As an organization implements Six Sigma thinking, it needs to restructure how it approaches quality. These changes impact everyone and change the way business is managed.

Six Sigma management can be broken down into several different areas. These include the management of a Six Sigma initiative, the management of projects within the Six Sigma initiative and the management of everyday business activities during a Six Sigma initiative.

Within this latter topic, the activities of the quality department are critical for success and need to be examined carefully. In a Six Sigma organization, the quality department cannot continue to function using the traditional approach to quality. So what is the new role of the quality department and quality manager?

Two Views: Customer vs. Process

Quality of products provided much of the motivation for Motorola to initiate the work that launched the Six Sigma movement.

Before the implementation of Six Sigma, most companies were created with traditional quality departments. This traditional structure emphasized the customer view of quality. Quality’s activities included inspection of incoming raw materials using acceptance sampling techniques, inspection of product quality during production, inspection of quality of finished product prior to shipment to the customer, and making decisions regarding the dispensation of product and approval of the use of product that did not meet all requirements.

These activities were driven by a company’s desire to ensure that all products met the customer requirements. This approach to quality kept the focus on checking product for conformance to specifications. Unfortunately, in this traditional model, responsibility for ensuring quality of the product resided in the quality department rather than with production.

Manufacturing made the product and tried to get quality to “pass” it, allowing shipment to the customer. Thus the traditional quality department is a product- or output-focused entity and, by the nature of the organizational structure that creates silos between departments, is in conflict with manufacturing.

With the launch of a Six Sigma initiative, the focus changed to reducing defects in an organization’s products and services by improving the processes that create the products and services vs. inspecting the products. This process view for ensuring quality shifts the responsibility from the quality department to production.

As this shift is made, traditional activities of the quality department become redundant. Production now uses control and response plans to monitor the processes. Control plans include data collection and charting of key process measures to know how each process behaves. Response plans include the details of how to respond to signals from the process behavior charts, also known as Shewhart’s control charts.

Process response plans are based on process behavior. If a signal of exceptional variation (assignable cause) shows on the process behavior chart, the response plan has the specific instructions for taking action. Actions are specific to the process, not to the product.

After the process is once again predictable, that is in control and exceptional variation has been removed, the organization must face the issue of what to do about product produced at or around the time of the process signal.

Quality personnel should be designed to work with production on disposition of this product. Because quality brings the customer view to the table, they are in a good position to represent the needs of the customer in making these difficult decisions. Their experience in product evaluation is useful and essential in making these decisions.

Quality’s new role

With the shift to improving processes and maintaining the improvements through control and response plans, what is quality’s role in a Six Sigma company? If quality will no longer be focused on inspecting and approving product during production, what will be its major activities? Let’s start with the strategic level and continuing down to the product level.

  • Strategic activities. Strategic quality work begins with an understanding of where the company and its products fit in the marketplace. The vice president of quality or the quality manager must join top management in setting the strategic direction of the company. Quality should team with marketing and sales to conduct market studies, as well as purchase company and competitor products for analysis and benchmarking.


    • From the benchmarking studies, quality can then assist in the development of critical-to-quality product characteristics (CTQs). These CTQs will determine the priorities for future Six Sigma projects, as well as the measures operation uses for process control.

    The quality department should help select Six Sigma improvement projects. Quality should analyze customer feedback information including complaint data as well as customer survey data. By helping the organization focus on issues of most importance to the customer, quality keeps the focus on critical to customer issues.

  • Operations or production level activities. At the operations or production level, the quality department partners with production to ensure that all critical-to-quality characteristics of the product are supported by process and intermediate product measures. For example, the motors used to power equipment in a hospital intensive care unit must operate with a very low amount of mechanical noise. Thus, mechanical noise is a CTQ that must meet the customer requirements.

    During production of the motors, multiple process and intermediate product measures of the motor components should be monitored by operations to ensure the end product meets the mechanical noise requirements.

    Monitoring process measures and intermediate product measures is the responsibility of production or operations. The quality technicians who previously performed inspections to approve product will now concentrate on assisting in the setup and use of the process and intermediate product measures. Where audits were of product, they will now be audits of the quality process. Quality people watch how the production department is using the control system to ensure it is done in a thorough and professional manner.

    This work begins with selecting the measures to monitor and setting up data collection plans. In many situations, measures will already be identified through previously completed Six Sigma projects. Where Six Sigma projects have not been done, quality personnel should assist operations to set up control and response plans similar to those from the control phase of a Six Sigma project. As responses are done, they are documented in the process behavior tracking system. Quality monitors this process to ensure that the standard operating procedures are being followed.

    Quality personnel can participate in training operations on how to use the control and response plans. This includes instruction on how to collect the data, including making measurements where required, and then entering the data on a process behavior chart.

    At this stage process behavior charts are critical. The correct use of process behavior charts by operations personnel with assistance from quality will ensure that detrimental process changes are caught and fixed as quickly as possible with little impact on the product quality.

    Quality also can help ensure that process changes indicating an improvement in the process can be observed and thereby apply lessons learned. When this happens, quality and operations must work together to ensure that the process improvements are made part of the standard operating procedures and thus will lead to corresponding product improvements.


Company assessment

As an organization moves to a data-driven, strategic Six Sigma organization, changes are needed. The following questions will help determine whether the correct changes have been made in the quality department’s role or how an organization needs to adjust to the new approaches demanded by Six Sigma thinking.

  • Is someone held responsible for quality in the organization? If so, who and what is his current responsibility? Is it production, operations or quality?


  • Has the role of quality changed to match the needs of a Six Sigma organization? Process vs. product focus. If so, how?


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  • Have product quality decisions that allow exceptions to specifications been discontinued? If so, what controls are in place to handle such requests for exceptions?


  • Does the organization prevent individuals from approving shipments of unacceptable product? If so, what policies are in place to prevent this from happening?


  • Has the organization discontinued AQL inspections? If so, how is incoming and outgoing quality ensured?


  • Does the organization use control and response plans? If so, how are they created and used?


  • Do operational definitions exist for all measures? If so, how are they created and used?


  • Are data collection plans in place to support process monitoring? If so, how are they created and used?


  • Does quality participate at a strategic level, helping to establish, set and achieve business strategy? If so, what is the result?


  • Does quality help in selecting improvement projects, such as Six Sigma projects? If so, what does their role contribute?


If the answer was “no” to three or more of these questions, it is time to reconsider the role the quality department is currently playing in Six Sigma implementation.

Next Steps

Based on the answers to the assessment, what actions are now required to evolve the role of the quality department to support and sustain implementation of Six Sigma?

Review the changes that need to take place in the organization and the impact this may have on strategic goals and objectives. For each question with a “no” answer, determine what actions are necessary to change the answer to “yes.”

Some of these actions may require outside expertise where experience and knowledge can help accelerate the transition to a more strategically-functioning quality department and to optimize the results to the organization as a whole. 

After all, Six Sigma is about achieving results-bottom-line profitability, top-line growth and increased customer satisfaction-and the new role of the quality department ultimately must contribute to the success of a Six Sigma implementation.

Tech Tips

  • The role of quality is restructured as Six Sigma is implemented.

  • Strategic quality work begins with an understanding of where the company and its products fit in the marketplace.

  • At the operations or production level, the quality department partners with production to ensure that all critical-to-quality characteristics of the product are supported by process and intermediate product measures.