1) List the documents, used in QMS?

a) Statements of Quality Policy and Quality Objective b) Quality manual-providing consistent information
about the organisation’s QMS c) Quality plans-providing description as to how QMS is applied to specific
product, project or contract.

d) Specifications—state requirements d) Guidelines—recommendations or suggestions e) Documents

needed by the organization, to ensure effective and consistent activities and control of its processes,
and f) Records to provide objective evidence of activities performed or results achieved.

2) What is meant by Quality Manual?

The Quality manual contains:

a) the scope of the QMS, including details of and justification for any exclusions.

b) the documented procedures established for the QMS, or reference to them, and

c) a description of the interaction between the processes of the QMS

3). Define ‘audit’

It is a systematic, independent and documented process, for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit criteria are fulfilled.

4) Write briefly on the two types of audit system.

(1) Internal audit: This is also called first-party audit. This is conducted by, or

on behalf of, the organization itself for internal purposes and can form the basis for an organisation’s
self-declaration of conformity.

(2) External audit: a) This is also called second or third party audit. The

second party audits are conducted by parties having an interest in the organization, such as customers,
or by other persons on their behalf. b) The third party audits are conducted by external independent
organisations, to provide certification or registration of conformity with requirements, such as those of
ISO 9001:2000 and ISO 14001:1996
5) What are the benefits of QMS?

a) Improvement in internal quality (reduction in scrap, rework and non-conformities in the shop)

b) Improvement in external quality (customer satisfaction, claims of non-conforming products, returned

products, warranty claims, penalty claims etc)

c) Improvement in Production reliability (number of break downs, percentage down time etc) d)
Improvement in Time performance (on-time delivery, time to market etc)

e) Reduction in the cost of poor quality (external non-conformities, scrap, rework etc)

6) Name some certifying agencies for ISO standards in India?

Det Norske Veritas, Bureau of Indian Standards, TUV Suddeutschland India,, Bureau Veritas Quality
International, NQA, American Quality Assessors (India), KVQA etc

ENVIRONMENT MGT SYSTEM:

7) Name the elements in ISO 9001 that are similar to ISO 14001.

Planning, Implementation, Checking and Management review.

8) List two differences between the QMS and EMS.

QMS EMS

1) Focus on customer 1) Focus on the society

2) Process evaluation 2) Organisation evaluation and

product evaluation
9) Define ‘environment’.

It is defined as global surroundings where the organisation operates. It includes land, water, air, space,
human being and their interactions.

10) Define environmental impact.

Any change in the organisation activity, either wholly or partially affecting the environment.

11) Define ‘environmental aspect’.

The organizational activities, products, and services interacting with the environment.

12) Define ‘environmental objective’.

It is the environmental goal (which is quantified), that any organization desires to achieve, which is
practically possible.

13) List the basic principles of quality management and explain briefly on each of these.

a) Customer focus: Organisation should understand the current needs and future expectations, should
meet the customer requirements and strive not only to delight them, but also to enchant them.

b) Leadership: Top management should establish unity of purpose and direction of the organization.
They should create and maintain the internal environment, wherein people become fully involved in
achieving the objectives.

c) Involvement of people: Their abilities are used for the benefit of organization

d) Process approach: The desired result is achieved efficiently when activities and related resources are
managed as a process

e) System approach to management: Identifying, understanding and managing inter-related processes

as a system, helps in organisation’s effectiveness and efficiency in realizing its objectives.

f) Continual improvement means continual actions

g) Factual approach to decision making: Effective decisions are based on the analysis of data, facts, and
information

h) Mutually beneficial supplier relationship. This enhances the ability to create value for both.

14) Define ‘process’

An activity (or a set of inter-related or interacting activities) using resources and managed to transform
inputs to outputs, is a process.

15) Define ‘process approach’.

The application of system of processes within the organization, the identification and interactions of
these processes and their management, is referred to as ‘process approach’

16) Define ‘a product’.

(1) The result of a set of interrelated or interacting activities

(2) The result of a process. There are four generic product categories:

a) services (e.g. transport) b) software (e.g. dictionary) c) hardware (e.g. tyre, tube)

d) processed material (e.g. lubricant)

(3) Product can also mean ‘service’, as per ISO 9001:2000

17) Define ‘customer satisfaction’.

It is the customer’s perception of degree to which one’s requirements have been fulfilled

18) Define ‘management’.

Coordinated activities to direct and control an organization. It is the manipulation (utilization, including
non-utilisation) of the available resources to achieve the desired objectives.

19) Define ‘quality management system’.

It is a system to direct and control an organization, with regard to Quality.

20) Define ‘quality policy’

It consists of overall intentions and directions of an organization related to quality, normally and
formally expressed by top management. It provides a frame work for establishing and reviewing quality
objectives.

21) Define ‘quality objectives’.

It consists of statement or target aimed and related to quality, in quantitative (measurable) terms. The
objectives need to be consistent with the quality policy and commitment to continual improvement.

22) Define ‘quality planning’.

The part of quality management focused on setting objectives and specifying necessary operational
processes and resources to realise the objectives

23) Define ‘continual improvement’.

It is the recurring activity to increase the ability to fulfill the requirements. This is achieved by continual
process through the use of audit findings, conclusions, analysis of data, management reviews etc and
generally lead to corrective actions and preventive actions.

24) Define ‘an organization’.

It is a group of people and infrastructure facilities with specified authorities, responsibilities and
interrelationships.

25) Differentiate between ‘effectiveness’ and ‘efficiency’.

Effectiveness is the extent to which planned activities are realized and planned results are achieved. But
efficiency is the ratio of the results achieved (output) to the resources used (input)
26) Distinguish between a non-conformity and a defect.

Non-conformity means non-fulfillment of a requirement, whereas, a defect means non-fulfillment of a

requirement related to an intended or specified use.

27) Distinguish between ‘corrective action’ and ‘correction’.

Corrective action is an action to eliminate the cause of a detected non-conformity or other undesirable
situation. It is taken to prevent recurrence. But Correction is an action to eliminate the detected non-
conformity. Rework or re-grade is the example for correction.

28) Distinguish between ‘corrective action’ and ‘preventive action’.

Corrective action is the action taken to eliminate the cause of a detected non-conformity. It is taken to
prevent recurrence. But Preventive action is the action taken to eliminate the cause of a potential non-
conformity or other undesirable potential situation. It is taken before the occurrence and to prevent
occurrence.

29) What are the contents of a ‘quality manual’?

a) the scope of QMS b) documented procedures established for QMS and

c) description of the interaction between the processes of the QMS

30) Name a few needs and expectations of (1) Customer and end user, related to organisation’s
product / service (2) Employees and (3) Owners / Investors?

(1) Customer and end user: a) Conformity b) Dependability c) Availability

d) Delivery e) Price and life cycle costs f) Product safety

g) Product liability h) Environmental impact

(2) Employees: a) Recognition, b) work satisfaction and c) personal development

(3) Owners/Investors: Financial and other results.

31) What are the three Ds referred to in QMS?

Declare what are going to Do,

Do as you have Declared, and

Document all actions and results

Bench Marking:

1) What are the advantages of bench marking?

a) It inspires the organization to compete with others b) It inspires the people to compete and achieve
the goals c) Bench marking testing procedures, helps in assuring the quality of the product/service d)
This identifies the strengths and weakness of one’s product or service with competitors e) It helps the
organization to build marketing strategies f) This is time and cost efficient, because the process involves
only copying and adapting.

2) What are the limitations of bench marking?

a) The target always keeps changing. Hence the critical objectives have to be constantly innovated, to
overcome technology barriers. b) Bench marking will not be effective, if it is focused on processes with
no opportunity for improvements.

3) Define, ‘break through’ performance.

Innovation or creative e ideas converted into actions and results. It is also called ‘quantum jump’.

4) Define the ‘voice of the customer’

The needs and the expectations of the customer are called the voice of the customer.

5) What is the role of QFD?

QFD translates the customer’s needs and expectations (voice of the customer) into the Technical
characteristics and then the Design specifications (voice of the engineer)
6) What is the pre-requisite to QFD?

Market Research is the pre-requisite, to understand the customer’s needs and expectations.

7) Write briefly on the house of quality.

This is an effective management tool, which uses the voice of the customer to drive design process,
meets the specified target values, and matches against how an organization will meet those
requirements.

For the house of quality: the left side indicates the voice of the customer (WHAT), Prioritised customers
voice and Planning matrix on the right exterior side, ceiling of the house indicates how each desires of
the customer can be achieved (HOW), relationship matrix between What? and How? at the center (hall)
of the house, roof of the house indicating the interrelationship between the technical characteristics,
and thus accommodates five areas for design.

8) What is meant by technical competitive assessment?

This part of study is added beneath the relationship matrix. For each technical characteristic, the gap
between our product and the competitor’s product is identified by appropriate ranking.

9) What is meant by customer competitive assessment?

This part of the study is added to the right side of the relationship matrix. It is done to check, if all the
customer requirements are met and to identify the areas for improvement in the design. Based on the
customer’s perception, this comparison tells us, where our products stand.

TAGUCHI LOSS FUNCTION:

10) Define ‘loss function’.

According to Taguchi, the quality is the loss, imparted to the society, after the product is transported
from the shop. The societal loss includes the failure to meet the customer requirements, loss of good-
will due to unsatisfactory performance, reduced market share, producer’s loss and also environmental
pollution. The loss function is proportional to the square of the deviation of the performance
characteristic from the target value.
11) Define ‘signal’.

The desired part of the performance is called ‘the signal’

12) Define ‘noise’ and its types.

The undesirable part of the performance is called ‘the noise’. The three types of noise are: a) External
noise, effected by the environment b) Internal or Deterioration noise, caused by usage or non-usage or
storage c) Unit to unit noise, i.e. difference between the individual parts that are produced to the same
specifications

13) Define ‘robust design’.

Taguchi defined design for quality, in three levels as follows: a) Primary, the System design, which
considers the customer’s requirements, and the prototype is developed using technology principles b)
Secondary, the Parametric design, which involves the cost reduction and performance improvement,
without removing the causes of variation and c) Tertiary, the Tolerance design, which concentrates on
eliminating or reducing the variation by controlling the causes.

Another definition is: It is the design of a product, which is insensitive to the disturbances, which may
occur due to controlled or uncontrolled factors.

TOTAL RPODUCTIVE MAINTENANCE:

14) Define TPM.

It is a team based productive maintenance, which involves every level and function in the organisation
from top management to the shop floor employees. TPM combines preventive maintenance,
involvement of operators, and appropriate training to the operators. This eliminates unplanned
maintenance and ensures maximum equipment / plant effectiveness.

15) Name the three Ms for effective TPM.

Avoid 1. MUDA or Muddling, i.e., waste, cut or minimize the waste

2. MURI or Muscling, i.e., fatigue, over burden or strain

3. MURA or Murkiness, i.e., Instability or discrepancy

16) Define predictive maintenance.

Predictive or diagnostic maintenance means the usage of sensors, monitoring and diagnosing the
failures before they occur. It facilitates identification of bad performing parts and their removal or
replacement, and also elimination of the damage to the mating parts as a consequential effect.

17) Define preventive maintenance.

The inspections are carried out and the selected parts are replaced periodically as preventive measure.
It is a planned maintenance and hence does not affect the manufacturing or service of the equipment.

18) Define breakdown maintenance.

Repair or maintenance is done only after the failure occurs. This is permitted when equipment failure is
not significant. For example the electric bulbs are replaced after they fuse.

19) Define periodic maintenance.

Maintenance of equipment is done at specified time intervals and the parts are replaced if found
necessary, to avoid sudden failure thereafter.

20) Define ‘maintenance prevention’.

It is the principle and practice of design and installation of the equipment that needs little or no
maintenance.

21) Define ‘availability’ in maintenance.

It is the ratio of the time a machine is actually available to the total time it should be available for use. It
is also defined as the probability that a machine or equipment, when used under stated conditions in an
actual / ideal environment, will operate satisfactorily, at any time.
22) Define performance efficiency.

It is the ratio of the theoretical cycle time to the operating time per unit

23) Define ‘rate of quality’.

It is the ratio of the number of parts accepted to the total number of products produced. This is
sometimes called, the yield.

24) Define Life cycle cost.

It is the total cost of acquisition and ownership of the product / service, incurred by the purchaser,
throughout its full life cycle.

25) Define equipment effectiveness.

Equipment effectiveness is the product of Availability, Performance efficiency, and Rate of quality.
Normally the target is 90% for the Overall equipment effectiveness, and 80% for the Overall plant
effectiveness

26) Define Autonomous work groups, in maintenance

It is a team consisting of operators and maintenance crew. This team is authorised to make decisions to
keep the machine fit for production. These groups are usually trained by skilled maintenance personnel
in Minor maintenance works, trouble shooting of problems, and also the set-up.

FAILURE MODE AND EFFECT ANALYSIS

27) List different types of FMEA?

One way of classification:

System FMEA, focusing on global system functions,

Design FMEA, focusing on components and sub-systems,

Process FMEA, focusing on manufacturing and assembly process,

Service FMEA, focusing on service function, and

Software FMEA, focusing on software function

Another way of classification: Design FMEA and Process FME

28) What is meant by ‘design FMEA’?

The design FMEA, consists of: Identification and anticipation of the failure modes, ranking them
according to their severity on the product performance, keeping these design characteristics out of the
system or minimising their resulting effects, and includes the testing of the products to ensure their
safety, while in use.

29) What is meant by ‘process FMEA’?

The process FMEA consists of: Identification of potential failure modes and ranking them according their
severity and frequency, as per the customer requirements. This helps one in establishing control or
reducing the occurrence and in easy detection.

30) Define RPN.

It is a measure of priority on the failure modes, and is viewed as a relative measure of the design risk. Its
value is obtained as the product of Severity, Probability of occurrence, and the difficulty in detection.

31) What is meant by potential failure mode?

A potential failure mode is defined as the mode of failure wherein the component or sub-system or
system or process could potentially fail to meet the intent of the design or function

32) What is meant by the potential effect of failure?

It is defined as how a customer perceives the failure. The failure effect may include injury or impairment
to the user or degraded environment or damaged equipment or erratic operation or degraded
performance or poor appearance. The effect of failure, whose mode scores highest RPN, is said to be the
potential effect of failure.
33) Define ‘occurrence’.

It is the probability that one of the specific causes will occur.

34) Define ‘detection’.

It is the difficulty with which the design control or process control can prevent or detect each of the
failure modes. (can not detect is ranked 10 to almost certain to detect is ranked 1)