4. Improve: Determine the root causes and establish methods to control them.
5. Control: Monitor and make sure the problem does not come back.
Within each DMAIC phase, there is a set of deliverables that must be completed to ensure all project requirements are met.
A summary of the deliverables and typical activities for each phase of the DMAIC process is shown in Table 1.
Looking closely at the tools within the DMAIC methodology reveals elements that have been part of the quality toolkit since
its inception. Cause and effect diagrams, Failure Mode and Effects Analysis (FMEA), and process capability analysis, among
others, have been used broadly by process and quality engineers in multiple industries for years. What separates the DMAIC
roadmap from the isolated application of these individual tools is the methodology around the application of the tools. In
DMAIC, the process evaluation is based on the objective acquisition and analysis of data, in lieu of representative testing
and inference.
LEAN MANUFACTURING
Although Six Sigma and the DMAIC toolkit focused on eliminating process variability, there still remained the need to bring
products to market faster and more cheaply. As a result, the biopharmaceutical industry has turned to the principles of Lean
Manufacturing to increase the efficiency of our processes. The ideas of Lean Manufacturing are based on the Toyota Production
System approach of eliminating waste in every aspect of a company's operation. Lean focuses on time variability, in contrast
to Six Sigma's focus on process variability. In their book Lean Thinking, Jim Womack and Daniel Jones7 recast the principles of Lean into five principles:
1. Value: Every company needs to understand the value customers place on their products and services. It is this value that determines
how much money the customer is willing to pay for them. This analysis leads to a top-down, target-costing approach that has
been used by Toyota and others for many years. Target costing focuses on what the customer is willing to pay for certain products,
features, and services. From this, the required cost of these products and services can be determined. It is the company's
job to eliminate waste and cost from the business processes so that the customer's price can be achieved at great profit to
the company. In the biopharmaceutical and pharmaceutical world, value is often associated with quality and data, rather than
with standard cost.
2. Value Stream: The value stream is the entire flow of a product's lifecycle, from the origin of the raw materials used to make the product
through to the customer's cost of using, and ultimately disposing of, the product. Only by studying and obtaining a clear
understanding of the value stream (including its value-added and waste) can a company truly understand the waste associated
with the manufacture and delivery of a product or service.
3. Flow: One significant key to the elimination of waste is flow. If the value chain stops moving forward for any reason, then waste
occurs. The trick is to create a value stream in which the product (or its raw materials, components, or sub-assemblies) never
stops in the production process, because each aspect of production and delivery is in harmony with the other elements. Carefully
designed flow across the entire value chain will minimize waste and increase value to the customer. Achieving this kind of
flow is a challenge in our industry because many of our processes are batch processes. Even so, within the context of the
total value stream, there are significant opportunities to move towards continuous flow.
4. Pull: A traditional Western manufacturer uses a style of production planning and control whereby production is "pushed" through
the factory based upon a forecast and a schedule. A pull approach dictates that we do not make anything until the customer
orders it. To achieve this requires great flexibility and very short cycle times of design, production, and delivery of the
products and services. It also requires a mechanism for informing each step in the value chain what is required of them today,
based on customers' needs.
5. Perfection: A lean manufacturer sets perfection as a target. The idea of total quality management is to systematically and continuously
remove the root causes of poor quality from the production processes so that the plant and its products move toward perfection.
This relentless pursuit of the perfect is the key attitude of an organization that is "going for lean."
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