• 월간산업보건
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• s.88
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• pp.57-60
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• 1995

PAT program(The Proficiency Analytical Testing Program)은 미국산업위생협회(American Industrial Hygiene Association AIHA)와 미국산업안전보건연구원(National Institute for Occupational Safety and Health NIOSH)에서 공동주관하는 정도관리로서 일년에 4회 실시하고 있다. 실시항목은 금속(납, 카드뮴, 크롬, 아연), 유리규산, 석면, 유기,용제(Benzen, O-Xylene, Toluene, Carbon Tetrachloride, 1, 1, 1-Trichloroethane, Chloroform, Tetrachloroethylene, 1, 2-Dichloroethane, methanol, p-Dioxane)이다. 대한산업보건협회 산업보건연구소에서는 위의 4가지 항목을 모두 신청하여 1995년 1월에 실시된 120회 부터 참여하였는데 다음은 본 연구소의 120화에 대한 분석방법과 NIOSH로 부터 받은 결과이다.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.23 no.3
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• pp.243-249
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• 2013

Objectives: This study assessed the status of domestic industrial hygiene laboratories using data from on-site investigation for revision of quality control systems in 2012-2013. Methods: The target laboratories were 60 industrial hygiene laboratories chosen by random selection and nationwide distribution which had participated in on-site investigations for revision of quality control systems from March 2012 to August 2013. The investigation was performed on-site following standard quality control procedures. The score between each group was compared using Mann-Whitney and Kruskal-Wallis tests, and the correlation between analytical career, sex, academic major of analyst and score of analytical performance was expressed as Spearman's rank correlation coefficient. Results: The assessment revealed that the items to be improved, in sequence, were effort at staff training (score 65.5), ability to calculate data (score 73.4), establishment of internal quality control guidelines (score 75.7), laboratory facilities (score 77.1), degree of understanding and skill at gas chromatography (score 77.1). Analysis performance showed a positive correlation with career of analyst (r=0.56, p<0.01). Conclusions: The practice of on-site investigation for quality control systems showed the current status of industrial hygiene laboratories in the first trial. There were many laboratories which needed improvement and development of analytical systems. This assessment can provide information for the systematic operation and improvement of facilities at each laboratory. Further practice of this investigation will lead to a proficiency testing and accreditation system for autonomous quality control as is the practice in many countries, rather than mandatory practice by legal regulation.

• Safety and Health at Work
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• v.8 no.3
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• pp.322-326
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• 2017

In 1992, the quality control program was introduced in Republic of Korea to improve the reliability of the work environment monitoring, which was introduced in the 1980s. The commission entrusted by the Ministry of Employment and Labor, the Occupational Safety and Health Research Institute has conducted the program for industrial hygiene laboratories including designated monitoring institutions and spontaneously participating agencies. The number of institutions that participated in the program has increased from 30 to 161. The initial conformance ratio in the participants was 43% (organic solvents) and 52% (metals). Thereafter, the conformance ratio increased rapidly and it has remained in a stable state at more than 89% since 1996. As subject materials, 13 kinds of organic solvents and 7 kinds of metals were used. To improve the capability of measurement and analysis of private institutions, educational courses were conducted annually. An assessment at the actual sites of participants was additionally introduced into the program in 2013. Thus, the program turned into a system that administrates the overall process of participants. For the future, the scope of target materials will be extended through additional items. Thus, the reliability of the results of the work environment monitoring is expected to increase accordingly.

• Journal of Soil and Groundwater Environment
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• v.19 no.6
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• pp.49-58
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• 2014

This study was implemented as a part of the experiment to develop two kinds of soil-based Benzo[a]pyrene (BaP) proficiency testing materials (PTMs) for soil analysis. A test was carried out for the check of solubility of the reference material (high purity reagent) using several solvents. Another test was also conducted for the evaluation of homogeneity and stability of two kinds of candidate soil reference materials. The test analysis of BaP in terms of the candidate materials was conducted according to the Standard Soil Analytical Methods by Ministry of Environment. Dissolution of the reference material was shown to vary depending on solvent type and was higher in the order of Dichloromethane > Acetone > Acetone/MeOH (9 : 1) > N-hexane. In addition, the slope on calibration curve for BaP standard solutions was largest on BaP standard solutions prepared with dichloromethane of the tested solvents. Such tendency appeared egually in the commercial BaP standard solution. Therefore, it is thought to be reasonable to use dichloromethane as the solvent in case of the standard stock solution that is used for the measurement of BaP concentration in soil. ISO 13528 and IUPAC protocol were used for verification of homogeneity on the two kinds of soil candidate materials, Both candidate materials were sufficiently homogeneous. Stability assessment of the two candidate materials was made according to ISO Guide 35 and the result showed that both batches did not have any long-term and short term stability issues that might occur during shipping. However, monitoring results of BaP concentration in soil showed that BaP concentration of the two batches measured at 15 days after the sample preparation was reduced by about 24~37% compared with that of the samples measured on 0 day of the sample preparation. Identification was done with several treatments such as irradiation and sterilization etc. The major cause was shown to be irradiation to the samples.

• Analytical Science and Technology
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• v.15 no.4
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• pp.381-387
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• 2002

In this study, we introduced experience participated in ELPAT (Environmental Lead for Proficiency Analytical Testing) program that is administered by the American Industrial Hygiene Association and EPA. The 126 sample results of total 128 samples met reference value, as a result accepted 'proficient'. The concentration of Pb in air, paint chips, soils and dust wipes are $0.0089{\sim}0.3956mg/m^3$, 0.0500~8.9149%, 29.0${\sim}$1697 mg/kg and $18.00{\sim}900.3{\mu}g/sample$, respectively. The lead in environmental matrix prepared adequate techniques and analysed by flame atomic absorption spectrometry. The lead in air was extracted hydrochloric acid, in paint chips and soils were digested with microwave and hotplate and in dust wipes were prepared microwave digestion. No differences of each preparation techniques was found and all methods were to be proper.

• Journal of Environmental Health Sciences
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• v.42 no.6
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• pp.450-464
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• 2016

Objectives: This study developed and validated reference materials (RMs) to analyze metal compounds in blood. Methods: We referred to KoNEHS (Korea National Environmental Health Survey) to estimate concentrations of blood metals (cadmium, Cd; lead, Pb; mercury, Hg) and applied analytical methods (inductively coupled plasma - mass spectroscopy, ICP-MS, for Cd and Pb; graphite furnace - atomic absorption spectrometry, GF-AAS, for Cd and Pb; and direct mercury analyzer, DMA, for Hg). Homogeneity and stability tests were carried out. In addition, certified values and uncertainties of RMs were calculated through internal and external experiments. All RMs were developed and assessed in various forms according to element, analytical method, and two types of concentration levels high concentration for occupational exposure and low concentration for environmental exposure. Results: All samples showed acceptable homogeneity, except for low concentration of Cd in the GF-AAS method. Short- and long-term stabilities were satisfied by ANOVA testing. In the inter-laboratory comparison, robust medians were lower than the certified values of all RMs (robust median/reference value; $1.301/1.327{\mu}g/L$ for Cd, ICP-MS, low concentration; $3.152/3.388{\mu}g/L$ for Cd, ICP-MS, high concentration; $1.219/1.301{\mu}g/L$ for Cd, GF-AAS, low concentration; $3.074/3.321{\mu}g/L$ for Cd, GF-AAS, high concentration; $14.473/14.516{\mu}g/L$ for Pb, ICP-MS, low concentration; $50.069/50.114{\mu}g/L$ for Pb, ICP-MS, high concentration; $12.881/14.147{\mu}g/L$ for Pb, GF-AAS, low concentration; $47.015/47.591{\mu}g/L$ for Pb, GF-AAS, high concentration; $4.059/4.218{\mu}g/L$ for Hg, DMA, low concentration; $11.474/11.181{\mu}g/L$ for Hg, DMA, high concentration). Conclusion: This study demonstrates procedures for developing and validating RMs for biomonitoring in the field of the environmental health.

• Korean Journal of Veterinary Research
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• v.46 no.4
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• pp.295-304
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• 2006

Residual materials such as veterinary drugs, environmental contaminants, and pesticides are affecting food safety. High resolution techniques and quality controls are needed to analyze these materials from part per million to part per trillion quantities in food. In order to achieve quality results, standardized methods and techniques are required. Our laboratories were prepared to obtain a certificate of accreditation for ISO/IEC 17025 in the analytical criteria of animal drugs, dioxins, pesticides, and heavy metals. ISO together with IEC has built a strategic partnership with the World Trade Organization with the common goal of promoting a free and fair global trading system. ISO collaborates with the United Nations Organization and its specialized agencies and commissions, particularly those involved in the harmonization of regulations and public policies including the World Health Organization and CODEX Alimentarius for food safety measurement, management and traceability. Our goal was to have high quality analysts, proper analytical methods, good laboratory facilities, and safety systems within guidelines of ISO/IEC 17025. All staff members took requirement exams. We applied proficiency tests in the analysis of veterinary drugs (nitrofuran metabolites, sulfonamide and tetracyclines), dioxins, organophosphorus pesticides, and heavy metals (Cd, Pb, As) to the Food Analysis Performance Assessment Scheme (FAPAS) at Central Science Laboratory, Department for Environment Food and Rural Affairs (DEFRA), England. The results were very satisfactory. All documents were prepared, including system management, laboratory management, standard operational procedures for testing, reporting, and more. The criteria encompassed the requirements of ISO/IEC 17025:1999. Finally, the Korea Laboratory Accreditation Scheme (KOLAS) accredited our testing laboratories in accordance with the provisions of Article 23 of the National Standards Act. The accreditation will give us the benefit of becoming a regional reference laboratory in Asia.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.29 no.2
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• pp.217-225
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• 2019

Objectives: The aim of this study is to evaluate the quality management systems of domestic asbestos survey and monitoring service providers and the relationships with the number of licenses or designations and sales performances. Methods: Data on quality management systems were collected by assessors who were assigned by the Korea Occupational Safety and Health Agency(KOSHA) during a pilot evaluation program for designated asbestos survey and monitoring service providers in 2016 using evaluation criteria developed by KOSHA. Basic characteristics, evaluated scores, and sales performance were gathered and statistically analyzed. Results: The median and arithmetic mean of the total scores were 0.64 and 0.66. Evaluation fields that scored highly with the highest percentages were sales performance, installation and availability of equipment, compliance with the mandatory minimum number of airborne samples, laboratory independence, and results of proficiency analytical testing, in that order. Evaluation fields that received low marks with the highest percentages were the training of personnel, blank field samples, calibration of flow rates, preliminary check and visual inspection of the work area prior to the clearance test, and review and approval of final reports, in that order. Comparison of normalized scores between service providers registered for asbestos and other tasks and those designated for only asbestos showed significant differences in their evaluated scores. Sales performance did not show a positive correlation with evaluated scores. Conclusions: The quality management systems of domestic asbestos survey and monitoring service providers were poor. High scores were recorded mostly in evaluation fields related to regulatory requirements. Low scores were recorded mostly in evaluation fields related to documentation and recordkeeping. Considering the low influence of quality on sales performance, the government needs to evaluate the quality management of asbestos survey and monitoring service providers and provide the results to public in order to address their low levels of quality management.

• 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.