Articles

• 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.
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• 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.
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• 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.
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• 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
  organizations.
  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.
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• 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.
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• 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.
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• 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.
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• 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.
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Content / Abstracts