IMPACT OF SIX SIGMA IN QUALITY MANAGEMENT SYSTEM

Presented by:Ronak Parmar B Pharm Final Year

Guided By:Dr. Ravindra R.PProfessorDepartment of Pharmaceutics

CONTENTSIntroductionHistoryMethodologyControl ChartsApplication

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 company’s operational performance, practices and systems.

Six Sigma identifies and prevents defects in manufacturing and service-related processes.

What’s 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 SigmaSix Sigma is originally developed by 

Motorola, USA in 1986.The key person in inventing Six Sigma

concept in Motorola is Bill SmithBill 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 ChartsThe 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 ChartsThere 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 ChartX Moving R ChartX-Bar and S Chart

Selection of Control Chart

Selection Flowchart:

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

patient data Integration will be imperative between customer facing

technology and the supply chainFactories will be product specific - traditional, mass customized

and targeted productsProcess compliance will be measured and driven to new levels

of performanceUse of six sigma principles effectively to reduce cycle time for

the pilot plant and drug manufacturing process.How to implement Design of Experiments into one’s robustness

testsHow 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:

ThankYou