The Quality and Productivity Section will host several roundtable events at JSM 2015. These intimate sessions encourage deeper discussions with roundtable leaders on topics of interest. This year’s topics include a wide range of areas within industrial statistics, including statistical process control, statistical engineering, and design of experiments, along with additional challenges practitioners face such as outsourcing and manufacturing systems.

The Role of Confirmation in Designed Experiments, led by Willis A. Jensen of W.L. Gore & Associates—Throughout the literature on design of experiments, the need to perform confirmation runs has been emphasized repeatedly. We provide a high-level framework for design of experiments and discuss how the confirmation phase is becoming increasingly important. However, the literature provides little guidance for assessing the confirmation runs or how many confirmation runs to perform. We will discuss the following four questions:

• Why is confirmation needed in practice?
• How do I know the confirmation is successful?
• How many confirmation runs are needed?
• What if I fail the confirmation?

Quality Anyone? Statistical Process Control to Make Better Decisions and Get Your Process Under Control, led by Erin Tanenbaum of NORC at the University of Chicago—This roundtable will focus on statistical process control (SPC) fundamentals and how statisticians use them to understand and improve process quality or timeliness. Whether in manufacturing, market research, health care, or other disciplines, use of SPC charts provide a structured approach for data analysis and dissemination of results. Participants are encouraged to bring their experiences or questions, as the challenges and rewards of using SPC will be discussed. Common misconceptions related to SPC philosophy, methods, and techniques also will be discussed, along with the challenges of carefully crafting a proper outcome measure. Attendees will gain an appreciation for how SPC can be applied to develop a better understanding of any type of process.

Statistical Engineering: Talking the Language of Impact, led by Christine Anderson-Cook and Brian P. Weaver of Los Alamos National Laboratory—The results of statistically sound data collection and analysis are sometimes misunderstood and not well received by nonstatisticians because of a potential disconnect between what was found and what difference it makes going forward. In this roundtable, we will discuss strategies for increasing the impact of statistical methods on the problems they tackle. By focusing on return on investment, cost reduction, efficiency, quality improvement, and reliability, statisticians’ messages can resonate more with colleagues and they can play important roles as part of problem-solving teams. Examples of successes will be described from our experiences at Los Alamos National Laboratory.

Considerations, Challenges, and Opportunities in the Use of Outsourced Statisticians for CMC Statistical Support, led by Benjamin Ahlstrom of Amgen, Inc.—A trend in industry is the outsourcing of various corporate functions. In the biopharmaceutical and medical device sector, outsourcing has been used for clinical research through the use of contract research organizations (CROs). On the manufacturing and quality side of the business (chemistry, manufacturing, and control—CMC), contract staff have been used to perform statistical analyses to a lesser extent, while in-house statisticians have been employed more widely. However, the potential exists for the expanded use of statisticians contracted from outside organizations and located either onsite or offsite. The purpose of this roundtable is to discuss considerations, challenges, and opportunities in the use of contract statisticians within the quality or manufacturing organizations in a biopharmaceutical or medical device company.

Quality Excellence in Design and Manufacturing: A Roadmap to Customer Delight, led by Daksha Chokshi of Aerojet Rocketdyne—Quality excellence in both design and manufacturing are keys to the success for any business in delighting the customers with products that meet or exceed their expectations. This roundtable will explore important linkages, protocols, and lessons learned from successful manufacturing and Six Sigma design applications. In particular, the cost of a design change made in the engineering phase prior to release to manufacturing is much lower than the same change if it is made after the design is released to manufacturing. The importance of using the right tools for the right applications in manufacturing and design will be stressed. We also will discuss understanding the influence design choices have on achieving a robust manufacturing system.