Business Considerations - Fundamentals of Industrial Chemistry: Pharmaceuticals, Polymers, and Business - page 66

and the role they are expected to play. For example, Six Sigma Black Belts
[5] should be technically oriented highly regarded individuals who work
to extract knowledge from the organization. They might receive three to
six weeks of training. Green Belts are project leaders capable of forming
and facilitating teams and might receive a week of training. They are often
advised by Black Belts.
As the DMAIC process is followed, it is important that a phase be com-
pleted before the next phase commences. It does not make sense to embark
upon the measurement phase prior to having a clear definition of what is
important. This can be done informally or by a formal “gate” mechanism
where the project cannot proceed to the next phase until it undergoes a gate
review.
Lean is an effort to improve efficiency by removing tasks that do not add
value. When it was implemented at GE, it was called “work out” because the
focus was to get rid of unnecessary work. Even seemingly little things like
filling out time cards or writing reports can take time away from efforts that
add value to the customer. By eliminating unimportant tasks, process steps,
reports, reviews and other practices, the organization can focus on work that
adds value, be more efficient and be more agile. Lean requires you to know
what is important and eliminate the unimportant. The implementation of Lean
delivers speed and low cost. The use of Six Sigma techniques in a focused
effort to reduce wasted efforts is called Lean Six Sigma.
These techniques can be used throughout an organization or in smaller
pieces such as a particular chemical process. For example Lean Six Sigma
has been used to improve a selenium analysis [6] and showed the importance
of improving the digestion of the sample.
6.3 STAGE-GATE™
There is never enough time and resources to pursue everything to comple-
tion. Also why would you want to? Most projects fail. In the chapter on the
pharmaceutical industry, we discuss the failure rates. For drug candidates
that enter Phase 1 testing, there is less than a 12% success rate. Even those
entering Phase 3, have a success rate around 50% [7]. Think about what this
means. After 10 - 15 years and perhaps $1 billion in costs, you still fail half
the time. Failure is not peculiar to the pharmaceutical industry, but is com-
mon in all new product research. Yet we need to introduce new products to
remain competitive. The key is being prudent about which projects to pursue
and which ones to shut down. As an analogy, if you are driving or hiking
somewhere new to you and take a wrong turn, the sooner you recognize it
and turn back, the less time and energy you have lost and the less time to