An Expedition to Quality: A Review

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An Expedition to Quality: A Review Jyoti Sharma* Assistant General Manager and R&D Coordinator, Division of Quality Control, Bharat Immunologicals & Biologicals Corporation Ltd. (CPSU under Department of Biotechnology), Chola, Bulandshahr, India Summary Quality has a long and complex history. The concept of quality developed with population growth and the subsequent increase in industrial activity. From visual inspection to Total Quality Management and beyond, quality has progressed from infancy to adulthood. Each era has its distinctive contribution to quality improve- ment. It has taken many years and the inestimable effort of quality gurus to present quality as a holistic approach equipped with scientic tools. Copyright © 2011 John Wiley & Sons, Ltd. Key Words: Strategic Quality Management; Total Quality Management; Business Process Reengineering; Enterprise Resource Planning Introduction Quality guru J. M. Juran dened quality as tness for purpose. Another quality guru Philip Crosby dened quality as conformance to specications. Thus the interpretation of the term qualityvaries from individual to individ- ual. The perception of the quality of a product or service from the customers perspective may be different from that of the producer. One of the problems faced by suppliers of goods or services is that each customer may have a different perception of quality [1]. Notwithstanding, it seems sensible to under- stand that quality should be perceived from the customers point of view because it is the customer who decides whether or not to buy a product or service. Garvin, while focusing on the strategic potential of quality, recognized eight dimensions of quality as the basis for developing strategic options namely: perfor- mance, features, reliability, conformance, dura- bility, serviceability, aesthetics and perceived quality [2,3]. Attainment of quality for a product with all required parameters and in tune with the customers point of view heavily depends on the culture of an organization. Understanding this need, an organization must prepare a product denition document, in which the expectation and requirements of the customer should be clearly specied. Quality culture differs from company to company, from well developed to rudimentary [1]. This concept requires more than just pro- ducing zero defects to meet engineering speci- cations. The scope of quality technology has *Correspondence to: Jyoti Sharma, Principal Scientific Officer, SEED (Science for Equity, Empowerment and Development) Division, Department of Science and Technology, Ministry of Science and Technology, Delhi, India. E-mail: [email protected], [email protected] Copyright © 2011 John Wiley & Sons, Ltd. Qual Assur J 2010; 13,113 DOI: 10.1002/qaj.480

Transcript of An Expedition to Quality: A Review

Page 1: An Expedition to Quality: A Review

An Expedition to Quality: A Review

Jyoti Sharma*

Assistant General Manager and R&D Coordinator, Division of Quality Control, Bharat Immunologicals &Biologicals Corporation Ltd. (CPSU under Department of Biotechnology), Chola, Bulandshahr, India

Summary

Quality has a long and complex history. The concept of quality developed withpopulation growth and the subsequent increase in industrial activity. From visualinspection to Total Quality Management and beyond, quality has progressed frominfancy to adulthood. Each era has its distinctive contribution to quality improve-ment. It has taken many years and the inestimable effort of quality gurus to presentquality as a holistic approach equipped with scientific tools. Copyright © 2011 JohnWiley & Sons, Ltd.

Key Words: Strategic Quality Management; Total Quality Management; Business ProcessReengineering; Enterprise Resource Planning

Introduction

Quality guru J. M. Juran defined quality as‘fitness for purpose’. Another quality guruPhilip Crosby defined quality as ‘conformanceto specifications’. Thus the interpretation of theterm ‘quality’ varies from individual to individ-ual. The perception of the quality of a productor service from the customer’s perspective maybe different from that of the producer. One ofthe problems faced by suppliers of goods orservices is that each customer may have adifferent perception of quality [1].

Notwithstanding, it seems sensible to under-stand that quality should be perceived from thecustomer’s point of view because it is the

*Correspondence to: Jyoti Sharma, Principal ScientificOfficer, SEED (Science for Equity, Empowerment andDevelopment) Division, Department of Science andTechnology, Ministry of Science and Technology, Delhi,India. E-mail: [email protected], [email protected]

Copyright © 2011 John Wiley & Sons, Ltd.

customer who decides whether or not to buya product or service. Garvin, while focusing onthe strategic potential of quality, recognizedeight dimensions of quality as the basis fordeveloping strategic options namely: perfor-mance, features, reliability, conformance, dura-bility, serviceability, aesthetics and perceivedquality [2,3].

Attainment of quality for a product with allrequired parameters and in tune with thecustomer’s point of view heavily depends onthe culture of an organization. Understandingthis need, an organization must prepare aproduct definition document, in which theexpectation and requirements of the customershould be clearly specified. Quality culturediffers from company to company, from welldeveloped to rudimentary [1].

This concept requires more than just pro-ducing zero defects to meet engineering speci-fications. The scope of quality technology has

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been expanded beyond performance param-eters of products and services to include allaspects of business. The shift from basicconcepts of quality to Total Quality Manage-ment (TQM) and beyond has been evolvedthrough a series of gradual refinements con-ceiving both a thought revolution and abehavioral revolution.

The Inspection Era

Until the 19th century, goods were manufac-tured by skilled craftsman in small volume.Parts were handcrafted and connected togetherto form a unique product that was informallyinspected. Industrialization and populationgrowth necessitated the production of largervolumes of product. In the 1800s, increasedspecialization and mass production requiredmore formal product inspection. Inspectorsexamined products to detect flaws and separatethe good from the bad. Gauges were used tocatch deviant parts to ensure that parts wouldfit together at final assembly. The gaugingsystem made inspections more consistent thanthose conducted solely by eye, and gaveinspection a new respectability [4].

By the early 1900s, gauging had becomemore refined and inspection was even moreimportant. G. S. Radford formally linkedinspection to QC [5]. For the first time, qualitywas regarded as an independent function witha distinct management responsibility. Throughthe 1920s, however, QC was most oftenlimited to inspection and focused on activitiessuch as counting, grading and rework. Inspec-tion departments and quality professionalswere not required to troubleshoot, to under-stand and address the causes of the poorquality, until the 1930s, with the creation ofstatistical QC [4].

The Statistical Quality Control Era

Shewhart gave quality a scientific footing withthe publication of his book Economic Control

Copyright © 2011 John Wiley & Sons, Ltd.

of Quality of Manufactured Product [6]. Thestatistical approach that Shewhart advocatedwas based on his views of quality that requirethe numbers derived from measures of process-es or products be analyzed according to atheory of variation that links outcomes to uses[4].

Shewhart offered a pragmatic concept ofquality. The measure of quality is a quantitythat may take on different numerical values. Inother words, the measure of quality, no matterwhat the definition of quality may be, is avariable. For example quality of an object canbe expressed numerically in terms of threevariables: height, width, and symmetry. She-whart’s emphasis on measurement in hisdefinition of quality relates to his prescriptionsfor statistical quality control (SQC), whichrequires numbers. His philosophy of qualitywas based in terms of three categories: product-based, manufacturing-based, and user-based[6].

Process Variation and Control

Shewhart recognized that variation, or fluctu-ation in events or outcomes over time, was afact as no two parts were likely to bemanufactured exactly alike even if producedby the same operator using the same equip-ment. The issue of quality became one ofacknowledging variation and using principlesof probability and statistics to distinguishacceptable and unacceptable variation.

Shewhart’s analytical techniques for deter-mining the range of acceptable variation werebased on his concept of statistical control: “Aphenomenon will be said to be controlled when,through the use of past experience, we canpredict, at least within limits, how the phenom-enon may be expected to vary in the future.Here it is understood that prediction means thatwe can state, at least approximately, theprobability that the observed phenomenon willfall within the given limits” [6].

By the late 1940s, QC was an establisheddiscipline. However, its methods remainedlargely inspection-based applications on the

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factory floor before it ushered in the nextquality era in the 1950s and early 1960 [4].

The Quality Assurance Era

During the QA era, the concept of qualityevolved from a narrow, manufacturing-baseddiscipline to one with implications for manage-ment throughout a company. Statistics andmanufacturing control remained important,but coordination with other areas, such asdesign, engineering, planning, and service ac-tivities also became important to quality. Whilequality remained focused on defect prevention,the QA era brought a more proactive approachand some new tools. Four elements are theessence of the QA era: quantifying the costs ofquality, total QC, reliability engineering, andzero defects [4].

Costs of Quality

Until 1950s, itwas assumed that itwas importantto improve quality because defects were costly.But there was no idea of how costly defects wereand consequently how much quality should beimproved. In fact there was no yardstick formeasuring the costs of quality [4].

“Quality is Free” is the title of the famousbook by quality guru Crosby [7]. However,Juran is known for the concepts propounded byhim regarding the cost of quality. Juran pro-posed the idea of dividing the costs of qualityinto avoidable costs and unavoidable costs.Unavoidable costs are those related to prevent-ing defects that include inspection, sampling,sorting and other QC initiatives. Avoidable costsare related to defects and product failures thatinclude scrapped materials, labor hours requiredfor rework and repair, complaint processing,and financial losses resulting from unhappycustomers [8].

Juran called avoidable costs “gold in themine” because investment in quality improve-ment can sharply reduce them and lead tosubstantial savings. Juran’s cost of quality ap-proach also illustrated the important principle

Copyright © 2011 John Wiley & Sons, Ltd.

that early decisions, as in engineering design,affected the quality costs incurred later on, inboth the factory and the field [4].

It should be emphasized that there is aninverse relationship between the cost of pre-vention of defects and the other three types ofcosts. If the money spent on the prevention ofdefects is increased, usually, the cost of detec-tion of defects, cost of scrap and rework, andcost of warranty claims will decrease [9].

• Cost of preventing of defects training andperforming acceptance sampling of raw ma-terials, SQC, Six Sigma and other techniques.

• Cost of detecting defects in the final productoutgoing inspection of products before theyare shipped to customers.

• Cost of scrap and rework of defectiveproducts this includes the extra paper work,delays, rescheduling required etc.

• Cost of warranty claims this includes the lossof goodwill on the part of customers.

Total Quality Control

To attain quality one must begin by establishingthe vision, policies and goals of the organiza-tion. Converting these goals into results is donethrough three managerial processes called theJuran Trilogy.

1. Quality Planning: Quality does not happenby accident, it must be planned. The struc-tured processes for designing products andservices that meets new breakthrough goalsand ensures that customer needs aremet. Thesteps in the quality planning process are:

i Establish the projectii Identify the customersiii Discover the customer needsiv Develop the productv Develop the processvi Develop the controls and transfer to

operations

2. Quality Control: A universal managerial

process for conducting operations so as toprovide stability to prevent adverse change

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and to “maintain the status quo”. QC canalso be described as “a process for meetingthe established goals by evaluating andcomparing actual performance andplanned performance, and taking actionon the difference”. The steps in the QCprocess are:

Copy

i Choose control subjectii Establish measurementiii Establish standards of performanceiv Measure actual performancev Compare to standards (interpret the

difference)vi Take action on the difference

3. Quality Improvement: The process forcreating breakthrough levels of perfor-mance by eliminating wastes and defectsto reduce the cost of poor quality. Thesteps in the quality improvement processare:

i Prove the need for improvementii Identify the improvement projectsiii Establish project improvement teamsiv Provide the project teamswith resources,

training, andmotivation to: diagnose thecauses, stimulate the remedies, andestablish controls to hold the gains [9]

Feigenbaum extended this principle bysuggesting that high quality products are morelikely to be produced through total qualitycontrol (TQC) than when manufacturingworks in isolation. The underlying principleof this total quality view is that, to providegenuine effectiveness, control must start withthe design of the product and end only whenthe product has been placed in the hands of acustomer who remains satisfied. The firstprinciple to recognize is that quality is every-body’s job [10].

Both Juran and Feigenbaum acknowledgethat statistical methods and manufacturingcontrol were still important. However, TQCwould require new skills to deal with areas suchas new product development and vendorselection. It would also be required to be

right © 2011 John Wiley & Sons, Ltd.

engaged in activities like quality planning andcoordinating cross-functional teamwork [4].

Reliability Engineering

While TQC was emerging, another branch ofthe quality discipline, reliability engineering,was developing with even more heavy relianceon probability theory and statistics. Engineersdeveloped mathematical models for predictingequipment performance over time for differentproducts under different operating conditions.Engineers attempted to improve reliability andreduce failure rates over time through a varietyof techniques, including Failure Mode andEffect Analysis, Individual Component Analy-sis, De-rating, Redundancy, and Monitoring ofField Failures [4].

Zero Defects

Both TQC and reliability engineering aimed toprevent defects and emphasized engineeringskills and attention to quality throughout thedesign process. By contrast, zero defects fo-cused on management expectations and humanrelations. The zero defects approach wasdeveloped between 1961–62 with a programfocused on worker motivation and awareness,with the goal to “promote a constant, consciousdesire to do a job right the first time”. The zerodefects program was heavy on philosophy,motivation, and awareness, and lean on specificproposals and problem-solving techniques [11].

Japan on Quality Front

After the Second World War, Japan decided tomake quality improvement a national impera-tive as part of rebuilding their economy, andsought the help of Shewhart, Deming, Juranand others. Deming championed Shewhart’sideas in Japan from 1950 onwards. He isprobably best known for his managementphilosophy establishing quality, productivity,and competitive position. Deming formulated14 points of attention for managers, which are

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a high level abstraction of many of his deepinsights. They should be interpreted by learningand understanding the deeper insights andinclude [12]:

• Break down barriers between departments• Management should learn their responsibil-

ities, and take on leadership• Improve constantly• Institute a programme of education and self-

improvement

Deming taught the Japanese Shewhart’sprinciples of scientific thinking embodies inthe Plan, Do, Study, Act (PDSA) cycle (Figure 1),which the Japanese soon referred to as Demingcycle. The PDSA cycle provides managers with ascientific method for learning how to makeimprovements [12].

While America and the Western worldseemed to discount these approaches as wartime efforts not relevant to a booming postwareconomy, the Japanese subscribed to them asthe means of rebuilding their economy. Theycontinued to develop and apply methods forcontinuous improvement with an emphasis onquality [4].

The QA era significantly expanded theinvolvement of all other functions through totalQC, and inspired managers to pursue perfec-tion actively. However, the approaches toachieving quality remained largely defensive.Controlling quality still meant acting on de-fects. Quality was something that could hurt if

4. ACT 1. PLAN

3. STUDY 2. DO

1. Plan what is needed 2. Do it

3. Study that it works 4. Act to correct any problems or improveperformance

Figure 1. PDSA Cycle, also known as DemingCycle [4]

Copyright © 2011 John Wiley & Sons, Ltd.

ignored, rather than a positive characteristicnecessary in obtaining competitive advantage.The view started to change in the 1970s and1980s recognizing the strategic importance ofquality [4].

The Strategic Quality Management Era

Strategic Quality Management (SQM) is asystematic approach for setting and meetingquality goals throughout the organization. Thepresent quality era of SQM, incorporateselements of each of the proceeding eras,particularly the contribution of Shewhart,Deming, Juran, and Feigenbaum. So manyelements of previous eras are incorporated intoSQM that the last two decades may at firstappear to be just a repackaging of old ideas.There are, however, dramatic differences fromearlier eras. For the first time, managers beganto view quality positively as a competitiveadvantage and to address it in their strategicplanning processes, which focused on customervalue. Quality was no longer just for theinspectors or people in the QA department toworry about. This era marks the emergence of anew paradigm for management. A number ofdevelopments were brought together and re-configured into a new approach to managementin all departments and specialties.

A variety of external forces brought qualityto the attention of top management. Theybegan to see a link between loss of profitabilityand poor quality. Producing products withsuperior quality, lower cost and more reliabledelivery, firms gained market shares andachieved immense profitability [4]. The on-slaught of these events may be observed in themid 1970s and 1980s when Japanese firmsflooded the market with products producedwith high industrial capabilities and withdeveloped and refined approaches to quality.

During this period many important techni-ques for quality improvement emerged focusingon various aspects of quality including SixSigma which combines established methodssuch as statistical process control, design of

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experiments and Failure Mode and EffectAnalysis (FMEA) in an overall framework;Kansei Engineering, an approach that focuseson capturing customer emotional feedbackabout products to drive improvement; Taghuchimethods, statistical oriented methods includingquality robustness, quality loss function, andtarget specifications [1,4].

The fundamental nature of SQM is toensure a continuous assessment of internaland external changes with regard to quality,and an adjustment of the competitive ap-proach based on that assessment. Based onthis concept, Aravindan, Devadasan, and Sell-adurai have identified five phases involved inSQM. Phase I marks the beginning of SQM,

Establishing quality

Developing Quality profile

Declaring quality p

Listing/modifying long-terquality objectiv

Designing for qu

Quality planning

Quality control

Quality Strategies

Performance in glob

II

III

IVSQ

Need totalrefinement

Figure 2. Phases of Strategic Q

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during which the quality mission of the firm isestablished with the involvement of the manu-facturer. Phase II passes through the develop-ment of a quality profile with the considerationsof quality mission and external environmentcomprising competitors and customers percep-tions. The end of phase II is marked by thedeclaration of a quality policy. Phase III isdevoted to listing or modifying long-term andannual quality objectives. During phase IV,efforts are made to infuse quality at the designstage. Phase V compares with the desiredperformance at the global level (Figure 2). Theoutcome of this comparison determines the needfor further refinement of the SQM processpresently being followed [13].

mission

External environment Competitors Customers’ demands and feed back

olicy

m and annual es

ality

Quality improvement

al market

Quality System

Evaluation

I

M

V

Improvementobserved

uality Management [1,13]

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Total Quality Management Era

Total Quality Management (TQM) is a qualityphilosophy evolved by quality gurus such asDeming, Juran, Crosby, Feigenbaum, Ishikawa,and Garvin. Using the TQM principles pro-pounded by these gurus, Japanese companiesbecame world leaders in producing qualityproducts [1]. The Japanese Union of Scientistsand Engineers (JUSE) defines TQM as ‘TotalQuality Management is a set of systematicactivities carried out by the entire organizationto effectively and efficiently achieve companyobjectives so as to provide products andservices with a level of quality that satisfiescustomers, at the appropriate time and price’[14].

Indeed, the SQM era borrows a number ofits elements from the developments that quietlytook place in Japan at the same time as the QAera in United States. Some of these elements fitwell into TQM. Ideally, managers in the SQMera regard TQM as something more than aprogram, and take it beyond all the deficienciesmentioned earlier. In this context, the word‘Total’ conveys the idea that all employees,throughout every function and level of anorganization, pursue quality. The word ‘Qual-ity’ suggests an excellence in every aspect of theorganization. ‘Management’ refers to the pur-suit of quality results through a qualitymanagement process [4].

This begins with strategic managementprocesses and extends through product design,manufacturing, marketing, finance, and so on.It encompasses, yet goes beyond, all of theearlier definitions of quality by pulling themtogether into a never-ending process of im-provement. Accordingly, TQM is as muchabout the quality process as it is about qualityresults or quality products.

The Concept of Customer Value

Value is quality divided by price. In realitycustomers do not separate quality from price;they consider both parameters simultaneously.Improvements in quality that can be provided

Copyright © 2011 John Wiley & Sons, Ltd.

to customers without an increase in price resultin better “value”. As customers comparesources of supply, organizations must evaluatethe value they provide relative to the competi-tion. The concept itself is sound because value iswhat customers demand [15].

Value-based approaches expand on the user-based view of quality by incorporating thenotion of “price or costs.” Regarding value-based approaches, Garvin suggests, “a qualityproduct is one that provides performance orconformance at an acceptable price or cost”.Where, customer value is defined as a combi-nation of benefits and sacrifices occurring whena customer uses a product or service to meetcertain needs. Those consequences that contrib-ute to meeting one’s need are benefits, whilethose consequences that detract from meetingone’s need are sacrifices [4].

The concept of customer value encompassesall the definitions of quality mentioned so far.To provide value to customers, Quality ofDesign/Redesign, Quality of Conformance andQuality of Performance must be ensured.

TQM may yet be regarded as a passing fad.However, the underlying themes of manage-ment being addressed by those who are strivingto define and move to a new paradigm are notfads. These themes include the importance ofunderstanding customer needs, formulatingstrategies to provide value to customers, andcontinuously improving organizational systemto provide that value [4].

Business Process Reengineering

Business process reengineering (BPR) is theanalysis and redesign of workflow within andbetween enterprises. BPR reached its heyday inthe early 1990’s when Hammer and Champypublished their best-selling book in 1993,“Reengineering the Corporation”. They pro-moted the idea that sometimes radical redesignand reorganization of an enterprise (wiping theslate clean) were necessary to lower costs andincrease quality of service and that informationtechnology was the key enabler for that radical

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change. Hammer and Champy felt that thedesign of workflow in most large corporationswas based on assumptions about technology,people, and organizational goals that were nolonger valid [16,17]. They suggested sevenprinciples of reengineering to streamline thework process and thereby achieve significantlevels of improvement in quality, time manage-ment, and cost:

• Organize around outcomes, not tasks• Identify all the processes in an organization

and prioritize them in order of redesignurgency

• Integrate information processing work intothe real work that produces the information

• Treat geographically dispersed resources asthough they were centralized

• Link parallel activities in the workflowinstead of just integrating their results

• Put the decision point where the work isperformed, and build control into the process

• Capture information once and at the source

“Reengineering is the fundamental rethink-ing and radical redesign of business processes toachieve dramatic improvements in critical,contemporary measures of performance suchas cost, quality, service, and speed” [17]. Thisactivity begins with the development of execu-tive consensus on the importance of reengineer-ing and the link between breakthrough businessgoals and reengineering projects. A mandate forchange is produced and a cross-functional teamis established with a game plan for the processof reengineering. While forming the cross-functional team, steps should be taken to ensurethat the organization continues to function inthe absence of several key players [18].

BPR advocates that enterprises go back tothe basics and reexamine their very roots. Itdoes not believe in small improvements, ratherit aims at total reinvention. As for results, BPRis clearly not for companies who want a 10%improvement. It is for the ones that need a ten-fold increase. According to Hammer andChampy, the last but the most important ofthe four key words is the word ‘process.’ BPR

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focuses on processes and not on tasks, jobs orpeople. It endeavors to redesign the strategicand value added processes that transcendorganizational boundaries [16,17].

By the mid-1990’s, BPR gained the reputa-tion of being a nice way of saying “down-sizing”. According to Hammer and Champy,lack of sustained management commitment andleadership, unrealistic scope and expectations,and resistance to change prompted manage-ment to abandon the concept of BPR andembrace the next new methodology, enterpriseresource planning (ERP) [16].

Enterprise Resource Planning

Enterprise Resource Planning (ERP) is princi-pally an integration of business managementpractices and modern technology. InformationTechnology (IT) integrates with the core busi-ness processes of a company to streamline andaccomplish specific business objectives. Conse-quently, ERP is an amalgamation of three mostimportant components; Business ManagementPractices, Information Technology and SpecificBusiness Objectives [19].

ERP is an integrated computer-based systemused to manage internal and external resourcesincluding tangible assets, financial resources,materials, and human resources. It is a softwarearchitecture whose purpose is to facilitate theflow of information between all businessfunctions inside the boundaries of the organi-zation and manage the connections to outsidestakeholders. Built on a centralized databaseand normally utilizing a common computingplatform, ERP systems consolidate all businessoperations into a uniform and enterprise widesystem environment [19–21].

ERP was first employed by research andanalysis firm Gartner Group in 1990 as anextension of Material Requirement Planning;later Manufacturing Resource Planning (MRP)and Computer Integrated Manufacturing(CIM), and while not supplanting these terms,it has come to represent a larger whole. Itcame into use as makers of MRP software

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started to develop software applications be-yond the manufacturing arena. ERP systemsnow attempt to cover all core functions of anenterprise, regardless of the organization’sbusiness or charter. These systems can nowbe found in non-manufacturing businesses,non-profit organizations and governments[22–24].

To be considered an ERP system, a softwarepackage should have the following traits:

• Should be integrated and operate in real-timewith no periodic batch updates

• All applications should access one databaseto prevent redundant data and multiple datadefinitions

• All modules should have the same look andfeel

• Users should be able to access any infor-mation in the system without neededintegration work on the part of the ISdepartment [23]

In simpler words, an ERP is a massivesoftware architecture that supports the stream-ing and distribution of geographically scatteredenterprise wide information across all thefunctional units of a business house. It providesthe business management executives with acomprehensive overview of the complete busi-ness execution, which in turn influences theirdecisions in a productive way [22].

The key objective of an ERP system is tointegrate information and processes from allfunctional divisions of an organization andmerge it for effortless access and structuredworkflow. The integration is typically accom-plished by constructing a single databaserepository that communicates with multiplesoftware applications providing different divi-sions of an organization with various businessstatistics and information.

Risk-Based Quality Management

Risk-based quality management is a newapproach to risk mitigation in the end-to-end

Copyright © 2011 John Wiley & Sons, Ltd.

quality effort that has a critical linkage torequirements and requirements traceability.

In developing requirements, one has toconsider both the business and the risk ofimplementing new capabilities. The notion ofbeing able to capture both dimensions of risk,by requirement, provides a powerful way toevaluate the criticality of the functionality to thebusiness. If one looks at each requirementindividually and assesses the type of process itrepresents (e.g. new functionality), the frequen-cy of use, the number of users affected by thefeatures, the impact to the business if thatrequirement fails, and the probability of failure,one can arrive at an objective assessment of thepriority/risk associated with that requirement.

What would that allow to do? Understand-ing the priority/risk associated with eachrequirement enables to drive the right focus inthe development/ validation effort. The weight-ing provides the ability to make the righttradeoffs and channel one’s activities to ensurethat the development, testing and validationresources are prioritized against the highest-risk, highest priority requirements for thebusiness.

With risk-based quality management, onecan unlock a new opportunity after the initialapplication deployment, while the application isin production. Requirements traceability is acritical capability to provide visibility to all ofthe tests, test assets, defects and relatedrequirements associated with any individualrequirement. By identifying which requirementsare touched by the application when it changesand the risk levels associated with thoserequirements, combined with a profile of howlong the quality cycle takes, one can buildintelligence into the quality process and toenable process improvement throughout thelifecycle of the application.

Capturing an objective assessment of risk,fixing requirements to downstream activitiesand pulling it into a set of integrated informa-tion across the application lifecycle, gives a levelof visibility and estimation that was neverpossible before. This is the value of risk-basedquality management [25].

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Table 1. India’s rank based on differentquality parameters [28]

Rank out of 41 Quality parameter

39 Price to quality38 Practice of TQM39 Customer orientation28 Product liability40 Time to innovate38 Time to market22 Corporate credibility

J. Sharma10

Need for Strategic QualityManagement in DevelopingCountries: India on Quality Front

The need for SQM has been highlighted indeveloping countries such as India. Quality is amajor factor in achieving competitiveness. Withthe increased globalization of markets andliberalization of local economies, it has becomenecessary for business all over the world todevelop competitive strategies. Such strategiesoften recognize quality management as theirfocal point. Developing countries like Indiamust therefore, adapt to environmental changesand develop programs to enable them qualita-tively to compete effectively [26].

Phase I of quality concern in India andevolution of TQM related activities can beobserved in independent India. For35 years afterindependence, there was a virtual stagnation inthe quality movement as business was protectedfrom competition by the government-regulatedmarket using licensing and custom duties as abarrier. The basic technique used for quality wasthe outdated and relied on a reactive approach ofinspection.This resulted in an enormouswaste ofresources through the generation of scrap andrework.This ledtoahigh-costeconomy,slowrateof economic growth, growing trade deficit, lowershare of the internationalmarket, high incremen-tal capital-output ratio, low productivity, poorquality, and hardship for the consumer [1].

Phase II, from 1983 to 1994, witnessed thefirst tentative steps towards relaxing controlover the business activity, which resulted inintroducing a small degree of competitionamong producers. The economic growth ratepicked up. The need for quality improvementwas felt and awareness for quality grew [1].

Phase III, from 1995 to the present day,witnessed many major policy changes towardsderegulation of the economy and growingdomestic competition. The rate of economicgrowth dropped sharply and export growthwas slow. In such an environment, qualitygained relevance, and the enlightened industry,though small in size, started learning andadapting to new technologies [1].

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Companies started working towards TQM,and many others focused on development andimplementation of QA systems in conformancewith the international standards.The effortof thequality movement is intensifying due to compe-tition in the market. Companies have started tofollowbusiness strategies integrating quality intothese for competitive advantage [27].

A survey conducted in 1994, in whichproducts and services from 41 countries wereranked by the World Competitiveness Report,indicated that the quality of Indian productsand services was disappointing. According tothe summary of results given by Skaria in 1995,India’s rank based on different quality param-eters was as follows in Table 1 [28].

The report clearly suggested that on a globalscale, Indian products and services were farfrom satisfactory and had a poor image at thattime. The next decade has not seen a drasticchange in the situation. According to the GlobalCompetitiveness report 2005–2006, released bythe World Economic Forum, Finland remainsthe most competitive economy in the world andtops the rankings for the third consecutive year.India was placed at 50th rank after improvingthe five stages from its last year position [1].

A study conducted by Maheshwari andZaho, and Raghunathan to assess the currentstatus of quality management practices in Indiashowed that a majority of the Indian companiesare aware of the modern quality managementconcepts and philosophies. In comparison tothe companies from United States, German,Japanese and Canadian, Indian companies arenot behind in terms of efforts for improving

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quality and the application of modern qualitymanagement principles [29,30].

Kaplan and Norton of Harvard Universitymade an observation about Indian companies.According to them, “Indian firms are good atquality. India’s intangible skills in terms ofcreativity and data management are akin towhat US possessed and used in 1980s tocompete with Japan, which had a more efficientwork force. India may be lacking China’stangible product process, but it scores inintangible assets” [31].

India is on the same journey of quality asJapan after the Second World War. World-renowned TQM expert, Professor YasutoshiWashio, has predicted that the quality of Indianmanufacturing will overtake that of Japan by2013. Indeed, many Indian companies havereceived a Deming Prize. This is an awardsystem that originated in Japan in 1951 by theJapanese Union of Scientists and Engineers.Indian companies are well represented on theDeming Award list, with five out of eightawards in 2003 being awarded to Indiancompanies. So far, China has not even enteredthe Deming radar [1].

According to the Global CompetitivenessReport 2008–09, India may boast of itseconomic growth and open market economy,still ranks 50th in global competitiveness.Although, India derives substantial advantagesnot only from its market size (ranked 4th for itsdomestic market size and 5th for its foreignmarket size), but also from its strong businesssophistication (ranked 27th) and innovation(ranked 32nd), its overall competitive posi-tion is weakened by its macroeconomicinstability (109th), with the government run-ning one of the highest deficits in the world(ranked 127th), unsustainable levels of gov-ernment debt (ranked 113th), and fairly highinflation [32].

Luther has stated that the resurgence ofIndia’s manufacturing sector has been quitemagical in recent years. Not only are profitssoaring, the sector is fast spreading rootsabroad as many Indian manufacturing firmsinch close to become true multinationals. The

Copyright © 2011 John Wiley & Sons, Ltd.

Indian manufacturing sector also leveragesinnovation like never before, using it to pushthe envelope on operational efficiencies. Fastproduct development, smart supply chains anddeployment of lean manufacturing have be-come the order of the day. However, the trendcan be noted only in select industries [33].

Thus, in the current scenario, Indian com-panies have a high level of awareness aboutquality-related issues and the available qualitytechniques. What is lacking is a continuous zealto apply these concepts to improve the qualityof product and services. Hopefully the nextdecade will experience the emergance of Indiancompanies with the latest quality techniques forhealthy global competition.

Conclusion

Striving towards quality seems to be a basicinstinct of human beings as evidenced by thedrive for continuous improvement passingthrough various eras. Apart from the qualitygurus who have made an immeasurable contri-bution to the present holistic approach toquality, everyone has its own contribution inthe refinement of and the search for newtechnology and tools for further improvedapproach from industry to management, work-ers and consumers.

Quality management has been most benefi-cial where it has provided clear instructions forreform and has served the purpose of designingand managing organizational processes in amore efficient and transparent way. The rise ofJapan after World War II is the greatestexample of how a quality approach leads tocost cutting, finally boosting the economy of acountry.

No two companies or industries are alikeand are different in their size, product profile,financial status, and culture and ethics. Selec-tion of approaches for quality managementmay also differ for different companies depend-ing on their need. Enterprises therefore, need toconsider carefully which quality improvementmethods to adopt, and certainly should not

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J. Sharma12

adopt all to avoid failure. It is important not tounderestimate the human factor, such ascompany and national culture, in selecting aquality improvement approach. Any improve-ment takes time to implement, gain acceptanceand stabilize as accepted practice. Improvementmust allow pauses between implementing newchanges so that the change is stabilized andassessed as a real improvement, before the nextimprovement is made (hence continual im-provement, not continuous improvement). It isclearly understood that in today’s competitiveworld and in the era of globalization, it isessential to focus on quality improvement. Thisis especially true for the developing countriessuch as India.

Indian industry is facing stiff competitionfrom other countries including China. Tocompete, it must focus more upon attainingworld-class standards in terms of the quality ofits product and services. Though Indian com-panies have demonstrated many successes onquality front, such as winning Deming prizes, itmust be understood that Indian companies havejust won the crucial battle of saving their hometurf, the war is still not over as long as they donot gain a stronghold in the international arena.They must have a continuous zeal and seriousintentions of improving the quality of theirproducts and services. This is the only way bywhich India can be projected as an epitome ofquality in the coming decade.

Acknowledgements

The author expresses her extreme gratitude toMr. Satish Kumar Tyagi, Head of QualityAssurance, Bharat Immunologicals and Biolo-gicals Corporation Ltd., India for his expertcomments, worthy suggestions and continuousencouragement in preparation of manuscript.

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