MQc a l l i d u s .Ve r l a g w i s se n sc h af t lic he r P u b lik at ione n

Imprint 2008 c a l l i d u s .Ve r l a g w i s se n sc h a f t l i c h e r P u b l i k at io n e nQAll rights reserved. No part of this book may be reproduced in any form or by any electronic ormechanical means including information storage and retrieval systems without permission in writingfrom the publisher, expect by a reviewer, who may quote brief passages in a review.Published with the support of the programme PNCDI2.Published by:c a l l i d u s .Verlag wissenschaftlicher PublikationenTechnologie- und ForschungszentrumAlter Holzhafen 19D-23966 .deCover and interior designed by:callidus. Verlag wissenschaftlicher Publikationen, WismarTranslated by:Eva Nicoleta Burdusel, Sibiu/RomaniaPrinted by:PRESSEL Digitaldruck, RemshaldenPrinted in GermanyISBN 978-3-940677-50-1

MQConstantin OpreanClaudiu Vasile KiforQuality Managementc a l l i d u s .Ve r l a g w i s se n sc h af t lic he r P u b lik at ione n

ContentsForewordChapter 1. Quality. Definitions and Basic Concepts1.1 The Organization. The Internal and External Environment of the Organization1.2 The Importance of Quality within the Current Economic Context1.3 Quality. Short History and Definition1.3.1 Systems for Inspection or Assessing Conformity1.3.2 Quality Control Systems1.3.3 Systems of Quality Assurance1.3.4 Quality Management Systems1.4 Concerns Regarding the People in Charge of Quality for the Developmentof the Quality Systems and Techniques1.4.1 An Approach to Quality by W. Edwards Deming1.4.2 An Approach to Quality by Joseph M. Juran1.4.3 An Approach to Quality by Armand V. Feigenbaum1.4.4 An Approach to Quality by Philip Crosby1.4.5 An Approach to Quality by Kaouru Ishikawa1.4.6 An Approach to Quality by Genichi Taguchi1.4.7 Quality Improvement in Sigheo Shingo’s Opinion1.4.8 An Approach to Quality by Claus Møller1.5 Internal and External Organizational Factors that Influence Quality1.5.1 The Influence of Environmental Factors and their Partnershipof the Organization1.5.1.1 The Market Factors and the Clients1.5.1.2 Technical and Technological Factors1.5.1.3 The Factors of the Suppliers‘ Environment1.5.1.4 Competition Factors1.5.1.5 Legal Factors1.5.1.6 Economic Factors1.5.1.7 Educational Factors for Human Resources1.5.1.8 The Socio-political and Cultural Factors1.5.2 The Internal Factors of the Organization which Influence the Qualityof the Accomplished Products1.5.2.1 The Structure of the Organization1.5.2.2 Organizational Processes1.5.2.3 The Staff, their Values and Creed1.6 Modern Concepts in Approaches to Quality. Competitive Global Quality1.6.1 The Dimensions of Quality1.6.2 The Competitive Global Quality1.7 Chronological Landmarks in the Evolution of Quality1.8 Romanian Legislation and Institutions in the Field of 434444464647474848495050565765

Chapter 2. Quality Management. Fundamental Principles and Elements2.1 Vision, Mission, Policy and Commitment2.1.1 The Concept of Quality Policy and Its Relationship withOrganizational Policy2.2 Organizational Culture and Quality2.3 Principles of Quality Management2.3.1 Client-oriented Approach2.3.2 Leadership2.3.3 Employee Involvement2.3.4 Process-based Approach2.3.5 Systemic Approach2.3.6 Continuous Improvement2.3.7 Information and Data-based Decision Making2.3.8 “Win-win” Relationship with Suppliers6970Chapter 3. Quality and Environment Patterns3.1 Introduction3.2 The ISO 9000:2000 Quality Management Standards3.2.1 The ISO 9000:2000 Standard3.2.1.1 The Structure of the ISO 9000:2000 Standard3.2.1.2 Conceptual Relationships and Graphic Representationof ISO 9000:2000 Terminology3.2.2 The ISO 9001:2000 Standard3.2.3 The ISO 9004:2000 Standard. Requirements, Comments, Case Studies3.2.3.1 The ISO 9004:2000 – An Overview3.2.3.2 The Quality Management System3. Quality Management System Documentation3. Document Control3. Records Control3.2.3.3 Management Responsibility3. Management Commitment3. Focusing on the Customer3. Quality Policy3. Quality Objectives3. Planning the Quality Management System3. Responsibility and Authority3. Management‘s Representative3. Internal Communication3. Management‘s Analysis3.2.3.4 Resource Management3. Human Resources3. Infrastructure and Work Environment3.2.3.5 Product 1121123124 Product Realization Planning3. Processes Related to Customer Relationship3. Design and Development3. Supply3. Service Production and Supply3. The Control of Monitoring and Measuring Devices3.2.3.6 Measurement, Analysis and Improvement3. Monitoring and Measurements3. Controlling Nonconformance3. Data Analysis3. Improvement3.3 The ISO 14000 Standard Series for Environmental Management3.3.1 Environmental Management and the ISO 14000 Standard Series3.3.2 Integrated Systems – Quality and Environment3.3.3 Implementing the Community System of EnvironmentalManagement and Audit3.4 The QS-9000 Standard3.5 The VDA Standard3.6 The ISO 16949 Standard3.7 The HACCP Model3.7.1 Description of Terms and Concepts Occurring in the HACCP System3.7.2 Reference Documents3.7.3 Principles of the HACCP Structure3.7.4 The HACCP Process3.8 The BS 8800:1996 Standard for Occupational Health and SafetyManagement Systems3.9 Patterns of Business Excellence3.9.1 European Quality Prize3.9.1.1 Fundamental Excellence Concepts(According to the EFQM Model) Evaluation and Qualification Procedure3.9.1.3 Basic Criteria for the European Quality Prize – Large Enterprise3.9.1.4 Basic Criteria for the European Quality Prize – Small andMedium Enterprises (SME)3.9.2 The Malcolm Baldrige American Quality Award3.9.3 The Edwards Deming Quality Award3.9.4 The Canadian Award for Business Excellence3.9.5 The Australian Quality Award3.9.6 The “J. M. Juran” Romanian Quality Award3.9.6.1 The Foundation for the “J. M. Juran” Romanian Quality Award3.9.6.2 The Mission, Vision and Values of the “J. M. Juran” RomanianQuality Award Foundation3.9.6.3 The Evaluation Pattern for the “J. M. Juran Romanian Quality 8180181181182183184184 Criteria Regarding the “Determination Factors” Criteria Referring to “Results”185186Chapter 4. Implementing the Quality Management System4.1 The Management of Organizational Change4.2 Implementing Quality Management4.2.1 Quality Management and Change4.2.2 Implementing Quality Management4.3 Organization for Quality4.3.1 The Quality Manager4.3.2 Executive Committees and Teams4.3.3 Quality and Process Improvement Teams4.3.3.1 Team Selection and Management4.3.3.2 Team Objectives4.3.3.3 Team Meetings4.3.3.4 Team Tasks4.3.3.5 Team Dynamics4.3.3.6 Team Results and Analyses4.3.4 Quality Circles or Kaizen Teams4.3.4.1 The Structure of Quality Circles4.3.4.2 Training Quality Circle Leaders and Members4.3.3.3 Quality Circle/Kaizen Team Activity4.3.5 Departmental Purpose 210210211212212212Chapter 5. Quality Systems Audit and Certification5.1 Quality Evaluation5.2 Quality Audit5.3 Quality Certification5.3.1 TÜV Rheinland Berlin Brandenburg Certification5.3.1.1 TÜV Rheinland Berlin Brandenburg – Brief Description5.3.1.2 TÜV Rheinland Berlin Brandenburg – Certification Process5.3.2 SIMTEX-OC Certification5.3.3 Romanian Auto Registry (RAR) Certification5.3.3.1 RAR – Outline5.3.3.2 The Evaluation and Recording Process5.3.3.3 Final Evaluation, Quality System Certification and Registration5.3.3.4 Using the RAR-OCS x. List of Renar Authorised Organizations233Bibliography / List of Abbreviations236Biography240

QM Quality ManagementForewordQuality – an essential principle and concept in the evolution of things and phenomena– has been long dealt with and thoroughly studied by specialists in various areas. However, research on quality has never been comprehensive or completed, precisely because of its complexity and the multiplicity of approaches in order to unveil its essence.Therefore, any theoretical approach to the concept of quality evinces contradictoryopinions as well, and this is not surprising for any thorough and objective research.Any attempt to define quality levels entails even more controversial issues, as thesenotions cannot be generally and unanimously accepted by everyone. The main reasonof differentiated or even differing perceptions of these aspects stems from the tremendous variety of its beneficiary, i.e. client.Experience has shown that an organization is the result of maintaining balance in thecontext of major turbulences triggered by internal and external constraints in pursuitof profit - the output of organizational process that justifies survival.In this context, organizations are able to improve their managerial strategies so that allefforts are focused on meeting client needs and requirements, provided that trust inproduct accomplishment is testified by quality assurance.Experience has testified that open borders allow free circulation of products, services,capital and people all over the world, facilitated by the European Union area. Consequently, one can notice a growing personalization of products that are going to becomebetter known than the name of most countries worldwide. Such personalization canonly be achieved in the world by means of a quality standard placing them at the top ofa great number of similar products.Organizations need to invest much effort in order to attain this level of competitiveness in a highly competitive economy, where supply greatly exceeds demand. Giventhis situation, it is imperative to develop and implement a system of quality management at the organizational level in order to achieve objectives included in the strategicplans of the organizations.The present study aims to clarify important quality-related concepts, as well asapproaches to quality by some weel-known specialists in the field. Quality management is presented in a modern perspective, accompanied by related issues in the fieldof environment management and occupational health and safety management. Thebook also provides an original scientific approach to other important aspects of auditing and certifying quality systems.

ForewordAll the issues dealt with in the present study represent a fundamental basis for furtherunderstanding and knowledge for specialists in all areas that evince any interest inaccomplishing quality.The study is also addressed to undergraduates and postgraduates who study QualityManagement as a discipline included in their curriculum. The book, however, is animportant reference for anyone interested in further aspects about quality and itseffects.The authors would like to express their heartfelt thanks to all colleagues, membersof the Quality Research Center, whose activity and unfailing contribution have helpedincrease the competence and prestige in the field of quality for all academics at the“Lucian Blaga” University of Sibiu.Authors

QM Quality Managementwhere a company meets with many suppliers, regulations, consumer groups and atough competition.A maximum level of uncertainty, given by a very dynamic and complex environment, is to be found on the computer market, marked by a rapid rate of technological innovation and significant changes as regards consumers, suppliers andcompetitors.Thompson set forth a new way to assess the environment where the organizationworks. The organizations consider the environments where they act according to fivecompetitive factors: Danger of new entries on a certain market or market segment. This is consideredto be business that needs small capital (cleaning services, pastry) but also new entriesrequiring large capital (Mercedes, Toyota in the U.S.A, Daewoo in Romania) Competition among the dominant organizations on the market (jockeying amongcontestants - deceit among the competitors). For example, “Coca-Cola” and “Pepsi”,which so often undertake a war of prices, as well as the advertising companies and thepresentation of new products. The large car companies often find themselves in sucha situation. Danger of substitution products represents the degree to which alternative products or services lower the demand for products or existing services. Therefore, microcomputers have cut down the demand for huge computers and typewriters; saccharinereduces the demand for sugar. Purchasing power represents the extent to which merchandisers have the possibility to influence the supplying organizations. For example, only certain organizationscan buy Boeing 747 planes. Or let us consider the general decrease of the purchasingpower in Romania nowadays, which has an influence on the output of many organizations providing goods and services. The power of suppliers represents the extent to which suppliers have the ability toinfluence the buyers’ potential. Therefore, one should mention the case of the monopoly market when the suppliers can enforce whatever they wish (e.g. electricity). Insuch cases the state intervention to cut down the effect of the monopoly is imperative.Another example is the manufacture of large planes with more than 300 passengerseats – extremely advantageous to purchase.Environment disturbance is linked to the devastating results of some accidentssuch as earthquakes, nuclear accidents at Chyrnobel and Three Mile Island, leaks oftoxic gas in Bhopal India, the explosion of the spaceship Challenger.Understanding the way in which the organizations act when changes occur in theenvironment is a necessary step in order to realize the consequences of the environmental impact on the organizational culture. There are five different ways in whichthe organizations react to the influence of the environment on them, namely: Information. Information management is important for the understanding of theenvironment and in order to take steps to employ the favorable elements of the environment or counteracting the unfavorable elements.18

Chapter 1. Quality. Definitions and Basic Concepts Strategic response. After the managers have accomplished the required level ofunderstanding they must create a strategic answer. Mergers, takeovers and acquisitions. The merger takes place when two ormore companies combine themselves in order to create a new one, and the takeoverarises when a company buys another company (in spite of its will) The design of the organizational structure. This is being accomplished according to the environment. Organizations that operate within an environment with a lowdegree of uncertainty can project a bureaucratic- like organizational structure, andthose operating within an environment with rapid changes will project a more flexible,organic-like organizational structure. The direct influence on the environment. Organizations are not always powerless facing the environment. They can and must influence the environment in differentways. Organizations use some techniques to influence suppliers (more suppliers, longterm contracts with pegged prices), competitors (prices, quality), clients (advertisement, new use for products, new requirements), trade unions.Organizations must take into account the environmental conditions of wherethey carry out their activity. And to function best, they must continuously tally theirorganizational culture with the changes that may occur. This adjustment is a matter ofdecision-making, organizing and planning and requires adequate attention.1.2 The Importance of Quality within the Current Economic ContextThe realities of the contemporary world highlight a very dynamic evolution both froma political and economic point of view. This occurs after a relatively long period ofmore than 50 years. The ‘90s have also meant the decline from a political point of viewand practically the failure of the communist system, due mostly to the huge discrepancy between the communist and the capitalist systems. The excessive centralizationof decision elements in all fields of social life, mostly in the economic area, proved tobe unprofitable, cumbersome and unproductive. The consequence was that a greatnumber of communist countries, which have experimented or rather were compelledto adopt the economic communist model, were forced to admit its failure and turn itinto a new system. Our country belongs to this category and the end of the centuryfound the Romanian society under the aegis of a tough fight to overcome the discrepancy created within this historical period as compared to other European countriesand from other parts of the world. The transition towards such an organization hasimplied and entails many problems to be solved, and different solutions are beinglooked for. The difficulties of the transition are emphasized by the characteristics ofthis period in which the economic outlook highlights a diversity and rapid renewal ofmerchandise supply under the impact of revolutionary progress in science and technology and a serious growth of home and foreign competition. This happens since moreand more organizations take over and practice free trade and new industrial policies.We can outline the following as in figure 1.5 [46] by analyzing the evolution of the mainfactors of competitiveness:19

QM Quality ManagementInfluence (%) on competitiveness Until 1950 the most important factor was to manufacture products with lowerprices by using cheap labor force, achieved by a specialization of the working place soas to allow the employment of a weakly trained staff, therefore having poor claims inbeing paid. Until 1980 the price of products continued to be a competitive factor, accomplishedby taking into account the automation of production. This cut down manual laborexpenses and increased work productivity. After 1980 two new important competition factors arose, such as the quality ofproducts and adjustment to the market requirements. Under the conditions of apowerful intensification of competition, the high demands of clients increased and,consequently, only those organizations won the competition that were able to ensurethe required flexibility to satisfy the demands of the consumers regarding the rangeand accrued specifications asked for the products.QualityAbility toadapt tothe marketProductionautomationLow wagespolicy195019601970198019902007YearFig. 1.5 The influence of major factors on organization competitivenessUnder the conditions of the free market, of free competition, the fundamentalrequirement for the success of an organization is competitiveness. Its objectives are towin and maintain the market segment to which it appeals with the products (goods orservices) offered under conditions of profitability. Organizations delivering the samekind of products are found in continuous competition and therefore, there is a continuous preoccupation for the growth in competition. It is a process which starts with the20

Chapter 1. Quality. Definitions and Basic Conceptssetup of the organization and never comes to an end because the loss of competitionmay lead to bankruptcy.The characteristics for the competitiveness of any organization are rendered infigure 1.6 [37]. These are product quality, industrial activity, staff, commercial andfinancial activity [52].EFFICIENT MANAGEMENT– TOTAL QUALITY –Product Operation Design Innovation Investigation Prospect Material Prototype TestsIndustrialactivityHumanresource Buildings Installation Equipment Organization Material Quality Methods Processes Logistics Professionalism Motivation Training Payment Mobility Passivity Cooperation Life quality InvolvementTradeFinance Marketing Image Sales Service Guarantee Customers Costs Advertisements Resources Assets Investment Reimbursement Loan Financialmatters Balance PlanningFig. 1.6 The characteristics of organization competitivenessAn organization is the more competitive as the quality of its product improves, itsindustrial activity becomes more efficient, the staff becomes better trained and moreinvolved in the working process, the commercial and financial activities are carried outin time, while assuring and continuing competitiveness.This represents the basic targetfor any management pattern.Any organization, whether small or large, state run or private, providing goods orservices (even commerce only) can be competitive only if it produces, sells and earnsfrom sales. Many factors might occur throughout this process some may disturb andeven hinder the activity and some may determine the success of the sales. They includethe market conditions, the nature of the product, the image created by the advertise21

QM Quality Managementimplementation of ISO 14001. The ISO 9001:2000 standard even presents a correspondence between requirements of the ISO 9001 and the ISO 14001. The realizationof such a quality-environment integrated system will have as a result the same area ofdocumentation, but also specific documents, requested by the two standards.One can identify two large categories of similarities between the two systems: atthe core structure of reference standards and at the concrete aspects of the two maindomains: quality and environment.In the first case we are talking about the main ideas of the management systems,which are to be found in both the ISO 900 and ISO 14000 standards, as seen in table 3.7General principlesof managementsystemsDesign andimplementation of an internalsystem – guidelinesOperation – specificationsAssessmentinstruments Internal(assessment) External(certification)ISO 14000 standard- environment -ISO 14004Guidelines for EMSISO 14001Specifications and guidanceISO 14010,14011, 14012EMS auditISO 9000 standard- quality -ISO 9004Guidelines for QMSISO 9001Quality management patternISO 19011QMS auditTable 3.7 Similarities between ISO 9000 and ISO 14000 standards principlesThese resemblances may be detailed at paragraph level, which are almost identicalfor the reference standards of the two systems, ISO 9001 and ISO 14001 (table 3.8)ISO 14001 - 1996ISO 9001 - nment policy4.25.3Quality policyTraining, awareness, competence4.4.16.2Human resourceDocument control4. controlRecords4. controlEMS audit4. auditAnalysis performed by management4.65.6Analysis performed by managementTable 3.8 Similarities between ISO 9001 and ISO 14001 standards requirementsa. Similarities between particular approaches regarding the two areas:quality and environmentThere are numerous similarities and that is why organizations that choose distinctquality and management systems are becoming fewer and fewer. The most importantaspects regarding the common denominator of the concrete level of designing, implementing and operating environment and quality management are listed below:154

Chapter 3. Quality and Environment Patterns both standards take into account the concept of “continuous upgrading” both standards take into account the “prevention concept” both standards have placed the human factor at the core of creating, implementingand operating the management system.b. Differences between the quality management system and the environment management systemThe most often quoted difference is that each system has its own reference document, its own standard with special requirements.Except the differences strictly connected to the contents of the two standards,there are numerous differences to be seen regarding the specific nature of the domainsthat we compare: quality and environment.c. Types of integration of the quality – environment management systemResemblances and differences between the two management systems may beused as arguments for implementing them completely or partially for each separateorganization. The fact that there are both fully integrated systems and partially or nonintegrated systems reveals the fact that the particular conditions of each organizationare very important in making the right decision. The relationship between the QMSand EMS may be revealed in three situations: fully integrated systems, partially integrated systems, separate systems.Complete integration requires: Drafting the quality and environment policies in a single document Elaborating a unique manual of quality – environment, based on common proceduresand special procedures Elaborating a documentation containing as many common documents as possible,with the participation of staff which has responsibilities in both quality and environmental areas Process integration Human resources integration.Partial integration may be summed up in several ways, by combining the followingsituations: separated or unique quality-environment policies separated or unique quality – environment manual partially integrated system procedures specific environment instructions and procedures specific quality instructions and procedures partial process integration partial human resources integration.Separate systems include the drafting of: distinct policies distinct manuals for quality and environment environmental procedures, instructions and recordings quality procedures, instructions and recordings.155

QM Quality ManagementThe elements stated above are to be found in table 3.9Complete integrationPartial integrationEnvironment and qualitymanual. Methods andguidance for environment and qualityEnvironment and quality manual.Methods andguidance forenvironmentMethods andguidance forqualityDatabase inputSeparate systemsEnvironment manualQuality manualMethods and guidancefor environmentMethods andguidance forqualityEnvironment inputQuality inputTable 3.9 Quality-environment systems: types of integrationAn organization undergoing a certification process, or which does already holda certificate for a quality management system and aims to implement an environmentmanagement system, is advised to develop an environment management system, butwith a unitary conception and to obtain the ISO 9000 and ISO 14000 certificates.For an organization that has neither a quality management system nor an environment management system, a simultaneous manner of obtaining them is advised, in aunique organizational concept and with a concentrated effort to implement and certifythe two systems.3.3.3 Implementing the Community System of EnvironmentalManagement and AuditThe preoccupation for promoting sustainable development has become more andmore obvious within the European Union for the past few years. We may single outthe following landmarks, in this respect: The Maastricht treaty of 07.02.1992, which sets forth, among others, promotion ofsustainable development in the E.U. CEE resolution of 01.02.1993 regarding the action program “Towards a sustainabledevelopment”, a special program for the implementation of EU policy regarding environment protection and ensuring such a development CEE regulation no.1836/29.06.1993 regarding voluntary participation by organizations from the industrial sector to a community environment and audit managementsystem (European Environmental Management and Auditing Scheme – EMAS), whichbecame valid on the 13.04.1995.With the community system for audit and environmental management the European Union hopes to achieve the continuous upgrading of its results regarding theenvironment of industrial activities, taking the following elements into account: Elaborating and implementing environmental management systems, policies and programs by the organizations Systematic and objective assessment of the efficiency of applied environmentalmanagement systems, policies and programs Keeping the public informed about organization results in this respect.156

Chapter 3. Quality and Environment PatternsIn order to implement the community system for environment and audit management, the EEC regulation sets forth the following prerequisite stages (chart 3.28)[37,38]:Adopting environment policyLocation environment programDrafting environment programEnvironment management systemdesign and implementationPerforming location internal auditsDefining objectives for continuousimprovement of environment – related resultsDrafting environment statementChecking conformity in keeping withEU regulationContinuousimprovementEnvironment statement validationDissemination of validated statementto the competent bodyLocation recordingDissemination of validated environmentstatement to the publicUsage of participation statementChecking conformity with E.U. regulationFig. 3.28 The stages of applying the community system for audit and environmental management Adopting an environment policy, in keeping with the requests stated in theregulation, namely: defining the policy in writing, its connection with the environmen157

QM Quality ManagementBiographyProfessor Constantin Oprean, Rector of the „Lucian Blaga” University of Sibiu,was born in Spring, Alba county, in 1948. He graduated from the Polytechnical University of Bucharest, Faculty of Machine Building Technology (1971), was awarded a engineering (1985) and has been a doctoral advisor (since 1992). Professor Constantin Oprean has over 30 years of experience in higher education.His academic tours abroad include USA, France, Great Britain, Italy, Germany, Sweden, Denmark, Belgium, Holland, Finland, Australia and Greece. He is specialized inthe fields of: quality management, academic management, strategic management, occupational safety and health management, and technological transfer.Professor Constantin Oprean has authored and co-authored over 35 books/manuals,310 scientific lectures and papers, 26 patents and over 50 nati

callidus. Verlag wissenschaftlicher Publikationen, Wismar Translated by: Eva Nicoleta Burdusel, Sibiu/Romania Printed by: PRESSEL Digitaldruck, Remshalden Printed in Germany ISBN 978-3-940677-50-1. M Q . ness in a highly competitive economy, wh