Black Belt Not Required

PharmaManufacturing.com

Don't wait for top management support -- improve quality from the inside out by applying Six Sigma in your everyday work. The first step in achieving this goal is to begin thinking about managing quality from a more personal perspective.

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 Sigma
In 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 Concepts
To 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 Cycle
Six 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 Focus