Federal State Autonomous Educational Institution on Further Vocational Training, «Academy for Standardization, Metrology and Certification (Educational)»
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Journal Kompetentnost': 4 / 155 / 2018


  • 1
    Individual Approach to Employees: Everything is Done Well and on Time
    Authors: Prof. Dr. V.N. Voronin, Rector, FSAEI FVT Academy of Standardization, Metrology and Certification (training) (ASMS), Moscow, Russia prvoronina@asms.ru 
    G.V. Fomicheva, Lecturer, FSAEI FVT ASMS, Moscow, Russia
    Each manager expects from his subordinates that they will successfully get the job done.
    It's mean that perform the task on time and with the desired result. But in practice it
    does not always happen. There are many reasons why employees do not perform the task
    quality and on time. In this article, I analyzed the reasons associated with the notion of
    degree of readiness of the employee to perform the task set by the manager. I consider
    it is important and necessary to apply an individual approach to each category of staff,
    I bring specific recommendations that allow to achieve the desired result. In the next
    article, I will describe how the manager should monitor the fulfillment of his task, how
    to ensure the most effective feedback to his subordinates on the results of work.
  • 2
    Resourcing Science in Modern Russia
    Authors: Dr. Prof. L.P. Kleeva, Academician of International Organization Science Academy, Professor of Russian Presidential Academy of National Economy and Public Administration, Head of Sector in Institute for Study of Science of RAS, Moscow, Russia 
    Dr. A.K. Nikitova, Scientific Worker, Russian Presidential Academy of National Economy and Public Administration 
    A.Yu. Krotov, Scientific Worker, Russian Presidential Academy of National Economy and Public Administration
    We continue to analyze the current state of the RF scientific and innovative sphere.
    Earlier we investigated the trends in the development of the education system in
    Russia, the financing of its scientific and innovation sphere. Today’s our investigation
    is devoted to the analysis of the conditions of the domestic science functioning, its
    resource support.
    We have studied the statistical data that characterize the dynamics of organizations
    conducting research and development in our country, providing resources for domestic
    science: its frames, basic foundations of science, finances, and also compared the
    level of funding for research and development in the Russian Federation and abroad.
    The results of the research led us, in particular, to the conclusion that the organizations
    conducting research and development, especially in applied science and developmental
    design, in Russia is declining.
  • 3
    Technical Regulation оf Safe Handling оf Pharmaceutical Products
    Authors: K.Z. Nemesh, D. Mendeleev University of Chemical Technology of Russia, Moscow, Russia, korneliya_nemesh@mail.ru 
    Assoc. Рrof. Dr. S.G. Komarova, Associate Рrofessor, D. Mendeleev University of Chemical Technology of Russia, Moscow, Russia, komsvetka@muctr.ru
    Medicines have specificity that distinguishes them from other consumer goods
    and causes the need for special legal regulation of their treatment.
    Medicinal products differ from other consumer goods, and this specificity requires
    special legal regulation of their treatment. We examined the system of medicine
    regulation as a product throughout the life cycle — from development to retail.
    We also analyzed the activities of the regulatory and permissive system for quality
    assurance of medicines, including state registration, permission to use medicine,
    as well as examination, preclinical and clinical trials, standardization, state control
    and certification of medicines, medical equipment and medical products. We talked
    about state quality standards for medicines, which are developed and approved in
    the following types: general pharmacopoeial article, pharmacopoeial article and
    pharmacopoeial article of the manufacturer of the medicine.
  • 4
    Organizational Aspects of Auditing Risks and Opportunities
    Authors: Dr. S.L. Aleksandrov, Senior Researcher, Head, Quality Control Sector, Samara Center of Standardization, Metrology and Certification, Samara, Russia 
    Assoc. Prof. Dr. V.A. Novikov, Vice-rector, Head, Quality Management Department, ASMS, Moscow, Russia 
    N.B. Timofeeva, Acting Director, Samara Center of Standardization, Metrology and Certification, Samara, Russia
    We have identified the distinctive features, the factors that determine the effectiveness,
    and formulated the functions of the quality management systems internal audits,
    focused on checking and assessing the risks and opportunities for the activities of
    We showed that the risks and opportunities identification is related to the creative
    activity and interaction of participants in small groups that are constantly changing in
    composition, typical for QMS internal audits.
    To improve the effectiveness of internal audits of quality management systems, it is
    proposed to structure the issues for the audit of risks and opportunities in accordance
    with the requirements of GOST R ISO 9001–2015 and the elements of models reflected
    in the process maps.
    The purpose of internal audits of risks and opportunities, as a management tool,
    is recommended to be supported by management and all participants of the work,
    including when performing external audits of the activities of organizations.
  • 5
    High-tech Pharmaceutical Substances Manufacture: Control Points
    Authors: Yu.N. Karpova, External PhD Student, Moscow Technological University, Moscow, Russia, yulia_karpova@inbox.ru 
    Dr. E.G. Khomutova, Professor, Moscow Technological University, Moscow, Russia, khomutova@mail.ru
    We have analyzed the domestic and international regulation, documents and proposed
    a methodology for determining critical control points in the production of high-tech
    synthetic pharmaceutical substances.
    We presented the results of the analysis of regulatory documents to justify the
    introduction of the new term checkpoint, formulated the definition. For unification,
    we proposed to use the term control points, which combine the terms control point and
    critical control point. A selection of control points for a typed production scheme for a
    pharmaceutical substance of a synthetic nature is described.
    To produce a high-tech substance of a synthetic nature, it is recommended to apply
    the principle of typification in describing the process and its subsequent analysis in
    order to improve production. Management of the production process is carried out
    at critical control points, for the identification of which it is necessary to propose an
    algorithm based on risk assessment. Evaluation should be based on the influence of the
    process parameter on the quality score.
  • 6
    Modernization of Process Management System due to the Ores Grinding of the Ore Mining and Processing Enterprise
    Authors: Dr. E.R. Fedorova, Assistant, Department Automation of Technological Processes and Productions, St. Petersburg Mining University, St. Petersburg, Russia, Apm_07_2@mail.ru 
    Dr. N.V. Vasil’eva, Assistant, Department Automation of Technological Processes and Productions, St. Petersburg Mining University, St. Petersburg, Russia, Apm_07_2@mail.ru 
    Dr. А.А. Vinogradova, Assistant, Department Automation of Technological Processes and Productions, St. Petersburg Mining University, St. Petersburg, Russia, a.a_vinogradova@mail.ru
    We have consistently outlined the main steps in the creation of a management system
    for the semi-autogenous grinding section of the mining and processing plant. The main
    task was to build a model that accurately describes the process under consideration,
    with the use of new software packages that simplify calculations and further training the
    model. We analyzed the historical production data with the GE Proficy Troubleshooter
    component. The resulting mathematical model was refined using the GE Proficy
    Architect software component. As a result, the model and controller were launched
    in real time and as a consultant, and as a full-fledged control link in conjunction with
    the SCADA system CIMPLICITY. In the first case, the operator has the right to accept
    or not to accept the advice of the system.
    We believe that the model can be launched in real time as a full functional link.
    Preliminary in the model it is necessary to adjust so that the output parameter
    recommended flow of circulating water is supplied directly to the parameter flow
    of return water so that the operator’s participation is not necessary.
  • 7
    Organization of the Wheat Flour Quality Traceability
    Authors: Assoc. Prof. Dr. E.I. Cherkasova, Associate Professor, Department of Metrology, Standardization and Quality Management, Russian State Agrarian University — Moscow Timiryazev Agricultural Academy, Moscow, Russia 
    Dr. P.V. Golinitskiy, Senior Lecturer, Department of Metrology, Standardization and Quality Management, Russian State Agrarian University — Moscow Timiryazev Agricultural Academy, Moscow, Russia, gpv@rgau-msha.ru
    We have examined the quality of the organization of the traceability process wheat
    flour at the present stage, including a constant incoming inspection of raw materials,
    control of all process steps and quality control of the finished product with the use of
    information technology, and analyzed the economic costs of their implementation.
    Thus, we propose to use RFID tags, for example, the RFID passive tags or NFSPASS
    label recording information on an Internet resource, which contains information
    about a particular consignment, sending information about the region, data about
    intermediaries and others.
    We believe that the use of information technology will allow bona fide producers of
    flour to create a competitive advantage and optimize supply chains and mini-bakeries
    to improve product quality without a significant increase in its cost to the end user.
  • 8
    Metrological Support of ECG Systems: Problems and Prospects
    Authors: A.V. Ivashchenko, Graduate Student, Department Physics and Technology Institute of MIREA, Moscow, Russia, alekceu1988@mail.ru 
    T.O. Sovetova, Doctor of Functional Diagnostics, Clinical Sanatorium Barvikha, Administrative Department of the RF President, Moscow, Russia
    We analyzed the technical devices of the electrocardiography systems metrological
    support. We found out that the current List of measurements related to the state
    regulation of ensuring the uniformity of measurements performed in health care
    contains only 20 measurements, to which mandatory metrological requirements have
    been established. Today in the field of health, much more measurements are being made,
    which are the basis for diagnosis and treatment patients.
    So, in the current List there are no measurements conducted using EСG systems.
    Lack of metrological maintenance of this medical equipment can harm the health of
    Russian citizens, we believe. In connection with this, the List requires improvement:
    the inclusion of measurements conducted using ECG systems, their revision with
    a frequency of 5–10 years.

Content / Abstracts