A Case Study of Strategic Six Sigma at BD
A Japanese pharmaceutical company purchases components from BD, assembles them to make syringes, and pre-fills them with a drug to market in Japan. The customer expected zero defects in all components, but one component had defects and could not satisfy them. A global team made up of customer, supplier and BD associates applied successfully Six Sigma to improve the current process and then to develop technology for a new product.
What is Six Sigma?
Developed by Motorola in 1987, Popularized by GE, Six Sigma drives breakthrough quality improvement by reducing variation. It is also a strategic tool for developing products and technologies, linked with the voice of customer. It is being used in a broad range of industry and service organizations.
Six Sigma Applications in Developing a Commercial Product.
The project had two phases: 1) Fix current process; 2)Develop better technology.
In Phase 1, we identified eight CTQs (Critical to Quality characteristics as defined by the customer), prioritized them through the use of Pareto analysis and validated the measurement system. The team, through brainstorming, mapped the process, generated Cause-Effect matrix, FMEA, targeted DOEs, and implemented control plan. As a result, the current process was improved and stabilized. The customer received acceptable quality and quantity, and on time delivery.
In Phase 2, the team developed a new injection mold, then optimized the design to give the required assembly process performance. The final product was defect free and assembly was better than target. This was the result of multiple experiments and pilot runs, and depended on strong collaboration with the machine builder.
The customer was delighted with the improved product made by the new mold. The team won the Becton Quality award in 2004
Keywords: Ø Six Sigma Quality, Ø Strategic Six Sigma, Ø Voice of Customer, Ø Quality in Design Phase, Ø Quality Tools
Dr. Mohamed Rawoof
Manager, Corporate Quality Management, Six Sigma Implementation and Supplier Quality Management
Six Sigma Resource Team member involving curriculum development and teaching the Six Sigma to Champions, Black Belts, and Green Belts at BD worldwide.
Corporate lead in Supplier Management Program, involving procedure development and subsequent training to BD associates and suppliers; audit of suppliers as needed.
Worked previously at Johnson and Johnson as quality professional, at E. I. Dupont as Senior Process Engineer, and at GAF as research scientist.