Six-Sigma Concept in Quality management.pptx

Six-Sigma
Concept in
Quality
Management
Presented by
Krish Lakhera
• 8 April 2025

Six Sigma
Content
Introduction
Methodologie
s
Tools/
Software
Applications
and
Demerits
Objectives
Presentation Title
2

3
Introduction
 The term Six Sigma refers to a set of
quality control tools that business can
use to eliminate defects and improve
process to help boost their profits.
 It is a statistical term signifying 3.4
defects per million opportunities
(DPMO).
 Origin: Introduced by Motorola in the
1980s, later adopted by companies like
GE and pharmaceutical industries.
 Goal: Achieve near-perfect processes
with only 3.4 defects per million
opportunities (DPMO).
Six Sigma

4
Objective
 Improve Process Quality
Reduce defects and errors in processes to ensure high-quality outputs.
 Enhance Customer Satisfaction
Deliver consistent, reliable products or services that meet or exceed customer
expectations.
 Reduce Process Variation
Standardize operations by minimizing variability to make processes more
predictable.
 Increase Efficiency and Productivity
Streamline workflows, eliminate waste, and improve the overall performance of
processes.
 Lower Operational Costs
Identify and remove non-value-added activities to reduce costs and increase
profitability.
 Support Data-Driven Decision Making
Use statistical tools and data analysis to guide problem-solving and improvements.
 Promote Continuous Improvement
Foster a culture of ongoing improvement and innovation across all levels of
the organization.

Six Sigma
Distribution Curve
and Levels

Six sigma 6
DMAIC DMADV
It is the more
well-known and
most-used LSS
project method.
DMAIC focuses
on improving an
existing process
by incorporating
the phases
It is focused on
the process of
designing a new
product, service
or process,
incorporating
the phases
Methodologies

Presentation title 7
Phases
Define
Establish the
goals and
customer
requirements for
the new process,
product, or
service
Measure
Determine the
critical-to-quality
characteristics
and
performance
metrics
Analyze
Develop and
evaluate design
alternatives to
meet the CTQs
Design
Implement and
test solutions to
address the root
causes and
enhance
process
performance.
Verify
Monitor and
maintain the
improved
process to
ensure long-term
stability and
sustainability

Phases
Define
Establish the
goals and
customer
requirements for
the new process,
product, or
service
Measure
Determine the
critical-to-quality
characteristics
and
performance
metrics
Analyze
Develop and
evaluate design
alternatives to
meet the CTQs
Design
Select the best
design
alternative and
develop detailed
design plans
Verify
Test and validate
the design to
ensure it meets
customer
requirements and
performance
goals.

9
When to Use DMAIC DMAIC Example
 DMAIC: Process
for Improvement
• Use DMAIC when a
product has already
been released or a
process already exists
but there are problems
that you want to
improve.
• To boost customer
satisfaction, a call
center might
implement DMAIC to
define what factors,
such as wait times and
staff education, are
causing problems for
customers.
When to Use DMADV DMADV Example
 DMADV:
Developing a
New Product,
• Use DMADV to design a
new process, service, or
project or when no
established procedure
exists for the present
• DMADV can be used by
a service provider
planning to design a
new customer care
team in order to define
DMAIC
vs
DMADV

10
Differences of DMAIC and DMADV
 DMAIC addresses the current process; DMADV
addresses the design process.
 DMAIC reduces/eliminates defects (reactive); DMADV
prevents defects (proactive).
 DMAIC includes specific solutions; DMADV is part of
the solution design process.
 DMAIC includes controls to sustain the gains; DMADV
includes verification and validation of the finished
design.

Six sigma
Tools/Software (DMAIC)
Define
• Project
Charters
• SIPOC
Diagram
• Voice of the
Customer
(VOC) Analysis
• Stakeholder
Analysis
• Affinity
Diagrams
Measure
• Data Collection
Plans
• Process
Mapping
(Flowcharts)
• Sampling
Techniques
• Measurement
Systems
Analysis (MSA)
• Statistical
Process
Control (SPC)
Analyze
• Cause-and-
Effect
Diagram
(Fishbone
Diagram)
• Pareto Chart
• Hypothesis
Testing (e.g.,
t-tests, chi-
square tests,
ANOVA)
• Scatter Plot
• 5 Whys
Analysis
Improve
• Brainstorming
• Failure Mode
and Effects
Analysis
(FMEA)
• Design of
Experiments
(DOE)
• Pilot Testing
• Control Charts
Control
• Control Plan
• Statistical
Process
Control (SPC)
Charts
• Process
Documentatio
n (SOPs)
• Lean
Principles
(e.g., 5S,
Kaizen)
• Training and
Knowledge
Transfer 11

Six sigma
Tools/Software (DMADV)
Define
• Project
Charters
• SIPOC
Diagram
• Voice of the
Customer
(VOC) Analysis
• Stakeholder
Analysis
• Affinity
Diagrams
Measure
• Data Collection
Plans
• Process
Mapping
(Flowcharts)
• Sampling
Techniques
• Measurement
Systems
Analysis (MSA)
• Statistical
Process
Control (SPC)
Analyze
• Cause-and-
Effect
Diagram
(Fishbone
Diagram)
• Pareto Chart
• Hypothesis
Testing (e.g.,
t-tests, chi-
square tests,
ANOVA)
• Scatter Plot
• 5 Whys
Analysis
Design
• Simulation
Modeling
• Process
Mapping
• Prototyping
• Risk
Assessment
Tools
Verify
• Pilot Runs
• Control Plans
• Statistical
Process
Control (SPC)
• Validation
Protocols (IQ,
OQ, PQ)
12

Lean Six sigma 13
Lean
Six
Sigma
Lean Six Sigma

14
Applications
 Process Optimization – Reduces variability in
manufacturing (e.g., tablet weight, coating).
 Defect Reduction – Minimizes batch rejections and
improves product quality.
 Cycle Time Reduction – Speeds up production and
approvals.
 Lab Efficiency (QA/QC) – Reduces testing errors and
ensures accuracy.
 Regulatory Compliance – Improves documentation and
meets GMP standards.
 Waste Reduction – Eliminates non-value-added steps using
Lean tools.

15
Application
s Supply Chain & Inventory Control - Enhances
forecasting, procurement, and cold chain management.
 Validation & Qualification - Ensures robust
equipment/process validation and documentation.
 Technology Transfer - Improves efficiency during scale-up
or product transfers between sites.
 Risk Management - Uses data-driven tools (like FMEA) to
reduce operational risks.
 Employee Training - Builds a quality-driven, data-
focused culture.

Demerits
 High Implementation Cost
Training (Green/Black Belt), software, and consultancy can be expensive.
 Time-Consuming
Projects may take months to show results, which can delay decision-making.
 Complex for Smaller Companies
SMEs may lack resources, staff, or data to apply Six Sigma effectively.
 Resistance to Change
Employees in pharma are often used to traditional GMP practices and may resist new quality methods.
 Too Much Focus on Data
Over-reliance on data and statistics may overlook practical experience and intuition.

Demerits
 Not Always Suitable for R&D
Six Sigma is more effective in repetitive processes than in highly creative or innovative R&D work.
 Requires Strong Leadership Support
Without top management commitment, Six Sigma projects may fail or lose momentum.
 Limited Flexibility
Strict Six Sigma protocols may reduce flexibility in fast-changing regulatory environments.
 Short-Term Focus Risk
Sometimes prioritizes quick wins over long-term strategic improvements.

Six Sigma 19
Phases
DMAIC
D C
I
A
M
Define Analyze
Measure Control
Improve
Identify the
problem, scope,
and goals of the
project.
Monitor and
maintain the
improved process
to ensure long-term
stability and
sustainability
Implement and test
solutions to address
the root causes and
enhance process
performance.
Investigate the
data to identify
root causes of
variation and
defects.
Collect data to
establish a
baseline for the
current process
performance.

Six Sigma 20
Phases
DMADV
D V
D
A
M
Define Analyze
Measure Verify
Design
Establish the goals
and customer
requirements for
the new process,
product, or service.
Test and validate the
design to ensure it
meets customer
requirements and
performance goals.
Select the best
design
alternative and
develop detailed
design plans
Develop and
evaluate design
alternatives to
meet the CTQs.
Determine the
critical-to-quality
characteristics
and performance
metrics.

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Six-Sigma Concept in Quality management.pptx

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