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UDC 614.3/614.7: 658.56
OPERATIONAL EXPERIENCE OF THE SCIENTIFIC LABORATORY OF THE ENVIRONMENTAL AND HYGIENIC PROFILE ON ACCREDITATION FOR THE COMPLIANCE WITH GOST ISO/IEC 170252009 "GENERAL REQUIREMENTS TO THE COMPETENCE OF TESTING AND CALIBRATING LABORATORIES"
Altai State Medical University, Barnaul
Center of hygiene and epidemiology in Altai Krai, Barnaul
B.A. Balandovich, A.A. Krasikov, N.Yu. Tulin, O.N. Mazko, O.G. Makarova, K.B. Balandovich, R.O. Shchekochikhina
The article presents the analysis of the preparation of the laboratory for hygienic monitoring of the working conditions of the Institute of Occupational Health and Industrial Ecology of the Altai State Medical University for the accreditation procedure in the National Accreditation System for compliance with the interstate standard GOST ISO/IEC 17025-2009 "General requirements for the competence of testing and calibration laboratories". Particular attention is paid to the procedurefor introducing methods for studying the physical, chemical and radiation factors of the environment and the production environment as a key component of the successful accreditation of the testing laboratory, as well as the need to integrate the quality management system of the scientific laboratory of the ecological and hygienic profile into the overall quality management system of the university. Key words: accreditation, testing laboratory, quality management system, methods for performing measurements, in-laboratory testing, interlaboratory comparative tests.
Federal Law No. 412-FZ of December 28, 2013 "On Accreditation in the National Accreditation System" regulates the need for research by various laboratories, including scientific, at a high professional level, which guarantees reliable results and the provision of quality services to customers within established area of accreditation [1]. At the same time, the accreditation procedure in the Russian national accreditation system is a confirmation by the national accreditation body (currently the Federal Accreditation Service or RusAccreditation) that the legal entity meets the accreditation criteria, which is an official evidence of the competence of the testing laboratory to operate in a specific area of accreditation. In turn, the accreditation criteria, approved by Order No. 326 of the Ministry of Economic Development the Russian Federation dated May 30, 2014, imply the mandatory availability of a quality management system in the testing laboratory, necessary professional training of competent personnel, material and technical base, all necessary documents in the field of standardization, rules and methods of research, metrologically certified measuring instruments and test equipment, programs for conducting internal audit, laboratory testing and inter laboratory comparative tests (ICT), corrective and preventive action plans [2]. In this regard, along with the accreditation criteria, the main document regulating the activities of all laboratories regardless of the number of personnel and their test activities, and which should be used for accreditation in the national system is the interstate standard GOST ISO/IEC 17025-
2009 "General requirements to the competence of testing and calibrating laboratories"[3]. The accreditation of the testing laboratory of the Institute of Occupational Hygiene and Industrial Ecology of the Federal State Budgetary Educational Institution of Higher Medical Education of the Altai State Medical University of the Ministry of Health of the Russian Federation was carried out on the basis of this standard. By the decision of the Federal Accreditation Service No.AA-471 of July 16, 2017, the laboratory of hygienic monitoring of the working conditions of the Institute of Occupational Health and Industrial Ecology of the ASMU was entered into the Register of Accredited Agents, including the National Part of the Unified Register of Certification Bodies and Testing Laboratories of the Customs Union. The laboratory has been assigned the number of the accreditation certificate RA.RU.2№94 dated July 16, 2018, which will be valid indefinitely with periodic confirmation of the competence of the laboratory to the accreditation criteria. For the first time in the history of ASMU, the testing laboratory of environmental, hygienic and labor protection directions received recognition of its independence and competence in the National Accreditation System, and the experience of accreditation will be taken into account by other laboratory units of the university.
Materials and methods
The field of accreditation of the laboratory of hygienic monitoring of working conditions contains 57 techniques that can be conventionally differentiated into five main groups of methods: 1) methods
for studying the physical factors of the production and environment (electromagnetic fields, microclimate parameters, ultraviolet, infrared and laser radiation, noise, vibration, ultrasound and infrasound, light environment, air ion and aerosol composition of air); 2) methods for studying ionizing radiation (gamma, alpha, beta, x-ray and neutron radiation, radon in water, indoor air and soil air); 3) research methods of chemical factors in the air of the working area (quantitative chemical analysis of manganese, iron, sulfuric acid, caustic alkalis, vitamin B6 and cephalosporin antibiotics, as well as measurement of concentrations of 22 chemicals in indoor air using an ANT-3M gas analyzer); 4) research methods of pharmaceutical indicators of the quality and safety of plant materials and medicinal plants (the amount of flavonoids in terms of rutin, humidity, total ash); 5) research methods of the severity and intensity of the labor process in accordance with the Order of the Ministry of Labor and Social Protection of the Russian Federation No. 33n dated January 24, 2014 "On Approval of the Methodology for conducting a special assessment of working conditions, Classifier of harmful and (or) hazardous production factors, report forms on conducting a special assessment of working conditions and instructions for filling it out." All 57 methods were officially introduced into the practice of the laboratory by a permanent commission of the Institute of Occupational Health and Industrial Ecology from December 2016 to July 2018 with the preparation of accompanying reporting documents - a program for introducing measurement techniques, an act of implementing a methodology, a working protocol for measuring and a final protocol for laboratory tests, which is made for the customer of laboratory tests. In terms of the implementation of scientific and laboratory research methods, 14,885 measurements of production environment factors (microclimate, light environment, air ion composition, electromagnetic radiation, noise, vibration, chemicals and aerosols) were carried out at 375 workplaces of employees of the Altai State Medical University. In addition, in accordance with the agreement on scientific and practical cooperation with the medical institution "Sanatorium of the Tsentrosoyuz of the Russian Federation in Belokurikha", 1550 measurements of the factors of the working environment at the workplaces of medical personnel, as well as a study of the equivalent dose rate of gamma radiation equivalent to the equilibrium volumetric activity of radon in indoor air (320 measurements) and the specific activity of radon in medicinal water (130 measurements).
Results and discussion
During the accreditation of the laboratory, the quality management system of laboratory tests, the material and technical base of the laboratory,
measuring instruments, provision of necessary documentation, qualifications and experience of employees, as well as monitoring the implementation of the measurement procedure according to the main methods implemented in the laboratory were assessed: microclimate study, light environment, electromagnetic fields, noise, vibration, indicators of environmental radiation safety, harmful chemical substances in the air of the working area and medicinal plants. In particular, it was necessary to measure the parameters of microclimate, illumination, pulsation coefficient and brightness of the working surface, electromagnetic fields of industrial frequency (50 Hz), dose rates of gamma radiation, EEVA of radon -222 and toron-220 according to the guidelines of MU 2.6.1.2838 -11 "Radiation monitoring and sanitary-epidemiolog-ical assessment of residential, public and industrial buildings and structures after the completion of their construction, refurbishment, reconstruction according to radiation safety indicators", and also to perform a study of the local vibration of a handheld mechanized instrument according to GOST 31192.2.-2005, an equivalent noise level according to the "work function" strategy according to GOST ISO 9612-2016, demonstrate procedures for conducting studies of harmful substances in a welding aerosol for manganese, examine the concentrations of cephalosporin antibiotics (cephalexin) in the air of the working area and determine the amount of flavonoids in terms of rutin in an elder black FS.2.5.0008.15. Of particular interest is the analysis of verification methods for conducting a quantitative chemical analysis of harmful substances in the air of the working area. The examination of the verification of technical competence of the laboratory in this area was carried out in the analytical hall. The expert examined the room, installed equipment, dishes, checked the inscriptions on the prepared solutions for photometric and po-tentiometric studies, the availability of methods for their implementation. Next, the expert checked the weighing room and the washing room, the storage place of the chemicals. Having walked around the premises, the expert assessed the declared analytical equipment in detail - the PE-5400UF spec-trophotometer, making a note about the absence of a metrologically certified program for constructing calibration schedules for it in the laboratory. This remark was eliminated during the audit.
Then, the next day, the laboratory staff had to demonstrate the method of air sampling of the working area at the workplace of the welder in the laboratory premises declared in the field of accreditation and determining the concentration of manganese in the welding aerosol (MU 4945-88). Sampling was carried out using the electric aspirator PU-4E, in strict accordance with the method of selection without significant comments from the expert. Next, a sample of air was pre-
pared to determine the manganese concentration on the spectrophotometer. It was necessary to confirm the stability of the calibration dependence on the control solution. Stability has not been confirmed, and new graduation was built. The stability of the calibration characteristics directly depends on the quality of chemical reagents, which are used to obtain colored solutions. To increase the reliability of the obtained results, facilitate calculations and verify stability during accreditation, an application for the purchase of a metro-logically certified calibration dependence creation program was submitted. The result of the study is less than the detection limit. To confirm the stability and accuracy of the analysis result, a control solution of manganese of unknown concentration prepared from a standard solution was measured. The result was accepted as satisfactory, taking into account the magnitude of the measurement error.
Further, the expert assessed the process of building a calibration dependence, according to the method for determining the content of ceph-alosporin antibiotics declared in the field of accreditation (MU 3994-85). Graduation is constructed without comment with a linear correlation coefficient close to 1.00.
The laboratory staff successfully completed all nine control tasks covering all areas of the accreditation field - the study of physical, chemical and radiation factors, as well as pharmaceutical indicators. The expert group was shown that the laboratory has a quality control system for laboratory tests that is integrated into the overall quality management system of the university and is a combination of the organizational structure, responsibility, procedures, types of work, capabilities and tools aimed at providing conditions that allow to obtain reliable measurements and objective results.
According to the results of the inspection, an on-site expert examination report was drawn up in which an unambiguous conclusion was drawn that the laboratory of occupational health and industrial ecology of the hygienic monitoring of working conditions of the Institute of Occupational Health and Industrial Ecology complies with the accreditation criteria and GOST ISO/IEC 170252009 "General requirements for the competence of testing and calibrating laboratories".
Conclusion
The main key component of the successful accreditation of an environmental-hygienic testing laboratory is the preparatory work in the following areas:
1) The phased development of a laboratory quality management system integrated into the university's overall quality management system.
2) Creating the necessary material and technical base and equipping the scientific laboratory with modern high-tech equipment to measure the phys-
ical, chemical, radiation factors of the surrounding and working environment, the severity and intensity of the labor process, the study of pharmaceutical indicators of the quality and safety of medicinal plant materials.
3) Timely metrological certification of measuring instruments and testing laboratory equipment.
4) Careful selection and placement of laboratory personnel, development and implementation of staff development programs.
5) Conduction of interlaboratory comparison tests at accredited laboratories on the basic research methods.
References
1. Federal Law No. 412-FZ of December 28, 2013 "On Accreditation in the National Accreditation System".
2. Order of the Ministry of Economic Development of the Russian Federation of 30.05.2014 No. 326 "On approval of accreditation criteria, list of documents confirming compliance of an applicant, accredited person with accreditation criteria, and list of documents in the field of standardization, compliance of which with applicants, accredited persons ensures their compliance with the criteria of accreditation."
3. GOST ISO/IEC 17025-2009 "General requirements to the competence of testing and calibrating laboratories"
Contacts
Corresponding author: Balandovich Boris Anato-lievich, Doctor of Medical Sciences, Associate Professor, Head of the Institute of Occupational Health and Industrial Ecology of the Altai State Medical University, Barnaul. 656038, Barnaul, Lenina Prospekt, 40. Tel.: (3852) 566898. E-mail: dr.balandovich@mail.ru
Author information
Krasikov Aleksandr Anatolyevich, junior research associate of the Institute of Occupational Health and Industrial Ecology, Altai State Medical University, Barnaul.
656038, Barnaul, per. Nekrasova, 65. Tel.: (3852) 566898. E-mail: grizly137@yandex.ru Tulin Nikolai Yurievich, junior research associate of the Institute of Occupational Health and Industrial Ecology, Altai State Medical University, Barnaul.
656038, Barnaul, per. Nekrasova, 65. Tel.: (3852) 566898. E-mail: none184@yandex.ru
Mazko Olesya Nikolayevna, Candidate of Biological Sciences, Senior Scientific Researcher of the Biomedical Laboratory of the Center of medico-biological research of ASMU, Barnaul.
Tel.: (3852) 669927. E-mail: olesia.mazko@yandex.ru Makarova Olesya Gennadyevna, Candidate of Pharmaceutical Sciences, Senior Scientific Researcher of the Biomedical Laboratory of the Center of medico-biological research of ASMU, Barnaul. Tel.: (3852) 669927. E-mail: olesia552@mail.ru
Balandovich Konstantin Borisovich, engineer of the laboratory of the Center of hygiene and epidemiology in Altai Krai, Barnaul. Tel.: (3852) 503040.
E-mail: mr.balandovich@mail.ru Shchekochikhina Rita Olegovna, lecturer of the Department of pharmacology of ASMU, Barnaul. Tel.: (3852) 566806. E-mail: ritashekochihina@mail.ru
