• Title/Summary/Keyword: Safety Evaluation

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A Study for Evaluation Method of Safety Critical Software in Avionics Industry (안전필수 항공 산업용 소프트웨어 평가 방법 연구)

  • Lee, Hongseok;Kwon, Goohoon;Ko, Byeonggak
    • Journal of Advanced Navigation Technology
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    • v.19 no.2
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    • pp.91-97
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    • 2015
  • This paper specifies several considerations about assessing safety-critical software in the aerospace domain. In order to evaluate safety critical software in the aerospace industry, it is required to identify an information of evaluation criteria of software under evaluation. The information is specified in the standard, but determination of evaluation criteria cannot be decided by itself and depends on the results of safety assessment of a system and system design. Thus, this paper explains required information of system development standard and safety assessment standard to determine software evaluation criteria. It surveys existing methodologies about evaluating software, and suggests method which is adapted to evaluation of an advanced surface movement guidance and control system (A-SMGCS) software.

Development and Validation of the Analytical Method for Oxytetracycline in Agricultural Products using QuEChERS and LC-MS/MS (QuEChERS법 및 LC-MS/MS를 이용한 농산물 중 Oxytetracycline의 잔류시험법 개발 및 검증)

  • Cho, Sung Min;Do, Jung-Ah;Lee, Han Sol;Park, Ji-Su;Shin, Hye-Sun;Jang, Dong Eun;Cho, Myong-Shik;Jung, ong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.3
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    • pp.227-234
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    • 2019
  • An analytical method was developed for the determination of oxytetracycline in agricultural products using the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method by liquid chromatography-tandem mass spectrometry (LC-MS/MS). After the samples were extracted with methanol, the extracts were adjusted to pH 4 by formic acid and sodium chloride was added to remove water. Dispersive solid phase extraction (d-SPE) cleanup was carried out using $MgSO_4$ (anhydrous magnesium sulfate), PSA (primary secondary amine), $C_{18}$ (octadecyl) and GCB (graphitized carbon black). The analytes were quantified and confirmed with LC-MS/MS using ESI (electrospray ionization) in positive ion MRM (multiple reaction monitoring) mode. The matrix-matched calibration curves were constructed using six levels ($0.001{\sim}0.25{\mu}g/mL$) and coefficient of determination ($r^2$) was above 0.99. Recovery results at three concentrations (LOQ, $10{\times}LOQ$, and $50{\times}LOQ$, n=5) were from 80.0 to 108.2% with relative standard deviations (RSDs) less than of 11.4%. For inter-laboratory validation, the average recovery was in the range of 83.5~103.2% and the coefficient of variation (CV) was below 14.1%. All results satisfied the criteria ranges requested in the Codex guidelines (CAC/GL 40-1993, 2003) and the Food Safety Evaluation Department guidelines (2016). The proposed analytical method was accurate, effective and sensitive for oxytetracycline determination in agricultural commodities. This study could be useful for safety management of oxytetracycline residues in agricultural products.

A Study on the Effect of Organizational Safety and Health Management Activities on Safety and Health Performance : Focusing on the Case of Public Organizations Safety Activity Level Evaluation (조직의 안전보건경영 활동이 안전보건 성과에 미치는 영향 연구 : 공공기관 안전활동 수준평가 사례 중심으로)

  • Seol, Mun-Su;Lee, Joon-Won;Park, Man-Su;So, Hansub;Kim, Byung-Jick
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.44 no.2
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    • pp.132-139
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    • 2021
  • The purpose of this study is to investigate the effect of organizational safety and health management activities on safety and health performance by using the results of safety activity level evaluation of public organizations. To this end, a research model was established by using three fields as independent variables among the four areas of the safety activity level evaluation index: safety and health system, safety and health activity plan, and safety and health activity level, and the safety and health activity performance field as a dependent variable. Correlation analysis and regression analysis between major variables were performed. As a result of the correlation analysis, the safety and health activity performance had a significant positive (+) correlation with all of the safety and health system, safety and health activity plan, and safety and health activity level. The safety and health system had a significant positive (+) correlation with the safety and health activity plan and safety and health activity level, and the safety and health activity plan had a significant positive (+) correlation with the safety and health activity level. And as a result of the regression analysis, it was found that the organization's safety and health system, safety and health activity plan, and safety and health activity level all had a significant positive (+) effect on safety and health activity performance.

Sample Size Estimation for Risk Assessment and Monitoring Based on Heavy Metal Monitoring Data from Food Items (위해평가 및 모니터링 수행을 위한 표본크기 추정연구: 식품 중 중금속 모니터링 데이터를 중심으로)

  • Kang, Hui Seung;Ko, Ahra;Jeong, Da-Hyun;Ha, Mira;Hwang, Myung-Sil;Hong, Jin-Hwan;Hwang, In Gyun;Yoon, Hae-Jung
    • Journal of Food Hygiene and Safety
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    • v.30 no.2
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    • pp.127-131
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    • 2015
  • This study aimed to calculate the required sample size to monitor food items during risk assessment studies. Based on a data set from a previous study (2,400 data points for heavy metal assessment from 17 food items), the required sample size was estimated by using a single equation with the standard deviation value, error range, and 95%-99% confidence intervals. The required sample size was calculated with each of the heavy metals for the assessment. The results showed that cadmium, lead, and mercury of required sample sizes for further monitoring were range of 7-90, 7-1, 062, and 11-238, respectively. We found that the required sample size varied depending on the standard deviation of the previous monitoring data. This study provides a basic method to determine the minimum sample size required in food monitoring to devise practical sampling strategies.

A Study on the Development of Evaluation Index for Safety Management Level of Shipping Company(2) : Development of Evaluation Items for Safety Management Index (해운선사 안전관리 평가지표 개발에 관한 연구(2) : 안전경영 지표 평가항목 개발)

  • Kim, Joo Hwan;Kim, Hwa Young
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.21 no.6
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    • pp.696-703
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    • 2015
  • This paper is a follow-up research of 'A study on the development of Safety Management Evaluation Index for Shipping Company'. It aims to develop the evaluation items of Safety Management Index(hereafter called as 'SMI') applicable to 'Safety Advantage Point', which is suggested as the sub-index of 'Safety Management Evaluation Index' function in the preceding research and also verify their adequacy. For that purpose, firstly, the 11 evaluation items were developed after collecting the practical opinions from safety management personnels in Korean shipping companies. Secondly, the survey was carried out for the verification of the adequacy of the 11 evaluation items. And lastly, its results was analysed, whether it has statistical meanings of differences in adequacy awareness amongst safety managers grouped depending on business type(coastal, ocean-going) and business capacity(number of owned-operating ships). As a result, there was no relevance between their adequacy awareness and business type of their companies. However, a difference in their adequacy awareness existed depending on their companies' business capacity(small, medium and large sized). In conclusion, when the safety management level of shipping companies is evaluated by SMI, the same indices can be applicable to both coastal and ocean-going shipping companies by a grouping of companies' business capacity.

Detection of phenobarbital adulteration in dietary supplements: simultaneous analysis of 16 sedative-hypnotics and sleep-inducers by ultra-high-performance liquid chromatography with UV detection (UPLC-UV) and quadruple Orbitrap mass spectrometry (Q-Orbitrap-MS)

  • Lee, Ji Hyun;Choi, Ji Yeon;Park, Hanna;Min, Ah Young;Kim, Nam Sook;Park, Seong Soo;Park, Sung-Kwan;Kang, Ho-il
    • Analytical Science and Technology
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    • v.32 no.1
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    • pp.24-34
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    • 2019
  • The safety of food is occasionally questionable, as there have been some reports of products contaminated with illegal adulterants. In this study, the presence of 16 sedative-hypnotics and sleep inducers in dietary supplements was determined by ultra-high-performance liquid chromatography with UV detection (UPLC-UV) and quadruple Orbitrap mass spectrometry (Q-Orbitrap-MS). The UPLC method was validated, providing a linearity (R2) of more than 0.999, and LODs and LOQs that ranged from 0.2 to 0.5 and 0.6 to $1.5{\mu}g\;mL^{-1}$, respectively. The repeatabilities were 0.2-8.4 % (intra-day) and 0.3-4.5 % (inter-day), and the accuracies were 89.0-117.0 % (intra-day) and 87.8-111.9 % (inter-day). The mean recoveries of the spiked samples ranged from 98.7 to 107.3 %. The relative standard deviation (%RSD) of the stability was less than 2.4 %. Using the developed method, one sedative-hypnotic compound, phenobarbital, was detected in one of the nineteen samples tested. In addition, the major characteristic fragment ions of each target compound were confirmed using Q-Orbitrap-MS for higher accuracy. Monitoring the presence of these 16 sedative-hypnotics and sleep inducers in dietary supplements should be pursued in the interest of human health, and the results of this study confirmed that the developed method has value for this application.

Simultaneous Determination and Recognition Analysis of Coumarins in Angelica decursiva and Peucedanum praeruptorum by HPLC-DAD

  • Kim, Hye Mi;Jeong, Su Yang;Kim, Sun Min;Lee, Kyu Ha;Kim, Jong Hwan;Seong, Rack Seon
    • Natural Product Sciences
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    • v.22 no.3
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    • pp.162-167
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    • 2016
  • Peucedani Radix is the root of Angelica decursiva Franchet et Savatier (=Peucedanum decursivum Maximowicz) or Peucedanum praeruptorum Dunn in several Asian countries. The coumarins contained in Peucedani Radix were quantitatively analyzed using HPLC-DAD to develop a simultaneous determination for the quality control of A. decursiva and P. praeruptorum. For quantitative analysis, four major coumarins contained in these medicinal plants were assessed. Nodakenin (1), nodakenetin (2), praeruptorin A (3), and praeruptorin B (4) were separated with a Phenomenex Luna C18 column ($5{\mu}m$, $4.6{\times}250mm$) under the gradient conditions using distilled water with 0.1% phosphoric acid and acetonitrile with 0.1% phosphoric acid as the mobile phase, at a flow rate of 1.0 ml/min and a detection wavelength of 330 nm. This method was fully validated for linearity, accuracy, precision, recovery, and limit of detection and quantification. As a result, A. decursiva and P. praeruptorum were clearly classified by the quantification of four major coumarins in extracts. Also, the pattern recognition analysis based on HPLC indicates that all of the samples were largely clustered into two groups. Therefore, it is possible to distinguish between A. decursiva and P. praeruptorum and contribute to quality control.

Repeated Dose Oral Toxicity Study of Alismatis Rhizoma in SD Rats (택사(Alismatis Rhizoma) 추출물의 반복 경구투여 독성 연구)

  • Roh, Hang-Sik;Seok, Ji-Hyun;Jeong, Ja-Young;Lee, Jong-Kwon;Kim, Tae-Sung;Choi, Hye-Kyung;Ha, Hun-Yong
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.1
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    • pp.79-90
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    • 2014
  • Objectives : This study was carried out to evaluate the repeated dose oral toxicity of Alismatis Rhizoma in Sprague-Dawley(SD) rats. Methods : Male and female rats were administered orally with Alismatis Rhizoma water extract of 500 mg/kg(low dosage group), 1,000 mg/kg(middle dosage group) and 2,000 mg/kg(high dosage group). We daily observed number of deaths, clinical signs and gross findings for 14 days(twice a day). After 14 days, we measured body and organs weight. Also we analyzed hematological changes. Results : No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. In addition no significant changes of gross body and individual organs weight. Conclusions : These results suggest that water soluble extract of Alismatis Rhizoma has not repeated dose oral toxicity and oral LD50 value was over 2,000 mg/kg in SD rats. As a result, we can determine Alismatis Rhizoma is a relatively safe substance.

Effect of Enterotoxigenic Escherichia coli on Microbial Communities during Kimchi Fermentation

  • Lee, Woojung;Choi, Hyo Ju;Zin, Hyunwoo;Kim, Eiseul;Yang, Seung-Min;Hwang, Jinhee;Kwak, Hyo-Sun;Kim, Soon Han;Kim, Hae-Yeong
    • Journal of Microbiology and Biotechnology
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    • v.31 no.11
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    • pp.1552-1558
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    • 2021
  • The diverse microbial communities in kimchi are dependent on fermentation period and temperature. Here, we investigated the effect of enterotoxigenic Escherichia coli (ETEC) during the fermentation of kimchi at two temperatures using high-throughput sequencing. There were no differences in pH between the control group, samples not inoculated with ETEC, and the ETEC group, samples inoculated with ETEC MFDS 1009477. The pH of the two groups, which were fermented at 10 and 25℃, decreased rapidly at the beginning of fermentation and then reached pH 3.96 and pH 3.62. In both groups, the genera Lactobacillus, Leuconostoc, and Weissella were predominant. Our result suggests that microbial communities during kimchi fermentation may be affected by the fermentation parameters, such as temperature and period, and not enterotoxigenic E. coli (ETEC).

Simultaneous Determination of 80 Unapproved Compounds using HPLC and LC-MS/MS in Dietary Supplements

  • Kwon, Jeongeun;Shin, Dasom;Kang, Hui-Seung;Suh, Junghyuck;Lee, Gunyoung;Lee, Eunju
    • Mass Spectrometry Letters
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    • v.13 no.3
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    • pp.58-83
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    • 2022
  • We developed analytical methods using high performance chromatography (HPLC) and liquid chromatography tandem mass spectrometry (LC-MS/MS) for the simultaneous determination of 80 unapproved compounds in dietary supplements. The target compounds for analysis were unapproved ingredients (e.g., pharmaceuticals) that have potential adverse effects on consumers owing to accidental misuse, overuse, and interaction with other medication in dietary supplement. Two analytical methods were tested to identify the optimal validation results according to AOAC guideline. As a result, limit of quantification (LOQ) was 0.14-0.5 ㎍ mL-1; linearity (r2) was ≥ 0.99; accuracy (expressed as recovery) was 78.9-114%; precision (relative standard deviation) was ≤ 4.28% in the HPLC method. In the LC-MS/MS method, LOQ was 0.01-2 ng mL-1, linearity (r2) was ≥0.98, accuracy was 71.7-119%; precision was ≤ 12.5%. The developed methods were applied to 51 dietary supplements collected from 2019 to 2021 through MFDS alert system. Based on our previous monitoring study, major compounds were icariin, sibutramine, yohimbine, sildenafil, tadalafil, sennosides (A, B), cascarosides (A, B, C, D), and phenolphthalein. In this study, we re-analyzed samples of detected compounds, and evaluated the statistical difference using Bland-Altman analysis to compare two analytical approaches between HPLC and LC-MS/MS. These results showed a good agreement between two methods that can be used to monitor the unapproved ingredients in dietary supplements. The developed two methods are complementarily suitable for monitoring the adulteration of 80 unapproved compounds in dietary supplements.