Quality Management in Engineering

TL 2220
DR. T G G UTHPALA
USJ/ SLIIT/ UOM

1
 2

3/23/2024
 "Six Sigma" refers to a statistical measure of how far
a process deviates from perfection.
 A process that operates at six sigma has a failure
rate of only 0.00034%, which means it produces
virtually no defects.
Overview of Six  Developed by Motorola in the 1980s, and it has since
Sigma been adopted by many other companies around the
world, including General Electric, Toyota, and
Amazon.
 Used in manufacturing, healthcare, finance, and
service industries to improve customer satisfaction,
reduce costs, and increase profits.
  Six Sigma is a QM methodology that aims to
achieve near-perfect processes by systematically
identifying and eliminating defects or variations.
 The goal of Six Sigma is to achieve a level of
What is Six quality that is nearly perfect, with only 3.4 defects
Sigma? per million opportunities.
 Achieved by using a structured approach called
DMAIC to identify and eliminate causes of
variation and improve processes.

3/23/2024 3
4

3/23/2024
3/23/2024 5
3/23/2024 6
 Six Sigma 6б

Etymology is based on the Greek symbol "sigma" or

"σ," a statistical term for measuring process
deviation from the process mean or target.

"Six Sigma" comes from the bell curve used in

statistics, where one Sigma symbolizes a single
standard deviation from the mean.

If the process has Six Sigma, three above and three

below the mean, the defect rate is classified as
"extremely low."

3/23/2024 7
 Basic stages of Six Sigma methodology, referred to the DMAIC
framework,
1. Define
The goals and objectives are clearly defined, along with the
problem/ opportunity that needs to be addressed. Scope and the
customer requirements are identified.
Six Sigma 2. Measure

Methodology Involves identifying key metrics and collecting relevant data to

understand the current performance of the process. Data is
(DMAIC ) gathered and analyzed to establish a baseline and quantify the
extent of the problem/opportunity.
3. Analyze
Data collected in the previous stage is analyzed to identify the
root causes of the issues and determine the factors contributing to
process variations. Statistical analysis and other tools are used to
identify patterns, relationships, and potential sources of
improvement.

3/23/2024 8
 4. Improve
Based on the previous analysis, potential solutions and
improvement opportunities are identified.
These solutions are evaluated, tested, and implemented to
address the identified root causes and improve the process
performance.
Goal is to achieve measurable and sustainable improvements.

Six Sigma
5. Control
Methodology  Focuses on establishing control mechanisms to ensure the
gains are sustained over time.
Control plans are developed, and appropriate monitoring and
measurement systems are put in place to track the process
performance and take corrective actions if deviations occur.

These five stages, Define, Measure, Analyze, Improve, and

Control (DMAIC), form the basic framework of the Six Sigma
methodology and provide a structured approach for problem-
solving and process improvement.
3/23/2024 9
Dyeing Process in Textile Industry
Define
10
Problem Statement: Company experiences color variations in dyed fabrics, leading to rejects and customer
dissatisfaction.
Goal: Reduce color variations and achieve consistent dyeing results within specified color tolerances.

Measure Key Metrics: Color Variation Index, Reject Rates

Data Collection: Collect samples from different batches, measure color variations,
and record the reject rates based on color discrepancies.
Analyze Root Cause Analysis:
Investigate factors contributing to color variations
(dye concentration, water quality, and equipment calibration)
Data Analysis:
Use statistical tools to analyze the data and identify correlations between variables and color discrepancies.
Improve Generate Solutions:
Implement a robust quality control system for monitoring dye concentrations.
Upgrade equipment for more accurate temperature and pressure control during the dyeing process.
Pilot Testing: Test the proposed changes on a limited scale to assess their impact on color consistency.
Control Establish Controls:
Implement real-time monitoring of dye concentrations during production.
Develop SOPs for equipment calibration and maintenance.
Training and Communication:
Train operators on the updated procedures and the importance of maintaining consistent dyeing conditions.
3/23/2024
 11
Key Benefits of Six Sigma

DEFECT PROCESS COST SAVINGS CUSTOMER

REDUCTION EFFICIENCY SATISFACTION

DATA-DRIVEN STRATEGIC EMPLOYEE COMPETITIVE

DECISION ALIGNMENT ENGAGEMENT ADVANTAGE
MAKING 3/23/2024
 12
What is Lean Six Sigma?

 A methodology that combines two powerful process improvement techniques: Lean and Six
Sigma.
 Lean focuses on minimizing waste and maximizing efficiency by identifying and
eliminating non-value-adding activities.
 Involves streamlining processes, reducing defects, improving quality, and optimizing resources
to deliver more value with less effort.
 Six Sigma is a statistical approach to process improvement that aims to reduce variation and
defects by using data-driven decision making.
 Involves defining, measuring, analyzing, improving, and controlling processes to achieve
consistent and predictable results.

3/23/2024
13

3/23/2024
 14
Fact Lean Six Sigma
Goal Less waste, higher speed Improve performance on
customer requirements
Focus Identify and eliminate waste Eliminate variation, optimize
output
Method Team Event, Inspection Use DMAIC and Tools
Used Trained individuals
(yellow, green , black belts)
Lower cost Quality+ culture

3/23/2024
 15
Six Sigma Techniques
Tools
Brainstorming
Uses a mix of statistical and data Root Cause Analysis
analysis tools such as process 5 Why Analysis
mapping and design and proven
qualitative and quantitative 5S System
techniques, to achieve the Kaizen
desired outcome. Bench Marking
Value Stream Mapping

3/23/2024
 16
Product Design Process

Process flow chart

Quality and Process improvement (kaizen, breakthrough

improvements)
Process
Improvements Tools for process improvement

Voice of customer

Voice of supplier

3/23/2024
 Product Design Process
Requirements gathering: 17
Understand customer needs, market trends, and quality requirements.
Conceptualization and ideation:
Generate and evaluate design concepts.

Design development:
Create detailed design specifications considering quality and manufacturability.

Prototyping and testing:

Build prototypes and test them for performance and quality.

Design refinement:
Incorporate feedback from testing and make improvements to the design.
Documentation and validation:
Create detailed documentation and conduct validation tests.

Production implementation:
Transfer the design to production and implement process improvements.

Post-production evaluation:
Gather feedback from customers and stakeholders to identify areas for
3/23/2024
improvement
18

3/23/2024
 Product Design Process (PDP)

 PDP refers to the series of steps and

activities involved in creating a new product
or improving an existing one.
Quality and  It encompasses various stages from
conceptualization to final production, with
Process the goal of delivering a high-quality product
Improvements that meets customer requirements and
expectations.
 It involves integrating quality considerations
and process improvements into every stage
of the product design lifecycle.

3/23/2024 19
 1. Requirements gathering:
 The process starts with understanding customer needs, market
trends, and industry standards.
 Quality requirements are identified, including performance,
reliability, safety, and regulatory compliance.
 Process improvements are also considered at this stage to
enhance efficiency and reduce waste.
Product Design
Process Quality: A company developing a new smartphone conducts market
research to understand customer preferences and identifies quality
requirements such as high-resolution display, durable materials, and
excellent camera performance.

Process Improvement: The company also considers process

improvements, such as streamlining the supply chain to reduce lead
times and implementing automated testing procedures to enhance
efficiency.

3/23/2024 20
 21
Product Design Process

2. Conceptualization and ideation:

Design concepts are generated and evaluated, considering both quality aspects and process
efficiency.
Design thinking techniques may be employed to encourage innovation and user-centered design.
• Quality: An automobile manufacturer explores design concepts for a new electric vehicle,
emphasizing safety features like advanced driver-assistance systems (ADAS) and crash-test
performance.

• Process Improvement: The manufacturer also seeks innovative design solutions to reduce
production time and material waste, such as using lightweight materials and optimizing the
vehicle's aerodynamics.

3/23/2024
 22
Product Design Process

3. Design development
Detailed design specifications are created, incorporating quality features and considering
manufacturing processes.
Design for manufacturability (DFM) principles are applied to ensure efficient production and assembly.
Quality: A medical device company designing a new implantable pacemaker ensures compliance with
regulatory standards, incorporates fail-safe mechanisms, and conducts rigorous reliability testing.

Process Improvement: The company focuses on designing the device for manufacturability,
simplifying assembly steps, and integrating automated quality checks to improve productivity and
reduce errors.

3/23/2024
 4. Prototyping and testing:
Prototypes are built and tested to validate the
design's performance, quality, and reliability.
Feedback from testing informs further design
iterations and improvements.

Quality: An aerospace company builds prototypes

Product Design of a new aircraft wing and subjects them to
extensive structural testing to ensure they meet
Process safety requirements and perform optimally under
various conditions.

Process Improvement: The company utilizes rapid

prototyping techniques, such as 3D printing, to
accelerate the development process and enable
faster iteration cycles.

3/23/2024 23
 24
Product Design Process

5. Design refinement:
Based on the testing results and feedback, the design is refined to address any identified issues or areas for
improvement.
This stage involves continuous collaboration between design, quality, and process improvement teams.

Quality: An appliance manufacturer receives customer feedback indicating that the controls on their new
dishwasher are confusing.
They redesign the control panel layout to improve usability and customer satisfaction.

Process Improvement: The manufacturer also optimizes the production process by reconfiguring assembly
stations, introducing error-proofing techniques, and training operators to reduce defects and rework.

3/23/2024
 6. Documentation and validation:
 Detailed documentation of the final design is created,
including technical specifications, manufacturing instructions,
and quality control procedures.
Validation tests and simulations may be conducted to ensure
the design meets all requirements.

Product Design Quality: A pharmaceutical company develops a new

medication and thoroughly documents the formulation,
Process manufacturing process, and quality control measures to
ensure compliance with regulatory standards and patient
safety.

Process Improvement: The company employs statistical

process control (SPC) techniques during manufacturing to
monitor critical parameters, minimize variability, and improve
batch-to-batch consistency.

3/23/2024 25
 26
Product Design Process

7. Production implementation:
• The finalized design is transferred to production, where process improvements such as lean
manufacturing principles, automation, and quality control measures are implemented.
• Continuous monitoring and feedback loops help identify areas for further improvement.

Quality: An electronics manufacturer implementing a new product design invests in automated

inspection systems to detect defects, implements rigorous quality audits, and trains operators on
best practices to maintain high product quality.

Process Improvement: The manufacturer adopts lean manufacturing principles, such as just-in-
time inventory management and cellular manufacturing layouts, to eliminate waste, reduce cycle
times, and improve overall efficiency.

3/23/2024
 8. Post-production evaluation:
 Once the product is in the market, feedback from
customers and stakeholders is collected to identify any
quality issues or potential process improvements.
This information is used to drive future iterations and
enhancements.

Quality:
Product Design A software company releases a new mobile application
and actively collects user feedback to identify bugs, crashes,
Process and usability issues.
They promptly address these concerns through software
updates to ensure a high-quality user experience.
Process Improvement:
The company uses agile development methodologies to
iterate quickly, respond to customer feedback, and
continuously improve the software's performance and
stability.

3/23/2024 27
 DEVELOPMENT PROCESS FOR A NEW LINE OF ECO-FRIENDLY BALLPOINT PENS
28
Requirements Conceptualization and Ideation Design Development
Gathering pen designs that prioritize detailed specifications for the
preferences for pen sustainability, functionality, and pens, including dimensions,
features such as ink color aesthetics. materials, ink type, and refill
options, comfort grip, and writing comfort, ink flow compatibility.
refill ability. consistency, and environmental
impact.
Prototyping and Testing Design Refinement Documentation and Validation
Produce prototypes of the Make necessary design Prepare comprehensive
pens based on the adjustments to improve manufacturing instructions for
finalized design performance, usability. producing.
specifications and test
them.
Production Post-Production Evaluation
Implementation Engage with retailers, environmental organizations, and schools or
Transfer the Design to businesses to assess market reception and identify opportunities for
Production. Establish product improvements.
quality control measures
to maintain consistency
across batches. 3/23/2024
PRODUCT DESIGN PROCESS
29
REQUIREMENTS GATHERING

CONCEPTUALIZATION AND IDEATION

DESIGN DEVELOPMENT

PROTOTYPING AND TESTING

DESIGN REFINEMENT

DOCUMENTATION AND VALIDATION

PRODUCTION IMPLEMENTATION

POST-PRODUCTION EVALUATION
3/23/2024
Thank You!

30