• Journal of Korean Society for Quality Management
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• v.50 no.4
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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.

• Proceedings of the KSR Conference
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• 2009.05a
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• pp.1557-1565
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• 2009

According to the GM/RT2141, to assess the safety of vehicle, the validated the vehicle dynamic model should be applied. The validation of the vehicle model is against the static test, some kind of vehicle type test results have been used to determine the suspension characteristics and the vehicle dynamic characteristics. To validate the vehicle model and the test results, first the test results has been analysed as to specified the suspension characteristics and than the parameters to related with the test result has to be adjusted to show the same results of the test. In this process the parameters of vehicle model have been determined to show the coherence of the two results of the simulation and the test by trial & error. In this report, the optimization tool has been introduced in this model validation process and shows the efficient and well validated model.

• 한국IT서비스학회:학술대회논문집
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• 2006.11a
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• pp.190-193
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• 2006

Ther are many stages of the development for the embedded systems' hardware and software as well, which results in many test stages of it with respect to corresponding development stages. The software validation of embedded systems is taken into consideration for the testers to make sure that the systems work correctly after the deployment. Among test stages, especially control logic level testing and system validation testing are considered as the most important test, because the robustness of embedded systems' software can be validated by those two level of tests. in this paper, we would like to introduce the idea of how software test system for embedded systems can be established and of what necessary components are needed

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2008.04a
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• pp.795-800
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• 2008

The sound transmission loss is a key index to evaluate the acoustic performance of a car-body structure at the high frequency range. From this paper, a new validation method for in-situ sound transmission loss is proposed. First, in-situ sound transmission loss is measured by using PU intensity probe on the condition of complete vehicle. Second, validation test, which is consisted of internal, external and total frequency response function test, is performed by using volume acceleration source and microphones. Then, these test results are compared to validate the accuracy of in-situ sound transmission loss. Finally, the test result of in-site method is compared with results of two reverberant room test method and SEA analytical method. The reliability of in-situ method is confirmed by these procedures.

• Structural Engineering and Mechanics
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• v.15 no.1
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• pp.1-19
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• 2003

This paper presents the formulation of a new bridge-vehicle system with validation using the field data. Both pitching and twisting modes of the vehicle are considered in the contribution of the dynamic effects in the bridge responses. A heavy vehicle was hired as a control vehicle with known axle weight, axle spacing and spring coefficients. The measured responses were generated from the control vehicle running at a particular speed at a test span at Ma Tau Wai Flyover. The measured responses were acquired using strain gauges installed beneath the girder beams of the test bridge. The simulated responses were generated using BRVEAN that is a self-developed program based on the proposed bridge-vehicle system. The validation shows that the bridge model is valid for representing the test bridge and the governing equations are valid for representing the motion of moving vehicles.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.19 no.2
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• pp.96-101
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• 2009

The purpose of this study was to conduct the field validation of alternative method(ETM method) by using non-carcinogenic, and less toxic solvents than NIOSH (National Institute for Occupational Safety and Health) analytical method 5524 for measuring the airborne metalworking fluids in workplaces. We carried out the field validation test by using the exposure chamber, guaranteeing the air sampling homogeneously in a machining environment. The ETM mixed solvent presented the complete solubility of MWFs used in test field. Based on the field test data, the bias of the ETM method from reference method, NIOSH analytical method 5524, was from -7.0% to 5.1%. The overall uncertainty of the ETM nethod was 21.6%, which satisfied the NIOSH criteria for the sampling and analytical criteria.

• Journal of Soil and Groundwater Environment
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• v.15 no.5
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• pp.8-15
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• 2010

The purpose of this research is to check the validation of an auto-analysis method combined with aqua regia digestion apparatus for improvement of water distillation method used as a fluorine test of soil. Fluorine contents of CaO used in the pretreatment course of water distillation method were 120 mg/kg ~ 5,064 mg/kg at the blank test, which was exceeded up to maximum 12.5 times of the soil standard, so it was estimated due to a effect of fluorine existing as impurities of CaO. The recovery test of the same samples indicated that water distillation method and auto-analysis method were 134.5mg/kg and 161.7mg/kg respectively, the recovery ratio of the latter was 16.8% higher than the formal. The validation test of two methods satisfied the standard, but auto analysis method was excellent more than distillation method. Also, auto analysis method could save a analysis time up to maximum 4.7 times by comparison with water distillation method.

• Journal of the Korea Institute of Military Science and Technology
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• v.17 no.3
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• pp.318-326
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• 2014

The Shipyard Test of Naval Combat System depends on external factors, such as weather conditions and availability of its sensor-weapon, due to the need of on-board sensor-weapon during the test. This paper suggests the Supportive Equipment using virtual simulator for Shipward Test, in case of the unavailability of the on-board sensor-weapon or the test support force(aircraft, surface ship etc.), to pre-check the functions of the combat system as well as to prepare the Shipyard Test. To mock the real sensor-weapon functions as similar as possible, the Supportive Equipment for Shipyard Test was verified by the Verification and Validation process, which is usually performed while developing models in the Modeling & Simulation field.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.4 no.2
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• pp.197-207
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• 2006

The engineering performance of a high level waste repository is significantly dependent upon the T-H-M behavior in the engineered barrier system. An engineering-scale test facility (KENTEX) was set up to validate the T-H-M behaviors in the buffer of a reference disposal system developed in the 2002. The validation tests started on May 31, 2005 and is now in progress. The KENTEX facility and validation test programme are introduced, and pre-operation calculations are also presented to give information on the sensitive location of sensors and operational conditions. This test will provide information (e.g., large-scale apparatus, sensors, monitoring system etc.) needed for 'in-situ' tests, make the validation of a T-H-M model for the T-H-M performance assessment of the reference disposal system, and demonstrate the engineering feasibility of fabricating and emplacing the buffer of a repository.

• International Journal of Naval Architecture and Ocean Engineering
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• v.3 no.1
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• pp.9-19
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• 2011

The paper describes the validation of two time domain methods to simulate the behaviour of a destroyer operating in steep, stern-quartering seas. The significance of deck-edge immersion and water on deck on the capsize risk is shown as well as the necessity to account for the wave disturbances caused by the ship. A method is described to reconstruct experimental wave trains and finally two deterministic validation cases are shown.