A Quantitative Approach of Risk Management in Laboratories: Treating the risk or treating the area? -

Marcelo Ricardo Magalhães; Alexandre Cascardo Carneiro; Luciano do Nascimento Batista

doi:10.18540/jcecvl11iss1pp21861

Authors

Marcelo Ricardo Magalhães Instituto Nacional de Metrologia, Qualidade e Tecnologia, Brazil
Alexandre Cascardo Carneiro Universidade Salgado de Oliveira, Brazil Universidade Federal Fluminense, Brazil
Luciano do Nascimento Batista Instituto Nacional de Metrologia, Qualidade e Tecnologia, Brazil https://orcid.org/0009-0002-3395-7223

DOI:

https://doi.org/10.18540/jcecvl11iss1pp21861

Keywords:

Quality, Risk Assessment;, Pressure measurement;, Metrology

Abstract

This study aims to conduct a comprehensive risk assessment of the pressure laboratories at the National Institute of Metrology, Quality and Technology (Inmetro), emphasizing the strategic importance of effective risk control to ensure quality across the entire national metrology chain. The research acknowledges the inherent challenges of these technical environments and proposes, as an alternative to immediate solutions, the systematic reduction of the probability of specific risks. In certain cases, a holistic approach is recommended, involving the integrated management of entire areas rather than isolated, individual actions. A total of 66 risks were identified, distributed across six distinct areas. The environmental area proved to be the most critical, with approximately 75% of its risks classified as having high probability and significant impact. In light of this, the study suggests the adoption of broad and structured strategies for its management. In contrast, the measurement and machinery areas exhibited fewer high-level risks, making them more suitable for traditional risk-by-risk management approaches. The areas related to personnel, materials, and methodology presented average risk values ranging from 9.8 to 10.4, allowing for greater flexibility in the choice of control strategies, depending on the organizational structure. This research provides valuable contributions to the field of risk management in laboratory environments, offering methodological and practical insights for institutions facing similar challenges. By advocating the careful use of risk matrices and the adoption of integrated approaches when necessary, the study reinforces the importance of robust, preventive practices tailored to the specific operational context.

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References

Abbas J. Impact of total quality management on corporate green performance through the mediating role of corporate social responsibility. J Clean Prod. 2020;242:118458.

Mondejar ME, Avtar R, Diaz HLB, Dubey RK, Esteban J, Gómez-Morales A, et al. Digitalization to achieve sustainable development goals: Steps towards a Smart Green Planet. Science of The Total Environment. 2021;794:148539.

Trienekens J, Zuurbier P. Quality and safety standards in the food industry, developments and challenges. Int J Prod Econ. 2008;113:107–22.

Rab S, Yadav S, Wan M, Aswal DK. An insight on quality infrastructure. Handbook of Metrology and Applications. Springer; 2023. p. 113–32.

Harmes-Liedkte U, Oteiza Di Mateo JJ. Measurement and performance of Quality infrastructure. A proposal for a global quality infrastructure Buenos Aires and Duisburg: Mesopartner and Analyticar. 2019;

Yadav S, Titus SSK, Kumar R, Elizabeth I, Sharma ND, Kumar A, et al. Physico-Mechanical Metrology: Part IV: Force, Pressure and Flow Metrology. Metrology for Inclusive Growth of India. 2020;377–456.

Fang H, Bielsa F, Li S, Kiss A, Stock M. The BIPM Kibble balance for realizing the kilogram definition. Metrologia. 2020;57:45009.

H Haitjema, P H J Schellekens, S F C L Wetzels. Calibration of displacement sensors up to 300 µm with nanometre accuracy and direct traceability to a primary standard of length. Metrologia. 2000;37:25.

Moljevic S. INFLUENCE OF QUALITY INFRASTRUCTURE ON REGIONAL DEVELOPMENT. International Journal for Quality Research. 2016;10:433–52.

Casteleiro C, Mendes L. Exploring the influence of quality management systems in work engagement and psychological empowerment in private institutions of social solidarity. Total Quality Management & Business Excellence. 2022;33:243–77.

Heras-Saizarbitoria I, Cilleruelo E, Allur E. ISO 9001 and the Quality of Working Life: An Empirical Study in a Peripheral Service Industry to the Standard’s Home Market. Human Factors and Ergonomics in Manufacturing & Service Industries. 2014;24:403–14.

Oliveira GS, Corrêa JE, Balestrassi PP, Martins RA, Turrioni JB. Investigation of TQM implementation: empirical study in Brazilian ISO 9001-registered SMEs. Total Quality Management & Business Excellence. 2019;30:641–59.

Cheng Y, Fisk A. Contingency theory informs relationship management: Exploring the contingent organization-public relationships (COPR) in a crisis of Mainland China. Public Relat Rev. 2022;48:102178.

McAdam R, Miller K, McSorley C. Towards a contingency theory perspective of quality management in enabling strategic alignment. Int J Prod Econ. 2019;207:195–209.

Mnif Y, Gafsi Y. A contingency theory perspective on the analysis of central government accounting disclosure under International Public Sector Accounting Standards (IPSAS). Meditari Accountancy Research. 2020;28:1089–117.

Romero-Silva R, Santos J, Hurtado M. A note on defining organisational systems for contingency theory in OM. Production Planning & Control. 2018;29:1343–8.

Coffin N, Tang H. Investigating the strategic interaction between QMS, organisational agility and innovative performance. Total Quality Management & Business Excellence [Internet]. 2023;34:1096–107. Available from: https://doi.org/10.1080/14783363.2022.2157711

McAdam R, Miller K, McSorley C. Towards a contingency theory perspective of quality management in enabling strategic alignment. Int J Prod Econ [Internet]. 2019;207:195–209. Available from: https://www.sciencedirect.com/science/article/pii/S0925527316301396

Aquilani B, Silvestri C, Ruggieri A, Gatti C. A systematic literature review on total quality management critical success factors and the identification of new avenues of research. The TQM Journal. 2017;29:184–213.

United Nations Industrial Development Organization. QUALITY INFRASTRUCTURE BUILDING TRUST FOR TRADE. 2016. p. 5.

Moljevic S. INFLUENCE OF QUALITY INFRASTRUCTURE ON REGIONAL DEVELOPMENT. International Journal for Quality Research [Internet]. 2016;10:433–52. Available from: https://www.proquest.com/scholarly-journals/influence-quality-infrastructure-on-regional/docview/2555370750/se-2?accountid=26631

Renard M-C. Quality certification, regulation and power in fair trade. J Rural Stud. 2005;21:419–31.

Cagnin F, Oliveira MC de, Cauchick Miguel PA. Assessment of ISO 9001: 2015 implementation: focus on risk management approach requirements compliance in an automotive company. Total Quality Management & Business Excellence. 2021;32:1147–65.

Demissie M, Beshah B, Ebinger F. A comprehensive review of the national quality infrastructure framework. International Journal of Productivity and Quality Management. 2022;37:361–83.

Hussain T, Eskildsen JK, Edgeman R. The intellectual structure of research in ISO 9000 standard series (1987–2015): a Bibliometric analysis. Total Quality Management & Business Excellence. 2020;31:1195–224.

Isharyadi F, Kristiningrum E. Profile of system and product certification as quality infrastructure in Indonesia. 2021;11:556–69.

Li Q, Li X, Jiang Z, Mingcheng E, Ma J. Industry Quality Infrastructure: A Review. 2019 International Conference on Quality, Reliability, Risk, Maintenance, and Safety Engineering (QR2MSE). 2019. p. 180–5.

Zhao L, Gu J, Abbas J, Kirikkaleli D, Yue X-G. Does quality management system help organizations in achieving environmental innovation and sustainability goals? A structural analysis. Economic Research-Ekonomska Istraživanja. 2023;36:2484–507.

Sun R, Xiao H-F, Niu C-H, Cao Q-W, Yao Z-Y. National Quality Infrastructure System and Its Application Progress in Photovoltaic Industry. Electronics (Basel). 2022.

Kumar A, Thakur VN, Zafer A, Sharma ND, Yadav S, Aswal DK. Contributions of National Standards on the growth of Barometric Pressure and Vacuum Industries. MAPAN. 2019;34:13–7.

Aswal DK. Quality Infrastructure of India and Its Importance for Inclusive National Growth. MAPAN. 2020;35:139–50.

Kumar V, Albashrawi S. Quality Infrastructure of Saudi Arabia and Its Importance for Vision 2030. MAPAN. 2022;37:97–106.

Choi DG, Hyun O-S, Hong J-I, Kang B-G. Standards as catalyst for national innovation and performance – a capability assessment framework for latecomer countries. Total Quality Management & Business Excellence. 2014;25:969–85.

ISO 9001:2015. ISO 9001:2015. Quality management system–requirements. International Organization for Standardization, Geneva. Geneva: International Organization for Standardization; 2015. p. 20.

BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP and O. International vocabulary of metrology | Basic and general concepts and associated terms (VIM). Joint Committee for Guides in Metrology, JCGM 200:2012. (3rd edition. 2012.

Vesper HW, Thienpont LM. Traceability in Laboratory Medicine. Clin Chem. 2009;55:1067–75.

Thienpont LM, Uytfanghe K Van, Cabaleiro DR. Metrological traceability of calibration in the estimation and use of common medical decision-making criteria. 2004;42:842–50.

ISO 17511. In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials. 2003. p. 20.

ISO 31000. Risk management — Guidelines. 2018. p. 20.

Luca L. The study of applying a quality management tool for solving non-conformities in a automotive. Applied mechanics and materials. 2015;809:1257–62.

Carvalho R, Lobo M, Oliveira M, Oliveira AR, Lopes F, Souza J, et al. Analysis of root causes of problems affecting the quality of hospital administrative data: A systematic review and Ishikawa diagram. Int J Med Inform. 2021;156:104584.

Fahim A, Tan Q, Naz B, Ain Q ul, Bazai SU. Sustainable higher education reform quality assessment using SWOT analysis with integration of AHP and entropy models: A case study of Morocco. Sustainability. 2021;13:4312.

Leiber T, Stensaker B, Harvey LC. Bridging theory and practice of impact evaluation of quality management in higher education institutions: a SWOT analysis. Impact Evaluation of Quality Management in Higher Education. Routledge; 2020. p. 117–32.