Quality Aspects of Product and Process Design

Quality Aspects of Product and Process Design
Technology and Innovation

Contents
1 Introduction
2 Quality By Design
3 Quality Aspects Of product Design
4 Quality Of Design, Quality Of Conformance
5 Quality Functional Deployment (QFD)
6 Quality Aspects of Process Design
7 Process Design
8 Six Sigma
9 International Organization for Standardization (ISO)
10 Quality Tools
11 References
© 2017. All Rights Reserved.

Introduction
• Understanding Quality By Design: The concept was
given first time by Joseph M. Juran
Quality
Features
satisfying
customers
Quality
Improvement:
Removing
Failures in
features
Quality by
Design:
Creating
Features
Creating
features in
response to
customer’s
needs
Reliability of
Features
Note: The sum of all features is the new product, service, or
process

Steps involved in Quality by design
1.
• Establish the project design targets and goals
2.
• Define the market and customers that will be targeted.
3.
• Discover the market, customers, and societal needs
4.
• Develop the features of the new design that will meet needs
5.
• Develop or redevelop the processes to produce the features.
6.
• Develop process controls to be able to transfer the new
designs to operations

Example: Quality by design in
Pharmaceutical Industry
• A quality target product profile (QTPP) that identifies the critical
quality attributes (CQAs) of the drug product
• Product design and understanding including identification of
critical material attributes (CMAs)
• Process design and understanding including identification of
critical process parameters (CPPs), linking CMAs to CQAs
• A control strategy that includes specifications for the drug
substance(s), excipient(s), and drug product as well as controls
for each step of the manufacturing process; and
• Process capability and continual improvement. Quality by Design
tools and studies include prior knowledge, risk assessment,
mechanistic models, design of experiments (DoE) and data
analysis, and process analytical technology (PAT).

Quality Aspects of Product Design

8 Dimensions of Quality
Performance
Features
Reliability
Conformance
Durability
Serviceability
Aesthetics
Perceived Quality

The five aspects of Product Quality
Quality is considered a non-functional requirement in engineering, affecting
the execution and evolution of a product. Product qualities can be divided into
two main categories:
 Execution qualities, such as security and usability.
 Evolution qualities, such as testability, maintainability, extensibility,
portability, and scalability.
• Providing an product or serviceProducing
• Confirming that a product or service has been
produced correctly.Checking
• Controlling a process to ensure that the
outcomes are predictable.Quality Control
• Directing an organization so that it improves
performance through analysis and innovationQuality Management
• Obtaining confirmation that a product or
service will be satisfactory.Quality Assurance

Understanding Quality Aspects of
Product in Toyota
• Toyota has achieved a reputation for high quality vehicles
because of its approach towards quality control and quality
assurance which is unique to Toyota.
• Toyota considers quality control as a key part of the
activities to produce products or services economically and
to be of a standard, which exceeds customer needs.
• Customer satisfaction is at the heart of all Toyota activities.
• Toyota follows a “Company Wide Quality Control” approach
as everybody from research and development to
manufacturing, retailing and servicing contribute to the
quality control process.

Understanding Quality Aspects of Product in
Toyota….
• At Toyota, total quality control is carried out using two basic
principles:
 quality is built in at every stage
 and quality is continually improved
• The use of standardized work together with visual control
clearly indicate the current status and make it very easy to
spot problems or unusual conditions as they occur.
• Other principles that help in making quality products in
Toyota are:
 Poka-yoke
 Use of Andon Boards
 5 Why Analysis
 Kaizen or Continuous Improvement

The quality of the completed vehicle is greatly dependent
upon a reliable supply of high quality parts and materials.
Toyota’s philosophy is to establish a long term working
relationship with its suppliers, through early selection and
continuous joint development.

Quality of Design and Quality of
Conformance
• Creation of any product involves two major stages –
intellectual creation and physical creation.
• During intellectual creation a product is conceived in the
mind and a design is created and after that it is physically
produced.
• The term quality involves two complementary aspects,
quality of design and quality of conformance. So, good
quality can be attained only when both of them are
controlled satisfactorily. Quality is designed into a product
as much as it is built in during its production or service
processes.
• Fitness for use (quality of design) and conformance
to specification (quality of conformance) provide the
fundamental basis for managing the processes to produce
quality products.
Note: Good quality can be attained only when both,
quality of design and quality of conformance are good.

Quality of Design
• Quality of design is the quality which the producer or
supplier is intending to offer to the customer. When the
producer is making the quality of design of the product, he
should take into consideration the customer's requirements
in order to satisfy them with fitness for use of the
product.
• If the quality of design does not reflect the customer's
requirements, the product which the producer offers him
would not probably satisfy the customer, even if it does
sufficiently conform to the design.
Note: Quality of design is usually indicated by
completeness and correctness of specifications,
drawings, catalogues, etc. and is measured with fitness
for use.

Quality of Conformance
• Quality of conformance is the level of the quality of
product actually produced and delivered through the
production or service process of the organization as per the
specifications or design. When the quality of a product
entirely conforms to the specification (design), the quality
of conformance is deemed excellent.
• Specifications are targets and tolerances determined by
the designer of a product. Targets are the ideal values for
which production is expected to strive; tolerances are
acceptable deviations from these ideal values recognizing
that it is difficult to meet the exact targets all the time due
to variability in material, machine, men and process. For
E.g. if an engineering component manufacturer specifies
the diameter of a steel pin as 2.525 + 0.005 mm, the value
2.525 is the target value and + 0.005 is the tolerance.

Quality characteristics of a Product
Quality
Characteristics
True Quality
Characteristics
Demanded by
customers and
expressed in the
language of the
customer in his own
words
Substitute Quality
Characteristics
Customer
Requirements in the
language of producer
like specifications,
targets and tolerance
Forward Looking Quality: That are positive
advantage of the product – the special
features that make it superior to competing
products and can be used as sales points,
such as, ‘easy to use', ‘comfortable to use.
Backward Looking Quality: the absence of
defects is a backward looking quality or a
must-be quality, bcoz it is essential, but not
a sufficient condition for selling in
competitive situations.

Quality Functional Deployment(QFD)
• It provides a set of planning and communication tools that
focuses on customer requirements in co-coordinating the
design, production and marketing of customer- driven
quality products.
• It provides a means of translating customers' requirements
(VOC) into appropriate technical parameters for each stage
of product development and production.
• The voice of customer expressed in the form of ‘whats' is
translated into technical language – the ‘hows' that
determine the means which meet customer attributes.
Eg. : A customer wants higher mileage from a new
model of a car, then by use of QFD a car can be
designed which can meet the customer requirements.

House of Quality
• The house of quality relates
customer attributes to technical
features to ensure that all
design decisions are based on
the customer needs.
• House of quality development
consists of six basic steps:
 Identify customer attributes
 Identify technical features
 Relate customer attributes to
technical features
 Conduct an evaluation of the
competing product
 Evaluate technical features and
develop targets
 Determine which technical
features to deploy in the
remainder of the production
process.

Quality Aspects of Process Design

Process Design
19
• The activity of determining the workflow, equipment needs,
& implementation requirements for a particular process.
Process design typically uses a number of tools including
flowcharting, process simulation software, and scale
models.
• A successful process design has to take into account the
appropriateness of the process to overall organization
objective. Process design requires a broad view of the
whole organization and should not have a myopic outlook.
And the process should deliver customer value with
constant involvement of the management at various stages.

Process Design
Processes that
Design Products
and Services
Concept Generation
Screening
Preliminary Design
Evaluation and
Improvement
Prototyping and final
design
Processes that
Produce Products
and Services
Supply Network Design
Layout
and Flow
Process
Technology
Job
Design
20

Aspects of Process Quality
Aspects of process quality which will be covered by quality
assessments are outlined below:
• Clarity of process: This refers to the extent to which the process
for producing statistics is clear as evidenced by the existence of
documentation describing the process.
• Repeatability of process: This refers to the extent to which
systems and documentation are in place to allow a process to be
repeated.
• Monitoring of process: This refers to the existence of
management systems and metrics which enable the monitoring of
process performance.
• Evaluation and review of processes: This refers to whether a
system of evaluation and review of processes and outputs is in
place. Such systems are important to ensure improvement of
process performance, and hence data quality, over time.

Six Sigma
• What??-
Six Sigma at many organizations simply means a measure of
quality that strives for near perfection. Six Sigma is a
disciplined, data-driven approach and methodology for
eliminating defects (driving toward six standard deviations
between the mean and the nearest specification limit) in any
process – from manufacturing to transactional and from product
to service.
• Why??-
The central idea behind Six Sigma is that if you can measure
how many "defects" you have in a process, you can
systematically figure out how to eliminate them and get as
close to "zero defects" as possible. To achieve Six Sigma
Quality, a process must produce no more than 3.4 defects per
million opportunities. An "opportunity" is defined as a chance
for nonconformance, or not meeting the required specifications
“Six Sigma is a quality program that, when all is said and
done, improves your customer’s experience, lowers your
costs, and builds better leaders.” - Jack Welch

Process Capability
• Definitions
Cp= Process Capability.
Cpk= Process Capability Index. Adjustment of Cp for the effect of
non-centered distribution.
• Interpreting Cp, Cpk
Consider a car and a garage. The garage defines the specification
limits; the car defines the output of the process. If the car is only a
little bit smaller than the garage, you had better park it right in the
middle of the garage (center of the specification) if you want to get
all of the car in the garage. If the car is wider than the garage, it
does not matter if you have it centered; it will not fit. If the car is a
lot smaller than the garage (Six Sigma process), it doesn’t matter
if you park it exactly in the middle; it will fit and you have plenty of
room on either side. If you have a process that is in control and
with little variation, you should be able to park the car easily within
the garage and thus meet customer requirements. Cpk tells you the
relationship between the size of the car, the size of the garage and
how far away from the middle of the garage you parked the car.

International organization for
Standardization
International Standards are the backbone of our society, ensuring the
safety and quality of products and services, facilitating international
trade and improving the environment in which we live in.
ISO standards help businesses to:
– Cut costs, through improved systems and processes
– Increase customer satisfaction, through improved safety,
quality and processes
– Access new markets, through ensuring the compatibility of
products and services
– Reduce their impact on the environment.
Some of the examples are :
– ISO 9001: shown to improve sales, customer satisfaction,
corporate image and market share
– ISO 14001: shown to have a positive impact on environmental
performance

Quality tools
Some of the tools are:
– Histogram
– Scatter diagram
– Statistical process control
– Pareto analysis
– Cause and effect diagram
– Flowchart

References
• www.oxbridgenotes.co.uk/
• www.eibertdraisma.nl
• www.managementstudyguide.com
• www.technologyreview.com/
• www.isixsigma.com
• http://www.openlearningworld.com/books/Quality%20by%
20Design/Quality%20by%20Design/True%20quality%20Ch
aracteristics%20and%20Substitute%20quality%20Characte
ristics.html
• https://qualityinspection.org/product-design-quality-issues/
• https://www.boundless.com/marketing/textbooks/boundles
s-marketing-textbook/products-9/differentiating-factors-in-
product-design-72/quality-361-4098/
• https://en.wikipedia.org/wiki/Quality_by_Design
• http://www.bbc.co.uk/schools/gcsebitesize/design/systemsc
ontrol/designevaluationrev3.shtml

Quality Aspects of Product and Process Design

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