A PROJECT REPORT On

A STUDY OF TOTAL QUALITY MANAGEMENT

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SAMARTH CHEMICAL PRODUCTS PVT LTD.

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MASTER OF *USINESS ADMINISTRATION

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INDEX

1. COMPANY PROFILE 2. CHAPTER ONE 3. CHAPTER TWO

INTRODUCTION INTRODUCTION CONCEPTS AND PHILOSOPHIES OF TQM

4. CHAPTER THREE 5. CHAPTER FOUR 6. CHAPTER FIVE . CHAPTER SIX !. CHAPTER SEVEN

THE ACCEPTABILITY OF TQM THE ESSENTIALS OF TQM THE EFFECTS OF TQM IMPLEMENTATION OF TQM TQM TOOLS

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CHAPTER 2" COMPANY PROFILE

OR#ANI$ATION PROFILE
This chapter gives detailed information about the Industry Profile Pharmaceutical Industry, Organizational Profile rampus Pharmaceuticals and training needs in rampus Pharmaceuticals Organization

THE PHARMACEUTICAL INDUSTRY-#LOBAL VIEW ORI#INS AND EVOLUTION The modern pharmaceutical industry is a highly competitive non!assembled global industry" Its origins can be traced bac# to the nascent chemical industry of the late nineteenth century in the $pper %hine &alley near 'asel, ()itzerland )hen dyestuffs *|Page

)ere found to have antiseptic properties" + host of modern pharmaceutical companies all started out as %hine!based family dyestuff and chemical companies e"g" ,offman!-a %oche, (andoz, .iba! eigy /the product of a merger bet)een .iba and eigy0, 1ovartis etc" 2ost are still going strong today" Over time many of these chemical companies moved into the production of pharmaceuticals and other synthetic chemicals and they gradually evolved into global players" The introduction and success of penicillin and other innovative drugs in the early forties institutionalized research and development /%340 efforts in the industry" The industry e5panded rapidly in the si5ties, benefiting from ne) discoveries and a la5 regulatory environment" 4uring this period healthcare spending boomed as global economies prospered" The industry )itnessed ma6or developments in the seventies )ith the introduction of tighter regulatory controls, especially )ith the introduction of regulations governing the manufacture of 7generics8" The ne) regulations revo#ed permanent patents and established fi5ed periods on patent protection for branded products, a result of )hich the mar#et for 7branded generics8 emerged" #LOBAL SCENARIO The global pharmaceutical mar#et can be classified into t)o categories9 regulated and unregulated:semi regulated" The regulated mar#ets are governed by government regulations li#e intellectual property protection, including product patent recognition" +s a result, they have greater stability in both volumes and prices li#e the $nited (tates" The unregulated:semi!regulated mar#ets have lo)er entry barriers in terms of regulatory re;uirements and hence, they are highly competitive" The global pharmaceutical companies till 2<1< )ill be closely regulated by emerging issues li#e patent safety, side effects, adverse action reporting, strengthening harmonization and regulations and stronger clinical evidence" lobal pharmaceutical mar#et has increased its focus on novel drugs, good delivery system, and ne) chemical entities" The other factor )hich is driving the gro)th of global pharmaceutical mar#et is speeding up regulation in bio! generic segment" 2oreover there )ill be shift in gro)th from top ten mar#ets to emerging economies" The global pharmaceutical mar#et )ill change its shape from primary care driven to specialty care driven that is oncology and biotech" The global =|Page

pharmaceutical industry )ill ta#e a shape of virtually integrated pharmaceutical company" There is a )idening gap bet)een mature mar#et performance and emerging mar#et performance, )hich )ill re;uire many pharmaceutical companies all over the globe to ma#e changes throughout their operations from shifting their sales and mar#et, revising there strategies, changing there business models to fuel there gro)th"

>or the global pharmaceutical industry, 2<<? )ill be a year of softening gro)th and a )idening gap in performance bet)een the increasingly generalized and cost!constrained mature mar#ets, as )ell as the burgeoning 7pharmerging8 sectors )here demand is gro)ing and economies and access to healthcare are e5panding at record levels" 2ar#ing an important inflection point for the industry, for the first time the )orld8s seven #ey mar#ets /$(, @apan, $A, ermany, >rance, (pain and Italy0 )ill drive less than half of the industry8s gro)th in 2<<?, )hile the pharmerging mar#ets )ill contribute nearly a ;uarter of gro)th )orld)ide />igure 10" >urther divergence )ill be apparent bet)een primary care!driven and specialist!driven therapy areas, and bet)een therapy classes )ith ma6or unmet needs and innovations, and those dominated by generics"

RECORD LOW #ROWTH FOR THE US In the $(, pharmaceutical gro)th )ill slo) to =!BC in 2<1B, mar#ing an all!time lo) for this mar#et" This is due in part to a lessening of the volume gro)th generated by the 2edicare Part 4 prescription drug benefit" It also reflects the continued high level of genericisation in this mar#et )ith appro5imately D1B billion in branded products e5pected to lose patents in the 2<1B timeframe" The $( )ill also continue to feel the impact of heightened safety scrutiny, as the $( >4+ ac;uires more po)er, slo)ing the introduction of ne) medicines" B|Page

+ similar level of gro)th is anticipated in the top five European mar#ets />rance, ermany, $A, Italy and (pain0, as the industry faces significant generics e5posure and governments struggle to manage their aging populations and embrace ne) treatment innovations" Increasing therapeutic substitution can be e5pected in these mar#ets, along )ith an upturn in parallel trade, particularly )ith specialist!driven products" .ost!saving initiatives are li#ely to become more aggressive and )ill include price cuts, contracting and rebating, as )ell as the e5pansion of reference pricing schemes in ermany, Italy and (pain" &alue gro)th in these mar#ets )ill be limited to areas of unmet needs" In @apan, cost!containment drives including incentives for prescribing generics )ill also impact mar#et performance as the country embar#s on another year of national health insurance price cuts" 1ot)ithstanding this do)nturn, @apan remains in economic recovery and access to drugs continues to improve for its aging population" + rise in the level of ne) product launches is e5pected as the Pharmaceutical and 2edical 4evices +gency becomes fully staffed and focuses on accelerating approvals" This )ill be particularly noticeable in areas of unmet needs, such as oncology, )here approvals have already been granted for +vastin and Tarceva" ACCELERATIN# #ROWTH IN EMER#IN# MAR%ETS 'y contrast, much stronger gro)th of 12!1*C is e5pected in the seven pharmerging mar#ets of .hina, India, 'razil, %ussia, 2e5ico, Tur#ey and (outh Aorea, driving sales of D?B!F< billion in 2<1B" +lthough these mar#ets have their o)n uni;ue characteristics, common to each is a rising 4P and e5panding access to both generic and innovative ne) medicines as primary care improves and e5tends through rural areas, and private health insurance becomes more commonly available" .hina )ill be a particularly strong performer in 2<1B, reflecting the country8s booming economy and greater government involvement in healthcare policy" This involvement e5tends to annual price cuts, enforced generic prescribing and an anticorruption campaign that targets promotional activity, product approvals and manufacturing"

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Overall, the global pharmaceutical mar#et )ill gro) B!GC to over DH*B billion in 2<1B, do)n from G! HC in 2<12" Aey dynamics shaping this gro)th are the continued )ave of genericisation, e5panded use of innovative specialty products, increasing reliance on value!based medicine and higher levels of uncertainty around safety issues"

TOP TEN PHARMACEUTICAL COMPANIES WORLDWIDE BY TOTAL R&D EXPENDITURE >ourteen pharmaceutical companies featured in the top B< %34 spenders according to European .ommission research in 2<12, including * in the top ten9 Pfizer, @ohnson 3 @ohnson, and and +bbott" K Pharmaceutical companies ran#ed as the highest sector of %34 investment across the )orld8s top 1=<< companies, spending over LH< million euros" K Pfizer spent nearly $(DH"G billion on %34 globally, follo)ed by @ohnson 3 @ohnson /$(DH"1 billion0 and la5o(mithAline /$(DG"F billion0" K Of the top ten pharmaceutical companies, +mgen spent the largest proportion on %34 )ith e5penditure e;ualling over 2=C of total sales" la5o(mithAline" Other companies to feature )ere (anofiaventis, %oche, 1ovartis, 2erc#, +straIeneca, +mgen, 'ayer, Eli -illy, Jyeth

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THERAPEUTIC MAR%ET SE#MENTATION .ommencing )ith repac#aging and preparation of formulations from imported bul# drugs, the Indian industry has moved on to become a net foreign e5change earner, and has been able to underline its presence in the global pharmaceutical arena as one of the top *B drug producers )orld)ide" .urrently, there are more than 2,=<< registered pharmaceutical producers in India" There are 2=,<<< licensed pharmaceutical companies" Of the =GB bul# drugs used in India, appro5imately =2B are manufactured here" India has more drug!manufacturing facilities that have been approved by the $"(" >ood and 4rug +dministration than any country other than the $(" Indian generics companies supply ?=C of the +I4( drugs that 4octors )ithout 'orders uses to treat G<,<<< patients in more than *< countries" ,o)ever total pharmaceutical mar#et is as follo)s9

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It is very much evident from above figure that chronic therapy area / astro .ardiac, %espiratory, 1euro Psychiatry and +nt diabetics0 is dominating the mar#et in long run.

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INTRODUCTION" INDIAN PHARMACEUTICAL INDUSTRY Pharmaceutical Industry in India is one of the largest and most advanced among the developing countries" It is ran#ed =th in volume terms and 11th in value terms globally " It provides employment to millions and ensures that essential drugs at affordable prices are available to the vast population of India" Indian Pharmaceutical Industry has attained )ide ranging capabilities in the comple5 field of drug manufacture and technology" >rom simple pain #illers to sophisticated antibiotics and comple5 cardiac compounds, almost every type of drug is no) made indigenously" Indian Pharmaceutical Industry is playing a #ey role in promoting and sustaining development in the vital field of medicines" +round H<C of the countryMs demand for bul# drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and vaccines is met by Indian pharmaceutical industry" + number of Indian pharmaceutical companies adhere to highest ;uality standards and are approved by regulatory authorities in $(+ and $A" The Indian pharmaceutical industry traditionally relied on Nreverse engineeringO i"e" product copying, through )hich vast profits )ere made" In recent years, ho)ever, the larger domestic companies have realised the need to underta#e original research and : or penetrate into the regulated generics mar#ets in the $(+:E$ in order to survive in the global mar#et" +t the same time, the Indian pharmaceutical industry is reno)ned for supplying affordable generic versions of patented drugs for illnesses li#e ,I&:+I4( to some of the )orld8s poorest countries" (ome of the strategies that have been follo)ed by Indian pharmaceutical companies for their gro)th in the global mar#ets have been as follo)s9 1< | P a g e

eographic diversification )ith fe) companies focussing on increasing presence in the regulated mar#ets and others e5ploring the developing:under! developed mar#ets of the )orld" +s a part of diversification strategy, some of the companies have ac;uired brands, facilities and businesses overseas" (ome companies have even started their local mar#eting in foreign mar#ets" Partnerships for supply of bul# drugs and formulations )ith the generic companies as )ell as innovators" >or regulated mar#ets such as the $(, there are companies focussing on value added generics, niche segments or patent challenges in the $(" >ocus on offering research and manufacturing services on a contractual basis/.2Os and .%Os0

+part from these strategies Indian companies have to devise ne)er strategies continuously to survive in the highly competitive global mar#et in an industry that is characterised by ! high capital re;uirement, high technical re;uirement, high process s#ills, high value addition prospects, high e5port volumes, high mar#et sophistication" Indian companies are follo)ing the route of mergers and ac;uisitions to ma#e inroads in the foreign mar#ets" They need to consolidate further in different parts of the )orld to become trans!national players" Indian companies )ill have to rise above the statement of 2ichael Porter /1FF<0, that most multi!national firms are 6ust national firms )ith international operations" They shall certainly be at an advantage, as their strong national identities )ill give them a competitive advantage in the global mar#ets" INDUSTRY STRUCTURE The Pharmaceutical industry in India is fragmented )ith over *,<<< small:medium sized generic pharmaceutical manufacturers" It has over 2<,<<< units out of )hich *<< units are in the organized sectorP )hile others e5ist in the small scale:unorganised sector" The leading 2B< pharmaceutical companies control H<C of the mar#et )ith mar#et leader 11 | P a g e

holding nearly HC of the mar#et share" There are also B .entral Public (ector $nits that manufacture drugs" These companies are9 Indian 4rugs 3 Pharmaceuticals ,industan +ntibiotics -td" 'engal .hemical and Pharmaceuticals -td" 'engal Immunity -td" (mith (tanistreet Pharmaceuticals -td"

The Indian pharmaceutical industry consists of manufacturers of bul# drugs and formulations" 'ul# drugs include the active pharmaceutical ingredients /+PIs0 )hich are used for the manufacture of formulations" +ccording to estimates, the proportion of formulations and bul# drugs is in the order of HB92B" There are over G<,<<< formulations manufactured in India in more than G< therapeutic segments" 2ore than ?BC of the formulations produced in the country are sold in the domestic mar#et" India is largely self!sufficient in case of formulations, though some life saving, ne)!generation! technology!barrier formulations continue to be imported" The Indian pharmaceutical industry has the highest number of plants approved by the $( >ood and 4rug +dministration outside the $(" It also has the large number of 4rug 2aster >iles /42>s0 filed )hich gives it access to the high gro)th generic bul# drugs mar#et" The industry no) produces bul# drugs belonging to all ma6or therapeutic groups re;uiring complicated manufacturing processes and has also developed Ngood manufacturing practicesO / 2P0 compliant facilities for the production of different dosage forms" (etting up a plant is =<C cheaper in India compared to developed countries and the cost of bul# drug production is G<!H< percent less" The strength of the industry is in developing cost effective technologies in the shortest possible time for drug intermediates and bul# activities )ithout compromising on ;uality" In accordance )ith JTO stipulations, India grants product patent recognition to all 1e) .hemical Entities" TYPES OF DRU# SYSTEM IN INDIA

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+ncient civilization allo)ed India to develop various #inds of medical and pharmaceutical systems" In addition to the allopathic system, )hich is prevalent in the $nited (tates, @apan and Europe, the follo)ing types of medical and pharmaceutical systems are used by the Indian people9 A'()*+,-" +yurveda translates as the Nscience of lifeO" It encompasses fundamentals and philosophies about the )orld and life, diseases and medicines" The #no)ledge of +yurveda is compiled in .hara# (amhita and (ushruta (amhita" The curative treatment lies in drugs, diet and general mode of life" S.,,/-" The (iddha system is one of the oldest Indian systems of medicine" (iddha means NachievementO" (iddhas )ere saintly figures )ho achieved healing through the practice of yoga" The (iddha system does not loo# merely at a disease but ta#es into account a patient8s age, se5, race, habits, environment, diet , physiological constitution and so forth" (iddha medicines have been effective in curing some diseases, and further )or# is needed to truly understand )hy this system )or#s" U0-0." The $nani system originated in reece and progressed to India during the

medieval period" It involves promotion of positive health and prevention of disease" The system is based on the humoral theory i"e" the presence of blood, phlegm, yello) bile and blac# bile" + person8s temperament is accordingly e5pressed as sanguine, phlegmatic, choleric or melancholic" 4rugs derived from plant, metal, mineral and animal origins are used in this system" H12+13-4/'" ,omoeopathy is a branch of therapeutics that treats the patient on the principle of NSIMILIA SIMILIBUS CURENTUR5 )hich simply means 6L+4 7.8+9 :+ ;()+, :' 7.8+95" ,omeopathy see#s to stimulate the bodyMs defense mechanisms and processes so as to prevent or treat illness" Treatment involves giving very small doses of substances called remedies that, according to homeopathy, )ould produce the same or similar symptoms of illness in healthy people if they )ere given in larger doses" Treatment in homeopathy is individualized /tailored to each person0" ,omeopathic 1* | P a g e

practitioners select remedies according to a total picture of the patient, including not only symptoms but lifestyle, emotional and mental states, and other factors" Y1<- -0, N-4()13-4/'" Qoga and 1aturopathy are )ays of life" In naturopathy one applies simple la)s of nature" It advocates proper attention to eating and living habits" It also involves hydrotherapy, mud pac#s, baths, massage and so forth" Qoga consists of eight components9 restraint, observance of austerity, physical postures, breathing e5ercises, restraining of the sense organs, contemplation, meditation and (amadhi" Increasing interest e5ists in revisiting these ancient drug systems" INDUSTRY SE#MENTATION Indian pharmaceutical industry can be )idely classified into bul# drugs, formulations and contract research" 'ul# drugs are the Indian name for +ctive Pharmaceuticals Ingredients /+PI0" >ormulations cover both branded products and generics" Indian pharmaceutical sector is self sufficient in meeting domestic demand and e5ports successfully to various mar#ets globally" The e5istence of process patents in India till @anuary 2<<B fuelled the gro)th of domestic pharmaceutical companies and developed them in areas li#e organic synthesis and process engineering, as a result of )hich, Indian pharmaceuticals sector is able to meet almost FB percent of the country8s pharmaceutical needs" India is globally recognized as a lo) cost, high ;uality bul# drugs and formulations manufacturer and supplier" .ontract %esearch, a nascent industry in India has )itnessed commendable gro)th in the last fe) years" +s per Qes 'an# :OPPI report /2<<H!<?0, formulation segment /including domestic formulation and formulation e5ports0 constituted H2Cof the total pharmaceutical industry /in terms of sales0 )hile bul# drugs and contract research constituted 2BC and *C of pharmaceutical industry respectively"

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F.<" S+<2+04-=.9+ 9-7+9

BUL% DRU#S 'ul# drug industry is the bac#bone of the Indian pharmaceutical industry" ro)th of

Indian bul# drug industry in the last five decades has been impressive and highest among developing countries" >rom a mere processing industry, Indian bul# drug industry has evolved into sophisticated industry today, meeting global standards in production, technology and ;uality control" Today, India stands among the top five producers of bul# drugs in the )orld" The mar#et is fragmented )ith far too many players" +bout *<< organised companies are involved in the production of bul# drugs in India" Over H< percent of India8s bul# drug production is e5ported to more than B< countries and the balance is sold locally to other formulators" Indian bul# drug industry is mainly concentrated in the follo)ing regional belts ! 2umbai to +n#lesh)ar, ,yderabad to 2adras and .handigarh" +round, 1?<<< bul# drug manufacturers e5ist in India" (ome ma6or producers of bul# drugs in Indian pharmaceutical industry are %anba5y -aboratories, (un Pharma, .adila, Joc#hardt, +urobindo Pharma, .ipla, 4r" %eddy8s -aboratories, Orchid Pharmaceuticals 3 .hemicals, 1icholas Piramal, -upin, +risto Pharmaceuticals, etc" 2ost are involved in bul# as )ell as formulations )hile a fe) are solely into bul# drugs" 1B | P a g e

India is the )orld8s fifth largest producer of bul# drugs" The mar#et size is e5pected to gro) at higher percentages in future years )ith more and more international companies depending on India to meet their bul#!drug supply needs" 2oreover, India is )ay ahead of competitors in the total number of 4rug 2aster >ile /42>0 filings" Of the overall 42> filings to $( >4+, the portion of filings by Indian players has 6umped from around 1=C in 2<<< to =GC of total filings in 2<<?/ @anuary!@une0 This gro)th in proportion spea#s volumes about the ;uality standards follo)ed in Indian manufacturing facilities"

F.<" I0;)+-9.0< 9/-)+ 1> I0,.-0 ;123-0.+9 .0 DMF >.7.0<9 ?US FDA@ ?SOURCE" CRISINFACA YES BAN%B OPPI@ The gro)ing number of 42> filings signifies the increase in number of contracts that Indian players have garnered" Jhile India has recorded 1GH1 42> filings, .hina sho)s a tally of B2<, the second largest number of 42> filings after India" In 2<<? /@anuary! @une0, India8s 42> filings )ere around *"B times that of .hina !1?H from India vis!R!vis B1 from .hina" The bul# drug segment is a lo)!margin and volume!driven business" The thrust is on manufacturing" In manufacturing operation, efficiency through better process s#ills to 1G | P a g e

reduce both manufacturing time and cost is critical" -o) cost manufacturing is a distinct advantage gained by Indian companies over a period of time )ith a steep learning curve" 'ul# 4rugs e5ports have gro)n significantly in the past on account of gro)th in generic industry, increasing share of Indian companies in 42> filings and contract manufacturing opportunity" 'ul# drugs e5ports gre) robustly by 2?C .+ % bet)een 2<<1!<2 and 2<<H!<? to reach an estimated $(4="2 billion"

F.<. I0,.-C9 B(78 D)(< ED31)4 ?CRISINFACA YES BAN%B OPPI@ +s already e5plained, India has carved a niche for itself by being one of the largest bul# drug suppliers" India offers a number of distinctive advantages in the pharmaceutical industry, as illustrated in the figure belo)9

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F.<" A,*-04-<+ I0,.--API ?SOURCE" CRISINFACA YES BAN%B OPPI@ India has many local manufacturing e;uipment manufacturers" These e;uipments are of high ;uality and lo) cost, thus reducing the cost of capital" +ccording to industry estimates, Indian companies are able to reduce the upfront capital cost of setting up a pro6ect by as much as 2B!B<Cdue to locally manufactured e;uipment and high ;uality technology:engineering s#ills" .ompetition in the India8s domestic formulation mar#et has made it inevitable for +PI suppliers to continuously develop alternative production methods to improve yield or reduce costs" This ensures that India has a significant cost advantage due to process engineering" +part from availability of a high number of s#illed chemists, India also offers scientists )ith vast e5perience and unmatched s#ills" The scientific staff in India though e;uivalent or better ;ualified are also available at a fraction of the cost" This ma#es Indian research firms more competitive than many international firms )hile being cost competitive" -abour costs are also lo) in India, being almost 1:H th of that in many developed countries and offer an obvious cost advantage"

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FORMULATIONS >ormulations are broadly categorized into patented drugs and generic drugs" + patented drug is an innovative formulation that is patented for a period of time /usually 2< years0 from the date of its approval" + generic drug is a copy of an e5pired patented drug that is similar in dosage, safety, strength, method of consumption, performance and intended use" >ormulation Industry can be subdivided into t)o segments9 4omestic >ormulation Industry Indian >ormulation E5ports D12+94.; F1)2(7-4.10 I0,(94)' 'et)een 2<<2 and 2<<H, the domestic formulation industry gre) at a .+ % of 1=C from around $(4="* billion in 2<<2 to $(4 ?"= billion in 2<<H" 4emand in India is gro)ing mar#edly due to rising population, increasing per capita income, increasing access to medicine, especially in the rural areas and an increasing population of over si5ty years of age"

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F.<" #)1=4/ .0 ,12+94.; >1)2(7-4.10 .0,(94)' ?OPPIA OR#IMS@ ?SOURCE" CRISINFACA YES BAN%B OPPI Presently, the gro)th of a domestic pharmaceutical company is critically dependant on its therapeutic presence" In terms of end!use, the pharmaceutical industry is sub!divided into several therapeutic segments" These segments are broadly defined on the basis of therapeutic application" (ome of these segments are lo)!volume, high margin segments, )hile the others are high!volume )ith relatively lo) margins" The ne) lifestyle categories li#e .ardiac, %espiratory and &itamins are e5panding at double!digit gro)ing rates" The long term ailment, chronic therapies is no) accounting 2=C of the mar#et" The only gro)th driver for acute therapies is the ne) product introduction under this segment" Today, anti!infective )hich used to be the single largest therapeutic segment in Indian pharmaceutical industry is increasing" +nti!infective segment is no) 1 st in terms of value contribution follo)ed by astrointestinal and .ardiac" The #ey therapeutic segments include9 +nti!infective .ardio vascular .entral nervous system drugs 2< | P a g e

+nti!infective is currently the largest therapeutic segment in India" It accounts for one! fifth of total mar#et turnover" 1e5t in line, and accounting for one!tenth each, are cardio! vascular preparations, cold remedies, pain #illers and respiratory solutions"

F.<. T/+)-3+(4.; =.9+ ,.94).:(4.10 ?OR#IMS@ ?SOURCE" CRISINFACA YES BAN%B OPPI@ INDIAN FORMULATION EXPORTS Indian formulation e5ports gre) at a .+ % of 2*"2C touching around $(4 = billion in 2<<H!<?" The gro)th has been spurred mainly due to the focus on regulated mar#ets by most Indian companies, thereby increasing revenues"

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F.<" I0,.-0 F1)2(7-4.10 ED31)49 /(O$%.E9 .%I(I1>+., QE( '+1A: OPPI0 CONTRACT RESEARCH AND MANUFACTURIN#9 Increasing costs of %34, coupled )ith lo) productivity and poor bottom lines, have forced ma6or pharmaceutical companies )orld)ide to outsource part of their research and manufacturing activities to lo)!cost countries, thereby saving costs and time in the process" The global pharmaceutical outsourcing mar#et )as )orth $(4BH"2 billion in 2<<H" It is e5pected to gro) at a .+ % of 1<C to reach $(4HG billion by 2<1<" lobal mar#et for .ontract %esearch and 2anufacturing (ervices /.%+2(0 in 2<<H is estimated to be $(4BB"=? billion" Out of the total global .%+2( mar#et, contract research )as $(41G"B? billion, gro)ing at a .+ % of 1*"?C and contract manufacturing )as $(4*?"?F billion accounting for the ma6or share /appro5imately G?C0 of the total global pharmaceutical outsourcing mar#et" India, )ith more than ?< $( >4+!approved manufacturing facilities, is one of the most preferred locations for outsourcing manufacturing services in India by the multinationals and global pharmaceutical companies" The Indian pharmaceutical outsourcing mar#et )as valued at $(41"2Hm in 2<<H and is e5pected to reach $(4*"** billion by 2<1<,

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gro)ing at a .+ % of *H"GC" The Indian .%+2( mar#et stood at $(41"21 billion in 2<<H, and is estimated to reach $(4*"1G billion by 2<1<" India holds the lionMs share of the )orldMs contract research business as activity in the pharmaceutical mar#et continues to e5plode in this region" Over 1B prominent contract research organisations /.%Os0 are no) operating in India attracted by her ability to offer efficient %34 on a lo)!cost basis" Thirty five per cent of business is in the field of ne) drug discovery and the rest GB per cent of business is in the clinical trials arena" India offers a huge cost advantage in the clinical trials domain compared to Jestern countries" The cost of hiring a chemist in India is one!fifth of the cost of hiring a chemist in the Jest" DOMESTIC #ROWTH DRIVERS" Pharmaceutical sector is one of the most globalized sectors among the Indian industries" The do)nside is pharmaceutical sector traditionally has been immune to business cycles" The upside of Indian pharmaceutical sector, ho)ever, is influenced by a mi5 of global and local factors" lobal factors are important as most Indian companies ship a ma6or portion of their production to overseas mar#ets" +lso, multinationals operating in the Indian mar#et follo)s the central research and global mar#eting model" Their actions are largely dictated by global trends although local issues are given due importance" The domestic mar#et is critical for both Indian companies and multinationals" >or Indian companies, the domestic mar#et lends stability to bottom line and offer means to cope )ith fluctuations in global demand" The gro)th drivers for Indian pharmaceutical mar#et are9 #)1=.0< P13(7-4.10 -0, I23)1*.0< I0;12+9" ,ousehold incomes are rising in IndiaP the proportion of middleclass in Indian population is also increasing" (tatistics sho) a clear migration of population to)ards middle and upper classes" %ise in income levels is al)ays accompanied by greater demand for medical facilities and pharmaceutical products" 2iddle class is already H< million strong 2* | P a g e

and is e5pected to gro) even fast, accounting for a higher share of total population" Increase in living standards )ill lead to longer life e5pectance and higher consumption of drugs and health care services" C/-0<.0< 7.>+94'7+9" %ising incomes and improving literacy rates are leading to change in lifestyles" Jhile incomes provide the means to access medical facilities and products, improving literacy boost a)areness about diseases and lead to higher consumption of drugs" .hanging lifestyles, ho)ever, is leading to a change in disease profile especially in urban areas" ,ectic lifestyles and high cholesterol diets are resulting gro)ing incidence of diseases such as cardio vascular diseases and cancer" R+9+-);/ -0, D+*+7132+04" The %34 efforts of Indian companies have been largely focussed on chemical synthesis of molecules and their cost effective production thereof" India has a large pool of technical and scientific personnel )ith good English language s#ills" Indian scientists have developed a high degree of chemical synthesis s#ills )hile engineers have developed competencies in producing molecules cost effectively" These s#ills have helped Indian companies tap generic mar#ets abroad successfully in the past and )ill continue to do so" H+-74/;-)+ ED3+0,.4()+" Indian healthcare system is largely run by the govt )ith private sector playing a small, but important part" The healthcare system in India comprises government hospitals in cities and to)ns and a net)or# of health centres in rural areas" This is supplemented by a string of private hospitals and clinics in largely urban areas" The public e5penditure on health has been gro)ing at a decent rate )hile private e5penditure has been recording marginal gro)th" I09()-0;+ S+;41) <.*.0< - L.>4" Indian insurance sector has been thro)n open to private sector" -arge sections of Indian population are not covered by health 2= | P a g e

insurance schemes" .urrently, less than 1<C of the Indian population is covered by some form of health insurance"

DOMESTIC EXPORTS Pharmaceutical e5ports touched a level of %s" 2=F=2 crores during 2<<G!<H" E5ports constitute a substantial part of the total production of pharmaceuticals in India" YEAR 1EE!-1EEE 1EEE-2FFF 2FFF-2FF1 2FF1-2FF2 2FF2-2FF3 2FF3-2FF4 2FF4-2FF5 2FF5-2FF6 2FF6-2FF EXPORT /%s" in .rores0 6256.F6 23F.16 ! 5 .4 E 51.2F 12!26.1F 15213.24 1 !5 .!F 225 !.E! 24E42.FF

/(ource9!4irectorate eneral of .ommercial Intelligence and (tatistics ! 4 .I(, Aol#ata0 The formulations contribute nearly BBC of the total e5ports and the rest =BC comes from bul# drugs" Pharmaceutical e5ports cloc#ed DH"2 billion in 2<<H!<?, accounting for si5 per cent of the country8s total e5ports, according to Pharme5cil, the Pharmaceutical E5port Promotional .ouncil" CRITICAL SUCCESS FACTORS The rules of pharmaceutical business are changing" Indian pharmaceutical companies can no longer get a)ay )ith plundering intellectual properties of multinational 2B | P a g e

companies" Pharmaceutical business has become a ne) ballgame altogether after the introduction of product patents in @anuary 2<<B"

?-@ NEW PRODUCT DEVELOPMENT P)+ 2FF5" 1e) product development efforts of Indian pharmaceutical companies in process patents era )ere limited to reverse engineering molecules discovered by other companies" Than#s to absence of product patents, Indian companies did not have to go through long )inded drug development process" 1or did Indian companies have to e5pend any effort on research focus" Indian companies simply zeroed in on bloc#buster drugs and tried to come up )ith an alternative process as fast as they could" The focus of the Indian companies )as to launch a copy of a bloc#buster drug ahead of their rivals in India and abroad" Aey areas to focus on %34 for Indian companies9 1" Potential product identification .omple5 +PI .omple5 finished product .ommercial potential of products Out!licensing opportunity to 21.s

2" 1ovel 4rug 4elivery (ystem /144(0 *" 1e) 4rug 4evelopment P194 2FF5" + large number of drugs are going Noff patentO in the ne5t fe) years" +ccording to I2, ,ealth, more than DG< billion )orth of drugs are going Noff patentO by 2<11" Thus, Indian companies )ill not be short of ne) products for at least another t)o years" In the long run, ho)ever Indian companies may find it hard to ma#e money from drugs coming off patent" +lready competition in generic mar#et is intense and 2G | P a g e

li#ely to increase further in the future" ,ence, ne) molecules rather than generics )ill drive revenues and profits in the product patents area" Indian companies need to discover ne) drugs either through their o)n efforts or research alliances" Perhaps licensing deals )ith multinationals could also provide Indian companies access to ne) drugs" >ocus on basic research )ill come )ith its o)n issues" Indian companies )ill have to ac;uire the s#ills of identifying research areas that offer e5cellent revenue and profit potential" This )ill entail a closer trac#ing of disease profiles and related therapies as )ell as #eeping a close tab on the research programmes of rivals" 'esides, Indian companies )ill have to pay more attention to economics of drug development process" + product patent is granted for a period of 2< years ?:@ THERAPEUTIC COVERA#E P)+-2FF5" In the absence of product patents, Indian pharmaceutical companies did not feel the need to focus on specific therapeutic areas" 2ost Indian pharmaceutical companies esche)ed narro) focus and tried to cover as many therapeutic areas as possible" 1o) the product portfolio of many Indian companies has considerable breadth and depth" iven the price controls in the mar#et, diversification )or#ed to the advantage of companies in the domestic mar#ets" In the e5port mar#ets, a )ider product portfolio gave companies the option of pic#ing and choosing from an array of opportunities" P194 2FF5" Opinion is divided over the therapeutic strategy that Indian companies should pursue in product patent era" (ome companies believe that focus on select therapeutic segment )ill fetch them greater dividends in terms of ne) chemical entities and mar#et share" Other companies believe such a strategy is ris#y given the size of Indian companies and that a big setbac# in research could sin# the company" Instead such companies are pursuing a de!ris#ing strategy of building a )ide product portfolio" In the domestic mar#et, such a strategy )ill result in economies of scale at production and mar#eting stage, putting the company in a better place to )eather competition from multinationals" In the e5port mar#ets even after the introduction of product patents, products under patent protection )ill comprise only 1B percent of the mar#et" (o a vast 2H | P a g e

chun# of the mar#et )ill be still open for competition although margins )ill be )afer thin" EXPORTS P)+-2FF5" 2ost Indian companies focused on e5ports" E5ports improve the valuation of companies o)ing to higher margin in overseas mar#ets" Indian companies built fortunes by ma#ing cheaper versions of bloc#buster drugs and selling them in domestic and e5port mar#ets" Indian companies built especially strong position in manufacture of bul# drugs" Out of the total e5ports, formulations constituted BB percent and bul# drugs constituted =B percent" (uccess in e5port mar#et allo)ed some Indian companies to build a strong position in the domestic mar#et organically and through ac;uisitions of brands and companies" P194 2FF5" E5ports has continued to be a priority for Indian companies" 2a6or bloc#buster drugs )ill come off patent in the near future, creating a big generic opportunity for Indian companies" +lso, a gro)ing demand for anti!+I4( drugs in +frica )ill #eep Indian companies busy" E5ports have and )ill continue to provide Indian companies )ith the strength to )ithstand the onslaught of multinationals in the domestic mar#et" ?,@ LOW COST PRODUCTION THROU#H SCALE P)+-2FF5" Indian pharmaceutical companies have mastered the science of producing drugs cheaply" Than#s to benign patents regime, Indian companies have developed a high level of chemical synthesis s#ills" The absence of development costs together )ith efficient production has enabled Indian companies to establish a solid position in bul# drug manufacturing" 'ut scale did not receive as much importance as it should have, because the cost of Indian pharmaceutical companies )as already lo) o)ing to aforesaid reasons" 2any Indian companies did not find the return on investment of )orld class plants compelling enough" P194 2FF5" 'y 2<11, drugs )orth DG< billion )ill come off patent, presenting a huge generic opportunity to Indian companies" 'ut the competition in the generic mar#et )ill be brutal, resulting in thin margins" The cost of production )ill hold the #ey to success 2? | P a g e

in the generic mar#et" The production cost in turn depends on scale" Indian pharmaceutical companies need to build global scale to stand a chance in the generics mar#et" PHARMACEUTICAL RE#ULATORY BODIES IN INDIA N-4.10-7 P/-)2-;+(4.;-7 P).;.0< A(4/1).4' ?NPPA@ 1PP+ is an organization of the overnment of India )hich )as established, to

fi5: revise the prices of controlled bul# drugs and formulations and to enforce prices and availability of the medicines in the country, under the 4rugs /Prices .ontrol0 Order, 1FFB" The organization is also entrusted )ith the tas# of recovering amounts overcharged by manufacturers for the controlled drugs from the consumers" It also monitors the prices of decontrolled drugs in order to #eep them at reasonable levels" C+04)-7 D)(<9 S4-0,-), -0, C104)17 O)<-0.G-4.10 ?CDSCO@ ! .4(.O lays do)n standards and regulatory measures of drugs, cosmetics, diagnostics and devices in the country" It regulates clinical trials and mar#et authorization of ne) drugs" It also publishes the Indian Pharmacopeia" The main functions of the .entral 4rug (tandard .ontrol Organization /.4(.O0 include control of the ;uality of drugs imported into the country, co!ordination of the activities of the (tate:$T drug control authorities, approval of ne) drugs proposed to be imported or manufactured in the country, laying do)n of regulatory measures and standards of drugs and acting as the .entral -icensing +pproving +uthority in respect of )hole human blood, blood products, large volume parenterals , sera and vaccines" The .4(.O functions from = zonal offices, * sub!zonal offices besides H port offices" The four .entral 4rug -aboratories carry out tests of samples of specific classes of drugs"

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D+3-)42+04 1> C/+2.;-79 & P+4)1;/+2.;-79 ?DCP@ 4.P is responsible for the policy, planning, development, and regulation of the chemical, petrochemical, and pharmaceutical industries in India" This department aims9 To provide impartial and prompt services to the public in matters relating to chemical, pharmaceutical and petrochemical industriesP To ta#e steps to speedily redressal of grievances receivedP To formulate policies and initiate consultations )ith Industry associations and to amend them )henever re;uired"

INDUSTRY PROFILE

The pharmaceutical industry in India is among the most highly organized sectors" This industry plays an important role in promoting and sustaining development in the field of global medicine" 4ue to the presence of lo) cost manufacturing facilities, educated and s#illed manpo)er and cheap labor force among others, the industry is set to scale ne) heights in the fields of production, development, manufacturing and research" In 2<12 the domestic pharma mar#et in India )as e5pected to be $(D 1B"HG

*< | P a g e

billion and this is li#ely to increase at a compound annual gro)th rate of F"F per cent until 2<12 and subse;uently at F"B per cent till the year 2<1B" I0,(94)' T)+0,9 The Pharma industry generally gro)s at about 1"B!1"G times the 4omestic Product gro)th lobally, India ran#s third in terms of manufacturing pharma products by volume The Indian pharmaceutical industry is e5pected to gro) at a rate of F"F C till 2<12 and after that F"B C till 2<1B In 2<11!12, India e5ported drugs )orth $(D12"2 billion in to the $( and Europe follo)ed by .entral and Eastern Europe, +frica and -atin +merica The Indian vaccine mar#et )hich )as )orth $(DFGB million in 2<11!12 is gro)ing at a rate of more than 2<C The retail pharmaceutical mar#et in India is e5pected to cross $(D 1*!1B billion by 2<1* C/-77+0<+9 Every industry has its o)n sets of advantages and disadvantages under )hich they have to )or#P the pharmaceutical industry is no e5ception to this" (ome of the challenges the industry faces are9

ross

%egulatory obstacles -ac# of proper infrastructure -ac# of ;ualified professionals E5pensive research e;uipments -ac# of academic collaboration $nderdeveloped molecular discovery program 4ivide bet)een the industry and study curriculum

#1*+)02+04 I0.4.-4.*+9

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The government of India has underta#en several including policy initiatives and ta5 brea#s for the gro)th of the pharmaceutical business in India" (ome of the measures adopted are9 Pharmaceutical units are eligible for )eighted ta5 reduction at 1B<C for the research and development e5penditure obtained" T)o ne) schemes namely, 1e) 2illennium Indian Technology -eadership Initiative and the 4rugs and Pharmaceuticals %esearch Program have been launched by the overnment" The overnment is contemplating the creation of (%& or special purpose

vehicles )ith an insurance cover to be used for funding ne) drug research The 4epartment of Pharmaceuticals is mulling the creation of drug research facilities )hich can be used by private companies for research )or# on rent

P/-)2- ED31)4 In the recent years, despite the slo)do)n )itnessed in the global economy, e5ports from the pharmaceutical industry in India have sho)n good buoyancy in gro)th" E5port has become an important driving force for gro)th in this industry )ith more than B< C revenue coming from the overseas mar#ets" >or the financial year 2<12!1* the e5port of drugs is estimated to be D1G"2B billion as per the Pharmaceutical E5port .ouncil of India, )hich is an organization, set up by the overnment of India" + survey underta#en by >I..I, the oldest industry chamber in India has predicted 1GC gro)th in the e5port of IndiaMs pharmaceutical gro)th during 2<12!2<1*" %+' 37-'+)9 .0 I0,.-0 P/-)2-;+(4.;-7 I0,(94)'

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There are several national and international pharmaceutical companies that operate in India" 2ost of the countryMs re;uirements for pharmaceutical products are met by these companies" (ome of them are briefly described belo)9 R-0:-D' L-:1)-41).+9 L.2.4+, is the biggest pharmaceutical manufacturing company in India" The company is ran#ed at the ?th position among the global generic pharmaceutical companies and has presence in =? countries including )orld class manufacturing facilities in 1< countries and serves to customers from over 12B countries" D). R+,,'H9 L-:1)-41).+9 manufactures and mar#ets a )ide range of pharmaceuticals both in India and abroad" The company has G< active pharmaceutical ingredients to manufacture drugs, critical care products, diagnostic #its and biotechnology products" C.37- is an Indian pharmaceutical company reno)ned for the manufacture of lo) cost anti +I4( drugs" The companyMs product range comprises of anthelmintics, oncology, anti!bacterial, cardiovascular drugs, antibiotics, nutritional supplements, anti!ulcerants, anti!asthmatics and corticosteroids" .ipla also offers other services li#e ;uality control, engineering, pro6ect appraisal, plant supply, consulting, commissioning and #no)!ho) transfer, support" N.;/17-9 P.)-2-7 is the second largest pharmaceutical healthcare company in India" The brands manufactured by the company include ardenal, Ismo, (temetil, %e6oint, (upradyn, Phensedyl and ,aemaccel" 1icholas Piramal has entered into 6oin ventures and alliances )ith several international corporations li#e .heissi, ItalyP I&+S .orpP $A, >" ,offmann!-a %oche -td", +llergen Inc", $(+ etc" #7-D1 S2.4/87.0+ ?#S%@ is a $nited Aingdom based pharma companyP it is the )orldMs second largest pharmaceutical company" The companyMs portfolio of ** | P a g e

pharma products consist of central nervous system, respiratory, oncology, vaccines, anti!invectives and gastro!intestinal:metabolic products among others" C-,.7- P/-)2-;+(4.;-79 L4," is one of the largest privately held pharmaceutical companies in India, head;uartered at +hmedabad, in the state of u6arat" Over the last five decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in over B< countries around the )orld" +n integrated healthcare solutions provider )ith pharmaceutical product bas#et, it caters to over =B therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti!infectives and antibiotics, respiratory agents, antidiabetics and immunologicals" The company focuses on providing high ;uality, appropriately priced products to its customers and supports all these )ith dedicated customer service" .adila Pharmaceuticals has a multicultural, multilingual and multinational )or#force of more than four thousand employees including over t)o hundred people outside India in forty!nine countries of +frica, .I(, @apan and $(+"

I0,.-H9 D12+94.; P/-)2-;+(4.;-7 M-)8+4 ?12 M104/9 E0,+, I-0(-)' 2F13@ C123-0' Total Pharma 2ar#et .ipla %anba5y la5o (mith#line Piramal ,ealthcare .adila S.G+ ?J B.77.10@ G"F "*G "*= "2F "2H "2= M-)8+4 S/-)+ ?K@ 1<<"< B"* B"< ="* *"F *"G #)1=4/ R-4+ ?K@ F"F 1*"= 11"B !1"2 11"H G"?

#RAMPUS PHARMACEUTICALS Established in the year 1FF=, at @asmeet 1agar, +mbala ! 1*=<<*, ,aryana, India, 6 rampus PharmaceuticalsO are one of the prominent manufacturer and suppliers *= | P a g e

of a )ide range of Pharmaceutical 4rugs. Our portfolio of products includes A04.:.14.;9BI0>(9.10 ?P-)+04+)-7@A A04.-M-7-).-7BA04/+72.04.;9A A04.--77+)<.;BA04.-94/2-4.;9A C-),.-;BD.-:+4.;A A04.-.0>7-22-41)' D)(<9A E0+)<' S(337+2+049A O.042+049 and many other medicines for treating different health disorders" These are formulated by using the finest ;uality of ingredients that are procured from authentic vendors of the mar#et" +cclaimed for their effective and fast results, these are recommended by many reno)ned physicians and medicos" To carry for)ard our business process efficiently and competently, )e have developed an outstanding manufacturing facility that is installed )ith the latest machines and e;uipment" The entire formulation is done as per the J,O! 2P certified norms under the guidance of e5perts, thus leaving no room for ;uality degradation" 'eing a customer centric organization, )e deliver our consignments )ithin the stipulated time frame" $nder the support and guidance of our mentor, M). P-=-0 %(2-) M-.0., )e have become a reno)ned organization in this domain" ,is e5ceptional management s#ills and sound mar#eting strategies have helped us to earn a substantial mar#et share in a very limited time span" O() P)1,(;49 + professionally managed organization, )e are engaged in the formulation of a range of Pharmaceutical 4rugs for treating different health disorders" These are formulated by using ;uality approved ingredients that are sourced from reliable vendors of the industry" Processed under the supervision of e5perts, our drugs play an instrumental role in improvising the human life and help in eradicating ailments, thereby, assuring better and healthier life" O() )-0<+ +0;123-99+9 +ntibiotics:infusion/parenteral0 medicines +nti!malarial:anthelmintics medicines +nti!allergic:anti!asthmatics drugs +nti!inflammatory drugs &itamin Protein +nti flatulent drugs +ardiac:diabetic medicines +nalgesic: antispasmodic drugs 2inerals 1utritional supplements +nti ulcer and anti emetics drugs *B | P a g e

Eye:ear drops Ointments Perfect compositions Pure content Efficacious -ong lasting shelf life Iero side effects Infrastructure

1asal drops Pediatrics drugs, and other drugs

T/+9+ -)+ =.,+7' ,+2-0,+, 1=.0< 41 4/+ >1771=.0< >+-4()+99

Je are bac#ed by a sophisticated manufacturing facility that is furnished )ith ultra modern machines and e;uipment" (pread over a vast area, it is segregated into various independent sections li#e manufacturing, ;uality testing, %34, pac#aging and )arehousing facility to conduct a hassle free production process" Each division is e;uipped )ith the re;uisite facilities and is managed by e5perienced professionals" Quality Assurance 'eing a ;uality driven organization, )e maintain strict control over all processes of procurement, processing, pac#aging, storage and transport" Je process our range of Pharmaceutical 4rugs using supreme ;uality ingredients, )hich are sourced from authentic vendors of the mar#et" Every tas# is e5ecuted as per standardised ;uality norms, thus leaving no room for ;uality degradation" To ensure that our entire gamut meets the )ell defined industry standards, our e5perts conduct a series of testing procedures on )ell!defined ;uality parameters such as9 Iero side effects .omposition of the ingredients -onger shelf life Precise p, value Effectiveness ,ygiene ;uotient *G | P a g e

Research and Development 'eing a ;uality driven organization, )e lay great emphasis on research activities" Therefore, )e have developed an advanced research division that is installed )ith all re;uisite facilities" It is managed by e5perienced professionals, )ho #eep a tab on the current medical researches, emerging diseases and other allied disciplines and inform the same to the management" They also conduct e5tensive mar#et surveys regarding the performance of our offered range" These professionals are also responsible for updating our manufacturing facilities as per technological advancements" W-)+/1(9.0< -0, P-;8-<.0< Je #no) the perishable nature of our productsP therefore, )e have al)ays laid strong emphasis in preservation and appropriate storage of the products that )e process" >or this, )e have developed a modern )arehousing unit that spreads over a vast area" It is installed )ith all re;uisite facilities and is )ell!protected against any hindrances" (alient features of this unit9 .ontrolled temperature Jell lit 2anaged by efficient personnel

>or pac#aging our entire assortment, )e use pharmaceutical grade pac#aging material for pac#aging these drugs" Why Us? Je have emerged as a leading organization in our domain o)ing to the follo)ing factors9 Tuality formulations Effective ;uality control measures Jide mar#et reach .ompetitive prices Timely delivery

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Products & Services Je are one of the leading 2-0(>-;4()+) -0, 9(337.+) of a )ide range of P/-)2-;+(4.;-7 D)(<9 that includes medicines such as ;-39(7+9A 4-:7+49A 1.042+049A 7.L(., 9')(39 -0, .0M+;4.109 such as anti allergic medicines, antibiotics medicines, cardiac medicines, antacids medicines and many more" These are formulated under the supervision of the e5pert professionals )ho uses premium ;uality components in the formulation process" C-39(7+9 Je are involved in offering a )ide range of C-39(7+9 that are formulated using high ;uality components and advance processing machines" Our range includes %+2+->1)4+A R-:.8.0-DSR and %+0*.4-$#. These capsules are developed under the able guidance of team of e5perts, )ho have in depth #no)ledge about the formulation of the pharmaceutical capsules as per medical standards"

I0M+;4.10 Je are one of the leading manufacturers and suppliers of a )ide range of In6ections, )hich are used against severe viral infections" These products are specially formulated )ith utmost care )ith the right compounds under the hygienic and advanced technology laboratory" Jith stringent monitoring in all the stages, these products have the right composition to provide instant relief from viral infections )ithout causing any side effects" Our available range of products includes %.0,+;-25A %.0,+;-5FA B10+-D3 and many more"

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S(93+09.10 Je are one of the leading manufacturers and suppliers of a varied range of (uspension, )hich is )idely used to fight against various viral infections" These products are specially processed )ith the most advanced technologies using optimum ;uality ra) materials procured from the trusted and certified vendors" Jith their rich e5perience and #no)ledge, )e are able to provide these products )hich are highly effective )ithout any side effects" (ome of our available range of products includes S(;)-9.7A S(;)-9.7-1A D109. and %+>71D-NT.

S')(3 Je are one of the reputed organizations engaged in manufacturing and supplying of a varied range of S')(3 in the mar#et" These products are formulated under hygienic laboratories by our scientists using right compounds for accurate composition" Our available products are highly effective and provide instant relief from severe viral infections )ithout any side effects to the patient" Our available range of products includes P.;1=.0A D.9-QA C17.8., and many more"

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T ! "R#WT

S$!%ARI#

The Industry is a largely fragmented and highly competitive )ith a large number of players having interest in it" I0,.-0 ;104)-;4 )+9+-);/ .0,(94)' <)1=.0< -4 4F-5F 3+) ;+04 The Indian contract research Industry has gro)n tremendously over the past fe) years" It has )itnessed the emergence of several .%Os in the area of drug discovery 3 development over the last decade" I0,.- 41 ;-34()+ USJ 35F-4FF 2.77.10 1) 1F 3+) ;+04 1> <71:-7 ;7.0.;-7 4).-79 :' 2F13. India is emerging as a favored global destination for global drug development companies" %ecent changes in India8s healthcare policies and a maturing regulatory environment have significantly brought do)n the ris# of shifting more clinical research from the developed countries to India" The clinical research industry in India is presently estimated at over $(D 1<< million. N+= 3)1,(;4 7-(0;/+9 (0,+)7.+ 2-)8+4 <)1=4/ The mar#et has been gro)ing bet)een G!? per cent over the last t)o years, primarily driven by ne) launches and to some e5tent by volumes" In the last t)o years, more than *,F<< ne) products /largely branded generics0 have been launched in India, contributing about $(D *BB"G million /million0 )orth of mar#et value" Jhile the Indian pharma ma6ors launched more than ten products per year, global 21.s averaged one or t)o annually"

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DEPARTMENTS" The main departments of rampus Pharmaceuticals, India are e5plained belo) 1. PROIECT DEPARTMENT The primary responsibility of the Pro6ect department is to install ne) manufacturing process plants and machinery at the location specified" The function of Pro6ect department ends only )hen they hand over the commissioned assembly to manufacturing department In other )ords pro6ects acts as the internal supplier for manufacturing department" 2. MAR%ETIN# DEPARTMENT The 2ar#eting department of rampus Pharmaceuticals is divided into sub!

divisions, each )ith specific ob6ectives, )or#ing to)ards a common goal" Jhile (ales concentrates on bringing in the customers, .%2 2ar#eting functions to)ards catering their needs and so on" A :).+> *.+= 10 *-).1(9 9(: ,.*.9.109 1> 2-)8+4.0< .9 -9 >1771=9" SALES B BUSINESS DEVELOPMENT The (ales or the 'usiness 4evelopment arm of the rampus Pharmaceuticals

concentrates on bringing in .ustomers to the organization" The initial function of the sales department is .ollecting database of all prospects and to find their needs" The needs of these prospective customers are analyzed" On ac;uiring an appointment, a (ales Presentation follo)s )here the various features and benefits of the product )ere e5plained to the customer" The sales presentation is generally tuned according to the needs of the prospects and the duration of appointment" In other )ords, (ales

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department identifies the suspects /by the database0 and converts them to prospects /by convincing them about the product0 and then to customers /by ac;uiring the order0" CUSTOMER RELATIONSHIP MANA#EMENT The primary responsibility of the .%2 department is to have a constant relationship )ith the customers, understand their needs and act as a connecting bridge bet)een them and organisation" The primary responsibility of .%2 2ar#eting is to act as the .ustomer8s representative to the Organisation and vice!versa till the Jind Turbine enerator is commissioned" 3. FINANCE DEPARTMENT >inance 4epartment is responsible in managing the finance in the Organization optimally and to raise funds as re;uired" 4uties and functions >inancial reports monthly, half!yearly and annuals actuals estimates and budgets" (tatutory financial and legal returns" +nalysis of pro6ect cost )ith estimates and sales calculation" >und management to ensure financial are #ept to the minimum" .oordination )ith ban#ers, auditors and la)yers" Overseeing the IT 3 ,%4 functions of rampus Pharmaceuticals" Installaton of 'OT pro6ect in rampus Pharmaceuticals for Indian operations" (ales ta5 3 service ta5 Physical cash count chec#s .hennai and Pondicherry" Passing of 6ournal vouchers" .hec#ing and passing pro6ect costing information" 2iscellaneous

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4. HUMAN RESOURCE DEPARTMENT M.99.10 1> HR ,+3-)42+04& T1 +*17*+ HR 3)-;4.;+9 4/-4 +09()+ ;123+4+0;+ -0, +2371'++ 9-4.9>-;4.10. 4uties (alary administration 2aintenance of statutory compliance 2aintenance of employees details eneral administration li#e )or#men compensation, P>, health, travel shield policy, plant and

2aintenance of insurance for all company vehicles, and all other insurance machinery etc e5cept insurance related to )ind mills" THE ROLES OF HR PERSONNEL ARE" To collaborate )ith the senior management to formulate effective human resource strategies, policies and programs to support the Organization8s goals and ob6ectives, improve the effectiveness of management processes and address employees needs" To provide the functional:divisional heads )ith the information, tools, systems and support services that enable them to effectively manage and develop their human resources to achieve departmental goals To ma#e available to employees information, tools, systems and support services that enable them to progress their careers in alignment )ith the goals of the Organization" =* | P a g e

THE HR FUNCTION IS MANA#ED THROU#H THE FOLLOWIN# %EY PROCESSES

HUMAN RESOURCE PLANNIN# SEPARATION RECRUITMENT

HRD
PERFORMANCE MANA#EMENT INDUCTION

TRAININ# & DEVELOPEMENT

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INTRODUCTION
1" D+>.0+ T14-7 Q(-7.4'N =B | P a g e

TT2 is an enhancement to the traditional )ay of doing business" It is the art of managing the )hole to achieve e5cellence" It is defined both a philosophy and a set of guiding principles that represent the foundation of a continuously improving organization" It is the application of ;uantitative methods and human resources to improve all the processes )ithin an organization and e5ceed customer needs no) and in the future" It integrates fundamental management techni;ues, e5isting improvement efforts, and technical tools under a disciplined approach" 2" D+>.0+ Q(-7.4'N Tuality U Performance 5 E5pectations *" W/-4 -)+ 4/+ D.2+09.109 1> Q(-7.4'N K >eatures K .onformance K %eliability K 4urability K (ervice K %esponse K +esthetics K %eputation =" #.*+ 4/+ B-9.; C10;+349 1> TQMN K + committed and involved management to provide long!term top!to!bottom organizational support" K +n un)avering focuses on the customer, both internally and e5ternally" K Effective involvement and utilization of the entire )or# force" =G | P a g e

K .ontinuous improvement of the business and production process" K Treating suppliers as partners" K Establish performance measures for the processes" B" #.*+ 4/+ P).0;.37+9 1> TQMN V .onstancy of purpose9 short range and long range ob6ectives aligned V Identify the customer/s0P .ustomer orientation V Identification of internal and e5ternal customers V .ontinuous improvement V Jor#flo) as customer transactions V Empo)er front!line )or#er as leader V Tuality is everybody8s business V >or a service industry, some elements of ;uality are9 ! empathy ! trustP i"e" e5pertise, integrity, courtesy ! responsiveness ! tangible product attractiveness /curb appeal0 ! reliability, on time, no interruptions K .ustomer orientation to child care services, a mar#eting perspective K 'arriers that e5ist to a customer orientation G" #.*+ 4/+ O:94-;7+9 -991;.-4+, =.4/ TQM I237+2+04-4.10N K -ac# of management commitment K Inability to change organizational culture K Improper planning K -ac# of continuous training and education K Incompatible organizational structure and isolated individuals and departments K Ineffective measurement techni;ues and lac# of access to data and results" K Paying inade;uate attention to internal and e5ternal customers" K Inade;uate use of empo)erment and team)or# " =H | P a g e

H" #.*+ 4/+ A0-7'9.9 T+;/0.L(+9 >1) Q(-7.4' C1949N i" Trend +nalysis ii" Pareto +nalysis ?" D+>.0+ Q(-7.4' C1949N Tuality .osts are defined as those costs associated )ith the nonachievement of product or service ;uality as defined by the re;uirements established by the organization and its contracts )ith customers and society" F" #.*+ 4/+ 3).2-)' ;-4+<1).+9 1> Q(-7.4' ;194N K Preventive cost category K +ppraisal cost category K Internal failure cost category K E5ternal failure cost category 1<" #.*+ 4/+ 4'3.;-7 ;194 :-9+9N K -abor K Production K $nit K (ales

11. H1= =.77 '1( ,+4+)2.0+ 4/+ 134.2(2 ;194N K 2a#e comparison )ith other organizations K Optimize the individual categories K +nalyze the relationships among the cost categories 12" S4-4+ 4/+ Q(-7.4' I23)1*+2+04 S4)-4+<'N K %educe failure costs by problem solving K Invest in the NrightO prevention activities =? | P a g e

K %educe appraisal costs )here appropriate and in a statistically sound manner K .ontinuously evaluate and redirect the prevention effort to gain further ;uality improvement" 1*. D+>.0+ Q(-7.4' P7-00.0<N + ;uality plan sets out the desired product ;ualities and ho) these are assessed and define the most significant ;uality attributes" It should define the ;uality assessment process" It should set out )hich organizational standards should be applied and, if necessary, define ne) standards" 1=" #.*+ 4/+ O:M+;4.*+9 1> TQMN To develop a conceptual understanding of the basic principles and methods associated )ith TT2P K To develop an understanding of ho) these principles and methods have been put into effect in a variety of organizationsP K To develop an understanding of the relationship bet)een TT2 principles and the theories and models studied in traditional managementP K To do the right things, right the first time, every time" 1B" W/-4 .9 0++,+, >1) - 7+-,+) 41 :+ +>>+;4.*+N To be effective, a leader needs to #no) and understand the follo)ing9 K People, parado5ically, need security and independence at the same time" K People are sensitive to e5ternal re)ards and punishments and yet are also strongly selfmotivated" K People li#e to hear a #ind )ord of praise" K People can process only a fe) facts at a timeP thus, a leader needs to #eep things simple" K People trust their gut reaction more than statistical data" =F | P a g e

K People distrust a leader8s rhetoric if the )ords are inconsistent )ith the leader8s actions" 1G" W/-4 .9 4/+ .231)4-04 )17+ 1> 9+0.1) 2-0-<+2+04N W -istening to internal and e5ternal customers and suppliers through visits, focus groups and surveys" W .ommunication" W To drive fear out of the organization, brea# do)n barriers, remove system roadbloc#s, anticipate and minimize resistance to change and in general, change the culture" 1H" W/-4 -)+ 4/+ <+0+)-7 ,(4.+9 1> - L(-7.4' ;1(0;.7N /i04evelop, )ith input from all personnel, the core values, vision statement, mission statement, and ;uality policy statement" /ii04evelop the strategic long!term plan )ith goals and the annual ;uality improvement program )ith ob6ectives" /iii0.reate the total education and training plan" /iv04etermine and continually monitor the cost of poor ;uality" /v04etermine the performance measures for the organization, approve those for the functional areas, and monitor them" /vi0.ontinually, determine those pro6ects that improve the processes, particularly those that affect e5ternal and internal customer satisfaction" /vii0Establish multifunctional pro6ect and departmental or )or# group teams and monitor their progress" /viii0Establish or revise the recognition and re)ard system to account for the ne) )ay of doing business" 1?" W/-4 ,1+9 - 4'3.;-7 2++4.0< -<+0,- ;104-.0 ->4+) +94-:7.9/.0< 4/+ TQMN W Progress report on teams W .ustomer satisfaction report W Progress on meeting goals B< | P a g e

W 1e) pro6ect teams W %ecognition dinner W 'enchmar#ing report 1F" W/-4 -)+ 4/+ *-).1(9 L(-7.4' 94-4+2+049N o &ision (tatement o 2ission (tatement o Tuality Policy (tatement 2<" #.*+ 4/+ :-9.; 94+39 41 94)-4+<.; L(-7.4' 37-00.0<N K .ustomer needs K .ustomer positioning K Predict the future K ap analysis K .losing the gap K +lignment K Implementation

21" W/-4 .9 - L(-7.4' 317.;'N The Tuality Policy is a guide for everyone in the organization as to ho) they should provide products and service to the customers" The common characteristics are K Tuality is first among e;uals" B1 | P a g e

K 2eet the needs of the internal and e5ternal customers" K E;ual or e5ceed the competition" K .ontinually improve the ;uality" K Include business and production practices" K $tilize the entire )or# force"

THE EI#HT ELEMENTS OF TQM"

Total Tuality 2anagement is a management approach that originated in the 1FB<Ms and has steadily become more popular since the early 1F?<Ms" Total Tuality is a description of the culture, attitude and organization of a company that strives to provide customers )ith products and services that satisfy their needs" The culture re;uires ;uality in all aspects of the companyMs operations, )ith processes being done right the first time and defects and )aste eradicated from operations" To be successful implementing TT2, an organization must concentrate on the eight #ey elements9 Ethics Integrity Trust Training Team)or# -eadership %ecognition .ommunication This paper is meant to describe the eight elements comprising TT2" Aey Elements TT2 has been coined to describe a philosophy that ma#es ;uality the driving force behind leadership, design, planning, and improvement initiatives" >or this, TT2 re;uires the help of those eight #ey elements" These elements can be divided into four groups according to their function" The groups are9 B2 | P a g e

I" >oundation ! It includes9 Ethics, Integrity and Trust" II" 'uilding 'ric#s ! It includes9 Training, Team)or# and -eadership" III" 'inding 2ortar ! It includes9 .ommunication" I&" %oof ! It includes9 %ecognition" I" >oundation TT2 is built on a foundation of ethics, integrity and trust" It fosters openness, fairness and sincerity and allo)s involvement by everyone" This is the #ey to unloc#ing the ultimate potential of TT2" These three elements move together, ho)ever, each element offers something different to the TT2 concept" 1" Ethics ! Ethics is the discipline concerned )ith good and bad in any situation" It is a t)o!faceted sub6ect represented by organizational and individual ethics" Organizational ethics establish a business code of ethics that outlines guidelines that all employees are to adhere to in the performance of their )or#" Individual ethics include personal rights or )rongs" 2" Integrity ! Integrity implies honesty, morals, values, fairness, and adherence to the facts and sincerity" The characteristic is )hat customers /internal or e5ternal0 e5pect and deserve to receive" People see the opposite of integrity as duplicity" TT2 )ill not )or# in an atmosphere of duplicity" *" Trust ! Trust is a by!product of integrity and ethical conduct" Jithout trust, the frame)or# of TT2 cannot be built" Trust fosters full participation of all members" It allo)s empo)erment that encourages pride o)nership and it encourages commitment" It allo)s decision ma#ing at appropriate levels in the organization, fosters individual ris#! ta#ing for continuous improvement and helps to ensure that measurements focus on improvement of process and are not used to contend people" Trust is essential to ensure customer satisfaction" (o, trust builds the cooperative environment essential for TT2" II"'ric#s 'asing on the strong foundation of trust, ethics and integrity, bric#s are placed to reach the roof of recognition" It includes9 =" Training ! Training is very important for employees to be highly productive" (upervisors are solely responsible for implementing TT2 )ithin their departments, and teaching their employees the philosophies of TT2" Training that employees re;uire are B* | P a g e

interpersonal s#ills, the ability to function )ithin teams, problem solving, decision ma#ing, 6ob management performance analysis and improvement, business economics and technical s#ills" 4uring the creation and formation of TT2, employees are trained so that they can become effective employees for the company" B" Team)or# ! To become successful in business, team)or# is also a #ey element of TT2" Jith the use of teams, the business )ill receive ;uic#er and better solutions to problems" Teams also provide more permanent improvements in processes and operations" In teams, people feel more comfortable bringing up problems that may occur, and can get help from other )or#ers to find a solution and put into place" There are mainly three types of teams that TT2 organizations adopt9 +" Tuality Improvement Teams or E5cellence Teams /TIT(0 ! These are temporary teams )ith the purpose of dealing )ith specific problems that often re!occur" These teams are set up for period of three to t)elve months" '" Problem (olving Teams /P(Ts0 ! These are temporary teams to solve certain problems and also to identify and overcome causes of problems" They generally last from one )ee# to three months" ." 1atural Jor# Teams /1JTs0 ! These teams consist of small groups of s#illed )or#ers )ho share tas#s and responsibilities" These teams use concepts such as employee involvement teams, self!managing teams and ;uality circles" These teams generally )or# for one to t)o hours a )ee#" G" -eadership ! It is possibly the most important element in TT2" It appears every)here in organization" -eadership in TT2 re;uires the manager to provide an inspiring vision, ma#e strategic directions that are understood by all and to instill values that guide subordinates" >or TT2 to be successful in the business, the supervisor must be committed in leading his employees" + supervisor must understand TT2, believe in it and then demonstrate their belief and commitment through their daily practices of TT2" The supervisor ma#es sure that strategies, philosophies, values and goals are transmitted do)n through out the organization to provide focus, clarity and direction" + #ey point is that TT2 has to be introduced and led by top management" .ommitment and personal B= | P a g e

involvement is re;uired from top management in creating and deploying clear ;uality values and goals consistent )ith the ob6ectives of the company and in creating and deploying )ell defined systems, methods and performance measures for achieving those goals"

III.B.0,.0<M1)4-) H" .ommunication ! It binds everything together" (tarting from foundation to roof of the TT2 house, everything is bound by strong mortar of communication" It acts as a vital lin# bet)een all elements of TT2" .ommunication means a common understanding of ideas bet)een the sender and the receiver" The success of TT2 demands communication )ith and among all the organization members, suppliers and customers" (upervisors must #eep open air)ays )here employees can send and receive information about the TT2 process" .ommunication coupled )ith the sharing of correct information is vital" >or communication to be credible the message must be clear and receiver must interpret in the )ay the sender intended" There are different )ays of communication such as9 +" 4o)n)ard communication ! This is the dominant form of communication in an organization" Presentations and discussions basically do it" 'y this the supervisors are able to ma#e the employees clear about TT2" '" $p)ard communication ! 'y this the lo)er level of employees are able to provide suggestions to upper management of the affects of TT2" +s employees provide insight and constructive criticism, supervisors must listen effectively to correct the situation that comes about through the use of TT2" This forms a level of trust bet)een supervisors and employees" This is also similar to empo)ering communication, )here supervisors #eep open ears and listen to others" ." (ide)ays communication ! This type of communication is important because it brea#s do)n barriers bet)een departments" It also allo)s dealing )ith customers and suppliers in a more professional manner" BB | P a g e

I&"%oof ?" %ecognition ! %ecognition is the last and final element in the entire system" It should be provided for both suggestions and achievements for teams as )ell as individuals" Employees strive to receive recognition for themselves and their teams" 4etecting and recognizing contributors is the most important 6ob of a supervisor" +s people are recognized, there can be huge changes in self!esteem, productivity, ;uality and the amount of effort e5horted to the tas# at hand" %ecognition comes in its best form )hen it is immediately follo)ing an action that an employee has performed" %ecognition comes in different )ays, places and time such as, Jays ! It can be by )ay of personal letter from top management" +lso by a)ard ban;uets, pla;ues, trophies etc" Places ! ood performers can be recognized in front of departments, on performance boards and also in front of top management" Time ! %ecognition can given at any time li#e in staff meeting, annual a)ard ban;uets, etc"

Je can conclude that these eight elements are #ey in ensuring the success of TT2 in an organization and that the supervisor is a huge part in developing these elements in the )or# place" Jithout these elements, the business entities cannot be successful TT2 implementers" It is very clear from the above discussion that TT2 )ithout involving integrity, ethics and trust )ould be a great remiss, in fact it )ould be incomplete" Training is the #ey by )hich the organization creates a TT2 environment" -eadership and team)or# go hand in hand" -ac# of communication bet)een departments, supervisors and employees create a burden on the )hole TT2 process" -ast but not the least, recognition should be given to people )ho contributed to the overall completed tas#" ,ence, lead by e5ample, train employees to provide a ;uality product, create an environment )here there is no fear to share #no)ledge, and give credit )here credit is due is the motto of a successful TT2 organization BG | P a g e

THE TQM MODEL" +t the century close, the creation of the global mar#et, international orientation of management that s)eeps national boundaries, introduction of ne) technologies, and shift to)ards customer focused strategies, ma#e the competition stronger than ever" The criteria for success in this global, internationally oriented mar#et have been changing rapidly" In order to e5pand business, enter ne) mar#ets, and set realistic, competitive long!term ob6ectives, e5cellence became an imperative" 2anagementMs effort has been directed to)ards discovering )hat ma#es a company e5cellent" To achieve e5cellence, companies must develop a corporate culture of treating people as their most important asset and provide a consistent level of high ;uality products and services in every mar#et in )hich they operate" (uch an environment has supported the )ide acceptance of Total Tuality 2anagement /TT20 )hich emerged recently as a ne), challenging, mar#etable philosophy" It involves three spheres of changes in an organization !! people, technology and structure" There is also a need for a systematic approach so that each element of TT2ES can be bonded together smoothly" Oa#land X1F?FY originated the idea of a *!cornerstone model" The proposed =!pillar model />igure *"10 brings the customerMs re;uirement into the system" This ma#es the approach to TT2 more complete" The additional pillar !! satisfying customers !! is vital because it e5plicitly addresses customers re;uirements" Jithout it TT2 )ould have no ob6ective"

BH | P a g e

The >our Pillars of TT2 The role of top management in implementation of total ;uality is crucial and its input on people far!reaching" TT2, therefore, should be understood as management of the system through systems thin#ing, )hich means understanding all the elements in the company and putting them to )or# together to)ards the common goal" The TT2ES 2odel advocates an integrated approach in order to support the transition to systems management )hich is an ongoing process of continuous improvement that begins )hen the company commits itself to managing by ;uality" The 2odel illuminates the elements that form a base to the understanding of TT2 philosophy and implementation of the process company!)ide" T/+ S4)(;4()+ 1> TQMEX"

B? | P a g e

 T/+ L1<.; 1> TQMEX"

In order to have a systematic approach to TT2, it is necessary to develop a conceptual model" enerally, a model is a se;uence of steps arranged logically to serve as a guideline for implementation of a process in order to achieve the ultimate goal" The model should be simple, logical and yet comprehensive enough for TT2 implementation" It also has to sustain the changes in business environment of the ne) era" The 2odel also reflects teachings of the contemporary ;uality gurus" The idea )as to develop a universally applicable step!by!step guideline by including recognized practices in TT29

@apanese B!( Practice /B!(0 'usiness Process %e!engineering /'P%0 Tuality .ontrol .ircles /T..s0 I(O F<<1:2 Tuality 2anagement (ystem /I(O0 Total Productive 2aintenance /TP20

+s Osada pointed out, B!( is the #ey to total ;uality environment" Therefore, it should be the first step" 'P% is concerned )ith re!defining and designing your business process in order to meet the needs of your customers effectively" It is more concerned )ith the BF | P a g e

business ob6ectives and systems, and should follo) as (tep 2" T..s are concerned )ith encouraging the employees to participate in continuous improvement and guide them through" They improve human resources capability to achieve the business ob6ectives" Therefore, this should be (tep *" I(O F<<< is to develop a ;uality management system based on the good practices in the previous three steps" TP2 is a result of applying B!( to e;uipment based on a sound ;uality management system" In fact I(O F<<1 re;uires procedures for process control and inspection and testing e;uipment )hich are part of TP2" Therefore TP2 should be implemented in (tep B"
If the above five steps have been implemented successfully, the organization is already very close towards achieving TQM. TQMEX is a se uential model which is easy to remember and simple to implement. This is in line with the uality principle of !eep It "hort and "imple #!I""$, although it is not simple to ma%e a model simple&

.ompanies starting to implement TT2 should follo) TT2ES step!by!step" .ompanies )hich have already gone through some degree of improvement using some of the steps should revie) )hat have not been done and do it as their ne5t step of improvement" In order to ma5imize your benefits from TT2ES, you have to start early too"

CHAPTER THREE

THE ACCEPTABILITY OF TQM '()(*E"E TQM M+,E-.

(t first, few but the 'apanese too% ,eming seriously. !nown for his legendary attac%s on e/ecutives and compassion for the wor%er, the 'apanese sense of responsibility to one0s superiors and subordinates made it easier to accept ,eming0s message that management0s role was to provide the optimal conditions for the wor%ers to do the best 1ob. The 'apanese then e/tended ,eming0s teaching to many dimensions of management. 2ere are TQM models from the 'apanese "ociety of Quality and the 'apan "tandards (ssociation that show how e/tensive their definition of TQM is. The 'apanese identify three ma1or dimensions of TQM. ,aily Management, 2oshin3)olicy Management, and 4ross 5unction Management. 6e will study these in detail in the course. They can be visualized with the following picture.

G< | P a g e

 TT2 I1 $(+9
+s regards ;uality, $(+ is at crossroads today"Inspite of the fact that $(+ developed the techni;ues and concepts of (T. and TT. and the 6apenese imported these techni;ues, the further orientation and development in philoshophy, concept and techni;ues in terms of T"." circles and company )ide ;uality control too# place in @apan more rapidly and successfully" Jhile the +merican companies remained G1 | P a g e

concerned about detecting and segregating defective parts from good ones, the @apanese companies devised systems to reduce defects and produce good ;uality products"This resulted in +merica losing its position of dominance not only in the +merican mar#et but also in the )orld" 2uch of the ;uality movement in $(+ is based on tools and techni;ues developed by the 6apenese" +doption of these techni;ues re;uires complete re!development in both methods and emphasis"The most critical challenge facing $"( ;uality movement is the development and implementation of ;uality focused corporate management systems that achieve the coherence, integration and comprehensiveness of ;uality management in 6apan" The +merican companies are characterized by9 1. + high concentration of industry on relatively fe) companies" 2. (tress on promoting share!holders, and 3. %unning the company by professional managers" These features of autonomous organisations and professional management have a considerable impact on the conduct of ;uality function" Each organisation determines independently )hat it )ill produce and )hat ;uality policies it )ill adopt" 2arguardt divides the evolution of ;uality movement in $(+ in three periods9 1. +dvocates for (T.! Emphasis on technical tools of control charts, lot inspection and sampling schemes" 2" +dministrators for system of ;uality control! Emphasis on the cost of ;uality and managerial aspects of organizing the ;uality" *" +dvertising and selling ;uality consciousness!Emphasis on changing organizational culture and providing an environment that )ill enable people to activate and sustain in G2 | P a g e

their o)n )or# and in products and services produced by the organistions )ith the focus on needs of customers" TT2 in (ervice Industry TT2 in (ervice Industry Introduction Today8s customer has before him the possibility of a )ider choice of products 3 (ervices than ever before ",e is going to be demanding 3 #een on having the best services in the shortest possible time 3 at the minimum cost ",e )ill loo# for solutions that are more specific to his needs thus creating opportunity of many niche mar#et" !Today customers avail +T2 services 2= hrs !'oo# airline tic#ets 3 chec#!in over phone !(elf!service at fast food restaurant" !+nd many more Jhat is different Z !(ervice is also a product of different #ind " !1o time delay bet)een the production 3 delivery of service !+ defective product can be replaced but a defective service may create a permanent damage" ro)th of (ervice sector (ervice sector is gro)ing rapidly due to !.hange in environment , life style etc !4emand for ne) #ind of services !+dvent of ne) technologies !>ast development of information technology 3 computerisation !-ean manufacturing " /contracting out most activities0 .hallenge of (ervice sector 4elight customers !In a dynamic environment )hich is changing fast !In gro)ing competitive mar#et !Jith relatively shorter product life cycle !%e;uiring more customisation G* | P a g e

(ervice Tuality 4imensions Tuality of (ervices differs from manufactured products !(pecial characteristics including intangibility" !(imultaneity / promptness 0 !,eterogeneity !$ni;ue dimensions of some services /e"g" 'an#ing0

CHAPTER FOUR

THE ESSENTIALS OF TQM

I04)1,(;4.10 TT2 is the )ay of managing for the future, and is far )ider in its application than 6ust assuring product or service ;uality it is a )ay of managing people and business processes to ensure complete customer satisfaction at every stage, internally and e5ternally" TT2, combined )ith effective leadership, results in an organization doing the right things right, first time.

G= | P a g e

The core of TT2 is the customer'supplier interfaces, both e5ternally and internally, and at each interface lie a number of processes" This core must be surrounded by commitment to ;uality, communication of the ;uality message, and recognition of the need to change the culture of the organisation to create total ;uality" These are the foundations of TT2, and they are supported by the #ey management functions of people, processes and systems in the organisation. This section discusses each of these elements that, together, can ma#e a total ;uality organisation" Other sections e5plain people, processes and systems in greater detail, all having the essential themes of commitment, culture and communication running through them" W/-4 .9 L(-7.4'N + fre;uently used definition of ;uality is Delighting the customer by fully meeting their needs and expectations" These may include performance, appearance, availability, GB | P a g e

delivery, reliability, maintainability,cost effectiveness and price" It is, therefore, imperative that the organisation #no)s )hat these needs and e5pectations are" In addition, having identified them, the organisation must understand them, and measure its o)n ability to meet them" Tuality starts )ith mar#et research to establish the true re;uirements for the product or service and the true needs of the customers" ,o)ever, for an organisation to be really effective, ;uality must span all functions, all people, all departments and all activities and be a common language for improvement" The cooperation of everyone at every interface is necessary to achieve a total ;uality organization, in the same )ay that the @apanese achieve this )ith company )ide ;uality control" C(9412+)9 -0, 9(337.+)9 There e5ists in each department, each office, each home, a series of customers, suppliers and customer supplier interfaces" These are Nthe ;uality chainsO, and they can be bro#en at any point by one person or one piece of e;uipment not meeting the re;uirements of the customer, internal or e5ternal" The failure usually finds its )ay to the interface bet)een the organization and its e5ternal customer, or in the )orst case, actually to the e5ternal customer" >ailure to meet the re;uirements in any part of a ;uality chain has a )ay of multiplying, and failure in one part of the system creates problems else)here, leading to yet more failure and problems, and so the situation is e5acerbated" The ability to meet customers8 /e5ternal and internal0 re;uirements is vital" To achieve ;uality throughout an organization, every person in the ;uality chain must be trained to as# the follo)ing ;uestions about every customer!supplier interface9

C(9412+)9 ?.04+)0-7 -0, +D4+)0-7@ GG | P a g e

K Jho are my customersZ K Jhat are their true needs and e5pectationsZ K ,o) do, or can, I find out )hat these areZ K ,o) can I measure my ability to meet their needs and e5pectationsZ K 4o I have the capability to meet their needs and e5pectationsZ /If not, )hat must I do to improve this capabilityZ0 K 4o I continually meet their needs and e5pectationsZ /If not, )hat prevents this from happening )hen the capability e5istsZ0 K ,o) do I monitor changes in their needs and e5pectationsZ S(337.+)9 ?.04+)0-7 -0, +D4+)0-7@ K Jho are my internal suppliersZ K Jhat are my true needs and e5pectationsZ K ,o) do I communicate my needs and e5pectations to my suppliersZ K 4o my suppliers have the capability to measure and meet these needs and e5pectationsZ K ,o) do I inform them of changes in my needs and e5pectationsZ +s )ell as being fully a)are of customers8 needs and e5pectations, each person must respect the needs and e5pectations of their suppliers" The ideal situation is an open partnership style relationship, )here both parties share and benefit" GH | P a g e

P11) 3)-;4.;+9 To be able to become a total ;uality organization, some of the bad practices must be recognized and corrected" These may include9 K -eaders not giving clear direction K 1ot understanding, or ignoring competitive positioning K Each department )or#ing only for itself K Trying to control people through systems K .onfusing ;uality )ith grade K +ccepting that a level of defects or errors is inevitable K >irefighting, reactive behaviour K The Its not my problem attitude ,o) many of these behaviours do you recognize in your organizationZ T/+ +99+04.-7 ;12310+049 1> TQM O ;122.42+04 & 7+-,+)9/.3 TT2 is an approach to improving the competitiveness, effectiveness and fle5ibility of an organization for the benefit of all sta#eholders" It is a )ay of planning, organizing and understanding each activity, and of removing all the )asted effort and energy that is G? | P a g e

routinely spent in organizations" It ensures the leaders adopt a strategic overvie) of ;uality and focus on prevention not detection of problems" Jhilst it must involve everyone, to be successful, it must start at the top )ith the leaders of the organization" +ll senior managers must demonstrate their seriousness and commitment to ;uality, and middle managers must, as )ell as demonstrating their commitment, ensure they communicate the principles, strategies and benefits to the people for )hom they have responsibility" Only then )ill the right attitudes spread throughout the organization" + fundamental re;uirement is a sound ;uality policy, supported by plans and facilities to implement it" -eaders must ta#e responsibility for preparing, revie)ing and monitoring the policy, plus ta#e part in regular improvements of it and ensure it is understood at all levels of the organization" Effective leadership starts )ith the development of a mission statement, follo)ed by a strategy, )hich is translated into action plans do)n through the organization" These, combined )ith a TT2 approach, should result in a ;uality organization, )ith satisfied customers and good business results" The B re;uirements for effective leadership are9 K 4eveloping and publishing corporate beliefs, values and ob6ectives, often as a mission statement K Personal involvement and acting as role models for a culture of total ;uality K 4eveloping clear and effective strategies and supporting plans for achieving the mission and ob6ectives K %evie)ing and improving the management system GF | P a g e

K .ommunicating, motivating and supporting people and encouraging effective employee participation The tas# of implementing TT2 can be daunting" The follo)ing is a list of points that leaders should considerP they are a distillation of the various beliefs of some of the ;uality gurus9 K The organisation needs a long!term ;122.42+04 to continuous improvement" K +dopt the philosophy of zero errors:defects to change the ;(74()+ to right first time K Train people to understand the ;(9412+)B9(337.+) relationships K 4o not buy products or services on price alone loo# at the 414-7 ;194 K %ecognise that improvement of the 9'94+29 must be managed K +dopt modern methods of 9(3+)*.9.0< -0, 4)-.0.0< eliminate fear K Eliminate barriers bet)een departments by managing the 3)1;+99 improve ;122(0.;-4.109 and 4+-2=1)8 K Eliminate goals )ithout methods, standards based only on numbers, barriers to pride of )or#manship and fiction get >-;49 by studying 3)1;+99+9 K .onstantly educate and retrain develop +D3+)49 in the organisation K 4evelop a 9'94+2-4.; approach to manage the implementation of TT2 C(74()+ ;/-0<+ H< | P a g e

The failure to address the culture of an organisation is fre;uently the reason for many management initiatives either having limited success or failing altogether" $nderstanding the culture of an organisation, and using that #no)ledge to successfully map the steps needed to accomplish a successful change, is an important part of the ;uality 6ourney" The culture in any organisation is formed by the beliefs, behaviours, norms, dominant values, rules and the NclimateO" + culture change, e"g, from one of acceptance of a certain level of errors or defects to one of right first time, every time, needs t)o #ey elements9 K .ommitment from the leaders K Involvement of all of the organisation8s people There is )idespread recognition that ma6or change initiatives )ill not be successful )ithout a culture of good team)or# and cooperation at all levels in an organisation, as discussed in the section on People"

T/+ :(.7,.0< :71;89 1> TQM" 3)1;+99+9A 3+137+A 2-0-<+2+04 9'94+29 -0, 3+)>1)2-0;+ 2+-9()+2+04 Everything )e do is a Process, )hich is the transformation of a set of inputs, )hich can include action, methods and operations, into the desired outputs, )hich satisfy the customers8 needs and e5pectations"

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In each area or function )ithin an organisation there )ill be many processes ta#ing place, and each can be analysed by an e5amination of the inputs and outputs to determine the action necessary to improve ;uality" In every organisation there are some very large processes, )hich are groups of smaller processes, called #ey or core business processes" These must be carried out )ell if an organisation is to achieve its mission and ob6ectives" The section on Processes discusses processes and ho) to improve them, and Implementation covers ho) to prioritise and select the right process for improvement"

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The only point at )hich true responsibility for performance and ;uality can lie is )ith the P+137+ )ho actually do the 6ob or carry out the process, each of )hich has one or several suppliers and customers" +n efficient and effective )ay to tac#le process or ;uality improvement is through team)or#" ,o)ever, people )ill not engage in improvement activities )ithout commitment and recognition from the organisation8s leaders, a climate for improvement and a strategy that is implemented thoughtfully and effectively" The section on People e5pands on these issues, covering roles )ithin teams, team selection and development and models for successful team)or#" +n appropriate documented Q(-7.4' M-0-<+2+04 S'94+2 )ill help an organisation not only achieve the ob6ectives set out in its policy and strategy, but also, and e;ually importantly, sustain and build upon them" It is imperative that the leaders ta#e responsibility for the adoption and documentation of an appropriate management system in their organisation if they are serious about the ;uality 6ourney" The (ystems section discusses the benefits of having such a system, ho) to set one up and successfully implement it" Once the strategic direction for the organisation8s ;uality 6ourney has been set, it needs P+)>1)2-0;+ M+-9()+9 to monitor and control the 6ourney, and to ensure the desired level of performance is being achieved and sustained" They can, and should be, established at all levels in the organisation, ideally being cascaded do)n and most effectively underta#en as team activities and this is discussed in the section on Performance"

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CHAPTER FIVE

THE EFFECTS OF TQM

I23)1*.0< F.0-0;.-7 S+)*.;+9 4/)1(</ TQM

The wor% described in this case study was underta%en in a young, rapidly e/panding company in the financial services sector with no previous e/perience with Total Quality Management #TQM$. The uality pro1ect began with a two7day introductory awareness program covering concepts, cases, implementation strategies and imperatives of TQM. The program was conducted for the senior management team of the company. This program used interactive e/ercises and real life case studies to e/plain the concepts of TQM and to interest them in committing resources for a demonstration pro1ect. The demonstration pro1ect, which used the "even "teps of )roblem "olving #similar to ,M(I4$, was to show them how TQM concepts wor%ed in practice before they committed resources for a company7wide program.

S4+3 1. D+>.0+ 4/+ P)1:7+2

1.1) Selecting the theme: ( meeting of the senior management of the company was held. 8rainstorming produced a list of more than 9: problems. The list was prioritized using the weighted average table, followed by a structured discussion to arrive at a consensus on the two most important themes 77 customer service and sales productivity. ;nder the customer service theme, <=educing the Turnaround Time from an Insurance )roposal to )olicy< was selected as the most obvious and urgent problem. The company was young, and therefore had few claims to process so far. The proposal7to7policy process therefore impacted the greatest number of customers. (n appropriate cross functional group was set up to tac%le this problem. 1.2) P !"lem # c$%t!me &e%i e ' c$ ent %t(t$%: C$ ent %t(t$%: 6hat did the individual group members thin% the turnaround is currently> (s each member began thin%ing uestions came up. <6hat type of policies do we address>< Medical policies or non7 medical> The latter are ta%e longer because of the medical e/amination of the client re uired. <8etween what stages do we consider turnaround>< )erceptions varied, with each person thin%ing about the turnaround within their department. The %ey process stages were mapped.

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"everal sales branches in different parts of the country sent proposals into the 4entral )rocessing 4enter. (fter considerable debate it was agreed at first to consider turnaround between entry into the computer system at the 4ompany "ales 8ranch and dispatch to the customer from the 4entral )rocessing 4enter #4)4$. -ater the entire cycle could be included. The perception of the length of turnaround by different members of the team was recorded. It averaged. *on7Medical )olicies Medical )olicies ?@ days AB days

Invo%ing the slogan from the awareness program <In Cod we trust, the rest of us bring data< the group was as%ed to collect data and establish reality. (rmed with a suitably designed chec% sheet they set about the tas%. C$%t!me &e%i e: 6hat was the turnaround desired by the customer> "ince a customer survey was not available, individual group members were as%ed to thin% as customers 77 imagine they had 1ust given a completed proposal form to a sales agent. 6hen would they e/pect the policy in hand> 5rom the customer0s point of view they realized that they did not differentiate between medical and non7medical policies. Their perception averaged out si/ days for the re uired turnaround. <Is this the average time or ma/imum time that you e/pect>< they were as%ed. <Ma/imum,< they responded. It was clear therefore that the average must be less than si/ days. The importance of <variability< had struc% home. The concept of sigma was e/plained and was rapidly internalized. 5or DD.@ percent delivery within the customer limit the metric was defined. C$%t!me &e%i e: (verageEA "igma turnaround F less than G days C$ ent %t(t$%: *on7medical policies #(verage ?D3"igma ?B$ (verageEA sigmaF GH days Medical #(verage A@3"igma 9@$ (verageEA sigmaF ??I days

T/+ P)1:7+2 =-9 4/+)+>1)+ ,+>.0+," R+,(;+ A*+)-<+P3 9.<2- 1> 4()0-)1(0, >1)" HB | P a g e

*on7Medical )olicies 5rom GH to G days Medical )olicies 5rom ??I to G days The performance re uirement appeared daunting. Therefore the initial target ta%en in the Mission "heet #pro1ect charter$ was to reduce the turnaround by B: percent 77 to A9 and BD days respectively.

S4+3 2. A0-7'9.9 1> 4/+ P)1:7+2

In a session the factors causing large turnaround times from the principles of 'IT were e/plained. These were.Input arrival patterns

Jaiting times in process ! 'atching of )or# ! Imbalanced processing line ! Too many handovers ! 1on!value added activities, etc"

Processing times (cheduling Transport times 4eployment of manpo)er

Typically it was found that waiting times constitute the bul% of processing turnaround times. )rocess Mapping #Jalue "tream Mapping in -ean$ was underta%en. The aggregate results are summarized below. *umber of operations IH *umber of handovers ?A In7house processing time #estimated$ ?9G man7mins. =ange of individual stage time 9 to ?A mins. 4ould this be true> 4ould the turnaround be ?9G minutes for internal processing without waiting> The group started to uestion of the status uo. The change process had begun. To chec% this estimate it was decided to collect data 77 run two policies without waiting and record the time at each stage. The trial results amazed everyone. )olicy *o. ? too% ?:: minutes and )olicy *o. 9 too% D@ minutes. (lmost instantly the mindset changed from doubt to desire. <6hy can0t we process every proposal in this way><

S4+3 3. #+0+)-4.0< I,+-9

In the introductory program of TQM during the 'IT session the advantages of flow versus batch processing had been dramatically demonstrated using a simple e/ercise. ;sing that bac%ground a balanced flow line was designed as follows. ?. ,etermine the station with the ma/imum time cycle which cannot be split up by reallocation 77 I minutes. 9. 8alance the line to ma%e the time ta%en at each stage e ual I minutes as far as possible. A. =educe the stages and handovers 77 ?A to I. H. Eliminate non7value added activities 77 transport 77 ma%e personnel sit ne/t to each other. B. (gree processing to be done in batch of one proposal.

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4hanging the mindset of the employees so they will accept and welcome change is critical to building a self7sustaining culture of improvement. In this case, the line personnel were involved in a Quality Mindset )rogram so that they understood the reasons for change and the concepts behind them and are %een to e/periment with new methods of wor%ing. The line was ready for a test run.

S4+3 4. T+94.0< 4/+ I,+Testing in stages is a critical stage. It allows modification of ideas based upon practical e/perience and e ually importantly ensures acceptance of the new methods gradually by the operating personnel. St(ge 1: =un five proposals flowing through the system and confirm results. The test produced the following results. (verage turnaround time. K ? day In7house processing time. @G mins. There was 1ubilation in the team. The productivity had increased by 9H percent. The head of the 4)4 summarized. <I gave five files for processing, and went for a meeting. Emerging from the meeting about A: minutes later I was greeted by the dispatch cler% 1ubilantly reporting, <0Madam, the TQM files are ready for dispatch.0< The mindset was dramatically changed and line personnel were now %een to push the implementation. St(ge 2: It was agreed to run the new system for five days 77 and compute the average and sigma of the turnaround to measure the improvement. It was agreed that only in7house processing was covered at this stage and that the test would involve all policies at the 4)4 but only one branch as a model. This model, once proved, could be replicated at other branches. The test results showed a significant reduction in turnaround. ?. 5or all non7medical policies 5rom GH to H9 days or AHL 9. 5or policies of the model branch 5rom GH to 9@ days of G:L The Mission "heet goal of B: percent reduction had been bettered for the combined model branch and 4)4. 5urther analysis of the data revealed other measures which could reduce the turnaround further. +verall reduction reached an amazing @B percent. Turnaround, which had been pegged at GH days, was now happening at DD.@ percent on7time delivery in ?B days.

S4+3 5. I237+2+04.0< 4/+ I,+-9

=egular operations with the new system was planned to commence. 2owever, two wee%s later it was still not implemented. +ne of the personnel on the line in 4)4 had been released by his department for the five7day trial to sit on the line but was not released on a regular basis. The departmental head had not attended the TQM awareness program and therefore did not understand why this change was re uired. There were two options 77 mandate the change or change the mindset to accept the change. "ince the latter option produces a robust implementation that will not brea% down under pressures it was agreed that the group would summarize TQM, the 1ourney and the results obtained in the pro1ect so far and also simulate the process with a simple e/ercise in front of the department head. This session was highly successful and led to the release of the person concerned on a regular basis.

S4+3 6. C/+;8 4/+ R+9(74

The process was run for one month with regular chec%s. The results obtained were marginally better than the trials conducted in "tep B.

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(verage ?? days "igma D days (verageEA sigma AI days

S4+3 . S4-0,-),.G+ C104)17BD1;(2+04 4/+ I23)1*+2+04 S41)'

Essentially the in!house processes in t)o centers of processing !! the .P. and one sales branch !! had been impacted so far" To ma#e sure that the gains )ere held, control charts )ere introduced in both locations" (ample 5!bar and sigma! control charts for the 4)4 are shown below.

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+ special [ rind It In[ session )as conducted for line personnel to ensure that the control chart )as updated every day, and any deterioration )as dealt )ith by finding and #illing the root causes of the problems"

.ustomer reaction9 (ales management and sales agents /internal customers0 clearly noticed the difference" >or instance one sales manager reported that a customer had received a policy )ithin a )ee# of giving a proposal and )as so amazed that he said, [If you give such service I )ill give you the ne5t policy also\[

+doption of a similar process at the .P. and the model branch for medical policies has already reduced the average]* sigma of turnaround time by H< percent !! from 11? days to *H days" The corresponding all!India reduction )as from 11? days to H1 days !! a G< percent reduction"

The pro6ect ob6ective of B< percent in the first stage has been achieved" + ;uality improvement story )as compiled by the pro6ect -eader for training and motivating all employees"

F(4()+ A;4.109
)!n*me&ic(l +!licie%: Coal to reduce turnaround from H9 days to about ?B days. ?. =oll out process to branches to achieve 9H days throughout the country. 9. Minimize rewor% by analyzing, prioritizing and training sales branches to avoid the causes of rewor%. A. 6or%ing with the ban% to improve the turnaround time of ban%ing chec%s. H. 4onsidering processing proposals while chec% clearance is in progress. Me&ic(l +!licie%: Coal to reduce turnaround from @? days to about 9H days.

1" %oll out process to branches to reduce turnaround from H1 to *H days" 2" (treamline the process of medical e5am of the client from *H to 2= days"

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CHAPTER SIX

IMPLEMENTATION OF TQM
Im+lement(ti!n P inci+le% (n& P !ce%%e%

( preliminary step in TQM implementation is to assess the organization0s current reality. =elevant preconditions have to do with the organization0s history, its current needs, precipitating events leading to TQM, and the e/isting employee uality of wor%ing life. If the current reality does not include important preconditions, TQM implementation should be delayed until the organization is in a state in which TQM is li%ely to succeed. If an organization has a trac% record of effective responsiveness to the environment, and if it has been able to successfully change the way it operates when needed, TQM will be easier to implement. If an organization has been historically reactive and has no s%ill at improving its operating systems, there will be both employee s%epticism and a lac% of s%illed change agents. If this condition prevails, a comprehensive program of management and leadership development may be instituted. ( management audit is a good assessment tool to identify current levels of organizational functioning and areas in need of change. (n organization should be basically healthy before beginning TQM. If it has significant problems such as a very unstable funding base, wea% administrative systems, lac% of managerial s%ill, or poor employee morale, TQM would not be appropriate.

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2owever, a certain level of stress is probably desirable to initiate TQM. )eople need to feel a need for a change. !anter #?DIA$ addresses this phenomenon be describing building bloc%s which are present in effective organizational change. These forces include departures from tradition, a crisis or galvanizing event, strategic decisions, individual <prime movers,< and action vehicles. ,epartures from tradition are activities, usually at lower levels of the organization, which occur when entrepreneurs move outside the normal ways of operating to solve a problem. ( crisis, if it is not too disabling, can also help create a sense of urgency which can mobilize people to act. In the case of TQM, this may be a funding cut or threat, or demands from consumers or other sta%eholders for improved uality of service. (fter a crisis, a leader may intervene strategically by articulating a new vision of the future to help the organization deal with it. ( plan to implement TQM may be such a strategic decision. "uch a leader may then become a prime mover, who ta%es charge in championing the new idea and showing others how it will help them get where they want to go. 5inally, action vehicles are needed and mechanisms or structures to enable the change to occur and become institutionalized. Ste+% in M(n(ging the T (n%iti!n 8ec%hard and )ritchard #?DD9$ have outlined the basic steps in managing a transition to a new system such as TQM. identifying tas%s to be done, creating necessary management structures, developing strategies for building commitment, designing mechanisms to communicate the change, and assigning resources. Tas% identification would include a study of present conditions #assessing current reality, as described above$M assessing readiness, such as through a force field analysisM creating a model of the desired state, in this case, implementation of TQMM announcing the change goals to the organizationM and assigning responsibilities and resources. This final step would include securing outside consultation and training and assigning someone within the organization to oversee the effort. This should be a responsibility of top management. In fact, the ne/t step, designing transition management structures, is also a responsibility of top management. In fact, 4ohen and 8rand #?DDA$ and 2yde #?DD9$ assert that management must be heavily involved as leaders rather than relying on a separate staff person or function to shepherd the effort. (n organization wide steering committee to oversee the effort may be appropriate. ,eveloping commitment strategies was discussed above in the sections on resistance and on visionary leadership. To communicate the change, mechanisms beyond e/isting processes will need to be developed. "pecial all7staff meetings attended by e/ecutives, sometimes designed as input or dialog sessions, may be used to %ic% off the process, and TQM newsletters may be an effective ongoing communication tool to %eep employees aware of activities and accomplishments. Management of resources for the change effort is important with TQM because outside consultants will almost always be re uired. 4hoose consultants based on their prior relevant e/perience and their commitment to adapting the process to fit uni ue organizational needs. 6hile consultants will be invaluable with initial training of staff and TQM system design, employees #management and others$ should be actively involved in TQM implementation, perhaps after receiving training in change management which they can then pass on to other employees. ( collaborative relationship with consultants and clear role definitions and specification of activities must be established. In summary, first assess preconditions and the current state of the organization to ma%e sure the need for change is clear and that TQM is an appropriate strategy. -eadership styles and organizational culture must

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be congruent with TQM. If they are not, this should be wor%ed on or TQM implementation should be avoided or delayed until favorable conditions e/ist. =emember that this will be a difficult, comprehensive, and long7term process. -eaders will need to maintain their commitment, %eep the process visible, provide necessary support, and hold people accountable for results. ;se input from sta%eholder #clients, referring agencies, funding sources, etc.$ as possibleM and, of course, ma/imize employee involvement in design of the system. (lways %eep in mind that TQM should be purpose driven. 8e clear on the organization0s vision for the future and stay focused on it. TQM can be a powerful techni ue for unleashing employee creativity and potential, reducing bureaucracy and costs, and improving service to clients and the community.

The C!nce+t !, C!ntin$!$% Im+ !-ement ". TQM

TQM is mainly concerned with continuous improvement in all wor%, from high level strategic planning and decision7ma%ing, to detailed e/ecution of wor% elements on the shop floor. It stems from the belief that mista%es can be avoided and defects can be prevented. It leads to continuously improving results, in all aspects of wor%, as a result of continuously improving capabilities, people, processes, technology and machine capabilities. 4ontinuous improvement must deal not only with improving results, but more importantly with improving capabilities to produce better results in the future. The five ma1or areas of focus for capability improvement are demand generation, supply generation, technology, operations and people capability. ( central principle of TQM is that mista%es may be made by people, but most of them are caused, or at least permitted, by faulty systems and processes. This means that the root cause of such mista%es can be identified and eliminated, and repetition can be prevented by changing the process. The e ( e th ee m(/! mech(ni%m% !, + e-enti!n:

1" Preventing mista#es /defects0 from occurring /2ista#e ! proofing or Po#a!Qo#e0" 2" Jhere mista#es canMt be absolutely prevented, detecting them early to prevent them being passed do)n the value added chain /Inspection at source or by the ne5t operation0" *" Jhere mista#es recur, stopping production until the process can be corrected, to prevent the production of more defects" /(top in time$.
. TQM i% the ,!$n&(ti!n ,! (cti-itie%0 1hich incl$&e:

.ommitment by senior management and all employees 2eeting customer re;uirements %educing development cycle times @ust In Time:4emand >lo) 2anufacturing Improvement teams %educing product and service costs (ystems to facilitate improvement ?2 | P a g e

-ine 2anagement o)nership Employee involvement and empo)erment %ecognition and celebration .hallenging ;uantified goals and benchmar#ing >ocus on processes : improvement plans (pecific incorporation in strategic planning

This shows that TQM must be practiced in all activities, by all personnel, in Manufacturing, Mar%eting, Engineering, =N,, "ales, )urchasing, 2=, etc.

TQM .0 2-0(>-;4().0< Tuality assurance through statistical methods is a #ey component in a manufacturing organization, )here TT2 generally starts by sampling a random selection of the product" The sample can then be tested for things that matter most to the end users" The causes of any failures are isolated, secondary measures of the production process are designed, and then the causes of the failure are corrected" The statistical distributions of important measurements are trac#ed" Jhen partsM measures drift into a defined [error band[, the process is fi5ed" The error band is usually a tighter distribution than the [failure band[, so that the production process is fi5ed before failing parts can be produced" It is important to record not 6ust the measurement ranges, but )hat failures caused them to be chosen" In that )ay, cheaper fi5es can be substituted later /say, )hen the product is redesigned0 )ith no loss of ;uality" +fter TT2 has been in use, itMs very common for parts to be redesigned so that critical measurements either cease to e5ist, or become much )ider" It too# people a )hile to develop tests to find emergent problems" One popular test is a [life test[ in )hich the sample product is operated until a part fails" +nother popular test is called [sha#e and ba#e[, in )hich the product is mounted on a vibrator in an environmental oven, and operated at progressively more e5treme vibration and temperatures until something fails" The failure is then isolated and engineers design an improvement"

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+ commonly!discovered failure is for the product to disintegrate" If fasteners fail, the improvements might be to use measured!tension nutdrivers to ensure that scre)s donMt come off, or improved adhesives to ensure that parts remain glued" If a gearbo5 )ears out first, a typical engineering design improvement might be to substitute a brushless stepper motor for a 4. motor )ith a gearbo5" The improvement is that a stepper motor has no brushes or gears to )ear out, so it lasts ten or more times as long" The stepper motor is more e5pensive than a 4. motor, but cheaper than a 4. motor combined )ith a gearbo5" The electronics are radically different, but e;ually e5pensive" One disadvantage might be that a stepper motor can hum or )hine, and usually needs noise!isolating mounts" Often, a [TT2ed[ product is cheaper to produce because of efficiency:performance improvements and because thereMs no need to repair dead!on!arrival products, )hich represents an immensely more desirable product" TQM -0, ;104.0<+0;'-:-9+, )+9+-);/ TT2 has not been independent of its environment" In the conte5t of management accounting systems /2.(s0, (im and Aillough /1FF?0 sho) that incentive pay enhanced the positive effects of TT2 on customer and ;uality performance" Ittner and -arc#er /1FFB0 demonstrated that product focused TT2 )as lin#ed to timely problem solving information and fle5ible revisions to re)ard systems" .hendall /2<<*0 summarizes the findings from contingency!based research concerning management control systems and TT2 by noting that NTT2 is associated )ith broadly based 2.(s including timely, fle5ible, e5ternally focused informationP close interactions bet)een advanced technologies and strategyP and non!financial performance measurement"O TT2, 6ust another management fadZ +brahamson /1FFG0 argued that fashionable management discourse such as Tuality .ircles tends to follo) a lifecycle in the form of a bell curve" Ponzi and Aoenig /2<<20 sho)ed that the same can be said about TT2, )hich pea#ed bet)een 1FF2 and 1FFG, )hile rapidly losing popularity in terms of citations after these years" 4ubois /2<<20 argued that the use of the term TT2 in management discourse created a positive utility regardless of )hat managers meant by it /)hich sho)ed a large variation0, )hile in the ?= | P a g e

late 1FF<s the usage of the term TT2 in implementation of reforms lost the positive utility attached to the mere fact of using the term and sometimes associations )ith TT2 became even negative" 1evertheless, management concepts such as TT2 leave their traces, as their core ideas can be very valuable" >or e5ample, 4ubois /2<<20 sho)ed that the core ideas behind the t)o management fads %eengineering and TT2, )ithout e5plicit usage of their names, can even )or# in a synergistic )ay" Total Tuality 2anagement is an approach to the art of management that originated in @apanese industry in the 1FB<Ms and has become steadily more popular in the Jest since the early 1F?<Ms" Total Tuality is a description of the culture, attitude and organization of a company that aims to provide, and continue to provide, its customers )ith products and services that satisfy their needs" The culture re;uires ;uality in all aspects of the companyMs operations, )ith things being done right first time, and defects and )aste eradicated from operations" 2any companies have difficulties in implementing TT2" (urveys by consulting firms have found that only 2<!*GC of companies that have underta#en TT2 have achieved either significant or even tangible improvements in ;uality, productivity, competitiveness or financial return" +s a result many people are sceptical about TT2" ,o)ever, )hen you loo# at successful companies you find a much higher percentage of successful TT2 implementation" (ome useful messages from results of TT2 implementations9 if you )ant to be a first!rate company, donMt focus on the second!rate companies )ho canMt handle TT2, loo# at the )orld!class companies that have adopted it

the most effective )ay to spend TT2 introduction funds is by training top management, people involved in ne) product development, and people involved )ith customers

itMs much easier to introduce E42:P42 in a company )ith a TT2 culture than in one )ithout TT2" People in companies that have implemented TT2 are more li#ely to have the basic understanding necessary for implementing E42:P42" ?B | P a g e

>or e5ample, they are more li#ely to vie) E42:P42 as an information and )or#flo) management system supporting the entire product life cycle then as a departmental solution for the management of .+4 data Important aspects of TT2 include customer!driven ;uality, top management leadership and commitment, continuous improvement, fast response, actions based on facts, employee participation, and a TT2 culture" C(9412+)-,).*+0 L(-7.4' TT2 has a customer!first orientation" The customer, not internal activities and constraints, comes first" .ustomer satisfaction is seen as the companyMs highest priority" The company believes it )ill only be successful if customers are satisfied" The TT2 company is sensitive to customer re;uirements and responds rapidly to them" In the TT2 conte5t, ^being sensitive to customer re;uirementsM goes beyond defect and error reduction, and merely meeting specifications or reducing customer complaints" The concept of re;uirements is e5panded to ta#e in not only product and service attributes that meet basic re;uirements, but also those that enhance and differentiate them for competitive advantage" Each part of the company is involved in Total Tuality, operating as a customer to some functions and as a supplier to others" The Engineering 4epartment is a supplier to do)nstream functions such as 2anufacturing and >ield (ervice, and has to treat these internal customers )ith the same sensitivity and responsiveness as it )ould e5ternal customers" TQM 7+-,+)9/.3 >)12 413 2-0-<+2+04 TT2 is a )ay of life for a company" It has to be introduced and led by top management" This is a #ey point" +ttempts to implement TT2 often fail because top management doesnMt lead and get committed ! instead it delegates and pays lip service" .ommitment and personal involvement is re;uired from top management in creating and deploying clear ;uality values and goals consistent )ith the ob6ectives of the company, and in creating and deploying )ell defined systems, methods and performance measures for achieving those goals" These systems and methods guide all ;uality activities and ?G | P a g e

encourage participation by all employees" The development and use of performance indicators is lin#ed, directly or indirectly, to customer re;uirements and satisfaction, and to management and employee remuneration" C104.0(1(9 .23)1*+2+04 .ontinuous improvement of all operations and activities is at the heart of TT2" Once it is recognized that customer satisfaction can only be obtained by providing a high!;uality product, continuous improvement of the ;uality of the product is seen as the only )ay to maintain a high level of customer satisfaction" +s )ell as recognizing the lin# bet)een product ;uality and customer satisfaction, TT2 also recognizes that product ;uality is the result of process ;uality" +s a result, there is a focus on continuous improvement of the companyMs processes" This )ill lead to an improvement in process ;uality" In turn this )ill lead to an improvement in product ;uality, and to an increase in customer satisfaction" Improvement cycles are encouraged for all the companyMs activities such as product development, use of E42:P42, and the )ay customer relationships are managed" This implies that all activities include measurement and monitoring of cycle time and responsiveness as a basis for see#ing opportunities for improvement" Elimination of )aste is a ma6or component of the continuous improvement approach" There is also a strong emphasis on prevention rather than detection, and an emphasis on ;uality at the design stage" The customer!driven approach helps to prevent errors and achieve defect!free production" Jhen problems do occur )ithin the product development process, they are generally discovered and resolved before they can get to the ne5t internalcustomer" F-94)+93109+ To achieve customer satisfaction, the company has to respond rapidly to customer needs" This implies short product and service introduction cycles" These can be achieved )ith customer!driven and process!oriented product development because the resulting simplicity and efficiency greatly reduce the time involved" (implicity is gained through concurrent product and process development" Efficiencies are realized from the elimination of non!value!adding effort such as re!design" The result is a dramatic ?H | P a g e

improvement in the elapsed time from product concept to first shipment" A;4.109 :-9+, 10 >-;49 The statistical analysis of engineering and manufacturing facts is an important part of TT2" >acts and analysis provide the basis for planning, revie) and performance trac#ing, improvement of operations, and comparison of performance )ith competitors" The TT2 approach is based on the use of ob6ective data, and provides a rational rather than an emotional basis for decision ma#ing" The statistical approach to process management in both engineering and manufacturing recognizes that most problems are system!related, and are not caused by particular employees" In practice, data is collected and put in the hands of the people )ho are in the best position to analyze it and then ta#e the appropriate action to reduce costs and prevent non!conformance" $sually these people are not managers but )or#ers in the process" If the right information is not available, then the analysis, )hether it be of shop floor data, or engineering test results, canMt ta#e place, errors canMt be identified, and so errors canMt be corrected" E2371'++ 3-)4.;.3-4.10 + successful TT2 environment re;uires a committed and )ell!trained )or# force that participates fully in ;uality improvement activities" (uch participation is reinforced by re)ard and recognition systems )hich emphasize the achievement of ;uality ob6ectives" On!going education and training of all employees supports the drive for ;uality" Employees are encouraged to ta#e more responsibility, communicate more effectively, act creatively, and innovate" +s people behave the )ay they are measured and remunerated, TT2 lin#s remuneration to customer satisfaction metrics" A TQM ;(74()+ ItMs not easy to introduce TT2" +n open, cooperative culture has to be created by management" Employees have to be made to feel that they are responsible for customer satisfaction" They are not going to feel this if they are e5cluded from the development of visions, strategies, and plans" ItMs important they participate in these activities" They are unli#ely to behave in a responsible )ay if they see management behaving irresponsibly ! ?? | P a g e

saying one thing and doing the opposite" P)1,(;4 ,+*+7132+04 .0 - TQM +0*.)102+04 Product development in a TT2 environment is very different to product development in a non!TT2 environment" Jithout a TT2 approach, product development is usually carried on in a conflictual atmosphere )here each department acts independently" (hort! term results drive behavior so scrap, changes, )or#!arounds, )aste, and re)or# are normal practice" 2anagement focuses on supervising individuals, and fire!fighting is necessary and re)arded" Product development in a TT2 environment is customer!driven and focused on ;uality" Teams are process!oriented, and interact )ith their internal customers to deliver the re;uired results" 2anagementMs focus is on controlling the overall process, and re)arding team)or#" A=-),9 >1) Q(-7.4' -;/.+*+2+04 The 4eming Prize has been a)arded annually since 1FB1 by the @apanese $nion of (cientists and Engineers in recognition of outstanding achievement in ;uality strategy, management and e5ecution" (ince 1F?? a similar a)ard /the 2alcolm 'aldrige 1ational Tuality +)ard0 has been a)arded in the $(" Early )inners of the 'aldrige +)ard include +T3T /1FF20, I'2 /1FF<0, 2illi#en /1F?F0, 2otorola /1F??0, Te5as Instruments /1FF20 and Sero5 /1F?F0"

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CHAPTER SEVEN

TQM TOOLS

T14-7 Q(-7.4' M-0-<+2+04 ?TQM@ T1179

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Total ;uality management /TT20 tools help organizations to identify, analyze and assess ;ualitative and ;uantitative data that is relevant to their business" These tools can identify procedures, ideas, statistics, cause and effect concerns and other issues relevant to their organizations" Each of )hich can be e5amined and used to enhance the effectiveness, efficiency, standardization and overall ;uality of procedures, products or )or# environment, in accordance )ith I(O F<<< standards /(T, 2<<=0" +ccording to Tuality +merica, Inc" /%e&elle, 2<<*0 the number of TT2 tools is close to 1<< and come in various forms, such as brainstorming, focus groups, chec# lists, charts and graphs, diagrams and other analysis tools" In a different vein, manuals and standards are TT2 tools as )ell, as they give direction and best practice guidelines to you and:or your staff" TT2 tools illustrate and aid in the assimilation of complicated information such as9 _ identification of your target audience _ positive and negative forces affecting business _ assessment of customer needs _ competition analysis _ mar#et analysis _ brainstorming ideas _ productivity changes _ various statistics F1 | P a g e

_ staff duties and )or# flo) analysis _ statement of purpose _ financial analysis _ model creation

_ business structure _ logistics analysis The list goes on, though essentially TT2 tools can be used in any situation, for any number of reasons, and can be e5tremely effective if used properly" TQM T1179 The follo)ing are some of the most common TT2 tools in use today" Each is used for, and identifies, specific information in a specific manner" It should be noted that tools should be used in con6unction )ith other tools to understand the full scope of the issue being analyzed or illustrated" (imply using one tool may inhibit your understanding of the data provided, or may close you off to further possibilities"

P.+ C/-)49 -0, B-) #)-3/9 _ $sed to identify and compare data units as they relate to one issue or the )hole, such as budgets, vault space available, e5tent of fonds, etc" H.941<)-29

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_ To illustrate and e5amine various data element in order to ma#e decisions regarding them" _ Effective )hen comparing statistical, survey, or ;uestionnaire results"

R(0 C/-)4 _ >ollo)s a process over a specific period of time, such as accrual rates, to trac# high and lo) points in its run, and ultimately identify trends, shifts and patterns"

P-)+41 C/-)49 B A0-7'9.9 /designed by &ilfredo Pareto0 _ %ates issues according to importance and fre;uency by prioritizing specific problems or causes in a manner that facilitates problem solving"

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Identify groupings of ;ualitative data, such as most fre;uent complaint, most

commonly purchased preservation aid, etc" in order to measure )hich have priority" _ .an be scheduled over select periods of time to trac# changes" They can also be created in retrospect, as a before and after analysis of a process change"

F1);+ F.+7, A0-7'9.9 _ To identify driving and restraining forces occurring in a chosen process in order to understand )hy that particular process functions as it does" >or e5ample, identifying the driving and restraining forces of catering predominantly to genealogists" _ To identify restraining forces that need to be eradicated, or driving forces that need to be improved, in order to function at a higher level of efficiency" C-(9+ -0, E>>+;4A I9/.8-=- 1) F.9/:10+ D.-<)-29 /designed by Aauro Ishi#a)a0 _ Illustrates multiple levels of potential causes /inputs0, and ultimate effects /outputs0, of problems or issues that may arise in the course of business" _ 2ay be confusing if too many inputs and outputs are identified" +n alternative )ould be a tree diagram, )hich is much easier to follo)" F= | P a g e

 F1;(9 #)1(39 _ $seful for mar#eting or advertising organizations to test products on the general public" _ .onsist of various people from the general public )ho use and discuss your product, providing impartial feedbac# to help you determine )hether your product needs improvement or if it should be introduced onto the mar#et" B)-.0941)2.0< -0, A>>.0.4' D.-<)-29 _ Teams using creative thin#ing to identify various aspects surrounding an issue" _ +n affinity diagram, )hich can be created using anything from enabling soft)are to post!it notes organized on a )all, is a tool to organize brainstorming ideas" T)++ D.-<)-2 _ To identify the various tas#s involved in, and the full scope of, a pro6ect" FB | P a g e

_ To identify hierarchies, )hether of personnel, business structure, or priorities" _ To identify inputs and outputs of a pro6ect, procedure, process, etc"

F71=;/-)49 -0, M1,+77.0< D.-<)-29 _ +ssist in the definition and analysis of each step in a process by illustrating it in a clear and comprehensive manner" _ Identify areas )here )or#flo) may be bloc#ed, or diverted, and )here )or#flo) is fluid" _ Identify )here steps need to be added or removed to improve efficiency and create standardized )or#flo)"

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S;-44+) D.-<)-2

_ To illustrate and validate hunches _ To discover cause and effect relationships, as )ell as bonds and correlations, bet)een t)o variables _ To chart the positive and negative direction of relationships

R+7-4.109 D.-<)-2 FH | P a g e

_ To understand the relationships bet)een various factors, issues, events, etc" so as to understand their importance in the overall organizational vie)" PDCA _ The Plan!4o!.hec#!+ct style of management )here each pro6ect or procedure is planned according to needs and outcome, it is then tested, e5amined for efficiency and effectiveness, and then acted upon if anything in the process needs to be altered" _ This is a cyclical style to be iterated until the process is perfected" +ll of these TT2 tools can be easily created and e5amined by using various types of computer soft)are /Polloc#, 2<<*0 or by simply mapping them out on paper" They can also be easily integrated into team meetings, organizational ne)sletters, mar#eting reports, and for various other data analysis needs" Proper integration and use of these tools )ill ultimately assist in processing data such as identifying collecting policies, enhancing )or# flo) such as mapping ac;uisition procedures, ensuring client satisfaction by surveying their needs and analyzing them accordingly, and creating an overall high level of ;uality in all areas of your organization"

P7-00.0< - C/-0<+"

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 TQM PROBLEM SOLVIN# SEQUENCE"

TQM P !ce%% Im+ !-ement (n& P !"lem S!l-ing Se2$ence

3O PLA) #)-(* ( 42(*CE$ T2E 42(*CE$ 3EFI)E THE PROBLEM 1" %ecognize doing is a [P%O.E(([ 9. Identify the commodity being processed. 7 )rocess Inference G" I3E)TIFY POSSIBLE CA5SES E6AL5ATE POSSIBLE CA5SES ?" 4etermine the MA4E A CHA)7E )hat change Qour #no)ledge CHEC4 T2E E55E4T"$ TEST THE CHA)7E )hat change )or#ed ,istograms .ontrol charts - sampling (catter .ontinue to monitor the process to ensure9 +" The problem is fi5ed and 8. The process is good enough o 4ontrol charts * sampling H. ,escribe the <)=+4E""< o )rocess 5low OOOOTo ensure continuous improvement, return for good" ACTIO) #EM8E, T2E 5IX I*T+ T2E )=+4E"" 5+= C++,$ TA4E PERMA)E)T ACTIO) embedded in process the is #IM)-EME*T #+8"E=JE

1<" 4etermine 11" 4etermine 12" Ensure the fi5 is process and that the used"

that )hat you are ['%+I1(TO%2[ relationship problem" @. ,etermine what past data shows. o 5re uency distribution o )areto charts o 4ontrol charts A. ,efine some * sampling measurable characteristics of value to the commodity. o (catter diagrams o %egression analysis

)hat is causing the bet)een cause and effect )ould help

/confirmation0" resulting

D. ,etermine what the of the process process is doing now (catter o 4ontrol charts 7 sampling diagrams - sampling Pareto analysis OOOOThen ma%e the change.

.ontrol .harts diagrams

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(nalysis0s o 5low charts o -ist of steps B. Identify the <8igPproblem o 8rainstorming o 4hec%lists o )areto analysis

to step B.

CONCLUSION

This pro6ect concludes that Total Tuality 2anagement /TT20 has many benefits but implementing TT2 is not a bed of roses" It cannot be left to its o)n fate after the launch and re;uires constant nurturing and follo)!up by the management" 2anagement must #eep its fingers on the pulse of TT2 efforts as bringing a change in culture, attitudes, and beliefs in a sensitive and delicate matter" Problems in implementation are, therefore, to be e5pected and are universal in nature" ,o)ever patience and loyal efforts are re;uired to solve these problems" TT2 can lead to a drastic change in the productivity of an org" if implemented properly" In recent years, TT2 has been the most focused area of research

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as compared to other disciplines both in the industrial and academic )orld" The literature is abundant )ith theories and applications" (ince the benefits of TT2 are many therefore it doesn8t pervade only to all the sectors of the business but also to the society"

TEXT REFERENCES

1. 6,+14'OOA O> TOT+- T$+-ITQ 2+1+ E2E1TO, R.P.MO !"#$ 2. JJJ"I(IS(I 2+".O2 3. JJJ"JIAEPE4I+".O2 4. NTT2 TOO-( +14 TOO- AIT(O, %.Re&elle 1<2 | P a g e

5. JJJ"*G<!I'2".O2

DIA#RAMATIC REFERENCES

1. JJJ"QE+4O1I1.".O2:4I+ %+2" I> 2. JJJ"T+P%O@E.T"O% :I2+ E(:(.+TTE%4I+ %+2" I>

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