Makaeva A.R., Denisova Ya.V. Application of Quality Management Methods to Analyze the Problems of the Accreditation Procedure of the Testing Laboratory

DOI: 10.18503/1995-2732-2024-22-2-190-198

Abstract

To ensure functioning of the quality management system and get competitive advantages, many organizations use various quality methods and tools. The range of these methods is quite wide and is used to achieve various purposes. Accreditation of testing and calibration laboratories for compliance with GOST ISO/IEC 17025 is a complex task and a strategic decision for the laboratory based on an approach, factoring into risks and opportunities. The accreditation procedure, like any laboratory procedure, must be assessed from a risk-based thinking perspective. There are several quality management tools to identify factors, influencing the process under study. One of them is the Ishikawa diagram, which clearly shows the relationship between the identified problem and its potential causes. Objectives. The research is aimed at obtaining a positive decision on the accreditation of the testing laboratory by preliminary elaboration of the bottlenecks identified during the expert analysis, using quality management tools and methods. Originality. It lies in the fact that for the first time an approach was proposed based on preventive actions, so that the laboratory can reduce the risks of all the identified bottlenecks during the accreditation and achieve the intended goal with the least losses. In the course of the research, experts determined the factors, influencing the key purpose: management (organization of work), equipment, personnel, premises and methods. The calculated concordance coefficient (0.725) has showed that expert judgments have a fairly high reliability. Result. Using quality management methods, it has been established that management (organization of work), equipment and personnel have the greatest influence on achieving the ultimate goal, namely obtaining a positive decision on accreditation. Based on this fact, testing laboratories, preparing to go through this procedure, are recommended to pay especially close attention to these factors.

Keywords

testing laboratory, accreditation, Ishikawa diagram, GOST ISO/IEC 17025, risks

For citation

Makaeva A.R., Denisova Ya.V. Application of Quality Management Methods to Analyze the Problems of the Accreditation Procedure of the Testing Laboratory. Vestnik Magnitogorskogo Gosudarstvennogo Tekhnicheskogo Universiteta im. G.I. Nosova [Vestnik of Nosov Magnitogorsk State Technical University]. 2024, vol. 22, no. 2, pp. 190-198. https://doi.org/10.18503/1995-2732-2024-22-2-190-198

Alsu R. Makaeva – PhD (Biology), Senior Researcher, Head of Laboratory, Federal Center for Toxicological, Radiation and Biological Safety, Kazan, Russia. Email: This email address is being protected from spambots. You need JavaScript enabled to view it.. ORCID 0000-0002-0891-9826

Yana V. Denisova – PhD (Economics), Associate Professor, Department of Analytical Chemistry, Certification and Quality Management, Kazan National Research Technological University, Kazan, Russia. Email: This email address is being protected from spambots. You need JavaScript enabled to view it.. ORCID 0000-0003-1242-6909

1. About accreditation [Electronic resource]. Available at: https://fsa.gov.ru/infrastructure/ob-akkreditatsii/ (free, accessed on January 04, 2024). (In Russ.)

2. Srivastav A. Impact of ISO 9000 implementation on the organization. International Journal of Quality and Reliability Management. 2009;27(4):438-450.

3. Saetova R.T., Battalov I.A., Denisova Ya.V. A corporate accreditation system of PJSC Gazprom as a tool for ensuring uniformity of measurements of the organization. Omskii nauchnyi vestnik [Omsk Scientific Bulletin]. 2021;(4(178)):34-40. (In Russ.) DOI: 10.25206/1813-8225-2021-178-34-40. EDN MNMJAB.

4. Aijaz Panhwar, M. Azhar Naeem, Ateeq Rehman Memon, Mehtab Ahmed, Siraj ul Haq, Aijaz ul Haq, Syed Zain ul ibad. ISO/IEC-17025 Standard and steps towards accreditation of testing & calibration laboratories in Pakistan. Journal of Chemical, Biological and Physical Sciences. Section C: Physical Sciences. 2020;10(2):76-84.

5. Almitova L.I., Makaeva V.I. Hygienic assessment of the spring water quality. Veterinarnyi vrach [Veterinarian]. 2023;(6):15-19. (In Russ.) DOI: 10.33632/ 1998-698Х_2023_6_15

6. Samatova A.A., Shlyamina O.V., Kashevarov G.S., Makaeva A.R. Parasitical control of food products safety. Veterinariya [Veterinary]. 2022;(6):70-72. (In Russ.) DOI: 10.30896/0042-4846.2022.25.6.70-73. EDN YQMTGK.

7. Vasilieva A.I., Vasiliev M.N., Sadriev A.R., Kushlubaeva A.I. Time standards for handling objects of research (tests) in a veterinary laboratory. Veterinarnyi vrach [Veterinarian]. 2023;(3):39-43. (In Russ.) DOI: 10.33632/1998-698X_2023_3_39. EDN GLTCLF.

8. Aijaz Panhwar, M. Azhar Naeem, Syed Zainulibad, Mehtab Ahmed, Aijaz ul Haq, Siraj ul Haq. Laboratory quality improvement by ISO/IEC-17025 accreditation: A case study of PCSIR. International Journal of Current Research. 2020;12(1):9942-9945.

9. Khodabocus F., Balgobin K. Implementation and practical benefits of ISO/IEC 17025:2005 in a testing laboratory. University of Mauritius Research Journal. 2011;(17):27-60.

10. State Standard GOST ISO/IEC 17025-2019. General requirements for the competence of testing and calibration laboratories. Moscow: Standardinform, 2021, 26 p. (In Russ.)

11. Yoshihiro Nara. Research laboratories conforming to ISO/IEC 17025. International Journal of PIXE, World Scientific. 2003;13(2):5-9.

12. Resolution of the Government of the Russian Federation No. 2050 dated November 26, 2021 "On Approval of the Rules for Accreditation in the National Accreditation System, Rules for Conducting the Procedure for Confirming the Competence of an Accredited Person, Rules for Making Changes to Information about an Accredited Person Contained in the Register of Accredited Persons and Provided for by Paragraphs 7 and 8, Part 1, Article 21 of the Federal Law "On Accreditation in the National Accreditation System", the Rules for Considering the Accredited Person's Application for Termination of Accreditation and the Decision of the National Accreditation Body to Terminate Accreditation, Amend and Invalidate Some Legislative Acts and Certain Provisions of Some Legislative Acts of the Government of the Russian Federation". Available at: http://www.consultant.ru / (Accessed on January 10, 2024).

13. Aijaz Panhwar, M. Azhar Naeem, Aijaz ul Haq, Syed Zainulibad, Mehtab Ahmed, Siraj ul Haq. Laboratory management system and competency of accredited laboratories. International Review of Basic and Applied Sciences. 2020;8(2):9-13.

14. Makaeva A.R., Makaeva V.I., Denisova Ya.V., Ermolaeva E.A. Application of the tool for analyzing failure types and subsequences at a testing laboratory for a risk analysis. Vestnik IzhGTU imeni M.T. Kalashnikova [Bulletin of Kalashnikov ISTU]. 2024;27(1):14-25. (In Russ.)

15. Ishikawa K. Introduction to quality control. Tokyo: 3A corp., 1990. 435 p. ISBN 4-906224-61-X

16. Luca L. Study on the determination and classification of the causes that determine the faulty operation of a vehicle fuel pump. Recent Researches in Manufacturing Engineering. The 3rd WSEAS International Conference on Manufacturing Engineering, Quality and Production System (MEQAPS‟11). 2011, pp. 21-24. ISBN 978-960-474-294-3.

17. Vikulov V.V., Tarasova E.Yu. Introducing GOST ISO/IEC 17025-2019 into practice of a testing laboratory. Sovremennoe sostoyanie, perspektivy razvitiya APK i proizvodstva spetsializirovannykh produktov pitaniya: materialy Mezhdunarodnoy nauchno-prakticheskoy konferentsii posvyashchennoy yubileyu zasluzhennogo rabotnika vysshey shkoly Rossiyskoy Federatsii, doktora tekhnicheskikh nauk, professora Gavrilovoy Natali Borisovny [The current state, prospects for the development of the agricultural and industrial complex and manufacturing of specialized food products: Proceedings of the International Scientific and Practical Conference Dedicated to the Anniversary of the Honored Worker of Higher Education of the Russian Federation, Doctor of Technical Sciences, Professor Natalia Borisovna Gavrilova]. Omsk: Omsk State Agrarian University, 2020, pp. 654-656. EDN ERCHNL. (In Russ.)

18. Avchukhova E.V. Assessment of agreement between experts, when selecting personnel. Vestnik Samarskoy gumanitarnoy akademii. Seriya: Psikhologiya [Bulletin of Samara Humanitarian Academy. Series: Psychology]. 2018;(1(23)):136-150. (In Russ.) EDN YVAUIP