Qms (6 sigma concepts) six sigma concept

Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
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Si x sigma concepts.
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Aim of 6 sigma concepts.
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Process of 6 sigma concepts.

1. B.PHARM. VII-SEMESTER
BP 702 T.
INDUSTRIAL PHARMACY-II (Theory)

2. QUALITY MANAGEMENT SYSTEMS
Dr. Ajay K. , Maharishi Arvind College of Pharmacy, Jaipur

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LEARNING OBJECTIVES
After completing this presentation, you will be able to understand:
Six sigma concepts.
Aim of 6 sigma concepts.
Process of 6 sigma concepts.
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SIX SIGMA CONCEPTS

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Six sigma concepts are a principle for the process improvement.
Six sigma represents the quality level, implemented for reducing
the operational costs in pharmaceutical industry and serving the
best customer satisfaction and services.
Six sigma is symbolized as “6σ”.
Six sigma is a statistical measurement of product variables.
This concept helps to achieve stable and predictable process
resultswith continuous quality improvement.
SIX SIGMA CONCEPTS

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1. Process improvement
2. Improved methodology
3. Improved quality
4. Customer satisfaction
5. Reduction in process variation
6. Reduction in costs
7. Fewer defects to achieve the goal
8. Continuous quality improvement
SIX SIGMA CONCEPTS
: Aim

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The concept is designed in “DMAIC” process.
DMAICstands for
Define
Measure
Analyze
Improve and
Control
SIX SIGMA CONCEPTS
: Process

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SIX SIGMA CONCEPTS
: Process

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SIX SIGMA CONCEPTS
: Process

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SIX SIGMA CONCEPTS
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First and most difficult step of six sigma
approach.
The basic aim of this step is defining the
problemsand objectives.
‘Define’ explainsproject goal, aim,
difficulties, target magnitude and time span
to achieve the improved process.
SIX SIGMA CONCEPTS
: Process

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SIX SIGMA CONCEPTS
: Process
process of collecting expected future data.
The data
will help to understand the magnitude of
improvement and
will answer either the expected
improvement can be measured or not.
The data is not necessarily quantitative.

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SIX SIGMA CONCEPTS
: Process
The analysis of the whole process and helps
to understand the factors of influence.
This is nothing but the analysis of raw data
to establish a correlation between input
variablesand the possible output that
implies critical quality attributes (CQAs).

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SIX SIGMA CONCEPTS
: Process
improvement of the process that has been
outlined in the define step to achieve the
expected outcome and result.
The principles, specifications and process
outflow selected in the first step should be
improved and incorporated in the lifecycle
with fewer defects.

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SIX SIGMA CONCEPTS
: Process
The improvement done in the last step
should be retained and
additional procedures may be included in the
workflow.

16. B.PHARM. VII-SEMESTER BP 702 T. INDUSTRIAL PHARMACY-II (Theory)
DR. AJAY K. TIWARI, ASSOCIATE PROFESSOR
MAHARISHI ARVIND COLLEGE OF PHARMACY, JAIPUR (RAJ.)
[email protected] WHATSAPP: [phone]
To be continued...