Managing for Continuous and Breakthrough Improvement

As a set of state-of-the-art tools for solving operations problems, Six Sigma can be used for both continuous and breakthrough improvement. What separates the two is the structure by which they are managed. When managers confuse the two types, the result is usually below-par performance. Even worse, such confusion could result in yet another dead-end quality program.

Continuous and Breakthrough Improvement

Continuous improvement is about many, small improvements initiated and implemented by anyone and everyone in the organization to improve the quality of their working processes and practices. Simplifying administrative processes by eliminating unnecessary copies, installing racks for organizing equipment in a more visual and orderly fashion, color-coding dossiers in a lab for easy identification are all examples of continuous improvement. It both reflects and creates a culture of quality.

Breakthrough improvement involves major improvements in key business areas. They are often chronic problems solved permanently through focused, dedicated resources working for a limited period of time. Due to the investments in time and attention required, breakthrough improvement projects are selected by a management group that typically acts as a steering group. The improvement goal is between 50 and 95 percent improvement in four to 12 months, depending on project scope. Usually the scope of inquiry crosses multiple functional boundaries. These are good opportunities for developing next-generation leaders, an equally important aspect of creating an enduring quality culture. Breakthrough improvement projects yield the highest economic return in the short- to medium-term.

In Six Sigma parlance, continuous improvement is done by Yellow Belts and White Belts trained in the basic DMAIC approach and tools. Black Belts are involved in breakthrough improvements. Depending on the project, Green Belts could be involved in both types of improvement. Design for Six Sigma projects are typically aiming for breakthroughs.

Guidelines for managing both continuous and breakthrough improvement are outlined in the figure below.

Two Management Approaches

The following examples of using Six Sigma for continuous and breakthrough improvements are from a medium-sized European pharmaceutical company.

Reducing Packaging Equipment Downtime

A pharmaceutical company began a restructuring process that included an investment of €20 million to create a Lean operations factory. After coping with the teething problems of starting up the new plant, the plant manager was confronted with yet another challenge: The mind-set of the employees in the organization had not changed. This was reflected in the fact that while raw materials and products could flow continuously from the granulation to the packaging of finished products, supervisors and operators followed old practices in running the equipment and managing time within their departments.

Six Sigma was chosen as the continuous improvement methodology to identify and solve the problems relating to continuous flow production. The first step was to coach packaging supervisors and operators in the application of the Six Sigma method, and thereby provide them with the tools to quantify the downtime problem, identify root causes, develop solutions and implement them.

The initiative started with a three-day team training project. It was designed to give participants an overview of Six Sigma, further refine the scope of their project and build cohesion among a group of people who were not accustomed to working in project teams. At first, there was resistance to the whole idea of measuring because operators saw it as a camouflaged step toward reducing their work freedom. However, what seemed to open their minds to measuring were the benefits (know-how and insight) to be gained by taking part in the Six Sigma teams.

The operators identified several potential root causes and succeeded in building a measurement system to document cause-and-effect relationships. By fixing chronic issues that irritated the operators, the maintenance engineering staff won the credibility of the operators. The project indicated to them that management was serious about improvement.

During a period of nine months, the company reduced unplanned downtime in packaging by identifying several critical problems – dust, lack of cooperation between packaging lines, incorrect machine calibration and lack of proactive maintenance. This situation called for a new common working culture. Measuring, analyzing and taking action to reduce downtime became part of an everyday practice.

All in all, the most durable benefit was the teamwork and leadership skills that were learned. The project not only succeeded in implementing proactive procedures for machine maintenance, but also created closer cooperation among technicians, operators and packaging lines. This increased operator responsibility and empowerment toward preventative maintenance – all improvements that control measures have validated as durable.

Solving a Chronic Yield Problem

For 15 years a pharmaceuticals manufacturer experienced variations in a production process that resulted in periodic batch failures. Everyone in the company had their own theories about the reasons why – the chemistry of particle sizes, humidity depending on the time of the year, equipment settings, etc.

The company used Six Sigma for breakthrough improvement to solve this chronic production problem. A group consisting of a quality manager, a cross-functional team of operators, lab technicians and process engineers started out by re-labeling every pet theory as a hypothesis and testing them against data. As it turned out, several favorite theories failed to stand up to the scrutiny of fact-based analysis.

The process led to interesting results, the breakthrough coming from the collective knowledge of the cross-functional team. Taking a closer look at the data on lost batches, the operators remarked that problems in content uniformity occurred at the same time as agglomerates in the base material. Also, the team found that the agglomerates had more than the expected amounts of flavor additive. Finally, the team concluded that the process of mixing flavor additives was one of the root causes for lumps resulting in too little vitamin D3 in some tablets. This gave the team a chance to develop and implement simple procedural changes for mixing in flavor additives.

Control measures are now in place to monitor other critical variables. Furthermore, this pointed to the need for a future project variation reduction project further upstream. Now, more than ever before, there are frequent fact-based discussions between functions and levels in the organization working together to improve production yields.

The company succeeded in reducing batch failures from a yearly average of 12 to two, and is on its way to eliminating them entirely. By approaching the problems with fact-based analytical tools, the company improved the production process to the extent that the company generated net savings of nearly €500,000 per year. As it improved the uniformity of content, the company set off a positive chain reaction affecting downstream operations of tablet compression and packaging.