Unit V

MAILAM ENGINEERING COLLEGE GE6757 - TQM
PART A
1. What is Quality system?

The Quality systems are the organizational structures, responsibilities,
procedures, processes and resources for implementing quality management.
2. List the functions of Quality system.

Functions of Quality system:
 The system is well understood and effective.
 The products or services actually do satisfy customer expectations.
 The emphasis is placed on problem- prevention rather than dependence on
detection, after occurrence.
3. What is the need for ISO? (Dec 2017)

The International Organization for Standardization (ISO) was established in 1946
in Geneva, Switzerland, where it is still based.
 ISO is an association of National Standards Bodies of more than 150
countries.
 ISO is a specialized agency for standardization. The primary objective of
ISO is coordination and unification of international standards.
 ISO employs a system of technical committees, sub committees and
working groups to develop international standards. Besides the national
standard bodies, ISO permits other international organizations that develop
standards to participate in its work, by accepting them as Liaison members.
 ISO works in accordance with an agreed set of rules of procedures, the ISO
directives, which also include requirements on the presentation of standards.
4. What is ISO 9000?

ISO 9000 has become an international reference for quality management
requirements in business-to- business dealings. This means what the organization does
to fulfill:
 The customer’s quality requirements and
 Applicable regulatory requirements, while aiming to
 Enhance customer satisfaction and
 Achieve continual improvement of its performance in pursuit of these
objectives.
5. Give the ISO 9000 Series of Standards?

 ISO 9000, “Quality Management and Quality Assurance Standards
Guidelines for Selection and Use”.
 ISO 9001, “Quality Systems - Model for Quality Assurance in Design,
Development, Production, Installation & Servicing”.
 ISO 9002, “Quality Systems - “Model for Quality Assurance in Production,
Installation & Servicing”.
 ISO 9003, “Quality Systems - “Model for Quality Assurance in Final
Inspection and Test”.
PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 1

 ISO 9004-1, “Quality Management and Quality System Elements -
Guidelines”.
6. What is the need for ISO 9000?

ISO 9000 is needed to unify the quality terms and definitions used by
Industrialized nations and use terms to demonstrate a supplier’s capability of
controlling its processes.
7. Why should consider ISO 9000 registration?

 Establishes standard operating system for the business
 Emphasizes Continuous Improvement and Prevention instead of Reaction.
 Empowers employees by establishing responsibilities and decision making
process
 Improved communication and cooperation within the organization
 Institutes procedures for greater customer satisfaction by joint efforts by
management, all employees and the Quality Department.
8. Give some other quality systems?

 QS-9000
 TE-9000
 AS9000
9.What are the reasons for implementing a quality system that conforms to an ISO
standard?
 Improved employee involvement (average gain is 100%)
 Improved housekeeping (average gain is 140 %)
 Improved decision making based on facts and data (average gain is 95%)
 Improved customer satisfaction (gain is 55 %)
 Improved safe working (gain is 45 %)
 Reduced customer complaints (about 40%)
 Reduced inspection efforts (about 45%)
 Reduced quality cost (about 50%)
10. What are the ISO 9000 Standards?

The ISO 9000 standards are a collection of formal International Standards,
technical reports, handbooks and web based documents on quality management and
quality assurance.
11. Who is responsible for developing the ISO 9000 Standards?

ISO technical committee and its sub committees are responsible for the
development of the standards. The work is conducted on the basis of “consensus”
among quality and industry experts nominated by the national standards bodies,
representing a wide range of interested parties.
12. Comparison of ISO 9001, 9002 and 9003.

ISO 9001 ISO 9002 ISO 9003
Design -- --

Manufacture Manufacture --
Test Test Test
13. Compare ISO 9001 and ISO 9004.

 ISO 9001 can be used for internal application by organizations for certification
or contractual purposes.
 ISO 9004 is not intended for certification or contractual purposes. It is used in
non contractual situations.
 ISO 9004 gives guidance on wider range of objectives of a quality management
system than ISO 9001, with respect to organization’s continuous improvement
and performance.
14. What are the benefits of ISO?(Nov/Dec 2012)

 Fewer on-site audits by customers.
 Increased market share.
 Improved quality, both internally and externally.
 Improve product and service quality levels from suppliers.
 Greater awareness of quality by employees.
 A documented formal systems
 Reduced operating costs.
15. List the elements of ISO 9000.

 Management Responsibility
 Quality system
 Contract Review
 Design control
 Document control
 Purchasing
 Purchaser supplied product
 Product Identification and Traceability
 Process Control
 Inspection and Testing
 Inspection, Measuring and Test Equipment
 Inspection and Test status
 Control of Non-conforming Products
 Corrective and Preventive Action
 Handling, Storage , Packaging, Preservation and Delivery
 Control of Quality Records
 Internal Quality Audit
 Training
 Servicing
 Statistical Techniques
16. List the steps to implement ISO 9000.

Step 1: Top management Commitment
Step 2: Appoint the Management Representative

Step 3: Awareness
Step 4: Appoint an Implementation Team
Step 5: Training
Step 6: Time schedule
Step 7: Select Element Owners
Step 8: Review the present system
Step 9: Write the Documents
Step 10: Install the New system
Step 11: Internal Audit
Step 12: Management Review
Step 13: Preassessment
Step 14: Registration
Step 15: Award of ISO 9000 certificate
17. What is the necessity for documentation of quality system?

 It is understood that the proper documentation is the pre- requisite for
implementing quality system.
 The documentation serves as a reference for the management, the staff and other
agencies whose involvement is essential for implementation of the quality
system.
18. What is the advantage of documented quality system?

Advantages of having a documented quality system:
 Serves as a standardization in work procedures;
 Brings about consistency in operations;
 Develops confidence amongst employees;
 Generates customer’s confidence;
 Provides a basis for continuous improvement;
19. Draw the Document Pyramid.(Nov/Dec2011)
20. Give some of the guidelines for writing a document.

 Keep the language simple.
 Follow a simple paragraph numbering system address one idea per paragraph.

 Use 13 or 14 point type (font size), because it is easier to read and have plenty
of white space.
 Write only what is needed and avoid the use of special jargons.
 Use flow diagrams and check whenever possible.
21. Give the ISO 9001 requirements?
 Scope
 Normative Reference
 Terms and Definitions
 Quality Management System
 Management Responsibility
 Resource Management
 Product Realization
 Measurement, Analysis & Improvement
22. Define Quality Audits. (Dec 2017)

Quality Audits examine the elements of a quality management system in order to
evaluate how well these elements comply with quality system requirements.
23. What are the qualities of a good auditor?

 Good in written and oral communication
 A good listener
 Able to focus on the task at hand should not get disturbed by other activities that
are taking place at the same time.
 Able to identify the vital facts from the ocean of information
 Honest and impartial.
24. Give the objectives of Internal Audit.

 Check whether the actual performance conforms to the documented QMS.
 Start corrective action to eliminate the cause of non- conformities.
 Follow up on non- conforming items from previous audits.
 Provides continued improvement in the system.
 Cause the auditee to think about the process, and encouraging possible
improvements.
25. List the features of internal audit.
 The quality audit typically applies to quality systems or elements such as processes,
products or services. Such audits are often called “ quality system audits” , “
process quality audits”,” product quality audits” and “service quality audits”
respectively.
 Quality audits are carried by staff who are not directly responsible in the areas
being audited. But preferably auditors should work in cooperation with relevant
personnel.
 Quality audit is an information gathering activity. It is not a police kind of activity.
 Quality audit may be conducted for internal or external purposes. They need not
cover whole quality system, at once, but may cover elements of it.

26. What are the types of audit?DEC’13 (May 2017)
First Party Audit (Internal audit): This refers to an internal audit where the auditee is
its own client that is audit is done by an organization, working on itself.
Second party audit: This refers to audit by one organization on another organization
(auditee). This type of audit is normally done on a supplier by a customer.
Third party Audit: This refers to audit by an independent organization on a supplier,
for accreditation assessment purposes.
27. What are the four stages of an audit?
 Audit Planning
 Audit Performance
 Audit Reporting
 Audit Follow up
28. What are the methods of actual audit?

i. Examination of documents
ii. Observation of activities
iii. Interviews
29. What is QS 9000?

 QS 9000 is a set of quality system requirements recently adopted by members of
the automotive industry.
 QS 9000 was proposed by Chrysler, Ford and General Motors in 1994.
 QS 9000 is harmonization of Chrysler’s supplier Quality Assurance Manual,
Ford’s Q-101 Quality System standard and General Motor’s NAO Targets for
Excellence.
 QS 9000 focuses on helping automotive suppliers to ensure that they are
meeting/exceeding automotive customer requirements.
 QS 9000 is now being replaced by a newer related standard called ISO/TS
16949. TS 16949 contain all of ISO 9000, QS 9000 and many European
standards.
30. What is the objective of QS 9000?

To develop fundamental quality systems based on continuous improvement, direct
prevention, reduction of variation and waste elimination in the automobiles supply
chain.
31. List the applications of QS 9000.

QS 9000 can be applied to all internal and external suppliers of:
 Production materials,
 Production or service parts, and
 Heat treating, painting, plating or finishing services.
32. What are the contents of QS 9000?

Section I: ISO 9000 Based Requirements
Section II: Automotive Sector Specific Requirements
Section III: Customer Specific Requirements

33. What are the documents required for QS 9000? (May 2017)
Section I: ISO 9000 based requirements
Section II: Automotive sector specific requirements
Section II: Customer specific requirements
 QS 9000 quality system requirements

 Advanced Product Quality Planning (APQP)and Control Plan
 Failure Mode and Effects Analysis (FMEA)
 Measurement system analysis
 Fundamental statistical process control
 Production Part Approval Process (PPAP) manual and
 Quality System Assessment (QSA) manual.

The ISO 14000 is a set of norms for Environmental Management system (EMS)
either at organization and process level or product level.
35. Why do we need ISO 14000 standards?

 The ISO 14000 standard brings a world- wide focus to the environment,
encouraging cleaner, safer, healthier world for all. The existence of the
standards allows organizations to focus environmental efforts against
internationally accepted criteria.
 Nowadays, companies require environmental management certification to
compete in the global marketplace. So the ISO 14000 registration may become
the primary requirement for doing business in many regions or industries.
36. List the ISO 14000 series of standards.

Two areas:
 Organization evaluation standards
 Product evaluation standards
37. What are the purposes of series of ISO 14000 standards?

The series of ISO 14000 standards are designed to cover:
 Environmental management systems,
 Environmental auditing,
 Environmental performance evaluation
 Life cycle assessment and
 Environmental aspects in product standards.
38. What are the requirements of ISO 14001?

General requirements
 Environmental policy
 Planning
 Implementation and operation
 Checking and corrective action
 Management review

39. 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
40. What are the four elements for the checking & corrective action of ISO 14001?
 Monitoring and measuring
 Nonconformance and corrective and preventative action
 Records
 EMS audit
41. 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
42. What are the four elements for the planning of ISO 14001? (May 2016)
 Environmental aspects
 Legal and other requirements
 Objectives and targets
 Environmental Management Programs
43. Give the types of Organizational Evaluation Standards?

 Environmental Management System
 Environmental Auditing
 Environmental Performance Evaluation
44. Give the types of Product Evaluation Standards?

 Environmental Aspects in Product Standards

 Environmental Labeling
 Life-Cycle Assessment
45. List some organization which has ISO standard.

Neda Telecommunications, district passport office- Delhi, Computer
Maintenance corporation, Infosys.
46. Differentiate the terms environmental aspects and environmental impact.

Environmental aspect: is defined as an element of an organisation’s activities, or
services that can interact with the environment. Examples are waste water discharges,
air emissions, and energy usage.
Environmental impact: is defined as any change, whether adverse or beneficial,
wholly or partially resulting from an organisation’s activities, products, or services.
Examples are impact on water supply and soil erosion.
47. Contrast environmental objective and environmental target.

Environmental objective: is an overall environmental goal, arising from the policy
statement, that an organisation sets for itself.
Environmental target: is a detailed performance requirement and should be quantifies
when practical.
48. What is the purpose of EMS audit?

The purpose of EMS audit is to ensure that the EMS conforms to plans.
49. Where we can apply the ISO 9000 series of standards?

ISO 9000 series of standards are applied to any organization , large or small, whether
its product, whether it is a business enterprise, a public administration or a government
department.
50. What is the concept of environment management system?(May/June 2013)
1.Environmental
policy
2. Planning
3 Implementation
5.Management
review Continual improvement and operation
4. checking and
corrective action

51. What is meant by environmental policy?
 The environmental policy should address the following issues:
 Management commitment to continual improvement
 Prevention of pollution
 Compliance with environmental laws and regulation, cooperation with public
authorities
 Creating a framework for setting objectives
52. What are the organization standard and products standard? (May/June 2013)
Organization standard
(i) Environmental Management system,
(ii) Environmental Auditing (EA) and
(iii) Environmental Performance Evaluation (EPE)
Product standard
(i) Environmental Aspects in product Standards(EAPS),
(ii) Environmental Labels and Declaration(ELD),and
(iii) Life Cycle Assessment(LCA)
53. What is general requirement of quality management system?(Nov/Dec 2011)
 To achive, maintain and seek to continuously improve product/service quality.
 To improve the quality operation to continually meet customers and stakeholder and
implied needs.
 To provide confidence to internal management and other employees that quality
requirements are being fulfilled and that improvement is taking place.
54. Differentiate between ISO 9000 and QS 9000.(Nov/Dec 2012)
ISO 9000 has become an international reference for quality management requirements
are being achieved in the delivered product.
QS 9000 is set of quality system requirements to help automotive suppliers to ensure
that they are meeting/exceeding customer requirement.
55. What are the benefits of ISO-9000 certification? NOV’13 (May 2016)
 It forms a solid foundation for improvement, consistency, and profitability.
 It provides good platform for continuous quality improvement.
 It provides a status symbol for the organization and acts as powerful marketing tool.
 It increases the potential market share.
 It increases awareness of employee in company requirements and activities.
 It ensures customer satisfaction.
 It improve documentation, operating standards, and housekeeping.
56. What are the objectives of ISO 9000?

 Customer Focus: Understand customer needs, meet customer requirements, and
strive to exceed customer expectations.
 Leadership: Establish unity of purpose and organizational direction.
 Involvement of people: Use abilities of employees for the benefit of the
organization.

 Process approach: Things accomplished are the results of processes and processes
and resources must be managed.
 System approach to management: Multiple processes contribute to system and
should be managed as a system.
 Continual improvement: Of people, processes, systems and products.
 Factual approach to decision making: Decisions must be based on the analysis of
accurate, relevant, and reliable data and information.
 Mutually beneficial supplier relationships: Both the organization and the supplier
benefiting from each other’s resources and knowledge results in value for all.
57. Compare QS 9000 with TS 16949 quality system
 Both are related to automotive quality system standards, now QS 9000 is being
replaced by ISO /TS 16949 standards.
 QS 9000 is basically product approach whereas TS 16949 is a process approach.
 The other difference between QS 9000 and ISO/TS 16949 relate to the aspects
of customer satisfaction and employee motivation
 TS 16949 is much less focus on documentation and more focus on how the
system is performing in achieving customer satisfaction
58. What are the core elements of QMS?

1. Quality policy
2. Quality objectives
3. Quality manual
4. Organizational structure and responsibilities
5. Data Management
6. Processes - including purchasing
7. Product quality leading to Customer satisfaction
8. Continuous improvement including corrective and preventive action
9. Quality instruments
10. Control of Document
59. Name any two generic ISO standards. Why it is called generic standards?
 ISO 9000
 ISO 14000
PART B

1.Explain the various elements of ISO 9000 in detail. (Nov/Dec 2012) (May/June 2013)
(NOV/DEC 2013) (Dec 2017)
ELEMENTS OR CLAUSES OF ISO 9000

1. Management responsibility
 The management should define and document its quality policy and objectives.
 The responsibility, authority and interrelations of all employees should be clearly
defined.
2. Quality system
 The organization should document, establish and maintain a quality system.
 The document of quality system include preparation of quality manual, procedures,
process work instructions, workmanship standards, drawing specifications and
relevant quality records.
3. Contract review
 The element states that the customer’s requirement should be formally reviewed to
ensure that the supplier is capable in terms of both technical and organizational
requirement.
 The records of those reviews should be properly maintained.
4. Design control
 This element requires that the design process should be documented and planned
correctly.
 Both the design inputs and the design output should be identified and documented.
5. Document control
 The ISO 9000 quality management system is totally documented system.
 This element explains the method the method of documentation, approval and issue
of all quality documents.
6. Purchasing
 This clause addresses issues relating to assessment of subcontractor, purchasing
data verification of purchased component, materials and procedures therefore are
specified
7. Purchaser supplied product
 This clause also lays down the responsibility for preventing damage or loss and the
same to be recorded and reported to the customer.
8. Product identification and traceability
 This clause lays down the requirement for the product or service to be correctly
identified throughout the production process.
 Traceability means the method by which the item can be selected.
9. Process control
 This clause specifies that the supplier shall identify and plan the production and
installation processes which directly affect the quality
 Control conditions mean the following:
--- Continuous monitoring to ensure continuing process capability
--- Compliance with relevant codes.
10. Inspection and testing
 Receiving inspection and testing
 In-process inspection and testing
 Final inspection and testing
11. Inspection, Measuring and test equipment
 Identifying the maintenance to be made and the accuracy required.
 Calibrating the measuring equipment ad test devices.
12. Inspection and test status
 This clause explains how the system should be laid down to indicate that the
product has been inspected and tested and conforms or does not conform to
specifications at various stages of production.
13. Control of non-conforming product
 Record of reviews has to be maintained
 This part of the standard is sometimes referred to as the calibration section.
14. Corrective and preventive measures
 This clauses explains the system for removing actual and potential non-conformities
a) Corrective action
b) Preventive action
15. Handling, storage, package, preservation and delivery
 This clauses explains how the supplier ensures that there is no degradation of
quality of product due to handling, storage, preservation and delivery at different
stages of production
 This part of the standard is sometimes referred to as the housekeeping sections.
16. Control of quality records
 This record of the performance of the quality system should be established and
maintained.
17. Internal quality audit
 This audit is used to verify the effectiveness of the quality systems.
 The audit results should be documented and reported to the concerned managers to
take any identified corrective actions.
18. Training
 Appropriate records of all training should be maintained.
 This clause describes how training needs of personal are identified, organized,
implemented and maintained.
19. Servicing
 This clause explain how servicing will be planned and executed whereas it is a
specified requirement.
 Record of service provided should be maintained.
20. Statistical techniques
 This clause describes that the organization has to identify the most useful statistical
techniques for its operations.

2. Explain the following
i. Implementation of ISO 9000(step to registration)
ii. Documentation of ISO 9000
IMPLEMENTATION OF QUALITY SYSTEM

Step 3: Awareness
Step 5: Training

 The most important step inimplementation a quality stem is to get the full support
of upper management.
 The top management must be willing to commit the resources necessary to achieve
certification.
 The next step is the appoinment of a management representative.the representative
can be a member of the top management group.
 The management representative is responsible for coordinating the implementation
and maintenace of the quality system.also he is the contact person for all parties
involved in the process,both internal and external.
Step 3: Awareness
 The next step to create awareness about the ISO 9000QMS.
 Since the implementation of the quality system requires involvement of all member
in the organisation,the members should understand the process and implication of
ISO program.
 Now the implementation team should be formed.
 This team should be drawn from all levels and areas of the organisation.
 The team should identify the QMS processes and their sequence and interaction.
Step 5: Training
 The inmplementation team,supervisors,and internal audit team shold be trained.
 This activity can be accomplished through in-house training
programes,seminors,workshops etc.,
 This activity develop a time schedule for the implementation and registration of the
system.

 This time frame will vary,depending on the size and type of organisation.
 The imlementation team selects owners for each of the system elements.many of
these ownera will be members of the implementation team.
 Each owner has will option of selecting ateam to assist in the process.
 A review of the present quality system should be performed.
 Copies of all the quality manuals,procedures,work instructions, and forms presently
in use are obtained.
 This activity is agap analysis and can be perfomed by the element owners and their
teams or by an externalconsultant.
 Written quality policy and procedure manuals should be prepared.
 This documentation of work instruction should be done by the employee who
performs the job.
 The policies, procedures, and work instructions should be integrated into the da-to-
day workings of the organisation.
 Noe the new system is installed.
 An internal audit of the quality systemshould be conducted.
 This step ensures that the system is working effectively and to provide management
with information for the comprehensive magement review.
 The magement review should be conducted inorder to determine the effectiveness
of the system in achiveing the stated quality goals.
 The Preassessment is an optional step.if a good job has been done on the previous
step,then Preassessment is not necessary.
 The Registration activity includes:choosing a registrar,submitting an application,
and conducting the registrar’s system audit.
 While choosing the registrar,one should consider so many factors such as cost, lead
time, customer’s acceptance of the registrar, registrar’s acreditation,and familiarity
with the industry.
 The application for registration should also include supplying the registrar with
policy and procedure manuals for their review.
 The time involved in the registrar’s system audit will vary depending on the size
and complexity of the organisation and the number of auditors involved.
 After accepting the application and setting atime frame for registration,the registrar
will review the quality system documentation.
 Based on satisfactory report of the assessment team,licence i.e.,ISO certificate will
be granted to the organisation by ISO/BIS to use the certification mark in letter
heads,quality certificates,etc.
 The certificates awarded is normally for 3 years.during the period of
validity,surveillance audits are conducted toensure that the documentation quality
system is being effectivetly maintained.

 The surveillance audits will not be full audits but random checks of some elements
to ensure that the system continues to function.
DOCUMENTATION (May 2016)
NECESSITY FOR DOCUMENTATION

 It is understood that the proper documentation is the pro-requisite for implementing
quality system.
 The documentation serves as a reference for the management.
Advantages of documentation quality system:

 Serves as a reference;
 Brings about clarity of objectives and targets;
 Provides standardisation in work procedures;
 Bring about consistency in operations;
 Develops confidence amongst employees;
 Generates customer’s confidence;
 Provides abasis for continuous improvement,etc.
DOCUMENTS TO BE PREPARED
The documents requires by most organization are:
 Quality policy manual
 Quality System Procedures (QSPs)
 Work Instructions (WIs)
 Rocords/Formats/Forms
Fig:The documentation pyramid
QUALITY POLICY MANUAL

 Quality policy manual is the first level of documentation.This is the document that
defines ‘what will be done’ and ’why’.
 The ‘why’ can be stated just once as aquality policy statement.this statement shoule
be ashort and simple definition of the organisation’s quality intentions.
 The reminder of the policymanual addresses what will be done to comply with the
standard being used.
 The policy manual communicates the quality policy and objectives of an
organization.
QUALITY SYSTEM PROCEDURES (QSPs)

 The second level of documentation is the quality procedure. These procedures
describe the methods that will be used to implement and perform the stated
policies.
 These procedures define who should perform specific tasks, when the task
should be done, and where documentation will be made.
 These documents collectively define the organisation’s operations from
receiving an enquiry to delivering ac completed product or service.
 These procedures are confidential documents of the organisation and therefore
need not be revealed to outsiders.
WORK INSTRUCTIONS (WIs)

 This third level of documentation is generally company specific.
 It gives details of how individual work processes are carried out within a
company.
 Work instruction should also specify how the work should be done; who should
undertake the work and what records are to be maintained.
 The work instructions may be in the form of a detailed drawing,recipe,routing
sheet, specific job function,photograph,video,or simply a sample for comparison
of conformity.
 The work instructions should be written by the employee who performs the task.
RECORDS/FORMATS/FORMS
 These provide evidence of activity having been performed in compliance with
quality system procedure.
 Records may be forms that are filled out, stamp of approval on a product or a
signature and date on some type of document.
 Records are used to provide traceability of actions taken on a specific product or
batch of products.
BENEFITS OF DOCUMENTATION
 Performing day-to-day activities
 Provides formats for standardizing practices
 Provides reference for assessing degree of enforcement practice
 Facilitates trouble shooting for tracing back on the processes
 Demonstrates the ISO quality system certification
3. Explain in detail about the quality auditing with its types and also give the various
stages of an audit.(Nov/Dec 2011) (May 2017)
QUALITY AUDITING:
A quality system audit is defined as”a systematic and independent examination to
determine whether quality activities and related results comply with planned arrangements,
whether these are suitable to achieve objectives”.
FEATURES OF QUALITY AUDITING:

 The quality audit typically applies to quality systems or elements such as processes,
product or services. such audit are often called ‘quality system audits’,’ process
quality audits’,’ product quality audits’, ’service quality audits’ respectively
 Quality audit is an information gathering activity. It is not a ‘police’ kind of
activity.
 Quality audits are carried by staff who are not directly responsible in the areas
being audited. But preferably auditors should work in cooperation with relevant
personnel.
 Quality audit may be conducted for internal or external purposes. They need not
cover whole quality system, at once, but may cover elements of it.
TYPES OF AUDITS:
(I)First party audit (or internal audit): this refers to an internal audit where the auditee
is its own client, i.e, audit is done by an organization, working on itself.
(II)Second party audit: This refers to audit by one organization on another
organization(auditee). This type of audit is normally done on a supplier by a customer.
(III)Third party audit: This refers to audit by an independent organization on a supplier,
for accreditation assessment purposes.
OBJECTIVES OF QUALITY AUDITS (NEED FOR QUALITY AUDITS):

 To determine the conformity or non-conformity of the quality system elements with
regard to specified requirements.
 To meet regularly requirements, if applicable.
 To evaluate an organization’s own quality system against a quality system standard.
STAGES OF AN AUDIT:
1. Audit planning
2. Audit performance
3. Audit reporting
4. Audit follow-up
STAGE 1: Audit plannig

(i)Audit schedules:It is a matrix of the timings, which details when each audit element is
to be checked throughout the year.
(i)Audit personnel: It refers to the appointment of an auditor.
(i)Notification to the auditee: This is the formal and timely request by audit to auditee
for making available all quality system document relevant to the audit.
(i)Preparation of checklist: This lists all specific questions to be asked during audit.

STAGE 2: Audit performance

(i)Opening /entry meetings: Opening meeting is organized to initially brief the auditee
about the scope of audit.
(ii)Audit process: Audit is run to schedule and should cover entire scope, as planned.
(iii)Audit deficiencies: During auditing, clear and precise discrepancy reports are raised.
All discrepancies should be based on sound and objective evidence.
STAGE 3: Audit reporting

Audit reporting deals with the recording of any non-conformity and summarizing the audit
findings.
It may contain;
 Identification of the reference documents against which audit is conducted(i.e.,
quality system standard),company quality manual,etc.
 Observation of non-conformities.
 Corrective action requests.
STAGE 4: Audit follow-up

 The audit is responsible only for identifying the non-conformity. But the auditee is
responsible for determining and initiating corrective action needed to correct a non-
conformity.
 Corrective action and subsequent follow-up should be completed within a time
period agreed to by the client and the autidee in consultation with the auditing
organization.
Qualities of a good auditor

 Good in written and oral communication
 A good listener
 Able to focus on the task at hand should not get disturbed by other activities that
are taking place at the same time.
 Able to identify the vital facts from the ocean of information
 Honest and impartial.
4. Explain the various requirements of ISO 14000. (May 2016) (May 2017) (Dec 2017)
REQUIREMENTS OF ISO 14000(MAJOR ELEMENTS OF EMS STANDARD)

The major elements of EMS standards are:
1. General requirements,
2. Environmental policy,
3. Environmental aspects,
4. Legal aspects,
5. Objectives and targets,
6. Environmental management programme,
7. Structure and responsibility,

8. Training, awareness and competency,
9. Communication,
10. Environmental management systems documents,
11. Documents control,
12. Operational control,
13. Emergency preparedness and response,
14. Monitoring and measuring,
15. Non-conformance and corrective and preventive action,
16. Records,
17. EMS audit, and
18. Management review.
General Requirements
 This clause addresses the general requirements of ISO 14000 to the organizations.
This element requires that the organization should establish and maintain
environmental managements systems (EMS).
 The EMS includes policy, planning, implement and operation, checking and
corrective action, and management review.
 This element also insists the organization to include a brief description of the
company.
Environmental policy
This clause explains the contents to be included in the environmental policy. The
environmental policy should address the following issues:
 Management commitment to continual improvements,
 Prevention of pollution,
 Compliance with environment laws and regulations, cooperation with public
authorities,
 Creating a framework for setting objectives,
 Communication requirements with shareholders, and
 Education and training for environments,
Environmental Aspects
 This clause explains about the environmental aspects and its relationship with the
environmental impacts.
 The process of identification of environmental aspects is somewhat similar to
FMEA analysis.
Legal Aspects
 This clause explains the organization to have a identify and have access to all
legal requirements to which it subscribes.
Objectives and Targets
 This element describes the organization to establish and maintain the objectives and
targets at each relevant functions and levels.

Environmental Management programme
 This clause details the organization to establish and maintain a program for
achieving the objectives and targets.
 The program shall include designation of the responsible function, team, or
individual and a timeframe for achievement.
Structure and Responsibilities
 This element addresses the roles, responsibilities, and authorities of all personnel
affecting the EMS.
 The management should provide the resources in terms of people, technology, and
money to implement and maintain an effective system that achieves its objectives.
Training, Awareness, and Competency
 This clause details the training needs to be evaluated, to ensure the system
effectiveness.
 The two types of training are:
1. General awarenessàimportance of conformance to the EMS.
2. Job competency
Communication
This element describes the procedures to be established and maintain for
communication with the all stakeholders.
Environmental Management Systems Document

This element requires that information be established and maintained to describe
the core elements of the systems and their interaction and provide direction to applicable
related documents.
Document control
 This element requires that procedure be established and maintained to control all
EMS documents.
 Examples: blueprint, test procedure, work instructions.
Operational control
 This element aligns operations and activities with the identified significant
environmental aspects, environmental policy, and environmental objectives and
targets.
Emergency Preparedness and Response
 This element describes the procedures to identify and respond to potential accidents
and emergency situations.
 These procedures should also prevent the environmental impacts of these accidents
and emergency situations.
Monitoring and Measuring
 This element requires that the organization to monitor and measure the key
characteristics of its objectives and activities in order to assess its performance
meeting environmental operations and targets.
Non-conformance and corrective and preventive action
 This clause describes the procedures to define responsibility and authority for:
1. Handling and investigating non-conformance,
2. Talking action to minimize any impacts, and
3. Initiating corrective and preventive action.
Records
 This systems requires procedure for the identification, maintenance, and disposition
of environmental records.
 Environmental records include training, audits, equipment calibrations and reviews.
EMS Audits
 The purpose of EMS audit is to ensure that the EMS conforms to plans
 Audit procedures should cover the scope, frequency and methodologies, and
responsibilities and requirements for conducting audits and reporting results.
 Internal or self audits and external audits information should be forwarded to the
top management to assist in the management review process.
Management review
 The intent of this clause is to involve top management in the EMS continuous
improvement process.
 Management should evaluate the feedback data and make improvements to the
system.
5. Give a brief note on EMS model (Nov/Dec 2011)(Nov/Dec 2013) (May 2017)
CONCEPT OF ISO 14000

(ENVIROMENTAL MANAGEMANT SYSTEM MODEL)
ISO 14000 series of standards can be applicable to all types and sizes of organization and
to accommodate diverse geographical, cultural and social conditions. EMS approach is
based on PDCA.
The EMS model consists of the following five stages:

1. Environmental policy
2. Planning
3. Implementation and operation
4. Checking and corrective action, and
5. Management review.
1.Environmental
policy

2.Planning
nn
5.Managem 3.Implementati
ent review on & operation
4.Checking &
corrective action
Continual Improvement
Stage1: Environmental policy (EP)
The environment policy should address the following issues:
1) Management commitment to continual improvement, i.e., core values and beliefs in
making environment policy;
2) Prevention of pollution
3) Education and training for environment.
4) Compliance with environment laws and regulation, operation with public authorities;
5) Communication requirements with shareholders;
The management should ensure that the policy is implemented and carried out.
Stage2: Planning
This planning stage contains four elements such as:
 environmental aspect,
 legal and other requirements,
 objectives and targets, and
 EM program.
 The environment aspects of an organization’s activities, product, and services
should be identified in order to determine the environment impact.
 The organization should identify and have access to all legal and other
requirements to which it subscribes.
 the organization should establish and maintain the objectives and targets at each
relevant function and level.
 The organization should establish and maintain a program(s) for achieving the
objectives and targets.
Stage3: Implementation and operation

This stage contains seven elements such as:
i. Structure and responsibility,
ii. Training, awareness and competency,
iii. Communication,
iv. EMS documentation,
v. Document control,
vi. Operational control and
vii. Emergency preparedness and response.
 Roles, responsibilities and authorities should be defined, documented and
communicated for all personnel affecting the EMS.

 Training needs should be evaluated on a regular basis to ensure their effectiveness.
 The EMS implementation requires proper communication with all stakeholders.
 The organization should establish and maintain information, in paper or electronic
form, to describe the core elements of the system.
 Procedures should be established and maintained to control all EMS documents.
 Procedures should be formed to identify and respond to potential accidents and
emergency situations.
Stage4: Checking and corrective actions

This stage contains four elements such as:
i. monitoring and measuring,
ii. non-conformance and corrective and preventive action,
iii. records and
iv. EMS audit.
 The organization should monitor and measure the key characteristics of its objectives
and activities in order to assess its performance in meeting environmental operations
and targets.
 Procedure should be established to define responsibility and authority for
(i) Handling and investigating non-conformance; and (ii) initiating corrective and
preventive action.
(ii) The organization should establish procedures for the identification, maintenance,
and preventive action.
 The organization should establish procedures for the identification, maintenance and
disposition of environment records such as training, audits, equipment calibration, and
reviews.
 EMS audit should be carried out to ensure that the EMS conforms to plans.
Stage5: Management Review

1) Management should review and revise the system in order to ensure the continuing
suitability, adequacy and effectiveness of the EMS.
2) The management must evaluate the feedback data and make improvement to the
systems.
Thus EMS implementation is base on PDCA cycle.
BENEFITS OF ISO 14000(Nov/Dec 2013) (May 2016)

There are two categories:
1. GLOBAL BENEFITS
2. ORGANISATION BENEFITS
GLOBAL BENEFITS:
The three major global benefits of implementing ISO 14000 are:
(i)To facilitate trade and remove trade barriers.
(ii) To improve environmental performance of planet earth, and
(ii)To build consensus that there is a need for environmental management and a common
terminology for EMS.
2) ORGANISATION BENEFITS
Significant benefits have been observed in the organization in the following ways:
(i) Satisfying customer requirements
(ii) Improving teamwork
(iii) Increasing market share that results from a competitive advantage.
(iv) Assuring customers of a commitment to environmental management.
(v) Improving access to capital by improving the confidence of the investors.
(vi) Satisfying insurance criteria and obtaining insurance at reasonable cost.
(vii) Increasing market share that results from a competitive advantage .
(viii) Reducing incidents that result in liability.
(ix) Facilitating the attainment of permits and authorization.
(x) Conserving input resources.
(xi) Improving industry/government relations
(xii) Maintaining a good relationship with public/community/society.
6. Discuss QS 9000 (May/June 2013) (NOV/DEC 2013)
QS-9000—AUTOMOTIVE QUALITY MANAGEMENT SYSTEMS

WHAT IS QS 9000?
QS 9000 is a set of quality system requirements to help automotive suppliers to ensure that
they are meeting/exceeding customer requirements.
OBJECTIVES OF QS 9000
The objectives of QS 9000 is to develop fundamental quality systems based on continuous
improvement, direct prevention, reduction of variation and waste elimination in the
automobiles supply chain.
APPLICAYIONS OF QS 9000
(i) Production materials
(ii) Production or service parts
(iii) Heat treating, painting, plating or finishing services
CONTENT OF QS 9000(structure of QS 9000)
QS 9000 standards can be dividing into three sections
1. ISO 9000 based requirements
2. Automotive sector specific requirements
3. Customer specific requirements
Section I: ISO 9000 based requirements
 This requirement includes the exact text of ISO 9001 with the addition of
automotive/ heavy trucking requirements.
Section II: Automotive sector specific requirements
 This requirement includes common requirements for all automotive supplies,
agreed by the ‘big three’ (i.e., chryster, ford motor, and general motors’)
 The sector specific requirements are:
1. production-part approved process (P-PAP),
2. Continuous improvement, and
3. Manufacturing capabilities (such as facilities planning, mistake proofing, and
tooling management).
Section II: Customer specific requirements
 This section deal with the specific requirements of each customer over and above
the requirements specified in section II
DOCUMENT REQUIRED FOR QS 9000 PROGMME
1. QS 9000 quality system requirements
2. Advanced Product Quality Planning (APQP) and control plan

3. Failure Mode and Effect Analysis (FMEA)
4. Measurement system analysis
5. Fundamental statistical process control
6. Production Part Approval Process (PPAP) manual
7. Quality System Assessment (QSA) manual
7. What methodology would you suggest to implement TQM in an automobile

manufacturing company? (NOV/DEC 2012)
Gilmore (2008) illustrated that today; manufacturers in the world are facing
competitions from the other competitors and the customers seeking quality products and
services at a lower cost. In order to fulfill that requirement, the manufacturers have to produce
those products which are economical, cost effective in nature.
The framework of manufacturing of automobile industry will help in improving the
operational and remain in the competing industry.
According to Hoyle (2010), the total quality management benefits the automobile
sector which was started in the year 1983 astructures, one has to implement the total quality
management. There were many research studies were done on the automobile sector, but there was
no such studies done to implement the which had 3 car companies and 2motorcycle
companies. This company has provided 60,000 employments to the people in 2006. Those manufactures
succeeds in the market who have world lass practices in the competing markets (Hakes, 2008).To
become one of the world class infr intergraded total quality management.
The study was done to implement the total quality management among the vendors
(Silos, 2008).The six practices were like the leadership, suppliers, organization,
management of customer practices, product management, product management, information
management, human resource management and the management of the process.
Five Measurements
The performance of five measurement were the customer involvement and satisfaction level,
leadership effectiveness level, human resource management effectiveness level, process and system
approach effectiveness level and the quality measurement level.
These performances were done in financial and non-financial measurement of performance
(Hendricks and Singhal, 2008).In the words of Kalpande and Gupta (2010), the study in this
industry is used for the collection of descriptive data through the system of questionnaires.
30 highly performance and active vendors were studied.
The vendors were evaluated by the automobile industry and graded them as highly
committed and high performance vendors and the rest as benchmark (Dandekar,
2010).According to Kelemen (2009), the personal from various fields like quality, factory,
operations, production managers and the top management were the respondents of the survey.
The respondents allowed any queries from the vendors to ensure better understanding
of the questionnaire.
MAJAICO and PROTON

Plunkettet al.(2008) noted that the survey was done to meet the current scenarioof
total quality management of the automobile sector. 30 vendors were taken inaccount. The
next 17 vendors were later described as the PROTON development vendors. All the
vendors will be used as benchmark for PROTON through vendor management group. Those
who were interested in implementing the system they boosted their performance of the company
(Lagrosen, 2009).

In the words of Kemp (2007), the total 30 questionnaire were distributed to the vendors
who were highly active and high performance. Out of the 30 vendors, 17vendors were
MAJAICO improved vendors where as the rest 13 were the PROTON and have showed high
performance. The questionnaire was divided into three segments. The 17 vendors for MAJAICO
participated in the case study.
Integrated Measurement
According to Prajogo et al.(2008), the analysis of the descriptive used in the Total
Quality Measurement are classified into independent variables and the dependent variables.
In independent variable contained all the six practices of Total Quality Management
comprising of leadership, suppliers, organization, management of customer practices, product
management, product management, information management, human resource management and the
management of the process.
The five dependent variables were the customer involvement and satisfaction level,
leadership effectiveness level, human resource management effectiveness level, process and system
approach effectiveness level and the quality measurement level(Lemak and Reed, 2006).
As per Longenecker and Scazzero (2007), the findings from this survey indicate
that all the independent and dependent variables have shown that the value is more than 4
which indicates strong practices of Total Quality Management practices.
Mishra (2009) opined that most of the companies believes in open minded
leaderships with percentage of implementation is 88%. It is followed with the focuses on the
management of suppliers, organization and the customers with an aggregate of 80%
implementations.
Financial and non-financial performance

One of the basic needs of an organization is the performance of the financial
andnon-financial. Without these assets no organization will able to perform in themarket.
Finance deals with the monetary terms like the cash and banks but non-financial deals with
the employees, staffs, customers, land and building and machinery (Mann and Kehoe,
2006).
In the words of Patel (2011), the performances of financial and non financial are needed by any
organization now to giving more assessment of the performance. Sole dependent on a
particular finance is no longer sufficient to remain in this competitive market.
The automobile industry should emphasis on non financial performance which can lead to
financial performance. Morse (2007) stated that in context to the survey conducted,
leadership practices will not only effect on the part of financial profits.
This results in world class organization. Quality raw materials, better working
environment, modern facilities with gadgets, better packages and compensations, provided.
Toyota case study on cracks in TQM implementation

The world wide population for the Toyota has doubled in between 1985 and 2008.To
establishes this growth, Toyota employed additional employees and suppliers to achieve
the given targets (Love and Holt, 2000).
Dysfunctional structure
The problem in the Toyota’s manufacturing company was the plastic parts in the accelerator
pedal. The Toyota although rectified the mistake but they did not change the system in the

US. The Toyota industry initially denied the problems in the brake system and the runway
vehicles but minimized it.
Toyota would have been saved if it would have been deal openly about the
industrial problems upfront and substantially would have saved the industries monies and
the public outrages (Mukherjee, 2006).
Flaw of product development

The car makers in US had to line up all the cars lined for the programming codes
that have helped the cars to control the complexes and the system basedcomputer.Ohno
(2008) analyzed that apart from the above problems of the Toyota automobile industry;
there were other issues like the designs for the products.
In the year 2010, the automobile industry called off 2050 Tacoma pickup trucks to make over
the problems found in it. Again in the year 2009 in the month of August the industry
recalled 98,000 small cars from 16 cold states to fix the problems faced by the cars of the
company. Various sources said that Toyota automobile industries quality began decades
ago (Murthy, 2007).
Conclusion
Total Quality Management helps to better the product and the service of accompany.
With the coming of the globalization, the scenarios have been changed now; people saw the
industry adopting TQM processes which lead to the developments of new and better products,
services available to them for use.
People saw the process as a tool for betterment of usable product and service. There are
a lot issues involved with the implementation of TQM in organizations. Despite these
disadvantages they would love to adopt and have people following practice.
The process helps in minimizing the losses and maximizes the revenues, amends the
marketing strategies, asks for modern management practices, demands for safety of the employees
and the organization. Besides the wastages of the raw materials is reduced.
8. Discuss the implementation of TQM with a case study from the manufacturing industry.
(NOV/DEC 2011)
The organizations that responded to the study varied in industry, turnover and size.
The demographic profile of the responding organizations is not very much different from
the distribution offered by the population of firms targeted in this research.
The manufacturing industry in India consists of number of sectors automobile,
textile, light engineering industry etc. The profile of the sample with respect to nature of
industry is shown in the figure. It is interesting to note that most of the industries are from
automotive sector (52%).
This may be due to the fact that among other manufacturing sectors, the automotive
manufacturing sector in India is understood to be the most dynamic. It is one of the world’s
fastest growing Brazilian Journal of Operations & Production Management, automotive
industries. It is exposed to a highly competitive market and is adopting the latest
management techniques, therefore, is more willing to participate in this type of research in
order to gain knowledge about systems to improve quality and operational performance.
The other industries which participated in the study are from Electrical (6%), Electronics
(12%), and textile (12%). Other industries include
primary metals(6%), consumer products (6%), cement(2%) and pharmaceutical(4%)
organizations.

Turnover of the Companies
The responding organizations are classified on the basis of turnover of the company. It has
been observed that most of the companies (26%) are in 500-1000 million group and 22 %
companies are from above 4000 million group.
This is due to the reason that most of the responding organization are from automotive
industry. The automotive industries are either multinationals or part of large groups.
No of Employees
The table 3 shows the profile of the companies on the basis of number of employees.
Twenty four percent of the organizations belong to third group of 501-1000 employees.
The distribution shows that all the four groups have adequate frequency of number of
employees which shows that sample is representative. All the four categories are
represented in the study.
Integration of Management Systems

In terms of integration of management systems, 70% of the respondents have integrated
ISO 9001 and ISO 14000. This is followed by 58 % ISO 9001, ISO 14000 and OHSAS;
50% having ISO 9001, TS 16949 and ISO 14000. Some companies are in the process of
certifying to MS ISO 14001 and TS 16949. This indicates that Indian companies emphasize
in integration of their MS to compete in the global market.
Competitive Priorities
Competitive priorities are a set of consistent goals for manufacturing. These are
foundations of customer satisfaction. Firstly they were asked about their competitive
priorities. The companies indicated that the quality is number one priority of all the
companies (mean-4.40). The table shows the mean and standard deviation of the
competitive priorities of the companies.
Use of Techniques and Tools for Quality Management

A single quality management tool may be described as a method which has a clear role and
defined application; it is often limited in its focus and can be and usually is used on its own
(e.g., a cause-and-effect diagram).
A quality management technique, on the other hand, has a wider application than a tool.
There is also a need for more intellectual thought, skill, knowledge, understanding, and
training to use a technique in an effective and efficient manner.
A technique may even be viewed as a collection of tools. If the companies are
implementing total quality management, next issue was to how much extent the companies
are aware of tools and techniques (T&T) of TQM. For this the two things were asked to
organization. First was awareness of T&T and second was implementation of T&T.
The list of tools and techniques of was provided in the questionnaire. The finding
revealed that most of T&T are known to these organization but the implementation of only
few tools are there .The table below shows the list of T&T and there awareness and
implementation by these organizations.
The tools and techniques can contribute to improving the level of QM if a climate of
managerial commitment is created. This means that techniques and tools are a reliable
indicator of a superior level of QM and therefore, of a superior performing company in
terms of quality, cost, etc.
Another issue that was included in the study was to determine the breadth of use of
the different methods of quality improvement in the manufacturing sector. Mean use values

were calculated for each and are presented in Figure 8. It should be noted that the opinion
of both users and occasional users was taken into consideration to calculate the average
ratings.
This is because the author felt it appropriate to analyze not only the ‘voice of users’ but
also the ‘voice of occasional users’ to gain a general view within the sector. The
responding companies seem to have adopted a wide variety of initiatives to improve
quality, as shown in Figure 8. Indian manufacturing organizations most frequently adopt a
``Continuous Improvement’’ program (mean-3.92), followed by ``Zero Defects’’ (mean-3)
and ``World Class Manufacturing’’ (mean-3).
S. No CSF Importance Implementatio Difference

n
1 Top 4.43(.41) 3.57(.55) 0.86
Management
Commitment
2 Human 4.38(.43) 3.36(.60) 1.02
Resources
Management
3 Suppliers 4.41(.39) 3.11(.68 ) 1.30
Management
4 Process 4.76(.45) 3.85(.57) 0.91
Management
5 Product 4.51(.44) 3.51(.81) 1.00
Design
6 Role of 4.60(.24) 3.38(.62) 1.22
quality
department
7 Quality 4.51(.35) 3.17(.73) 1.34
Information
System
8 TQM culture 4.69(.35) 3.27(.77) 1.42
9 Training 4.66(.35) 3.14(.65) 1.52
10 Use of IT 4.45(.42) 3.54(.69) 0.91
11 Quality 4.45(.48) 3.51(.72) 0.94
citizenship
12 Customer 4.68(.32) 3.78(.60) 0.90
Focus
Overall 4.55 3.43 1.12
Mean
The other techniques used by the organizations are Lean (mean-2.84), 5S(mean-
2.74), BPR(mean-2.72). Six Sigma(mean-2.12), CEL(mean-1.62) and TOC(mean-1.76) are
the lowest used techniques for quality improvement. Although Just in Time, Lean, TOC etc

are aimed at improving the productivity of operations. These also result in improving
quality and customer satisfaction (Brown et al., 2008).
This list is by no means exhaustive given the huge range of approaches that have been
proposed. An attempt was made to focus on relatively broad areas, and those that represent
a range of levels of sophistication and incorporate aspects of both the ``hard’’ and the
``soft’’ aspects of QM. One of the objectives of the survey was to determine the level of
awareness and level of implementation of the different tools used in automobile and other
manufacturing industries. Mean implementation and mean awareness values were
calculated for each and are presented in Table 8 shows the difference between awareness
and implementation of tools.
Quality improvement projects(QIP), Internal Audit(IA), Cause and Effect

Diagram(CAED), Control Charts(CC), Flow Charts(FC) and Brain Storming(BS) are the
most the techniques of which the responding companies are aware of. However the most
widely implemented techniques are Internal Audit(IA), Quality Improvement
projects(QIP), Quality Awards(QA), Flow Charts(FC), Competitive Benchmarking(BEN)
are the most widely implemented tools and techniques of quality management. The mean
of implementation in all the cases is less than the awareness. As stated earlier, generally the
respondent companies rated the awareness of the methods higher than the extent to which
they were implemented. Statistical tests were performed, however, to ascertain whether
these differences were significant or not. Two further tests were conducted to see if there
were differences between the automobile and other manufacturers. The following
hypotheses were formulated and a 5% level of significance used throughout.
1) To test for a significant difference between the awareness and the implementation
for all the manufacturing organizations:
H0: μa - μi = 0, i.e. there is no difference between the two means;
H1: μa - μi ≠ 0, i.e. there is a significant difference between the two
means.
2) To test for a significant difference in the extent of use between respondent
companies in the automobile and other manufacturing sectors:
H0: μman - μauto = 0, i.e. there is no difference between the level of
implementation of each of the methods in automobile companies and other
respondent companies;
H1: μman - μauto ≠ 0, i.e. there is a significant difference between the
implementation in methods in automobile companies and other respondent
companies.
The t-test between awareness and implementation shows that except in case of Quality
Awards (QA), Internal Audit (IA), Poka Yoke (PY) and Process Mapping (PM) the
difference between awareness and implementation of techniques is significant.
Conclusion
Indian manufacturing industry is aware of and appreciates QM. Tools and
techniques are vital to support and develop the quality improvement process. The

organizations are aware of all the tools and techniques. But when it comes to
implementation, it is less. There is significant difference between awareness and
implementation when these are measured on five point scale. The use of latest quality tools
and techniques is somewhat less in all the industries. The findings also indicate the
weakness of Indian manufacturing organizations in lack of implementation of tools and
techniques for quality improvement, mainly regarding the advanced. The use of Six Sigma
is very less than the other quality improvement approaches; this finding corroborates the
work of Khanna (2009). This paper has also presented the results of survey conducted on
the Indian manufacturing companies with the main purpose of finding the awareness and
implementation of tools and techniques of QM. This study has also identified crucial issues
for organization to consider especially on areas found lacking in implementation. There is
no significant difference between quality practices being followed by followed by
automotive and other manufacturing organizations. The findings seem to indicate that there
is no difference in use of quality tools and techniques in automobile and other
manufacturing industries. So it can be inferred that the quality management is not industry
context dependent. This finding of the study is in tandem with a recently conducted study
in another developing country (Mady, 2009)
9. Explain about the various processes used in ISO 9001 quality management system (Nov
2016)
Quality Glossary Definition: Quality management system (QMS)
A quality management system (QMS) is a formalized system that documents processes,

procedures, and responsibilities for achieving quality policies and objectives. A QMS helps
coordinate and direct an organization’s activities to meet customer and regulatory
requirements and improve its effectiveness and efficiency on a continuous basis.
ISO 9001:2015, the international standard specifying requirements for quality management
systems, is the most prominent approach to quality management systems.
While some use the term QMS to describe the ISO 9001 standard or the group of
documents detailing the QMS, it actually refers to the entirety of the system. The
documents only serve to describe the system.
Quality management systems serve many purposes, including:
 Improving processes
 Reducing waste
 Lowering costs
 Facilitating and identifying training opportunities
 Engaging staff
 Setting organization-wide direction
Quality management systems: industrial influence on quality and standardization
The history of quality can trace its roots back centuries when craftsmen began organizing
into unions called guilds. When the Industrial Revolution came, early quality management

systems were used as standards that controlled product and process outcomes. As more
people had to work together to produce results and production quantities grew, best
practices were needed to ensure quality results.
Eventually, best practices for controlling product and process outcomes were established
and documented. These documented best practices turned into standard practices for
quality management systems.
Quality became increasingly important during World War II, for example, when bullets
made in one state had to work with rifles made in another. The armed forces initially
inspected virtually every unit of product. To simplify the process without sacrificing safety,
the military began to use quality techniques of sampling for inspection, aided by the
publication of military-specification standards and training courses in Walter Shewhart’s
statistical process control techniques.
The importance of quality only grew after the war. The Japanese enjoyed a quality
revolution, improving their reputation for shoddy exports by fully embracing the input of
American thinkers like Joseph M. Juran and W. Edwards Deming and shifting focus from
inspection to improving all organization processes through the people who used them. By
the 1970s the U.S. industrial sectors such as electronics and automobiles had been
broadsided by Japan’s high-quality competition.
The rise of quality management systems
The American response to the quality revolution in Japan gave birth to the concept of total
quality management (TQM), a method for quality management that emphasized not only
statistics but approaches that embraced the entire organization.
In the late 20th century, independent organizations began producing standards to assist in
the creation and implementation of quality management systems. It is around this time that
the phrase “Total Quality Management” began to fall out of favor. Because of the multitude
of unique systems that can be applied, the term “Quality Management System” or “QMS”
is preferred.
At the start of the 21st century, QMS had begun to merge with the ideas of sustainability,
and transparency, as these themes became increasingly important to consumer satisfaction.
The ISO 19011 audit regime deals with both quality and sustainability and their integration
into organizations.
Benefits of quality management systems
Implementing a quality management system affects every aspect of an organization's

performance.
Two overarching benefits to the design and implementation of documented quality

management systems include:

1. Meeting the customer’s requirements, which helps to instill confidence in the
organization, in turn leading to more customers, more sales, and more repeat
business
2. Meeting the organization's requirements, which ensures compliance with
regulations and provision of products and services in the most cost- and resource-
efficient manner, creating room for expansion, growth, and profit
Within these overarching benefits are advantages like helping to communicate a readiness
to produce consistent results, preventing mistakes, reducing costs, ensuring that processes
are defined and controlled, and continually improving the organization's offerings.
ISO 9001:2015 and other quality management standards
ISO 9001:2015 is by far the most recognized and implemented quality management system
standard in the world. ISO 9001:2015 specifies the requirements for a QMS that
organizations can use to develop their own programs.
Other standards related to quality management systems include the rest of the ISO 9000
family (including ISO 9000 and ISO 9004), the ISO 14000 family (environmental
management systems), ISO 13485 (quality management systems for medical devices), ISO
19011 (auditing management systems), and ISO/TS 16949 (quality management systems
for automotive-related products).
Elements and requirements of a quality management system
Although any quality management system should be created to address an organization’s

unique needs, there are some general elements all systems have in common, including:
 The organization’s quality policy and quality objectives

 Quality manual
 Procedures, instructions, and records
1. Data management
2. Internal processes
3. Customer satisfaction from product quality
4. Improvement opportunities
5. Quality analysis
Each element of a quality management system serves a purpose toward the overall goals of
meeting the customers’ and organization’s requirements. Ensuring each of the elements of
a QMS is present ensures proper execution and function of the QMS
Establishing and implementing a QMS
Establishing a quality management system helps organizations run effectively. Before

establishing a quality management system, the organization must identify and manage
various connected, multi-functional processes to ensure customer satisfaction is always the
target achieved.

There are many things to consider when establishing a QMS for your organization. Of great
importance is ensuring it is a strategic choice influenced by the varying objectives, needs,
and products and services provided. This structure is based largely on the Plan-Do-Check-
Act (PDCA) cycle and allows for continuous improvement to both the product and the
QMS. The basic steps to implementing a quality management system are as follows:
 Design
 Build
 Deploy
 Control
 Measure
 Review
 Improve
Design and build
The design and build portions serve to develop the structure of a QMS, its processes, and
plans for implementation. Senior management must oversee this portion to ensure the needs
of the organization and the needs of its customers are a driving force behind the systems
development.
Deploy
Deployment is best served in a granular fashion via breaking each process down into
subprocesses, and educating staff on documentation, education, training tools, and metrics.
Company intranets are increasingly being used to assist in the deployment of quality
management systems.
Control and measure
Control and measurement are two areas of establishing a QMS that are largely
accomplished through routine, systematic audits of the quality management system. The
specifics vary greatly from organization to organization depending on size, potential risk,
and environmental impact.
Review and improve
Review and improvement deal with how the results of an audit are handled. The goals are
to determine the effectiveness and efficiency of each process toward its objectives, to
communicate these findings to the employees, and to develop new best practices and
processes based on the data collected during the audit.
MAY/JUNE 2016
PART A
1. List down the main elements of ISO 14000. (Q.NO.42)
2. Write down the benefits of ISO 9000 certification. (Q.NO.55)

PART B
1. Discuss the need for standardization procedures for quality assurance. Explain the
requirements of ISO system to documentation.(Q.No.2)
2. What are the requirements, objectives and benefits of ISO 14000 system? (Q.NO.4 & 5)
NOV/DEC 2016
PART A
1. Name any two generic ISO standards. Why it is called generic standards?(Q.NO.59)
2. What are the core elements of QMS? (Q.NO 58)
PART B
1. Explain about the various processes used in ISO 9001 quality management system.
(Q.NO:9)
2. With the help of flow chart explain the various divisions of ISO 14000 standard. (Q.NO:4
& 5)
MAY/JUNE 2017
PART A
1. What are the important requirements of QS9000?(Q.No.33)
2. Mention the different types of quality audits?(Q.No.26)
PART B
1. Enumerate the various aspects of ISO 14000 environmental management system? Brief
various principles of ISO 14000 series? (Q.No.4 & 5)
2. Explain the detailed procedure for quality auditing? Brief good attributes of good auditor?
(Q.No.3)
NOV/DEC 2017
PART A
1. What is need for ISO?(Q.No.3)
2. What is quality audit?(Q.No.22)
PART B
1. Explain how each element of TQM contribute to products and services of superior quality?
(Q.No.1)
2. Describe the implementation of ISO 14000 requirements and benefits?(Q.No.4)
Important questions all five units

UNIT-I PART-A
1. Define TQM.
2. What are the objectives of TQM?

3. Define Quality? Or How can quality be quantified and List the Factors that help in
improving the quality?
4. What are the Dimensions of Quality?
5. List out the six basic concepts of Total Quality Management.
6. List the elements of TQM.
7. What are the four pillars of TQM?
8. Give the characteristics TQM?
9. List the Principles of TQM?
10. What are the benefits TQM?
11. Give the Obstacles associated with TQM Implementation?
12. What are the general duties of a quality council?
13. What is fitness of use?
14. Define quality assurance.
15. List the psychological criteria of the quality.
16. What is meant by evolution of quality?
17. What are four absolutes of quality observed by Crosby?
18. Define service quality.
19. Write the stages of industrial cycle applied by TQM.
20. Define the quality in manufacturing organization.
UNIT-I PART-B
1. Enumerate the Deming’s 14 points of management.
2. Explain the principles and barriers to TQM implementation?
3. Explain the various dimensions of quality.
4. Discuss in detail about the Basic concepts & Elements of TQM.
5. Discuss in detail about the basic concepts of quality.
6. Discuss the contributions of Juran.
7. Discuss the contribution of Crosby.
8. Brief the history of evolution of TQM.
UNIT-II PART-A
1. Who are internal and external customers?
2. What are the important habits of quality leader?
3. Name a few barriers to Team’s progress.
4. State the importance of customer retention.
5. What is kaizen?
6. List out any four benefits of Employee involvement.
7. What are the different types of quality statements?
8. What is 5s?
9. What is strategic planning?
10. Difference between Strategic Quality planning and Traditional strategic planning.
11. Define Recognition and Reward. Why should one recognize the employees?
12. What is performance appraisal?
13. Differentiate Intrinsic and extrinsic rewards.

14. What are the basic ways for a continuous process improvement?
15. Compare kaizen and kairyo.
16. Define team and teamwork.
17. List four common barriers to team progress.
18. Define empowerment.
19. What are the common ways to collect customer needs?
20. Define supplier rating and list its objectives.
UNIT-II PART-B
1. Explain the different approaches towards Continuous Process Improvement.
2. Give detail about Theory of motivation.
3. Explain the strategic planning process in detail. Narrate the seven steps procedure
of strategic planning cycle.
4. Explain the concepts of Leadership?
5. Explain the team and teamwork in detail.
6. Write about the system of recognition and reward followed in an organization.
7. Explain in detail about performance appraisal.
8. Explain the PDSA cycle.
9. Explain 5S Concept.
10. Brief on Employee empowerment.
UNIT-III PART-A
1. Give the seven tools of quality?
2. When a Histogram is used and how to construct it.
3. What is meant by failure mode and effect analysis?
4. What are the stages of FMEA methodology?
5. List some of the benefits of FMEA.
6. List the types of FMEA.
7. List the types of Histogram.
8. List the various types of Benchmarking.
9. What are the reasons for benchmarking?
10. List the benefits and pitfalls of Benchmarking.
11. Define Benchmarking and give the objectives of Benchmarking.
12. What are the factors that distinguish six sigma concepts from traditional quality
management concepts?
13. Write down the five steps of Six sigma. List the advantages of six sigma.
14. Define Six Sigma.
15. Define Matrix data Analysis diagram. Give some of the uses of Matrix data
Analysis diagram.
16. Define Affinity diagram. What is the purpose of affinity diagram?
17. Define control chart. List the types of control chart.
18. What is a scatter diagram? List the different types of scatter diagram patterns.
19. Define flow chart. When a flow chart is used and how to construct it.
20. What are the new seven management tools?
UNIT-III PART-B
1. Explain the QC or SPC tools?

2. Discuss the new seven tools in detail with their typical applications & examples?
3. Explain the six sigma (DMAIC) process,& concept of six sigma with example?
4. Discuss the benchmarking process & explain the various types of benchmarking in
detail list the advantages, applications?
5. Explain the different steps involved in FMEA with an example & types of FMEA?
UNIT-IV PART-A
1. Define Quality cost. Give some examples for quality cost.
2. What are the various types of quality costs?
3. What are the various analysis techniques for quality costs?
4. What is a QFD? Give the objectives of QFD.
5. How to capture the voice of the customer.
6. Define House of Quality.What are the parts of house of quality (QFD Deploy)?
7. Define Taguchi method. Define Taguchi Loss function
8. Write the formula for Taguchi’s QLF.
9. Define TPM? What are t he goals of TPM?
10. What are the 6 big losses?
11. Define terotechnology.
12. Write down the formula of OEE (Overall Equipment Effectiveness)
13. What are the elements of quality circle?
14. What are the objectives of performance measures?
15. What are the techniques commonly used for performance measure presentation?
16. Draw the general structure of House of Quality.
17. List some of the benefits of TPM.
18. Give the seven basic steps to get an organization started toward TPM?
19. Define maintenance. List the types of maintenance.
20. What are the phases of QFD process?
21. What are functions of quality circle?
22. Who constitute a quality circle?
UNIT-IV PART-B
1. What is quality circle? Explain its characteristics, objectives, benefits and pitfalls of
quality circle?
2. Explain the structure of quality costs and the process of quality costs.
3. i. Explain the QFD process?
4. ii. Explain the House of Quality in Quality Function Deployment?
5. i. Derive the Taguchi Loss function.
ii. Explain the various types of maintenance.
6. What are the goals of TPM? List the basic steps to get an organization started towards
7. What is quality cost? Explain the techniques used for of quality cost.
8. Explain the objectives of performance measures
UNIT-V PART-A
1. Compare QS 9000 with TS 16949 quality system
2. What are the benefits of ISO-9000 certification?

3. Differentiate between ISO 9000 and QS 9000.
4. What is general requirement of quality management system?
5. What are the organization standard and products standard?
6. What is the concept of environment management system?
7. What are the types of audit?
8. Draw the Document Pyramid.
9. What is the need for ISO 9000?
10. What is QS 9000?
12. What are the objectives of ISO 9000?
13. What is the necessity for documentation of quality system?
14. What are the elements of ISO-9000 certification?
15. What are the qualities of a good auditor?
16. Differentiate the terms environmental aspects and environmental impact.
17. What is internal quality audit and external quality audit?
18. What are the documents required for QS 9000?
19. List the functions of Quality system.
20. Give some of the guidelines for writing a document.
UNIT-V PART-B
1. Explain the various elements of ISO 9000 in detail.
2. Explain the following
Implementation of ISO 9000(step to registration)
Documentation of ISO 9000
3. Explain in detail about the quality auditing with its types and also give the various stages
of an audit.
4. Explain the various requirements of ISO 14000.
5. Give a brief note on EMS model.
6. What methodology would you suggest to implement TQM in an automobile manufacturing
company?
7. Discuss QS 9000?
8. Discuss the implementation of TQM with a case study from the manufacturing industry.
9. Explain in detail about the service sectors









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MAILAM ENGINEERING COLLEGE GE6757 - TQM

1. What is Quality system?

2. List the functions of Quality system.

3. What is the need for ISO? (Dec 2017)

4. What is ISO 9000?

5. Give the ISO 9000 Series of Standards?

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 1

6. What is the need for ISO 9000?

7. Why should consider ISO 9000 registration?

8. Give some other quality systems?

10. What are the ISO 9000 Standards?

11. Who is responsible for developing the ISO 9000 Standards?

12. Comparison of ISO 9001, 9002 and 9003.

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 2

13. Compare ISO 9001 and ISO 9004.

14. What are the benefits of ISO?(Nov/Dec 2012)

15. List the elements of ISO 9000.

16. List the steps to implement ISO 9000.

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 3

17. What is the necessity for documentation of quality system?

18. What is the advantage of documented quality system?

19. Draw the Document Pyramid.(Nov/Dec2011)

20. Give some of the guidelines for writing a document.

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 4

22. Define Quality Audits. (Dec 2017)

23. What are the qualities of a good auditor?

24. Give the objectives of Internal Audit.

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 5

28. What are the methods of actual audit?

29. What is QS 9000?

30. What is the objective of QS 9000?

31. List the applications of QS 9000.

32. What are the contents of QS 9000?

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 6

 QS 9000 quality system requirements

34. What is ISO 14000?

35. Why do we need ISO 14000 standards?

36. List the ISO 14000 series of standards.

37. What are the purposes of series of ISO 14000 standards?

38. What are the requirements of ISO 14001?

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 7

43. Give the types of Organizational Evaluation Standards?

44. Give the types of Product Evaluation Standards?

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 8

45. List some organization which has ISO standard.

46. Differentiate the terms environmental aspects and environmental impact.

47. Contrast environmental objective and environmental target.

48. What is the purpose of EMS audit?

49. Where we can apply the ISO 9000 series of standards?

50. What is the concept of environment management system?(May/June 2013)

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 9

56. What are the objectives of ISO 9000?

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 10

58. What are the core elements of QMS?

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 11

ELEMENTS OR CLAUSES OF ISO 9000

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 13

IMPLEMENTATION OF QUALITY SYSTEM

Step 1: Top management Commitment

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 14

PREPARED BY: Mr.R.MOHAN & Mr.K.LAKSHMINARAYANAN - CSE 15

DOCUMENTATION (May 2016)