• Title/Summary/Keyword: 허용오차

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A Study of Six Sigma and Total Error Allowable in Chematology Laboratory (6 시그마와 총 오차 허용범위의 개발에 대한 연구)

  • Chang, Sang-Wu;Kim, Nam-Yong;Choi, Ho-Sung;Kim, Yong-Whan;Chu, Kyung-Bok;Jung, Hae-Jin;Park, Byong-Ok
    • Korean Journal of Clinical Laboratory Science
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    • v.37 no.2
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    • pp.65-70
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    • 2005
  • Those specifications of the CLIA analytical tolerance limits are consistent with the performance goals in Six Sigma Quality Management. Six sigma analysis determines performance quality from bias and precision statistics. It also shows if the method meets the criteria for the six sigma performance. Performance standards calculates allowable total error from several different criteria. Six sigma means six standard deviations from the target value or mean value and about 3.4 failures per million opportunities for failure. Sigma Quality Level is an indicator of process centering and process variation total error allowable. Tolerance specification is replaced by a Total Error specification, which is a common form of a quality specification for a laboratory test. The CLIA criteria for acceptable performance in proficiency testing events are given in the form of an allowable total error, TEa. Thus there is a published list of TEa specifications for regulated analytes. In terms of TEa, Six Sigma Quality Management sets a precision goal of TEa/6 and an accuracy goal of 1.5 (TEa/6). This concept is based on the proficiency testing specification of target value +/-3s, TEa from reference intervals, biological variation, and peer group median mean surveys. We have found rules to calculate as a fraction of a reference interval and peer group median mean surveys. We studied to develop total error allowable from peer group survey results and CLIA 88 rules in US on 19 items TP, ALB, T.B, ALP, AST, ALT, CL, LD, K, Na, CRE, BUN, T.C, GLU, GGT, CA, phosphorus, UA, TG tests in chematology were follows. Sigma level versus TEa from peer group median mean CV of each item by group mean were assessed by process performance, fitting within six sigma tolerance limits were TP ($6.1{\delta}$/9.3%), ALB ($6.9{\delta}$/11.3%), T.B ($3.4{\delta}$/25.6%), ALP ($6.8{\delta}$/31.5%), AST ($4.5{\delta}$/16.8%), ALT ($1.6{\delta}$/19.3%), CL ($4.6{\delta}$/8.4%), LD ($11.5{\delta}$/20.07%), K ($2.5{\delta}$/0.39mmol/L), Na ($3.6{\delta}$/6.87mmol/L), CRE ($9.9{\delta}$/21.8%), BUN ($4.3{\delta}$/13.3%), UA ($5.9{\delta}$/11.5%), T.C ($2.2{\delta}$/10.7%), GLU ($4.8{\delta}$/10.2%), GGT ($7.5{\delta}$/27.3%), CA ($5.5{\delta}$/0.87mmol/L), IP ($8.5{\delta}$/13.17%), TG ($9.6{\delta}$/17.7%). Peer group survey median CV in Korean External Assessment greater than CLIA criteria were CL (8.45%/5%), BUN (13.3%/9%), CRE (21.8%/15%), T.B (25.6%/20%), and Na (6.87mmol/L/4mmol/L). Peer group survey median CV less than it were as TP (9.3%/10%), AST (16.8%/20%), ALT (19.3%/20%), K (0.39mmol/L/0.5mmol/L), UA (11.5%/17%), Ca (0.87mg/dL1mg/L), TG (17.7%/25%). TEa in 17 items were same one in 14 items with 82.35%. We found out the truth on increasing sigma level due to increased total error allowable, and were sure that the goal of setting total error allowable would affect the evaluation of sigma metrics in the process, if sustaining the same process.

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Development and validation of an analytical method for fungicide fenpyrazamine determination in agricultural products by HPLC-UVD (HPLC-UVD를 이용한 살균제 fenpyrazamine의 시험법 개발 및 검증)

  • Park, Hyejin;Do, Jung-Ah;Kwon, Ji-Eun;Lee, Ji-Young;Cho, Yoon-Jae;Kim, Heejung;Oh, Jae-Ho;Rhee, Kyu-Sik;Lee, Sang-Jae;Chang, Moon-Ik
    • Analytical Science and Technology
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    • v.27 no.3
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    • pp.172-180
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    • 2014
  • Fenpyrazamine which is a pyrazole fungicide class for controlling gray mold, sclerotinia rot, and Monilinia in grapevines, stone fruit trees, and vegetables has been registered in republic of Korea in 2013 and the maximum residue limits of fenpyrazamine is set to grape, peach, and mandarin as 5.0, 2.0, and 2.0 mg/kg, respectively. Very reliable and sensitive analytical method for determination of fenpyrazamine residues is required for ensuring the food safety in agricultural products. Fenpyrazamine residues in samples were extracted with acetonitrile, partitioned with dichloromethane, and then purified with silica-SPE cartridge and eluted with hexane and acetone mixture. The purified samples were determined by HPLC-UVD and confirmed with LC-MS and quantified using external standard method. Linear range of fenpyrazamine was between $0.1{\sim}5.0{\mu}g/mL$ with the correlation coefficient (r) 0.999. The average recovery ranged from 71.8 to 102.7% at the spiked level of 0.05, 0.5, and 5.0 mg/kg, while the relative standard deviation was between 0.1 and 7.3%. In addition, limit of detection and limit of quantitation were 0.01 and 0.05 mg/L, respectively. The results revealed that the developed and validated analytical method is possible for fenpyrazamine determination in agricultural product samples and will be used as an official analytical method.

Development of an Analytical Method for Fluxapyroxad Determination in Agricultural Commodities by HPLC-UVD (HPLC-UVD를 이용한 농산물 중 Fluxapyroxad 잔류분석법 개발)

  • Kwon, Ji-Eun;Kim, HeeJung;Do, Jung-Ah;Park, Hyejin;Yoon, Ji-Young;Lee, Ji-Young;Chang, Moon-Ik;Rhee, Gyu-Seek
    • Journal of Food Hygiene and Safety
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    • v.29 no.3
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    • pp.234-240
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    • 2014
  • Fluxapyroxad is classified as carboxamide fungicide that inhibits succinate dehydrogenase in complex II of mitochondrial respiratory chain, which results in inhibition of mycelial growth within the fungus target species. This study was carried out to assure the safety of fluxapyroxad residues in agricultural products by developing an official analytical method. A new, reliable analytical method was developed and validated using High Performance liquid Chromatograph-UV/visible detector (HPLC-UVD) for the determination of fluxapyroxad residues. The fluxapyroxad residues in samples were extracted with acetonitrile, partitioned with dichloromethane, and then purified with silica solid phase extraction (SPE) cartridge. Correlation coefficient($R^2$) of fluxapyroxad standard solution was 0.9999. The method was validated using apple, pear, peanut, pepper, hulled rice, potato, and soybean spiked with fluxapyroxad at 0.05 and 0.5 mg/kg. Average recoveries were 80.6~114.0% with relative standard deviation less than 10%, and limit of detection (LOD) and limit of quantification (LOQ) were 0.01 and 0.05 mg/kg, respectively. All validation parameters were followed with Codex guideline (CAC/GL 40). LC-MS (Liquid Chromatograph-Mass Spectrometer) was also applied to confirm the analytical method. Base on these results, this method was found to be appropriate fluxapyroxad residue determination and can be used as the official method of analysis.

Development of Preliminary Quality Assurance Software for $GafChromic^{(R)}$ EBT2 Film Dosimetry ($GafChromic^{(R)}$ EBT2 Film Dosimetry를 위한 품질 관리용 초기 프로그램 개발)

  • Park, Ji-Yeon;Lee, Jeong-Woo;Choi, Kyoung-Sik;Hong, Semie;Park, Byung-Moon;Bae, Yong-Ki;Jung, Won-Gyun;Suh, Tae-Suk
    • Progress in Medical Physics
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    • v.21 no.1
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    • pp.113-119
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    • 2010
  • Software for GafChromic EBT2 film dosimetry was developed in this study. The software provides film calibration functions based on color channels, which are categorized depending on the colors red, green, blue, and gray. Evaluations of the correction effects for light scattering of a flat-bed scanner and thickness differences of the active layer are available. Dosimetric results from EBT2 films can be compared with those from the treatment planning system ECLIPSE or the two-dimensional ionization chamber array MatriXX. Dose verification using EBT2 films is implemented by carrying out the following procedures: file import, noise filtering, background correction and active layer correction, dose calculation, and evaluation. The relative and absolute background corrections are selectively applied. The calibration results and fitting equation for the sensitometric curve are exported to files. After two different types of dose matrixes are aligned through the interpolation of spatial pixel spacing, interactive translation, and rotation, profiles and isodose curves are compared. In addition, the gamma index and gamma histogram are analyzed according to the determined criteria of distance-to-agreement and dose difference. The performance evaluations were achieved by dose verification in the $60^{\circ}$-enhanced dynamic wedged field and intensity-modulated (IM) beams for prostate cancer. All pass ratios for the two types of tests showed more than 99% in the evaluation, and a gamma histogram with 3 mm and 3% criteria was used. The software was developed for use in routine periodic quality assurance and complex IM beam verification. It can also be used as a dedicated radiochromic film software tool for analyzing dose distribution.

Verification of Skin Dose in Tomotherapy Using the Developed Phantom for Image Based Radiation Treatment System (영상 기반 치료 장비용 팬톰을 이용한 토모테라피 피부 선량 검증)

  • Park, Ji-Yeon;Chang, Ji-Na;Oh, Seung-Jong;Kang, Dae-Gyu;Jung, Won-Gyun;Lee, Jeong-Woo;Jang, Hong-Suk;Kim, Hoi-Nam;Park, Hae-Jin;Kim, Sung-Hwan;Suh, Tae-Suk
    • Progress in Medical Physics
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    • v.20 no.2
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    • pp.88-96
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    • 2009
  • Radiation treatment for skin cancer has recently increased in tomotherapy. It was reported that required dose could be delivered with homogeneous dose distribution to the target without field matching using electron and photon beam. Therapeutic beam of tomotherapy, however, has several different physical characteristic and irradiation of helical beam is involved in the mechanically dynamic factors. Thus verification of skin dose is requisite using independent tools with additional verification method. Modified phantom for dose measurement was developed and skin dose verification was performed using inserted thermoluminescent dosimeters (TLDs) and GafChromic EBT films. As the homogeneous dose was delivered to the region including surface and 6 mm depth, measured dose using films showed about average 2% lower dose than calculated one in treatment planning system. Region indicating about 14% higher and lower absorbed dose was verified on measured dose distribution. Uniformity of dose distribution on films decreased as compared with that of calculated results. Dose variation affected by inhomogeneous material, Teflon, little showed. In regard to the measured dose and its distribution in tomotherapy, verification of skin dose through measurement is required before the radiation treatment for the target located at the curved surface or superficial depth.

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The Study on the Confidence Building for Evaluation Methods of a Fracture System and Its Hydraulic Conductivity (단열체계 및 수리전도도의 해석신뢰도 향상을 위한 평가방법 연구)

  • Cho Sung-Il;Kim Chun-Soo;Bae Dae-Seok;Kim Kyung-Su;Song Moo-Young
    • The Journal of Engineering Geology
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    • v.15 no.2 s.42
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    • pp.213-227
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    • 2005
  • This study aims to assess the problems with investigation method and to suggest the complementary solutions by comparing the predicted data from surface investigation with the outcome data from underground cavern. In the study area, one(NE-1) of 6 fracture zones predicted during the surface investigation was only confirmed in underground caverns. Therefore, it is necessary to improve the confidence level for prediction. In this study, the fracture classification criteria was quantitatively suggested on the basis of the BHTV images of NE-1 fracture zone. The major orientation of background fractures in rock mass was changed at the depth of the storage cavern, the length and intensity were decreased. These characteristics result in the deviation of predieted predicted fracture properties and generate the investigation bias depending on the bore hole directions and investigated scales. The evaluation of hydraulic connectivity in the surface investigation stage needs to be analyze by the groundwater pressures and hydrochemical properties from the monitoring bore hole(s) equipped with a double completion or multi-packer system during the test bore hole is pumping or injecting. The hydraulic conductivities in geometric mean measured in the underground caverns are 2-3 times lower than those from the surface and furthermore the horizontal hydraulic conductivity in geometric mean is six times lower than the vertical one. To improve confidence level of the hydraulic conductivity, the orientation of test hole should be considered during the analysis of the hydraulic conductivity and the methodology of hydro-testing and interpretation should be based on the characteristics of rock mass and investigation purposes.

Comparison of Human Health Risk Assessment of Heavy Metal Contamination from Two Abandoned Metal Mines Using Metal Mine-specific Exposure Parameters (국내 폐금속 광산에 특화된 노출인자를 이용한 두 폐금속 광산 중금속 오염에 대한 인체위해성평가 비교)

  • Lim, Tae-Yong;Lee, Sang-Woo;Cho, Hyen Goo;Kim, Soon-Oh
    • Journal of Environmental Impact Assessment
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    • v.25 no.6
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    • pp.414-431
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    • 2016
  • There are numerous closed and abandoned mines in Korea, from which diverse heavy metals (e.g., As, Cd, Cu, Pb, Zn) are released into the surrounding soil, groundwater, surface water, and crops, potentially resulting in detrimental effects on the health of nearby residents. Therefore, we performed human risk assessments of two abandoned metal mines, Yanggok (YG) and Samsanjeil (SJ). The exposure parameters used in this assessment were specific to residents near mines and the included exposure pathways were relevant to areas around metal mines. The computed total excess carcinogenic risks for both areas exceeded the acceptable carcinogenic risk ($1{\times}10^{-6}$), indicating that these areas are likely unsafe due to a carcinogenic hazard. In contrast, the non-carcinogenic risks of the two areas differed among the studied receptors. The hazard indices were higher than the unit risk (=1.0) for male and female adults in YG and male adults in SJ, suggesting that there are non-carcinogenic risks for these groups in the study areas. However, the hazard indices for children in YG and female adults and children in SJ were lower than the unit risk. Consumption of groundwater and crops grown in the area were identified as major exposure pathways for carcinogenic and non-carcinogenic hazards in both areas. Finally, the dominant metals contributing to carcinogenic and non-carcinogenic risks were As and As, Cu, and Pb, respectively. In addition, the carcinogenic and non-carcinogenic risks of YG were evaluated to be 10 and 4 times higher than those of SJ, respectively, resulted from the relatively higher exposure concentration of As in groundwater within SJ area. Because of lacking of several exposure parameters, some of average daily dose (ADD) could not be computed in this study. Furthermore, it is likely that the ADDs of crop-intake pathway included some errors because they were calculated using soil exposure concentrations and bioconcentration factor (BCF) rather than using crop exposure concentrations.

Development of an Analytical Method for the Determination of Pyriofenone residue in Agricultural Products using HPLC-UVD (HPLC-UVD를 이용한 농산물 중 살균제 pyriofenone 분석법 확립)

  • Park, Hyejin;Kim, HeeJung;Do, Jung-Ah;Kwon, Ji-Eun;Yoon, Ji-Young;Lee, Ji-Young;Chang, Moon-Ik;Rhee, Gyu-Seek
    • The Korean Journal of Pesticide Science
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    • v.18 no.2
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    • pp.79-87
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    • 2014
  • Pyriofenone is an aryl phenyl ketone fungicide that is newly registered in Korea in 2013 to control powdery mildew on food. The objective of this study was to develop reliable and sensitive analytical method for determination of pyriofenone residue in agricultural products for ensuring the food safety. The pyriofenone residues in all samples(Korean melon, pepper, potato, mandarin, soybean, and hulled rice) were extracted with acetonitrile, partitioned with dichloromethane, and then purified with a silica cartridge. The purified samples were analyzed by HPLC-UVD and confirmed with LC-MS. The linear range of pyriofenone was 0.05~5 mg/kg with the correlation coefficient ($r^2$) > 0.999. Average recoveries of pyriofenone ranged from 72.8% to 99.5% at the spiked level of 0.05 and 0.5 mg/kg, while the relative standard deviation was 2.3%~6.4%. In addition, the limit of detection and limit of quantification were 0.01 and 0.05 mg/kg, respectively. The results revealed that the developed and validated analytical method was suitable for pyriofenone determination in agricultural products.

Review on Usefulness of EPID (Electronic Portal Imaging Device) (EPID (Electronic Portal Imaging Device)의 유용성에 관한 고찰)

  • Lee, Choong Won;Park, Do Keun;Choi, A Hyun;Ahn, Jong Ho;Song, Ki Weon
    • The Journal of Korean Society for Radiation Therapy
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    • v.25 no.1
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    • pp.57-67
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    • 2013
  • Purpose: Replacing the film which used to be used for checking the set-up of the patient and dosimetry during radiation therapy, more and more EPID equipped devices are in use at present. Accordingly, this article tried to evaluated the accuracy of the position check-up and the usefulness of dosimetry during the use of an electronic portal imaging device. Materials and Methods: On 50 materials acquired with the search of Korea Society Radiotherapeutic Technology, The Korean Society for Radiation Oncology, and Pubmed using "EPID", "Portal dosimetry", "Portal image", "Dose verification", "Quality control", "Cine mode", "Quality - assurance", and "In vivo dosimetry" as indexes, the usefulness of EPID was analyzed by classifying them as history of EPID and dosimetry, set-up verification and characteristics of EPID. Results: EPID is developed from the first generation of Liquid-filled ionization chamber, through the second generation of Camera-based fluoroscopy, and to the third generation of Amorphous-silicon EPID imaging modes can be divided into EPID mode, Cine mode and Integrated mode. When evaluating absolute dose accuracy of films and EPID, it was found that EPID showed within 1% and EDR2 film showed within 3% errors. It was confirmed that EPID is better in error measurement accuracy than film. When gamma analyzing the dose distribution of the base exposure plane which was calculated from therapy planning system, and planes calculated by EDR2 film and EPID, both film and EPID showed less than 2% of pixels which exceeded 1 at gamma values (r%>1) with in the thresholds such as 3%/3 mm and 2%/2 mm respectively. For the time needed for full course QA in IMRT to compare loads, EDR2 film recorded approximately 110 minutes, and EPID recorded approximately 55 minutes. Conclusion: EPID could easily replace conventional complicated and troublesome film and ionization chamber which used to be used for dosimetry and set-up verification, and it was proved to be very efficient and accurate dosimetry device in quality assurance of IMRT (intensity modulated radiation therapy). As cine mode imaging using EPID allows locating tumors in real-time without additional dose in lung and liver which are mobile according to movements of diaphragm and in rectal cancer patients who have unstable position, it may help to implement the most optimal radiotherapy for patients.

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Fault reactivation potential during $CO_2$ injection in the Gippsland Basin, Australia (호주 Gippsland Basin에서 $CO_2$ 주입 중 단층 재활성화의 가능성)

  • Ruth, Peter J. van;Nelson, Emma J.;Hillis, Richard R.
    • Geophysics and Geophysical Exploration
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    • v.9 no.1
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    • pp.50-59
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    • 2006
  • The risk of fault reactivation in the Gippsland Basin was calculated using the FAST (Fault Analysis Seal Technology) technique, which determines fault reactivation risk by estimating the increase in pore pressure required to cause reactivation within the present-day stress field. The stress regime in the Gippsland Basin is on the boundary between strike-slip and reverse faulting: maximum horizontal stress $({\sim}\;40.5\;Mpa/km)$ > vertical stress (21 Mpa/km) ${\sim}$ minimum horizontal stress (20 MPa/km). Pore pressure is hydrostatic above the Campanian Volcanics of the Golden Beach Subgroup. The NW-SE maximum horizontal stress orientation $(139^{\circ}N)$ determined herein is broadly consistent with previous estimates, and verifies a NW-SE maximum horizontal stress orientation in the Gippsland Basin. Fault reactivation risk in the Gippsland Basin was calculated using two fault strength scenarios; cohesionless faults $(C=0;{\mu}=0.65)$ and healed faults $(C=5.4;\;{\mu}=0.78)$. The orientations of faults with relatively high and relatively low reactivation potential are almost identical for healed and cohesionless fault strength scenarios. High-angle faults striking NE-SW are unlikely to reactivate in the current stress regime. High-angle faults oriented SSE-NNW and ENE-WSW have the highest fault reactivation risk. Additionally, low-angle faults (thrust faults) striking NE-SW have a relatively high risk of reactivation. The highest reactivation risk for optimally oriented faults corresponds to an estimated pore pressure increase (Delta-P) of 3.8 MPa $({\sim}548\;psi)$ for cohesionless faults and 15.6 MPa $({\sim}2262\;psi)$ for healed faults. The absolute values of pore pressure increase obtained from fault reactivation analysis presented in this paper are subject to large errors because of uncertainties in the geomechanical model (in situ stress and rock strength data). In particular, the maximum horizontal stress magnitude and fault strength data are poorly constrained. Therefore, fault reactivation analysis cannot be used to directly measure the maximum allowable pore pressure increase within a reservoir. We argue that fault reactivation analysis of this type can only be used for assessing the relative risk of fault reactivation and not to determine the maximum allowable pore pressure increase a fault can withstand prior to reactivation.