Application to Risk Management as Part of the Transition of the Quality Management System from ISO 17025 v2005 to ISO 17025 v2017: Case of MULTILAB Laboratory in Tunisia

Ines Harzli^1,

¹Department of Biology, Faculty of Arts and Sciences, Ondokuz Mayıs University, Samsun, 55270, Turkey

Cite this paper:
Ines Harzli. Application to Risk Management as Part of the Transition of the Quality Management System from ISO 17025 v2005 to ISO 17025 v2017: Case of MULTILAB Laboratory in Tunisia. Journal of Business and Management Sciences. 2021; 9(3):130-144. doi: 10.12691/jbms-9-3-5

Abstract

Background: Accreditation ensures a very high level of control of the risks that laboratories may face during their cycle regardless of a systemic situation, internal or external change or even in a state of crisis. MULTILAB, which is an Agri-Food and Environmental analysis laboratory, decided in 2018 to start the project accreditation for the microbiological analysis unit according to the new version of the ISO / CEI 17025: 2017 standard. This study evaluates 3 processes at MULTILAB to identify, evaluate, and control all the risks related to each process using a risk management process. The aim of this study is to reduce the identified risks of the 3 chosen processes in MULTILAB to ensure a complete identification of probable risks to enable then the laboratory to succeed the transition and accreditation project. Methods: This study was performed from March to May 2018 in MULTILAB. The samples chosen for the study were 3 processes of MULTILAB; Monitoring and Measurement as a management process, Request Review as realization process and Provision of Skills as a support process. The internal process sheets which include all the data relating to the processes were used to collect data. The risks are defined according to the 5M method and the risk process used comprised 3 phases; identification, assessment and action phase. To evaluate the risks, different rating benchmarks were used for each process. After the definition of the risk’s likelihood and severity, the criticality was calculated and then the priority number was defined for all risks. For the action phase, different actions were defined according to the priority level of each risk in each process to reduce or eliminate risks. Results: The total number of identified risks was 85 in MULTILAB; Skills Provisioning process had the majority of identified risks (37 risks), Monitoring and Measurement process represented 25 risks and Request Review process had the lowest number of risks (23 risks). Regarding the 5M method, in a total of 3 processes, the highest number of identified risks belongs to the Methods (30 risks) and there are no risks that belong to Machines within MULTILAB. Regarding the treatment priorities, the majority of the identified risks for the three processes were moderate risks. Conclusion: A risk management approach is necessary to succeed not just in the accreditation project according to the new version of the ISO17025: 2017 standard but also to succeed in all next projects and to ensure the credibility of the tests carried out. Most of the risks identified do not require immediate action, but permanent control and monitoring can mitigate and even eliminate them completely.

Keywords:
MULTILAB accreditation ISO17025: 2017 Risk management

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References:

[1]	Patra, N.C. and S. Mukhopadhayay, Laboratory accreditation in India including latest ISO/IEC 17025: 2017: An overview. Indian Journal of Pathology and Oncology, 2019. 6(1): p. 1-8.
[2]	Tranchard, S. (2017). ISO/IEC 17025 - moves to final stage of revision, 2017. Available from: https://www.iso.org/news/ref2212.html, Accessed: 2017-06-06.
[3]	Islek, D. S., & Yukseloglu, E. H. (2018). Accreditation of forensic science laboratories in Turkey in the scope of TS EN ISO/IEC 17025: 2017 standard. Medicine Science, 7(4), 962-966.
[4]	https://www.cofrac.fr - Importance of Accreditation for Supporting Social Action Health Systems, Accessed: 04-2018.
[5]	Silva, V. V. M. dan Ribeiro, J. L. D. “Obtaining laboratory accreditation – required activities”, International Journal of Health Care Quality Assurance.
[6]	Kanitvittaya S, Suksai U, Suksripanich O (2016). Laboratory quality improvement in Thailand’s northernmost provinces. International Journal of Health Care Quality Assurance.
[7]	Kurniadi, D., & Amrina, E. (2020). Designing ISO/IEC 17025: 2017–Based Laboratory Quality Manual: A Case of Laboratory of Environmental Engineering in Andalas University. International Journal of Progressive Sciences and Technologies, 19(1), 14-21.
[8]	ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories.
[9]	S. Tranchard, New edition of ISO/IEC 17025 just published, (Accessed on 1/12/17) https://www.iso.org/news/ref2250.html.
[10]	U. Ricci, Establishment of an ISO 17025:2005 accredited forensic genetics laboratory in Italy, Accred. Qual. Assur. 19 (2014) 289-299.
[11]	Djamel Ghernaout, Mohamed Aichouni, Abdulaziz Alghamdi. Overlapping ISO/IEC 17025:2017 into Big Data: A Review and Perspectives. International Journal of Science and Qualitative Analysis. Vol. 4, No. 3, 2018, pp. 83-92.
[12]	S. Wong, Risk-based thinking for chemical testing, Accred. Qual. Assur. 22 (2017) 103-108.
[13]	ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. *International Organization for Standardization/International Electrotechnical Committee, Geneva, 2017.
[14]	ISO, ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories, (1/12/17). https://www.iso.org/publication/PUB100424.html (Accessed on 21/04/18).
[15]	ISO, Discover the new ISO/IEC 17025:2017, (1/12/17). https://www.youtube.com/watch?time_continue=46&v=dH1K (Accessed on 21/04/18).
[16]	C. N. Murphy, J. Yates, The International Organization for Standardization (ISO) (2009). Global governance through voluntary consensus, T. G. Weiss, R. Wilkinson (Eds.), Routledge Global Institutions, Taylor & Francis, New York.
[17]	Vasilnakova, A. (2018). RISK MANAGEMENT IN ACCREDITED TESTING LABORATORIES. Annals of DAAAM & Proceedings, 29.
[18]	Çuhadar, S. (2013). Preanalytical variables and factors that interfere with the biochemical parameters: a review. The Journal of Physiology and Biochemistry 2013, Vol. 2, No. 2, 2013, pp. 1-7.
[19]	Neogi, S. S.; Mehndiratta, M.; Gupta, S. & Puri, D. (2016). Pre-analytical phase in clinical chemistry laboratory. Clin Sci Res, 2016, pp. 171-178.
[20]	Lemos, D. T. & Almeida, D. L. T. (2001). Whole Life Cycle Risk Management. Assessment and Management of Environmental Risks 2001, 4, pp. 401-407.
[21]	International Organization for Standardization. Medical devices - Application of risk management to medical devices ISO 14971: 2007. Geneva: International Organization for Standardization, 2007.
[22]	Nichols, H. J. (2011). Laboratory Quality Control Based on Risk Management. Annals of Saudi Medicine 2011, Vol. 31, No. 3, pp. 223-228.
[23]	Raz, T. & Michael, E. (2001). Use and benefits of tools for project risk management. International Journal of Project Management 2001, Vol. 19, No. 1, pp. 9-17.
[24]	Boehm, W. B. (1991). Software Risk Management: Principles nad Practices. IEEE Software 1991, Vol.8, No.1, pp. 34-35.
[25]	Kremljak, Z. (2010). Risk Management, Proceedings of the 21st International DAAAM Symposium, Vienna, ISSN 1726-9679, ISBN 978-3-901509-73-5, Katalinic, B. (Ed.), 127, Published by DAAAM International, Vienna, Austria, http://www.daaam.info/Downloads/Pdfs/proceedings/proceedings_2010/19106_Symp_1_head.pdf.
[26]	Chapman, C. & Ward, S. (1997). Project Risk Management - Processes, Techniques and Insights, John Wiley & Sons Ltd: England, 1997, pp. 9-12.
[27]	Hallikas, J.; Karvonen, I.; Pulkkinen, U.; Virolainen, V.-M. & Tuominen, M. (2004). Risk management processes in supplier networks. Int. J. Production Economics 90, 2004, pp. 47-58.
[28]	Simsekler MCE, Kaya GK, Ward JR, Clarkson PJ. Evaluating inputs of failure modes and effects analysis in identifying patient safety risks. Int J Health Care Qual Assur. 2019; 32(1): 191-207.
[29]	Rin, D. G. (2009). Pre-analytical workstations: A tool for reducing laboratory errors. Clinica Chimica Acta 2009, Vol. 404, No. 1, pp. 68-74.
[30]	Rastogi, N. I. T. A. N. K., & Trivedi, M. K. (2016). PESTLE technique–a tool to identify external risks in construction projects. International Research Journal of Engineering and Technology (IRJET), 3(1), 384-388.
[31]	Ogaro, H.M.; Kiiyukia, C.; Mbatha, S.; Ngayo, M.O. Biorisk Status: A Comparative Assessment of Private and Public Medical Diagnostic Laboratories in Western Kenya. Appl. Biosaf. 2018, 23, 47-54.
[32]	Juma, B.W.;Wadegu,M.;Makio, A.; Kirera, R.; Eyase, F.; Awinda, G.; Kamanza, J.; Schnabel, D.;Wurapa, E.K. A Survey of Biosafety and Biosecurity Practices in the United States Army Medical Research Unit-Kenya (USAMRU-K). Appl. Biosaf. 2014, 19, 28-34.
[33]	Samuel, S.; Kayode, O.; Musa, O.; Nwigwe, G.; Aboderin, A.; Salami, T.A.; Taiwo, S. Nosocomial Infections and the Challenges of Control in Developing Countries. Afr. J. Clin. Exp. Microbiol. 2010, 11, 102-110.
[34]	AlShammari, W., Alhussain, H., & Rizk, N. M. (2021). Risk Management Assessments and Recommendations Among Students, Staffs, and Health Care Workers in Educational Biomedical Laboratories. Risk Management and Healthcare Policy, 14, 185.
[35]	Moazzam, M., Akhtar, P., Garnevska, E., & Marr, N. E. (2018). Measuring agri-food supply chain performance and risk through a new analytical framework: a case study of New Zealand dairy. Production Planning & Control, 29(15), 1258-1274.
[36]	Leat, P., & Revoredo-Giha, C. (2013). Risk and resilience in agri-food supply chains: The case of the ASDA PorkLink supply chain in Scotland. Supply chain management: An international journal.