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From total quality management to Quality 4.0: A systematic literature review and future research agenda

• Review Article
• Open access
• Published: 13 March 2023
• Volume 10 , pages 191–205, ( 2023 )

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• Hu-Chen Liu 1 ,
• Ran Liu 1 ,
• Xiuzhu Gu 2 &
• Miying Yang 3  

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Quality 4.0 is an emerging concept that has been increasingly appreciated because of the intensification of competition, continually changing customer requirements and technological evolution. It deals with aligning quality management practices with the emergent capabilities of Industry 4.0 to improve cost, time, and efficiency and increase product quality. This article aims to comprehensively review extant studies related to Quality 4.0 to uncover current research trends, distil key research topics, and identify areas for future research. Thus, 46 journal articles extracted from the Scopus database from 2017 to 2022 were collected and reviewed. A descriptive analysis was first performed according to the year-wise publication, sources of publication, and research methods. Then, the selected articles were analyzed and classified according to four research themes: Quality 4.0 concept, Quality 4.0 implementation, quality management in Quality 4.0, and Quality 4.0 model and application. By extracting the literature review findings, we identify the Quality 4.0 definitions and features, develop the quality curve theory, and highlight future research opportunities. This study supports practitioners, managers, and academicians in effectively recognizing and applying Quality 4.0 to enhance customer satisfaction, achieve innovation enterprise efficiency, and increase organizational competitiveness in the era of Industry 4.0.

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Ali K, Johl S K (2022). Soft and hard TQM practices: Future research agenda for Industry 4.0. Total Quality Management & Business Excellence, 33(13–14): 1625–1655

Article   Google Scholar  

Alzahrani B, Bahaitham H, Andejany M, Elshennawy A (2021). How ready is higher education for Quality 4.0 transformation according to the LNS research framework? Sustainability, 13(9): 5169

Antony J, McDermott O, Sony M (2022a). Quality 4.0 conceptualisation and theoretical understanding: A global exploratory qualitative study. TQM Journal, 34(5): 1169–1188

Antony J, Sony M, Furterer S, McDermott O, Pepper M (2022b). Quality 4.0 and its impact on organizational performance: An integrative viewpoint. TQM Journal, 34(6): 2069–2084

Antony J, Sony M, McDermott O, Jayaraman R, Flynn D (2023). An exploration of organizational readiness factors for Quality 4.0: An intercontinental study and future research directions. International Journal of Quality & Reliability Management, 40(2): 582–606

Asif M (2020). Are QM models aligned with Industry 4.0? A perspective on current practices. Journal of Cleaner Production, 258: 120820

Balouei Jamkhaneh H, Shahin A, Parkouhi S V, Shahin R (2022). The new concept of quality in the digital era: A human resource empowerment perspective. TQM Journal, 34(1): 125–144

Baran E, Korkusuz Polat T (2022). Classification of Industry 4.0 for total quality management: A review. Sustainability, 14(6): 3329

Broday E E (2022). The evolution of quality: From inspection to Quality 4.0. International Journal of Quality and Service Sciences, 14(3): 368–382

Bui L T C, Carvalho M, Pham H T, Nguyen T T B, Duong A T B, Truong Quang H (2022). Supply chain quality management 4.0: Conceptual and maturity frameworks. International Journal of Quality & Reliability Management, in press, doi: https://doi.org/10.1108/IJQRM-07-2021-0251

Chiarini A (2020). Industry 4.0, quality management and TQM world: A systematic literature review and a proposed agenda for further research. TQM Journal, 32(4): 603–616

Chiarini A, Kumar M (2022). What is Quality 4.0? An exploratory sequential mixed methods study of Italian manufacturing companies. International Journal of Production Research, 60(16): 4890–4910

Christou I T, Kefalakis N, Soldatos J K, Despotopoulou A M (2022). End-to-end industrial IoT platform for Quality 4.0 applications. Computers in Industry, 137: 103591

Clancy R, Bruton K, O’Sullivan D T J, Cloonan A J (2022). The HyDAPI framework: A versatile tool integrating Lean Six Sigma and digitalisation for improved quality management in Industry 4.0. International Journal of Lean Six Sigma, in press, doi: https://doi.org/10.1108/IJLSS-12-2021-0214

Di Vaio A, Hassan R, Alavoine C (2022). Data intelligence and analytics: A bibliometric analysis of human-artificial intelligence in public sector decision-making effectiveness. Technological Forecasting and Social Change, 174: 121201

Dias A M, Carvalho A M, Sampaio P (2022). Quality 4.0: Literature review analysis, definition and impacts of the digital transformation process on quality. International Journal of Quality & Reliability Management, 39(6): 1312–1335

Elibal K, Özceylan E (2022). Comparing Industry 4.0 maturity models in the perspective of TQM principles using Fuzzy MCDM methods. Technological Forecasting and Social Change, 175: 121379

Emblemsvåg J (2020). On Quality 4.0 in project-based industries. TQM Journal, 32(4): 725–739

Escobar C A, McGovern M E, Morales-Menendez R (2021). Quality 4.0: A review of big data challenges in manufacturing. Journal of Intelligent Manufacturing, 32(8): 2319–2334

Fonseca L, Amaral A, Oliveira J (2021). Quality 4.0: The EFQM 2020 model and Industry 4.0 relationships and implications. Sustainability, 13(6): 3107

Gebhardt M, Kopyto M, Birkel H, Hartmann E (2022). Industry 4.0 technologies as enablers of collaboration in circular supply chains: A systematic literature review. International Journal of Production Research, 60(23): 6967–6995

Glogovac M, Ruso J, Maricic M (2022). ISO 9004 maturity model for quality in Industry 4.0. Total Quality Management & Business Excellence, 33(5–6): 529–547

Hyun Park S, Seon Shin W, Hyun Park Y, Lee Y (2017). Building a new culture for quality management in the era of the Fourth Industrial Revolution. Total Quality Management & Business Excellence, 28(9–10): 934–945

Jacob D (2017). What is Quality 4.0? Online Blog

Kannan K S P N, Garad A (2021). Competencies of quality professionals in the era of Industry 4.0: A case study of electronics manufacturer from Malaysia. International Journal of Quality & Reliability Management, 38(3): 839–871

Maganga D P, Taifa I W R (2022). Quality 4.0 transition framework for Tanzanian manufacturing industries. TQM Journal, in press, doi: https://doi.org/10.1108/TQM-01-2022-0036

Maganga D P, Taifa I W R (2023). Quality 4.0 conceptualisation: An emerging quality management concept for manufacturing industries. TQM Journal, 35(2): 389–413

Nenadál J, Vykydal D, Halfarová P, Tylečková E (2022). Quality 4.0 maturity assessment in light of the current situation in the Czech Republic. Sustainability, 14(12): 7519

Prashar A (2022). Quality management in Industry 4.0 environment: A morphological analysis and research agenda. International Journal of Quality & Reliability Management, in press, doi: 10.1108/IJQRM-10-2021-0348

Ramezani J, Jassbi J (2020). Quality 4.0 in action: Smart hybrid fault diagnosis system in plaster production. Processes, 8(6): 634

Ranjith Kumar R, Ganesh L S, Rajendran C (2022). Quality 4.0: A review of and framework for quality management in the digital era. International Journal of Quality & Reliability Management, 39(6): 1385–1411

Sader S, Husti I, Daróczi M (2019). Industry 4.0 as a key enabler toward successful implementation of total quality management practices. Periodica Polytechnica Social and Management Sciences, 27(2): 131–140

Sader S, Husti I, Daroczi M (2022). A review of Quality 4.0: Definitions, features, technologies, applications, and challenges. Total Quality Management & Business Excellence, 33(9–10): 1164–1182

Saihi A, Awad M, Ben-Daya M (2023). Quality 4.0: Leveraging Industry 4.0 technologies to improve quality management practices, a systematic review. International Journal of Quality & Reliability Management, 40(2): 628–650

Santos G, Sá J C, Félix M J, Barreto L, Carvalho F, Doiro M, Zgodavová K, Stefanović M (2021). New needed quality management skills for quality managers 4.0. Sustainability, 13(11): 6149

Sariyer G, Mangla S K, Kazancoglu Y, Ocal Tasar C, Luthra S (2021). Data analytics for quality management in Industry 4.0 from an MSME perspective. Annals of Operations Research, in press, doi: https://doi.org/10.1007/s10479-021-04215-9

Silva C S, Borges A F, Magano J (2022). Quality Control 4.0: A way to improve the quality performance and engage shop floor operators. International Journal of Quality & Reliability Management, 39(6): 1471–1487

Singh J, Ahuja I P S, Singh H, Singh A (2022). Development and implementation of Autonomous Quality Management System (AQMS) in an automotive manufacturing using Quality 4.0 concept: A case study. Computers & Industrial Engineering, 168: 108121

Sony M, Antony J, Douglas J A (2020). Essential ingredients for the implementation of Quality 4.0: A narrative review of literature and future directions for research. TQM Journal, 32(4): 779–793

Sony M, Antony J, Douglas J A, McDermott O (2021). Motivations, barriers and readiness factors for Quality 4.0 implementation: An exploratory study. TQM Journal, 33(6): 1502–1515

Souza F F, Corsi A, Pagani R N, Balbinotti G, Kovaleski J L (2022). Total quality management 4.0: Adapting quality management to Industry 4.0. TQM Journal, 34(4): 749–769

Sozinova A A, Saveleva N K (2022). Marketing quality management in Industry 4.0 in transborder markets. International Journal of Qualitative Research, 16(3): 955–968

Sureshchandar G S (2022). Quality 4.0: Understanding the criticality of the dimensions using the analytic hierarchy process (AHP) technique. International Journal of Quality & Reliability Management, 39(6): 1336–1367

Sureshchandar G S (2023). Quality 4.0: A measurement model using the confirmatory factor analysis (CFA) approach. International Journal of Quality & Reliability Management, 40(1): 280–303

Tambare P, Meshram C, Lee C C, Ramteke R J, Imoize A L (2022). Performance measurement system and quality management in data-driven Industry 4.0: A review. Sensors, 22(1): 224

Tan T, Mills G, Papadonikolaki E, Liu Z (2021). Combining multi-criteria decision making (MCDM) methods with building information modelling (BIM): A review. Automation in Construction, 121: 103451

Thekkoote R (2022). Enabler toward successful implementation of Quality 4.0 in digital transformation era: A comprehensive review and future research agenda. International Journal of Quality & Reliability Management, 39(6): 1368–1384

Yadav N, Shankar R, Singh S P (2021). Critical success factors for Lean Six Sigma in Quality 4.0. International Journal of Quality and Service Sciences, 13(1): 123–156

Zheng T, Ardolino M, Bacchetti A, Perona M (2021). The applications of Industry 4.0 technologies in manufacturing context: A systematic literature review. International Journal of Production Research, 59(6): 1922–1954

Zonnenshain A, Kenett R S (2020). Quality 4.0: The challenging future of quality engineering. Quality Engineering, 32(4): 614–626

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Hu-Chen Liu & Ran Liu

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Group of Sustainability, School of Management, Cranfield University, Cranfield, MK43 0AL, UK

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This work was partially supported by the major project of National Social Science Fund of China (Grant No. 21ZDA024).

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Liu, HC., Liu, R., Gu, X. et al. From total quality management to Quality 4.0: A systematic literature review and future research agenda. Front. Eng. Manag. 10 , 191–205 (2023). https://doi.org/10.1007/s42524-022-0243-z

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Received : 31 July 2022

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Issue Date : June 2023

DOI : https://doi.org/10.1007/s42524-022-0243-z

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1 Introduction

2 presentation of the laboratory and its quality policy, 3 implementation of a quality management system: actions undertaken, 4 discussion, analysis and improvements, 5 conclusion.

• List of figures

Research Article

An overview of Quality Management System implementation in a research laboratory

Valérie Molinéro-Demilly 1 * , Abdérafi Charki 2 , Christine Jeoffrion 3 , Barbara Lyonnet 4 , Steve O'Brien 5 and Luc Martin 6

1 Horticulture and Seeds Research Institute (IRHS-MRU 1345), INRA/Agrocampus Ouest/University of Angers-42, rue Georges Morel, 49071 Beucouzé Cedex, France 2 Angevin Research Laboratory in Systems Engineering (LARIS–EA 7315), University of Angers, 62 avenue Notre Dame du Lac, 49000 Angers, France 3 Psychology Laboratory of Pays de la Loire (LPPL-UPRES EA 4638), University of Nantes, BP 81 227, 44312 Nantes cedex 3, France 4 Economy and Management Laboratory (LEMNA), University of Nantes, Chemin de la Censive du Tertre, B.P. 81227, 44312 Nantes Cedex 3, France 5 Decision Support Systems Research Centre (CERADE), ESAIP School of Engineering, 18 rue du 8 mai 1945, 49180 St Barthélemy d'Anjou, France 6 Agricultural Research Centre for International Development (CIRAD), Avenue Agropolis, 34398 Montpellier Cedex 5, France

* Corresponding author: [email protected]

Received: 7 June 2017 Accepted: 11 November 2017

The aim of this paper is to show the advantages of implementing a Quality Management System (QMS) in a research laboratory in order to improve the management of risks specific to research programmes and to increase the reliability of results. This paper also presents experience gained from feedback following the implementation of the Quality process in a research laboratory at INRA, the French National Institute for Agronomic Research and details the various challenges encountered and solutions proposed to help achieve smoother adoption of a QMS process. The 7Ms (Management, Measurement, Manpower, Methods, Materials, Machinery, Mother-nature) methodology based on the Ishikawa ‘Fishbone’ diagram is used to show the effectiveness of the actions considered by a QMS, which involve both the organization and the activities of the laboratory. Practical examples illustrate the benefits and improvements observed in the laboratory.

Key words: Quality / research / reliability / management / measurement / manpower / methods / materials / machinery / mother-nature

© V. Molinéro-Demilly et al., published by EDP Sciences, 2018

Over recent years, a number of public sector research entities have been adopting a Quality process in order to improve their organization. In France, French standards association (AFNOR) formally recommends adoption of a Quality process by scientists [ 1 , 2 ]. However, implementation of a quality process in a public organization can come up against specific problems not encountered in a private organization [ 3 ]. Research requires both rigour and transparency in the production of knowledge, and involves specificities in terms of objectives, resources and organizational skills that can be very different from those of the industrial sector in which a Quality process has traditionally been found. In view of this, it is clear that the implementation of a Quality Management System (QMS) within a public research organization cannot be carried out in the same way as in industry [ 4 ]. Clearly, the specific challenges that may be encountered in a research laboratory need to be addressed via specific solutions and actions to ensure the success of a QMS.

In the literature, few papers [ 5 – 7 ] deal with the implementation impact of QMS in a research laboratory. Spencer et al. [ 5 ] underline the advantages in Quality assessment of qualitative research for evaluations of research programmes. The quality of scientific research is often uneven and lacking in credibility, making it difficult to make a confident, concrete assertion or prediction regarding evidence for improving practice or consumer outcomes [ 6 , 7 ]. The debate is also due, in part, to the lack of consensus on the specific standards for assessing Quality research. Edmondson et al. [ 8 ] introduce a framework for assessing and promoting methodological fit as an overarching criterion for ensuring quality field research. Baker [ 9 ], Begley et al. [ 10 ], Giesen et al. [ 11 , 12 ], Bareille et al. [ 13 ] show the importance of a Quality process in sciences for improving research management and reliability.

In this paper, we identify the advantages of implementing a QMS in a laboratory of INRA, the French National Institute for Agronomic Research, whose mission is to produce and publish knowledge gained through reliable results, train researchers, offer expertise, create, and innovate.

After presentation of the quality policy of the laboratory, several Quality main actions are developed and discussed using a modified Ishikawa diagram [7Ms: Management, Measurement, Manpower, Methods, Materials, Machinery, Mother-nature (environment)] in order to show the effectiveness of implementing the QMS, which involve both the organization and the activities of the laboratory.

Practical examples are presented to demonstrate the benefits and improvements achieved by implementing a QMS in a research laboratory, as well as the challenges encountered and the solutions proposed to deal with these. The methodology uses the first author's own feedback drawn from three years' experience as Quality Manager in an INRA Laboratory.

2.1 Organization of the laboratory

The research laboratory (or to give it the INRA term, Unit) under observation was created in January, 2012 and is a relatively complex structure, operating under the auspices of three separate Institutions: INRA (French national institute for agronomic research), a School of Engineering (Agrocampus Ouest) specialized in agronomy and horticulture, and a University (University of Angers). As regards INRA, the laboratory is attached to three different scientific divisions, each covering several disciplinary fields where the research constantly explores new ground. The laboratory is the result of the merger of four MRUs (Mixed Research Unit), and currently numbers some 230 staff members organized into 16 teams ( Fig. 1 ). From INRA's point of view, this is a Very large scale unit (VLSU), as the number of staff exceeds 100, whereas the average number of staff in an INRA Unit is 25. However, we have become increasingly accustomed over recent years to Units that merge with a view to pooling resources (i.e. sharing equipment and reducing the number of posts in Research Support Services while giving greater visibility to the Units). The laboratory is therefore of recent formation and has been subjected to extensive structural change.

The laboratory conducts research projects in seeds and horticulture. It is committed to an integrated approach of coordinated effort and expertise in the fields of genetics, epigenetics, genomics, pathology, physiology, ecophysiology, biochemistry, modelling, statistics, and bioinformatics.

Prior to the creation of the laboratory in 2012, the four former MRU (Mixed research unit) teams were located on different geographical sites. Figure 1 also shows the institutional membership of the laboratory staff. The INRA teams had already begun implementation of a Quality process in the year 2000.

MRU 1 had been internally audited by the INRA Quality task force in 2008 in accordance with INRA Guidelines Version 1 [ 14 ]. The result of this audit concerning management responsibility, documentation and resources management was highly complimentary reflecting the considerable efforts the MRU had made to meet the requirements of the INRA Guidelines version 1.

MRU 2, a Biology Resource Centre (BRC) has had ISO 9001 certification [ 15 ] since 2008. This BRC has achieved international renown and has a very dedicated Quality manager.

In MRU 3, a Quality process had been introduced. Quality, equipment and metrology managers were appointed in this research unit.

MRU 4 was operating under the auspices of a University that had not adopted a Quality process for its research departments. The same was true for the teams working for the School of Engineering, which had ISO 9001 certification for academic activities only but not for the research activities. Nevertheless, all university and engineering school teams were using laboratory notebooks, had drawn up operating procedures, conducted equipment inventories, implemented life cycle files or equipment monitoring logs, and observed the minimum requirements concerning external checking of pipettes and weighing scales.

The first one was due to administrative dissimilarities between the three institutions (INRA, the School of engineering and the university). This obstacle has been solved by delegating management of the new VLSU to INRA via a contractual agreement;

The second one concerned the multidisciplinary nature of the scientific community and the need to get individuals with different backgrounds and habits working efficiently together as well as to create synergy around Quality within the laboratory. This necessity had already been identified when the four MRUs were created, and became even more apparent when the VLSU came into being. The laboratory defined an objective of constructing a common QMS for all its research activities. One of the actions decided upon was the recruiting in September 2013 of a Quality manager to work full-time on Quality, health, safety and environment;

The Quality manager's first task was to establish an inventory of the existing situation, before moving the laboratory towards harmonization of all practices, bringing them in line with INRA guidelines version 2 [ 16 ]. However, teams that had made significant progress as regards quality felt that they were being made to regress following the merger and there has been a need to involve and remotivate them via the Quality actions undertaken;

The third one was the geographical spread of the teams. In 2012, all teams were still dispersed over four distant sites. Communication and common working were facilitated when the Institutions that benefit from county council funding received a brand new building, which enabled teams to be relocated to a single site during the summer months of 2015.

2.2 The key to success: a committed Management Board

The success of a QMS depends on the commitment of staff, and most particularly that of top management. This commitment was formally expressed in a Quality policy statement (an obligatory step for any organization with ISO 9001 certification [ 15 ] or EN ISO/IEC 17025 accreditation [ 17 ]). The Quality policy outlines the objectives of the organization and the planned operational rollout of the associated action plan.

Guarantee reliability of measurable results via controlled methods and equipment;

Ensure traceability of research work;

Contribute to long-term conservation of data;

Guarantee quality of biological materials;

Guarantee quality of services provided by Biology Resource Centres (BRC);

Manage samples;

Contribute to human and environmental as well as collaborator risk management;

Ensure appropriate planning and organization of projects;

Harmonize practices, methods and operating procedures common to various teams;

Instigate appropriate and effective improvements.

2.3 Choosing Quality guidelines appropriate to a research organization

Convinced of the absolute necessity of the Quality process in the scientific environment, INRA officially embarked upon the Quality process in the year 2000. The INRA management coordination committee sent out its first Quality policy statement in March of that same year and instigated the INRA Quality task force. In 2005, INRA published its first Guidelines (Version 1) as well as introducing a self-assessment tool for the Units. These first Guidelines comprised five chapters: Quality Management and management responsibility; Documentation; Management of resources; Core activities; and Measurements, Analysis and improvement. In 2006, the first steps towards implementing the Quality process came into effect in INRA support services. A review of actions undertaken between 2000 and 2009 reveals the support given to the Quality process by the INRA Board of Management, the commitment of the research departments (12 out of 14), the commitment of the Units (25% in 2000 rising to 95% in 2004), and the application of international references such as ISO 9001 and EN ISO/IEC 17025 (15) for strategic platforms certified by the National commission for collective Tools (CNOC), as well as ISO 14001 [ 18 ] for Experimental Units, and ISO 9001 [ 15 ] or NF S 96-900 [ 19 ] for certified Biological resource centres.

INRA's next ambition was to extend the Quality process to research activities, thus bringing Quality to the very heart of INRA's activity. In 2012, the INRA Management coordination committee's new 2012–2016 Quality policy emerged. Version 2 [ 16 ] of the INRA Quality guidelines comprises five chapters: Quality management and responsibilities; Conducting research; Management of resources; Control of the documentation; and Measurements, analysis and improvement. This new version of the INRA Guidelines was presented to quality or metrology managers in laboratories.

This new guide is intended to be easy to read, using everyday language to ensure accessibility for the scientific community, since Quality terminology is rather specific and becoming familiar with it can take time. The INRA Quality task force also contributed to the drawing up of the NF X50-553 Standard (management of research activities) [ 2 ] and made sure the INRA Guidelines were consistent with this Standard. The INRA Guidelines deliberately make no reference to customers in order to avoid resistance from the scientific community to a concept commonly associated with the commercialization of knowledge. Version 2 of the INRA Guidelines is about accruement of experience and reinforcing continual improvement. It puts emphasis on conducting research as a process (design, implementation and publication/practical usefulness) with a view to managing and controlling the risks inherent during a research project. At the outset of the project, the person heading the research states the hypotheses involved, defines the experimental protocols, coordinates sampling/analyses/simulations, and interprets data and designates its uses.

The laboratory is required to draw up an inventory of all its research projects and establish research and/or experimental protocols. These protocols cover the objectives defined for the research project as well as the resources necessary to achieve them (methods, materials, resources, installations; persons and entities involved, provisional schedule, critical aspects requiring special attention and procedures for communication, retention period of samples and data, as well as any other specific criteria). The INRA version 2 Guidelines also put emphasis on management of methods: their formalization and validation, and the uncertainties associated with quantitative results. The version 2 INRA Guidelines come with a new dedicated self-assessment tool for the research units and specific tools for the implementation of the Quality process at national level: the INRA Quality task force is coordinated by a network of Quality managers located in centres across 17 different sites in France and the 13 scientific divisions. However, the ideal is not so easy to achieve in reality and many of the scientific divisions that were involved with the first version of the guidelines have since lost interest in the Quality process, and some centres are still without a Quality manager. The effect of this is to isolate the Quality managers in the units, just as these units undergo the process of merging and have growing staff levels.

When it comes to the VLSU, structural complexity complicates smooth coordination, as is evident in the case of the biology laboratory under observation: acceptance of the INRA guidelines needs to be achieved across 16 Laboratory teams (irrespective of the institute individuals belong to), in the centre of INRA Angers-Nantes, and in the three INRA scientific divisions (only one of which has a Quality manager).

At the same time, in the face of such extensive restructuring, the implementation of a QMS could actually be seen as an opportunity, offering the possibility on the one hand of managing risks specific to research activities, and on the other of enhancing cohesion between teams and ensuring that knowledge acquired is put to good purpose.

3.1 Managing the 7 Ms in a laboratory

The research community is agreed on the principle that scientific publications must be founded on reliable scientific data obtained in an environment where all factors capable of influencing the quality of a result (see Fig. 2 ) are tightly controlled [ 20 – 24 ]. These factors can be displayed in the manner of the Ishikawa Fishbone diagram with 7 principal categories (see Fig. 2 ): Machinery, Methods, Materials, Mother-nature (environment), Manpower, Management and Measurement.

Assessing the reliability of research results consists in attributing a confidence level relative to both the obtainment and the use of the results. In the case of research activities, it can be difficult to assess reliability with an appropriate confidence level but the minimum that can be expected is to be in control of all the factors mentioned in Figure 2 . The implementation of a QMS which integrates the principle of the 7 Ms constitutes an opportunity to ensure quality of research results, and to improve and obtain recognition of the work carried out in a research laboratory.

The main actions implemented in the laboratory under observation are described in the following sections, for each of the influence factors illustrated in Figure 2 . All actions that were put into effect came about as a result of the continual improvement dynamic brought to the laboratory by the existence of the QMS.

3.2 Management and Manpower

The QMS constitutes a tool with which to control and steer the activities of the unit.

The laboratory has chosen to adopt an integrated approach to Quality management that includes aspects linked to prevention and sustainable development. A participative management style was chosen by the Management Board for implementation of the QMS [ 23 ] with the intention of encouraging inter-team and inter-discipline exchange. In September 2013, the Quality manager was appointed with a brief to implement and steer a Quality system common to all laboratory research teams. He has extensive independent powers to enable him to fulfil this brief, as well as an operating budget. He attends monthly steering committee meetings for the laboratory, at which any matters relating to Quality and prevention can be raised if necessary.

The danger was of the Quality manager finding himself shouldering this huge task single-handed. With the support of the laboratory manager, a Quality network was created with more than 60 researchers of the laboratory: the laboratory manager, the 16 research team leaders, the 16 Quality representatives (one per team), and 35 Equipment and Metrology representatives. The Quality representatives meet every two months. A mission letter was sent to the Quality manager, the Quality representatives and the Equipment and metrology representatives.

In order to help the laboratory's Quality manager and Quality representatives to deploy the Quality process among research teams, the Quality manager made good use of the commitment of students on work experience in the laboratory. The advice of their mentor, a specialist in Quality management and metrology, went a long way in ensuring implementation of the QMS was possible with the cooperation of all concerned. This tight collaboration had a number of positive offshoots and several actions have been dealt with, such as process mapping (see Fig. 3 ), a Quality manual, and procedures for document and equipment control, all of which advances formalization of process and operating procedures [ 15 ].

To ensure reliability of research results, it is essential from the outset to pay due regard to Human Resource management [ 23 , 25 ]. This consists in identifying the functions and skills required (in terms of knowledge, know-how and experience) and hence training needs, welcoming new recruits and retaining records of initial and ongoing training.

Every two years, at the activity meetings held between the members of staff managed by INRA and their line managers, a review is made of the different activities, of prospects, of skills acquired and needing to be developed, and of training needs. A training programme is thus established for the laboratory, and priorities are set in line with the laboratory's Guidelines. It has been noted that staff training in Quality and metrology needs to be developed [ 25 , 26 ] as the lack of this is slowing down the progress of the laboratory.

3.3 Methods

When analysing test results, researchers need to have at their disposal all the information that could have an influence on results [ 20 ]. Therefore the formalization of methods is essential. This consists in noting down all sample collection, measurements, analysis of apparatus used, kit lot numbers, the samples themselves, their identification numbers, storage temperatures, etc. In accordance with INRA Guidelines, these operations are written down in a laboratory notebook when the method is being set up; the operating procedure is in place once the method has been fully defined and is workable. INRA is in the process of developing electronic notebooks to further encourage their use by scientists and facilitate the traceability of information. The use of laboratory notebooks by scientists in INRA laboratories is a long-standing practice. Once a method is deemed reliable, it is transcribed in the operating procedure (using the model defined by the laboratory).

In the laboratory, research teams formalize the validation steps of their methods in accordance with the instructions in INRA guidelines version 2. In other words, the evidence is created to confirm that the method utilized is appropriate to the question being treated; any question of the conditions required to produce interpretable results with a known level of uncertainty can be answered.

Data management is also a crucial matter, one which the bioinformatics team at the laboratory would like to improve. The development of a Laboratory information management system (LIMS) is underway and will improve the management of samples (identification, localisation) tested and the traceability of their associated data. The objective is to be able to find easily where a sample comes from, whose it is, to which methods it relates, everything that has been done throughout its life cycle and how to use dispose of it [ 16 , 17 ].

The LIMS will also be used for the management of equipment (which will facilitate the work of the Equipment and Metrology Representatives), and also consumables so as to avoid the use of different product or reagent lots where this would impact upon results.

Document management is another essential factor that has to be properly handled by the laboratory. The laboratory lists the operating procedures that need to be formalized, schedules their realization, has them written up, and disseminates them via any means considered appropriate to enable them to be used in operational conditions. The laboratory defines and utilizes template documents for the writing of operating procedures. An initial list of documents has been created. It is updated by the Quality representatives in such a way that every scientist can be aware of all operating procedures in existence as well as of modifications to them. Documents created and validated as part of the QMS are made available for use by means of a document management tool. This tool is encountering a certain amount of resistance as some scientists object to this general availability of what they consider to be their own documents.

All researchers know that it is essential to describe precisely their methods and to validate and to improve their scientific works. It is also important to record correctly the validation methods used and the associated results and data. For the continuous improvement of the research laboratory, the useful QMS tools allow the laboratory to also share knowledge and better capitalize on a know-how.

3.4 Machinery and Measurement

The laboratory has responsibility for managing equipment that is subject to regulations or is identified as having an impact on the quality of research results. This empowers it to ensure that the purchasing, maintenance, calibration, and verification of equipment are conducted appropriately [ 27 – 29 ].

When it was created in 2012, the laboratory had eight different types of inventory for the listing of equipment. Critical equipment was not always identified as such and several different service-providers could be involved in the regulatory control of a single apparatus type depending on which teams used it. It was a matter of high priority to standardize the inventory and equipment management systems (pertaining to information such as model, make, serial number, commissioning date, person responsible, etc.). It took almost two years to develop an internal network with a referent for each team (a matter of 35 Equipment and metrology representatives) and collectively define their brief: to ensure regulatory verifications with a view to prevention (autoclaves, fume hoods, centrifuges, oxygen meters, etc.) and/or metrological verification and calibration (weighing-scales, pipettes, thermometers, incubators, water baths, etc.).

Each critical device identified has its own service-life file enabling the tracing of incidents and the monitoring of maintenance, verification, and/or calibration. When a piece of equipment fails a conformity check, the validity of all preceding results must be re-established. All operations pertaining to equipment are covered in the common equipment management and control procedures, and in equipment user, maintenance, calibration, verification and monitoring instructions. An annual schedule for both internal and external verification of critical equipment has been set up [ 27 ]. For example: weighing-scales identified as critical are periodically checked in-house with calibration weights and control charts [ 28 – 33 ]. The weighing-scales are also verified annually by an external service-provider. Weighing-scales that are identified as non-critical undergo in-house verification only. In molecular biology, pipetting of reagents is a critical activity which can have a significant impact on a result, especially where small volumes are concerned. Due to the number of pipettes in use, these make up a significant proportion of the equipment to be checked. A joint decision has therefore been made to perform verification in-house for pipettes with a volume above 10 μL and to use an external service provider for pipettes with a volume below 10 μL as well as for multichannel pipettes [ 33 , 34 ]. For temperature, the laboratory has acquired a reference thermometer, calibrated annually, with which to verify operational laboratory thermometers. For verification of more complex equipment such as thermal cyclers, a workgroup has been set up with the aim of developing a procedure to be used for in-house verification.

For machines that carry a degree of safety risk to the user, such as centrifuges, autoclaves, etc., regulatory checks are compulsory at the intervals defined in the relevant regulations. For autoclaves, an authorization given by an external body is required.

3.5 Mother-nature and Materials

The INRA guidelines require units to ensure proper monitoring, recording, and if possible control of ambient conditions when these have an impact on the quality of research results.

Discussions are currently underway with Equipment Managers in charge of freezers and cold rooms on the subject of identifying critical aspects requiring special attention where samples need to be stored at −80 °C. The laboratory stores pathogenic agents (bacteria and fungi), seeds, leaves, twig fragments, pieces of fruit, and also DNA, RNA, and proteins. In order to control the risks associated with poor cold storage conditions (at temperatures of −80 °C, −20 °C and +4 °C), several requirements have been pinpointed: the requirement for an on-site power generator, the installation of −80 °C freezers in an air-conditioned room, of a monitoring system for each freezer and cool room to ensure reliability (for a backup −80 °C freezer, for maintenance of freezers and cool rooms by an external company with a rapid response time in the event of failure) and, finally, for an in-house team capable of dealing with failures at weekends.

The INRA version 2 guidelines require laboratories to ensure correct cold storage of samples (cryopreservation, −80 °C, −20 °C and 4 °C). To satisfy this requirement the laboratory is in the course of defining a clear policy concerning management of freezers and refrigerators, as well as standardized numbering for all samples within the laboratory in order to ensure their traceability. The Quality representatives are also discussing protocols for the collection and acquisition of samples, types of packaging (e.g. tubes, plates, bottle, boxes, etc.), and methods of identifying the samples. A disposal policy for samples (post publication, at end of project.) and the scheduling of cleaning days are also under discussion.

The laboratory is responsible for the traceability of consumable and other products (chemical and phytosanitary products, solvents, biological reagents, etc.). The question of traceability is not handled in exactly the same way by every team. Nevertheless, all teams adhere to use-by dates and required storage conditions. The storage of consumables, other products and reagents must conform to regulations and manufacturer specifications. After the merging of the research units, which saw more than half the research teams move to a new building and the construction of new greenhouses, a massive sorting of chemical products was undertaken, with comprehensive inventories being drawn up and appropriate storage made available: clearly defined product bins ensure that acids, bases, inflammables and toxic and carcinogenic, mutagenic, toxic to reproduction (CMR) substances are kept separately from each other. Ventilated cabinets have been purchased for all the laboratory buildings. A special room dedicated to the preparation of phytosanitary products has been built near the new greenhouses. Chemical safety information has been centralized in a computerized folder to which everyone has access.

4.1 Measuring effectiveness of the system

The effectiveness of the system is measured via internal audits and the annual self-assessment tool implemented by the INRA Quality Task Force. An internal audit is organized by the INRA Quality task force every five years, a year before the HCERES (French High Council for Evaluation of Research and Higher Education) assessment of the laboratory. To the overall laboratory assessment are adjoined the Quality audit report, the ensuing action plan, the results of the action plan and the quality indicators selected. Nevertheless, it would be a positive step if the bodies assessing the laboratory were to pay closer attention to the efforts made by the laboratory towards enhancing reliability of results. In order to foster a more self-critical view and further the objectives of continual improvement, it is intended that the laboratory will, for the first time, conduct a Quality review at the end of the year to evaluate the Quality actions undertaken, assess their effectiveness, and define new objectives for the coming year based on the indicators defined by the laboratory for each of its processes. It is hoped by this means to give individuals a real opportunity to enhance their relationship with the Quality system and to instil dynamism in the pursuance of improvement. The Quality process is progressing well and awareness of the benefits attached to a QMS is growing within the laboratory.

4.2 Effect of QMS on organization of the laboratory

The INRA Management coordination committee recommends laboratories to undergo a Quality audit a year ahead of the HCERES assessment which takes place every five years. In response to the wish of management, therefore, an INRA internal audit was held in the VLSU in March, 2015 organized by the INRA Quality task force. The auditors took the time to audit every team (on every site) in accordance with the different requirements of the INRA version 2 guidelines. This very pedagogical action allowed scientists to measure in real terms the improvements made or needed to be made by their teams. This internal audit made it possible to draw up individual team-oriented action plans based on specific needs, followed-up with an action plan for the laboratory as a whole. The actions decided upon were prioritized according to three objectives: improvement of documentation management, of equipment management, and of cold-stored samples management (cryopreservation, −80 °C, −20 °C, 4 °C and lyophilisation). These objectives were then confirmed in the management mission statement, which was updated in 2016. The audit was therefore a very effective means of continuing to involve teams in the Quality process and of facilitating interaction between the teams and the Quality manager, and was also a means through which the collective objectives of the laboratory could be developed. This is in keeping with the concept of participative management put into effect by the laboratory management board.

4.3 Effect upon commitment and motivation of laboratory staff

The fact that the laboratory is under no obligation to pursue the certification objective means the scientific community may suffer a lack of motivation. However, this is actually a very positive situation: it allows staff the time it takes to become fully conversant with the new managerial process, one which actively encourages the participation of individuals, promotes a shared outlook, and fosters an ongoing critical regard of the organization of the laboratory. The process management constitutes a tool with which to steer laboratory activities with regard to key performance indicators. It involves every member of laboratory staff, favouring continual improvement of the operation, organization, and practices of the research laboratory via the Quality policy, Quality objectives, and results of self-assessment and audits.

In order to deepen the commitment of its scientists to the Quality process the laboratory is developing, in conjunction with its closest partners, a network of Quality managers, which it is intended will be broadened in order to benefit from the experience of other Organizations, such as INSERM (French National Institute of Health and Medical Research) and CIRAD (French Agricultural Research Centre for International Development). As the Quality process is not inscribed in the official duties of staff, implementation is not easy. Fortunately, the laboratory is able to count upon the commitment of its willing staff.

Recognition for individuals who participate in collective tasks needs to be increased. While the contribution of individuals to collective tasks such as prevention and risk management does come up at activity meetings and in competition for promotion, staff generally feel that only their scientific contribution (in the form of scientific communication and publication) is taken seriously. Only this, it seems, has any real effect on career development. In the light of this it is easy to understand why a number of laboratory staff takes little or no part in this type of collective activity.

This paper presents the different actions involved in setting up a QMS in a very large French research laboratory (very large scale unit) through a voluntary approach.

This paper clearly illustrates the effectiveness of the actions considered by looking at the 7M method and giving practical examples which involve both the organization and the activities of the laboratory.

Many improvements were made at the time of setting up the QMS in the laboratory. These have had a positive impact on the functioning and the activities of the laboratory.

Putting a QMS into place certainly improves the functioning of the laboratory since it provides information on where people are, what they are doing, how they are doing it, how what they do is being checked and how things can be anticipated. Quality tools allow laboratory staff to be accompanied in a spirit of continual improvement in order to maintain effectiveness and robust activities of research of the laboratory.

The management of quality also aims at opening up discussion so researchers can put meaning into their work and improve their research activities. The participative management aspect of the Quality process encourages a shift, initially on an individual basis but consequently at organization level, from wanting change to enjoying it. This participative style of management brings together different perspectives that enable anticipation, cooperation and innovation.

The QMS is still young and more needs to be achieved for it to be completely operational and cover all the processes linked to the activities of the laboratory. All the laboratory staff needs to acknowledge the QMS and become involved for it to function correctly. Efforts to increase researchers' awareness are continuing in the laboratory and in field work by showing, step by step, that the QMS exists to enable the laboratory and its quality staff to continue to progress from an organisational as well as scientific point of view.

Although it enjoys the support of the laboratory management, the implementation and development of a QMS is encountering resistance both from scientists and from the Institutions, notably in the latter case, for financial reasons: the IT tools, for example, that improve the management of documentation, equipment, consumables, and chemical products take time to develop satisfactorily and necessitate a training budget. And yet these tools help underpin the management of collective intelligence. Currently, the financial support of the Institutions contributes to the cost of fluids and research projects but provides nothing for the development of structural tools. Despite the economic pressures, scientists within the laboratory do willingly support the QMS. The laboratory could also take its work on the validation of the methods further, increasing emphasis on the estimation of uncertainties associated with results. Among other aspects that need to be improved are the control of outsourced activities and the evaluation of supplies and suppliers. It is perhaps useful at this point to refer to the experience of other laboratories: despite the difficulties encountered during the implementation phase of a QMS, of all those questioned who had been in a position to observe the changes to the organization of their laboratories, none expressed a wish to backtrack. This seems to reinforce the claim that a QMS, while admittedly demanding a certain effort from everybody in the laboratory during the implementation phase, does serve to enhance reliability and improve the functioning of a laboratory.

• A. Jaime, M. Gardoni, D. Vinck, Quality Management, Framework of Knowledge Capitalization at Research Organizations IAMOT 2004 (International Association for Management of Technology, USA, 2004) [Google Scholar]
• NF X50-553, Management des activités de recherché (AFNOR, Paris, 2014) [Google Scholar]
• A. Matei, C. Antoni, The new public management within the complexity model, Procedia Soc. Behav. Sci. 109 , 1125–1129 (2014) [Google Scholar]
• G. Gruening, Origin and theoretical basis of new public management, Int. Public Manag. J. 4 , 1–25 (2001) [Google Scholar]
• L. Spencer, J. Ritchie, J. Lewis, L. Dillon, Quality in Qualitative Evaluation: A Framework for Assessing Research Evidence (National Centre for Social Research, London, 2003) [Google Scholar]
• What Are the Standards for Quality Research? Technical Brief Number 9, National Center for the Dissemination of Disability Research, 2005 [Google Scholar]
• R.J. Shavelson, L. Towne, Quality Research in Education (National Research Council, National Academy Press, Washington, 2002) [Google Scholar]
• A.C. Edmondson, S.E. Mcmanus, Methodological fit in management field research, Acad. Manage. Rev. 32 , 1246–1264 (2007) [Google Scholar]
• M. Baker, Quality time. It may not be sexy, but the quality process is becoming a crucial part of lab life, Nature. 529 , 456–458 (2016) [CrossRef] [PubMed] [Google Scholar]
• C.G. Begley, A.M. Buchan, U. Dirnagl, Robust research: Institutions must do their part for reproducibility, Nature 525 , 25–27 (2015) [CrossRef] [PubMed] [Google Scholar]
• E. Giesen, Quality management for robust and reliable research, Int. J. Metrol. Qual. Eng. 6 , 407 (2015) [CrossRef] [EDP Sciences] [Google Scholar]
• E. Giesen, Ethical and efficient research management: a new challenge for an old problem, Int. J. Metrol. Qual. Eng. 6 , 406 (2015) [CrossRef] [EDP Sciences] [Google Scholar]
• R. Bareille, B. Baudouin-Massot, M.P. Carreno, S. Fournier, N. Lebret, I. Remy-Jouet, E. Giesen, Preventive actions to avoid questionable research practices. Use of EERM (Ethical and Efficient Research Management) during arrival and departure of a co-worker, Int. J. Metrol. Qual. Eng. 8 , 10 (2017) [Google Scholar]
• INRA Quality Mission, INRA Quality Guidelines, Version 1. 2003-2005. INRA, contact: qualite[at]inra.fr. [Google Scholar]
• ISO 9001, Quality Management Systems − Requirements (2015) [Google Scholar]
• INRA Quality Mission, INRA Quality Guidelines for Research and Experimental Units (2013), Version 2. INRA Sciences and impact, contact: qualite[at]inra.fr. [Google Scholar]
• EN ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories (2005) [Google Scholar]
• ISO 14001:2015, Environmental Management Systems − Requirements with Guidance for Use (2015) [Google Scholar]
• NF S96-900, Qualité des centres de ressources biologiques (CRB)-Système de management d'un CRB et qualité des ressources biologiques (AFNOR, Paris, 2011) [Google Scholar]
• S. Belouafa, F. Habti, S. Benhar, B. Belafkih, S. Tayane, S. Hamdouch, A. Bennamara, A. Abourriche, Statistical tools and approaches to validate analytical methods: methodology and practical examples, Int. J. Metrol. Qual. Eng. 8 , 9 (2017) [CrossRef] [EDP Sciences] [Google Scholar]
• L. Martin, Ch. Baudassé, N. Leménager, M.-F. Thévenon, The metrological approach: a major key factor for the accreditation and continuous improvement of the wood preservation laboratory of Cirad, Int. J. Metrol. Qual. Eng. 4 , 117–120 (2013) [CrossRef] [EDP Sciences] [Google Scholar]
• F.M. Beyer, Language and strategies at work studied through the implementation of quality procedure standards, Sociol. Trav. 41 , 235–54 (1999) [Google Scholar]
• ISO 10018, Quality Management–Guidelines on People Involvement and Competence (2012) [Google Scholar]
• ISO 10012, Measurement Management Systems–Requirements for Measurement Processes and Measuring Equipment (2003) [Google Scholar]
• Guide on equipment qualification: http://www.edqm.eu/en/quality-management-guidelines-86.html . 2015 [Google Scholar]
• L. Martin, M.-F. Thévenon, Evaporation as an ageing procedure prior to wood preservative biological testing: when standardization needs metrology, Int. J. Metrol. Qual. Eng. 5 , 405 (2014) [CrossRef] [EDP Sciences] [Google Scholar]
• G. Gomah, A traceable time interval measurement with a reduced uncertainty, Int. J. Metrol. Qual. Eng. 6 , 301 (2015) [CrossRef] [EDP Sciences] [Google Scholar]
• S.B. Amara, J. Dhahri, N.B. Fredj, Control chart limits based on true process capability with consideration of measurement system error, Int. J. Metrol. Qual. Eng. 7 , 401 (2016) [CrossRef] [EDP Sciences] [Google Scholar]
• S.F. Beckert, W.S. Paim, Critical analysis of the acceptance criteria used in measurement systems evaluation, Int. J. Metrol. Qual. Eng. 8 , 23 (2017) [CrossRef] [EDP Sciences] [Google Scholar]
• J.-M. Pou, L. Leblond, Control of customer and supplier risks by the guardband method, Int. J. Metrol. Qual. Eng. 6 , 205 (2015) [CrossRef] [EDP Sciences] [Google Scholar]
• M. Wiederhold, J. Greipel, R. Ottone, R. Schmitt, Clustering of similar processes for the application of statistical process control in small batch and job production, Int. J. Metrol. Qual. Eng. 7 , 404 (2016) [CrossRef] [EDP Sciences] [Google Scholar]
• ISO 8655-1, Piston-operated Volumetric Apparatus-Part 1: Terminology, General Requirements and User Recommendations (2002) [Google Scholar]
• ISO 8655-2, Piston-Operated Volumetric Apparatus-Part 2: Piston Pipettes (2002) [Google Scholar]
• ISO Guide 30, Reference Materials-Selected Terms and Definitions (2015) [Google Scholar]

Cite this article as : Valérie Molinéro-Demilly, Abdérafi Charki, Christine Jeoffrion, Barbara Lyonnet, Steve O'Brien, Luc Martin, An overview of Quality Management System implementation in a research laboratory, Int. J. Metrol. Qual. Eng. 9 , 2 (2018)

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International Journal of Quality and Service Sciences

ISSN : 1756-669X

Article publication date: 15 June 2012

The purpose of this paper is to explore the nature of research topics and methodologies employed in existing studies of quality management (QM) in research and development (R&D).

Design/methodology/approach

Using a systematic review methodology (SRM), this paper analyzes the literature to identify major themes, shortcomings, and key management practices.

The literature review reveals that researchers have mainly explored only how to implement quality principles and practices in the R&D environment and made little effort to explore other aspects of QM. QM practices discussed in the literature consist of top management commitment, R&D workforce involvement, training, a process‐based approach, teamwork and cross‐functional teams, fact‐based measurement and feedback mechanisms, R&D client focus, and good communication with suppliers. The dominant methodology employed in existing studies is either a case study or conceptual approach.

Originality/value

The paper provides researchers with valuable information about how this research area has evolved, what main themes have been discussed in the literature, and what management practices are effective in pursuing quality efforts in R&D. This study also makes a contribution to the development of quality theory in R&D by pointing out significant gaps in the current literature and suggesting important areas for future study.

• Quality management
• Research and development

Kumar, V. , Kim, D. and Kumar, U. (2012), "Quality management in research and development", International Journal of Quality and Service Sciences , Vol. 4 No. 2, pp. 156-174. https://doi.org/10.1108/17566691211232891

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Copyright © 2012, Emerald Group Publishing Limited

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Total Quality Management Research Paper Topics

Total quality management research paper topics have grown to become an essential area of study, reflecting the critical role that quality assurance and continuous improvement play in modern organizations. This subject encompasses a wide array of topics, methodologies, and applications, all aimed at enhancing operational efficiency, customer satisfaction, and competitive advantage. The purpose of this text is to provide students, researchers, and practitioners with a comprehensive guide on various aspects of total quality management (TQM). It includes an extensive list of potential research paper topics categorized into ten main sections, a detailed article explaining the principles and practices of TQM, guidelines on how to choose and write on TQM topics, and an introduction to iResearchNet’s custom writing services that cater to this field. This comprehensive resource aims to assist students in navigating the complex landscape of TQM, inspiring insightful research, and offering practical tools and support for academic success.

100 Total Quality Management Research Paper Topics

Total Quality Management (TQM) has evolved to become a strategic approach to continuous improvement and operational excellence. It has applications across various industries, each with its unique challenges and opportunities. Below is an exhaustive list of TQM research paper topics, divided into ten categories, offering a rich source of ideas for students and researchers looking to explore this multifaceted domain.

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Total Quality Management transcends traditional boundaries and integrates concepts from various disciplines. Its goal is to create a culture where quality is at the forefront of every decision and process. The following list presents 100 TQM research topics divided into ten different categories. Each category represents a specific aspect of TQM, providing an extensive foundation for exploring this complex field.

• Historical Development of TQM
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• Challenges in Implementing TQM
• TQM in Healthcare
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• TQM in the Automotive Industry
• TQM in the Food and Beverage Industry
• TQM in Information Technology
• TQM in Hospitality
• TQM in the Banking Sector
• TQM in Construction
• TQM in Supply Chain Management
• TQM in Government Services
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• Quality Function Deployment (QFD)
• The Fishbone Diagram in TQM
• Process Mapping and Quality Improvement
• Benchmarking for Quality Enhancement
• The Role of FMEA in Quality Management
• Design of Experiments (DOE) in TQM
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• The Benefits of ISO 14001
• Understanding Six Sigma Certifications
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• Lean Manufacturing and Quality Standards
• Implementation of ISO 22000 in Food Safety
• The Role of ISO/IEC 17025 in Testing Laboratories
• Quality Management in ISO 27001 (Information Security)
• Achieving CE Marking for Product Safety
• The Influence of SA 8000 on Social Accountability
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• The Role of Service Quality in Customer Retention
• Customer Complaints and Quality Improvement
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• Customer Feedback and Continuous Improvement
• Customer Relationship Management (CRM) and TQM
• Emotional Intelligence and Customer Satisfaction
• The Impact of Branding on Customer Loyalty
• Customer Experience Management in TQM
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• Motivational Theories and TQM
• Building a Quality Culture Through Employee Engagement
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• Leadership Styles and Employee Performance in TQM
• Communication and Teamwork in TQM
• Managing Change in TQM Implementation
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• Key Performance Indicators (KPIs) in TQM
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• Value Stream Mapping and Process Optimization
• The Impact of E-business on Quality Performance
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• Environmental Sustainability and TQM
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• Green Manufacturing and Environmental Performance
• Corporate Social Responsibility (CSR) Strategies in TQM
• Waste Reduction and Recycling in TQM
• Community Engagement and Social Impact
• Sustainable Development Goals (SDGs) and TQM
• Energy Efficiency and Sustainable Quality Management
• Ethical Sourcing and Supply Chain Responsibility
• Human Rights and Labor Practices in TQM
• TQM Practices in Different Cultures
• The Influence of Globalization on TQM
• Cross-Cultural Communication and Quality Management
• International Regulations and Quality Standards
• TQM in Emerging Economies
• Quality Management in Multinational Corporations
• The Role of WTO in Global Quality Standards
• Outsourcing and Global Supply Chain Quality
• Global Competition and Quality Strategies
• International Collaboration and Quality Innovation
• Technological Innovations and Quality Management
• Big Data and Analytics in TQM
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• The Impact of Social Media on Quality Perception
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• The Future Role of Human Resource in Quality Management

The vast array of topics listed above provides a comprehensive insight into the dynamic and multifaceted world of Total Quality Management. From foundational principles to future trends, these topics offer students a diverse range of perspectives to explore, understand, and contribute to the ongoing dialogue in TQM. With proper guidance, dedication, and an open mind, scholars can delve into these subjects to create impactful research papers, case studies, or projects that enrich the existing body of knowledge and drive further innovation in the field. Whether one chooses to focus on a specific industry, a particular tool, or an emerging trend, the possibilities are endless, and the journey towards quality excellence is both challenging and rewarding.

Total Quality Management and the Range of Research Paper Topics

Total Quality Management (TQM) represents a comprehensive and structured approach to organizational management that seeks to improve the quality of products and services through ongoing refinements in response to continuous feedback. This article aims to provide an in-depth exploration of TQM, shedding light on its evolution, its underlying principles, and the vast range of research topics it offers.

Historical Background

Total Quality Management has its roots in the early 20th century, with the development of quality control and inspection processes. However, it wasn’t until the mid-1980s that TQM became a formalized, systematic approach, greatly influenced by management gurus like W. Edwards Deming, Joseph Juran, and Philip Crosby.

• Early Quality Control Era : During the industrial revolution, emphasis on quality control began, primarily focusing on product inspection.
• Post-World War II Era : The concept of quality management grew as the U.S. sought to rebuild Japan’s industry. Deming’s teachings on quality greatly influenced Japanese manufacturing.
• TQM’s Formalization : The integration of quality principles into management practices led to the formalization of TQM, encompassing a holistic approach towards quality improvement.

Principles of Total Quality Management

TQM is underpinned by a set of core principles that guide its implementation and contribute to its success. Understanding these principles is fundamental to any research into TQM.

• Customer Focus : At the heart of TQM is a strong focus on customer satisfaction, aiming to exceed customer expectations.
• Continuous Improvement : TQM promotes a culture of never-ending improvement, addressing small changes that cumulatively lead to substantial improvement over time.
• Employee Engagement : Engaging employees at all levels ensures that everyone feels responsible for achieving quality.
• Process Approach : Focusing on processes allows organizations to optimize performance by understanding how different processes interrelate.
• Data-Driven Decision Making : Utilizing data allows for objective assessment and decision-making.
• Systematic Approach to Management : TQM requires a strategic approach that integrates organizational functions and processes to achieve quality objectives.
• Social Responsibility : Considering societal well-being and environmental sustainability is key in TQM.

Scope and Application

Total Quality Management is applicable across various domains and industries. The following areas showcase the versatility of TQM:

• Manufacturing : Implementing TQM principles in manufacturing ensures efficiency and consistency in production processes.
• Healthcare : TQM in healthcare focuses on patient satisfaction, error reduction, and continuous improvement.
• Education : In educational institutions, TQM can be used to improve the quality of education through better administrative processes and teaching methods.
• Service Industry : Whether in hospitality, banking, or IT, TQM’s principles can enhance service quality and customer satisfaction.
• Public Sector : Governmental bodies and agencies can also employ TQM to enhance public service delivery and satisfaction.

TQM’s multifaceted nature offers a wide range of research paper topics. Some areas of interest include:

• TQM Tools and Techniques : Research on tools like Six Sigma, Kaizen, and statistical process control.
• Quality Standards : Investigating the impact and implementation of ISO standards.
• Industry-Specific Applications : Exploring how TQM is applied and adapted in different industries.
• Challenges and Opportunities : Assessing the difficulties and advantages of implementing TQM in contemporary business environments.
• Emerging Trends : Examining future trends in TQM, such as the integration of technology and sustainability considerations.

Total Quality Management has evolved from a simple focus on product inspection to a strategic approach to continuous improvement that permeates the entire organization. Its application is not confined to manufacturing but has spread across various sectors and industries.

Research in TQM is equally diverse, offering students and scholars a rich and complex field to explore. Whether delving into the historical evolution of TQM, examining its principles, evaluating its application in different sectors, or exploring its myriad tools and techniques, the study of TQM is vibrant and multifaceted.

By undertaking research in Total Quality Management, one not only contributes to the academic body of knowledge but also plays a role in shaping organizational practices that emphasize quality, efficiency, customer satisfaction, and social responsibility. In a global business environment characterized by competitiveness, complexity, and constant change, the principles and practices of TQM remain more relevant than ever.

How to Choose Total Quality Management Research Paper Topics

Choosing the right topic for a research paper in Total Quality Management (TQM) is a crucial step in ensuring that your paper is both engaging and academically relevant. The selection process should align with your interests, the academic requirements, the targeted audience, and the available resources for research. Here is an in-depth guide, including an introductory paragraph, ten essential tips, and a concluding paragraph to help you make an informed choice.

Total Quality Management encompasses a broad spectrum of theories, tools, techniques, and applications across various industries. This richness and diversity offer a plethora of potential research topics. However, selecting the perfect one can be daunting. The following tips are designed to guide students in choosing a research topic that resonates with their interests and the current trends in TQM.

• Identify Your Area of Interest : TQM has many facets, such as principles, tools, applications, challenges, and trends. Pinpointing the area that piques your interest will help in narrowing down your topic.
• Consider Academic Relevance : Your chosen topic should align with your course objectives and academic guidelines. Consult your professor or academic advisor to ensure that the topic fits the scope of your course.
• Research Current Trends : Stay up-to-date with the latest developments in TQM by reading scholarly articles, attending conferences, or following industry leaders. Current trends may inspire a relevant and timely topic.
• Evaluate Available Resources : Make sure that your chosen topic has enough existing literature, data, and resources to support your research.
• Assess the Scope : A too broad topic might be overwhelming, while a too narrow one might lack content. Balance the scope to ensure depth without over-extending.
• Consider Practical Implications : If possible, choose a topic that has real-world applications. Connecting theory to practice makes your research more impactful.
• Check Originality : Aim for a topic that offers a new perspective or builds on existing research in a unique way. Your contribution to the field should be clear and valuable.
• Evaluate Your Expertise : Choose a topic that matches your level of expertise. Overly complex subjects might lead to difficulties, while overly simple ones might not challenge you enough.
• Consider the Target Audience : Think about who will be reading your research paper. Tailoring your topic to the interests and expectations of your readers can make your paper more engaging.
• Conduct a Preliminary Research : Before finalizing your topic, conduct some preliminary research to ensure there’s enough material to work with and that the topic is feasible within the given timeframe.

Selecting the right topic for a Total Quality Management research paper is a thoughtful and multifaceted process. It requires considering personal interests, academic requirements, current industry trends, available resources, and practical implications.

By following the guidelines provided, students can align their research with both personal and academic objectives, paving the way for a successful research experience. The ideal topic is one that not only aligns with the ever-evolving field of TQM but also resonates with the researcher’s passion and curiosity, laying the foundation for a meaningful and insightful investigation into the dynamic world of Total Quality Management.

How to Write a Total Quality Management Research Paper

Writing a Total Quality Management (TQM) research paper is a valuable endeavor that requires a clear understanding of the subject, strong analytical skills, and a methodical approach to research and writing. This guide outlines how to write an impressive research paper on TQM, including an introductory paragraph, ten actionable tips, and a concluding paragraph.

Total Quality Management is a comprehensive approach that emphasizes continuous improvement, customer satisfaction, employee involvement, and integrated management systems. Writing a research paper on TQM is not just an academic exercise; it is an exploration into the principles and practices that drive quality in organizations. The following detailed guidance aims to equip you with the necessary knowledge and skills to compose a compelling TQM research paper.

• Understand the Basics of TQM : Start by immersing yourself in the foundational principles of TQM, including its history, methodologies, and various applications across industries. A deep understanding will form the basis of your research.
• Choose a Specific Topic : As outlined in the previous section, select a specific and relevant topic that aligns with your interest and the current trends in the field of TQM.
• Conduct Comprehensive Research : Use reputable sources such as academic journals, books, industry reports, and expert opinions to gather information. Always critically evaluate the reliability and relevance of your sources.
• Create a Thesis Statement : Your thesis statement is the guiding force of your paper. It should be clear, concise, and articulate your main argument or focus.
• Develop an Outline : Organize your research into a logical structure. An outline will guide you in presenting your ideas coherently and ensuring that you cover all essential points.
• Write the Introduction : Introduce the topic, provide background information, and present the thesis statement. Make sure to engage the reader and provide a roadmap for the paper.
• Compose the Body : Divide the body into sections and subsections that explore different aspects of your topic. Use evidence, examples, and logical reasoning to support your arguments.
• Incorporate Case Studies and Examples : If applicable, include real-world examples or case studies that demonstrate the application of TQM principles in a practical context.
• Write the Conclusion : Summarize the key findings, restate the thesis, and provide insights into the implications of your research. A strong conclusion leaves a lasting impression.
• Revise and Edit : Pay attention to both content and form. Check for logical flow, coherence, grammar, and formatting. Consider seeking feedback from peers or professionals.

Writing a research paper on Total Quality Management is a complex but rewarding task. By understanding the fundamentals of TQM, selecting a precise topic, conducting thorough research, and following a structured writing process, students can produce a paper that not only meets academic standards but also contributes to the understanding of quality management in the modern world.

Emphasizing critical thinking, analytical prowess, and attention to detail, the journey of writing a TQM research paper enriches the student’s academic experience and provides valuable insights into the field that continues to shape organizations globally.

The strategies and tips provided in this guide serve as a roadmap for aspiring researchers, helping them navigate the challenges and triumphs of academic writing in the realm of Total Quality Management. With dedication, creativity, and adherence to scholarly standards, the result can be a meaningful and enlightening piece that resonates with both academics and practitioners alike.

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iResearchNet takes pride in delivering excellence in custom Total Quality Management research paper writing. By combining the expertise of seasoned writers, comprehensive research capabilities, and a student-focused approach, we aim to facilitate academic success. Our carefully curated features provide a reliable, quality-driven solution to TQM research paper writing. Let iResearchNet guide you in creating exceptional, engaging, and authoritative papers in the realm of Total Quality Management.

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