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Introduction To Quality Management System and ISO TS 16949:2002
Introduction To Quality Management System and ISO TS 16949:2002
QUALITY
MANAGEMENT
SYSTEM AND
ISO TS 16949:2002
Quality
Quality
Quality
What is this quality ?
Quality is fitness for use or purpose
- Juran
Quality is conformance to requirements
- Crosby
A predictable degree of uniformity and dependability
at low cost and suited to market
- Deming
The Totality of features and characteristics of a
product or service that bear on its ability to satisfy
stated or implied needs of customer
- ISO 8402 : Quality vocabulary
Quality Vs quality
Quality is about products
It is technical
It is for inspector
It is led by experts
Good quality is of high
grade
Quality is about control
Little q
Quality is about
organizations
Quality is strategic.
Quality is for everyone
Quality is led by
management
Quality is appropriate
grade
Quality is about
improvement
Big Q
Quality is never an accident , it
is always the result of an
intelligent efforts
John ruskin
WHAT IS QUALITY MANAGEMENT SYSTEM
(QMS)?
A set of coordinated activities with regard to
quality which directs and controls an organization
enabling it to achieve its policy and objectives and
consistently meet the expectation of customer
QUALITY MANAGEMENT PRINCIPLES
8 QMS principles have been identified that can be
used by top management in order lead the
organization toward improved performance
CUSTOMER FOCUS
LEADERSHIP
INVOLVEMENT OF PEOPLE
PROCESS APPROACH
SYSTEM APPROACH TO MANAGEMENT
CONTINUAL IMPROVEMENT
FACTUAL APPROACH TO DECISION MAKING
MUTUALLY BENEFICIAL SUPPLIER RELATION
Eight Quality Management Principles
Principle 1 : Customer-Focused
Organization
Organizations depend on their
customers and therefore should
understand current and future customer
needs, should meet customer
requirements and strive to exceed
customer expectations.
Eight Quality Management Principles
(contd.)
Principle 2 : Leadership
Leaders establish unity of purpose and
direction of the organization. They should
create and maintain the internal
environment in which people can become
fully involved in achieving the
organization's objectives.
Eight Quality Management Principles
(contd.)
Principle 3 : Involvement of People
People at all levels are the essence of an
organization and their full involvement
enables their abilities to be used for the
organization's benefit.
Eight Quality Management
Principles (contd.)
Principle 4 Process Approach
A desired result is achieved more
efficiently when activities and related
resources are managed as a process.
Eight Quality Management Principles
(contd.)
Principle 5 : System Approach to
Management
Identifying, understanding and
managing interrelated processes as a
system contributes to the
organizations effectiveness and
efficiency in achieving its objectives.
Eight Quality Management Principles
(contd.)
Principle 6 : Continual Improvement
Continual improvement of the
organization's overall performance
should be a permanent objective of the
organization.
Eight Quality Management Principles
(contd.)
Principle 7 Factual approach to
decision making
Effective decisions are based on the
analysis of data and information.
Eight Quality Management Principles
(contd.)
Principle 8 Mutually beneficial
supplier relationships
An organization and its suppliers are
interdependent and a mutually beneficial
relationship enhances the ability of both
to create value.
QMS APPROACH
Determining the needs and expectations of
customer and other interested parties .
Establish the quality policy and quality objectives
of the organization
Determining the processes and responsibilities
necessary to attain the quality objectives
Determining and providing the resources
necessary to attain the quality objectives
Contd..
Establish methods to measures the
effectiveness and efficiency of each process
Applying these measures to determine the
effectiveness and efficiency of each process
Determining means of preventing non
conformance and eliminating their causes
Establish and applying a process for continual
improvement of the quality management system
DEVELOPMENT OF A BETTER QUALITY
MANAGEMENT SYTEM
PLANNING - QMS
DEVELOPING - QMS
IMPLEMENTING QMS
IMPROVING QMS
MATURIZING -QMS
What are standards ?
Documented agreements containing technical
specification,guidelines or procedure .
International standard simplify the exchange of
goods and services (they make life simplifier)
For example an international standard exist for
optimal thickness of a credit card ( 0.76 mm )
compliance with international standard allows
products and services to be used world wide .
What is ISO ?
International organization for standardization
Note: ISO is not an acronym , it is the prefix which iso which means
equality
ISO is a non governmental agency (established in 1947)
Headquarter in Geneva , Switzerland
Over 100 countries participate in ISO .
Each country has its own standard organization which interfaces with the
world wide ISO organization .
Iso has technical committees which investigates and publishes standard .
ISO standard often replaces national standard.
ISO Organizational goals
Facilitates the exchange of goods and services and to develop
cooperation among the economic activities
What does an ISO standard looks like ?
It may be a technical specifications, a set of procedures
,a definition , a test method or a set of symbols .
Examples of ISO standard :
Universal system of measurement (SI)- metric system
(kg, m, sec .)
Symbols for automobiles control (headlight switch ) .
ISO metric screw threads a major ISO
accomplishment was to standardize the description of
the screw by their threads . (this solved the numerous
maintenance problem resulting from the diversity of
screws)
Quality system model (ISO 9000 series )
WHAT IS ISO 9000 ?
ISO 9000:2000 is the latest version of
quality management standard which has
been in existence for many years and which
has been applied to more than 60,000
organization world wide . It specifies the
minimum requirements for a quality
management system
ISO 9000 FAMILY
1. ISO 9000
This standard describes fundamentals of quality
management systems and specifies the terminology
for quality management system .
2. ISO 9001
It specifies the requirements for a quality
management system where an organisation needs to
demonstrate its ability to provide products that fulfil
customer and applicable regulatory requirements and
aim to enhance customer satisfaction
ISO 9000 FAMILY
3. ISO 9004
it provides guidelines that consider both the
effectiveness and efficiency of the quality
management system . The aim of this standard is
improvement of the performance of the organisation
and satisfaction of customer and other interested
parties .
4. ISO 19011
This standard provides guidance on auditing
quality and environmental management system
ISO 9000 BACKGROUND
ISO quality standard were released in 1987
ISO 9000 are not standard for product but are
standard for operating a quality management
system
Note : ISO 9000 certified companies indicate that
they have and follows a quality system but it
does not imply that they have better quality
PROCESS APPROACH
An activity using resources and managed in
order to enable the transformation of inputs into
output can be considered as process (often the
output from one process directly forms the input
to the next )
The application of system of processes within
organization, together with the identification and
interaction of these processes and their
management can be referred to as the
process approach .
Basic concept in development of
PROCESS APPROACH
PLAN:
Establish the objectives
and process necessary
to deliver result in
accordance with
customer requirements
and the organization's
policy
DO:
Implement the
processes
CHECK:
Monitor and
measure processes
and product against
policies, objectives
and requirements
for the product and
report the result
ACT :
Take actions to
continually
improve process
performance
BASIC REQUIREMENTS
GENERAL REQUIREMENTS
DOCUMENTATION REQUIREMENTS
MANAGEMENT RESPONSIBILTY
Management commitment
Customer focus
Quality policy
Planning
Responsibility and authority
Management review
Resources management
Provision of resources
Human resources
Infrastructure
Work environment
Product realization
Planning of product realization
Customer related processes
Design and development
Purchasing
Production and services provision
Control of monitoring and measuring devices
Measurement , analysis and
improvement
Establishing monitoring , measurement, analysis,
and improvement processes
Monitoring and measurement of the process
Control of non conforming product
Analysis of data
Continual improvement
What Is Lean Manufacturing?
Lean manufacturing is a
philosophy that reduces
customer order-to-delivery
cycles by eliminating sources of
waste.
Value preferred by customer
Value stream
Synchronous flow
Characteristics of lean
manufacturing organization
Customer centric
Process mapping
Simplicity
Visibility
Regularity
Synchronization
Characteristics of lean
manufacturing organization
Time
Prevention
Waste control
Participation
Partnership
Improvement
Benefits of Lean
Manufacturing
Speed
Quality
Flexibility
Efficiency
WHAT IS ISO TS 16949 ?
ISO technical specification 16949 :2002
represent an expansion of the ISO 9001
requirements for production and relevant
service and parts organization in the
automotive industry
It was prepared by international automotive
task force and Japan automobile
manufacturer association under the auspices
of ISO technical committee 176.
Why adopt ISO TS 16949 ?
Customer requires conformance or certification
Organization want to attain competitive advantage
in domestic and international market
Organization want to bring greater consistency and
discipline to their QMS
Organization want to minimize multiple audits
Organization want to improve as automotive
suppliers
Goal of ISOTS 16949:2002
The goal of ISO TS 16949 :2002 is the
development of a quality management
system that provides for continual
improvement , emphasizing defect
prevention and reduction of variation
and waste in the supply chain .
BASIC STRUCTURE OF
REQUIREMENTS IN ISO TS 16949
ISO 9000 BASED REQUIREMENTS
TS 16949 BASED REQUIREMENTS
CUSTOMER SPECIFIC
REQUIRMENT
REGULATORY
AND STUATORY
REQUIREMENT
Reasons of failure
QMS implementation without building the quality
culture
Lack of top management commitment and
involvement
Employees resistance to change
Barriers between departments
Measuring Quality
QMS viewed as quick fix with emphasis on short terms
goals
Reasons of failure
Although QMS was conceptually applicable to all
depts./ functional areas , in actual practice it was
confined to Quality Assurance or Quality control of
product or service.
Failure to deploy the quality policy throughout the
workforce.
Too many project improvement teams with lost
focus.
Lack of proper understanding of customers and
competition.
Inefficient processes or inadequate process
capability.
Reasons of failure
QMS overly complicated by various tools and
Control techniques. Employees did not see much
purpose.
Clashes with other initiatives. Failure to link QMS
strategically with business goals.
Since QMS has a lot to do with downsizing and
delayring, the middle management did not support.
Many initiatives were left half way because they did
not result in improved profits.
References
1. ISO 9000 :2000
2. ISO 9001:2000
3. ISO 9004:2000
4. ISO TS 16949:2002
Thank you