Presented by:

Ronak Parmar
B Pharm Final Year

Guided By:
Dr. Ravindra R.P
Professor
Department of
Pharmaceutics

CONTENTS
Introduction
History

Methodology
Control Charts

Application

Introduction

Six Sigma
Your first question is likely.
What is Six Sigma?
Your second question is likely
Why Six Sigma?

What is Six Sigma?

Six Sigma can be defined as a rigorous and
disciplined methodology that utilizes data and
statistical analysis to measure and improve a
companys operational performance, practices and
systems.
Six Sigma identifies and prevents defects in
manufacturing and service-related processes.

Whats in a name?

refers
to the highest
possible score on the
scale (0 being the
lowest score), this
would be a defect
score of 0.34% and an
on-time score of
99.966%

comes
from statistics and means the
measurement of variance.
Mainly Six Sigma is about
measuring defects (quality)
and production time. There is
a statistical scale for
measuring this.

Why Six Sigma?

To deal with a world of declining product prices
To compete successfully with the best companies in

the world, for that need to accelerate our rate of

improvement of quality and productivity faster than
our competitors
To establish standard language and approaches across
functions and across businesses
To develop the next generation of leaders

History of Six Sigma

Six Sigma is originally developed by Motorola, USA in

1986.
The key person in inventing Six Sigma concept
in Motorola is Bill Smith
Bill Smith is recognized as "The father of Six Sigma"
for his great contribution to the quality's evolution
journey.

Methods of Six Sigma

Six Sigma projects follow two project methodologies.
These methodologies, composed of five phases each,

bear the acronyms DMAIC and DMADV.

DMAIC is used for projects aimed at improving an
existing business process.
DMADV is used for projects aimed at creating new
product or process designs.

Six Sigma Control Charts

The chart that is used to display the upper and lower control

limits, the centerline, and the data points is called a control

chart.
Control charts monitor processes to show how the process is
performing and how the process and capabilities are affected by
changes to the process.
Control charts show if a process is in control or out of control.
They show the variance of the output of a process over time, such
as a measurement of width, length or temperature.
Control charts compare this variance against upper and lower
limits to see if it fits within the expected, specific, predictable
and normal variation levels.

Types of Control Charts

There are two main categories of Control Charts, those that display attribute

data, and those that display variables data.

Attribute data: is used to describe data that happens at discrete events during
the project lifecycle.
Variable data: encompasses measurements of a process that is occurring
nearly all the time.
These two categories encompass a number of different types of Control
Charts , there are three types that will work for the majority of the data
analysis cases you will encounter.
X-Bar and R Chart
X Moving R Chart
X-Bar and S Chart

 Selection Flowchart:

Selection of Control Chart

Application in Pharmaceutical
Industry
Companies will partner with MCO's and/or physicians for

patient data
Integration will be imperative between customer facing
technology and the supply chain
Factories will be product specific - traditional, mass customized
and targeted products
Process compliance will be measured and driven to new levels of
performance
Use of six sigma principles effectively to reduce cycle time for the
pilot plant and drug manufacturing process.
How to implement Design of Experiments into ones robustness
tests
How would one implement Six Sigma into a sterile
manufacturing environment

List of companies claim to have successfully

implemented Six Sigma in some form or another: