Qualification Plan Research Articles

Динамика возрастных характеристик профессорско-преподавательского состава высшей школы: актуальные тенденции и оценка рисков

The personnel renewal of the teaching staff of higher education (teaching staff) is considered one of the factors contributing to the development of the domestic education system, which implies an increase in the proportion of scientific and pedagogical staff of universities under the age of 35 according to the national project "Education" to 20%. The subject of the study is the dynamics of the structural characteristics of the PPP. The purpose of the work is to identify the main trends in the age dynamics of teaching staff. The study found that the age characteristics of teaching staff cannot fully serve as indicators of the maturity of university teachers to solve professional tasks and educate harmoniously developed and socially responsible individuals based on the spiritual and moral values of the peoples of the Russian Federation, although the process of "aging" teaching staff causes a number of risks to the higher education system due to age bias priorities of teachers in the professional qualification plan. The ambiguous assessment by the educational community of the tasks associated with the "rejuvenation" of the teaching staff, in the absence of optimal mechanisms of management activities to adjust the age structure of teachers in universities, is demonstrated. It is concluded that it is necessary to develop and implement a strategically sound personnel policy, within the framework of which there is no formal replacement of older teachers with younger staff, but systematic work is implemented based on compliance with the following principles: flexibility of professional trajectories, differentiated nature of support measures, transparency of competition criteria, inadmissibility of discrimination.

Biomarkers for Alzheimer's Disease: Context of Use, Qualification, and Roadmap for Clinical Implementation.

Background and Objectives: The US Food and Drug Administration (FDA) defines a biomarker as a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention. Biomarkers may be used in clinical care or as drug development tools (DDTs) in clinical trials. The goal of this review and perspective is to provide insight into the regulatory guidance for the use of biomarkers in clinical trials and clinical care. Materials and Methods: We reviewed FDA guidances relevant to biomarker use in clinical trials and their transition to use in clinical care. We identified instructive examples of these biomarkers in Alzheimer’s disease (AD) drug development and their application in clinical practice. Results: For use in clinical trials, biomarkers must have a defined context of use (COU) as a risk/susceptibility, diagnostic, monitoring, predictive, prognostic, pharmacodynamic, or safety biomarker. A four-stage process defines the pathway to establish the regulatory acceptance of the COU for a biomarker including submission of a letter of intent, description of the qualification plan, submission of a full qualification package, and acceptance through a qualification recommendation. Biomarkers used in clinical care may be companion biomarkers, in vitro diagnostic devices (IVDs), or laboratory developed tests (LDTs). A five-phase biomarker development process has been proposed to structure the biomarker development process. Conclusions: Biomarkers are increasingly important in drug development and clinical care. Adherence to regulatory guidance for biomarkers used in clinical trials and patient care is required to advance these important drug development and clinical tools.

Pharmaceutical industrial equipment qualification in Brazil: a strategic test proposal for vaccine secondary material packaging lines

This research has as main objective prepare a qualification plan for vaccines secondary material packaging lines, in order to guide its practice and to define the tests required for the pharmaceutical industry in Brazil. This study sought to ensure product quality and health through better testing planning needed for proper installation, operation and performance of the equipment, as the few existing national regulations are generic regarding this type of approach. For this, a literature review was conducted using the most comprehensive research bases of scientific articles to describe the state of the art on the subject. The survey questionnaire was applied to the qualification and validation specialists. The use of a statistical tooling helped in the process of identification of the tests which cannot be missed within a quality planning. It is expected that the result of this study, through the development of a qualification plan, will add safety, reproducibility and effectiveness to the quality of the product and facilitate regulatory compliance with regulatory agencies. In addition, this plan will aim to contribute to other equipment and systems aimed at guiding specialists in qualification activities and the advancement of literature research.

Educational Qualification and Family Planning Practices Among Married Persons in Southwest, Nigeria

This study examined the relationship between educational qualification and family planning practices among married persons in Southwest Nigeria. Descriptive research design of the survey type was adopted for this study and the sample consisted of one thousand and two hundred (1,200) married persons. Multistage random sampling technique was used to select the sample. Information was collected for the study through the administration of questionnaire to the respondents. Data obtained were analysed using mean, standard deviation, ANOVA and regression analysis. The result revealed that educational qualification of married persons will significantly influence the family planning practices. It was concluded that married person with high educational qualification will definitely plan their family by giving birth to few children, It was therefore recommended that married persons need to improve on their educational status in order to increase the level of family planning practices. Also they should see the need to plan and space child birth. Keywords: Marriage, Family, Educational Qualification, Family Planning Practices, Child Spacing. DOI: 10.7176/RHSS/10-6-05 Publication date: March 31 st 2020

ALFRED: A revised concept to improve pool related thermal-hydraulics

ALFRED, namely the Advanced Lead-cooled Fast Reactor European Demonstrator, has been conceived to serve the industrial deployment of the Lead-cooled Fast Reactor (LFR) technology. ALFRED is a demonstrator reactor designed with the specific purpose to test and qualify innovative components and procedures to be used in commercial reactors. In its role of European Technology Demonstrator Reactor, it will offer a representative operational environment of interest for research organizations, industry and safety authorities. Initially developed as part of a collaborative effort funded through the European 7th Framework Programme, the project was taken over by an international consortium Fostering ALFRED Construction (abbreviated to FALCON). As one of the priorities of the consortium Expert Board, the ALFRED design underwent an in depth review, aimed at identifying and addressing vulnerabilities in terms of reliability and safety, investigating also scalability of the design, flexibility for maintenance and replacement, manufacturability of components, availability of codes and standards for nuclear components and materials. The reactor coolant system arrangement was found susceptible to two main thermal-hydraulic issues typical of Fast Reactor (FR) pool-type designs: (i) thermal stratification in the upper part of the pool and (ii) potential steam entrainment in case of Steam Generator Tube Rupture or leakage. Moreover, (iii) the risk of lead freezing, more specific to the use of high melting point metals as coolants, represented a third issue, of particular concern in conjunction with the passive residual heat removal function in accident conditions.Starting with a general description of the ALFRED Project framework, including the experimental facilities in support to the LFR Research, Development and Qualification plan, the paper will focus on the new system arrangement and Decay Heat Removal (DHR) system of the ALFRED concept design, aimed at improving the pool thermal-hydraulics against the above described issues and risks. Since the ALFRED revised configuration is considered to offer improved safety and robustness, the FALCON consortium is willing to share the outcome of private and national investments, with hope of stimulating new opportunities for further developments and investigations through advanced computational tools and experimental tests within the LFR research community.

COTS based GNSS Receiver with Precise Point Positioning for CubeSats

The paper presents the work towards developing a COTS based GNSS receiver and integrating Precise Point Positioning algorithms to facilitate close proximity operations for CubeSats in formation flying and during docking or rendezvous manoeuvres. We initially present the driving requirements identified for these types of missions. Besides fitting a standard CubeSat, the receiver has to weigh less than 0.3 kg, consume less than 5 W and be multi-frequency and multi-onstellation. Next, follows the identification of a commercial off the shelf GNSS receiver that can be easily customized to fit the basic requirements of a GNSS space receiver and on which Precise Orbit Determination (POD) algorithms can be implemented. For the start of the activity three commercial receivers were selected as proposed candidates to be traded off regarding the degree to which they fulfil the requirements, the degree of openness and of manufacturer support. A COTS microcontroller shall be then selected to control the operation of the COTS receiver. We then expand on the proposed general architecture of the system from COTS modules to their integration philosophy, with a discussion on the means of delivering the correction factors to the receiver. PPP corrections are expected to be delivered either via ground stations or via the geostationary satellite based commercial services. The PPP algorithms are to be implemented on the microcontroller, which will also try to maximize the availability of a precise PVT solution by incorporating a neural network fed by an orbit propagator and the PPP algorithm. The neural network shall estimate a precise position whenever PPP corrections are not available. The training of the neural network shall be done on the ground, allowing for a small footprint on board. A preliminary design of the hardware and the planned qualification plan is concluding the work.

Risk Based Technology Qualification Method for HPHT Well

With the increasing demand for new technologies in HPHT (high pressure high temperature) wells, more and more attention has been paid to the system of technical qualifications. Most established norms, standards and recommended practices are written in prescribed formats, setting out methods, procedures and acceptance criteria for product design, manufacture and testing. However, established norms, standards or recommended practices may not adequately cover new technologies or applications. The technical qualification system is established in this paper, which can identify the potential failure modes and some activities in order to control the uncertainties and increase confidence of using new technology. A risk-based technical qualification system is used to assess non-traditional operations. It includes following seven main steps: system breakdown, technology assessment and classification, technical novelty, failure model and risk analysis, risk-based qualification planning and participation level development. The core of technical qualification system is to understand the ways and causes of system failure, and to carry out corresponding activities to provide evidence that the system will not fail. Through the technical identification process, the detailed equipment/operation specifications and identification requirements have been formulated. Different levels of participation are assigned for each eligibility activity, depending on the hazard and risk. It is proved that the application of the technical qualification principle in the systematic evaluation and control of the risks of new technologies or new applications is successful. In HPHT wells in particular, operators can move from a reactive approach to a proactive approach.

Failure Analysis of AISI 304 Stainless Steel Sleeve Used in High-Pressure Hose Assembly of Actuation System of a Satellite Launch Vehicle

Hydraulic control actuation systems in launch vehicles use flexible hoses for transmission of forces to actuators at different locations. The hose ends are connected to the interface adapters by AISI 304 stainless steel sleeves. These sleeves are assembled to nipple end fittings of the high-pressure hose by a swaging operation to obtain leak-proof hose assemblies. The swaging operation is carried out at room temperature by a hydraulically operated swaging machine. Performance of the system as a whole requires strict adherence to the quality standards maintaining the critical interface dimensions within specified tolerances and ensuring the compression given to the swaged joint through the sleeve. If the joining forces are less, this can result in loose joints and gross leakage, whereas excessive compression can cause damage to the parts of the system namely the sleeve, stainless steel braid, PTFE or the adapter. The swaged joint is a single-point failure mode, indicating that a failure in the joint can lead to mission failure. It has to withstand harsh environments such as high pressure, low and high temperature extremes, fatigue loading due to pressure cycling as well as vibration. Therefore, as part of design verification, a detailed qualification plan has been prepared and the hoses were tested as per the plan. As per the test plan, these hoses undergo acceptance tests which include pneumatic and hydraulic pressure testing. During acceptance testing of hoses, one of the hose sleeves was found to be cracked. The cracking was observed after carrying out the pneumatic test when the assembly was being prepared for hydraulic pressure set-up. This paper describes the detailed metallurgical investigation carried out to understand the cause of failure and actions taken to avoid similar failures.

Qualification and Life Testing of Li-Ion Ves16 Batteries

In the frame of an ESA GSTP 5.2 activity (contract 4000105105), the qualification and life testing of a Saft range of Li-ion batteries based on VES16 cells and theirs autonomous simplified balancing system (SBS) has been carried out. In this abstract the development, qualification plan and successful results from all various tests conducted on the VES16 qualification battery modules are synthetized.Up to the present time, Saft batteries have been mainly utilizing for space applications high capacity cells, like the 45 Ah VES180 and the 35 Ah VES140 cells, targeting predominantly space missions in Geostationary Earth Orbit (GEO). However following the qualification and commercialization of the Saft 4.5 Ah VES16 cell in October 2011 [1] & [2], Saft has been developing and qualifying in the frame of this ESA GSTP 5.2 contract, VES 16 batteries for space missions, targeting both GEO and Low Earth Orbit (LEO) satellite missions. The electrochemistry of the VES16 cells used for the battery modules under the ESA qualification program is not novel. For VES16 cells, the Saft knowhow from large capacity space cells used for space applications, since SMART 1 mission in 2003, has been tailored for a cell with smaller capacity in order to facilitate the modular philosophy that has been deployed in this battery range.

Large-Motor High-Voltage Insulation Systems Testing: Qualification and Acceptance for the Petrochemical Industry

The insulation system of a large, high-voltage (HV) industrial motor stator winding experiences various and significant stresses while in service. Motor manufacturers are responsible for designing and executing detailed test programs that ensure the proven reliability of an insulation system before its use in production. Qualification programs are designed to certify whether an insulation system is designed well enough to sufficiently handle its anticipated usage stress. These programs typically employ a rigorous series of tests for purpose-built samples, including system characterization, electrical breakdown, accelerated life tests, and detailed laboratory analysis. In contrast, factory-acceptance testing of a new rotating machine stator winding must be nondestructive yet still apply sufficient stress to ensure that its insulation system has been manufactured per the design. This article describes the typical insulation system components used for a multiturn form-wound coil design and the stresses that various parts of the system will face while in service. A recommended qualification plan is presented using industry-standard test methods to evaluate the long-term reliability of a vacuumpressure impregnated (VPI) insulation system under sinusoidal-voltage supply. It describes the diagnostic and withstand electrical tests for routine and special acceptance tests, especially those employed for petrochemical industry, where data may be used to establish a baseline condition assessment that is unique to the machine.

SiC layer microstructure in AGR-1 and AGR-2 TRISO fuel particles and the influence of its variation on the effective diffusion of key fission products

Tristructural isotropic (TRISO) coated particle fuel is a promising fuel form for advanced reactor concepts such as high temperature gas-cooled reactors (HTGR) and is being developed domestically under the US Department of Energy's Nuclear Reactor Technologies Initiative in support of Advanced Reactor Technologies. The fuel development and qualification plan includes a series of fuel irradiations to demonstrate fuel performance from the laboratory to commercial scale. The first irradiation campaign, AGR-1, included four separate TRISO fuel variants composed of multiple, laboratory-scale coater batches. The second irradiation campaign, AGR-2, included TRISO fuel particles fabricated by BWX Technologies with a larger coater representative of an industrial-scale system. The SiC layers of as-fabricated particles from the AGR-1 and AGR-2 irradiation campaigns have been investigated by electron backscatter diffraction (EBSD) to provide key information about the microstructural features relevant to fuel performance. The results of a comprehensive study of multiple particles from all constituent batches are reported. The observations indicate that there were microstructural differences between variants and among constituent batches in a single variant. Insights on the influence of microstructure on the effective diffusivity of key fission products in the SiC layer are also discussed.

Análise das Ações da Rede Cegonha no Cenário Brasileiro

A Rede Cegonha (RC), lançada em 2011 pelo Ministério da Saúde (MS), é uma estratégia instituída no Sistema Único de Saúde, com objetivo de reduzir a morbimortalidade materna no Brasil. Os objetivos deste estudo são analisar as ações de saúde materna e infantil implementadas no Brasil após a publicação da portaria 1.459 de 2011, que institui a RC, e identificar possíveis avanços decorrentes desta. Estudo descritivo de revisão da literatura especializada, por meio de busca on line entre abril e julho de 2015, nas bases Medline, Lilacs, Scielo, Google Acadêmico e Periódicos Capes e em documentos oficiais produzidos pelo MS. As publicações deveriam atender aos critérios de terem sido publicadas em português, no período compreendido entre 2011 e 2015. Foram encontrados oito artigos e dez documentos do MS relacionados ao tema. Na revisão, foram identificadas ações implementadas pela Rede Cegonha, que tem como bases organizacionais regionalização e integralidade. Uma das ações implantadas em todas as Unidades Básicas de Saúde é o Teste Rápido de Gravidez, criado para detecção precoce da gestação, com acolhimento da equipe de Atenção Básica e orientações baseadas nas necessidades de cada usuária. A RC ampliou o Plano de Qualificação das Maternidades (PQM) em extensão territorial. No quadro atual de atenção obstétrica, é imprescindível que a gestante seja informada sobre seus direitos. A RC mostrou avanço na proteção integral aos processos de gestação, parto, nascimento, puerpério e início da vida, mas, por envolver políticas de educação em saúde, seus efeitos serão mais tocantes apenas em longo prazo.

Technology Focus: Multilateral/Extended-Reach Wells (May 2016)

Technology Focus The development of multilateral wells and long-reach wells has become important to maximizing recovery for many fields. These technologies are often applied in offshore environments, where large reservoir areas are drained from one or more platforms. In the late 1980s, long-reach wells started to use existing infrastructure better by drilling beyond the design limits of that time. Several major operators were extending their limits, and, in the late 1990s, BP Wytch Farm showed that a horizontal departure exceeding 10 km was feasible. This had a significant effect on the industry because offshore platforms now could be designed for up to 10-km reach, as opposed to the early 1980s when 3-km reach was common. A field could now be developed with one platform instead of three, resulting in enormous savings. Multilateral-well technology also matured during the past 2 decades. There were many drivers for this development. One of the more important was the desire to increase production in tight reservoirs. Another advantage is directional control. Well stimulation with fracturing has the drawback that the fracture direction is controlled by the in-situ stresses in the rock. Multilateral branches, on the other hand, can be drilled in any direction. There has been considerable development around these technologies. Those that help clear the challenges, such as those related to wellbore stability, wellbore friction, equipment limitations, and operational aspects, can be considered mature technologies today. The main benefit from directional drilling is the maximizing of reservoir recovery. From this perspective, multilateral/ extended-reach wells may be considered one of the more important means of improved oil recovery. Although these directional-well concepts have been used for some years, they were initially costly with a high economic risk. There is a continuous technology development at many levels that leads to improvements. These result in more-efficient processes, with increased field recoveries as a consequence. Therefore, multilaterals and extended-reach wells are now common and will be very important for future cost-effective oil and gas production. Recommended additional reading at OnePetro: www.onepetro.org. SPE 174035 Technology Qualification and Installation Plan of Efficient and Accurate Multilaterals Drilling Stimulation Technology for Sandstone Oil Application by Kevin Rice, Fishbones, et al. SPE/IADC 168055 Expanding the Extended-Reach Envelope at Chayvo Field, Sakhlin Island by Vishwas P. Gupta, ExxonMobil, et al. SPE 168235 CT Extended Reach: Can We Reach Farther? by Ken Newman, KNewman Engineering, et al.

Развитие дополнительного профессионального образования в новой экономической ситуации

. The article considers the development trends of further professional education under the current uncertain economic conditions. It is based on the results of a study in the form of questionnaires for 500 human resource managers and 30 in-depth interviews with human resource managers from various enterprises across several industries. Even though research carried out by the RANEPA Center for the Economics of Continuous Education in 2015 reveals a noticeable downward trend in the economic status of many industries and enterprises, senior management does not consider this trend to be either dramatic or irreversible, with the majority expecting that the situation will improve, or at the very least become more stable. This attitude towards the economic realia of today and the future economic developments has not prompted any changes in job requirements; thus, necessary further employee training has not been revised. Those enterprises that enjoy a better economic status tend to be far more demanding towards the qualifications of their employees at all levels. The management has started fine-tuning further qualification plans, prioritizing short-term, inexpensive programs over longer, costlier courses. These strategies are driven by the current conditions in the labor market, with highly skilled workers of different levels becoming redundant. Economic entities that conduct their business in more favorable conditions (either due to their specific area of expertise or the advantage of being a monopoly) are so far the only ones to continue putting an active education policy in place, in order to develop their talent pool. Whereas those industries and entities that do not have these advantages lower their expectations for employees and training expenses, which only lowers their competitiveness further.

Use of Bayesian Networks for Qualification Planning: Early Results of Factor Analysis

This paper discusses the factor analysis that provides the basis for development and use of Bayesian Network (BN) models to support qualification planning in order to predict the suitability of Six Degrees of Freedom (6DOF) vibration testing for qualification. Qualification includes environmental testing such as temperature, vibration and shock to support a stochastic argument about the suitability of a design. Qualification is becoming more complex because it involves significant human expert judgment and relies on new technologies that have often never been fully utilized to support design assessment. Technology has advanced to the state where 6DOF vibration tests are possible, but these tests are far more complex than traditional single degree of freedom tests. This challenges systems engineers as they strive to plan qualification in an environment where technical and environmental constraints are coupled with the traditional costs, risk and schedule constraints. BN models may provide a framework to aid Systems Engineers in planning qualification efforts with complex constraints. Previous work identified a method for building a BN model for the predictive framework. This paper discusses validation efforts of models derived from the factor analysis and summarizes some recommendations on the factor analyses from industry subject matter experts.

Study on Qualification and Training Plans of the International Arbitrator

Study on Qualification and Training Plans of the International Arbitrator

산업안전 분야 NCS기반 자격설계 개발과정에 관한 연구 - 산업안전, 산업보건, 비파괴 분야를 중심으로 -

산업안전 분야 NCS기반 자격설계 개발과정에 관한 연구 - 산업안전, 산업보건, 비파괴 분야를 중심으로 -

Use of Bayesian Networks for Qualification Planning: A Predictive Analysis Framework for a Technically Complex Systems Engineering Problem

Abstract This paper discusses the viability of using Bayesian Network (BN) models to support qualification planning in order to predict the suitability of Six Degrees of Freedom (6DOF) vibration testing for qualification. Qualification includes environmental testing such as temperature, vibration, and shock to support a stochastic argument about the suitability of a design. Qualification is becoming more complex and restricted yet available new technologies are not fully utilized. Technology has advanced to the state where 6DOF vibration shakers and control systems capable of high frequency tests are possible, but the problem using these systems is far more complex than traditional single degree of freedom (SDOF) tests. This challenges systems engineers as they strive to plan qualification in an environment where technical, environmental, and political constraints are coupled with the traditional cost, risk and schedule constraints. New technologies are also available for systems engineers to combine technical understanding with cost, risk and schedule factors to aid in decision making for complex problems such as qualification planning. BN models may provide the framework to aid Systems Engineers in planning qualification efforts with complex constraints. This paper discusses related work, the current approach and results of this research.

Case study: Failure analysis for metal corrosion induced by pressure pot test

The transfer of a technology from a production line to another requires a product and process qualification plan, in order to warranty an adequate quality level. Often the difference in production equipments between the two sites forces to process changes that could introduce uncontrolled failure mode. In the present work an example of failure during qualification is presented. The analyses to identify the root cause are shows together with the recovery actions.

The Study on the qualification plan of the Jewelry CAD Designer

주얼리디자인은 친환경적이면서도 고부가 가치가 있는 패션분야의 대표인 수출진흥산업으로 지속적인 성장을 위해 변화가 필요하다. 주얼리디자인분야도 컴퓨터를 활용하는 디자이너가 많아지고 있어서 주얼리생산을 위한 디자인영역에서 컴퓨터활용을 위한 제도적 환경을 분석하고, 유사한 자격제도에 대한 문헌조사와 통계를 기초로 설문을 실시하여 전문인의 필요성과 필요한 방향을 설정하고자 한다. 자격제도의 개념과 기능, 귀금속디자인자격 자격제도에 관한 자료를 수집 분석함으로 주얼리 컴퓨터 디자이너 자격제도의 성격 및 적합성, 도입하는데 필요한 제반 문제와 검정 범위의 기본방향을 제시하고자 한다. <BR>