• Title/Summary/Keyword: Preventive Maintenance

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An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers (의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석)

  • Lee, Yoon Jin;Jang, Hye Yun;Lee, Yu-Mi
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.19-27
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    • 2021
  • Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

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Simplified Method for Estimation of Mean Residual Life of Rubble-mound Breakwaters (경사제의 평균 잔류수명 추정을 위한 간편법)

  • Lee, Cheol-Eung
    • Journal of Korean Society of Coastal and Ocean Engineers
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    • v.34 no.2
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    • pp.37-45
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    • 2022
  • A simplified model using the lifetime distribution has been presented to estimate the Mean Residual Life (MRL) of rubble-mound breakwaters, which is not like a stochastic process model based on time-dependent history data to the cumulative damage progress of rubble-mound breakwaters. The parameters involved in the lifetime distribution can be easily estimated by using the upper and lower limits of lifetime and their likelihood that made a judgement by several experts taking account of the initial design lifetime, the past sequences of loads, and others. The simplified model presented in this paper has been applied to the rubble-mound breakwater with TTP armor layer. Wiener Process (WP)-based stochastic model also has been applied together with Monte-Carlo Simulation (MCS) technique to the breakwater of the same condition having time-dependent cumulative damage to TTP armor layer. From the comparison of lifetime distribution obtained from each models including Mean Time To Failure (MTTF), it has found that the lifetime distributions of rubble-mound breakwater can be very satisfactorily fitted by log-normal distribution for all types of cumulative damage progresses, such as exponential, linear, and logarithmic deterioration which are feasible in the real situations. Finally, the MRL of rubble-mound breakwaters estimated by the simplified model presented in this paper have been compared with those by WP stochastic process. It can be shown that results of the presented simplified model have been identical with those of WP stochastic process until any ages in the range of MTT F regardless of the deterioration types. However, a little of differences have been seen at the ages in the neighborhood of MTTF, specially, for the linear and logarithmic deterioration of cumulative damages. For the accurate estimation of MRL of harbor structures, it may be desirable that the stochastic processes should be used to consider properly time-dependent uncertainties of damage deterioration. Nevertheless, the simplified model presented in this paper can be useful in the building of the MRL-based preventive maintenance planning for several kinds of harbor structures, because of which is not needed time-dependent history data about the damage deterioration of structures as mentioned above.

Evaluation of Microbial Contamination in the Manufacturing Process of Non-Heated Frozen Rice Cakes (비가열 냉동떡의 제조공정에 대한 미생물 오염도 평가)

  • Yong-Sik, Yoon;Eun-In, Yang;Young-Soo, Kim
    • Journal of Food Hygiene and Safety
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    • v.37 no.6
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    • pp.400-410
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    • 2022
  • This study was performed to analyze the microbial contamination levels of three non-heated rice cake manufacturers in terms of seasonal manufacturing process and to investigate the effects of summertime soaking on contamination levels and temperature-controlled soaking in water on reduction in microbial levels. The total aerobic bacteria (TAB) ranged from 2.69 log CFU/g to 5.08 log CFU/g in the produce, but the microbial contamination increased sharply during soaking. The levels of TAB and coliforms during summer soaking were 7.01 and 3.96 log CFU/g, respectively, and this was significantly higher than those in other seasons. The contamination level was high in the subsequent freezing, with the TAB level (6.24 log CFU/g) exceeding the legal standard. The temperature of soaking water in summer increased from 19.1℃ to 26.8℃ after 12 h of soaking. The microbial contamination was significantly high commensurate with increased soaking time, and the TAB level in the frozen process exceeded the legal standard from 9 h of soaking. The use of ice packs to prevent the increase in temperature of the soaking water in summer resulted in maintenance of temperature at 20.1℃ for up to 12 h. The average TAB value in the freezing process was 4.42 log CFU/g after 12 h of soaking, and this is 1.77 log CFU/g lower than that before. Based on these results, it was determined that controlling the soaking time and water temperature are essential for the production of a safe unheated frozen rice cake. The safety of the HACCP system could be established by applying these preventive management standards.

The Alignment Evaluation for Patient Positioning System(PPS) of Gamma Knife PerfexionTM (감마나이프 퍼펙션의 자동환자이송장치에 대한 정렬됨 평가)

  • Jin, Seong Jin;Kim, Gyeong Rip;Hur, Beong Ik
    • Journal of the Korean Society of Radiology
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    • v.14 no.3
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    • pp.203-209
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    • 2020
  • The purpose of this study is to assess the mechanical stability and alignment of the patient positioning system (PPS) of Leksell Gamma Knife Perfexion(LGK PFX). The alignment of the PPS of the LGK PFX was evaluated through measurements of the deviation of the coincidence of the Radiological Focus Point(RFP) and the PPS Calibration Center Point(CCP) applying different weights on the couch(0, 50, 60, 70, 80, and 90 kg). In measurements, a service diode test tool with three diode detectors being used biannually at the time of the routine preventive maintenance was used. The test conducted with varying weights on the PPS using the service diode test tool measured the radial deviations for all three collimators 4, 8, and 16 mm and also for three different positions of the PPS. In order to evaluate the alignment of the PPS, the radial deviations of the correspondence of the radiation focus and the LGK calibration center point of multiple beams were averaged using the calibrated service diode test tool at three university hospitals in Busan and Gyeongnam. Looking at the center diode for all collimators 4, 8, and 16 mm without weight on the PPS, and examining the short and long diodes for the 4 mm collimator, the means of the validation difference, i.e., the radial deviation for the setting of 4, 8, and 16 mm collimators for the center diode were respectively measured to 0.058 ± 0.023, 0.079 ± 0.023, and 0.097 ± 0.049 mm, and when the 4 mm collimator was applied to the center diode, the short diode, and the long diode, the average of the radial deviation was respectively 0.058 ± 0.023, 0.078 ± 0.01 and 0.070 ± 0.023 mm. The average of the radial deviations when irradiating 8 and 16 mm collimators on short and long diodes without weight are measured to 0.07 ± 0.003(8 mm sd), 0.153 ± 0.002 mm(16 mm sd) and 0.031 ± 0.014(8 mm ld), 0.175 ± 0.01 mm(16 mm ld) respectively. When various weights of 50 to 90 kg are placed on the PPS, the average of radial deviation when irradiated to the center diode for 4, 8, and 16 mm is 0.061 ± 0.041 to 0.075 ± 0.015, 0.023 ± 0.004 to 0.034 ± 0.003, and 0.158 ± 0.08 to 0.17 ± 0.043 mm, respectively. In addition, in the same situation, when the short diode for 4, 8, and 16 mm was irradiated, the averages of radial deviations were 0.063 ± 0.024 to 0.07 ± 0.017, 0.037 ± 0.006 to 0.059 ± 0.001, and 0.154 ± 0.03 to 0.165 ± 0.07 mm, respectively. In addition, when irradiated on long diode for 4, 8, and 16 mm, the averages of radial deviations were measured to be 0.102 ± 0.029 to 0.124 ± 0.036, 0.035 ± 0.004 to 0.054 ± 0.02, and 0.183 ± 0.092 to 0.202 ± 0.012 mm, respectively. It was confirmed that all the verification results performed were in accordance with the manufacturer's allowable deviation criteria. It was found that weight dependence was negligible as a result of measuring the alignment according to various weights placed on the PPS that mimics the actual treatment environment. In particular, no further adjustment or recalibration of the PPS was required during the verification. It has been confirmed that the verification test of the PPS according to various weights is suitable for normal Quality Assurance of LGK PFX.