GE8077 Total Quality Management UNIT 5 Notes.pdf

UNIT 5 QUALITY SYSTEMS
Need for ISO 9000 and Other Quality
Systems, ISO 9000:2000 Quality
System – Elements, Implementation
of Quality System, Documentation,
Quality Auditing, QS 9000, ISO 14000
– Concept, Requirements and
Benefits.
.
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WHAT IS ISO
• ISO- The International Organization for
Standardization was established in 1946 in Geneva,
Switzerland.
• ISO is a non- governmental organization have an
association of National standards Bodies of more
than 150 countries.
• ISO is a specialized agency of maintaining the
quality standards internationally.
• The set of rules and procedures are developed by a
system of technical committees, sub- committees
and working team to an international standards.
• In India, the Bureau of Indian Standards (BIS) is the
national standard body represented on ISO.
UNIT V – QUALITY SYSTEMS
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THE OBJECTIVE OF ISO
• The objective of ISO is to promote the development of
standardization and related activities in the world with a view
to facilitating international exchange of goods and services,
and to developing cooperation in the spheres of intellectual,
scientific, technological and economic activity.
• The results of ISO technical work are published as
International Standards.
• Bureau of Indian Standards (BIS) is the Indian representative
of ISO.
• ISO is the world‟s largest developer of standards that makes a
positive difference, not just to engineers and manufacturers for
whom they solve basic problems in production and
distribution, but to society as a whole.
• ISO provide governments with a technical base for health,
safety and environmental legislation.
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• ISO – 9000 is mainly concerned with “Quality
management”. This means what the organisation
takes an initiative to achieve:
– Customer’s quality requirements.
– Continuous improvement of the quality performance.
– Effective involvement of employees.
• ISO – 14000 is mainly concerned with the
“Environment management”. This means what
the organisation takes an initiative to:
– Minimize harmful development effect on the
environment caused by the several activities involved in
an organisation.
– Maintain sustain development in order to reduce the
environmental degradation.
– Achieve continuous improvement in the environment
system in order to protect the environment.
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ISO 9000 STANDARDS
ISO 9000
Guidelines on selection and use of quality management and
quality assurance standard
ISO 9001 Applicable for the industries which are doing their own design and
development, production, installation and servicing. It has 20
elements. (Design, Development, Production, Installation &
Servicing )
ISO 9002 Applicable for the units excluding R & D functions. It has 18
elements. (Production, Installation & Servicing )
ISO 9003 It covers the final inspection and testing for laboratories and
warehouses etc., it has 12 elements(
Inspection & Testing )
ISO 9004 It provides guidelines to interpret the quality management and
quality assurance. (Provides guidelines on the technical,
administrative and human factors affecting the product or
services. )
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BENEFITS OF ISO 9000 STANDARDS
• Achievement of international standard of quality.
• Higher productivity.
• Value for money.
• Customer satisfaction.
• Growth of the organization
• Competitive advantage in the global market.
• Increased profitability
• Improved corporate image
• Access to global market.
• Consistency in quality.
• Higher morale of employees
• Increased job satisfaction.
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ISO 9004:2000
• The title Quality Management Systems is ISO 9004:2000-
Guidance for Performance Improvement.
• It provides guidance on quality management systems as a
means for continual improvement of processes that contribute
to the satisfaction of an organization‟s customers and other
interested parties.
• The eight quality management principles are defined in ISO
9000:2000, Quality management systems Fundamentals and
vocabulary, and in ISO 9004:2000, Quality management
systems guidelines for performance improvements.
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GUIDELINES FOR PERFORMANCE
MEASUREMENT ISO 9000:2000
1. Customer Focus
Organizations depends on their customers and therefore should understand current
and future customer needs, should meet customer requirements and strive to
exceed customer expectations.
KEY BENEFITS
• Increased revenue.
• Increased customer satisfaction
• Improved customer loyalty.
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
KEY BENEFITS
• Employee motivation
• Minimization in miscommunication between the levels of organization.
• Activities are evaluated, aligned and implemented.
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3. People involvement
People at all levels are the essence of an essence of
organization and their full involvement enables their
abilities to be used for the organization‟s benefit.
KEY BENEFITS
• People involvement, commitment and motivation within
organization.
• Innovation and creativity in furthering the organization‟s
objectives.
• People performance being accounted.
• People‟s participation.
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4.Process approach
A desired result is achieved more efficiently when activities
and related resources are managed as a process.
KEY BENEFITS
• Lower cost and shorter cycle times through use of
resources.
• Improved, consistent and predictable results.
• Focused and prioritized improvement opportunities.
5. System approach to management
Identifying, understanding and managing interrelated
processes as a system contributed to the organization‟s
effectiveness and efficiency in achieving its objectives
KEY BENEFITS
• Integration and alignment of the process.
• Ability to focus on the key process.
• Provide confidence to interested parties.
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6. Continuous improvement
Continual improvement of the organization‟s overall performance should be a permanent
objective of the organization.
KEY BENEFITS
• Performance advantage.
• Alignment of improvement activities at all levels
• Flexibility to react quickly to opportunities.
7. Factual approach to decision making
Effective decisions are based on the analysis of data and information
KEY BENEFITS
• Informed decisions.
• Increased ability to demonstrate the effectiveness of past decisions through reference to
factual records.
• Increased ability to review, challenge, and change opinions and decisions.
8. Mutually beneficial supplier relationship
An organization and its suppliers are interdependent and a mutually beneficial relationship
enhances the ability of both to create value.
KEY BENEFITS
• Increased ability to
• Flexibility and speed of joint responses.
• Optimization of costs and resources
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ELEMENT OF THE QUALITY SYSTEM
ISO – 9001 : 2000 standard has eight elements. These elements (clause) are listed below.
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system (QMS)
a. General requirements
b. Documentation
5. Management responsibility
a. Management Commitment
b. Customer focus
c. Quality policy
d. Planning
e. Responsibility, Authority and communication
f. Management Review
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6. Resource management
a. Provision of management
b. Human resources
c. Infrastructure
d. Work environment
7. Product or service realization
a. Planning of product realization
b. Customer- related processes
c. Design and Development
d. Purchasing
e. Production and service provision
f. Control of monitoring and measuring devices
8. Measurement, Analysis and improvement
a. General
b. Monitoring and measurement
c. Controls of Non- conforming product
d. Analysis of Data
e. Improvement
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Process based Quality Management System
5. Management
Responsibility
8.
Measurement,
Analysis and
improvement
6. Resource
Management
4. QMS continual
improvement
OUTPUT
product/ service
7. Product
realization
INPUT customer
requirement
Customer
Satisfaction
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IMPLEMENTATION A QUALITY SYSTEM
1. Top Management Commitment
2. Appoint the Management Representative
3. Awareness
4. Appoint an Implementation Team
5. Training
6. Time Schedule
7. Select Element Owners
8. Review the Present System
9. Write the Documents
10. Install the New System
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11. Internal Audit
12. Management Review
13. Pre-assessment
14. Registration
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DOCUMENTATION OF QUALITY SYSTEM
The required document for an organisation are:
1. Quality policy manual
2. Quality system
3. Work instructions or practices
4. Records.
Policy
Procedure
Work Instruction or
Practices
Records or proof
HOW
Records or proof
Evidence
WHO ,WHEN &
WHERE
WHY stated once
The Documentation pyramid
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1. Quality policy manual
– Quality policy manual is the top level of documentation. This document
defines ‘What will be done’ and ‘Why’.
– The ‘Why’ part can be stated just once as a quality policy statement. This
statement should be a short, clear, practical, easy to understand and
simple definition of the organisation’s quality intention.
– The policy manual state the quality policy and objective of an organisation.
Each part of the policy should be written within one page or less and
addressed individually.
2. Quality system
– The second level of documentation is the quality procedures. These
procedures describe the methods that will be adopted to obtain the policy that
has been already stated.
– These procedure are the confidential documents and therefore it can be used
in all area of organisation in order to ensure the quality of the system.
– The procedures include the following:
✓ Who should perform the specific task?
✓ When the task should be done?
✓ What task has been completed?
✓ Where the documentation is done?
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3. Work instructions or practices
– Work instruction are the third level of documentation. It gives about “How a task
should be done ?” “Who should undertake the task ?” and“ What records are to be
maintained ?”
– These instructions are written for the department, task, machine and product
activities.
– The work instructions are :
✓ Detailed drawing
✓ Route sheet
✓ Process sheet
✓ Photographs
✓ Video
✓ Specific job instruction
✓ Sample comparison of Non- conformity
4. Records
– Records are the bottom level of documentation that are used to show the policies,
procedures and work instructions stated before are being followed
– Records may be forms that are filled up, stamps of approval, signature and date on
the document etc.
– Records are evidence that are used to identify “ What activity has completed ?” and
“ Who has done it ?”. UNIT V – QUALITY SYSTEMS
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BENEFITS OF DOCUMENTATION
1. It provides guidelines for managing the quality
system.
2. It provide formats and procedures for
standardizing practices.
3. It gives information for taking corrective action if
anything goes wrong.
4. It create confidence among the employees.
5. It satisfies the customer requirements.
6. It demonstrate the ISO quality system
certification.
7. It provide the basis for continual improvement.
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QUALITY AUDITING
• The term audit refers to a regular examination
and periodical checking of accounts or
adjustment of financial accounts and settlement
etc.
• It is also refers to checking, inspection and
verification of production processes.
• Definition - “ A Systematic and independent
examination to determine whether quality
activities and related results comply with planned
arrangements and whether these planned
arrangements are implemented effectively and
are suitable to achieve objective.”
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FEATURES OF QUALITY AUDITING
i. The quality audit applies to quality systems or quality
elements such as product, processes and service etc. Such
audits are often called ‘Quality system’, ‘process quality
audits’, and ‘service quality audits’ respectively.
ii. Quality audits are carried by staff who are not directly
responsible in the areas being audited, but preferably
they should work in cooperation with relevant personnel.
iii. Quality audits may be conducted for internal or external
purposes. It is not necessary to cover the whole quality
system, at once, but may cover its elements.
iv. Quality audit is an information gathering activity but it is
not finding the mistake.
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OBJECTIVE OF QUALITY AUDITING
i. To establish a good quality system.
ii. To establish the conformity of the quality system
elements with regards to specified requirement.
iii. To determine the effectiveness of the implemented
quality system with regards to the specific quality
objective.
iv. To meet regularity requirements, if applicable.
v. To permit the listing of the audited organisation’s quality
system in a register for outside agency certification.
vi. To evaluate the organisation’s present quality system
against a standard quality system.
vii. To help the organisation for decision making purposes.
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TYPES OF QUALITY AUDITING
I. According to the nature of audit.
a. Internal Audit (or) First party audit
b. External Audit (or)
i. Second – party audit.
ii. Third – party audit.
II. According to the areas selected in an
organisation.
a. System Audit
b. Process Audit
c. Product Audit
d. Adequate Audit
e. Compliance Audit
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i. Internal Audit (or) First party audit:
– The audit is carried out by the personnel within
the organisation. The personnel conducting the
audit is not directly connected with the process.
ii. Second – party audit:
– The audit is conducted by one organisation on
another organisation. The audit is performed by
customer on the supplier.
iii. Third – party audit:
– The audit is generally conducted by an
independent organisation or recognised certified
agencies for the purpose of accreditation
certification. UNIT V – QUALITY SYSTEMS
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a. System Audit:
– The System audit is carried out in order to check all the activities of the
organisation (performance) according to the documented procedure.
– This audit can be performed either internally or externally. This audit is to
be conducted before a contract is given to a supplier.
– The audit should be done in order to evaluate the ability of the potential
supplier for providing the quality products.
b. Process Audit:
– Process audit checks that the manufacturing processes and testing
operations are performing according to the prescribed standards.
– This can be performed either can internally or externally. This involves
auditing processes such as turning, welding, brazing, coil winding,
painting etc.
c. Product Audit:
– The product audit is carried out to measure the level of conformity of the
product to a specified quality standards.
– This audit verifies the accuracy of the equipment and calibration process.
It may be conducted by the customer before delivering to their
requirementd. UNIT V – QUALITY SYSTEMS
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d. Adequacy Audit (or) System management audit:
– To determine the extent to which the document system
represented by quality manual and the associated procedures
adequately meets the requirement of the customers.
e. Compliance Audit:
– It seeks to establish the extent to which the documented
system is implemented and observed by the work force of the
organisation in their various activities.
THE STAGES OFAN AUDIT
1. Information gathering 2. Preparation
3. Opening meeting 4. The audit process
5. The closing meeting 6. Audit report and completion
7. Corrective action and follow- up.
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QS 9000 QUALITY SYSTEM
• QS 9000 quality system was developed by the three
big U.S. automobile manufacturers – chrysler, Ford
and General motors in 1994.
• It is extension an extension of ISO – 9000 system
and has been developed specifically for automobile
industry.
• QS – 9000 replace the separate systems followed by
each of the automobile company and it makes the
suppliers to adopt one quality system that is
acceptable to all the automobile manufacturers.
• Thus QS – 9000 lays down a common set of
requirements for all automotive industries.
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Objectives of QS – 9000
– The goal of QS – 9000 is to develop fundamental quality system that provided
for continuous improvement, defect prevention, reduction in variations,
reduction in cycle time, waste eliminate, improved utilization of materials,
machines and man – power and man power, and customer satisfaction.
Clauses of QS – 9000
• Section I: ISO 9000 based requirement
• Section II: Automobile sector specific
requirement
• Section III: Customer specific requirement
Benefits of QS – 9000
1. It prevents the defects and thus reduction in variations.
2. It reduce the cycle time.
3. Improvement utilization of materials, machines and man power.
4. The company achieves the credibility as a high quality supplier of automotive
products.
5. Increased customer satisfaction.
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ISO 14000 – THE ENVIRONMENT
MANAGEMENT SYSTEM
• The International organisation for standards (ISO) has been
designed a comprehensive set of standards for environment
management (ISO 14000 series of standards) in 1992.
• The ISO 14000 standards aims a world wide focus on environment
and encouraging a cleaner, safer and healthier world for all.
• It allows the organisation to achieve the internationally criteria
with respect to environment.
• This standards build a global management system that allows the
organisation to effectively manage the environment
responsibilities, reduce liabilities, save costs and promotes the
organisation for the public.
• To compete with global market, it is very essential to get
environmental management certification.
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Terminology used in ISO 14000 standards
1. Environment
2. Environment aspect
3. Environment impact
4. Environment objective
5. Environment target
ISO 14000 series of standards
1. Organisation evaluation standards
a. Environment Management systems (EMS)
b. Environment Auditing (EA)
c. Environment Performance Evaluation (EPS)
2. Product evaluation standards
a. Environment Aspects in product standards (EAPS)
b. Environment Labels and declarations (ELD)
c. Life Cycle Assessment (LCA)
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CONCEPT OF ISO 14000
• The ISO 14000 series of standards can be applicable to all types
and sizes of organisations are designed to take into account of
diverse geographical, culture and social conditions.
• It is to be noted that the requirements of the standard are based on
the process but not on the product.
• The overall aim of the system is to provide continuous,
improvement, protection to the environment and to prevent
pollution.
Stages of EMS model:
1. Environment policy
2. 2. Planning
3. Implementation and operation
4. Checking and correction action
5. Management review UNIT V – QUALITY SYSTEMS
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Environment
policy
planning
Management
Review
Checking and
Correction
Action
Implementation
and operation
Continual
Improvement
Environment Management System model
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Requirement of ISO 14000
1. General requirement
2. Environment policy
3. Planning
a. Environment aspects
b. Legal and other requirements
c. Objective and targets
d. Environment management programs
4. Implementation and operation
a. Structure and responsibility
b. Training, awareness and competency
c. Communication
d. EMS documentation
e. Document control
f. Operation control and
g. Emergency preparedness and response.
5. Checking and correction action
a. Monitoring and measuring
b. Non – conformance, correction and prevention action
c. Records and
d. EMS audit
6. Management review
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BENEFITS of ISO 14000
GLOBAL BENEFITS
• Facilitate trade & remove trade barrier
• Improve environmental performance of planet earth
• Build consensus that there is a need for environmental management and a
common terminology for EMS
ORGANIZATIONAL BENEFITS
• Assuring customers of a commitment to environmental management
• Meeting customer requirement
• Improve public relation
• Increase investor satisfaction
• Market share increase
• Conserving input material & energy
• Better industry/government relation
• Low cost insurance, easy attainment of permits & authorization
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