• 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.

• 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.

• The Journal of Korean Academy of Sensory Integration
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• v.8 no.1
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• pp.27-40
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• 2010

Objective : This study is designed to identify effect of a sensory integration(SI) program provided to elementary school students as an after-school activity. The study is looking at both occupational performance components and school-task performance which is an area of occupational performance. Methods : SI program specially designed as an after-school activity was provided to three boys who are first- or second grade students of Y elementary school in Dae-Jeon city. The SI intervention was organized with 25 sessions and carried out for two months. One group pretest-posttest design was used to evaluate the effectiveness of the SI program. Measurements used are Short Sensory Profile(SSP), K-DTVP-2, and BOTMP for occupational performance components, and School Function Assessment for functional schooltask performance. Results : It is found that posttest scores were enhanced in all assessments SSP; BOTMP; K-DTVP-2; and SFA. Conclusion : Results of this study simply propose that sensory integration program designed as after-school activity may have positive effects on not only occupational performance components but also on school-task performance of elementary school student. Since sample size is too small, however, there is limitation to find statistical significance. Further researches testing large number of subjects are required to boost the finding of this study.

• 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.

• Steel and Composite Structures
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• v.48 no.2
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• pp.163-177
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• 2023

Complex and intricate preparation techniques, the imperative for utmost precision and sensitivity in instrumentation, premature sample failure, and fragile specimens collectively contribute to the arduous task of measuring the fracture toughness of concrete in the laboratory. The objective of this research is to introduce and refine an equation based on the gene expression programming (GEP) method to calculate the fracture toughness of reinforced concrete, thereby minimizing the need for costly and time-consuming laboratory experiments. To accomplish this, various types of reinforced concrete, each incorporating distinct ratios of fibers and additives, were subjected to diverse loading angles relative to the initial crack (α) in order to ascertain the effective fracture toughness (Keff) of 660 samples utilizing the central straight notched Brazilian disc (CSNBD) test. Within the datasets, six pivotal input factors influencing the Keff of concrete, namely sample type (ST), diameter (D), thickness (t), length (L), force (F), and α, were taken into account. The ST and α parameters represent crucial inputs in the model presented in this study, marking the first instance that their influence has been examined via the CSNBD test. Of the 660 datasets, 460 were utilized for training purposes, while 100 each were allotted for testing and validation of the model. The GEP model was fine-tuned based on the training datasets, and its efficacy was evaluated using the separate test and validation datasets. In subsequent stages, the GEP model was optimized, yielding the most robust models. Ultimately, an equation was derived by averaging the most exemplary models, providing a means to predict the Keff parameter. This averaged equation exhibited exceptional proficiency in predicting the Keff of concrete. The significance of this work lies in the possibility of obtaining the Keff parameter without investing copious amounts of time and resources into the CSNBD test, simply by inputting the relevant parameters into the equation derived for diverse samples of reinforced concrete subject to varied loading angles.