• Title/Summary/Keyword: Validation tests

검색결과 589건 처리시간 0.026초

QbD6시그마 프로세스를 통한 D-항원 정량 시험법의 유효성과 동등성에 관한 연구 (A Study on the Efficacy and Equivalence of D-antigen Quantitative Analysis through QbD6sigma Process)

  • 김강희;김현정
    • 품질경영학회지
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    • 제50권4호
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    • pp.831-842
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    • 2022
  • Purpose: This study carried out the Quality by Design (QbD)6σ process to verify the effectiveness and equivalence of the finished D-antigen quantitative test method, and compared the OFAT-based method validation and test result acceptance criteria with the Analytical Quality by Design (AQbD)-based method validation and test method. This is a study on how to reduce the risk of delay in permit change by increasing the reliability of permit data in the existing method by statistically analyzing the results. Methods: With the QbD6σ process, the effectiveness and equivalence of the D-antigen quantitative test method were verified with the data of the existing test method and the new test method. Results: Method validation tests are performed based on AQbD. Critical Method Parameters are identified through risk assessment, and single/combined actions are verified by designing and performing tests for Critical Method Parameters (analysis of variance, full factorial design method). Method validation can be effectively accomplished with the QbD6σ process. Conclusion: The use of QbD6σ can be used to achieve satisfactory results for both pharmaceutical companies and regulators by using appropriate statistical analytical methods for method validation as required by regulatory agencies.

On the Safety and Performance Demonstration Tests of Prototype Gen-IV Sodium-Cooled Fast Reactor and Validation and Verification of Computational Codes

  • Kim, Jong-Bum;Jeong, Ji-Young;Lee, Tae-Ho;Kim, Sungkyun;Euh, Dong-Jin;Joo, Hyung-Kook
    • Nuclear Engineering and Technology
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    • 제48권5호
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    • pp.1083-1095
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    • 2016
  • The design of Prototype Gen-IV Sodium-Cooled Fast Reactor (PGSFR) has been developed and the validation and verification (V&V) activities to demonstrate the system performance and safety are in progress. In this paper, the current status of test activities is described briefly and significant results are discussed. The large-scale sodium thermal-hydraulic test program, Sodium Test Loop for Safety Simulation and Assessment-1 (STELLA-1), produced satisfactory results, which were used for the computer codes V&V, and the performance test results of the model pump in sodiumshowed good agreement with those in water. The second phase of the STELLA program with the integral effect tests facility, STELLA-2, is in the detailed design stage of the design process. The sodium thermal-hydraulic experiment loop for finned-tube sodium-to-air heat exchanger performance test, the intermediate heat exchanger test facility, and the test facility for the reactor flow distribution are underway. Flow characteristics test in subchannels of a wire-wrapped rod bundle has been carried out for safety analysis in the core and the dynamic characteristic test of upper internal structure has been performed for the seismic analysis model for the PGSFR. The performance tests for control rod assemblies (CRAs) have been conducted for control rod drive mechanism driving parts and drop tests of the CRA under scram condition were performed. Finally, three types of inspection sensors under development for the safe operation of the PGSFR were explained with significant results.

KA-32T 헬기 시뮬레이터 검증을 위한 비행시험 (KA-32T Helicopter Flight Test for Full Flight Simulator Validation)

  • 최형식;장재원;전대근;전향식
    • 항공우주기술
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    • 제7권1호
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    • pp.1-7
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    • 2008
  • 국토해양부 지원을 통해 수행되는 KA-32 훈련용 헬기시뮬레이터 개발 프로그램의 목적은, FAA AC 120-63의 레벨 C 요구규격을 충족하는 헬기 시뮬레이터를 개발하는 것이다. 한국항공우주연구원(KARI)은 개발 총괄 프로그램을 주관하고 있으며, 또한 비행 역학 모델을 개발하고 시뮬레이터 설계 데이터와 비행 시험 데이터에 기초를 충실도를 검증하는 업무를 담당하고 있다. 대상 헬기는 산림항공관리소에서 운용되고 있는 Kamov KA32T이다. 비행시험은 7월 30일에서 8월 31일까지 익산 산림항공관리소에서 수행되었다. 본 논문은 시뮬레이터 검증을 위한 비행시험데이터 획득에 필요한 장비장착 및 비행시험에 대한 내용을 기술하고 있다.

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고준위폐기물 처분시스템의 열적-수리적-역학적 거동 규명을 위한 공학적 규모의 실증시험 (Engineering-scale Validation Test for the T-H-M Behaviors of a HLW Disposal System)

  • 이재완;박정화;조원진
    • 방사성폐기물학회지
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    • 제4권2호
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    • pp.197-207
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    • 2006
  • 고준위폐기물처분장의 공학적 성능은 공학적 방벽의 열적-수리적-역학적 거동에 의해 크게 좌우된다. 2002년에 제안된 기준처분시스템 완충재의 열적-수리적-역학적 거동 실증을 위해서, 엔지니어링 규모의 실증장치인 KENTEX를 제작설치 하였다. 이 실증실험은 2005년 5월 31일에 시작하여 현재 진행 중에 있다. 본 논문에서는 운전 중인 KENTEX시설과 이 시설에서 수행 중인실험 및 향후 연구내용을 소개하고, 또한 센서 설치 및 운전조건 결정을 위해 수행한 운전 전 T-H-M 모델 계산결과도 기술하였다. 한국형 기준처분시스템의 실증연구와 관련하여, KENTEX 실증실험은 향후 추진될 지하시험시설에서의 현장시험에 필요한 자료와 경험을 제공하고, 기준처분시스템의 열적-수리적-역학적 거동특성과 평가모델을 검증할 것이다. 실험적으로는 처분장 완충재로 사용되는 벤토나이트 블록의 제작 및 설치에 대한 엔지니어링 타당성을 보여 주는데 유용하게 활용될 것이다.

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HFFB technique and its validation studies

  • Xie, Jiming;Garber, Jason
    • Wind and Structures
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    • 제18권4호
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    • pp.375-389
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    • 2014
  • The high-frequency force-balance (HFFB) technique and its subsequent improvements are reviewed in this paper, including a discussion about nonlinear mode shape corrections, multi-force balance measurements, and using HFFB model to identify aeroelastic parameters. To apply the HFFB technique in engineering practice, various validation studies have been conducted. This paper presents the results from an analytical validation study for a simple building with nonlinear mode shapes, three experimental validation studies for more complicated buildings, and a field measurement comparison for a super-tall building in Hong Kong. The results of these validations confirm that the improved HFFB technique is generally adequate for engineering applications. Some technical limitations of HFFB are also discussed in this paper, especially for higher-order mode response that could be considerable for super tall buildings.

Validation of a non-linear hinge model for tensile behavior of UHPFRC using a Finite Element Model

  • Mezquida-Alcaraz, Eduardo J.;Navarro-Gregori, Juan;Lopez, Juan Angel;Serna-Ros, Pedro
    • Computers and Concrete
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    • 제23권1호
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    • pp.11-23
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    • 2019
  • Nowadays, the characterization of Ultra-High Performance Fiber-Reinforced Concrete (UHPFRC) tensile behavior still remains a challenge for researchers. For this purpose, a simplified closed-form non-linear hinge model based on the Third Point Bending Test (ThirdPBT) was developed by the authors. This model has been used as the basis of a simplified inverse analysis methodology to derive the tensile material properties from load-deflection response obtained from ThirdPBT experimental tests. In this paper, a non-linear finite element model (FEM) is presented with the objective of validate the closed-form non-linear hinge model. The state determination of the closed-form model is straightforward, which facilitates further inverse analysis methodologies to derive the tensile properties of UHPFRC. The accuracy of the closed-form non-linear hinge model is validated by a robust non-linear FEM analysis and a set of 15 Third-Point Bending tests with variable depths and a constant slenderness ratio of 4.5. The numerical validation shows excellent results in terms of load-deflection response, bending curvatures and average longitudinal strains when resorting to the discrete crack approach.

Force-deformation relationship prediction of bridge piers through stacked LSTM network using fast and slow cyclic tests

  • Omid Yazdanpanah;Minwoo Chang;Minseok Park;Yunbyeong Chae
    • Structural Engineering and Mechanics
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    • 제85권4호
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    • pp.469-484
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    • 2023
  • A deep recursive bidirectional Cuda Deep Neural Network Long Short Term Memory (Bi-CuDNNLSTM) layer is recruited in this paper to predict the entire force time histories, and the corresponding hysteresis and backbone curves of reinforced concrete (RC) bridge piers using experimental fast and slow cyclic tests. The proposed stacked Bi-CuDNNLSTM layers involve multiple uncertain input variables, including horizontal actuator displacements, vertical actuators axial loads, the effective height of the bridge pier, the moment of inertia, and mass. The functional application programming interface in the Keras Python library is utilized to develop a deep learning model considering all the above various input attributes. To have a robust and reliable prediction, the dataset for both the fast and slow cyclic tests is split into three mutually exclusive subsets of training, validation, and testing (unseen). The whole datasets include 17 RC bridge piers tested experimentally ten for fast and seven for slow cyclic tests. The results bring to light that the mean absolute error, as a loss function, is monotonically decreased to zero for both the training and validation datasets after 5000 epochs, and a high level of correlation is observed between the predicted and the experimentally measured values of the force time histories for all the datasets, more than 90%. It can be concluded that the maximum mean of the normalized error, obtained through Box-Whisker plot and Gaussian distribution of normalized error, associated with unseen data is about 10% and 3% for the fast and slow cyclic tests, respectively. In recapitulation, it brings to an end that the stacked Bi-CuDNNLSTM layer implemented in this study has a myriad of benefits in reducing the time and experimental costs for conducting new fast and slow cyclic tests in the future and results in a fast and accurate insight into hysteretic behavior of bridge piers.

Utilizing virtual vibration tests to optimize physical endurance tests

  • Kihm, Frederic
    • Advances in aircraft and spacecraft science
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    • 제5권2호
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    • pp.239-249
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    • 2018
  • Physical tests are performed at various stages of the development cycle of a product, from prototype validation to product qualification. Although costly, there are growing demands for qualification tests like endurance vibration testing to be more representative of the real world. At the same time there are growing demands to assess the durability of these items based on FEA simulation. In this paper, we will explain how to set up a CAE-based test and how to correlate the results with some physical measurements. Specific assumptions will be explained and some advantages of using virtual tests will be highlighted such as the reduction of the number of prototypes needed, investigations on failures, evaluation of the level of reliability via sensitivity analysis, evaluation of the margins are at the end of a successful test. This presentation will therefore focus on explaining and showing how virtual tests can enrich the exploitation of physical tests.

High-velocity impact of large caliber tungsten projectiles on ordinary Portland and calcium aluminate cement based HPSFRC and SIFCON slabs -Part II: numerical simulation and validation

  • Gulkan, P.;Korucu, H.
    • Structural Engineering and Mechanics
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    • 제40권5호
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    • pp.617-636
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    • 2011
  • We present the numerical implementation, simulation, and validation of the high-velocity impact experiments that have been described in the companion article. In this part, numerical investigations and simulations performed to mimic the tests are presented. The experiments were analyzed by the explicit integration-based software ABAQUS for improved simulations. Targets were modeled with a damaged plasticity model for concrete. Computational results of residual velocity and crater dimensions yielded acceptable results.

Neurobehavioral Tests for Occupational Screening의 타당도 평가 : 파킨슨병 환자들의 검사 성적 (Validation of Neurobehavioral Tests for Occupational Screening(NTOS) : results of patients of Parkinson's disease)

  • 이채용
    • Journal of Preventive Medicine and Public Health
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    • 제30권3호
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    • pp.577-584
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    • 1997
  • 이 연구는 최근 개발된 컴퓨터를 이용한 정신운동 기능 검사법인 Neurobehavioral Tests fur Occupational Screening(NTOS)의 타당도 평가를 위해 시도되었다. 일개 종합병원 신경과에 등록된 파킨슨병 환자 12명과 신경독성물질에 폭로된 적이 없는 근로자 21명을 대상으로 NTOS의 단순반응시간 검사, 2가지 선택반응시간 검사, 양 손의 수지타진검사를 실시하였다. 평균 단순반응시간은 근로자군은 245 msec, 환자군은 378 msec였으며, 2가지 선택반응시간은 근로자군은 444 msec, 환자군은 671 msec 로 나타나 T 검정에서 유의한 차이를 보였다. 주로 쓰는 손의 수지타진검사는 68.6회를 나타내었고, 파킨슨병 환자군은 51.6회, 주로 쓰지 않는 손은 각각 60.9회, 43.1회로 유의한 차이를 보였다. 환자군과 근로자군의 연령과 학력차이를 통계적으로 보정하고 두군에서 차이가 나는지를 알아보기 위해 공분산분석을 실시한 결과, 단순반응시간, 선택반응시간, 수지타진이 유의한 결과를 보였다. 이상으로 볼 때, NTOS는 정신운동기능의 장애를 발견할 수 있는 도구라고 생각된다. 그러나 선택반응 시간 검사의 실수 횟수 같이 상대적으로 민감하지 못한 지표에 대한 고려가 필요하며, 혼란변수를 연구 설계에서 조정할 수 있는 큰 규모의 연구와 정신운동기능의 잠재적 장애를 보이는 집단에 대한 연구들이 추후에 있어야 할 것이다.

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