SIX SIGMA

David Plaut

Six sigma (6- sigma), as is true for any process improvement system, seeks to
improve the quality of outputs by identifying and removing the causes of defects
(errors) and minimizing variability in the processes.

In a nutshell, six sigma (6-sigma) can be discussed at three levels: as a

management system, as a methodology, and as a metric (a statistic).

As management system, consider 6-sigma as another in a long series of

approaches to improving almost any process. Similar to 6-sigma are zero defects,
continuous quality improvement (CQI), total quality improvement (TQI) and to an
extent, LEAN. These names all suggest a common goal: improvement in a process
or processes. Each 6- Sigma project is supported by a team with defined
responsibilities and follows a defined sequence of steps and has quantified
targets.

As a methodology we can consider the following as vital ingredients in achieving

the statistical goal of 6-sigma:

 Understanding and managing customer requirements

 Aligning key business processes to achieve those requirements

 Utilizing rigorous data analysis to minimize variation in those

processes

 Driving rapid and sustainable improvement to business processes

The third level, 6-sigma as a metric, is the source of the name 6- sigma. 6-
sigma refers to 3.4 defects per one million opportunities (DPMO). 6- sigma started
as a defect reduction effort (as in zero defects) in manufacturing and was then
applied to other processes for the same purpose – quality improvement. A 6- sigma
project will use management, methods and metrics at the same time.
The metric as something with which you are all familiar – for 6- sigma refers to the
Gaussian (bell, normal) curve.

As you see in the figure, very little of the area under the curve is to the right or left
of 3 sigmas (the values in the table below the curve are the areas (in per centage)
between the + and – number. For example about 68% of the area is between -1
and + 1 SD (sigmas). Virtually none of the curve lies beyond even 4 sigma.

Lower specification level Upper specification level

1 2 3 4 5 6

68.3% 95.4 99.73 99.99 99.9999 99.9999998

Over time there has been, necessarily, less emphasis on achieving the literal
definition of 6- sigma with ‘only’ 3.4 defects per million opportunities (DPMO).
Today the emphasis is more on the idea of process improvement or continuing
process improvement beginning with an understanding of the requirements of
the end user. Some examples of 6-sigma projects are: turnaround time for
cardiac marker results for the ED, the number of contaminated blood cultures,
and improper patient identification.

Once the requirement is defined to the satisfaction of the 6-sigma team (e.g.
doctors, laboratory staff, nursing staff, and phlebotomists), an agreement on what
data need be collected and analyzed is established. Then a protocol is developed
to measure the number of ‘defects.’ In the case of the turnaround time in the ED,
the requirement might be a time from sample collection to a report to the ED of
less than 60 minutes. Thus any sample that took more than 60 minutes to report
is a defect. If this happens once for every 100 samples the defect rate is 1% or 2.4
sigma. In order to achieve a 4 sigma success rate only 1 in 10 000 samples would
take longer than 60 minutes to turn around. From this it is obvious why the
emphasis cannot be on 6 sigma for every process in the clinical laboratory. While
6-sigma may not be possible (for any number of reasons), does not mean that a
process improvement using a sigma metric cannot be undertaken. In any process
improvement, it is necessary to know from where you start and where you want
to go -- a goal must be set. In other words where is the process now in terms of
DPMO and where do we want to be at the end of the process improvement?

While 3.4 defects per million opportunities might work well for certain
products or processes, it might not operate optimally or cost-effectively for
others. A patient identification process might need higher standards, for
example, than a 6-sigma goal on blood glucose levels (where the existing
sigma is about 3 if mostly due to instrumentation which cannot do better).
The basis and justification for choosing 6 (as opposed to 5 or 7, for
example) as the number of standard deviations is not clearly explained.
This is related to the idea that 6-sigma as a goal is cast in stone. It could
be argued that the process improvement goal take into consideration the
needs of the user rather than an arbitrary 6-sigma.

6- sigma has not met without some criticism. A Fortune article stated that
"of 58 large companies that have announced 6- Sigma programs, 91
percent have trailed the S&P 500 since". The reason for this is perhaps that
6- Sigma is effective at what it is intended to do, but that it is "narrowly
designed to fix an existing process" and does not help in "coming up with
new products or disruptive technologies." Many of these claims have been
argued as being in error or ill-informed.

A BusinessWeek article stated that the introduction of 6- sigma at 3M may

have had the effect of stifling creativity. It cites two Wharton School
professors who say that 6- sigma leads to incremental innovation at the
expense of blue-sky work. This phenomenon is further explored in the
book, Going Lean, which provides data to show that Ford's "6 Sigma"
program did little to change its fortunes.

In addition, the 6- sigma model assumes that the process data always
conform to the normal distribution. The calculation of defect rates for
situations where the normal distribution model does not apply is not
properly addressed in the current 6- sigma literature.

Because 6-sigma centers on change, fear of change is an important topic to

discuss in the meetings on how to perform the study and how to implement it. It
as been my experience in talking about changing QC rules that fear of change or
related to it (if not just another way of showing fear of change) is the remark “We
have always done it this way. It must work.” Something may appear to work
(“We don’t fail proficiency surveys.) but not in every sense. There may be other
criteria against which ‘work’ might be defined. In the case of QC the number of
false rejects approaches 10%. These are things that need to be carefully
considered as 6-sigma (or whatever name you want to use for process
improvement) is brought up.

There are few if any processes that cannot be improved. 6-sigma is one approach
which has been shown to work, but which is not without its critics. Perhaps an
eclectic approach to process improvement might be a way to incorporate parts of
many of these ideas based on your needs and resources.
(Author’s note: I have prepared a bibliography with references to 6-sigma as well as other systems for
improving processes. I will send a copy to you by e mail if you send me a note at
davidplaut@yahoo.com)