Black Belt Not Required

By Penelope Przekop, Johnson & Johnson Pharmaceuticals"High-level support is critical for successful implementation of Six Sigma." As middle managers, we hear this message at every conference we attend. We read it in the current business literature. We attend the conferences and read the books because we care about quality and want to make a difference.Yet we also hear that quality should not be a program or a special initiative, or the province of an elite. It's time to dispel the myth that middle management is helpless without high-level support. We can, in fact, infuse Six Sigma concepts into our world.The first step in achieving this goal is to begin thinking about managing quality from a more personal perspective. Let's forget about the entire company for a while and focus on our responsibilities, our scope. We must strive to bring Six Sigma into the trenches where the work is done, the ideas are born, and the bottom line is supported. The truth is that the concepts at the heart of Six Sigma and most other quality philosophies can be applied to any scope of work - from the smallest to the largest. They can be applied whether you only manage yourself or oversee fifty , This is your organization. Choose how you will manage it.Six SigmaIn statistics, the lowercase Greek letter sigma is the symbol for standard deviation, which describes the degree of variation in a dataset, a group of items, or a process. A six sigma level of quality means that there are less than 3.4 defects, or deviations from the standard, per million units produced. It is a technical measure of customer satisfaction. A unit can be any product or service, or your job's deliverables. The principles of Six Sigma can be applied to many different situations. Consider geltabs as an example. If, in a sample of 100 geltabs, 5 defects were found, that would mean 0.05 or 5% defects, or that 95% of units were acceptable. According to the Sigma Conversion Table, this percentage of acceptable units falls between a Sigma level of 3 and 4. At a 3 sigma, you can expect 66,807 defects per one million geltabs and at a 4 Sigma you can expect 6,210 defects per one million geltabs.The management philosophy that has grown up around six sigma measurement focuses on customer satisfaction, management by data, and process improvement. Customer satisfaction is the key determinant of quality. If a product satisfies the customer or meets his or her specifications, then it is acceptable. Otherwise it is defective in some way. To define the quality of any product, one must fully understand one's customer's needs and specifications. For all pharmaceutical company employees, the ultimate customer is the patient taking the medicines it manufactures. For managers, though, "the customer" can also be the manager they report to, and "the products," the deliverables required. Create a Personal Management Framework using Six Sigma ConceptsTo make a conscious decision about how you will manage your own organization, you'll need to adopt a personal management framework to guide decisions. You'll need to have a clear understanding of the following basic concepts: Process Focus
As managers, we can ensure that the processes that fall within our scope are documented, communicated, measured, and continuously improved as time goes on. In order to focus on process improvement, identify the core processes for which you are responsible. Basically, what do you get paid to do? The easiest way to identify your core processes is to identify your outputs or deliverables, not those of your broader organization. Within the scope of your work, the outputs are defined as anything that you or your direct reports are responsible to deliver to someone else or another group ("the customer."). Each output should have an associated process that defines how it is generated. This is your core process, and it's distinct from support processes. Unlike core processes, support processes enable the successful delivery of the outputs. Examples include information systems, budgeting and staff recruitment and hiring. A strong focus on process requires that you evaluate your own core processes and those of your reports on an ongoing basis, a daunting task when time and resources are limited. It's easy to fall into the habit of focusing, instead, on "on-time delivery." However, if you shift your focus to the underlying process, you will reap the benefits of removing inefficiencies while improving quality. Don't expect to be able to do this all at once. Sometimes, this process may require a temporary "slowdown" period, during which you reevaluate what you're doing, why you're doing it and what it means for your customers. The DMAIC CycleSix Sigma process improvements are driven by the DMAIC cycle, short for Define, Measure, Analyze, Implement and Control. In traditional Six Sigma programs driven by top management directives, Six Sigma champions and black belts work closely with functional managers to understand, improve and maintain successful processes using Six Sigma tools. However, self-empowered managers can follow the same directive, as shown below. Customer FocusSix Sigma is all about the customer. Each person or group who accepts an output from you is your personal customer. Customer focus requires that you strive to understand their specifications or needs, constantly. Attitude is key! When you understand that your job is to deliver the most accurate rendition of what the customer desires, working relationships become more positive, collaboration improves, and barriers and silos begin to break down because goals start to merge. Business and process decisions should always tie back to customer needs, and each step of any process should always add value for your customer. For example, if your team is filing a particular Quality Assurance form in two places , why are they doing this? Is this a value added activity? Does it benefit the customer? To ask these questions, you must have a clear understanding of who your customers are and you must talk to them. CollaborationThe Six Sigma philosophy calls for collaboration to expose processes fully. Only through collaboration can managers determine if their piece of a larger process is meeting customer requirements. If you are willing to collaborate with customers and suppliers, you'll find they have many ideas that can help you add value to your core processes. Management by metrics
In Six Sigma, since decisions are based on data and facts, it is essential to collect and evaluate appropriate metrics. Any measurement that helps managers understand its processes and operations is a potential business metric. Some examples are: number of units completed per hour, percent defects or errors from a process, and hours required to deliver a certain number of units. You can begin the process of managing by data by identifying deliverables and understanding what the customer values. Managers can track value-added metrics to ensure that customer needs are being met and to support decisions about processes, people, and projects. You should learn about and use standard Six Sigma tools such as Pareto charts, histograms, control charts, and flowcharts as appropriate (For a list of good references, see p. TK). Many of these tools have been around for a while and are fairly easy to use. If deliverables are measured in ways that are meaningful to both you and your customer, discussions can be rooted in fact and proper decisions made by both parties. Don't underestimate the power of numbers coupled with excellent customer focus. When determining which metrics add value, managers should first consider the amount of time it will take to record and analyze the metrics relative to the value that the exercise will add. The general rule: "keep it simple." Strategic planningYou can strategically plan activities that ensure data-supported quality deliverables. If you cannot personally roll out Six Sigma to your entire organization with the aid of your CEO and his team, you can begin to embrace these concepts, and incorporate them into your day-to-day work. Once committed, you will need to develop a strategy for how you can introduce this new focus on the Six Sigma to your direct reports, your own organization. The ease of determining the value of a metrics increases with your understanding of the outcome they are working toward. To create a strategy, goals must be clearly defined and understood. Understanding the big picture, the vision, is critical to determining what metrics are important to track and which are not. There should be a reason why someone is spending time to record and analyze metrics. The purpose may be to:

• show that a new process is superior to the old
• ensure that customer specifications are met
• test several approaches and determine which is best or access productivity

There are numerous reasons why particular metrics are useful, but if you do not clearly understand the desired outcome, you will risk wasting valuable time.

Strive to Increase Understanding
We cannot manage what we do not understand. This holds true for management of people, projects, and processes. Many managers believe that they can be successful, that they have gained the right to manage, based on their keen technical knowledge.

However, it takes much more then an excellent understanding of cGMPs, a particular pharmaceutical product, or the intricate details of specialized equipment to rise above the management crowd. Managers, at all levels, who move ahead, end up with topnotch CVs, and please senior management, consistently strive to understand the motivations of those whom they manage, the specific needs of their customers, and the processes that ultimately provide these people satisfaction.

As a manager, whatever your level, you can use Six Sigma concepts and tools to improve performance. By doing so, over time, you'll improve your organization's quality from the inside out rather than the outside in. Then, if upper management gets the message, and starts a formal Six Sigma program, you'll be able to collaborate more effectively with the black belts.

In his book, The Six Sigma Way, Peter Pande tells us that a real Six Sigma organization is one that has taken up the challenge of measuring and improving all processes, with the objective of creating a culture of continuous improvement. Simply using Six Sigma measures or a few tools does not qualify a company to be a "Six Sigma Organization."

However, if you and your direct reports are an "organization," Six Sigma concepts and tools can be incorporated into your management framework. As managers, we are tasked with managing, whether it is people or projects. In the end, there must be an outcome, an output that we are responsible to pass to the next fellow or group or organization. Let's take responsibility rather than wait for high-level support.

About the Author
Penelope Przekop directs the Global Quality Management function for the Benefit-Risk Management Organization within the Johnson & Johnson Pharmaceuticals Group. She has held quality management positions of increasing responsibility at several major pharmaceutical companies including Hoechst Celanese, Novartis, and Wyeth, and also Covance, a Contract Research Organization. She is currently writing a book related to this article topic for McGraw-Hill, scheduled for publication in 2005.


Suggested Reading

Eckes, G., "Six Sigma for Everyone," John Wiley & Sons, Inc., 2003.

Pande, P., "The Six Sigma Way," McGraw-Hill, 2000.

Brue, G., "Six Sigma for Managers," McGraw-Hill, 2002.