The Application of Six Sigma

The Application of Six Sigma
by Randall Smith, Timothy Rhines, Ph.D., and Richard Crowley

In recent decades, industry has been deluged with various approaches to process improvement. Although the exercises recommended by quality gurus such as W. Edwards Demming and emphasized in the quest for the Baldridge Award were valuable, the results were often self-serving and difficult to measure. Six Sigma is a data-driven approach that relies heavily on the “voice of the client” as a focus for improving operational businesses and work environments. As a result, the process is far less subjective than previous “quality” programs and recognizes that measurable results are paramount to the impact of change.When employed effectively, Six Sigma becomes a part of a company’s culture and, from an organizational perspective, this translates to solutions that significantly improve the efficiency of business practices.

Six Sigma was pioneered by companies such as Motorola and General Electric and was focused on achieving efficiency gains in manufacturing processes. Today, the program has evolved into an effective tool for a diverse range of businesses. Although many of the tools used in the manufacturing sector still apply, most have been adapted to be more specific and dynamic to individual business models. For the laboratory environment, Six Sigma has been fine-tuned to make the tools more appropriate for a serviceoriented business that has science as its product. Because science itself is a rigorous process built on procedure and measurable data, the integration of Six Sigma in the analytical arena was a natural fit. The implementation of the Six Sigma process provides staff with documented evidence of the transformational changes needed to exceed regulatory and scientific requirements and expectations.

Team Design, Project Selection

Selecting appropriate projects is critical and requires comprehensive knowledge of the systems, processes and priorities of the business. As a result, the foundation of the Six Sigma process is people, and the roster of the project teams must include appropriate representatives of operational staff, management and financial analysts as well as specialists in the Six Sigma discipline. These specialists are known as Black Belts, who have received the highest level of training, and Green Belts, who have also undergone formal training and are assigned to lead individual projects. In addition, team members also receive extensive training before being assigned to projects. Some organizations also have designated Champions whose role it is to manage and apply the Six Sigma process for specific operational groups.

The selection of projects is based upon their impact on the critical components of cost, delivery and quality of services. In other words, projects should improve the quality and delivery of products to clients, reduce the cost of doing business, improve processes that will save the organization and clients money, and promote a safer and amenable work environment. There are a variety of tools that are used to identify appropriate projects. The most important factor is to collect a suitable amount of baseline data in order to provide a clear understanding of the scope and endpoints of the process. Projects should not be selected by “putting the cart before the horse” and assuming a process needs improvement based on anecdotal information. A preliminary high-level functional mapping exercise can be used to efficiently identify processes which meet the criteria for project selection and minimize the potential for wasting time on projects that will have a minimal organizational impact.

Teams assigned to projects undergo a rigorous process of data collection, review and analysis. Although it is important not to get bogged down in minutia, extensive documentation of the process in question is needed to properly assess the interactions and variables that comprise the procedures. Using rudimentary statistics (e.g., linear regression ANOVA), the data sets are analyzed to identify the factors that have the most significant impact. These factors then receive the primary focus in the reengineering of the process. In some cases, projects have led to the simple elimination of steps that were done for years but added nothing to the process. However, in many instances significant changes in staff responsibilities, data systems, and communication channels are required.The changes recommended should only be implemented if the data shows a clear beneficial impact to the cost, delivery, or quality of services.

Proof is in the Pudding

Any scientist will tell you that data, correctly collected and applied, doesn’t lie and several analytical processes have showed significant quantifiable improvements in laboratory procedures and data reporting techniques. The keys to quality analytical services are efficient processes and error-free data. Applying the Six Sigma model to the testing process can facilitate tremendous improvements in key integral components of sample flow and the reporting of data.

For example, effective sample management and handling play a sometimes overlooked but highly significant role in analytical testing. This process includes maintaining a chain-of-custody for the samples, proper storage and labeling as well as preparation for testing. Although the process would seem quite straightforward, one such analysis found that several staff hours were spent meeting these requirements for each batch of samples. A rigorous functional examination of the process revealed the factors most influential to inefficiencies in the process. Through error reduction and streamlined procedures, the time was reduced to less than 10 minutes.

The data review process may vary depending on the reviewer’s experience and techniques as well as the type of data, manner in which the data are presented and the purpose of the study. The lack of an optimized and standardized process for analytical data review and approval results in an inconsistent and inefficient review process. The Six Sigma process employed to evaluate the data review process had an objective to modify the process in order to reduce the hours associated with the review and approval process. In addition to improvements in the functional aspects of the review process, the project elucidated the need for a protocol checkout system and standardized peer-reviewing training program. In the end, process improvements resulted in a reduction of the time for data review and approval by 50 percent, as well as in the design and implementation of an efficient and consistent data review process, which enhances the integrity and quality of the scientific data.

Some initiatives move outside the walls and become collaborative projects involving both the laboratory and client. For example, while conducting product release testing for GMP (good manufacturing practice) purposes, the rejection rate more than doubled at one point. By reviewing all of the variables including those on the client side, the cause was discovered and resolved. This resulted not only in drastically lower rejection rates, but increased throughput, thus allowing faster and higher quantities of product release. Integrating best practices between companies solidifies strategic partnerships and exemplifies pursuit for unparalleled client service.

Six Sigma focuses on the customer and improves processes enabling the delivery of higher quality services and a competitive edge in the marketplace. In addition to process improvements and customer service, Six Sigma projects can make the work environment safer and more conducive to productivity. Sooner or later, everyone in the organization should have some degree of exposure to Six Sigma which leads to personal and professional development. This way, Six Sigma becomes not just a quality program, but also a way of doing business; in some organizations, Six Sigma training is required for management positions.The foundation of the process is facilitating reduced variability and increased efficiency while eliminating non-value-added activities. All this leads to the ultimate goal of retaining and building relationships with clients for a mutually beneficial future.

Randall Smith is the Six Sigma Champion and Business Manager for Covance’s Chemistry Services unit; Timothy Rhines, Ph.D., is the associate director of the Covance Pharmaceutical Analysis group; and Richard Crowley is a senior science writer and editor of the Covance publications Food Science Newsletter and Evolution. Covance is a leading provider of chemistry and life sciences testing services for the pharmaceutical, dietary supplement, and food industries. For more information, visit: www.covance.com.