Noida Institute of Engineering and Technology,

Greater Noida

Quality Systems and Certification

Unit: 05
Total Quality Management

Dr. Kamlesh Paswan

SUBJECT CODE: AOE0861 Assistant Professor

Department of Mechanical
Engineering
B Tech VIII Sem

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 NOIDA INSTITUTE OF ENGINEERING AND
TECHNOLOGY, GREATER NOIDA
Evaluation Scheme

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Dr. Kamlesh Paswan TQM Unit-V
 Subject Syllabus

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07/06/2024 MD.Raza DL&CD Unit1
 Branch wise Applications

• For all Braches of engineering the Total Quality Management is used to

• fault detection on production level

• Quality functions in services

• Total productive maintenance

• Leadership in quality control

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 Course Objective

The intended objectives of this course are given as follows:

• Study about evolution of Total Quality Management,
inspection and control of a product.
• Study about organization structure , design and quality
function
• Analysis of control chart and its application
• Study of defects diagnosis and its prevention
• Study about various standards and its concepts

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 Course Outcomes
Course outcomes : After completion of this course students will be able to

CO 1 K1, K2
Study about evolution of Total Quality Management, inspection
and control of a product.. .
CO 2 K1, K4
Study about organization structure , design and quality function

CO 3 K3
Analysis of control chart and its application

CO 4 Study of defects diagnosis and its prevention K2

CO 5 Study about various ISO standards and its concepts K2

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 Program Outcomes
• Program Outcomes are narrow statements that describe what the students
are expected to know and would be able to do upon the graduation.

• These relate to the skills, knowledge, and behavior that students acquire
through the programmed.

1. Engineering knowledge 9. Individual and team work

2. Problem analysis 10. Communication
3. Design/development of solutions 11. Project management and
4. Conduct investigations of complex finance
problems 12. Life-long learning
5. Modern tool usage
6. The engineer and society
7. Environment and sustainability
8. Ethics

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 CO-PO Mapping

COs PO1 PO2 PO3 PO4 PO5 PO6 PO7 PO8 PO9 PO10 PO11 PO12

AOE0861.1 3 2 1 2 - - - 2

AOE0861.2 3 3 2 - - - - - - - - 2

AOE0861.3 2 3 2 2 - - - - - - - 2

AOE0861.4 3 3 3 2 - - - - - - - 2

AOE0861.5 3 2 1 - - - - - - - - 2

AVERAGE 2.8 2.6 2 2 - - - - - - - 2

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 Program Specific Outcomes
• Program Specific Outcomes (PSOs) are what the students should be able to do at the time
of graduation. The PSOs are program specific. PSOs are written by the department offering
the program.
• On successful completion of B. Tech. (EC) Program, the Electronics and Communication
engineering graduates will be able to:

PSO1: To apply the knowledge of mathematics, science and electronics & communication
engineering to work effectively in the industry based on same or related area.

PSO2: To use their skills to work in modern electronics & communication engineering tools,
software and equipments to design solutions for complex problems in the related field
that meet the specified needs of the society.

PSO3: To function effectively as an individual and as a member or leader of a team by

qualifying through examinations like GATE (Graduate Aptitude Test in Engineering),
IES (Indian Engineering Services), PSUs (Public Sector Undertakings), TOEFL (Test of
English as a Foreign Language), GMAT (Graduate Management Admission Test) and
GRE (Graduate Record Examinations in US) etc.
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 CO-PSO Mapping

COs PSO 1 PSO 2 PSO 3

AOE0861.1 3 3
AOE0861.2
3 3
AOE0861.3
3 3
AOE0861.4
3 3
AOE0861.5
3 3
Avg.
3 3

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 Program Educational Objectives (PEOs)

Not applicable

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 End Semester Question Paper Template
B.Tech (Semester -Theory Examination 2021-22) Total Marks : 100
Note: Attempt all sections. If require any missing data, then choose suitably. Time: 3 hours
Section A
1. Attempt all questions in brief. 2 X 10 = 20
Q. No. Question Marks CO
a. to j 2
Section B
2. Attempt any three of the following 3 X 10 = 30
Q. No. Question Marks CO
a to e 10
Section C
Question no. 3,4,5,6,7. Attempt any one of the following 1 X 10 = 10
a 10
b 10

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 Prerequisite

Prerequisite:
• Basic knowledge of Statistical Analysis.
• Knowledge of Production process.
• Basic Knowledge of Management policy

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 Brief Introduction about the Subject with
videos
This course is intended to provide the students with a comprehensive all
essential quality control techniques needed for designers, engineers,
manufacturing plants and service sectors. It gives details of quality concepts,
control on purchased product, manufacturing quality, Total Quality
Management, human factor in quality, control charts, defects diagnosis and
prevention, quality standards
Video Link
• https://www.youtube.com/watch?v=Iecj9xmIfXM&ab/channel=nptelhrd
• https://nptel.ac.in/courses/117/106/11710686
• https://www.youtube.com/watch?v=yWlAOFs04gk
• https://www.youtube.com/watch?v=QifqIoUNTJl
• https://www.youtube.com/watch?v=qb3mvJ1gb9g
• https://www.youtube.com/watch?v=2ePeXePNLr
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 Unit Content

Statistical process and Quality control

 Introduction of Quality Systems- ISO 9000

 Introduction of Quality Systems- ISO 9000:2000

 Introduction of Quality Systems- ISO 14000

 Quality Auditing

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 Unit Objective

• The intended objective of this unit is to understand Continuous

Process Improvement in TQM.

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 Topic Objective/Topic Outcome

Topic Objective Topic outcome Mapping

with CO
Student can understand CO5
Introduction of Quality the ISO 9000 series of
standards
Systems- ISO 9000

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 INTRODUCTION (CO5)

Introduction to ISO 9000

ISO 9000 is a set of international standards for quality

management systems. These standards help organizations ensure
that they meet the needs of customers and other stakeholders
while meeting statutory and regulatory requirements. By
implementing ISO 9000, businesses can improve their efficiency,
reduce waste, and enhance customer satisfaction.

by Dr. KAMLESH PASWAN

 INTRODUCTION (CO5)

The International Organization for Standardization (ISO) was

founded in 1946 in Geneva, Switzerland, where it is still based.
• Its mandate is to promote the development of international
standards to facilitate the exchange of goods and services
worldwide.
• ISO is composed of more than 90 member countries.
• The United States representative is the American National
Standards Institute (ANSI).

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 Purpose (CO5)

The Purpose of ISO 9000

ISO 9000 is a set of international standards for quality management
and quality assurance. It aims to help organizations ensure they
meet the needs of customers and other stakeholders while meeting
statutory and regulatory requirements related to the product.
Standards (CO5)

The ISO 9000 family of

standards
• Quality management: The ISO 9000 family covers various aspects of
quality management systems.
• Process improvement: It focuses on enhancing processes and ensuring
consistent quality and customer satisfaction.
• International recognition: ISO 9000 standards are recognized globally
for their effectiveness in ensuring product and service quality.
 ISO 9001 standard (CO5)

The ISO 9001 standard

Benchmark for Quality Process Approach Risk-Based Thinking

ISO 9001 sets the criteria for a It emphasizes the importance of Organizations are required to
quality management system, understanding and managing consider risk in the context of
focusing on meeting customer interrelated processes as a their management system and
requirements and enhancing system, contributing to the address it accordingly to
satisfaction. organization's effectiveness and enhance its capabilities.
efficiency.
 Benefits (CO5)

Benefits of ISO 9000 certification

1 Improved Quality 2 International Recognition

ISO 9000 certification ensures consistent It enhances credibility and trust in the global
product and service quality, leading to market, opening doors to new international
increased customer satisfaction. business opportunities.

3 Operational Efficiency 4 Continuous Improvement Culture

Streamlined processes and improved resource It fosters a culture of continuous improvement
management result in cost savings and higher and innovation, driving long-term business
profitability. success.
 ISO 9000 (CO5)

Implementing ISO 9000

Implementing ISO 9000 involves integrating quality
management principles into the organization's
processes.

Clear communication, employee involvement, and

systematic approach are crucial for successful
implementation.

Continuous improvement and strong leadership

support are key factors in the implementation
process.
Common challenges in ISO 9000
implementation

Resistance to Change 1
Employees or management may resist
new processes and quality standards.
2 Resource Allocation
Allocating time and resources for
implementation can be a challenge.
Training and Awareness 3
Ensuring that all employees are fully
trained and aware of ISO 9000
requirements.
 Certification Process (CO5)

ISO 9000 Certification Process

Documentation Preparation Internal Audits
Compile all necessary documentation for the Conduct internal audits to identify any non-
organization's quality management system. conformities and areas for improvement.

Management Review Certification Audit

Hold a management review to assess the Undergo a certification audit conducted by an
effectiveness and suitability of the quality accredited certification body to assess compliance
management system. with ISO 9000 standards.
 Certification Process (CO5)

Maintaining ISO 9000 Certification

Quality Control Documentation Continual Improvement

Management
Regular audits and inspections Continuous review and
ensure adherence to quality Efficient management of enhancement of processes for
standards. documents and records is crucial ongoing compliance.
for compliance.
 ISO 9000 Series of Standards (CO5)

• The ISO 9000 Series of Standards is generic in scope. By design, the

series can be tailored to fit any organization’s needs,
whether it is large or small, a manufacturer or a service
organization.
• It can be applied construction, engineering, health care, legal, and
other professional services as well as the manufacturing of anything
from nuts and bolts to spacecraft.
• Its purpose is to unify quality terms and definitions used by
industrialized nations and use those terms to demonstrate a supplier’s
capability of controlling its processes.

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 ISO 9000 Series of Standards (CO5)

• The ISO Technical Committee (TC) 176 developed a series of international

standards for quality systems, which were first published in 1987.
• The standards (ISO 9000, 9001, and 9004) were intended to be advisory and
were developed for use in two-party contractual situations and internal
auditing.
• However, with their adoption by the European Community (EC) and a
worldwide emphasis on quality and economic competitiveness, the standards
have become universally accepted.

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 ISO 9000 Series of Standards (CO5)

• The fourth edition of ISO 9001 was released in the year 2008 and it
replaces the third edition (ISO9001:2000), which had been amended to
clarify the points in the text and also to enhance the compatibility with
ISO 14001:2004.
• Most countries have adopted the ISO 9000 series as their national
standards.
• Likewise, thousands of organizations throughout the world have quality
systems registered to the standard.

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 Benefits of ISO Registration
(CO5)
• Internal quality as measured by the percent of scrap, rework, and
nonconformities at final inspection.
• Production reliability as measured by the number of breakdowns per month,
percent of time dedicated to emergencies, and percent of downtime per shift.
• External quality as measured by product accepted by customers without
inspection, claims of nonconforming product, and returned product.

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 Benefits (CO5)

• Time performance as measured by time to market, on-time delivery, and

throughput time.
• Cost of poor quality as measured by external nonconformities, scrap, and
rework.
• On the negative side, prevention and appraisal costs increased.

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 Three standards (CO5)

ISO 9000:2005—Quality Management Systems (QMS)—fundamentals and vocabulary

discusses the fundamental concepts related to the QMS and provides the terminology
used in the other two standards.

ISO 9001:2008—Quality Management Systems (QMS)—requirements is the standard

used for registration by demonstrating conformity of the QMS to customers, regulatory,
and the organization’s own requirements.

ISO 9004:2000—Quality Management Systems (QMS)—guidelines for performance

improvement provides guidelines that an organization can use to establish a QMS
focused on improving performance.

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 Sector-specific Standards (CO5)

• The ISO 9000 system is designed as a simple system that

could be used by any industry.
• Other systems have been developed that are specific to a
particular industry such as automotive or aerospace.
• These systems use the ISO 9001 as the basic framework and
modify it to their needs.
• There are currently three other quality systems:
AS9100, ISO/TS 16949, and TL 9000

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 AS9100 (CO5)

• This aerospace industry quality system was officially released by the

Society of Automotive Engineers in May 1997.
• Its development and release represents the first attempt to unify the
requirements of NASA, DOD, and FAA, while satisfying the aerospace
industry’s business needs.
• In March 2001, the International Aerospace Quality Group (IAQG)
aligned AS9100 with ISO 9001:2000.
• Industry-specific interpretations and methodologies are identified in
italics and bold type.

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 AS9100 (CO5)

• These additions are accepted aerospace approaches to quality practices

and general requirements.
• Aerospace organizations in Europe, Japan, and the U.S. will certify
registrars and auditors.
• AS 9100 Revision C is released in January 2009.

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 ISO/TS 16949 (CO5)

• This standard is entitled Quality Systems Automotive Suppliers—Particular

Requirements for the Application of ISO 9001.
• It harmonizes the supplier quality requirements of the U.S. big three as provided in
QS 9000 Third Edition with the French, German and Italian automakers.
• The standard has been approved by Asian auto makers.
• The goal of this technical specification is the development of fundamental quality
systems that provide for continuous improvement, emphasizing defect prevention,
and the reduction of variation and waste in the supply chain.

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 ISO/TS 16949 (CO5)

There are three basic levels:

(1) ISO 9001,
(2) sector-specific requirements, and
(3)company-specific requirements, and
if appropriate levels for division-specific, commodity-specific, and part specific
requirements.
• Registrars will need to be certified to the standard and their number will be
limited.
• It is assumed that this standard will show the same rate of improvement as QS
9000.
• GM reported that supplier parts-per-million defect rate improved about 85% for
the first five years of the use of QS 9000.

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 TL 9000 (CO5)

• the structure of the TL 9000 standard and its five layers. The first layer is the ISO
9000 requirements.
• It is followed by Book 1, called TL9000 Quality System Requirements (QSR), which
establishes a common set of requirements applicable to hardware, software, and
services.
• The second layer of Book 1 provides specific requirements for hardware, software,
and services.

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 TL 9000 (CO5)

• The Quality Excellence for Suppliers of Telecommunications Forum

(QuEST) wrote TL 9000 to consolidate the various quality system
requirements within the telecommunications industry.
• This forum was created to develop the standard wherein suppliers such
as Motorola and Lucent, and telecom service providers such as Verizon,
Southwestern Bell, and AT&T would have an equal vote in developing
the new strategy.
• It is a specific set of requirements based on ISO 9001 that defines the
design, development, production, delivery, installation, and
maintenance of telecommunications products and services.

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 TL 9000 (CO5)

• In the first layer of Book 2, called Quality System Measurements

(QSM), the common industry measurements such as billing errors are
specified.
• In the last layer the specific measurements for hardware, software, and
services are defined.

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 TL 9000 (CO5)

Structure of the TL 9000 Requirements

ISO 9001 Requirement

Common TL 9000 Requirements (QSR)—Book 1

Software Specific Services Specific

Hardware Specific
Requirements Requirements
Requirements

Common TL 9000 Measurements (QSM)—Book 2

Hardware Specific Software Specific Services Specific
Measurements Measurements Measurements

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 TL 9000 (CO5)

• The unique feature of the standard is the use of the metrics specified in the
QSM book to communicate and monitor actual results.
• Cost and performance-based metrics provides information to enable the
industry to measure progress and evaluate results of quality system
implementation.

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 ISO 9001 Requirements
(CO5)
• The standard has eight clauses:
• Scope, Normative References, Definitions, Quality Management Systems, Management
Responsibility, Resource Management, Product and/or Service Realization, and
Measurement, Analysis, and Improvement
• The first three clauses are for information while the last five are requirements that an
organization must meet.
• The numbering system used in the standard is followed in this section.
• The application of a system of processes within an organization, together with their
identification and interactions and the managing of these processes, is referred to as
the process approach.

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 Requirements (CO5)

This approach emphasizes the importance of:

• Understanding and fulfilling the requirements.
• The need to consider processes in terms of value added.
• Obtaining results of process performance and effectiveness.
• Continual improvement of processes based on objective measure.

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 Requirements (CO5)

Model of a Process-Based Quality Management System

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 Topic Objective/Topic Outcome

Topic Objective Topic outcome Mapping

with CO
Students are able to CO5
Introduction of Quality understand Quality
Systems- ISO 9000:2000
Systems- ISO 9000:2000

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 ISO 9000:2000 (CO5)

Introduction to ISO
9000:2000
ISO 9000:2000 is a set of international standards for
quality management and quality assurance. It focuses
on meeting customer requirements and enhancing
customer satisfaction. The standards apply to
organizations of all sizes and industries, aiming to
improve processes and ensure consistent quality.
 Key principles (CO5)
Key principles of ISO 9000:2000
Customer Focus Leadership
Organizations depend on their customers and Establish unity of purpose and direction within
therefore should understand current and future the organization. Leaders should create and
customer needs, meet customer requirements, maintain the internal environment in which
and strive to exceed customer expectations. people can become fully involved in achieving
the organization’s objectives.

Full Involvement of People Process Approach

Engage the entire workforce to accomplish the Consistent, standardized procedures and
organization's objectives. Employees at all processes are essential to meet customer
levels are the essence of an organization and requirements effectively. Understanding and
their full involvement enables their abilities to managing interrelated processes as a system
be used for the organization's benefit. contributes to the organization’s effectiveness
and efficiency in achieving its objectives.
Benefits of implementing ISO
9000:2000
• Improved Efficiency: Streamlining processes to reduce waste and
improve productivity.
• Enhanced Customer Satisfaction: Meeting quality standards leads to
satisfied customers.
• International Recognition: Gaining credibility and access to global markets.
 Requirements (CO5)

Requirements of ISO 9000:2000

1 Documentation
Clear documentation of processes and procedures is required.

2 Standard Operating Procedures

Establishing and following standard operating procedures is mandatory.

3 Quality Control Measures

Implementing effective quality control measures is essential.
 Documentation (CO5)

Documentation and Record Keeping

Accurate Documentation Comprehensive Records

Effective record keeping ensures the Thorough documentation encompasses

accurate documentation of processes and quality manuals, work instructions, and
procedures within the organization. documented procedures.

It provides a clear trail of information for It also includes records of non-

audits and traceability. conformances and corrective actions for
continuous improvement.
 Auditing (CO5)

Auditing and Certification Process

The auditing process involves independent
assessment of the company's processes and
systems to ensure compliance with ISO 9000:2000
standards.
Certification is the formal recognition that an
organization meets the requirements of the ISO
9000:2000 standard.
Continuous improvement and corrective
actions
Continuous Corrective Actions Feedback
Improvement Mechanisms
These are steps taken to
It involves ongoing efforts address non-conformities Establishing effective
to enhance products, and prevent their feedback loops for
services, or processes. recurrence. gathering and acting on
insights.
 Case studies (CO5)

Case studies of successful ISO 9000:2000

implementation

Improved Quality Control Enhanced Employee Streamlined Supply Chain

Training
Achieved zero product defects, Optimized supply chain
resulting in increased customer Implemented comprehensive processes, reducing lead times
satisfaction and market training programs leading to a and minimizing inventory costs.
reputation. well-informed and skilled
workforce.
 Challenges (CO5)
Challenges and potential pitfalls
Implementation Complexity
1 Integrating ISO standards with existing processes

Resource Allocation
2
Allocating sufficient time and budget for compliance

Employee Resistance
3 Resistance to change and new documentation
requirements

Auditing Burden
4 Managing the workload for regular audits and
inspections
 Topic Objective/Topic Outcome

Topic Objective Topic outcome Mappi

ng
with
CO
Student are able to CO5
Introduction of Quality understand basic of Quality
Systems- ISO 14000
Systems- ISO 14000

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ISO 14000 (CO5)

ISO 14000:
Environmental
Management Standard

ISO 14000 is a family of international standards that provide

practical tools for companies and organizations of all kinds
looking to manage their environmental responsibilities. It offers a
framework for organizations to follow to set up an effective
environmental management system (EMS). The ISO 14000
standards are designed to be applicable to any organization,
regardless of its size, type, or nature.
 Introduction to ISO 14000 (CO5)

1 Evolution of ISO 14000

The ISO 14000 family of standards was first
published in 1996 and has since been revised to keep
it relevant to the evolving environmental challenges.
It covers various aspects of environmental
management, providing practical tools for
organizations looking to identify and control their 2 Core Objectives of ISO 14000
environmental impact. The standards are developed ISO 14000 aims to help organizations minimize how their
through a consensus-based approach involving operations negatively affect the environment and comply with
experts from various countries and stakeholders from applicable laws, regulations, and other environmentally
different sectors. oriented requirements. It promotes sustainable development by
encouraging organizations to consider environmental issues in
their decision-making processes and emphasizes the need for
3 Importance of ISO 14000 organizations to continually improve their environmental
Implementing ISO 14000 standards can provide performance.
organizations with a competitive edge, as it
demonstrates their commitment to environmental
responsibility. It helps in identifying and
managing potential environmental risks, reducing
the likelihood of environmental incidents and
ensuring compliance with legal and regulatory
requirements. Adhering to ISO 14000 standards
can enhance an organization's reputation and
build trust with stakeholders, including
customers, regulators, and the public.
 Benefits of Implementing ISO 14001
(CO5)

Environmental Legal and Regulatory Business

Performance Compliance Opportunities
Improvement
ISO 14001 helps ISO 14001 certification can
Implementing ISO 14001 can open doors to new markets by
organizations ensure
lead to improved resource demonstrating a commitment
compliance with
efficiency, reduced waste, and to environmental
environmental laws and
a lower consumption of responsibility and
regulations, reducing the risk
energy and materials. It often sustainability. It meets the
of legal penalties and
results in cost savings through expectations of
sanctions. It assists in
improved operational environmentally conscious
identifying and addressing
efficiencies and a reduction in customers who prefer to
potential environmental risks,
waste management costs. engage with environmentally
ensuring that organizations
Organizations can make a responsible organizations and
operate within legal
positive impact on the provides access to a wider
boundaries and enhances an
environment by reducing their range of business
organization's reputation and
carbon footprint and opportunities through public
credibility.
minimizing pollution. and private sector tenders.
 Key Elements of ISO 14001
(CO5)

1 Environmental Policy 2 Planning

Establishing an environmental policy that Identifying environmental aspects and
outlines the commitment to compliance, impacts, legal and other requirements, and
pollution prevention, and continual setting objectives and targets for the
improvement in environmental organization’s environmental performance.
performance.

3 Implementation 4 Measurement & Evaluation

Allocating resources, roles, responsibilities, Monitoring, measuring, analyzing, and
training, and communication to ensure evaluating the organization's environmental
effective implementation of the performance against its objectives and legal
environmental management system. and other requirements.
 Certification (CO5)

ISO 14001 Certification Process

Gap Analysis Documentation
Assessing the current system against the Developing the necessary documentation and
requirements of the ISO 14001 standard to records to support the implementation and
identify areas for improvement. operation of an organization's environmental
management system.

Internal Audit External Audit

Conducting internal audits to ensure Engaging a certification body to conduct an
compliance and effectiveness of the external audit for ISO 14001 certification.
environmental management system.
 FEM (CO5)

Future of Environmental Management

Technology Integration Renewable Energy Focus on Sustainability

Advancements in technology Greater adoption of renewable Businesses will prioritize
will lead to more efficient and energy sources will contribute sustainable practices to meet
sustainable environmental to reducing environmental evolving environmental
management practices. impact. standards and consumer
expectations.
Implementing ISO 14000: Best Practices
(CO5)

Thorough Training Continuous Engage Stakeholders

Monitoring
Ensure all employees Engage with internal
receive adequate Establish systems for and external
training on the continuous monitoring stakeholders to gather
requirements and and evaluation of insights, encourage
implementation of environmental participation, and
ISO 14000 standards. performance to drive promote transparency
ongoing improvement. in environmental
management efforts.
 Global Impact of ISO 14000 (CO5)

Environmental Performance Legal and Regulatory Business Opportunities

Improvement Compliance

Resource Efficiency Adherence to Laws Market Access

Cost Savings Risk Mitigation Customer Expectations

Positive Environmental Enhanced Reputation Tender Eligibility

Impact
 Key Elements (CO5)

Key Elements of ISO

14001
ISO 14001 sets the criteria for an environmental management system,
providing a framework for organizations to follow to enhance their
environmental performance. It comprises several key elements that
organizations must address to achieve ISO 14001 certification.
 Environmental Policy (CO5)

Environmental Policy
1 Establishing Policy
The first step in implementing ISO 14001 is to develop an environmental policy that outlines the
organization's commitment to compliance and continual improvement.

2 Communicating Objectives
The policy should be communicated to all employees and stakeholders, ensuring that everyone
understands their role in achieving environmental objectives.

3 Regular Review
It should be regularly reviewed and updated to reflect changes in the organization's environmental
objectives and the context in which it operates.
 Planning and Implementation (CO5)

Planning and Implementation

Environmental Aspects Legal and Other Objectives and Targets
Requirements
Organizations need to identify Setting environmental objectives
and assess the environmental They must establish and and targets that are consistent
aspects of their operations, maintain procedures to identify, with the environmental policy
products, and services to access, and ensure compliance and conducting planning to
determine potential impacts. with applicable legal and other achieve them.
requirements.
 INTRODUCTION (CO5)

Operational Control

Training and Awareness Emergency Preparedness Documented Information

Providing appropriate training
and ensuring that employees Establishing and maintaining Ensuring that the necessary
are aware of the relevance and procedures to identify potential documented information is
importance of their activities for and respond to accidents maintained to support the
and how they contribute to the and emergency situations. operation and control of
achievement of environmental processes.
objectives.
 Performance Evaluation (CO5)

Performance Evaluation
1 Monitoring and Measurement 2 Compliance Evaluation
Organizations need to establish and Conducting periodic evaluations to
maintain documented procedures to ensure compliance with applicable legal
monitor and measure key characteristics and other requirements.
of their operations that can have a
significant environmental impact.

3 Internal Audit
Performing internal audits at planned intervals to provide information on whether the EMS
conforms to the organization's requirements and ISO 14001.
 ISO 14001 (CO5)

ISO 14001 Certification Process

Preparing for External Audit and Corrective Actions and
Certification Certification Certification
Organizations conduct a gap Selection of Certification Addressing Non-
analysis to identify areas Body, Stage 1 Audit, Stage 2 Conformities, Certification
where their current practices Audit. Decision, Certification
do not meet the requirements Maintenance.
of ISO 14001.
 ISO 14001 Certification (CO5)

Maintaining ISO 14001 Certification

Continuous Improvement Surveillance Audits Recertification

Organizations should continually Periodic surveillance audits are ISO 14001 certification is
seek opportunities to enhance conducted by the certification typically valid for a set period,
their EMS and environmental body to verify the continued after which organizations need to
performance. effectiveness and improvement of undergo a recertification process
the EMS. to maintain their certification.
 Benefits (CO5)

Benefits of ISO 14001

Environmental Performance Improvement Compliance with Legal Requirements

Cost Savings through Resource Efficiency Enhanced Reputation and Stakeholder Relations
 Topic Objective/Topic Outcome

Topic Objective Topic outcome Mapping

with CO

CO5
Quality Auditing Student are able to

understand basic of Quality

Auditing

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 Introduction to Quality
Auditing (CO5)

Quality auditing is a systematic examination of a

company's quality management system. It ensures
adherence to quality standards and identifies areas
for improvement. Auditors review processes,
procedures, and documents to validate
compliance. Continuous improvement is a key goal
of quality audits.
 Importance of Quality Auditing (CO5)

Importance of Quality Auditing in Business

Quality Assurance Risk Management
Ensures products and services meet high Identifies potential risks and helps
standards and customer expectations. prevent quality-related issues before they
occur.

Compliance Customer Satisfaction

Ensures adherence to industry Improves customer satisfaction by
regulations and standards, avoiding delivering consistent, high-quality
penalties and legal issues. products and services.
 Principles (CO5)

Key principles of quality auditing

• Independence: Auditors must remain impartial and free from conflicts of interest, ensuring
unbiased assessments.
• Integrity: Upholding honesty and ethical conduct throughout the auditing process,
maintaining the trust of stakeholders.
• Professional judgment: Applying expertise and knowledge to evaluate processes,
identifying areas for improvement.
 Types of Quality Audits (CO5)

Types of Quality Audits

Process-Based Audits Product-Based Audits System-Based Audits

Focuses on evaluating the Examines the quality of the Reviews the overall
effectiveness of processes end product to ensure it management system of an
within an organization to meets the required organization, including
ensure compliance with specifications and policies, procedures, and
standards and regulations. standards. objectives.
 Planning (CO5)

Planning and preparation for a quality audit

1 Identify Audit Scope
Determine the areas and processes to be evaluated in the audit.

2 Develop Audit Criteria

Establish the standards and benchmarks against which to assess performance.

3 Assemble Audit Team

Select qualified individuals to conduct the audit, ensuring diverse expertise.
 Conducting a quality audit (CO5)

Conducting a quality audit

When conducting a quality audit, it's essential
to follow a structured approach.

Thoroughly review processes, procedures,

and documentation for compliance with
standards.
Interviewing staff and observing operations
are key methods to gather relevant
information.
 Documentation (CO5)

Reporting and documenting audit findings

Clear Communication Comprehensive Reports
It's essential to clearly communicate audit Reports should be comprehensive,
findings to ensure no misinterpretation. detailing all findings and observations
during the audit.

Objective Documentation Actionable Recommendations

Document the findings objectively, without Include actionable recommendations to
bias, to maintain the integrity of the audit address any identified issues or non-
process. conformities.
 Follow-up (CO5)

Corrective Actions and Follow-up After an

Audit
Evaluate Findings
Thoroughly assess the audit findings to identify root causes and trends.

Develop Action Plan

Create a detailed plan outlining specific actions to address the identified
issues.

Implement Changes
Execute the action plan with clear responsibilities and timelines for each
task.
 Best Practices (CO5)

Best Practices for Quality Auditing

Preparation Team Involvement Continuous Evidence-Based

Improvement Approach
Thoroughly review Engage a diverse
all relevant team of auditors to Implement feedback Rely on tangible
documentation and provide varied from audits to evidence to support
standards before perspectives and enhance audit findings and
the audit. expertise. organizational recommendations.
processes and
performance.
 DAILY QUIZ

• What does ISO 9000 refer to?

• What are the key components of the ISO 9000
standard?
• What does ISO 9000:20000 refer to?
• What is the primary focus of ISO 20000-
1:2018?
• What is the primary objective of a quality
audit?

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 WEEKLY ASSIGNMENT

1. What is a quality policy statement?

2. Prepare a list of internal audit questions for three elements.

3. Briefly describe the purpose of an ISO 9000 quality system.

4. What are the basic differences among the quality systems
discussed in the text?
5. Describe how a two-party audit system works. is the key
points of PDCA?

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 Topic Links

• https://www.youtube.com/watch?v=
QEOCAuExJU
• https://www.youtube.com/watch?v=y
WlAOFs04go
• https://www.youtube.com/watch?v\=
QifqIoUNTJM
• https://www.youtube.com/watch?v=q
b3mvJ1gb9g
• https://www.youtube.com/watch?v=e
07/06/2024 Dr. Kamlesh Paswan TQM Unit-V
86
 MCQs

1. Which of the following standards is applicable only to automotive

suppliers?
(a) ISO 9000 (b) ISO 9001
(c) ISO/TS 16949 (d) ISO 14000
2. Appropriate standard for quality assurance of measuring equipment
is
(a) ISO 9001 (b) ISO 10012
(c) ISO 14000 (d) ISO/TS 16949

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 MCQs

3. Who is responsible to organize internal audit?

(a) quality leader (b) chief executive
(c) certification agency (d) management representative

4. Which of the following is not an input to management review:

(a) status of corrective actions (b) budget variances
(c) internal audit findings (d) plant rejections

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 MCQs

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 MCQs
5. Match the pairs:
1) ISO 9001 A) Telecommunication industry quality standard
2) ISO/TS 16949 B) Quality management system requirements
3) AS 9100 C) Guidelines for performance improvement
4) TL 9000 D) Fundamentals and vocabulary
5) ISO 9000 E) Aerospace industry quality system
6) ISO 9004 F) Automotive suppliers–particular requirements
for application of ISO 9001

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 Glossary Questions

Pick the correct answer from given Glossary

(Quality Circle, defect, Failure, failure ,Training )
1. A non-conformance to a requirement is known as _______
2. A _____ is a defect that reaches the customer
3. A group of workers who do the same or similar work is known
as _____
4. One of the Cause of failure is a lack of ____

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 OLD QUESTION PAPERS

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 OLD QUESTION PAPERS

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 OLD QUESTION PAPERS

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 OLD QUESTION PAPERS

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 EXPECTED QUESTIONS FOR UNIVERSITY EXAM

1. Explain the reliability and factors affecting it.

2. Explain the procedure of calculation of reliability.
3. Explain quality circle in details.
4. What do you understand by quality function?
5. Explain PDCE cycle with example.
6. What is zero defect
7. What is MTTF
8. What are the phases of a Continuous Process Improvement Cycle?
9. Define 5S?
10. What is a Kaizen?

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 EXPECTED QUESTIONS FOR UNIVERSITY EXAM

7. What are the types of teams?

8. What are the stages of team development?
9. Give some common team problems?
10. Give the steps involved in training process?
11. What are the three components of the Juran Trilogy?
12. What are the phases of a Continuous Process Improvement Cycle?

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 Recap of Unit

• The MTTF formula is a key part of the overall reliability equation.

When failure of an individual component (such as a fan belt) will
lead to failure of a motor that will shut down an entire system or
production line, being able to predict when that component is likely
to fail, and replacing it before the failure occurs, is essential to
reduce costly repairs, minimize downtime and maximize equipment
lifespan.

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 Recap of Unit

• After understanding the key principles and process of ISO Standards

and quality auditing, it's essential to remember the importance of
thorough planning, accurate reporting, and practical corrective
actions. The main takeaways should include a focus on continuous
improvement, attention to detail, standards, Benchmarks and a
commitment to maintaining high quality standards.

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 REFERENCES

• Lt. Gen. H. Lal, “Total Total Quality Management”, Eastern

Limited, .

• Greg Bounds, “Beyond Total Total Quality Management”, McGraw

Hill

• Menon, H.G, “TQM in New Product manufacturing”, McGrawHill

• https://www.researchgate.net/publication/318654507_Total_Quality

_Management_Notes
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 Thank You
07/06/2024 Dr. Kamlesh Paswan TQM Unit-V 101