From the Editor: The Quest for Excellence

The pharmaceutical industry needs clarity on Six Sigma and Quality concepts. It also needs its own version of the Baldrige award, recognizing the manufacturing effort and commitment to continuous quality improvement.

By Agnes Shanley, Editor in Chief

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After being disconnected from the "quality revolution" for so long, pharmaceutical manufacturers are catching up, and developing continuous improvement programs. There's still a lot of confusion, though, about Six Sigma. The term is sacrosanct in business circles today, but it's often used as an umbrella term for different flavors of quality management and improvement. The fact is that many people use the term without understanding it, and only a handful of pharmaceutical companies are getting it right.

Six Sigma can be used by itself, but it can be applied incorrectly. Consider a facility that launches a Six Sigma program before it has undertaken "lean" process reengineering. In such a case, applying Six Sigma may reduce variability, but it will also improve some processes or sanction some investments that weren't really needed in the first place.

Six Sigma is really most powerful when combined with all the "other" quality improvement programs that the world owes to the Japanese automotive industry — the ones we've all heard of: Lean Manufacturing, Poka Yoke, Kan Ban — but a few others that may be new, such as "Five S" and Value Stream Mapping. In this issue, Noemi Santiago shows how she and her team at J&J's PSR in Puerto Rico have integrated these concepts and techniques and applied them to move toward process excellence.

But Six Sigma can also be used on the individual level, to improve your performance and career prospects, and help you build quality into your operation, facility or company "from the inside out." In her cover story, J&J quality executive Penelope Przekop demystifies the concepts behind Six Sigma. It's not just for the elite, or the "Black Belt" practitioners, as she will expand upon in a book expected to hit the shelves next year. It's achievable if you stop focusing on adhering to schedules and delivery dates and start thinking, on a deeper level, about the processes you're responsible for every day and how they can be improved. A key part of the process is discerning the needs of your "customers." On the day-to-day level, that may be your boss, but in the big picture for all drugmakers, your customers are consumers who, many would argue, are paying far more than they should for the medicines they need.

Growing awareness of the need to improve quality and customer service has underscored the importance of manufacturing, a function that remains under-recognized by an industry that often appears riveted on marketing and discovery. Pharmaceutical Manufacturing and the American Society for Quality (ASQ), sponsors of the Baldrige Award, are proud to announce the 2005 "Pharmaceutical Manufacturing Team of the Year" award. The "TOTY" award will honor individual manufacturing teams that have made the most substantial improvements in quality and efficiency and whose efforts, collectively, promise to transform drug making.

Perhaps you know of, or work on, a team that has made significant strides in reducing cycle time and product variability and empowering its workforce. We invite you to nominate them. See page 64 of the magazine and our website for more information and a prescreening nomination form. Participating will not require disclosure of any sensitive or proprietary information, and team efforts will be evaluated, impartially and anonymously, by a team of quality experts from various industries; all team members will be awarded at their facilities and team leaders flown to ASQ's International Quality Conference next May, where they will be awarded for their work, and invited to network with their peers from different industries around the world and to attend workshops, gratis.

Both large and small companies are eligible, and the team's starting point doesn't matter: what will count is the improvement achieved.

Pharmaceutical Manufacturing will also update you on the technologies that are becoming indispensable to improving quality. Next month, we will launch new monthly e-newsletters, in partnership with IFPAC and AIM, focusing on Process Analytical Technology (PAT) and "track-and-trace" technologies such as RFID. Featuring the latest news, case histories, and perspectives from FDA, standards-setting groups, vendors and implementation experts, they promise to be "must-reads" for manufacturing professionals. See our web site (which will also undergo a transformation of its own) for more details.

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