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LECTURE – 3
QUALITY OF DESIGN
AND
QUALITY OF
CONFORMENCE
By: Raj Kumar Bairwa,
Mechanical Engineering.
Assistant Professor (NPIU),
UD RTU, Kota.
Email : rkumar.npiu.me@rtu.ac.in
QUALITY BY DESIGN
2
 INTRODUCTION
Understanding Quality By Design: The concept was given first time by Joseph M. Juran.
Note: The sum of all features is the new product, service, or process
STEPS INVOLVED IN QUALITY BY DESIGN
3
Example: Quality by design in
Pharmaceutical Industry
4
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.
QUALITY ASPECTS OF PRODUCT DESIGN
5
8 Dimensions of Quality :
THE FIVE ASPECTS OF PRODUCT QUALITY
6
UNDERSTANDING QUALITY ASPECTS OF
PRODUCT IN TOYOTA
7
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
8
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
9
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
10
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
11
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.
Quality of design is usually indicated by completeness and correctness of
specifications, drawings, catalogues, etc. and is measured with fitness for use.
QUALITY OF DESIGN
12
OTHER DEFINITIONS :
Quality of design means the degree to which the product's design specifications meet
customers' exceptions. For example, a coffee mug designed with a handle that is too small
for the user's fingers would have poor quality of design.
Quality of design is all about set conditions that the product or service must minimally
have to satisfy the requirements of the customer. Thus, the product or service must be
designed in such a way so as to meet at least minimally the needs of the consumer.
 Starts with the market research, sales feedback analysis and ends with development of a
product satisfying the customers.
Example: Compare a BMW with a Honda Civic.
EXAMPLES OF POOR QUALITY
13
■ Product fails – (e.g. a breakdown or unexpected wear and tear).
■ Product does not perform as promised.
■ Product is delivered late.
■ Poor instructions/directions for use.
■ Customer service is hard to find - ( e.g. Telephone not answered).
■Business employees appear rude or uninterested in the customer
COSTS OF POOR QUALITY
14
■ There are many costs of poor quality, including :
■ Lost customers (expensive to replace – and they may tell other people about
their bad experience).
■ Cost of reworking or remaking product.
■ Costs of replacements or refunds
■ Wasted materials.
■ Poor quality is a source of competitive disadvantage.
■ If competitors are achieving higher quality, then a business will suffer.
QUALITY OF CONFORMANCE
15
 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 OF CONFORMANCE
16
Example: If the Honda Civic does what it is designed to do and does it well,
quality exists.
If an economy car is designed to provide reliable, low-cost, low-
maintenance transportation, the desired quality exists.
If there is a discrepancy between quality of design and quality of
conformance, it means that defects exist in the product or product needs
rework.
As quality of conformance improves, incidences of defects, reworks
and adjustments decline, resulting in cost reduction and productivity
gain.
QUALITY OF CONFORMANCE AND QUALITY
OF DESIGN
17
Figure : For Healthcare System
18

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Lecture 3 (quality of design and quality of conformance)

  • 1. LECTURE – 3 QUALITY OF DESIGN AND QUALITY OF CONFORMENCE By: Raj Kumar Bairwa, Mechanical Engineering. Assistant Professor (NPIU), UD RTU, Kota. Email : rkumar.npiu.me@rtu.ac.in
  • 2. QUALITY BY DESIGN 2  INTRODUCTION Understanding Quality By Design: The concept was given first time by Joseph M. Juran. Note: The sum of all features is the new product, service, or process
  • 3. STEPS INVOLVED IN QUALITY BY DESIGN 3
  • 4. Example: Quality by design in Pharmaceutical Industry 4 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.
  • 5. QUALITY ASPECTS OF PRODUCT DESIGN 5 8 Dimensions of Quality :
  • 6. THE FIVE ASPECTS OF PRODUCT QUALITY 6
  • 7. UNDERSTANDING QUALITY ASPECTS OF PRODUCT IN TOYOTA 7 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.
  • 8. UNDERSTANDING QUALITY ASPECTS OF PRODUCT IN TOYOTA 8 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
  • 9. 9 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.
  • 10. QUALITY OF DESIGN AND QUALITY OF CONFORMANCE 10 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.
  • 11. QUALITY OF DESIGN 11 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. Quality of design is usually indicated by completeness and correctness of specifications, drawings, catalogues, etc. and is measured with fitness for use.
  • 12. QUALITY OF DESIGN 12 OTHER DEFINITIONS : Quality of design means the degree to which the product's design specifications meet customers' exceptions. For example, a coffee mug designed with a handle that is too small for the user's fingers would have poor quality of design. Quality of design is all about set conditions that the product or service must minimally have to satisfy the requirements of the customer. Thus, the product or service must be designed in such a way so as to meet at least minimally the needs of the consumer.  Starts with the market research, sales feedback analysis and ends with development of a product satisfying the customers. Example: Compare a BMW with a Honda Civic.
  • 13. EXAMPLES OF POOR QUALITY 13 ■ Product fails – (e.g. a breakdown or unexpected wear and tear). ■ Product does not perform as promised. ■ Product is delivered late. ■ Poor instructions/directions for use. ■ Customer service is hard to find - ( e.g. Telephone not answered). ■Business employees appear rude or uninterested in the customer
  • 14. COSTS OF POOR QUALITY 14 ■ There are many costs of poor quality, including : ■ Lost customers (expensive to replace – and they may tell other people about their bad experience). ■ Cost of reworking or remaking product. ■ Costs of replacements or refunds ■ Wasted materials. ■ Poor quality is a source of competitive disadvantage. ■ If competitors are achieving higher quality, then a business will suffer.
  • 15. QUALITY OF CONFORMANCE 15  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.
  • 16. QUALITY OF CONFORMANCE 16 Example: If the Honda Civic does what it is designed to do and does it well, quality exists. If an economy car is designed to provide reliable, low-cost, low- maintenance transportation, the desired quality exists. If there is a discrepancy between quality of design and quality of conformance, it means that defects exist in the product or product needs rework. As quality of conformance improves, incidences of defects, reworks and adjustments decline, resulting in cost reduction and productivity gain.
  • 17. QUALITY OF CONFORMANCE AND QUALITY OF DESIGN 17 Figure : For Healthcare System
  • 18. 18