TQM 2 Marks and 16 Marks

UNIT IV
PART-A
1. What is meant by benchmarking?
The process of gathering information about the ‘best quality product manufacturing
company ‘ in order to copy , follow and excel, is known as benchmarking.
Benchmarking is defined as a systematic method (or) popular TQM tool by which

organizations can measure themselves against the best industry practices.
2. What are the six steps in benchmarking process?

1. Deciding what to benchmark
2. Understanding current performance
3. Planning
4. Studying others
5. Learning from the data
6. Using the findings and taking action
3. What is meant by quality function deployment (QFD)?

Quality function deployment (QFD) is a TQM tool which ensures that customer’s
requirements are met throughout the design process and also in the production systems.
4. Write about House of quality.
The primary planning tool in QFD is the House of Quality. House of Quality is a set of
matrix used to translate the voice of the customers into technical design requirement that meet
specific target values and characteristics of the final product. Because of its structure, it is
referred to as the ‘House of Quality’.
5. What are the six steps to build ‘House of Quality’?

1. Identify voice of the customers
2. Identify technical descriptors.
3. Relate the voice of the customers to the technical descriptors
4. Conduct an evaluation of competing products
5. Evaluate technical descriptors and develop targets.
6. What are the Taguchi’s Quality Loss Functions?
There are three common quality loss functions.
1. Nominal - the – best

2. Smaller – the – better
3. Larger – the – better
7. Define Total Productive Maintenance (TPM).

Total Productive Maintenance is defined as keeping the running plant and
equipment at its highest productive level with the cooperation of all areas of organization.
8. What is meant by predictive maintenance and preventive maintenance?

Predictive maintenance is the process of using data and statistical tool to determine
when a piece of equipment will fail.
Predictive maintenance is the process of periodically performing activities such as

lubrication on the equipment to keep it running.
9. Name different loss measurements in TPM?

a. Down time losses – Planned – Unplanned
b. Reduced Speed Losses
c. Poor Quality Losses
10. Name is meant by Availability?
Down time losses are measured by equipment availability (A) using the equation,
Availability A=(T/P)*100
Where T= Operation time (P-D)
P=Planned operation time
D= Down time.
11. What is meant by Failure Mode and Effect Analysis (FMEA) ?
Failure Mode and Effect Analysis (FMEA) is an analytical technique which combines the
technology and experience of the people
To identify foreseeable failure modes of a product(or) process

To plan for its elimination.
12. Define Reliability.
Reliability is defined as the probability of a product performing satisfactorily without

failure of a specified function under specified conditions for a specified period of time.
13. What are the three main categories of failure?

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1. Debug
2. Chance
3. Wear out
14. What is Debug failure ?
Debug includes a high failure rate at the initial stages because of inappropriate use (or)
flaws in the design (or) manufacturing.
15. What are the two important types of FMEA ?
1. Design FMEA
2. Process FMEA
16. Write some effects of failure.
1. Noise
2. Vibration
3. Erratic operation
4. poor performance
5. Lack of stability.
17. What is meant by performance efficiency?
Reduced speed losses are measured by tracking performance efficiency using the
equation,
Performance efficiency E=(C*N/T)*100
Where C=Cycle time
N= Number of units produced.
18. What are the three classes of customer needs?
1. Dissatisfiers: are the needs that are expected in a product (or) service
2. Satisfiers: are needs that customers say they want
3. Exciters/Delighters: are new (or) innovative features that customer do not except.
19. Name different types of matrix diagrams.
1. L- Matrix
2. T- Matrix
3. Y- Matrix
4. X- Matrix
5. C- Matrix.
20. What are the three types of benchmarking?
1. Internal benchmarking
2. Competitive benchmarking
3. Process benchmarking.
21. Draw the Taguchi Loss Function?
PART B –QUESTIONS
1. Discuss about design of FMEA document.

Design FMEA is used in the design process by identifying known and foreseeable
failure modes and then ranking failures according to relative impact on the product.
Design FMEA reduces development time and cost of manufacturing process by
eliminating many potential failure modes prior to operation of the process.
FMEA number space is given on the top right corner of the document which is
needed for reference.
ITEM space is used for component (or) process to be analysed.
Design Responsibility space is used for the team in-charge of the design or
process , (or) the name and the department of the person responsible for preparing the
document.
Model Number / Year of the component should be included in the space provided
to avoid confusion between similar components.
Key date space is used for initial Due date of FMEA.
FMEA date –original and FEMA date latest revision should be filled.
In the Core team space, the names of the responsible individuals and departments
having authority to perform tasks should be filled up. Item/Function :
In this column, the name and code number of the item being analysed is recorded.
This function of the item should be entered.
If the item has more than one function, they should be listed and analysed
separately.
The environment (temperature. pressure, humidity etc) in which the system

operates should be completely given.
2. Explain briefly above the “bench marking process” ?
There are six steps in benchmarking process which are given below.
1. Deciding what to benchmarking

2. Understanding current performace
3. Planning
4. Studying others
5. Learning from the data
6. Using the findings and taking action.
Deciding what to Benchmark
The initial stage of benchmarking is to determine what to benchmark and against whom to do so.
Improvement to best-in –class levels in some areas will contribute greatly to market and
financial success, where as improvement in other areas will have no significant impact.
Understanding current performance :
Self – analysis is an essential step in effective bench marking. It
is important to know your own processes, products, and services before you attempt to
understand the processes, products, and services of another organization. Because, without the
through knowledge of your own products and processes,you may not realize the extent of your
improvement opportunities.
Planning
Once the internal processes are understood,a benchmarking team should be formed. A
team represents different perspectives,special skills and a variety of business connections. The
team will decide what type of benchmarking to perform, what type of data are to be collected,
and the method of collection.
It is better to find appropriate benchmarking partner may be any person (or)
organization that supplies you with information contacts with the

suppliers,consultants,customers and people within the organization are the gold mines of
information.
Benchmarking planning process requires examination of several outside organization.

Normally a process is divided in to number of sub – processes. A single organization is not ‘best –
in – class’ for all studies for all sub-processes. Hence, multiple organizations should be studied
for benchmarking.
Studying Others
For studying other organizations,there are three techniques used.
1. Questionnaires
2. Site visits
3. Focus Groups.
Learning from the Data
The Objective of this benchmarking process is to identify and analyse the gaps between
the best practices and data are useful to identify performance gaps between benchmarking
partners.
The objective of this process is to develop strategies and action plans to bridge the
negative gap. To effect the change, the findings should be communicated to the people within the
organization who can enable 0improvement. The findings should be transformed as goals and
objectives and action plans should be developed to implement new processes.
3. (A) Explain Bench-mark Concept.
Benchmarking is the process of gathering, analyzing and evaluating the world

outside your organization and comparing it to your own. The concept of
benchmarking is shown in fig.
Bench marking Measures performance of ‘best-in-class’ organizations, determines how the best in
class achieve those performance levels and uses the information as the basis for adaptive creativity and
break-through performance.
There are two key elements of benchmarking.
1. Measure performance of best-in –class with numerical values and fix it as a target. Give
numerical value for your own performance and plot it against the target.
2. Now,the managers have to find out reasons why their performance differs
By understanding the differences, the managers are able to organize their improvement efforts
to meet the goal. Hence , benchmarking is used to set the goals and objectives and meet then by
improving processes.
(B) What are the reasons to bench mark ?
1. Benchmarking helps organization to develop their strengths and reduce their

weaknesses.
2. Benchmarking inspires managers and organizations to complete.
3. Benchmarking arouses the organization to be alert whether it has fallen behind the
competiton (or) failed to take advantage of important operating improvements
developed elsewhere.
4. In traditional method, the next year’s performance where as benchmarking allows

goals to be set based on external information.
5. When managers and workers are aware of external information, they are usually
much more motivated to attain the set goals.
6. No one can argue that attaining the new goal is impossiable, since it can be proved
that another organization have already achieved it.
7. Benchmarking is time and cost efficient because benchmarking process involves

imitation and adaptation rather than invention.
8. Benchmarking reduces some of the planning, testing and prototyping effort since it
copies the working model of an improved process.
9. Benchmarking helps to identify the current position of a business and determine the
priorities for improvement.
10. Benchmarking allows comparisons with previous Benchmarking profiles and against
recognized best practices.
11. Benchmarking encourages regular monitoring of process and continuous

improvement.
12. Benchmarking increases the competitiveness of the company by demonstrating

environmental improvements to customers and shareholders.
4. Explain the different types of needs
The Japanese have developed the concept of Quality Function Deployment (QFD). The
Quality Function Deployment (QFD) is a TQM tool which ensures that customer’s
requirements are met throughout the design process and also in the production systems.
QFD is basically a philosophy and a set planning and communication tool that focuses on
customer requirements in coordinating the design, manufacturing and marketing of
goods.
1.Dissatisfiers : are the needs that are expected in a product (or) service.
In a car, safety measures and cushioning seats are known as
dissatisfiers.
These features are generally not stated by customers but assumed as a

given. If they are not present, then the customer will be dissatisfied.
2. Satisfiers : are the needs that customers say they want. Air –
conditioning and Compact Disc player in a car are the examples of
satisfiers. Fulfilling these needs creates satisfaction.
3. Exciters/delighters: are new (or) innovative features that customers do

not expect . Antilock brakes and collision avoidance systems are known as
examples of exciters /delighters. The pressure such unexpected features
leads to high perceptions of quality.
5. a) Explain the Taguchi’s Quality Loss Function
Dr. Genichi Taguchi, a mechanical engineering who has won four Deming awards, has
introduced the Quality Loss Function concept, Which combines cost, target and variation in one
metric with Specifications being of secondary importance. Further more, he Developed Robust
Design in which noise factors are taken into account to ensure that the system functions
correctly.
Taguchi has defined quality as the loss imparted to society from the time a
product is shipped. Societal losses include failure to meet customer requirements,
failure to meet ideal performance and harmful side effects. The various losses due to
production are raw material, energy and labour consumed on unusable products (or) toxic-by –
products. Consider the following example to illustrate loss-to-society concept. There are three
stages in the evolution of polythene bag thickness.
6. What are the major benefits of quality function deployment (QFD).
Quality Function Deployment (QFD)-House of Quality –is an effective Management tool

to drive the design process and production process with the main aim of satisfying the customer
needs. The benefits of QFD are
1. A systematic way of obtaining information and presenting it.

2. Shorter product development cycle.
3. Considerably reduced start-up costs.
4. Fewer engineering changes.
5. Reduced chance of overnights during design process.
6. An environment of team work.
7. Consensus decision.
8. Everything is preserved in writing.
9. It facilitates identification of the causes of customer complaints

and makes it easier to takes prompt remedical action.
10. It is a useful tool for improving product Quality.

11. It is a useful tool for competitive analysis of product quality.
12. It is stabilizes quality.
13. It cuts down on rejects and rework at the production site.
14. It decreases claims substantially.
15. Marketing benefits are obtained by identifying sales point.
7. What is TPM philosophy. Explain the various steps of TPM.
Total Productive Maintenance (TPM) is an extension of the

Quality Management (TQM) philosophy to the maintenance Function. Total
TPM has the following steps:
1. Management should learn the new philosophy of TPM.

2. Management should promote the new philosophy of TPM.
3. Training should be funded and developed for every one in the origination
4. Areas of needed improvement should be identified.
5. Performance goals should be formulated.
6. An implementation plan should be developed.
7. Autonomous work groups should be established.
8. Write the main purposes of FEMA. Explain the 4 stages of FEMA.
Purpose of FEMA
1. FEMA is an analytical technique that combines the technology and experience

of people in identifying various failure modes of a product (or) process and
planning for its elimination.
2. FEMA implemented in both the design and the process areas to identify
potential failure modes and the effect of those on customers.
3. FEMA attempts to detect the potential product related failure modes.

4. FEMA anticipates the causes of failure and prevents from happening.
5. FEMA debugs and prevents problems that may occur in the manufacturing
process
6. FEMA compares the design characteristics relative to the planned

manufacturing (or) assembly methods
7. Corrective action are taken after a failure mode is identified.

8. FEMA provides justification for setting up a process in a certain manner.
9. FEMA is used by engineers to analyse all possible nonconformities and

problems that may arise in a given process (or) with a certain product.
8. What are the Phases of QFD?
Phase 1: Market analysis to establish knowledge about current customer requirements which
are considered as critical for their satisfaction with the product, competitors’ rating for the
same requirements and the translation into product characteristics.
Phase 2: Translation of critical product characteristics into component characteristics, i.e., the
product’s parts.
Phase 3: Translation of critical component characteristics into process characteristics.
Phase 4: Translation of critical process characteristics into production

characteristics, i.e., instructions and measurements.
9.
Draw the Matrix
of QFD?
10. Draw the FMEA Form ?

UNIT V
1. Why do we need a Quality system?
In order to assure the quality of a product, the manufacturer must ensure its
quality. So, to ensure this quality it is necessary to make a systematic study and control
check at every stage of production. It is also essential to take critical review of efforts and
achievements of the company with respect to the quality of the product. Thus it is
necessary to develop a standard quality system.
2. What do you mean by ISO 9000 quality standard?
The ISO 9000 system is a quality management system that can be adopted by all
types of organizations belonging to government, public, private, (or) joint sectors.
The ISO 9000 system shows the way in creating products by preventing
deficiencies, instead of conducting expensive post product inspections and rework.
3. What is two party quality system?
In two party quality system, the supplier of the product (or) service would
develop a quality system that would conform to his standard. The customer would then
audit this system for acceptability. Here the supplier and customer form the two parties.
4. What is a third party registration system?
In two party registration system – after auditing, it may be found that the
customer’s quality requirements are not met. In order to avoid this and also the cost
incurred in multiple audits, a standard quality system must be developed and audited by
a third party registration system.
5. Name some third party registration system?
The ISO 9000, QS 9000, ISO 14000 and other quality systems are such third party
registration systems that indicate to customers (or) potential customers that the
suppliers has a quality system in place and it is being monitored.
6. Define quality auditing?
The International Organization for Standardization (ISO) defines an audit as a

“systematic and independent examination to determine whether quality activities and
related results comply with planned arrangements and whether these arrangements are
implemented effectively and suitable to achieve objects”.
7. What is the two type’s quality audit?
Quality audit can be classified into two types – internal and external audit.
8. What do you mean by external and internal audit?
An internal audit is conducted by personnel within the organization.
An external audit is conducted by people from the organization such as the

purchasing party (second – party audit ) (or) a certified auditing agency (third – party
audit).
9. How can “Quality audit” be classified on the basis of the area taken into account for the
audit?
1. System Audit
2. Process Audit
3. Product Audit
4. Adequacy Audit
5. Compliance Audit
10. What is the use of QS 9000?
The QS 9000 standard defines the fundamental quality expectations from the
suppliers of production and service parts. The QS 9000 standard uses ISO 9000 as its
base with much broader requirements.
11. What is the use of ISO 14000 standard?
ISO 14000 standard gives the company a background on which to base its
Environmental Management System (EMS). This system can be joined with other quality
standards and can be implemented together to achieve the organizations environmental
targets.
The overall aim of the system is to provide protection to environment and to prevent
pollution.
12.What are the equivalents of various standards in Indian Standards System?
The equivalents of the above standards in Indian Standards System , developed by the Bureau of
Indian Standards are as below:
1.ISO :9000 -IS :14000 –1988
2.ISO :9001 - IS :14001 – 1988
3.ISO :9002 - IS : 14002 – 1988
4.ISO :9003 - IS :14004 – 1989
13.What are the other quality systems?

The other quality systems are AS 9100 used in aerospace industry, ISO/TS 16949,
which is called as Quality Systems Automotive Suppliers – Particular Requirements for the
application of ISO 9001, TS 9000 a consolidation of the various quality system requirements
within telecommunications industry , QS 9000 and ISO 14000. Out of these Qs 9000 uses ISO
9000 as its foundation.But its requirements are much broader.
15.What are the steps involved in implementing Quality system?
Systematic implementation of quality system involves the following essential
steps:
1.Initiating total quality management.
2.Planning to achieve objective in a coordinated manner.
3.Orientation of staff.
4.Implementation
5.Monitoring.
6.Consolidation.
16.What is a quality manual?
A quality manual is to be established and maintained.It should include:
1.The scope of the QMS with details and justification for any exclusions.
2.The documented procedure or references to them.
3.A description of the interaction among the QMS processes.
17.What are the essential qualities of a auditor?
An auditor should be adequately qualified and competent to perform quality

audit.He should have received training in auditing principles and processes.To be able to audit
efficiently , the auditor should possess the ability to concentrate on the task entrusted and not
distracted by other activities that are taking place at the same time.He should be objective ,
honest and impartial.
18.What are the resources needed to conduct quality audit?
Auditing necessarily needs considerable resources in terms of finance , facilities and

manpower.The auditing organization , which manages the audit has to provide auditors and
subject matter specialists.The auditee commits his time, personnel, office and local arrangements
for the auditors.
The following are the needs:
1.Human resources
2.Office facilities
3.Logistics , consisting of mode of travel, stay facilities, etc.

4.Appointment of team leader.
19.What are the strengths of ISO 14000?
One of the greatest strengths of ISO 14000 is that it establishes a process that spreads
responsibility and participation to every individual of the organization. It teaches employees the
effect on the environment of their own work duties, how these can be minimized, what the
benefits can be and what negative consequences can be if responsibilities are ignored.
20.What is EMS?
EMS stands for Environment management system, which gives the procedures and
methods to save the industries from pollution.It is more or less an abatement measure of
environment degradation effects caused by industries.
PART B
1.Why do we need a Quality system? Explain?
Organizations -- industrial, commercial or governmental -- supply products intended to satisfy a

customer's needs and/or requirements ... To be competitive and to maintain good economic
performance, organizations/suppliers need to employ increasingly effective and efficient
systems ... Customer requirements are often incorporated in specifications. However,
specifications may not in themselves guarantee that a customer's requirement will be met
consistently, if there are any deficiencies in the organizational system to supply and support the
product. These concerns have led to the development of quality system standards and guidelines
that complement relevant product requirements given in the technical specifications. The
cornerstone of the family is ISO 9000, which clarifies the principal quality-related concepts, and
the distinctions and inter-relationships among them, and provides guidance for the selection and
use of the ISO 9000 family.
In order to assure the quality of a product, the manufacturer must ensure its
quality. So, to ensure this quality it is necessary to make a systematic study and control
check at every stage of production. It is also essential to take critical review of efforts and
achievements of the company with respect to the quality of the product. Thus it is
necessary to develop a standard quality system.
The quality assurance system should provide for contract review to ensure that customer
requirements are adequately defined and documented and that the company has the capability
to meet these requirements.
Quality assurance comes from process control. Therefore, quality assurance systems include
documented procedures for production, installation, and service activities; the appropriate
equipment and working environment; methods for monitoring and controlling critical quality
characteristics; approval processes for equipment; criteria for workmanship, such as written
standards, samples, or illustrations; and maintenance activities. Process control also includes
monitoring the accuracy and variability of equipment, operator knowledge and skills, the
accuracy of measurement results and data used, and environmental factors.
Traditionally, quality assurance was a result of mass final inspection. Heavy reliance on
inspection proliferated because of the industrial revolution and the division of labor. The role of
the inspection department was to seek out defective items in production and remove them
prior to shipment.
Deming tried to eliminate mass inspection. According to him the true purpose of inspection is to
provide information to control and improve the process effectively.
Inspection and/or testing is performed at three points in the production process: at receipt of
incoming materials, during the manufacturing process, & upon completion of production.
2.Explain briefly about ISO 9000 Series of standards.
The history of the ISO 9000 family is a story both of success and of misunderstanding. Anybody
trying to implement the ISO norm in an enterprise will be confronted with both these sides, the
latter when middle management start becoming involved. People with no experience of quality
assurance find the ISO norm a bit difficult to handle, or at least hard to understand, without
experience or help. This is not only because of the formal structure of the ISO standard, but also
because of its technical language: even the words "shall", "must" and "have" are assigned their
own specific meanings.
As a first step, it is necessary to understand the history and structure of the ISO norm. ISO stands
for International Organization for Standardization, a Geneva-based worldwide federation. The
ISO 9000 standard was first published in 1987, one of its sources being the BS5750 series 1979,
developed by the British Standard Institution (BSI) on the basis of existing military standards.
The Single European Marketing Directive on Standards and Certification stipulates that the
application of ISO 9000 should be encouraged among its member countries. In clause 0, the EN
ISO 9000-1 states:
Organizations -- industrial, commercial or governmental -- supply products intended to satisfy a

customer's needs and/or requirements ... To be competitive and to maintain good economic
performance, organizations/suppliers need to employ increasingly effective and efficient
systems ... Customer requirements are often incorporated in specifications. However,
specifications may not in themselves guarantee that a customer's requirement will be met
consistently, if there are any deficiencies in the organizational system to supply and support the
product. These concerns have led to the development of quality system standards and guidelines
that complement relevant product requirements given in the technical specifications.
The ISO 9000 family comprises the following parts:
-- ISO 9000-1: 1994, Quality management and quality assurance standards -- Part 1: Guidelines for
selection and use. Any organization which is contemplating the development of a quality system
should refer to these guidelines.
-- ISO 9000-2: 1993, Quality management and quality assurance standards -- Part 2: Generic
guidelines for the application of ISO 9001, ISO 9002 and ISO 9003. These guidelines should be
consulted when assistance is needed in the implementation of ISO 9001, 9002 or 9003.
-- ISO 9000-3: 1991, Quality management and quality assurance standards -- Part 3: Guidelines
for the application of ISO 9001 to the development, supply and maintenance of software. These
guidelines are not relevant for public employment services.
-- ISO 9000-4: 1993, Quality management and quality assurance standards -- Part 4: Guide to
dependability program management. This guide is not relevant for public employment services.
-- ISO 9001: 1994, Quality systems -- Model for quality assurance in design, development,
production, installation and servicing. This model is relevant for public employment services
(especially head offices).
-- ISO 9002: 1994, Quality systems -- Model for quality assurance in production, installation and
servicing. This model is relevant for public employment services (especially for local offices).
-- ISO 9003: 1993, Quality systems -- Model for quality assurance in final inspection and tests.
-- ISO 9004-1: 1994, Quality management and quality system elements. This provides useful
guidance for public employment services.
-- ISO 9004-2: 1994, Quality management and quality system elements. This also provides
guidance for (public employment) services.
-- ISO 10011-1: 1990 Guidelines for auditing quality systems -- Part 1: Auditing.
-- ISO 10011-2: 1991 Guidelines for auditing quality systems -- Part 2: Qualification criteria for
quality systems auditors.
-- ISO 10011-3: 1991 Guidelines for auditing quality systems -- Part 3: Management of audit
programmes.
-- ISO 10012-1: 1992 Quality assurance requirements for measuring equipment -- Part 1:
Metrological confirmation system for measuring equipment.
-- ISO 10013: 1993 Guidelines for developing quality manuals.
-- ISO/TR 13425: 1993 Guidelines for the selection of statistical methods in standardization and
specification.
-- ISO 8402: 1994 Quality management and quality assurance -- Vocabulary.
ISO standards
ISO - 9000 - basic quality assurance definitions and guidance

ISO - 9001 - quality system for design, production, & service
ISO - 9002 - production and installation
ISO - 9003 - final inspection
Advantages
Better documentation
Greater Quality awareness by employees
Higher perceived quality in the market
Reduced customer quality audits
ISO - 14000 series
focuses on environmental management system that will ensure all operational processes are
consistent and effective and will achieve environmental objectives of the organization.
a company should review and continually improve its environmental management system, with
the objective of improving its overall environmental performance
QS-9000
1994- Ford, Chrysler, and GM released QS-9000, an interpretation and extension of ISO-9000 for
automotive suppliers.
QS-9000 applies to all internal and external suppliers of production and service parts and
materials
QS-9000 not only states what must be done, but often how to do it.
Registration to QS-9000 requires demonstration of effectiveness in meeting the intent of the
Registration under QS-9000 standards will also achieve ISO-9000 registration.
The cornerstone of the family is ISO 9000, which clarifies the principal quality-related concepts,
and the distinctions and inter-relationships among them, and provides guidance for the selection
and use of the ISO 9000 family. There is a hierarchy between some of the parts of the series, so
that ISO 9001 contains all the elements of ISO 9002 and ISO 9003, and ISO 9002 contains ISO
9003. Standards applicable to quality assurance in final inspection and tests are covered in ISO
9003, while ISO 9002 also includes standards applicable to quality assurance in production,
installation and servicing. As indicated above, ISO 9001, in addition, covers design and
development. Clearly, an enterprise that has nothing to do with the design and development of
products and services need not apply ISO 9001. An enterprise that produces goods or services
should aim to apply ISO 9002. When AMS Salzburg decided to implement the ISO norm, a
decision had to be taken on whether implementation of ISO 9002 was enough or whether it
would be necessary to refer to ISO 9001. Because there are some design processes for new
services in the organization it was decided to apply ISO 9001.
3. What are clauses in ISO 9001? Explain briefly
. ISO 9001 defines 20 elements necessary for a quality management system, as listed below:
Management Responsibility (Element 1)
The company has to define its commitment to a quality policy, which is understood, implemented
and maintained at all levels of the organization, and to define its quality goals. Responsibilities
and authorities have to be defined and documented. The company must provide adequate
resources and appoint a member of the management as a representative for quality
management. At least once a year, a management review must be held and recorded to evaluate
the quality system.
Quality System (Element 2)
A quality manual, covering all elements of the ISO standard, has to be prepared to document the
quality system. Procedures must be documented and controlled. The company has to prepare a
quality plan to ensure that quality requirements are understood and fulfilled.
Contract Review (Element 3)
The company has to establish and maintain documented procedures for contract review, to
document the customers' requirements and ensure the capability to fulfill the contract or order
requirements. Records of contract review shall be maintained.
Design Control (Element 4)
The company has to establish and maintain documented procedures to control and verify the
design of a new product or service to fulfill customers' requirements. The requirements must be
identified and there must be design reviews, design verification and design validation. Design
changes shall be documented, reviewed and authorized.
Document Control (Element 5)
All documents relevant for quality have to be controlled to ensure that the pertinent issues of
appropriate documents are available at all locations. When necessary, they are to be replaced by
updated versions. Changes shall be reviewed and approved by the same organization/person
that performed the original review or approval.
Purchasing (Element 6)
The company must monitor the flow of purchasing and evaluate the subcontractor's ability to
fulfill specified requirements.
Purchaser Supplied Product (Element 7)
Goods supplied by the customer have to be recorded. It must be ensured that they are separately
controlled and stored to prevent loss or damage.
Product Identification And Traceability (Element 8)
Where appropriate, purchased and delivered products or services must be made traceable
through documentation or batches.
Process Control (Element 9)

All processes of production or service that directly affect quality must be documented and
planned and carried out under controlled conditions to add consistency to the process. Control of
process parameters and product characteristics must ensure that the specified requirements are
met.
Inspection And Testing (Element 10)
The company must ensure receiving inspection and testing, in-process inspection and testing,
and final inspection and testing. These inspections and tests must be recorded.
Control of inspection, measuring and
Test Equipment (Element 11)
The items of equipment used for inspection, measuring and testing must be identified and
recorded. They must be controlled, calibrated and checked at prescribed intervals.
Inspection And Test Status (Element 12)
The status of the product or service must be identified at all stages as conforming or
nonconforming. This is to ensure that only conforming products or services are dispatched or
used.
Control Of Nonconforming Product (Element 13)
The company must establish procedures to ensure that nonconforming products or services are
prevented from unintended use. The disposal of nonconforming products must be determined
and recorded.
Correctional Prevention (Element 14)
Procedures must be established to ensure effective handling of customer complaints and

corrective actions after identifying nonconformities. The cause of nonconformities is to be
investigated in order to prevent recurrence. The corrective action shall be monitored to ensure
its long-term effectiveness. Preventive actions are to be initiated to eliminate potential causes of
nonconformance.
Handling, storage, packaging and
Delivery (Element 15)
Documented procedures must be established to ensure that products are not damaged and reach
the customer in the required condition.
Control Of Quality Records (Element 16)
All records related to the quality system must be identified, collected and stored together. The
quality records demonstrate conformity with specified requirements and verify effective
operation of the quality system.
Internal Quality Audits (Element 17)
The company must establish and maintain documented procedures for planning and
implementing internal quality audits to determine the effectiveness of the quality system. The
comments made by internal auditors must be recorded and brought to the attention of the
personnel having responsibility in the area audited. Follow-up audit activities shall verify and
record the implementation and effectiveness of the corrective action taken.
Training (Element 18)
The company shall establish and maintain documented procedures for identifying training needs
and must have a training record for each employee.
Servicing (Element 19)
Where servicing is a specific requirement, the company must establish and maintain documented
procedures for performing, verifying and reporting that the servicing meets the specified
requirements.
Statistical Techniques (Element 20)
The company must establish and maintain documented procedures to implement and control the
application of statistical techniques which have been identified as necessary for performance
information.
This structure looks very theoretical at first glance, but this is because ISO 9000 stipulates the
elements of a quality management system for any enterprise, irrespective of its branch of
activity. "ISO 9000 is not a prescriptive standard, it does not detail the how but rather the what.
This allows each individual company to define how it intends to comply with the standard in a
way that best suits that company's method of operation".It is possible that some of the elements
are of no relevance or almost no relevance in specific sectors. For example, elements 11 and 12
are not relevant for AMS Salzburg, and element 15 is only marginally relevant.
The 20 elements (or the relevant ones) of ISO 9001 must be addressed in a quality manual and in
operational procedures (possibly set out in a procedure manual) which comply with the
standards set in the quality manual. The quality manual defines and documents the quality policy
of the company. It is a statement of the company's intention to pursue a quality policy. The
operational procedures set out the specific way in which ISO 9000 is implemented throughout
the company's business process. Both types of document are required by ISO 9000: 1994. Almost
every element of the standard requires records. Besides these, there may be other documents in
the company, for example work instructions, specifications, check-lists, charts, data sheets, lists,
forms and so on. Some of them are used to record events, but they are not directly required by
the ISO norm, which allows the company a great deal of flexibility
regarding whether or not to use such documents. AMS Salzburg, for example, decided to add
work instructions (which define how an activity is performed) to documented procedures, as
work instructions are liable to alteration. In the management of change, it is relatively easy to
replace the work instructions addressed in the operating procedures, without touching the basic
processes.
4.What do you mean by documentation? Explain the Documentation Hierarchy.
ISO 9000 DOCUMENTATION
STRUCTURE
The documentation created for ISO 9000 registration is submitted to the company’s 3rd-party
registrar prior to them visiting the site to conduct the actual audit. In fact, one type of
documentation is used by the registrar to develop the audit plan for your company. Structuring
your ISO 9000 documentation to facilitate the audit process only serves to enhance the potential
for a successful audit. This structuring will also make it easy for you to plan and monitor your
documentation efforts, both for the registration audit and all subsequent maintenance audits.
DOCUMENT CONTROL AND ISO 9000
Once the documentation structure has been defined and the documentation written, a strategy
for controlling it must be put in place. ISO 9000 requires that documentation must be readily
available to those who need it, be of current issue, and that all obsolete material be completely
removed from the system. The control of documentation, from creation of new material through
to the destruction of obsolete material, presents one of ISO 9000’s biggest challenges. It is also
one of the elements audited by your 3rd-party registrar.
DOCUMENTING ISO 9000
A thorough analysis of each element prior to writing ensures the resulting documentation will
meet ISO 9000’s criteria. Specific characteristics exist for robust Quality Systems, and these must
be clearly established within the organization. Since ISO 9000 registration is not a one-time
occurrence, clearly documented procedures for maintaining a compliant Quality System must be
in place. Historically, companies have produced policy and procedure manuals which, because
they contained corporate policies, where often not made available to all employees. As a result,
the procedures were also not readily available. ISO 9000’s requirement that procedures be
readily available to all persons performing the work usually necessitate the separation of these
procedures from the policy manual Perhaps the biggest stumbling block for North American
businesses is the requirement to clearly define and document the processes that it uses.
Developing documentation that tells HOW we do something is not new to us, but accurately
describing WHAT it is we do is far less common. Most of our existing documentation is product
or department based. ISO looks only at the processes used to create products, and these
generally run across many areas of an organization. We can no longer
write documentation in isolation, the whole organization must be considered when writing ISO
compliant documentation.
WHEN IS ENOUGH, ENOUGH?
One of the complaints often heard about ISO 9000 refers to the large amount of documentation
that is perceived to be required. While procedural documentation is important to the proper
functioning of an effective Quality System, many companies tend to over document. First and
foremost, you must remember that it is your company and the documentation must fit the
company, not the standard.
The ISO 9000 series of Quality Standards does indicate key characteristics of a properly
functioning Quality System, but how they are implemented is the responsibility of the
organization. ISO documentation must reflect what the company does, not what it thinks the ISO
auditor will want to hear. In determining whether procedural documentation is required, look at
the skill sets of the people performing the task as well as any unique requirements the company
may have for completing the task. In many cases, documentation will not be required because
there is no unique process and/or the person has been trained in how to complete the task.
5.What do you mean by quality audit? Explain the types of audit.
This chapter describes the types of audits that government and nongovernmental audit
organizations conduct and those organizations arrange to have conducted, of government
organizations, programs, activities, functions, and funds. This description is not intended to limit
or require the types of audits that may be conducted or arranged. In conducting these types of
audits, auditors should follow the applicable standards included and incorporated in the
chapters, which follow.
All audits begin with objectives, and those objectives determine the type of audit to be
conducted and the audit standards to be followed. The types of audits, as defined by their
objectives, are classified in these standards as financial audits or performance audits.
Audits may have a combination of financial and performance audit objectives or may have
objectives limited to only some aspects of one audit type. For example, auditors conduct audits of
government contracts and grants with private sector organizations, as well as government and
nonprofit organizations, that often include both financial and performance objectives. These are
commonly referred to as "contract audits" or "grant audits." Other examples of such audits
include audits of specific internal controls, compliance issues, and computer-based systems.
Auditors should follow the standards that are applicable to the individual objectives of the audit.
The internal audits were carried out by the Managing Director and the quality system
representative, who drew up the audit plan, the audit check-list and the formats for the audit
report and for the reports by the regional office experts on their particular fields. The Managing
Director and the quality system representative audited the local offices in respect of the quality
system and the departments of the regional office in every respect. The experts audited the local
offices in respect of their particular business areas. The objective of the audit was to verify that
quality activities and related results comply with the definitions given in operating procedures
and work instructions, and to determine the effectiveness of the quality system. The internal
audit was announced several days before it took place, and all the required records (see the
check-list below) were delivered. The first audits focused on documents control as a basis for the
first stage in implementing the ISO norm. We then had to look closely into the question of
whether the operating procedures were in conformity with actual processes and were
appropriate. Nonconformities were noted and recorded, but it was astonishing that the quality
system worked so well despite the short duration of implementation. We made two audits before
the assessment to ensure that corrective action could be taken, and that approach was effective
in ensuring that AMS Salzburg was in good shape to face the assessment.
An example of an internal quality audit check-list
Audit
notification/program 0
carried out
Service order carried out 0
External service plan
carried out
Audit check-list available 0
Deficiency report form 0

available
Audit report form
available
Last audit report available 0
Pending deficiency report 0
available
Introductory discussion 0
Previous deficiencies and
corrective measures 0
discussed
Completed list of
participants
Audit plan discussed 0
Audit
questions/inspection 0
carried out
Deficiency report
completed 0
Audit report completed 0
Final discussions 0
Report signed 0
6.Explain the concepts of ISO 14000.
ISO - 14000 series
Focuses on environmental management system that will ensure all operational
processes are consistent and effective and will achieve environmental objectives of the
organization.
A company should review and continually improve its environmental management
system, with the objective of improving its overall environmental performance
Section 3.5 of ISO 14001 defines an environmental management system as "the part of the
overall management system that includes organizational structure, planning activities,
responsibilities, practices, procedures, processes, and resources for developing, implementing,
achieving, reviewing, and maintaining the environmental policy. " Although ISO 14001 was
developed independent of ISO 9000 to fulfill environmental rather than quality needs.
An EMS is a structured plan to address the impacts a company or organization has on the
environment. The EMS is implemented and checked to ensure that plan goals are being met.
With the plan being revised to meet new goals, the EMS can guide a company toward continual
environmental improvement.
A basic condition for any EMS is compliance with applicable environmental laws, regulations,
and permits. An effective EMS goes beyond compliance to provide an organization with a
systematic approach to the development, implementation, and maintenance of an environmental
policy.
Through planning, implementation, checking, management review, and continual improvement,

organizations become more effective and efficient in the management of their activities and the
impacts of those activities on the environment.
In response to widespread acceptance of the ISO 9000 quality management standards and to the
proliferation of various environmental management systems, the International Organization for
Standardization formed Technical Committee (TC) 207 to begin development of the ISO 14000
series of environmental management standards in 1992. As TC 207 carefully crafted the draft
EMS standard (ISO 14001), companies around the world began to assess their existing
environmental systems to learn what changes would be needed to meet ISO 14001.
Because many companies in the United States had not been prepared to step up to ISO 9000 in
the early 90s and had to struggle to catch up with their European and Asian counterparts, U.S.
companies are now carefully tracking the increase of certifications to ISO 14001. While there are
relatively few EMS certifications in the U.S., many savvy companies are aligning their
environmental management systems to conform to ISO 14001.
7.What are the benefits of ISO 14000?
The ISO 14001 standard provides specific requirements for an EMS and shares some common
management system principles with the ISO 9000 series of standards, including the "plan-do-
check-act model" mentioned above and the requirement for top management commitment. The
basic focus of the ISO 14000 series of standards is environmental protection, while the ISO 9000
series of standards focuses on quality and customer needs.
It should be noted that ISO 9000 is not a prerequisite for ISO 14001, although companies that
have both have successfully integrated the two management systems.
An effective EMS provides many benefits to the implementing organization, its customers and
stakeholders, and to regulators, including:
Reduced environmental risk.
Proactive environmental management.
Improved employee environmental awareness and performance.

Increased operating efficiency and cost-effectiveness.
Enhanced relationships and communication with employees, regulators, and

stakeholders.

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UNIT IV

1. What is meant by benchmarking?

Benchmarking is defined as a systematic method (or) popular TQM tool by which

2. What are the six steps in benchmarking process?

3. What is meant by quality function deployment (QFD)?

4. Write about House of quality.

5. What are the six steps to build ‘House of Quality’?

There are three common quality loss functions.

1. Nominal - the – best

7. Define Total Productive Maintenance (TPM).

8. What is meant by predictive maintenance and preventive maintenance?

Predictive maintenance is the process of periodically performing activities such as

9. Name different loss measurements in TPM?

10. Name is meant by Availability?

Where T= Operation time (P-D)

P=Planned operation time

11. What is meant by Failure Mode and Effect Analysis (FMEA) ?

To identify foreseeable failure modes of a product(or) process

12. Define Reliability.

Reliability is defined as the probability of a product performing satisfactorily without

13. What are the three main categories of failure?

14. What is Debug failure ?

15. What are the two important types of FMEA ?

16. Write some effects of failure.

17. What is meant by performance efficiency?

Performance efficiency E=(C*N/T)*100

Where C=Cycle time

N= Number of units produced.

18. What are the three classes of customer needs?

20. What are the three types of benchmarking?

21. Draw the Taguchi Loss Function?

1. Discuss about design of FMEA document.

ITEM space is used for component (or) process to be analysed.

Key date space is used for initial Due date of FMEA.

This function of the item should be entered.

The environment (temperature. pressure, humidity etc) in which the system

2. Explain briefly above the “bench marking process” ?

1. Deciding what to benchmarking

Understanding current performance :

Self – analysis is an essential step in effective bench marking. It

organization that supplies you with information contacts with the

Benchmarking planning process requires examination of several outside organization.

For studying other organizations,there are three techniques used.

3. (A) Explain Bench-mark Concept.

Benchmarking is the process of gathering, analyzing and evaluating the world

(B) What are the reasons to bench mark ?

1. Benchmarking helps organization to develop their strengths and reduce their

2. Benchmarking inspires managers and organizations to complete.

4. In traditional method, the next year’s performance where as benchmarking allows

7. Benchmarking is time and cost efficient because benchmarking process involves

11. Benchmarking encourages regular monitoring of process and continuous

12. Benchmarking increases the competitiveness of the company by demonstrating

4. Explain the different types of needs

These features are generally not stated by customers but assumed as a

3. Exciters/delighters: are new (or) innovative features that customers do

5. a) Explain the Taguchi’s Quality Loss Function

product is shipped. Societal losses include failure to meet customer requirements,

6. What are the major benefits of quality function deployment (QFD).

Quality Function Deployment (QFD)-House of Quality –is an effective Management tool

1. A systematic way of obtaining information and presenting it.

9. It facilitates identification of the causes of customer complaints

10. It is a useful tool for improving product Quality.

Total Productive Maintenance (TPM) is an extension of the

Performance efficiency E=(CN/T)100