Introduction to

UNIT 1 INTRODUCTION TO QUALITY Quality Control

CONTROL
Structure
1.1 Introduction
Objectives

1.2 Definition of Quality

1.3 Concept of Quality
1.3.1 Quality of Design
1.3.2 Quality of Conformance
1.3.3 Quality of Performance
1.3.4 Achieving and Maintaining Quality

1.4 Quality Control

1.5 Stakeholders and Their Expectations
1.6 Quality Assurance
1.6.1 Quality Audit
1.6.2 Quality Survey
1.6.3 Product Audit

1.7 Recognition of Quality Effects

1.8 Summary
1.9 Key Words
1.10 Answers to SAQs

1.1 INTRODUCTION
The opening of international trade market has brought many opportunities for improved
products and services. Consequently, for almost every product or service, there is more
than one organization trying to make a sale. Price may be a major issue in whether a sale
is made or lost, but another important factor is quality. In fact quality is often the major
issue and poor quality can be very expensive for both the producing firm and customer.
Consequently, the producer employs quality control (QC) tactics to ensure that a quality
product can be delivered at the right place and right time with the right price. Quality is
not only concerned with manufactured goods but also with services like banking, health
care, education etc. This unit starts with the definition of quality. An outline of how
quality is established, why quality control is necessary and who are affected by quality is
provided. The elements of quality assurance are discussed in detail. The unit ends with a
section on highlighting the need of recognizing the effects of quality.
Objectives
After studying this unit, you should be able to
• understand the concept of quality and its control, and
• explain quality assurance and its importance.

1.2 DEFINITION OF QUALITY

In the beginning, a high-quality product was understood as one that is stronger and is, in
general, more durable than other products. In some cases, this is a good definition of a
quality product, but not always. A good fuse (circuit breaker), for example, is not one
that lasts longer during periods of high current or voltage. So the quality of a product is
5
Quality Systems the degree to which the product meets specifications. This definition of quality is also
true for the service sector industry. In fact, today, quality is more visible in service sector
such as hospitals, restaurants, banks, etc. The health of an organizations producing
physical commodities thrives not only on manufactured products but also on the services
(annual maintenance, defect replacement, product updates, etc.). In today’s society,
organizations like insurance companies do not produce anything physical yet they are
crucial in providing security to the commodities (e.g., vehicle) acquired by an
individual. Increasingly, the definitions of quality include an added emphasis on meeting
these new needs of an individual. Several pioneers of quality have provided various
definitions of quality. Feigenbaum defines quality as “The total composite product and
service characteristics of Engineering, Manufacturing, Marketing and Maintenance
through which the product and service in use meet the expectation of the customer”.
According to Juran,
(i) Quality consists of those product features which meet the needs of
customers and thereby provide product satisfaction.
(ii) Quality consists of freedom from deficiencies.
“Product” is the output of any process. It consists of mainly goods, software and services.
A “product feature” is a property which is possessed by a product and which is intended
to meet certain customers’ needs. A “customer” is someone who is impacted by the
product. Customers may be external or internal. External customers are impacted by the
product but are not members of the company which produces the product. External
customers include clients who buy the product, government regulatory bodies, the public
etc. Internal customers are members of company who require the product for further
processing or in-house use. Some other definitions of quality quoted in the literature are
as follows :
• According to ANSI/ASQC Standard A3-1987 (draft), quality means “The
totality of features and characteristics of a product or service that bear on its
ability to satisfy stated or implied needs.”
• The European Organization for Quality Control Glossary (1981) defines
quality as “The totality of features and characteristics of a product or service
that bear on its ability to satisfy a given need. For example, with
manufactured products quality is mainly determined by quality of design
and quality of manufacture.”
• The Soviet encyclopedia defines quality as follows: “Quality of Products is
the aggregate of properties of a product determining its ability to satisfy the
needs it was built to satisfy.”

1.3 CONCEPT OF QUALITY

The concept of quality has evolved from one that is produced (product) or provided
(service) by an organization to an individual or society. Quality is a demand of customer
either internal or external. A product can be said to possess a good quality if it fulfills the
following requirements :
Fitness for Purpose
The product or service fulfils the purpose for which it has been produced or
provided.
Conformance to Requirements
The product performs satisfactory in an application intended by the user.
Grade
The product possesses distinguishing feature in terms of appearance, performance,
durability, safety, affordability and maintainability.
6
Degree of Performance Introduction to
Quality Control
The product scores over competitive products of equivalent grade, based on
comparative test by customers.
Degree of Excellence
The product gains a value derived from functions performed with the product, the
timeliness of product’s availability, aesthetics associated with ownership, quality
of performance and its cost.
With the principle that “customer is the king”, the producer or service provider
strives to meet the expectations of the customer. From the producer’s point of
view, quality must be observed in the aspects of designing, conformance and
performance. In the next sections, we shall study how quality is observed in the
above three areas in the product industry. The implications of quality in service
sector shall be discussed side by side.
1.3.1 Quality of Design
Prior to producing a product, it is essential for the producer or manufacturer to know
“what are the demands of the user? This information can be obtained by conducting
surveys, past market trends, etc. (These shall be discussed in detail in a later section.)
With this database, a collective assessment of user needs is made and the requirements
are quantified. These quantified requirements are called ‘specifications’ that decide the
characteristics of the product.
The quality of design is concerned with the tightness of specification for manufacture of
the product. In other words, it refers to the appropriateness of the process involved with
the manufacturing of the product. For example, a part with tolerance of ± 0.001 mm
would be considered a better design of quality than another with tolerance of ± 0.01 mm.
The manufacturer is said to deliver a good quality of design if the product performs
consistently within the stipulated life span. The performance can be measured in terms of
rated output, efficiency, overload capacity and continuous or intermittent operation as per
specific application. The quality of design is controlled by several factors :
(a) Type of Customer in Market
The pre-requisites to the design of a product involve conducting a market
survey because the taste and needs of customer vary with location,
socio-economic status and personal preference. For consumer goods, it is
important to study the consuming habits, prices the customer is willing to
pay and the choice of design of product i.e., its size, shape and packaging
etc. For example, a 10-seater 3-wheeler would be the best choice for
commuting in rural and semi-urban areas because people would share the
auto rather than hire the entire vehicle, whereas a small auto-rickshaw would
serve the purpose of a city commuter where he has to travel to a particular
place. Thus, the priority in designing a three-wheeler for travel in rural areas
is capacity whereas a city-vehicle should be compact and must run at higher
speeds on city roads. Similarly, for capital goods such as heavy machineries,
the decision to design for quality is governed by factors such as reliability,
trouble-free service and maintainability.
(b) Profit Consideration
It is important that the manufacturer minimizes internal waste besides
realizing the customer’s expectation. For example, if the customer is
demanding a product whose functional utility is of greater importance than
the physical attributes, the manufacturer can produce a quality design
without investing too much on aesthetics. Producing different grades of
products, catering to various segments of customers, also contributes to
increasing of the profit margin.
(c) Environmental Condition 7
Quality Systems A good design considers the effect of environment on the performance. A
well-designed bus body fails to provide ride comfort in village roads and
hilly tracks whereas a jeep makes it suitable for rough terrains and muddy
roads also. Similarly, laboratory appliances often fail to perform
satisfactorily in real-life situation because of absence of proper temperature,
humidity, etc. Increasing research has been called for designing appliances
that can perform in harsh conditions and inside factories.
(d) Special Requirements of Product
Generally, greater the requirements for strength, fatigue resistance,
interchangeability of parts, etc. tighter should be the tolerance to give goods
of better quality. In case of electronic items, where the breakdown of a part
is unavoidable due to voltage fluctuation, designs are made to enable quick
replacement.
The service sector is very sensitive to the changing needs of the customer. Often the
customer would like to avail the services as per his convenience. In general, quality of
design in service is viewed from the point of consumption and flexibility in service. For
example, medical aid can be sought at home if patient cannot be transported to hospital.
Although such design of service demands greater resources and time nevertheless it
ensures that customers are delighted. The coming of personalized insurance schemes is
an example of introducing flexibility in services. Such organizations deal with the
customer on an individual basis. The customer himself is in charge of designing his needs
(type of insurance) thereafter the organization modifies its working policy towards the
customer.
1.3.2 Quality of Conformance
The quality of design is an indicator of what we plan to do. The quality of conformance is
an indicator as to how well the manufactured product conforms to the plan. A product
can be designed by considering most of the factors affecting it. However, implementation
of those design concepts might fail during production planning or manufacturing. Some
of the key factors that ensure conformance of product to design specification are
discussed below.
(a) Quality of Incoming Raw Materials
Any compromise in any part of the product which may be due to poor
quality of the raw material is reflected in its use and period of use. Besides,
the machines and tools for producing the product and measuring instruments
must be kept at high level of maintenance.
(b) Selection of Process and Process Control
The conceptual design of a product is realized by transforming the raw
materials through appropriate processes and continuous monitoring of the
process. Thus the proper selection of process and adequate process control is
utmost essential to observe quality.
(c) Work Force
Well-trained, experienced and motivated operators, technicians and
engineers form the root of the organization. A proper work force at proper
place improves productivity and quality of product.
(d) Safe Transport and Storage
A well-designed product cannot achieve conformance to quality if proper
care is relaxed in shipment and storage of finished goods. Thus delivery
process to customer is an essential step in achieving the quality mark.
(e) Implementing Statistical Techniques
8
 Conformance to quality must put a check in the variability of process. This Introduction to
variability arises due to reasons – seen and unseen. Provision of statistical Quality Control
techniques is an important step in controlling variability.
(f) Inspection Programme
When the quality of product is said to conform to design and other factors, it
also indicates that defectives are minimal. This is accomplished by
inspection and feedback from user and implementing remedial procedures.
In the service sector, quality of each unit of service counts to provide the seal of
conformance. The service is said to conform to quality if the service provider not only
provides the appropriate facilities but also reverts to the customer based on customer
feedback. For example, a passenger traveling by an airline continuously assesses the
organizations resources ranging from ticket reservation to check-in, security checks to
luggage arrival. If the services in any section dissatisfy the passenger, he makes a quick
response and asks for the cause. A good service provider handles customer complaints
and takes action on the feedback from customer. Conformance to quality is dependent on
the service provider who has the knowledge and proper communication skills to deal
with the customer queries.
1.3.3 Quality of Performance
The quality of performance is concerned with how well the manufactured product gives
its performance. It depends upon quality of design and quality of conformance. The
product can be a best possible design, but poor conformance to design can cause poor
performance. Conversely, the best conformance cannot make the product function
correctly if design itself is not right. The performance of a product is observed from
experience of the customer. The approval of customer is essential for a product, well
designed and conforming to quality (stated by producer). The satisfaction of the
customer is immediately reflected in the number of sales and the organization can be said
to achieve the level of performance.
1.3.4 Achieving and Maintaining Quality
Quality can be viewed as a duty dictated by a customer and performed by the
manufacturer or service provider. The approval of customer is necessary for the
manufacturer to evaluate the manufacturing process. The functions concerned with
quality are performed by individuals and departments of the manufacturing organization
or a service company. A brief description of function of various departments, individuals,
specialists in the organization is listed below.
(i) Marketing
This department conducts market survey to create a database of customer
demands, the associated features of the demand, the type of service
expected, the frequency of use etc. The experience of the customer with
existing product also becomes the basis for a redesign or improvement in
product.
(ii) Research and Development
In this department, specialists conceptualize a product, which can meet the
quality needs of user.
(iii)Design
In this department, design engineers design product and specify materials
considering quality requirements.
(iv) Process Planning
Process engineers specify process, machines and instruments capable of
producing products through specified manufacturing processes.
(v) Purchase
9
Quality Systems Purchasing specialist buy materials and components possessing appropriate
qualities specified by designers.
(vi) Production
Operators are trained to use process and instruments to make the product as
per design.
(vii) Inspection
Inspectors examine product to reduce defects and process to reduce
variability.
(viii) Retail Houses
Retailer makes the products accessible to customer and also provides
maintenance service.
Thus, it is seen that the quality is everybody’s business.

1.4 QUALITY CONTROL

It is a process through which we measure the actual performance, compare it with some
standard and take corrective action if there is a deviation in observed performance from
standard. It is a systematic procedure for meeting the quality goals. Fiegenbaum defines
Total Quality Control as :
“….an effective system for integrating the quality development, quality maintenance and
quality improvement effects of various groups in an organization to enable the
production to be carried out at most economical level and to achieve satisfaction of the
customer.”
The reason for carrying out quality control is that processes are subjected to variations.
The variations can be due to materials, tools, machines, labours, working conditions, skill
of operator; anything that is involved with the creation of product. Some variations can
be rectified immediately but others cannot be and their causes are also not easy to trace.
This translates into deteriorated performance of the product and a loss of quality. Quality
control strives to match the targeted performance by minimizing the variation. The
processes involved in the production are bound to vary in time. Since the deviation can
take place in any stage of production, it is both economical as well as scientific to
introduce quality control at all levels of production.
Before understanding the basic objectives of quality control, it is important to question
who sets the standards of quality. The standards of quality are set according to its
specification i.e., its design. The design remains a concept in the mind of designer until it
is defined through quantified description such as drawing. Specifications are of
following types :
(a) Standard Specification
For example, Bureau of Indian Standard (BIS) formulates specifications of a
variety of product. The bodies that prescribe standards comprise members
drawn from industry, research organization, government department and
interested experts.
(b) Customer Specification
When standard specifications are not available for a particular customer
needs, the customer provides specification to meet his particular needs.
(c) Company Specification
These are a compromise decided by contract between the customer and
manufacturer because of constraints in manufacturing process, supply or
availability of raw materials etc.
Following are the basic objectives of quality control :
10
 (i) The foremost objective is to improve the company’s income by making the Introduction to
product more acceptable to customer. In other words, quality control (QC) is Quality Control
concerned with quality of future production, so that products provide
versatility, better manufacturability etc.
(ii) The second important objective is reduction of losses due to defects. Defects
can arise in production machinery, instruments raw material and also
processes. Inspection is the obvious answer for sorting defectives. But Q.C.
tries to achieve less sorting, less reworks, less shutdowns, few customer
returns and ultimately lower scrap. QC also puts a check to the flaws that
creep into service because of negligence or ignorance.
(iii) Quality control acts as a tool to judge the conformity of the process to
established standards and take suitable action when there are deviations.
(iv) Obtaining loyal customers in the long run is an important objective of QC.
In the deep understanding of quality, the efforts of an organization are
described as “customer-centric”. The phenomenon of “profit escalation” or
rise in profits is bound to occur once the organization has a base of loyal
customers.
(v) A major objective of quality control is associating a value to the product. A
manufacturing organization recognizes that the requirements of customer
change over time. In order to maintain the same value of the product, it is
necessary to obtain feedback from the customer on the present worth of
product in terms of usefulness and also price. This process is accompanied
by experimentation and modification of process. In fact, maintaining a value
is a step toward developing good customer relations. The ultimate aim of
QC is to ensure satisfaction of customers with products and services of high
quality level, to build customer’s goodwill, confidence, and reputation of
manufacturer.
The principle behind quality control is based on assumption that key quality
characteristics can be defined and that measures of these characteristics can be observed.
The key characteristics can be as simple as length of one part or percent impurities in a
chemical solution. Once the key characteristics are defined, systems are established for
controlling the mean value of the characteristics. In later units, you will learn that word
“control” refers to a statistical inference and hence the procedure of QC may not catch all
defectives arising of variation but can significantly reduce the number of defects to a few
parts per million. The key characteristics are not restricted to technological data such as
lengths, frequency or viscosity. Quality engineering recognizes four other characteristics.
(a) Psychological (sensory) – Taste, odour, beauty etc.
(b) Time Oriented – Reliability, maintainability, life etc.
(c) Contractual – Guarantee, safety etc.
(d) Ethical – Honesty, integrity etc.
In the health industry, key characteristics are based on emotional grounds such as trust
(on doctors). Although these are non-measurable, the one important feature of items
identified by such characteristics is that by QC, quality of future product or services can
be regulated. The quality policy of an organization is formulated on the basis of these
characteristics. The policy involves working out details of product requirement, setting
standard (specification) selecting inspection plans, detecting deviation, setting procedure
for checking and taking corrective action. Also it involves controlling the salvage value.
Quality Control affects the operational policy of an organization. It is a fact that the
ultimate aim of an organization is to produce optimum quality at minimum price and
ensure customer satisfaction. The competitiveness of an organization would be
determined by degree of QC undertaken. A strict quality policy involves monitoring all
observable characteristic and controlling the process at mean level. This involves
investment in the form of techniques and capital. This guarantees a higher quality
performance. Thus the working policy of the organization revolves about improving its 11
Quality Systems income without compromising on quality and improving the usefulness of future
products. In other words, quality policy dictates the working policy of an organization.
SAQ 1
(a) Define the term quality control and explain its objectives.
(b) Differentiate between inspection and quality control.
(c) What is the meaning of quality of design?

1.5 STAKEHOLDERS AND THEIR EXPECTATIONS

The people who are directly and indirectly affected in varying degrees by the operation
of companies or institutions are usually thought of as Stakeholders. Stakeholders are
those who have an interest in a particular decision, either as individuals or representatives
of a group. This includes people who influence a decision, or can influence it, as well as
those affected by it. The stakeholder may represent from the community of investors,
consumers, employees, surveyors, consumer panels and management-labour negotiators.
The relations between the organization and stakeholders are provided in the codes of
practice. The codes usually open with a statement that in its dealings, the corporation (or
member of a professional body) will always act with integrity, fairly and reasonably, the
acceptance of a social responsibility to the community. Thus the existence of codes
implies a sense of obligation for the organization to behave in certain ways towards
groups of people. As such the stakeholders have the following main roles :
Plan and Policy Development
The key stakeholder must play the role for the project to be successful. The
stakeholders have specific interests in an organization because it benefits him. Or
the project activities might cause damage or conflict for the stakeholder. A
stakeholder is involved in drawing up action plan(s) in light of review and new
guidance. They share their views with key stakeholders via established forums or
networks.
Quality Improvement Initiative
The role of stakeholder is very important in early stages of quality improvement
initiative. In case, the stakeholder senses the quality initiative as a hamper to his
interests, he might withdraw from the organization. Hence, the organization
develops strategies for obtaining support from the stakeholders.
Performance Monitoring for the Forward Planning Function
Periodic meetings are held between the organization and stakeholders for
monitoring the performance and taking corrective actions.

1.6 QUALITY ASSURANCE

The term “assurance” refers to protection of a product performance under actual
conditions. Quality is a fitness for use. To derive the best performance of a product, it
12
must be used only as stated. Thus, it is essential to recognize the early warning of trouble Introduction to
ahead. With quality assurance, the management makes available to the customer the Quality Control
proof that product is fit for use. Thus quality assurance is the activity of providing the
evidence needed to establish confidence that the quality function is being performed. The
type of evidence differs, widely according to the persons requiring the assurance and the
nature of product.
As an example, freshness of vegetable in the village market is attained through direct
sensory examination. In the case of packaged items, the evidence must be supplemented
by laboratory testing. The expiry date in tinned products, cosmetics and medicine is
mentioned after laboratory inspection. For long-life products, favourable environmental
conditions must be stated. The manager can assure quality performance if he has the
answer to the following questions :
(i) Is the product safe?
(ii) Are we complying with legal requirements?
(iii) Is the product(s) performing within warranted life period?
(iv) Is the product marketable?
Now, we shall discuss three forms of company practiced quality assurance used to
provide evidence.
(a) Quality audit,
(b) Quality surveys, and
(c) Product audit.
1.6.1 Quality Audit
A quality audit is an independent review conducted to compare some aspect of quality
performance with a standard for that performance. An independent audit provides an
unbiased picture of performance. The usual purpose of quality audits is to provide
independent assurance that :
• Plans for attaining quality are such that, if followed, intended quality will, in
fact, be attained.
• Products are fit and safe for use.
• Laws and regulations are being followed.
• There is a conformance to specifications.
• Data provide accurate and adequate information on quality to all concerned.
The purpose of an audit is valuable to the organization because it covers various aspects,
viz.
(i) Policies and procedures regarding :
(a) Operating.
(b) Quality control.
(c) Administration.
(ii) Operating effectiveness involving :
(a) Records, interpretations, corrective action.
(b) Equipment control.
(c) Inter-departmental co-ordination.
(d) Assessment of product quality.
(iii) System effectiveness covering :
(a) Storage and Handling practices. 13
Quality Systems (b) Field complaints and corrective action.
(c) Tool and Gauge control.
(d) Product design changes.
It is only up to the need of client what sort of auditing he would like to conduct. The
various types of audits generally carried out are :
The Adequacy Audit
It is called as management audit. It determines the extent to which the documented
system, represented in the quality manual and the associated procedures, work
instruction and forms, adequately meets the requirements of the standards.
A Compliance Audit
It is carried out to establish the extent to which the documented system is
implemented and observed by the workforce.
An External Audit
External audit is carried out by an organization or another with which, the
organization has either entered into contract for sale of goods or services. It may be
an adequacy and/or a compliance audit.
An Extrinsic Audit
This is an external audit carried out by an independent third party that may be
accredited, using a national or international standard, such as ISO: 9000 series to
provide assurance on the effectiveness of the quality systems.
Internal Audit
It is the audit carried out by the company on its own quality systems. Its purpose is
to give assurance to the management that its quality system is effectively achieving
the planned quality objectives. These audits are carried out by the organizations’
own staff, provided that they are independent of the system being audited or by an
outside agency.
The most common reasons for conducting an audit include:
• To determine if in-house field personnel are following Standard Operating
Procedures (SOPs) correctly.
• To determine if there are any deficiencies in how SOPs have been prepared
and how best to correct field practices.
• To determine if there are any misunderstandings by field personnel
regarding expectations of SOPs.
• To validate or dispute outside audit results (such as those of a regulatory
agency).
• To assist in the development of new SOPs where new sampling equipment
or techniques are being used.
• To conduct annual quality control checks.
In an engineering company the complete quality audit brings together the data from the
following investigations.
(A) To examine whether
• The design meets the functional requirements completely.
• Design specifications are clear without ambiguity.
• The design fulfils the customer’s requirements.
14
 (B) To examine whether Introduction to
Quality Control
• Manufacturing specification conforms to the functional design
specifications.
• The manufacturing specifications are complete and clear cut.
(C) To examine
• Customers quality complaints.
• The adequacy of corrective action taken by the company.
(D) To examine activities in shops as
• The adequacy of gauges and test equipment used.
• Completeness and sequence of performance of inspection procedure,
data collection system and action.
The design of an audit is tied directly to the objectives defined by the client. Some clients
simply want to find out if their contractors are following the SOPs outlined in their work
plans at a single site. This type of audit is simple and straightforward, consisting mainly
of filling out a detailed checklist. Other clients want to evaluate the field equipment used
by their field staff. While in the field, the auditors will make detailed observations about
actual field activities being conducted during the audit. Depending upon the objectives of
the audit, these observations may be evaluated against required SOPs, against best
available standard methods and practices; or against corporate field procedure guidance.
The timing of an audit is best decided by discussions between the auditors and the client.
In some cases, audits may be conducted as an unannounced visit to permit observation of
actual field practices. In other cases, the field team is well aware of the audit and works
with the auditors to structure field activities that will cover all key practices and
procedures defined in the SOPs. In still other instances, where the audit is conducted as
an independent third party review of field procedures, the field team may be given a
window of dates for the audit to be conducted.
The final product of an audit can vary from a simple checklist report to a very detailed
technical evaluation of the sampling team being audited. The client requesting the audit
makes the decision on report format. In addition to written reports, photographic
documentation of field activities can also be included in the report pending security
clearance with the field site.
An auditing task consists of the following steps :
Audit Initiation
The basic right to conduct audits is derived from the ‘charter’, which has been
approved by upper management. A specific audit is initiated on request of the
manager of activity.
Audit Planning
Element of a plan must include definition of scope and objective of audit,
identification of area to be audited and auditors, a schedule including expected
start and completion date, standard and audit documentations. In all, the plan
should be prepared to inform the manager of activity and the auditors regarding
details.
Audit Implementation
This phase involves collection, analysis and evaluation of factual information and
drawing of conclusion from these facts.
Audit Reporting
After the audit, the audit report is prepared. The report is viewed as credible if it is
balanced in reporting and depersonalized. A common criticism to the audit report
is the tendency for the report to emphasize deficiencies that are minor in nature. A 15
Quality Systems balanced report must determine the impact of deficiencies on activities. On the
other hand an audit that reports only deficiencies is bound to be unacceptable
because nothing is said about those elements that have performed well.
There are certain deficiencies associated with quality audits. Quality audits are not
sufficient to provide full assurance to upper management because they cannot address the
following things.
(i) Relative standing of the product in the marketplace with respect to quality.
(ii) Feedback of user.
(iii) Opportunities for reducing costs of poor quality.
The review of entire elements of an organization demands time, money and coordination.
The following points prove effective in conducting quality audits.
(i) Prioritize the Quality related Activities : Before preparing for an audit, it
is essential to estimate the improvement versus cost of performing the audit.
(ii) Define Clearly the Subject Matter of Audits : Identify broad areas and
establish a detailed checklist of features to be studied and question to be
raised.
(iii) Switch Resources : The audit resources should be switched to other areas as
soon as one area is improved.
(iv) Reference Standards : In absence of any reference, the auditing task
becomes very large. A Quality Assurance Manual (Reference IS,
10201-1988) incorporates :
Quality objective, Quality policy, Control of measuring tools, gauges and
instruments, Material management, Vendor evaluation, inspection plans,
System of handing of rework, rejection and deviations, Storage, packaging
and packing, Handling of customer complaints, Quality costs and Quality
reporting and review. Thus in absence of any company audit, it is best to
follow according to the manual.
1.6.2 Quality Survey
Quality Survey enables the manager of an organization to assess the quality of the
products and/or services of the organization by viewing the process from different
perspectives. A series of investigations are being carried out by full time staff specialists
who distribute forms and handouts to customers or the employees of an organization
from whom reasonable information can be derived. The quality surveys are very common
in production as well as service sector. A quality survey goes further than discovering
discrepancies as in auditing process. A good survey should discover opportunities and
unexpected threats. A quality survey allows to :
• understand where quality improvement efforts are succeeding,
• involve employees in quality improvement efforts from the beginning of the
process,
• pinpoint regions where quality improvement needs to occur, and
• improve customer satisfaction with increased quality.
Surveys can be conducted by distributing the forms to customer or by interviewing them.
A reference standard helps to define the activities that are needed to achieve quality
objectives, provide criteria for evaluation and thereby increase the objectivity of the
audits. The regulatory bodies issuing the standard surveys are ISO 9000 series, BS 5750
and MIL-Q-9858A.

16
1.6.3 Product Audit Introduction to
Quality Control
Product auditing is an independent evaluation of product quality to determine fitness of a
product for use and conformance to specification. Product auditing takes place after
inspections have been completed. The purpose of products auditing includes :
(i) Estimating the quality level as delivered to customers.
(ii) Evaluating the effectiveness of the inspection decisions in determining
conformance to specifications.
(iii) Providing information useful in improving the outgoing product quality
level and improving the effectiveness of inspection.
(iv) Providing additional assurance beyond routine inspection activities.
It may be performed by :
• One of the customer
• Internally as ‘Final Inspection’
• External product audits are typically oriented to a specific customer.
The main task in Product Audit is sampling for inspecting defects in a product. For
products manufactured by mass production, sample size is determined by statistical
procedures. For products manufactured as large unit such as automobiles, the number of
units might be small but the total number of characteristics that are sampled becomes
very large. However, certain products demand independent sampling, for example, drugs.
A sample of product audit is shown below :

(1) Name of Manufacturer _________________________________________

(2) Licence/Conditional Licence Number _____________________________

(3) Name of Product ______________________________________________

(4) End Use Product Formulation ____________________________________

• Were specifications consistent with registered particulars

Yes † No † N/A †

• Was the formula on the batch record consistent with registered formula
particulars Yes † No † N/A †
(5) Product Stability Profile

• Is an SOP for developing stability data available? Yes † No † N/A †

• Is it adequate? Yes † No † N/A †
• Is it being implemented? Yes † No † N/A †
(6) Is stability data on selected products available? Yes † No † N/A †
(7) Are there change control procedures in place for controlling formulation
change?
• Are changes internally approved? Yes † No † N/A †
• Is there a procedure for notifying the necessary changes
where appropriate? Yes † No † N/A † 17
Quality Systems (8) Product Label

• Is the label approved Yes † No † N/A †

• Is it current Yes † No † N/A †
• Is copy attached Yes † No † N/A †

The Product Audit is highly customized so as to reflect target market segments and key
competitors. As the product gets complex, it is essential to carry out the auditing process
in multiple stages. Some of the key stages that have been identified are tabulated in Table
1.1 with its merits and demerits.
Table 1.1 : Potential Stages for Product Auditing (as Described by Juran)
Stage at which Product Merits and Demerits of Using this Stage
Auditing is Conducted
After acceptance by Most economical, but does not reflect effect of packing,
inspectors shipping, storage, or usage
After packing but before Requires unpacking and repacking, but evaluates effect of
shipment to fields original packing
On receipt by dealers Difficult to administer at such multiple locations, but reflects
effect of shipping and storage
On receipt by users Even more difficult to administer, but evaluated the added effects
of dealer handing and storage plus effects of shipment to user
and unpacking
Performance in service The ideal, but also the most difficult to administer because of the
number and variety of usages; can be simplified through
sampling

In a report of product audit, the product is assigned a rating or a score. This running score
is used as one of the inputs for the executive reports on quality. One of the ways
managers prefer to rate the product is based on several levels of seriousness such as
critical, major, minor, incidental. The purpose of such auditing is that inspection reports
appear in the form of presence of defects, failures and other factors. Because these
discrepancies are unequal in nature a summary of % defectives does not present a
complete picture of the acceptable quality. The most direct method of quantifying the
seriousness is by assigning weights. Usually a weight of 100 “demerits” is arbitrarily
assigned to the most serious defect class and weight then assigned to the other classes.
For instance :
Seriousness Classification Weight or Demerit Value
A (Critical) 100
B (Major) 40-70
C (Minor) 10-25
D (Incidental) 1-10
To summarize, defects are converted to demerits to arrive at a composite demerits per
unit. For example, the result of product audit on one product line for 1 month were as per
Table 1.2. If there were 5000 units of products audited in a month, the demerits per unit
totaled 856/5000 = 0.17.
Table 1.2: Results of Product Audit
Defect Class Weight Number of Defects Total Demerits
Found
18
 Introduction to
A (Critical) 100 2 200
Quality Control
B (Major) 50 7 350
C (Minor) 10 28 280
D (Incidental) 1 26 26
Total 856

In addition to summarizing the defects found (both number and relative seriousness), the
audit result can be tallied by functional responsibility (i.e., design, purchasing,
production). Audit result can be summarized to show the effectiveness of the previous
inspection activities. Typically, a simple ratio is used such as the percentage of total
defects, which are detected by inspection. For example, if the previous inspection
revealed a total of 40 defects in a sample of N pieces and if the product audit inspection
revealed 10 additional defects, the inspection effectiveness would be 40/50 × 100 , or 80
percent.
The usual standard for comparison of product audit is previous practice; the managers
want to see whether quality is improving or worsening. To quantify past practice, the
auditors conduct the product audit over a sufficient number of months to acquire stable
data. This period is known as the base period. In calculating the base period, it is usual to
exclude known abnormalities such as new- product troubles and the effect of temporary
crises. The resulting “refined” base period then becomes a basis for comparison, mush as
previous year’s costs or expenses. Alternatively, the standard for comparison may be
“market quality”. In such cases, the product audit plan is applied to competitive products
in the same way that it is applied to the company’s own products.

1.7 RECOGNITION OF QUALITY EFFECTS

Quality affects a supplier’s economy in the following two principal ways :
The Effect on Costs
With respect to its effects on costs, the word ‘quality’ is used in the sense of
freedom from deficiencies. In this sense, higher quality means lower cost as the
defects are minimized. The cost of poor quality affects two parties : the
manufacturer and the users. Manufacturer suffers loss as a result of waste of
material, labour time and processing cost. Poor quality also increases the cost of
the user of the product in the form of repair costs after warrantee period, various
losses due to downtime etc.
The Effect on Income
With respect to its effect on income, the word quality is used in the sense of the
features of the product, which respond to customer needs. Those features make the
product saleable and provide “product satisfaction” to customers. With superior
quality, the company can earn higher share of market, firmer prices, a higher
percentage of successful bids, and still other benefits of income. The effect of
improved quality can be observed by observing the following :
(i) Increased production.
(ii) Reduction in scrap and re-work cost.
(iii) Increased sales of good quality product.
(iv) Reputation of manufacturer and goodwill of the customer.
(v) Psychological stability in the enterprise.
SAQ 2
(a) What is quality audit? Name and describe the various types of quality audits.

19
Quality Systems (b) An inspection revealed total 18 defects in a sample. Product audit found
2 additional defects. What is the inspection effectiveness?

1.8 SUMMARY
In this unit, an introduction to quality control is provided. First, quality is defined. It is
the total composite product and service characteristics of Engineering, Manufacturing,
Marketing and Maintenance through which the product and service in use meet the
expectation of the customers. For satisfactory quality of performance, quality of design
and conformance should be good. Quality control is the process through which we
measure the actual quality performance, compare it with the standards and take corrective
actions if there is a deviation. Quality assurance deals with the question of assuring the
desired quality, reliability, service and other aspects in the manufactured product through
scientific techniques. Quality audit, quality survey and product audit are the main tools
for achieving quality assurance. Finally, the effects of quality are described.

1.9 KEY WORDS

Customer : A customer is someone who is impacted by the
product or service.
Grade : A popular name for degrees of product satisfaction
is grade. It is sometimes called “quality of design”.
Product whose features are perceived as meeting
customer needs to a superior degree are called
“higher-grade” products.
Income : It refers to the gross receipts from sale.
Inspection : Inspection is an act of checking materials, parts,
components or products at various stages in
production and sorting out the faulty or defective
items from the good items.
Product : It is the output of any process.
Product Auditing : Product auditing is an independent evaluation of
product quality to determine its fitness for use and
conformance to specifications.
Quality : It is the totality of features and characteristics of a
product or service that bear on its ability to satisfy
stated or implied needs.
Quality Assurance : All those planned or systematic actions necessary
to provide adequate confidence that a product or
service will satisfy for given requirements of
quality.
Quality Audit : A quality audit is an independent review
conducted to compare some aspect of quality
performance with a standard for that performance.
20
Quality Control : Quality control is the process through which we Introduction to
Quality Control
measure the actual quality performance, compare
it with standards and take corrective actions if
there is a deviation.
Quality Engineering : It is the branch of engineering, which deals with
the principles and practices of product and service
quality assurance and control.
Quality Policy : The overall intention and direction of an
organization as regards quality as formally
expressed by top management.
Service : Service is work performed for someone else. The
service may be provided to consumer (e.g.
haircutting), to an institution (e.g., security
service) or to both.
Specification : The document that prescribes the requirements
with which the product or service has to conform.
Testing : A means of determining the capability of an item
to meet specified requirements by subjecting the
item to a set of physical, chemical, environmental,
or operating actions and conditions.

1.10 ANSWERS TO SAQs

SAQ 2
(b) 90%
Answer to all other SAQs may be found in the text.

QUALITY SYSTEMS
Quality has been a very important activity from the dawn of civilization. The goal of high
quality is common to all countries. As the international trade is increasing, need for
standardization of products and maintaining their quality is increasing. Application of
managerial tools to quality planning and quality control has gained much importance.
Early system of managing for quality was dependent on factory workers supervised by a
foreman. Quality was assured through the skills of the workers supplemented by
supervisory audit or by a departmental inspection. Top management involvement was
limited. Gradually, inspection departments took the form of quality control and quality
assurance departments. After World War II, the Japanese embarked on a course of 21
Quality Systems reaching national goals by trade rather than by military means. The Japanese adopted a
variety of strategies for improving the quality. The upper managers personally took
charge of leading the quality revolution. The functionaries at all levels underwent
training in managing for quality. Quality improvement was undertaken at a continuing,
revolutionary pace. Other nations started emulating Japanese way of managing quality.
Today Total Quality Management (TQM) has become a keyword.
In 1987, ISO 9000 standards were introduced. These pertain not to the quality of product
but to the practice of quality assurance methods within a company. ISO 9000 covers
varied activities such as design, manufacturing, software development, service activities,
auditing and methods for improving quality on the shop floor.
This block on Quality System contains four units. Unit 1 provides an introduction to
quality. Unit 2 presents information on total quality management and different
approaches. It also provides an idea of zero defect program, Poka-Yoke and concurrent
engineering. Unit 3 describes various tools of quality. Unit 4 is about the role of ISO and
OSHA.

QUALITY ENGINEERING
Quality is all of the features and characteristics of a product or service that contribute to
the satisfaction of a customer’s needs. These needs involve price, safety, availability,
maintainability, reliability and usability. Price is easily defined by the amount of money
to be spent for purchasing a particular product. The other needs are defined by translating
the features and characteristics for the manufacturer of a product or the delivery of a
service into specifications. Conformance of the product or service to these specifications
is measurable and provides a quantifiable definition of quality. Therefore, simply stated,
quality is conformance to specifications and the degree of conformance is the measure of
quality.
22
From the viewpoint of the customer, who has to use the product or service delivered to Introduction to
him, it is fitness for use. From the manufacturer’s point of view, it is conformance to Quality Control
those specifications that would result in customer satisfaction ultimately. In very general
terms, quality may also be defined as affordable excellence.
Quality then is simply meaning the customers requirements. Now let us try to understand
more about quality through the following definitions :
• Fitness for the purpose or use.
• The totality of features and characteristics of a product or service that beer
or its ability to satisfy stated or implied needs.
• Quality should be aimed at the needs of the consumer, present, and future.
• The total composite product and service characteristics of marketing,
engineering, manufacturing and maintenance through which the product and
service in use will meet the expectation by the customer.
• Conformance to requirements.
We shall be dealing more about Quality Engineering aspects in the course. The course
comprises four blocks. Block 1 deals with Quality Systems. In this block, you will be
introduced to quality control as well as concept of TQM. It is well known that happy
people alone can produce outstanding quality. ISO 9000 standards are quality
management systems, standards which are the bases for implementation assessment and
verification of the quality system in the production as well as service organization. The
standards include a number of ‘Good practices’ which must be followed to ensure the
effectiveness of the quality system.
Block 2 will introduce you the Concept of Quality Tools-Statistical. Statistical quality
control is a branch of quality control. It is the collection, analysis, and interpretation of
data for use in quality control activities.
We shall learn more about Quality Tools and others in Block 3. The evolution of quality
management stimulated, at least in part, by the impact of the demand by customer for
higher quality conformance levels and the increasing competitiveness in world markets
has resulted in the need to address quality management in all aspects of a business,
including customers and suppliers. This development is known as total quality
management (TQM).
In Block 4, you will see by these statements that TQM is a philosophy and set of guiding
principles for managing an organisation.

23