UNIT 5

Need for ISO 9000- ISO 9000-2000 Quality System – Elements,

Documentation, Quality auditing- QS 9000 – ISO 14000 – Concepts,
Requirements and Benefits – Case studies of TQM implementation in
manufacturing and service sectors including IT.

ANSI – American National Standard Institute

EC – European Community
ASQ 9000 – American Society for Quality
DOD – Department of Defence
FDA – Food and Drug Administration
ISI – Indian Standards Institute
BIS Hallmark – Bureau of Indian Standards

1. Explain the classification of ISO 9000 Quality System Standards. May 10

2. Discuss the various elements and documentation of ISO 9000:2000
quality system. Nov 12, FAQ*
3. What are the steps in the implementation of ISO 9000 quality system?
Discuss in detail. Nov 13, Dec 13

1. Explain the classification of ISO 9000 Quality System Standards. May 10

ISO 9000:

Definition of ISO 9000: ISO 9000 are a set of quality standards aimed at
promoting the growth of international trade by facilitating harmonious
interactions between suppliers and customers located in diverse locations
globally.

ISO 9000 is a set of international standards for both quality

management and quality assurance that has been adopted by over 90
countries worldwide.

It is a quality management system [QMS] to ensure quality of

products and services.

ISO stands for ‘International Organization for Standardization’ and is

headquartered at Geneva, Switzerland.

Since its creation in 1946, the ISO 9000 series is a set of generic
standards applicable to all types of organizations, products, and services as
a means of implementing best quality practices.
 The first version of ISO 9000 was published in 1987, the second version
came out in 1994, and the third (current) version (ISO 9000:2000) was released
in the year 2000.

ISO 9000 definition of Quality Management System: “The organizational

structures, responsibilities, processes, procedures, and resources used for
implementing quality”.

QMS involves

How – methods, processes;

Who – responsibilities, authorities;

When – records, evidence;

Where – identification, traceability.

BASIC REQUIREMENTS OF ISO 9000

 Scope
 Normative Reference
 Terms and Definitions
 Quality Management System
 Management Responsibility
 Resource Management
 Product Realization

COMPONENTS OR CLASSIFICATION OF ISO 9000 STANDARDS:

ISO 9000: 2000 Quality Management Systems:

Fundamentals and Vocabulary

ISO 9001: 2000 Quality Management Systems:

ISO 9002: 2000 Requirements
ISO 9003: 2000
ISO 9004: 2000 Quality Management Systems:
Performance Improvement Guidelines.

Provides guidelines on the technical,

administrative and human factors
affecting the product or services
The scope of the 9001, 9002, and 9003 standards varies as follows:

ISO 9001: 2000 Design, Development, Production, Installation & Servicing

ISO 9002: 2000 Production, Installation & Servicing

ISO 9003: 2000 Inspection and Testing

PHILOSOPHY OF ISO ISO 9000: 2000 STANDARDS

“Say what you will do, Do as you said, and Prove that you did what you said.”

Thus, documents and record keeping are an important aspect of ISO 9000:
2000.
2. Discuss the various elements and documentation of ISO 9000:2000
quality system. Nov 12, FAQ*

THE 20 ELEMENTS OF ISO 9000:2000 QUALITY SYSTEM:

[1] Management responsibility,

[2] Quality system,
[3] Contract review,
[4] Design control,
[5] Document control,
[6] Purchasing,
[7] Purchaser supplied product,
[8] Product identification and traceability,
[9] Process control,
[10] Inspection & testing,
[11] Inspection, measuring and test equipment,
[12] Inspection & test status,
[13] Control of nonconforming products,
[14]Corrective and preventive action,
[15] Handling, packaging, storage, and delivery,
[16] Control of quality records,
[17] Internal quality audit,
[18] Training,
[19] Servicing, and
[20] Statistical techniques.

TYPES OF DOCUMENTS FOUND IN ISO 9000:2000 QUALITY SYSTEM

(DOCUMENTATION):
1) Quality Policy Manual (What? Why?)
2) Quality System Procedures (Who? When? Where?)
3) Work Instructions (How?)
4) Records, formats, forms (Evidence).
5) Document Development

THE EIGHT QUALITY PRINCIPLES UNDERLYING ISO 9000: 2000 QUALITY

SYSTEM:
[1] Customer focus,
[2] Leadership,
[3] Involvement of people,
[4] Process approach,
[5] System approach to management,
[6] Continuous improvement,
[7] Decisions based on facts, and
[8] Mutually beneficial supplier relationships.

3. What are the steps in the implementation of ISO 9000 quality system?
Discuss in detail. Nov 13, Dec 13
STEPS IN OBTAINING ISO 9000 CERTIFICATION (IMPLEMENTATION):

[1]Top management commitment - flow of action starts from the top

[2]Appoint management representative - qualified, trained, eager, and
participative
[3]Awareness program - to all employees in the organization
[4]Implementation team - constitute a council from all departments
[5]Training - when new things are implemented then training is must
[6]Time schedule - process time, change time, implementation, parallel process
[7]Select the process owners
[8]Review present system - how the new is different and better from current
[9]Prepare the documents - step by step process
[10]Install the new system - implementation, change and acceptance take time
[11]Internal audit - inspection, check and review
[12]Management review - report to the top management
[13]Pre-assessment – Evaluation before going to registration
[14]Registration - apply for registration
[15] Award of ISO 9000.

REGISTRATION PROCESS OF ISO 9000:

Application for Registration – Basic process with the authorized registrar.
With initial supporting docs, fees, time frame etc.
Document Review – Scrutiny of docs and QMS, compare with latest ISO
standards.
Pre-assessment – overview of docs with the process, identify major flaws.
Assessment – Actual doing, certifies audit is compared with internal audit.
Less scope for variation.
Registration – verbal summary, audit findings, minor non compliances and
feedbacks are recorded.
Follow up of surveillance – periodicity of future visit. Random checks,
registration valid for 3 years.
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.

4. Explain in detail about the quality system auditing with its different
types. May 13, Nov 13, FAQ*

QUALITY SYSTEM AUDITS:

Definition of quality system audit: “a systematic, independent examination to

determine whether quality activities and results comply with planned
arrangements, whether these arrangements are implemented effectively, and
whether these are suitable to achieve objectives”.

Quality Audit means a systematic, independent examination of a quality

system.

PURPOSE OF QUALITY AUDIT:

 To establish the adequacy of the system.

 To determine the effectiveness of the system.
 To afford opportunities for system analysis.
 To help in problem solving.
 To make decision making easier etc.

TYPES OF AUDIT:

First party audit (internal), Second party audit (by customer or external), and
Third party audit (by independent agency or extrinsic).

Another classification: System audit, Process audit, Product audit, Adequacy

audit, and Compliance audit.
First Party:
 Required by ISO and Other Standards
 Any Trained personnel can be used
 Documentation Awareness
 Timing / Timescales easily adjusted to suit individuals
 Advice / Assistance with corrective actions
 Must not replace responsibility for Quality

Second Party:
 Supplier or Sub-Contractor approval
 Quality Personnel-Role
 Choice of Standards
 Timing / Timescales more important
 Team Leader’s Authority
 The power of the contract

Third Party:
 Totally Independent
 International / National Standards
 Qualified or Registered Assessors
 Timing / Timescales very important
 Team Leader only Recommends

STAGES IN CONDUCTING QUALITY AUDIT:

1. Audit planning – schedules, personnel, notifications, checklist.

2. Performance – opening meetings, audit process, noting of non-conformities.

3. Reporting – Observations, suggestions for corrective action

4. Follow-up – implementation of corrective action.

CHECKLISTS FOR CONDUCTING QUALITY AUDIT:

1] Whether the system to ensure quality has been established.

2] Whether the system is documented.
3] Whether the documented system meets requirements.
4] Whether the system is implemented as documented.
5] Whether the system is effective in achieving the organization’s objectives and
goals.
QUALITY AUDIT DOCUMENTATION:
In every organization, the quality system must be documented properly. The
documentation of the system can be seen as a hierarchical format as shown.

1 POLICY

2 PROCEDURE

3 PRACTICE

4 PROOF

There are 3 documents

1. AUDIT PLAN: The audit plan is sent to the department being audited a few
days prior, it should include the date of the audit, the planned time, duration,
auditors names, location and the policies and procedures that will be used
during the audit.

2. AUDIT NOTES: The notes are the Auditor’s questions that will be asked
during the audit.

3. AUDIT REPORT: The audit report is the official document used to report the
findings of the audit.

5. i) What is QS 9000? State its significance. Nov 13

ii) Specify the differences between ISO 9000 and QS 9000. May 13
QS9000:

QS9000 is a quality standard developed by a joint effort of the "Big Three"

American automakers, General Motors, Chrysler and Ford. It was introduced
to the industry in 1994. It has been adopted by several
heavy truck manufacturers in the U.S. as well. Essentially all suppliers to the
US automakers need to implement a QS9000 system.

Description:

The standard is divided into three sections with the first section being ISO
9001 plus some automotive requirements.
The second section is titled "Additional Requirements" and contains system
requirements that have been adopted by all three automakers - General
Motors, Chrysler and Ford.
The third section is titled the "Customer Specific Section" which contains
system requirements that are unique to each automotive or truck
manufacturer.
On December 14, 2006, all QS9000 certifications were terminated. This
standard is obsolete and has been replaced by either ISO/TS 16949 or ISO
9001.
Why QS9000:

QS-9000 will help companies to stay ahead of their competition. It will

do this by filling gaps in the business and quality systems that can
cause problems. QS-9000 eliminates redundant and unnecessary
work practices. QS-9000 tells current and potential customers that
the product has consistent quality and is manufactured under
controlled conditions. This system is globally accepted as proof of
quality in the automotive industry and is also a major customer
requirement.

How Does QS-9000 Differ From ISO-9000?

QS-9000 is sometimes seen as being identical to ISO 9000, but this is not true.
Even though each element of ISO 9000 is an element of QS-9000, QS-9000
adds clauses to the majority of the ISO 9000 elements. For example, QS-9000
adds requirements for a business plan, tracking customer satisfaction and
bench marking to element 4.1 of ISO 9000, Management Responsibility. QS-
9000 also uses sector-specific requirements. The following requirements are
not based on ISO 9000:

 production part approval process

 the requirements for gaining approval from the customer to run a new or
altered part or process
 continuous improvement
 automotive suppliers are required to have systems in place to ensure that
organized, measurable improvement activities take place for a variety for
business aspects
 manufacturing capabilities
 requirements for planning and effectiveness for equipment, facilities and
processes
 requirements for mistake proofing, and tooling management.
ISO 9000
ISO9000 is the first in a SERIES of
standards about quality management
for an enterprise.
It is used for all the industries.
Non-industry specific.
QS 9000
QS9000 (actually QS-9000 third
edition) is a sector-specific standard
developed by the automobile and truck
manufacturers for their suppliers.
It is used for the automotive industry.
Industry specific.

BENEFITS OF QS 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.

6. Discuss ISO 14000 concepts, requirements and its benefits in detail.

May 13, Nov 13, FAQ*, Nov 09

ISO 14000 – ENVIRONMENTAL MANAGEMENT SYSTEM:

ISO 14000: The overall aim of the Environmental Management System is to

provide protection to the environment and to prevent pollution.

In 1991, ISO formed SAGE – Strategic Advisory Group on the Environment

which leads to the formation of Technical Committee TC207 in 1992.
TC207 has established six sub-committees
1. EMS
2. EA
3. EL
4. EPE
5. LCA
6. Terms and conditions.
TWO DIFFERENT SET OF STANDARDS WHERE FORMED:

1. ORGANIZATIONAL EVALUATION STANDARD

i. Environmental Management System
ii. Environmental Auditing
iii. Environmental Performance Evaluation

2. PRODUCT EVALUATION STANDARD

i. Environmental Aspects in Product Standards
ii. Environmental Labelling
iii. Life Cycle Assessment

CONCEPT OF ISO 14001:

REQUIREMENTS OF ISO 14001 or EMS:
General Requirements EMS should include policy, planning,
implementation & operation, checking and
corrective action and management review.
Environment Policy (should be  Top management commitment and
based on mission) direction
 Current activities and future plans
 Policy must be made public
Planning  Environmental Aspects
 Legal and other Requirements
 Objectives and targets
 Environment Management Program
Implementation and Operation  Structure and responsibility
 Training, awareness, competency
 Communication
 EMS Documentation
 Document control
 Operational Control
 Emergency preparedness and response
Checking and Corrective Action  Monitoring and measuring
 Non-conformance and corrective and
 preventive action
 Records
 EMS Audit
Management Review  Review objective and targets
 Review performance against legal
requirement.
 Effectiveness of EMS elements
 Evaluation of the continuation of the
policy

BENEFITS OF ISO 14000 OR ENVIRONMENTAL MANAGEMENT SYSTEM:

a.Global
 Facilitate trade and remove trade barriers
 improve environmental performance of planet earth
 Build consensus that there is a need for environment management and a
common terminology for EMS.
b. Organizational
 Assuring customers of a commitment to environmental management
 Meeting customer requirements
 Maintaining a good public / community relations image
 Satisfying investor criteria and improving access to capital
 Obtaining insurance at reasonable cost
 Increasing market share that results from a competitive advantage
 Reducing incidents that result in liability
 Improving defense posture in litigation
 Conserving input materials and energy
 Facilitating the attainment of permits and authorization
 Improving industry/government relations

7. Discuss TQM implementation in manufacturing and service sectors

including IT with a case study. FAQ*

INTRODUCTION: IT is defined as computer technology (either hardware or

software) for processing and storing information, as well as communication
technology for transmitting information.

TYPES OF IT:
[i] Data are alphanumeric and can be moved about without regard to meaning.

[ii] Information is the meaningful arrangement of data that creates patterns and
activates meanings in a person’s mind.

[iii] Knowledge is the value-added content of human thought. It is the basis for
intelligent action. Organizations need to become proficient in converting
information to knowledge.

The first computer was the ENIAC which was created in 1946. Since then,
there has been a phenomenal growth in capacity, speed, and miniaturization
(reduced size) in the last 60 years. This growth will continue to accelerate with
a doubling of performance every 18 months.

NEED FOR QUALITY FUNCTION:

The quality function needs served by the computer are:

[1] data collection,

[2] data analysis and reporting,

[3] statistical analysis,

[4] process control,

[5] test and inspection, and

[6] system design.

[1] Data collection:

IT provides the link for diverse activities such as purchasing, inventory control,
design, marketing, accounting, production control, etc.

Computers are well suited for the collection of data. Major benefits are faster
data transmission, fewer errors, lower collection costs and the ability to quickly
update or change the information. Data are transmitted to the computer by
keyboard, paper, magnetic tape, optical character recognition, telephone,
wireless transmission, voice, pointer, bar-code scan, and direct interface with a
process.

Sources of data are operating instructions, specifications, drawings, inspection

reports, scrap and waste details, laboratory tests, customer complaints, service
information, process control, etc.
[2] Data analysis and reporting:

While some of the quality information is merely stored in the computer for
retrieval at a future time, most of it is analyzed and disseminated in the form of
a report.

The basic data can be summarized and analyzed in a number of different ways,
e.g. by operator, department, work center, type of defect, product line, part
number, vendor, material, etc.

Information of a graphical nature, such as for a p chart or c chart, can be

programmed, displayed, and reproduced. Decision rules can be employed in
the program which will automatically signal the likelihood of a quality problem.
Information concerning a potential problem is provided and corrective action
taken in real time.

[3] Statistical analysis:

The first and still an important use of the computer in quality control is for
statistical analysis. Most of the statistical techniques can be easily
programmed.

Most of these programs have been incorporated into software packages. Some
major software programs such as EXCEL, SPSS, etc. have very sophisticated
analysis techniques.

The advantages of programmed statistical software packages are: [1] Time-

consuming manual calculations are eliminated. [2] Timely, accurate analyses
can be performed. [3] Many users with limited knowledge in advanced statistics
can perform their own statistical analyses.

[4] Process control:

The first application of computers in process control was with numerically

controlled (N/C) machines. Instructions are transmitted to the computer which
then controls the sequence of operations.

Today, Computer Numerically Controlled (CNC) machines, robots, and

Automated Storage & Retrieval Systems (ASRS) provide the basic equipment for
an automated factory.

Automated process control systems use sensors to measure process variables

such as pressure, temperature, voltage, length, weight, etc. and feed this data
to computers which take appropriate action to operate an actuator, valve, etc.
A nuclear power station is another example of a fully automated system where
the only human interaction occurs at the computer console.

The major benefits of automated process control are: [1] Constant product
quality, due to a reduction in process variation, [2] Increased productivity,
since fewer people are needed to monitor the controls, and [3] Safer operation
by either stopping the process or failing to start the process when an unsafe
condition occurs.

[5] Test and inspection:

Automated test and inspection is similar to the previous section on automated

process control. It can be used for go/no-go inspection decisions, for sorting
and classifying parts in selective assembly, and for performing a complete
quality audit of a product.

Computer-controlled test and inspection systems offer the following

advantages: improved test quality, lower operating cost, greater speed,
improved accuracy, automated calibration, malfunction diagnostics, and better
report preparation.

[6] System design:

There are numerous packages that combine many of the quality functions.
These software packages are user-friendly with help provision and tutorials.

The following systems integrate the various quality functions with other
activities in an organization: CADD (Computer-Aided Drafting & Design), CAM
(Computer-Aided Manufacturing), CAE (Computer-Aided Engineering), MRP
(Material Requirements Planning), MRP-II (Manufacturing Resource Planning),
CAPP (Computer-Aided Process Planning), CIM (Computer-Integrated
Manufacturing), ERP (Enterprise Resource Planning), etc.

THE INTERNET AND OTHER ELECTRONIC COMMUNICATIONS:

The internet is a worldwide network of computer networks. It began in

1969 and since that time the number of computers connected to the internet
has grown exponentially. It contains an incredible amount of information and
knowledge on subjects ranging from abacus to Zulu. The various
manifestations of the internet as an enabler of quality management are briefly
discussed below:

1. Intranet:
Within organizations, local-area networks (LANs) efficiently share data among
users by keeping large amounts of transaction data on large central computers,
while connecting PCs to them. LANs facilitate data sharing such as e-mail
messages, transactions, decisions, calendars, scheduling, and access to the
internet. Employees can use chat rooms for suggestions, questions, and
comments.

2. Instant messaging:

Organizations are finding that e-mail clogs computer networks and are hence
using instant messaging rather than e-mail because it is faster. Unlike e-mail
that can languish unnoticed for hours, instant messages pop up on the
recipient’s screen.

3. Video Conferencing:

Video conferencing is a technique where people at remote locations participate

in a conference whereby they not only hear but also see each other.
Documents, photos, and graphics can be used to convey difficult concepts.

The setting consists of a dedicated room equipped with desks, chairs, large
screen monitors, camera, and network connection. Organizations that use
video conferencing save participant time and travel cost.

4. Virtual teaming:

A virtual team is a group of persons dependent on electronic techniques to

jointly complete a project, regardless of differences in members’ location, time
zone, or organization. Software, known as groupware, is used to help teams
communicate in cyberspace. Virtual teams use a combination of internet, e-
mail, instant messaging, and linked databases. Members are usually given a
distinct website for posting shared documents. Team members also rely on
telephone, fax, and teleconferencing, as well as one-to-one interactions.

Virtual teams reduce costs by hiring members without paying relocation costs.
New members, specialists, and consultants can be quickly and inexpensively
added to the team as needed. Large organizations can put their best people on
a particular project regardless of their location.

5. Document management:

Globally integrated, paperless documentation is being used by forward-

thinking organizations. The software is capable of [1] supporting multiple
organization, customer and supplier sites, [2] reliably managing organizational
knowledge, [3] providing powerful security, [4] enabling remote auditing, and
[5] integrating many kinds of information in mixed media such as text
documents, spreadsheets, flow charts, photographs, drawings, attachments,
etc.

6. E-learning:

E-learning is offered in a variety of formats such as CD-ROM-based, LAN-

based, and web-based. Advances in hardware and software make e-learning
the best way for organizations to achieve their education and training needs.
Some major advantages of e-learning over the traditional classroom are: [1]
Individuals/groups can access the instruction when it’s needed at a convenient
time and location. [2] Only a computer is necessary. Classroom learning
requires an instructor, room, equipment, and enough participants to make it
economical. [3] Learners can immediately apply what they learn, because the
topics are taken when they are needed. [4] It can be customized to meet the
individual’s needs. [5] Participants need not travel to obtain specialized
training.

7. E-commerce:

It takes two broad formats: B2B and B2C.

In B2B, all transactions are between the organization’s and supplier’s

computers. B2B e-commerce via the internet is expected to grow rapidly
because of [1] low-cost entry and operational costs, [2] global reach, and [3] the
benefits of reduced cycle time, product cost savings, and improved
coordination.

In B2C e-commerce, the buyer benefits from easy access to product

information, 24/7 sales and service, and online distribution. The seller benefits
from lower costs, global outreach, multimedia marketing channel, and 24/7
sales.

INFORMATION QUALITY ISSUES:

Information quality issues encompass sufficiency, accuracy, timeliness,
intellectual property, security, cybercrime, privacy, pollution, creativity, and
control & prevention.

1. Sufficiency: To make an intelligent decision, it is important to know when

enough information has been obtained. There is a fine line between too much
and too little information. In either case, the information needs to be simple.

2. Accuracy: If the information in the system is not accurate, its efficiency

won’t make any difference. “Garbage in, garbage out”.

3. Timeliness: It is important to product and service design time that

information is to be received in a timely manner so that the organization can
compete in world markets. Instant messaging, video conferencing, ERP, SCM,
etc. are tools for provision of timely information.

4. Intellectual property: Intellectual property includes patents, and

copyrighted material such as books, movies, music, etc. The developers of ISO
9000:2000 recognized the importance of intellectual property by including a
sub-clause which states: “The organization shall have policies that protect the
privacy of customer information including intellectual property”.

5. Security: Security involves safeguarding information from loss, destruction,

theft, tampering, or sabotage. There are two major security issues – access
security, which is the control of access to a computer that is connected to the
internet; and transaction security, which is the control of a communication
such as a business transaction to ensure that it is not violated.

For access security, Firewalls are the primary technique of access security.
They are devices that block unauthorized users from remote sites.

For transaction security, e-signatures are now legal. Encryption makes

sending personal information more secure. The US Army has developed a
biometrics system that identifies body parts, voice patterns, and even body
odors.

6. Cybercrime: Various types of fraud taking place on the internet are: auction
fraud, credit card fraud, identity theft, non-delivery of products, professional
services fraud, pyramid marketing scams, travel scams, stealing of domain
name, etc. Police departments are struggling to deal with cybercrime because:
few officers are trained in cybercrime; there are jurisdictional problems when
the parties are in different towns, states, or countries; and there are not
enough personnel.
7. Privacy: Commitment to protection of consumer privacy is a major issue.
Amazon.com announced that it was changing its privacy policy by sharing its
customer information with other marketing organizations. As online firms go
bankrupt, their customer information, which is considered an asset, goes to
the highest bidder. “Cookies” and “web bugs” track netizens’ online
movements. Organizations say tracking users’ movements helps them serve
customers better.

8. Pollution: There is too much outdated information, especially on the

internet. Two million web pages are added per day. Search engines have
become catalogues for useless information: however, because of competition,
they will become faster and better. Like road traffic, the more PCs added to a
system, the greater the pollution and the slower the entire system.

9. Creativity: Creativity is drawing insights and conclusions from existing

information to invent, innovate, or conceptualize new systems, products, or
services. In other words, it is new knowledge, which is the highest form of
information technology. With the fast-paced changes taking place in IT and
other areas, organizations need to constantly innovate and come out with
creative solutions to previously unforeseen problems and opportunities.

10. Control and Prevention: The control and prevention of quality problems
associated with IT will be similar to any product or service. Many of the TQM

principles and practices, tools and techniques will provide additional solutions.
In particular, ISO 9000, FMEA, and SPC will be most effective.

8. i)What are the barriers in the implementation of TQM? Explain in detail. May
13
ii) What are the gains realized by a company with the TQM implementation?
Nov 12

GAINS REALIZED BY A COMPANY WITH THE TQM IMPLEMENTATION

Tangible Benefits Intangible Benefits

 Improved product quality  Improved employee

 Improved productivity participation
 Reduced quality costs  Improved team work
 Increased market and  Improved working
customers relationships
 Increased profitability  Improved customer
 Reduced employee grievances satisfaction
 Improved communication
 Enhancement of job interest
 Enhanced problem solving
capacity
 Better company image

BARRIERS TO TQM IMPLEMENTATION

1. Lack of management commitment: Management does not allocate

sufficient time and resources for TQM implementation.

2. Inability to change organizational culture: Even individuals resist change;

changing an organization’s culture is much more difficult and may require as
much as 5 years or more. Exhortations, speeches, slogans are effective only in
the short run.

3. Improper planning: Absence of two-way communication of ideas during the

development of the plan and its implementation.

4. Lack of continuous training and education.

5. Incompatible organizational structure and differences between

individuals/departments.
6. Ineffective measurement techniques for key characteristics of the
organization. Lack of access to data and results.

7. Paying inadequate attention to internal and external customers. Inability

to understand the changing needs and expectations of customers. Absence of
effective feedback mechanisms.

8. Inadequate use of empowerment and teamwork.

9. Lack of employee involvement.

10. Non-cooperation of first-line managers and middle management.

11. Lack of clarity in vision.

12. Emphasis on short-term results.

13. Setting of unmanageable, unrealistic goals.

14. Bureaucratic system.

15. TQM is considered as a quick-fix solution to current problems.

16. Treating suppliers as adversaries to be manipulated, taken advantage of.

17. Adversarial relationship between workers/unions and management.

18. Motivating employees through fear of punishment.

19. Failure to continually improve. Tendency to sit back and rest on one’s
laurels. Rigidly sticking to one ‘success formula’.

PART - A (2 MARKS)
1. Give the ISO 9000 Series of Standards. Nov 09
i. ISO 9000, “Quality Management and Quality Assurance Standards
Guidelines for Selection and Use”.
ii. ISO 9001, “Quality Systems – Model for Quality Assurance in Design,
Development, Production, Installation & Servicing”.
iii. ISO 9002, “Quality Systems – “Model for Quality Assurance in Production,
Installation & Servicing”.
iv. ISO 9003, “Quality Systems – “Model for Quality Assurance in Final
Inspection and Test”.
v. ISO 9004-1, “Quality Management and Quality System Elements –
Guidelines”.

2. What is the need and objectives for ISO 9000 Standards? May 13, Nov 13
 ISO 9000 practically eliminates the need for many customer-driven quality
programs.
 ISO 9000 certification is a uniform standard, accepted and recognized
internationally. So you save money.
 The preparation for ISO 9000 registration involves a close analysis of your
existing quality systems.
 ISO 9000 can improve overall business efficiency.
 ISO 9000 can ensure timely, accurate, accessible information.
 ISO 9000 can help you develop "best practices" and eliminate costly
surprises.
 ISO 9000 improves the quality of your information.
you begin to accrue benefits even before you achieve ISO 9000 certification.

3. Give some other quality systems (or) What are the other ISO standards?
Apr 10
The quality systems are
i. ISO 9000 Quality Systems
ii. ISO 14000 Environmental Management System Standards
iii. TE 9000 Tooling and Equipment Quality System
iv. AS 9000 Aerospace Basic Quality System
v. IS0 27000 Information security management systems
vi. ISO 26000 Guidance on social responsibility
vii. ISO 1:2002 Geometrical Product Specifications (GPS)
viii. ISO 1000 SI units and recommendations for the use of their multiples and
of certain other units
4. Enumerate the steps necessary to implement the Quality Management
System. Nov 13
The steps necessary to implement the Quality Management System are
[1]Top management commitment - flow of action starts from the top

[2]Appoint management representative - qualified, trained, eager, and

participative

[3]Awareness program - to all employees in the organization

[4]Implementation team - constitute a council from all departments

[5]Training - when new things are implemented then training is must

[6]Time schedule - process time, change time, implementation, parallel

process

[7]Select the process owners

[8]Review present system - how the new is different and better from current

[9]Prepare the documents - step by step process

[10]Install the new system - implementation, change and acceptance take

time

[11]Internal audit - inspection, check and review

[12]Management review - report to the top management

[13]Pre-assessment – Evaluation before going to registration

[14]Registration - apply for registration

[15] Award of ISO 9000.

5. What are the three sections of QS-9000?

i. Common requirements, which include the exact text of ISO 9001 and the
addition of automotive/heavy trucking requirements.
ii. Additional requirements covering production part approval process,
continuous improvement and manufacturing capabilities.
iii. Customer-specific requirements.

6. Give the objectives of the internal audit.

a) Determine the actual performance conforms to the documented quality
systems.
b) Initiate corrective action activities in response to deficiencies.
c) Follow up on noncompliance items of previous audits.
d) Provide continued improvement in the system through feedback to
management.
e) Cause the auditee to think about the process, thereby creating possible
improvements.

7. What are the requirements of ISO 14001?

The requirements of ISO 14001 are
i. General requirements
ii. Environmental policy
iii. Planning
iv. Implementation and operation
v. Checking and corrective action
vi. Management review

8.What are the benefits of ISO 14000?

a.Global
 Facilitate trade and remove trade barriers
 improve environmental performance of planet earth
 Build consensus that there is a need for environment management and a
common terminology for EMS.
b. Organizational
 Assuring customers of a commitment to environmental management
 Meeting customer requirements
 Maintaining a good public / community relations image
 Satisfying investor criteria and improving access to capital
 Obtaining insurance at reasonable cost
 Increasing market share that results from a competitive advantage
 Reducing incidents that result in liability
 Improving defense posture in litigation
 Conserving input materials and energy
 Facilitating the attainment of permits and authorization
 Improving industry/government relations

9. What are the four elements for the checking & corrective action of ISO
14001?
a) Monitoring and measuring
b) Non-conformance and corrective and preventative action
c) Records and d) EMS audit

10. What are the seven elements for the implementation & operations of ISO
14001?
a) Structure and responsibility
b) Training, awareness and competency
c) Communication
d) EMS documentation
e) Documentation control
f) Operational control
g) Emergency preparedness and response

11. What are the four elements for the planning of ISO 14001? May 2012
a) Environmental aspects
b) Legal and other requirements
c) Objectives and targets
d) Environmental Management Programs

12. Give the types of Organizational Evaluation Standards.

i. Environmental Management System
ii. Environmental Auditing
iii. Environmental Performance Evaluation

13. Give the types of Product Evaluation Standards.

i. Environmental Aspects in Product Standards
ii. Environmental Labelling
iii. Life Cycle Assessment

14. Define Quality Audits. Mention the objectives of quality audits. Apr 10

Definition of Quality Audits examine the elements of a quality management

system in order to evaluate how well these elements comply with quality
system requirements.

Objectives of Quality Audits:

 To measure the effectiveness of an organization's quality management
system.
 To establish the adequacy of the system.
 To afford opportunities for system analysis.
 To help in problem solving.
 To make decision making easier.
 To ensure that the quality policy and objectives are met as per the
standards.

15. Give the usage of an effective recognition and reward system.

 Serves as a continual reminder that the organization regards quality and
productivity as important.
 Offers the organization a visible technique to thank high achievers for
outstanding performance.
 Provides employees a specific goal to work towards. It motivates them to
improve the process.
 Boosts morale in the work environment by creating a healthy sense of
competition among individuals and teams seeking recognition.

16. What are the typical measurements frequently asked by managers and
teams?
 Human Resource
 Customers
 Production
 Research & Development
 Suppliers
 Marketing/Sales
 Administration

17. Explain the ISO/QS 9000 elements.

 [1] Management responsibility,
 [2] Quality system,
 [3] Contract review,
 [4] Design control,
 [5] Document control,
 [6] Purchasing,
 [7] Purchaser supplied product,
 [8] Product identification and traceability,
 [9] Process control,
 [10] Inspection & testing,
 [11] Inspection, measuring and test equipment,
 [12] Inspection & test status,
 [13] Control of nonconforming products,
 [14]Corrective and preventive action,
 [15] Handling, packaging, storage, and delivery,
 [16] Control of quality records,
 [17] Internal quality audit,
 [18] Training,
 [19] Servicing, and
 [20] Statistical techniques.
18. What are the benefits of ISO quality systems? Apr 2011, Apr 2014
 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.

19. Give the ISO 9001 requirements.

 Scope
 Normative Reference
 Terms and Definitions
 Quality Management System
 Management Responsibility
 Resource Management
 Product Realization

20. What are the methods of actual audit?

i. Examination of documents
ii. Observation of activities
iii. Interviews

21. Specify the objective of Quality Policy. May 13

 To exceed our customers’ and stakeholders expectations for service
performance and quality
 To Improve our objectives and processes through continuous reviews
 To meet the requirements of International Quality Standards
 To engage our people, ensuring they are aware of and trained in customer
requirements and the Management System

22. What are the global benefits of ISO – 9000 certification? Nov 13, Nov 12,
Dec 12
 Cost savings - International Standards help optimize operations and
therefore improve the bottom line.
 Enhanced customer satisfaction - International Standards help improve
quality, enhance customer satisfaction and increase sales.
 Access to new markets - International Standards help prevent trade
barriers and open up global markets.
 Increased market share - International Standards help increase
productivity and competitive advantage.
 Environmental benefits - International Standards help reduce negative
impacts on the environment.

Other Benefits
 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.

23. What is internal quality audit and external quality audit? Nov 13
Internal Quality Audit: Internal Quality Audit is the first book to provide a
comprehensive guide designed for use by first party auditors or internal
auditors.
Note: Internal Quality Audit is done by an organization, working on itself.

External Quality Audit: External Quality auditing means an audit

conducted by the persons who is appointed by the Client Company or
second party auditors. (i.e. certification companies, or major customers or
suppliers or another organization or auditee) 
Note: External Quality Audit refers to audit by one organization (Auditor) on
another organization (Auditee).

24. List the benefits of documentation. Nov 13, Nov 09

Concept: Documentation is at the core of ISO 9000 conformance. In fact, the
standards have been described as this: "Say what you do. Do what you say.
Write it down."
Benefits of Documentation:
 Reduction of errors
 Improved Internal Operations
 Competitive Edge
 Sharing of Intellectual Knowledge 

25. How does the conceptual approach to ISO 14001 differ from ISO
9001? FAQ
ISO 9001 ISO 14001
A quality system will include an An environmental system will
evaluation of suppliers and a review of include methods of evaluating
customer contracts environmental impacts and
systems for responding to
emergencies.
As a quality management certification, The standard ISO 14001 is an
ISO 9001 is awarded based on set environmental management
standards being met in the key areas of certification that is designed to
quality management systems, assist organizations as they
management responsibility, resource develop in-house environmental
management, and how quality management systems. 
performance is measured, analyzed,
and improved.

26. Explain the need for ISO 14000 Quality Systems. May 2008
The needs for ISO 14001 are
i. General requirements
ii. Environmental policy
iii. Planning
iv. Implementation and operation
v. Checking and corrective action
vi. Management review

27. Mention the objectives of quality audits. May 10

Objectives of Quality Audits:
 To measure the effectiveness of an organization's quality management
system.
 To establish the adequacy of the system.
 To afford opportunities for system analysis.
 To help in problem solving.
 To make decision making easier.
 To ensure that the quality policy and objectives are met as per the
standards.

28. Differentiate between ISO 9000 and Qs 9000. Nov 12, Dec 12
ISO 9000 QS 9000
ISO9000 is the first in a SERIES of QS9000 (actually QS-9000 third
standards about quality management edition) is a sector-specific standard
for an enterprise. developed by the automobile and truck
manufacturers for their suppliers.
It is used for all the industries. It is used for the automotive industry.
Non-industry specific. Industry specific.

29. List the documents required for QS 9000. Apr 14

The minimum seven documents one will need for the QS-9000 program are:
1. QS-9000 Quality System Requirements
2. Advanced Product Quality Planning and Control Plan (APQP)
3. Failure Mode and Effects Analysis (FMEA)
4. Measurement Systems Analysis
5. Fundamental SPC
6. Production Part Approval Process (PPAP) manual, and
7. The Quality System Assessment (QSA) manual.

30. What is the use of quality auditing? May 12

 For verifying objective evidence of processes.
 To assess how successfully processes have been implemented.
 For judging the effectiveness of achieving any defined target levels.
 To provide evidence concerning reduction and elimination of problem areas.
 For the benefit of the organization, quality auditing should not only report
non-conformances and corrective actions, but also highlight areas of good
practice.

STORY:
This is a story about four people named Everybody, Somebody, Anybody,
and Nobody.

There was an important job to be done and Everybody was sure that
Somebody would do it.

Anybody could have done it, but Nobody did it.

Somebody got angry about that, because it was Everybody's job.

Everybody thought Anybody could do it, but Nobody realized that

Everybody wouldn't do it.

It ended up that Everybody blamed Somebody when Nobody did what

Anybody could have done!

FACTS

ITC Hotel Maurya Sheraton was the first hotel in India to get ISO 14001.
...

IndiaMART becomes the first ISO Certified Dotcom Company

This is one of those stories that get circulated via fax from time to
time. Could the aerospace company described below get ISO
certified? What are your thoughts?

Once upon time, an aerospace company in Maryland and a Japanese

automobile company decided to have a competitive boat race on the
Potomac river. Both teams practiced hard and long to reach their peak
performance. On the big day they both felt as ready as they could be.

The Japanese won by a mile.

Afterwards, the American team became very discouraged by the loss and
morale sagged. Corporate Management decided that the reason for the
crushing defeat had to be found. A "Continuous Measurable
Improvement" team was set up to investigate the problem and to
recommended appropriate corrective action. Their conclusion:

The problem was that the Japanese team had eight people rowing and
one person steering, whereby the American team had one person rowing
and eight people steering. The American Company Steering Committee
immediately hired a consulting firm to do a study on the management
structure. After some time and millions of dollars, the consulting firm
concluded that "Too many people were steering and not enough rowing!"

To prevent losing to the Japanese again next year, the team's

management structure was totally reorganized to four Steering
Managers, three Area Steering Managers, one Staff Steering Manager and
a new performance system for the person rowing the boat to give him
more incentive to work harder. "We must give him empowerment and
enrichment. That should accomplish our Total Quality Management
goals!!"

The next year the Japanese won by two miles.

Humiliated, the aerospace company laid off the rower for poor
performance, sold the paddles, canceled all capital investment for new
equipment, halted development of a new boat, gave a "High Performance"
award to the consulting firm, then distributed the money saved as
bonuses to the senior executives