Module 4

Quality Assurance

Function Quality program

• Quality Assurance
– Covers everything from raw materials and GMP (Good manufacturing
practice) verification through finished-product release
– HACCP (Hazard Analysis and Critical Control Points) is part of QA
– Written definition or policy
– Reporting pathways
– Authority
– Product standards

• Quality Control
– Actual manufacturing process
 What is Quality
• The ability to make the same thing the same way, over and over
again
• Customer buys today is same as what they bought last week or
will buy next week
• Product meets customer’s expectations 100% of the time
Customer expectations
This is where quality programs begin.
– Marketing has defined the customer expectations.
– Product development has created a product that meets those
expectations.
– Engineering has designed a process to make the desired
product.
– Now, all QA must do is design a control system that verifies
that everything is working as designed.
The Quality Gurus
• Walter Shewhart
– “Father of statistical quality control”
• W. Edwards Deming
• Joseph M. Juran
• Armand Feignbaum
• Philip B. Crosby
• Kaoru Ishikawa
• Genichi Taguchi
 Key Contributors to Quality Management

Contributor Known for

Deming 14 points; special & common causes of
variation

Juran Quality is fitness for use; quality trilogy

Feignbaum Quality is a total field

Crosby Quality is free; zero defects

Ishikawa Cause-and effect diagrams; quality

circles

Taguchi Taguchi loss function

Quality
 Dimensions of Quality
• Performance - main characteristics of the
product/service
• Aesthetics - appearance, feel, smell, taste
• Special Features - extra characteristics
• Conformance - how well product/service conforms to
customer’s expectations
• Reliability - consistency of performance
• Durability - useful life of the product/service
• Perceived Quality - indirect evaluation of quality (e.g.
reputation)
• Serviceability - service after sale
 Examples of Quality Dimensions
Dimension (Product) (Service)
Automobile Auto Repair
1. Performance Everything works, fit & All work done, at agreed
finish price
Ride, handling, grade of Friendliness, courtesy,
materials used Competency, quickness
2. Aesthetics Interior design, soft touch Clean work/waiting area

3. Special features Gauge/control placement Location, call when ready

Cellular phone, CD Computer diagnostics
player
 Examples of Quality Dimensions (Cont’d)
Dimension (Product) (Service)
Automobile Auto Repair
5. Reliability Infrequency of breakdowns Work done correctly,
ready when promised

6. Durability Useful life in miles, resistance Work holds up over

to rust & corrosion time

7. Perceived Top-rated car Award-winning service

quality department

8. Serviceability Handling of complaints and/or Handling of complaints

requests for information
 Examples of Service Quality
Dimension Examples
1. Tangibles Were the facilities clean, personnel neat?

2. Convenience Was the service center conveniently located?

3. Reliability Was the problem fixed?

4. Responsiveness Were customer service personnel willing and

able to answer questions?
5. Time How long did the customer wait?

6. Assurance Did the customer service personnel seem

knowledgeable about the repair?
7. Courtesy Were customer service personnel and the
cashierfriendly and courteous?
Determinants of Quality

Ease of
Design
use

Conforms
to design Service
 Determinants of Quality (cont’d)
• Quality of design
– Intension of designers to include or exclude features in a
product or service
• Quality of conformance
– The degree to which goods or services conform to the
intent of the designers

The Consequences of Poor Quality

– Loss of business
– Liability
– Productivity
– Costs
 Responsibility for Quality

• Top management
• Design
• Procurement
• Production/operations
• Quality assurance
• Packaging and shipping
• Marketing and sales
• Customer service
 What is ISO?
The International Organization for
Standardization (ISO) creates many
different types of standards
International Standards for ISO is made up of standards
Business, Government and institutes from 154 different
Society countries
Member countries work together to
develop and approve standards
Quality Certification
• ISO 9000
– Set of international standards on quality management and quality
assurance, critical to international business
• ISO 14000
– A set of international standards for assessing a company’s
environmental performance

International Quality Standards

ISO 9000:
A set of quality standards developed by the International
Organization for Standardization (ISO). ISO 9000 is the only
quality standard with international recognition.
ISO 9000 Quality Management Principles
• A systems approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships
• Customer focus
• Leadership
• People involvement
• Process approach
ISO 9000 series of standard published in 1987 are:
Standard Content

ISO 8402: 1987 Quality management and quality assurance;

vocabulary
ISO 9000: 1987 Quality management and quality assurance
standards; Guideline for selection and use.
ISO 9001: 1987 Quality system, model for quality assurance in
design, development, production, installation
and servicing.
ISO 9002: 1987 Quality system, model for quality assurance in
production and installation.
ISO 9003: 1987 Quality system model for quality assurance in
final inspection and test.
ISO 9004: 1987 Quality management and quality system
elements; guidelines.
ISO 14000:
…An environmental management standard
established by the international Organization for
Standardization(ISO). ISO 14000 is an
environmental management standard that contains
five core elements:
1. Environmental management
2. Auditing
3. Performance evaluation
4. Labeling
5. Life cycle assessment
The new standard could have several advantages:
ISO 14000 - A set of international standards for assessing a
company’s environmental performance
Standards in three major areas
– Management systems
– Operations
– Environmental systems

• Management systems
– Systems development and integration of environmental
responsibilities into business planning
• Operations
– Consumption of natural resources and energy
• Environmental systems
– Measuring, assessing and managing emissions, effluents, and
other waste
The new standard could have several advantages:
 Positive public image and reduced exposure to
liability
 Good systematic approach to pollution
prevention through the minimization of
ecological impact of product and activities.
 Compliance with regulatory requirements and
opportunities for competitive advantage.
 Reduction in need fro multiple audits.
 What is ISO 22000?
It is a Food Safety Management System (FSMS) that uses
a management systems approach as well as a HACCP
process.
The goal of ISO 22000 is to provide one internationally
recognized standard for a food safety management system
that can be applied to any organization in the food chain.

Some of the benefits of ISO 22000 are as follows:

 More efficient and dynamic food safety hazard control.
 Systematic management of prerequisite programmes.
 Valid basis for taking decisions
 Increase focused on what is necessary
 Saves resources by reducing overlapping
system audits
 Organizes and targets communication among
partners
 Resource optimization
 Better planning, less post-process verification
# Meaning and definition of TQM
Total quality management TQM is an integrative
system that uses strategy, data and effective
communication to integrate the quality principles
into the culture and activities of the organization. It
is focused to long term success through customer
satisfaction so
TQM=Customer-Driven Quality Management

According to Professor Leopald S. Vasin, “TQM

is the control of all transformation processes of an
organization to best satisfy customer’s needs in the
most economical manner”.
 Be customer focused

Continual improvement Employee involvement

communication organization Process centered

Integrated system
Fast based decision-making

Strategic and systematic approach

Characteristics of TQM:
• Customer satisfaction
• Leadership
• Integrated activities
• Corporate culture
• Strengthen employee commitment
• Totality
• Documentation
• Improvement
• Foundation
#Determinants of Quality (Quality Specification)
• Performance or effectiveness
• Ranges and types of features
• Reliability
• Serviceability and maintainability
• Conformance
• Aesthetics
• Ethics profile and image/perceived quality
Determinant of service quality
• Reliability
• Responsiveness
• Competence
• Access
• Courtesy
• Communication
• Credibility
• Security
• Understanding/knowing the customer
Importance of good quality
Market gains
Reputation
Volume
Price

Improved Increased
quality profits

Lower costs
Productivity
Rework/scrap
warranty
Element of TQM (philosophical elements of TQM)
• Customer orientation (internal and external)
• Do it right first time
• Continuous improvement and development
• Employee involvement
• Empowering the staff
• Benchmarking
• Feedback mechanism
• Quality Control Circles
# Implementation of TQM
W.E. Deming, father of TQM, has suggested Plan-
Do-Check-Act cycle for the implementation of
TQM in any organization. The various steps in
PDCA cycle are as shown:
Plan Do
• Policies and objectives • Education and training
• Methods to achieve • Implementation of
objectives change

Act Check
• Prevent undesired • Observe results
effects • Analyze Results
• Measures for
improvement
# TQM Models
• Integrated TQM model based on actions
approach
Systematic problem
Customer focus
solving process

TQC mission
statement is
Statistical quality continuous Management
control quality commitment
improvement

Total participation
• Oakland model of TQM

people

culture communic
ation

performance

system processes

Commitment
Business
 Leadership and
management commitment
• General TQM model

Team work and employee

involvement
Delightment
Total Customer

Quality system

Tools and techniques for

continuous improvement
#Quality Management Tools
(quality related data analysis tools / Quality
control tools)
• Flow chart
• Check sheets
• Histogram
• Cause and effect diagrams (fish bone diagram)
or Ishikawa diagram
• Pareto diagram
• Scatter diagram
• Control charts (refer page 172 sandeep shrestha)
# Cost of Quality
Cost of quality are those cost incurred by an organization in
preventing non-conforming products and services, in
evaluating processes, product and services; and cost associated
with failure to confirm with requirement.

Objectives of Quality Cost Evaluation:

• To quantify the size of quality problems in a language that
will have and impact on top management.
• To identify area of major opportunities for the cost reduction.
• To identify opportunity for reducing customer
dissatisfaction.
• To know overall size of quality cost
• To know major areas of potential improvement
# Types of Quality Cost
• Prevention costs: (quality planning costs, product
design costs, process control costs, training costs,
information costs, quality audit cost etc)
• Cost of appraisal: (inspection and testing, test
equipment costs, operator costs etc)
• Cost of internal failure: (scrap costs, rework
costs, process failure costs, process downtime
costs, price-downgrading costs etc)
• Cost of external failure: (customer complaint
costs, product return costs, warranty claims costs,
product liability costs, lost sales costs etc)
# Quality Control
According to Alfred and Betty, “Quality control may be
defined as that industrial management technique or
group of techniques by means of which products of
uniform acceptance quality are manufactured.”

Ultimate quality is the aggregate form of the following

factors and processes of production.
• Quality of materials
• Quality of manpower
• Quality of machines
• Quality of management
# Advantages of Quality Control
• Improvement in product quality and design.
• Reduction in operating cost and losses.
• Reduction in scrap.
• Saving in excess use of the materials.
• Removing production bottlenecks.
• Reduction in inspection.
• Evaluation of scientific tolerances.
• Improvement of employee morale.
• Maintenance of operating efficiency.
• Quality consciousness.
• Greater customer satisfaction.
• Enhanced productivity.
# Operating Characteristics Curve (OC Curve)
OC Curve shows the probability of accepting a lot
as a function of the lot fraction defective. The
probability of accepting a lot becomes less as the
quality of the lot declines.
Refer page 308 Azaya Sthapit
 Tools of TQM
 Check sheets
 Scatter Diagrams
 Cause and Effect Diagram
 Pareto Charts
 Flowcharts
 Histograms
 Statistical Process Control (SPC)
 Run charts