, the company already had existing structures and processes in place, including some Six Sigma processes. An example was its “Quality Summit,” an annual meeting where regional vice presidents (general managers), sales managers, plant managers and QA managers from each region or affiliate were invited, in addition to leaders from R&D and global operations.
The summit’s goal is to review past performance and address issues driving customer satisfaction, but it now includes a specific agenda item to discuss the Six Sigma initiative and set the direction for future projects, based on business and quality needs.
Capsugel also established a Six Sigma steering committee, which includes representatives from each of its global manufacturing facilities, under the leadership of a global Six Sigma manager. Members of the steering committee received four days of Six Sigma training before its first meeting.
“We were coming together as a global organization to discuss continuous quality improvements anyway. Now, we’ve added Six Sigma methodologies for analyzing and improving processes, but with respect to the circumstances specific to each facility,” says Chalmers.
The committee relies on methodologies such as Pareto Analysis and Voice of the Customer (VOC) data to determine, at a macro level, which projects each team will work on. Then, using the same Six Sigma methodologies, each team further narrows the scope of work into a manageable project and starts the DMAIC (Define, Measure, Analyze, Improve, Control) process.
Cultural change is usually the most difficult obstacle to overcome whenever any organization implements programs such as Six Sigma. Six Sigma manager Blair Chalmers believes that starting the implementation with a Black Belt from each region, guided by a global steering committee with top management support, ensured global top-down and bottom-up buy-in.
Any Six Sigma project requires top-down management support and bottom-up grassroots involvement. A training program is needed that involves enough people so that the project can reach a critical mass.
The company’s reporting structure also helped to encourage more rapid adoption. Black Belts report directly to their local site leader with “dotted line” responsibility to the global Six Sigma manager, ensuring that local facilities reap the benefits of Six Sigma first, Chalmers says. This pays dividends by creating more enthusiasm for the program at the local level, which benefits the company as a whole. The teams report that they are experiencing improvements every month.
“As a Black Belt, it becomes easier to change the culture and the mindset in your own region when you are backed by global support,” says European operations engineer Björn Mertens, part of the second wave of Six Sigma Black Belts. That same sentiment is echoed by other initial Black Belts who commented that the continuous improvement mindset is spreading exponentially as additional waves of Black and Green Belts are trained and assigned to projects.
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