The IAEA's programme in analytical quality control

International Nuclear Information System (INIS)

Suschny, O.

1980-10-01

The purpose of the Analytical Quality Control Programme of the International Atomic Energy Agency is to help laboratories in the Agency's Member States to assess and, if necessary, to improve the reliability of their analytical work in areas related to nuclear technology and radioisotope utilisation. This is done by the organisation of analytical intercomparisons and by the provision of certified or uncertified reference materials. Recently intercomparisons have been organised of trace element analysis in a soil and a lake sediment sample which have led to the certification of two new reference materials, SOIL-5 and SL-1 (lake sediment). A technique has been developed to recognise and to remove outlying results. Criteria have been established to classify element-concentration values into the categories ''established with a high degree of confidence'', ''established with a reasonable degree of confidence'' and ''information value only''. Four radionuclide intercomparisons have recently been carried out: W-1/1 and W-2/1 of the determination of selected radionuclides in water and Air-1/1 and Air-2/1 of that of selected radionuclides on simulated air filters. Details of the preparation of materials for these intercomparisons, and of data treatment and some results are discussed in the paper

ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories.

Science.gov (United States)

Flatland, Bente; Freeman, Kathy P; Friedrichs, Kristen R; Vap, Linda M; Getzy, Karen M; Evans, Ellen W; Harr, Kendal E

2010-09-01

Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance Guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. ©2010 American Society for Veterinary Clinical Pathology.

The analytical quality control programme of the IAEA

Energy Technology Data Exchange (ETDEWEB)

Suschny, O; Richman, D M [International Atomic Energy Agency, Division of Research and Laboratories, Seibersdorf (Austria)

1973-10-01

The International Atomic Energy Agency has distributed calibrated radioisotope solutions, standard reference materials and intercomparison materials in the nuclear and radioisotope materials and intercomparison materials in the nuclear and radioisotope fields since the early 1960's. The purpose of this activity was to help laboratories in the Member States to assess and, if necessary, to improve the reliability of their analytical work and to enable them, in this way, to render better service in a large number of areas ranging from nuclear technology to isotope applications in medicine and environmental sciences. The usefulness and the need for this service was demonstrated by the results of many intercomparisons which proved that without continued analytical quality control adequate reliability of analytical data could not be taken for granted. The scope and the size of the future programme of the Agency in this field has been delineated by recommendations made by several Panels of Experts. They have all agreed on the importance of it and made detailed recommendations in their areas of expertise.

The analytical quality control programme of the IAEA

International Nuclear Information System (INIS)

Suschny, O.; Richman, D.M.

1973-10-01

The International Atomic Energy Agency has distributed calibrated radioisotope solutions, standard reference materials and intercomparison materials in the nuclear and radioisotope materials and intercomparison materials in the nuclear and radioisotope fields since the early 1960's. The purpose of this activity was to help laboratories in the Member States to assess and, if necessary, to improve the reliability of their analytical work and to enable them, in this way, to render better service in a large number of areas ranging from nuclear technology to isotope applications in medicine and environmental sciences. The usefulness and the need for this service was demonstrated by the results of many intercomparisons which proved that without continued analytical quality control adequate reliability of analytical data could not be taken for granted. The scope and the size of the future programme of the Agency in this field has been delineated by recommendations made by several Panels of Experts. They have all agreed on the importance of it and made detailed recommendations in their areas of expertise

Analytical chemistry in semiconductor manufacturing: Techniques, role of nuclear methods and need for quality control

International Nuclear Information System (INIS)

1989-06-01

This report is the result of a consultants meeting held in Gaithersburg, USA, 2-3 October 1987. The meeting was hosted by the National Bureau of Standards and Technology, and it was attended by 18 participants from Denmark, Finland, India, Japan, Norway, People's Republic of China and the USA. The purpose of the meeting was to assess the present status of analytical chemistry in semiconductor manufacturing, the role of nuclear analytical methods and the need for internationally organized quality control of the chemical analysis. The report contains the three presentations in full and a summary report of the discussions. Thus, it gives an overview of the need of analytical chemistry in manufacturing of silicon based devices, the use of nuclear analytical methods, and discusses the need for quality control. Refs, figs and tabs

Analytical quality control service programme, intercomparison runs, certified reference materials, reference materials 1987-88

International Nuclear Information System (INIS)

1986-12-01

The purpose of the Analytical Quality Control Services (AQCS) programme provided by the IAEA, is to assist laboratories engaged in the analysis of nuclear, environmental, biological, and materials of marine origin for radionuclide, major, minor and trace elements, as well as stable isotopes using atomic and nuclear analytical techniques, to check the quality of their work. The tables give details of the intercomparison samples and reference materials distributed by the IAEA in the period 1987 to 1988. 2 tabs

Nuclear analytical methods in quality control of microanalysis

International Nuclear Information System (INIS)

Tian Weizhi

2004-01-01

Quantitative calibration and quality control have been a major bottleneck in microanalysis due to the lack of natural-matrix CRMs certified at sample sizes compatible with those of unknown samples. A solution is described to characterize sampling behavior for individual elements, so as to identify elements homogeneous enough at stated sample size levels in given CRMs/RMs. By using a combination of several nuclear analytical techniques, INAA-EDXRF-μPIXE, sampling behavior for individual elements can be characterized at sample size levels from grams down to pg. Natural-matrix CRMs specifically for QC of microanalysis may thus be created. Additional information in certificates of these new generation CRMs is imagined. (author)

Role of maintenance of analytical instruments in the proceedings of quality control laboratory

International Nuclear Information System (INIS)

Haribabu, A.; Sailoo, C.C.; Balaji Rao, Y.; Subba Rao, Y.

2015-01-01

Control Laboratory being a centralized analytical facility of Nuclear Fuel Complex (NFC) is engaged in chemical qualification of all nuclear materials processed/produced at NFC. The primary responsibility of control laboratory is to provide timely analytical results of raw materials, intermediates and final products to all the production plants of NFC for downstream processing. Annual analytical load of nearly five lakhs of estimations are being carried out at laboratory. For this purpose a gamut of analytical facilities ranging from classical methods like gravimetry, volumetry etc. to fully automated state-of-art analytical instruments like ICP-AES, Gas Analysers, Flame and Graphite Furnace-AAS, Direct Reading Emission Spectrometer (DRES), RF GD-OES, TIMS, WD-XRFS, ED-XRFS, Laser based PSD Analyser, Laser Fluorimeter, UV-Vis Spectrophotometer, Gamma Ray Spectrometer, Ion-Chromatography, Gas Chromatography are used to acquire analytical data to see the suitability of products for their intended use. Depending on the applications, analysts validate their procedures, calibrate their instruments, and perform additional instrument checks, such as system suitability tests and analysis of in-process quality control check samples. With the increasing sophistication and automation of analytical instruments, an increasing demand has been placed on maintenance engineers to qualify these instruments for the purpose

Multivariate control charts based on net analyte signal (NAS) and Raman spectroscopy for quality control of carbamazepine

Energy Technology Data Exchange (ETDEWEB)

Rocha, Werickson Fortunato de Carvalho [Institute of Chemistry, University of Campinas - UNICAMP, P.O. Box 6154, 13083-970 Campinas, SP (Brazil); National Institute of Metrology, Standardization and Industrial Quality, Inmetro, Dimci/Dquim - Directorate of Metrology, Science and Industry/Division of Chemical Metrology, Av. Nossa Senhora das Gracas 50, Building 6, 25250-020, Xerem, Duque de Caxias, RJ (Brazil); Poppi, Ronei Jesus, E-mail: ronei@iqm.unicamp.br [Institute of Chemistry, University of Campinas - UNICAMP, P.O. Box 6154, 13083-970 Campinas, SP (Brazil); National Institute of Science and Technology (INCT) for Bioanalytics, 13083-970 Campinas, SP (Brazil)

2011-10-31

Raman spectroscopy and control charts based on the net analyte signal (NAS) were applied to polymorphic characterization of carbamazepine. Carbamazepine presents four polymorphic forms: I-IV (dihydrate). X-ray powder diffraction was used as a reference technique. The control charts were built generating three charts: the NAS chart that corresponds to the analyte of interest (form III in this case), the interference chart that corresponds to the contribution of other compounds in the sample and the residual chart that corresponds to nonsystematic variations. For each chart, statistical limits were developed using samples within the quality specifications. It was possible to identify the different polymorphic forms of carbamazepine present in pharmaceutical formulations. Thus, an alternative method for the quality monitoring of the carbamazepine polymorphic forms after the crystallization process is presented.

Multivariate control charts based on net analyte signal (NAS) and Raman spectroscopy for quality control of carbamazepine

International Nuclear Information System (INIS)

Rocha, Werickson Fortunato de Carvalho; Poppi, Ronei Jesus

2011-01-01

Raman spectroscopy and control charts based on the net analyte signal (NAS) were applied to polymorphic characterization of carbamazepine. Carbamazepine presents four polymorphic forms: I-IV (dihydrate). X-ray powder diffraction was used as a reference technique. The control charts were built generating three charts: the NAS chart that corresponds to the analyte of interest (form III in this case), the interference chart that corresponds to the contribution of other compounds in the sample and the residual chart that corresponds to nonsystematic variations. For each chart, statistical limits were developed using samples within the quality specifications. It was possible to identify the different polymorphic forms of carbamazepine present in pharmaceutical formulations. Thus, an alternative method for the quality monitoring of the carbamazepine polymorphic forms after the crystallization process is presented.

Regional technical cooperation model project, IAEA - RER/2/2004 ''quality control and quality assurance for nuclear analytical techniques'

International Nuclear Information System (INIS)

Arikan, P.

2002-01-01

An analytical laboratory should produce high quality analytical data through the use of analytical measurements that is accurate, reliable and adequate for the intended purpose. This objective can be accomplished in a cost-effective manner under a planned and documented quality system of activities. It is well-known that serious deficiencies can occur in laboratory operations when insufficient attention is given to the quality of the work. It requires not only a thorough knowledge of the laboratory's purpose and operation, but also the dedication of the management and operating staff to standards of excellence. Laboratories employing nuclear and nuclear-related analytical techniques are sometimes confronted with performance problems which prevent them from becoming accepted and respected by clients, such as industry, government and regulatory bodies, and from being eligible for contracts. The International Standard ISO 17025 has been produced as the result of extensive experience in the implementation of ISO/IEC Guide 25:1990 and EN 45001:1989, which replaces both of them now. It contains all of the requirements that testing and calibration laboratories must meet if they wish to demonstrate that they operate a quality system that is technically competent, and are able to generate technically valid results. The use of ISO 17025 should facilitate cooperation between laboratories and other bodies to assist in the exchange of information and experience, and in the harmonization of standards and procedures. IAEA model project RER/2/004 entitled 'Quality Assurance/Quality Control in Nuclear Analytical Techniques' was initiated in 1999 as a Regional TC project in East European countries to assist Member State laboratories in the region to install a complete quality system according to the ISO/IEC 17025 standard. 12 laboratories from 11 countries plus the Agency's Laboratories in Seibersdorf have been selected as participants to undergo exercises and training with the

Validation of analytical method for quality control of B12 Vitamin-10 000 injection

International Nuclear Information System (INIS)

Botet Garcia, Martha; Garcia Penna, Caridad Margarita; Troche Concepcion, Yenilen; Cannizares Arencibia, Yanara; Moreno Correoso, Barbara

2009-01-01

Analytical method reported by USA Pharmacopeia was validated for quality control of injectable B 1 2 Vitamin (10 000 U) by UV spectrophotometry because this is a simpler and low-cost method allowing quality control of finished product. Calibration curve was graphed at 60 to 140% interval, where it was linear with a correlation coefficient similar to 0, 9999; statistical test for interception and slope was considered non-significant. There was a recovery of 99.7 % in study concentrations interval where the Cochran (G) and Student(t) test were not significant too. Variation coefficient in repetition study was similar to 0.59 % for the 6 assayed replies, whereas in intermediate precision analysis, the Fisher and Student tests were not significant. Analytical method was linear, precise, specific and exact in study concentrations interval

New analytical methods for quality control of St. John's wort

International Nuclear Information System (INIS)

Huck-Pezzei, V.

2013-01-01

In the present work, a novel analytical platform is introduced, which enables both anal-ysis and quality control of St. John´s wort extracts and tissue. The synergistic combina-tion of separation techniques (including thin-layer chromatography (TLC), high-performance liquid chromatography (HPLC)) with mass spectrometry (MS) and vibra-tional spectroscopy is demonstrated to get deeper insights into the ingredients composi-tion. TLC was successfully employed to identify some unknown ingredients being pre-sent in samples with Chinese provenience. The here described novel HPLC method allowed to differentiate clearly between European and Chinese samples on one hand, on the other hand this method could successfully be employed for the semi-preparative isolation of the unknown ingredient. Matrix-free laser desorption ionization time of flight mass spectrometry (mf-LDI-TOF/MS) using a special designed titanium oxide layer was employed to identify the structure of the substance. The analytical knowledge generated so far was used to establish an infrared spectroscopic model allowing both quantitative analysis of ingredients as well as differentiating between European and Chinese provenience. Finally, infrared imaging spectroscopy was conducted to get knowledge about the high resolved distribution of ingredients. The analytical platform established can be used for fast and non-destructive quantitation and quality control to identify adulteration being of interest according to the Deutsche Arzneimittel Codex (DAC) even for the phytopharmaceutical industry. (author) [de

Requirements for quality control of analytical data

International Nuclear Information System (INIS)

Westmoreland, R.D.; Bartling, M.H.

1990-07-01

The National Contingency Plan (NCP) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) provides procedures for the identification, evaluation, and remediation of past hazardous waste disposal sites. The Hazardous Materials Response section of the NCP consists of several phases: Preliminary Assessment, Site Inspection, Remedial Investigation, Feasibility Study, Remedial Design, and Remedial Action. During any of these phases, analysis of soil, water, and waste samples may be performed. The Hazardous Waste Remedial Actions Program (HAZWRAP) is involved in performing field investigations and sample analyses pursuant to the NCP for the US Department of Energy and other federal agencies. The purpose of this document is to specify the requirements of Martin Marietta Energy Systems, Inc., for the control of accuracy, precision, and completeness of samples and data from the point of collection through analysis. Requirements include data reduction and reporting of resulting environmentally related data. Because every instance and concern may not be addressed in this document, HAZWRAP subcontractors are encouraged to discuss any questions with the Analytical Quality Control Specialist (AQCS) and the HAZWRAP Project Manager. This revision supercedes all other versions of this document

Analytical method for high resolution liquid chromatography for quality control French Macaw

International Nuclear Information System (INIS)

Garcia Penna, Caridad M; Torres Amaro, Leonid; Menendez Castillo, Rosa; Sanchez, Esther; Martinez Espinosa, Vivian; Gonzalez, Maria Lidia; Rodriguez, Carlos

2007-01-01

Was developed and validated an analytical method for high resolution liquid chromatography applicable to quality control of drugs dry French Macaw (Senna alata L. Roxb.) With ultraviolet detection at 340 nm. The method for high resolution liquid chromatography used to quantify the sennosides A and B, main components, was validated and proved to be specific, linear, precise and accurate. (Author)

Quality assurance and quality control of nuclear analytical techniques

International Nuclear Information System (INIS)

Cincu, Emanuelathor

2001-01-01

Test and analytical laboratories in East and Central European countries need to prove the reliability and credibility of their economic, environmental, medical and legal decisions and their capacity of issuing reliable, verifiable reports. These demands imposed by the European Union aimed at avoiding a possible barrier to trade for the developing countries. In June 1999, in order to help Member States to develop according to EU objectives and the overall situation of the European market, IAEA launched a new co-operation programme designed to help the nuclear analytical laboratories in nuclear institutions and universities of Member States by training in the use of some Nuclear Analytical Techniques (NAT) that include: alpha, beta and gamma-ray spectrometry, radiochemical and neutron activation analysis, total reflection X-ray fluorescence. The Regional IAEA Project, named 'Quality Assurance/Quality Control of Nuclear Analytical Techniques' (NAT) aims at implementing the QA principles via a system of defined consecutive steps leading to a level on which the QA system is self-sustainable for formal accreditation or certification and satisfies the EU technical performance criteria; the requirements are in accordance with the new ISO/IEC 17025 Standard/Dec.1999 'General requirements for the competence of testing and calibration laboratories' - First edition. The Horia Hulubei National Institute for Nuclear Physics and Engineering, IFIN-HH, was admitted for participation in the IAEA Project in June 1999 account taken of its experience in the QA and metrology fields and its performance in the fields of beta and gamma-ray spectrometry, and radiochemical and neutron activation analysis, employed in both basic research and applications for external clients. Two working groups of specialists with the QA and Standardization and Metrology Departments and six analytical groups with the departments of Nuclear Applied Physics, Life Physics and Ionising Radiation Metrology are

New insight into the comparative power of quality-control rules that use control observations within a single analytical run.

Science.gov (United States)

Parvin, C A

1993-03-01

The error detection characteristics of quality-control (QC) rules that use control observations within a single analytical run are investigated. Unlike the evaluation of QC rules that span multiple analytical runs, most of the fundamental results regarding the performance of QC rules applied within a single analytical run can be obtained from statistical theory, without the need for simulation studies. The case of two control observations per run is investigated for ease of graphical display, but the conclusions can be extended to more than two control observations per run. Results are summarized in a graphical format that offers many interesting insights into the relations among the various QC rules. The graphs provide heuristic support to the theoretical conclusions that no QC rule is best under all error conditions, but the multirule that combines the mean rule and a within-run standard deviation rule offers an attractive compromise.

Identification of clinical biomarkers for pre-analytical quality control of blood samples.

Science.gov (United States)

Kang, Hyun Ju; Jeon, Soon Young; Park, Jae-Sun; Yun, Ji Young; Kil, Han Na; Hong, Won Kyung; Lee, Mee-Hee; Kim, Jun-Woo; Jeon, Jae-Pil; Han, Bok Ghee

2013-04-01

Pre-analytical conditions are key factors in maintaining the high quality of biospecimens. They are necessary for accurate reproducibility of experiments in the field of biomarker discovery as well as achieving optimal specificity of laboratory tests for clinical diagnosis. In research at the National Biobank of Korea, we evaluated the impact of pre-analytical conditions on the stability of biobanked blood samples by measuring biochemical analytes commonly used in clinical laboratory tests. We measured 10 routine laboratory analytes in serum and plasma samples from healthy donors (n = 50) with a chemistry autoanalyzer (Hitachi 7600-110). The analyte measurements were made at different time courses based on delay of blood fractionation, freezing delay of fractionated serum and plasma samples, and at different cycles (0, 1, 3, 6, 9) of freeze-thawing. Statistically significant changes from the reference sample mean were determined using the repeated-measures ANOVA and the significant change limit (SCL). The serum levels of GGT and LDH were changed significantly depending on both the time interval between blood collection and fractionation and the time interval between fractionation and freezing of serum and plasma samples. The glucose level was most sensitive only to the elapsed time between blood collection and centrifugation for blood fractionation. Based on these findings, a simple formula (glucose decrease by 1.387 mg/dL per hour) was derived to estimate the length of time delay after blood collection. In addition, AST, BUN, GGT, and LDH showed sensitive responses to repeated freeze-thaw cycles of serum and plasma samples. These results suggest that GGT and LDH measurements can be used as quality control markers for certain pre-analytical conditions (eg, delayed processing or repeated freeze-thawing) of blood samples which are either directly used in the laboratory tests or stored for future research in the biobank.

Experiences with IAEA project: TC Regional Project on Quality Control and Quality Assurance for Nuclear Analytical Techniques (RER/2/004)

International Nuclear Information System (INIS)

Glavic-Cindro, Denis; Korun, Matjaz

2002-01-01

In the TC Regional Project on Quality Control and Quality Assurance for Nuclear Analytical Techniques RER/2/004, 12 laboratories from east and central European countries participated. Within this project 4 workshops, 2 audit inspections and 2 proficiency tests were organized. The aim of this project was to help these laboratories to implement quality assurance system based on the ISO 17025 standard and to help them on the way towards accreditation. (author)

COLLABORATIVE TRIAL AND QUALITY CONTROL IN CHEMICAL ANALYSIS

Directory of Open Access Journals (Sweden)

Narsito Narsito

2010-06-01

Full Text Available Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of analytical method, quality assurance in chemical analysis. The assessment of quality parameter for analytical method like the use of standard materials as well as standard methods is given. Concerning with the quality control of analytical data, the use of several techniques, such as control samples and control charts, in monitoring analytical data in quality control program are described qualitatively.  In the final part of this paper, some important remarks for the preparation of collaborative trials, including the evaluation of accuracy and reproducibility of analytical method are also given Keywords: collaborative trials, quality control, analytical data Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of

Hanford analytical services quality assurance plan. Revision 1

International Nuclear Information System (INIS)

1995-02-01

This document, the Hanford Analytical Services Quality Assurance Plan (HASQAP), is issued by the U.S. Department of Energy, Richland Operations Office (RL). The HASQAP establishes quality requirements in response to U.S. Department of Energy (DOE) Order 5700.6C, Quality Assurance (10 CFR 830.120, open-quotes Quality Assurance Requirementsclose quotes). The HASQAP is designed to meet the needs of the RL for controlling the of analytical chemistry services provided by laboratory operations. The HASQAP is issued through the Analytical Services Branch of the Waste Management Division. The Analytical Services Branch is designated by the RL as having the responsibility for oversight management of laboratory operations under the Waste Management Division. The laboratories conduct sample analyses under several regulatory statutes, such as the Clean Air Act and the Clean Water Act. Sample analysis in support of the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) is a major role of the laboratory operations

Pre-analytic process control: projecting a quality image.

Science.gov (United States)

Serafin, Mark D

2006-09-26

Within the health-care system, the term "ancillary department" often describes the laboratory. Thus, laboratories may find it difficult to define their image and with it, customer perception of department quality. Regulatory requirements give laboratories who so desire an elegant way to address image and perception issues--a comprehensive pre-analytic system solution. Since large laboratories use such systems--laboratory service manuals--I describe and illustrate the process for the benefit of smaller facilities. There exist resources to help even small laboratories produce a professional service manual--an elegant solution to image and customer perception of quality.

Quality system implementation for nuclear analytical techniques

International Nuclear Information System (INIS)

2004-01-01

The international effort (UNIDO, ILAC, BIPM, etc.) to establish a functional infrastructure for metrology and accreditation in many developing countries needs to be complemented by assistance to implement high quality practices and high quality output by service providers and producers in the respective countries. Knowledge of how to approach QA systems that justify a formal accreditation is available in only a few countries and the dissemination of know how and development of skills is needed bottom up from the working level of laboratories and institutes. Awareness building, convincing of management, introduction of good management practices, technical expertise and good documentation will lead to the creation of a quality culture that assures a sustainability and inherent development of quality practices as a prerequisite of economic success. Quality assurance and quality control can be used as a valuable management tool and is a prerequisite for international trade and information exchange. This publication tries to assist quality managers, Laboratory Managers and staff involved in setting up a QA/QC system in a nuclear analytical laboratory to take appropriate action to start and complete the necessary steps for a successful quality system for ultimate national accreditation. This guidebook contributes to a better understanding of the basic ideas behind ISO/IEC 17025, the international standard for 'General requirements for the competence of testing and calibration laboratories'. It provides basic information and detailed explanation about the establishment of the QC system in analytical and nuclear analytical laboratories. It is a proper training material for training of trainers and makes managers with QC management and implementation familiar. This training material aims to facilitate the implementation of internationally accepted quality principles and to promote attempts by Member States' laboratories to obtain accreditation for nuclear analytical

Analytical quality by design: a tool for regulatory flexibility and robust analytics.

Science.gov (United States)

Peraman, Ramalingam; Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

Quality assurance management plan (QAPP) special analytical support (SAS)

Energy Technology Data Exchange (ETDEWEB)

LOCKREM, L.L.

1999-05-20

It is the policy of Special Analytical Support (SAS) that the analytical aspects of all environmental data generated and processed in the laboratory, subject to the Environmental Protection Agency (EPA), U.S. Department of Energy or other project specific requirements, be of known and acceptable quality. It is the intention of this QAPP to establish and assure that an effective quality controlled management system is maintained in order to meet the quality requirements of the intended use(s) of the data.

Quality assurance management plan (QAPP) special analytical support (SAS)

International Nuclear Information System (INIS)

LOCKREM, L.L.

1999-01-01

It is the policy of Special Analytical Support (SAS) that the analytical aspects of all environmental data generated and processed in the laboratory, subject to the Environmental Protection Agency (EPA), U.S. Department of Energy or other project specific requirements, be of known and acceptable quality. It is the intention of this QAPP to establish and assure that an effective quality controlled management system is maintained in order to meet the quality requirements of the intended use(s) of the data

Control Chart on Semi Analytical Weighting

Science.gov (United States)

Miranda, G. S.; Oliveira, C. C.; Silva, T. B. S. C.; Stellato, T. B.; Monteiro, L. R.; Marques, J. R.; Faustino, M. G.; Soares, S. M. V.; Ulrich, J. C.; Pires, M. A. F.; Cotrim, M. E. B.

2018-03-01

Semi-analytical balance verification intends to assess the balance performance using graphs that illustrate measurement dispersion, trough time, and to demonstrate measurements were performed in a reliable manner. This study presents internal quality control of a semi-analytical balance (GEHAKA BG400) using control charts. From 2013 to 2016, 2 weight standards were monitored before any balance operation. This work intended to evaluate if any significant difference or bias were presented on weighting procedure over time, to check the generated data reliability. This work also exemplifies how control intervals are established.

Quality Indicators for Learning Analytics

Science.gov (United States)

Scheffel, Maren; Drachsler, Hendrik; Stoyanov, Slavi; Specht, Marcus

2014-01-01

This article proposes a framework of quality indicators for learning analytics that aims to standardise the evaluation of learning analytics tools and to provide a mean to capture evidence for the impact of learning analytics on educational practices in a standardised manner. The criteria of the framework and its quality indicators are based on…

Quality assurance and statistical control

DEFF Research Database (Denmark)

Heydorn, K.

1991-01-01

In scientific research laboratories it is rarely possible to use quality assurance schemes, developed for large-scale analysis. Instead methods have been developed to control the quality of modest numbers of analytical results by relying on statistical control: Analysis of precision serves...... to detect analytical errors by comparing the a priori precision of the analytical results with the actual variability observed among replicates or duplicates. The method relies on the chi-square distribution to detect excess variability and is quite sensitive even for 5-10 results. Interference control...... serves to detect analytical bias by comparing results obtained by two different analytical methods, each relying on a different detection principle and therefore exhibiting different influence from matrix elements; only 5-10 sets of results are required to establish whether a regression line passes...

Analytical method validation for quality control and the study of the 50 mg Propylthiouracil stability

International Nuclear Information System (INIS)

Valdes Bendoyro, Maria Olga; Garcia Penna, Caridad Margarita; Fernandez, Juan Lugones; Garcia Borges, Lisandra; Martinez Espinosa, Vivian

2010-01-01

A high-performance liquid chromatography analytical method was developed and validated for the quality control and stability studies of 50 mg Propylthiouracil tablets. Method is based in active principle separation through a 100 RP-18 RP-18 (5 μm) (250 x 4 mm) Lichrospher chromatography with UV detection to 272 nm, using a mobile phase composed by a ungaseous mixture of a 0.025 M buffer solution-monobasic potassium phosphate to pH= 4,6 ad acetonitrile in a 80:20 ratio with a flux speed of 0,5 mL/min. Analytical method was linear, precise, specific and exact in the study concentrations interval

Quality control of radiopharmaceuticals

International Nuclear Information System (INIS)

Kristensen, K.

1981-01-01

Quality assurance was introduced in the pharmaceutical field long before it was used in many other areas, and the term quality control has been used in a much broader sense than merely analytical quality control. The term Good Manufacturing Practice (GMP) has been used to describe the system used for producing safe and effective drugs of a uniform quality. GMP has also been used for the industrial production of radiopharmaceuticals. For the preparation and control of radiopharmaceuticals in hospitals a similar system has been named Good Radiopharmacy Practice (GRP). It contains the same elements as GMP but takes into account the special nature of this group of drugs. Data on the assessment of the quality of radiopharmaceuticals in relation to present standards are reviewed. The general conclusion is that the quality of radiopharmaceuticals appears comparable to that of other drugs. It seems possible to establish the production of radiopharmaceuticals, generators and preparation kits in such a way that analytical control of the final product at the hospital may be limited provided the final preparation work is carried out in accordance with GRP principles. The elements of GRP are reviewed. (author)

Quantification of analytes affected by relevant interfering signals under quality controlled conditions

International Nuclear Information System (INIS)

Bettencourt da Silva, Ricardo J.N.; Santos, Julia R.; Camoes, M. Filomena G.F.C.

2006-01-01

The analysis of organic contaminants or residues in biological samples is frequently affected by the presence of compounds producing interfering instrumental signals. This feature is responsible for the higher complexity and cost of these analyses and/or by a significant reduction of the number of studied analytes in a multi-analyte method. This work presents a methodology to estimate the impact of the interfering compounds on the quality of the analysis of complex samples, based on separative instrumental methods of analysis, aiming at supporting the inclusion of analytes affected by interfering compounds in the list of compounds analysed in the studied samples. The proposed methodology involves the study of the magnitude of the signal produced by the interfering compounds in the analysed matrix, and is applicable to analytical systems affected by interfering compounds with varying concentration in the studied matrix. The proposed methodology is based on the comparison of the signals from a representative number of examples of the studied matrix, in order to estimate the impact of the presence of such compounds on the measurement quality. The treatment of the chromatographic signals necessary to collect these data can be easily performed considering algorithms of subtraction of chromatographic signals available in most of the analytical instrumentation software. The subtraction of the interfering compounds signal from the sample signal allows the compensation of the interfering effect irrespective of the relative magnitude of the interfering and analyte signals, supporting the applicability of the same model of the method performance for a broader concentration range. The quantification of the measurement uncertainty was performed using the differential approach, which allows the estimation of the contribution of the presence of the interfering compounds to the quality of the measurement. The proposed methodology was successfully applied to the analysis of

Analytical approaches to quality assurance and quality control in rangeland monitoring data

Science.gov (United States)

Producing quality data to support land management decisions is the goal of every rangeland monitoring program. However, the results of quality assurance (QA) and quality control (QC) efforts to improve data quality are rarely reported. The purpose of QA and QC is to prevent and describe non-sampling...

Development and validation of an analytical method for quality control and the stability of the eyedrops 10 % Phenylephrine and the 1 % Tropicamide

International Nuclear Information System (INIS)

Garcia Penna, Caridad Margarita; Botet Garcia, Martha; Troche Concepcion, Yenilen

2011-01-01

An analytical high-performance liquid chromatography method was developed and validated applicable to quality control and to stability study of 10 % phenylephrine plus eyedrops 1 % tropicamide. To quantify simultaneously both active principles in the finished product, separation was carried out through a Lichrosorb RP-18 (15 μm) (260 x 4 mm) column chromatography, with ultraviolet detection at 253 nm using the mobile phase composed of methanol: distilled water (1:1), with 1.1 g of sodium 1-octasulfanate by litre and pH fitted to 3.0 with phosphoric acid and the quantification of this front to a reference sample using the external standard method. The analytical method developed was linear, precise, specific and accurate in the rank of study concentrations, established for the quality control and stability study of the finished product since there were not analytical methods designed for these aims

Quality control of pesticide products

Energy Technology Data Exchange (ETDEWEB)

NONE

2009-07-15

In light of an established need for more efficient analytical procedures, this publication, which documents the findings of an IAEA coordinated research project (CRP) on “Quality Control of Pesticide Products”, simplifies the existing protocol for pesticide analysis while simultaneously upholding existing standards of quality. This publication includes both a report on the development work done in the CRP and a training manual for use by pesticide analysis laboratories. Based on peer reviewed and internationally recognized methods published by the Association of Analytical Communities (AOAC) and the Collaborative International Pesticides Analytical Council (CIPAC), this report provides laboratories with versatile tools to enhance the analysis of pesticide chemicals and to extend the scope of available analytical repertoires. Adoption of the proposed analytical methodologies promises to reduce laboratories’ use of solvents and the time spent on reconfiguration and set-up of analytical equipment.

Quality control of pesticide products

International Nuclear Information System (INIS)

2009-07-01

In light of an established need for more efficient analytical procedures, this publication, which documents the findings of an IAEA coordinated research project (CRP) on “Quality Control of Pesticide Products”, simplifies the existing protocol for pesticide analysis while simultaneously upholding existing standards of quality. This publication includes both a report on the development work done in the CRP and a training manual for use by pesticide analysis laboratories. Based on peer reviewed and internationally recognized methods published by the Association of Analytical Communities (AOAC) and the Collaborative International Pesticides Analytical Council (CIPAC), this report provides laboratories with versatile tools to enhance the analysis of pesticide chemicals and to extend the scope of available analytical repertoires. Adoption of the proposed analytical methodologies promises to reduce laboratories’ use of solvents and the time spent on reconfiguration and set-up of analytical equipment

Internal quality control of PCR-based genotyping methods

DEFF Research Database (Denmark)

Bladbjerg, Else-Marie; Gram, Jørgen; Jespersen, Jørgen

2002-01-01

Internal quality control programmes for genetic analyses are needed. We have focused on quality control aspects of selected polymorphism analyses used in thrombosis research. DNA was isolated from EDTA-blood (n = 500) and analysed for 18 polymorphisms by polymerase chain reaction (PCR), i...... because of positive reagent blanks (controls (Control of data handling revealed 0.1% reading mistakes and 0.5% entry mistakes. Based on our experiences, we propose an internal quality control programme......, electrophoresis (analytical factors), result reading and entry into a database (post-analytical factors). Furthermore, we evaluated a procedure for result confirmation. Isolated DNA was of good quality (42 micrograms/ml blood, A260/A280 ratio > 1.75, negative DNAsis tests). Occasionally, results were reanalysed...

Development and implementation of an analytical quality assurance plan at the Hanford site

International Nuclear Information System (INIS)

Kuhl-Klinger, K.J.; Taylor, C.D.; Kawabata, K.K.

1995-08-01

The Hanford Analytical Services Quality Assurance Plan (HASQAP) provides a uniform standard for onsite and offsite laboratories performing analytical work in support of Hanford Site environmental cleanup initiatives. The Hanford Site is a nuclear site that originated during World War 11 and has a legacy of environmental clean up issues. In early 1993, the need for and feasibility of developing a quality assurance plan to direct all analytical activities performed to support environmental cleanup initiatives set forth in the Hanford Federal Facility Agreement and Consent Order were discussed. Several group discussions were held and from them came the HASQAP. This document will become the quality assurance guidance document in a Federal Facility Agreement and Consent Order. This paper presents the mechanics involved in developing a quality assurance plan for this scope of activity, including the approach taken to resolve the variability of quality control requirements driven by numerous regulations. It further describes the consensus building process and how the goal of uniting onsite and offsite laboratories as well as inorganic, organic, and radioanalytic disciplines under a common understanding of basic quality control concepts was achieved

Development of statistical and analytical techniques for use in national quality control schemes for steroid hormones

International Nuclear Information System (INIS)

Wilson, D.W.; Gaskell, S.J.; Fahmy, D.R.; Joyce, B.G.; Groom, G.V.; Griffiths, K.; Kemp, K.W.; Nix, A.B.J.; Rowlands, R.J.

1979-01-01

Adopting the rationale that the improvement of intra-laboratory performance of immunometric assays will enable the assessment of national QC schemes to become more meaningful, the group of participating laboratories has developed statistical and analytical techniques for the improvement of accuracy, precision and monitoring of error for the determination of steroid hormones. These developments are now described and their relevance to NQC schemes discussed. Attention has been focussed on some of the factors necessary for improving standards of quality in immunometric assays and their relevance to laboratories participating in NQC schemes as described. These have included the 'accuracy', precision and robustness of assay procedures as well as improved methods for internal quality control. (Auth.)

Quality Measures in Pre-Analytical Phase of Tissue Processing: Understanding Its Value in Histopathology.

Science.gov (United States)

Rao, Shalinee; Masilamani, Suresh; Sundaram, Sandhya; Duvuru, Prathiba; Swaminathan, Rajendiran

2016-01-01

Quality monitoring in histopathology unit is categorized into three phases, pre-analytical, analytical and post-analytical, to cover various steps in the entire test cycle. Review of literature on quality evaluation studies pertaining to histopathology revealed that earlier reports were mainly focused on analytical aspects with limited studies on assessment of pre-analytical phase. Pre-analytical phase encompasses several processing steps and handling of specimen/sample by multiple individuals, thus allowing enough scope for errors. Due to its critical nature and limited studies in the past to assess quality in pre-analytical phase, it deserves more attention. This study was undertaken to analyse and assess the quality parameters in pre-analytical phase in a histopathology laboratory. This was a retrospective study done on pre-analytical parameters in histopathology laboratory of a tertiary care centre on 18,626 tissue specimens received in 34 months. Registers and records were checked for efficiency and errors for pre-analytical quality variables: specimen identification, specimen in appropriate fixatives, lost specimens, daily internal quality control performance on staining, performance in inter-laboratory quality assessment program {External quality assurance program (EQAS)} and evaluation of internal non-conformities (NC) for other errors. The study revealed incorrect specimen labelling in 0.04%, 0.01% and 0.01% in 2007, 2008 and 2009 respectively. About 0.04%, 0.07% and 0.18% specimens were not sent in fixatives in 2007, 2008 and 2009 respectively. There was no incidence of specimen lost. A total of 113 non-conformities were identified out of which 92.9% belonged to the pre-analytical phase. The predominant NC (any deviation from normal standard which may generate an error and result in compromising with quality standards) identified was wrong labelling of slides. Performance in EQAS for pre-analytical phase was satisfactory in 6 of 9 cycles. A low incidence

[Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

Science.gov (United States)

Ishibashi, Midori

2015-01-01

The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

AUTOMATION OF THE SYSTEM OF INTERNAL LABORATORY QUALITY CONTROL

Directory of Open Access Journals (Sweden)

V. Z. Stetsyuk

2015-05-01

Full Text Available Quality control system base d on the principles of standardi zation of all phases of laboratory testing and analysis of internal laboratory quality control and external quality assessment. For the detection accuracy of the results of laboratory tests, carried out internally between the laboratory and laboratory quality control. Under internal laboratory quality control we understand measurement results of each analysis in each anal ytical series rendered directly in the lab every day. The purpose of internal laboratory control - identifying and eliminating unacceptable deviations from standard perfor mance test in the laboratory, i.e. identifying and eliminating harmful analytical errors. The solutions to these problems by implementing automated systems - software that allows you to optimize analytical laboratory research stage of the procedure by automatically creating process control charts was shown.

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

Science.gov (United States)

Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

Validation of analytical methods for the quality control of Naproxen suppositories

International Nuclear Information System (INIS)

Rodriguez Hernandez, Yaslenis; Suarez Perez, Yania; Garcia Pulpeiro, Oscar; Hernandez Contreras, Orestes Yuniel

2011-01-01

The analysis methods that will be used for the quality control of the future Cuban-made Naproxen suppositories for adults and children were developed for the first time in this paper. One method based on direct ultraviolet spectrophotometry was put forward, which proved to be specific, linear, accurate and precise for the quality control of Naproxen suppositories, taking into account the presence of chromophore groups in their structure. Likewise, the direct semi-aqueous acid-base volumetry method aimed at the quality control of the Naproxen raw material was changed and adapted to the quality control of suppositories. On the basis of the validation process, there was demonstrated the adequate specificity of this method with respect to the formulation components, as well as its linearity, accuracy and precision in 1-3 mg/ml range. The final results were compared and no significant statistical differences among the replicas per each dose were found in both methods; therefore, both may be used in the quality control of Naproxen suppositories

Validation of analytical method to quality control and the stability study of 0.025 % eyedrops Ketotiphen

International Nuclear Information System (INIS)

Troche Concepcion, Yenilen; Romero Diaz, Jacqueline Aylema; Garcia Penna, Caridad M

2010-01-01

The Ketotiphen eyedrop is prescribed to relief the signs and symptoms of allergic conjunctivitis due to its potent H 1a ntihistaminic effect showing some ability to inhibit the histamine release and other mediators in cases of mastocytosis. The aim of present paper was to develop and validate an analytical method for the high-performance liquid chromatography, to quality control and the stability studies of 0.025 % eyedrop Ketotiphen. Method was based on active principle separation by means of a Lichrosorb RP-18 (5 μm) (250 x 4 mm), with UV detection to 296 nm using a mobile phase including a non-gasified mixture of methanol:buffer-phosphate (75:25; pH 8.5) adding 1 mL of Isopropanol by each 1 000 mL of the previous mixture at a 1.2 mL/min flow velocity. The analytical method was linear, accurate, specific and exact during the study concentrations

Advanced analytical techniques for boiling water reactor chemistry control

Energy Technology Data Exchange (ETDEWEB)

Alder, H P; Schenker, E [Paul Scherrer Inst. (PSI), Villigen (Switzerland)

1997-02-01

The analytical techniques applied can be divided into 5 classes: OFF-LINE (discontinuous, central lab), AT-LINE (discontinuous, analysis near loop), ON-LINE (continuous, analysis in bypass). In all cases pressure and temperature of the water sample are reduced. In a strict sense only IN-LINE (continuous, flow disturbance) and NON-INVASIVE (continuous, no flow disturbance) techniques are suitable for direct process control; - the ultimate goal. An overview of the analytical techniques tested in the pilot loop is given. Apart from process and overall water quality control, standard for BWR operation, the main emphasis is on water impurity characterization (crud particles, hot filtration, organic carbon); on stress corrosion crackling control for materials (corrosion potential, oxygen concentration) and on the characterization of the oxide layer on austenites (impedance spectroscopy, IR-reflection). The above mentioned examples of advanced analytical techniques have the potential of in-line or non-invasive application. They are different stages of development and are described in more detail. 28 refs, 1 fig., 5 tabs.

21 CFR 862.1660 - Quality control material (assayed and unassayed).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Quality control material (assayed and unassayed... Test Systems § 862.1660 Quality control material (assayed and unassayed). (a) Identification. A quality... that may arise from reagent or analytical instrument variation. A quality control material (assayed and...

Internal quality control of neutron activation analysis laboratory

Energy Technology Data Exchange (ETDEWEB)

Kim, S. H.; Mun, J. H.; BaeK, S. Y.; Jung, Y. S.; Kim, Y. J. [KAERI, Taejon (Korea, Republic of)

2004-07-01

The importance for quality assurance and control in analytical laboratories has been emphasized, day by day. Internal quality control using certified reference materials(CRMs) can be one of effective methods for this purpose. In this study, 10 kinds of CRMs consisting of soil, sediment and biological matrix were analyzed. To evaluate the confidence of analytical results and the validation of testing method and procedure, the accuracy and the precision of the measured elements were treated statistically and the reproducibility was compared with those values produced before 2003.

Standard guide for establishing a quality assurance program for analytical chemistry laboratories within the nuclear industry

CERN Document Server

American Society for Testing and Materials. Philadelphia

2006-01-01

1.1 This guide covers the establishment of a quality assurance (QA) program for analytical chemistry laboratories within the nuclear industry. Reference to key elements of ANSI/ISO/ASQC Q9001, Quality Systems, provides guidance to the functional aspects of analytical laboratory operation. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program. 1.2 The essential, basic elements of a laboratory QA program appear in the following order: Section Organization 5 Quality Assurance Program 6 Training and Qualification 7 Procedures 8 Laboratory Records 9 Control of Records 10 Control of Procurement 11 Control of Measuring Equipment and Materials 12 Control of Measurements 13 Deficiencies and Corrective Actions 14

Laboratory quality assurance and its role in the safeguards analytical laboratory evaluation (SALE) program

International Nuclear Information System (INIS)

Delvin, W.L.; Pietri, C.E.

1981-07-01

Since the late 1960's, strong emphasis has been given to quality assurance in the nuclear industry, particularly to that part involved in nuclear reactors. This emphasis has had impact on the analytical chemistry laboratory because of the importance of analytical measurements in the certification and acceptance of materials used in the fabrication and construction of reactor components. Laboratory quality assurance, in which the principles of quality assurance are applied to laboratory operations, has a significant role to play in processing, fabrication, and construction programs of the nuclear industry. That role impacts not only process control and material certification, but also safeguards and nuclear materials accountability. The implementation of laboratory quality assurance is done through a program plan that specifies how the principles of quality assurance are to be applied. Laboratory quality assurance identifies weaknesses and deficiencies in laboratory operations and provides confidence in the reliability of laboratory results. Such confidence in laboratory measurements is essential to the proper evaluation of laboratories participating in the Safeguards Analytical Laboratory Evaluation (SALE) Program

Quality control in the histopathology laboratory: An overview with stress on the need for a structured national external quality assessment scheme

Directory of Open Access Journals (Sweden)

Iyengar Jayaram

2009-01-01

Full Text Available The concept of quality control in histopathology is relatively young and less well understood. Like in other disciplines of laboratory medicine, the concept of quality and its control is applicable to pre analytical, analytical and post analytical activities. Assessment of both precision and accuracy performances is possible by appropriate internal and external quality control and assessment schemes. This article is a review of all processes that achieve quality reporting in histopathology. There is a special focus on external quality assessment - a scheme that lacks organization on a national level in our country. Statistical data derived from a small scale external quality assurance program is also analyzed along with recommendations to organize an effective national scheme with the participation of authorized zonal centers.

42 CFR 493.1289 - Standard: Analytic systems quality assessment.

Science.gov (United States)

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Analytic systems quality assessment. 493.1289 Section 493.1289 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... through 493.1283. (b) The analytic systems quality assessment must include a review of the effectiveness...

Quality control activities in the environmental radiology laboratory

International Nuclear Information System (INIS)

Llaurado, M.; Quesada, D.; Rauret, G.; Tent, J.; Zapata, D.

2006-01-01

During the last twenty years many analytical laboratories have implemented quality assurance systems. A quality system implementation requires documentation of all activities (technical and management), evaluation of these activities and its continual improvement. Implementation and adequate management of all the elements a quality system includes are not enough to guarantee quality of the analytical results generated at a time. That is the aim of a group of specific activities labelled as quality control activities. The Laboratori de Radiologia Ambiental (Environmental Radiology Laboratory; LRA) at the University of Barcelona was created in 1984 to carry out part of the quality control assays of the Environmental Radiology Monitoring Programs around some of the Spanish nuclear power plants, which are developed by the Servei Catala d'Activitats Energetiques (SCAR) and the Consejo de Seguridad Nuclear (CSN), organisations responsible for nuclear security and radiological protection. In these kind of laboratories, given the importance of the results they give, quality control activities become an essential aspect. In order to guarantee the quality of its analytical results, the LRA Direction decided to adopt the international standard UNE-EN ISO/IEC 17025 for its internal quality system and to accreditate some of the assays it carries out. In such as system, it is established, the laboratory shall monitor the validity of tests undertaken and data shall be recorded in such a way that trends are detectable. The present work shows the activities carried out in this way by the LRA, which are: Equipment control activities which in the special case of radiochemical techniques include measurement of backgrounds and blanks as well as periodical control of efficiency and resolution. Activities to assure the specifications settled by method validation, which are testing of reference materials and periodical analysis of control samples. Evaluation of the laboratory work quality

Quality by control: Towards model predictive control of mammalian cell culture bioprocesses.

Science.gov (United States)

Sommeregger, Wolfgang; Sissolak, Bernhard; Kandra, Kulwant; von Stosch, Moritz; Mayer, Martin; Striedner, Gerald

2017-07-01

The industrial production of complex biopharmaceuticals using recombinant mammalian cell lines is still mainly built on a quality by testing approach, which is represented by fixed process conditions and extensive testing of the end-product. In 2004 the FDA launched the process analytical technology initiative, aiming to guide the industry towards advanced process monitoring and better understanding of how critical process parameters affect the critical quality attributes. Implementation of process analytical technology into the bio-production process enables moving from the quality by testing to a more flexible quality by design approach. The application of advanced sensor systems in combination with mathematical modelling techniques offers enhanced process understanding, allows on-line prediction of critical quality attributes and subsequently real-time product quality control. In this review opportunities and unsolved issues on the road to a successful quality by design and dynamic control implementation are discussed. A major focus is directed on the preconditions for the application of model predictive control for mammalian cell culture bioprocesses. Design of experiments providing information about the process dynamics upon parameter change, dynamic process models, on-line process state predictions and powerful software environments seem to be a prerequisite for quality by control realization. © 2017 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Quality control in haemostasis.

Science.gov (United States)

Capel, P; Chatelain, B; Leclerq, R; Lust, A; Masure, R; Arnout, J

1992-01-01

Laboratory investigation of the haemostatic system deserves particular procedures in the quality control of analytical variables as well as preanalytical variables. This paper reviews the precautions that have to be taken in the blood prelevement, the transport of the tubes and the performance of the laboratory tests aimed to investigate the haemostatic system in order to obtain reliable results.

Analytical quality assurance procedures developed for the IAEA's Reference Asian Man Project (Phase 2)

International Nuclear Information System (INIS)

Kawamura, H.; Parr, R.M.; Dang, H.S.; Tian, W.; Barnes, R.M.; Iyengar, G.V.

2000-01-01

Analytical quality assurance procedures adopted for use in the IAEA Co-ordinated Research Project on Ingestion and Organ Content of Trace Elements of Importance in Radiological Protection are designed to ensure comparability of the analytical results for Cs, I, Sr, Th, U and other elements in human tissues and diets collected and analysed in nine participating countries. The main analytical techniques are NAA and ICP-MS. For sample preparation, all participants are using identical food blenders which have been centrally supplied after testing for contamination. For quality control of the analyses, six NIST SRMs covering a range of matrices with certified and reference values for the elements of interest have been distributed. A new Japanese reference diet material has also been developed. These quality assurance procedures are summarized here and new data are presented for Cs, I, Sr, Th and U in the NIST SRMs. (author)

Internal quality control of PCR-based genotyping methods in research studies and patient diagnostics

DEFF Research Database (Denmark)

Bladbjerg, Else-Marie; Gram, Jørgen; Jespersen, Jørgen

2002-01-01

Genetic analyses are increasingly integrated in the clinical laboratory, and internal quality control programmes are needed. We have focused on quality control aspects of selected polymorphism analyses used in thrombosis research. DNA was isolated from EDTA-blood (n = 500) by ammonium acetate....... Control of data handling revealed 0.1% reading mistakes and 0.5% entry mistakes. Based on our experiences we propose an internal quality control programme for widely used PCR-based haemostasis polymorphism analyses.......-isolation (pre-analytical factors), DNA-amplification, digestion with restriction enzymes, electrophoresis (analytical factors), result reading and entry into a database (post-analytical factors). Furthermore, we evaluated a procedure for result confirmation. Isolated DNA was of good quality (42 microg/ml blood...

Quality Control Guidelines for SAM Biotoxin Methods

Science.gov (United States)

Learn more about quality control guidelines and recommendations for the analysis of samples using the pathogen methods listed in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

Quality Control Guidelines for SAM Radiochemical Methods

Science.gov (United States)

Learn more about quality control guidelines and recommendations for the analysis of samples using the radiochemistry methods listed in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

Quality Control Guidelines for SAM Pathogen Methods

Science.gov (United States)

Learn more about quality control guidelines and recommendations for the analysis of samples using the biotoxin methods listed in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

Quality Control Guidelines for SAM Chemical Methods

Science.gov (United States)

Learn more about quality control guidelines and recommendations for the analysis of samples using the chemistry methods listed in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

ASVCP quality assurance guidelines: control of preanalytical and analytical factors for hematology for mammalian and nonmammalian species, hemostasis, and crossmatching in veterinary laboratories.

Science.gov (United States)

Vap, Linda M; Harr, Kendal E; Arnold, Jill E; Freeman, Kathleen P; Getzy, Karen; Lester, Sally; Friedrichs, Kristen R

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and provides recommendations for control of preanalytical and analytical factors related to hematology for mammalian and nonmammalian species, hemostasis testing, and crossmatching and is adapted from sections 1.1 and 2.3 (mammalian hematology), 1.2 and 2.4 (nonmammalian hematology), 1.5 and 2.7 (hemostasis testing), and 1.6 and 2.8 (crossmatching) of the complete guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

Implementation guide for Hanford Analytical Services Quality Assurance Plan

International Nuclear Information System (INIS)

1994-09-01

This implementation guide for the Hanford Analytical Services Quality Assurance Plan (HASQAP) was developed by the US Department of Energy, Richland Operations Office (RL) Waste Management Division, Analytical Services Branch. This plan formally presents RL's direction for Hanford Sitewide implementation of the HASQAP. The HASQAP establishes a uniform standard for quality requirements to meet US Department of Energy Order 5700.6C, Quality Assurance (10 CFR 830.120, ''Quality Assurance Requirements''), and is intended to satisfy the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) requirements for ''Guidance on Preparation of Laboratory Quality Assurance Plans''. The quality assurance criteria specified in the HASQAP shall serve as a baseline for implementing quality management systems for the laboratories that provide analytical services, for data requesters and users, and for oversight organizations that monitor the data-generation process. Affected organizations shall implement the HASQAP requirements that are applicable to their work scope. Full implementation of the HASQAP is scheduled to occur by August 1995. RL will work with the US Environmental Protection Agency (EPA) and Washington State Department of Ecology (Ecology) to have the HASQAP document incorporated into Appendix F of the Tri-Party Agreement by early Fiscal Year 1996

Physico-chemical quality control 131I-sodium 2-iodohippurate

International Nuclear Information System (INIS)

Morin, J.; Olive, E.; Issac, M.; Cruz, J.

1992-01-01

Some physico-chemical methods for analytical control 131 I-sodium 2-iodohippurate are compared. The most convenient to applicate in hospital and in more especialized quality control laboratories are recommended

Quality Assurance and Control in Laboratory using Neutron Activation Analysis

Energy Technology Data Exchange (ETDEWEB)

Chung, Y. S.; Moon, J. H.; Sun, G. M.; Kim, S. H.; Baek, S. Y.; Lim, J. M.; Kim, H. R

2007-01-15

In accordance with the increment of international trade associated with the worldwide globalization, the importance of quality assurance and control for the commodity produced from one's own country has been stressed. ISO (International Organization for Standards) defines quality control as 'the operational techniques and activities that are used to fulfill the requirements for quality'. Since 1996, the HANARO research reactor in the Korea Atomic Energy Research Institute has been operated thereafter initial critical operation on April 1995. Neutron activation analysis system and applied techniques which is one of a nuclear analytical technologies using reactor neutrons has been developed for user's supporting and the establishment of the quality system for a measurement and analysis, testing and inspection was implemented successfully. On the basis of the qualified NAA system, the test and measurement of more than 1500 samples which is requested from 30 organizations including industrial companies, universities and institutes carried out in NAA laboratory annually. Moreover, as the goal of mutual recognition agreement (MRA) which can be removed a technical barrier in international trade, the objectivity and the confidence of analytical quality in NAA laboratory became established through the installation of international accreditation system by implementing analytical quality system in accordance with international standards in 2001. The aim of the report was to summarize the technical management of introduction, methods and the results for a quality control and assurance which should be performed in NAA technique using the HANARO research reactor. The report will help building up effective quality control strategy in the future.

Quality Assurance and Control in Laboratory using Neutron Activation Analysis

International Nuclear Information System (INIS)

Chung, Y. S.; Moon, J. H.; Sun, G. M.; Kim, S. H.; Baek, S. Y.; Lim, J. M.; Kim, H. R.

2007-01-01

In accordance with the increment of international trade associated with the worldwide globalization, the importance of quality assurance and control for the commodity produced from one's own country has been stressed. ISO (International Organization for Standards) defines quality control as 'the operational techniques and activities that are used to fulfill the requirements for quality'. Since 1996, the HANARO research reactor in the Korea Atomic Energy Research Institute has been operated thereafter initial critical operation on April 1995. Neutron activation analysis system and applied techniques which is one of a nuclear analytical technologies using reactor neutrons has been developed for user's supporting and the establishment of the quality system for a measurement and analysis, testing and inspection was implemented successfully. On the basis of the qualified NAA system, the test and measurement of more than 1500 samples which is requested from 30 organizations including industrial companies, universities and institutes carried out in NAA laboratory annually. Moreover, as the goal of mutual recognition agreement (MRA) which can be removed a technical barrier in international trade, the objectivity and the confidence of analytical quality in NAA laboratory became established through the installation of international accreditation system by implementing analytical quality system in accordance with international standards in 2001. The aim of the report was to summarize the technical management of introduction, methods and the results for a quality control and assurance which should be performed in NAA technique using the HANARO research reactor. The report will help building up effective quality control strategy in the future

Internal quality control: best practice.

Science.gov (United States)

Kinns, Helen; Pitkin, Sarah; Housley, David; Freedman, Danielle B

2013-12-01

There is a wide variation in laboratory practice with regard to implementation and review of internal quality control (IQC). A poor approach can lead to a spectrum of scenarios from validation of incorrect patient results to over investigation of falsely rejected analytical runs. This article will provide a practical approach for the routine clinical biochemistry laboratory to introduce an efficient quality control system that will optimise error detection and reduce the rate of false rejection. Each stage of the IQC system is considered, from selection of IQC material to selection of IQC rules, and finally the appropriate action to follow when a rejection signal has been obtained. The main objective of IQC is to ensure day-to-day consistency of an analytical process and thus help to determine whether patient results are reliable enough to be released. The required quality and assay performance varies between analytes as does the definition of a clinically significant error. Unfortunately many laboratories currently decide what is clinically significant at the troubleshooting stage. Assay-specific IQC systems will reduce the number of inappropriate sample-run rejections compared with the blanket use of one IQC rule. In practice, only three or four different IQC rules are required for the whole of the routine biochemistry repertoire as assays are assigned into groups based on performance. The tools to categorise performance and assign IQC rules based on that performance are presented. Although significant investment of time and education is required prior to implementation, laboratories have shown that such systems achieve considerable reductions in cost and labour.

Hanford analytical services quality assurance requirements documents. Volume 1: Administrative Requirements

International Nuclear Information System (INIS)

Hyatt, J.E.

1997-01-01

Hanford Analytical Services Quality Assurance Requirements Document (HASQARD) is issued by the Analytical Services, Program of the Waste Management Division, US Department of Energy (US DOE), Richland Operations Office (DOE-RL). The HASQARD establishes quality requirements in response to DOE Order 5700.6C (DOE 1991b). The HASQARD is designed to meet the needs of DOE-RL for maintaining a consistent level of quality for sampling and field and laboratory analytical services provided by contractor and commercial field and laboratory analytical operations. The HASQARD serves as the quality basis for all sampling and field/laboratory analytical services provided to DOE-RL through the Analytical Services Program of the Waste Management Division in support of Hanford Site environmental cleanup efforts. This includes work performed by contractor and commercial laboratories and covers radiological and nonradiological analyses. The HASQARD applies to field sampling, field analysis, and research and development activities that support work conducted under the Hanford Federal Facility Agreement and Consent Order Tri-Party Agreement and regulatory permit applications and applicable permit requirements described in subsections of this volume. The HASQARD applies to work done to support process chemistry analysis (e.g., ongoing site waste treatment and characterization operations) and research and development projects related to Hanford Site environmental cleanup activities. This ensures a uniform quality umbrella to analytical site activities predicated on the concepts contained in the HASQARD. Using HASQARD will ensure data of known quality and technical defensibility of the methods used to obtain that data. The HASQARD is made up of four volumes: Volume 1, Administrative Requirements; Volume 2, Sampling Technical Requirements; Volume 3, Field Analytical Technical Requirements; and Volume 4, Laboratory Technical Requirements. Volume 1 describes the administrative requirements

General Quality Control (QC) Guidelines for SAM Methods

Science.gov (United States)

Learn more about quality control guidelines and recommendations for the analysis of samples using the methods listed in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

Examination of fast reactor fuels, FBR analytical quality assurance standards and methods, and analytical methods development: irradiation tests. Progress report, April 1--June 30, 1976, and FY 1976

International Nuclear Information System (INIS)

Baker, R.D.

1976-08-01

Characterization of unirradiated and irradiated LMFBR fuels by analytical chemistry methods will continue, and additional methods will be modified and mechanized for hot cell application. Macro- and microexaminations will be made on fuel and cladding using the shielded electron microprobe, emission spectrograph, radiochemistry, gamma scanner, mass spectrometers, and other analytical facilities. New capabilities will be developed in gamma scanning, analyses to assess spatial distributions of fuel and fission products, mass spectrometric measurements of burnup and fission gas constituents and other chemical analyses. Microstructural analyses of unirradiated and irradiated materials will continue using optical and electron microscopy and autoradiographic and x-ray techniques. Analytical quality assurance standards tasks are designed to assure the quality of the chemical characterizations necessary to evaluate reactor components relative to specifications. Tasks include: (1) the preparation and distribution of calibration materials and quality control samples for use in quality assurance surveillance programs, (2) the development of and the guidance in the use of quality assurance programs for sampling and analysis, (3) the development of improved methods of analysis, and (4) the preparation of continuously updated analytical method manuals. Reliable analytical methods development for the measurement of burnup, oxygen-to-metal (O/M) ratio, and various gases in irradiated fuels is described

Analytical quality control in studies of environmental exposure to mercury

International Nuclear Information System (INIS)

Byrne, A.R.; Prosenc, N.; Smerke, J.; Horvat, M.

1995-01-01

The work of the laboratory for quality control in this co-ordinated project for the period from November 1993 to June 1994 is presented. The major effort was devoted to assisting in establishing the homogeneity and total methylmercury levels in two new hair reference materials prepared as control materials for the project, numbered 085 (spiked) and 086 (natural level). Results for some hair materials from participants are also given. (author)

Chemical and physical quality control of the HIPPURAN-131I

International Nuclear Information System (INIS)

Morin Zorilla, J.; Olive, E.; Isaac, M.; Cruz, J.

1989-01-01

Some physico-chemical methods for analytical control of Hippuran- 131 I are compared. The most convenient to applicate in hospitals and in more specialized quality control laboratories are recommended. The quality of Hippuran- 131 I produced by ISOTOP (USSR) is also evaluated. The product met the requirement of the International Pharmacopeia

Educational intervention together with an on-line quality control program achieve recommended analytical goals for bedside blood glucose monitoring in a 1200-bed university hospital.

Science.gov (United States)

Sánchez-Margalet, Víctor; Rodriguez-Oliva, Manuel; Sánchez-Pozo, Cristina; Fernández-Gallardo, María Francisca; Goberna, Raimundo

2005-01-01

Portable meters for blood glucose concentrations are used at the patients bedside, as well as by patients for self-monitoring of blood glucose. Even though most devices have important technological advances that decrease operator error, the analytical goals proposed for the performance of glucose meters have been recently changed by the American Diabetes Association (ADA) to reach nurses in a 1200-bed University Hospital to achieve recommended analytical goals, so that we could improve the quality of diabetes care. We used portable glucose meters connected on-line to the laboratory after an educational program for nurses with responsibilities in point-of-care testing. We evaluated the system by assessing total error of the glucometers using high- and low-level glucose control solutions. In a period of 6 months, we collected data from 5642 control samples obtained by 14 devices (Precision PCx) directly from the control program (QC manager). The average total error for the low-level glucose control (2.77 mmol/l) was 6.3% (range 5.5-7.6%), and even lower for the high-level glucose control (16.66 mmol/l), at 4.8% (range 4.1-6.5%). In conclusion, the performance of glucose meters used in our University Hospital with more than 1000 beds not only improved after the intervention, but the meters achieved the analytical goals of the suggested ADA/National Academy of Clinical Biochemistry criteria for total error (<7.9% in the range 2.77-16.66 mmol/l glucose) and optimal total error for high glucose concentrations of <5%, which will improve the quality of care of our patients.

Quality management at the Safeguards Analytical Laboratory of IAEA

International Nuclear Information System (INIS)

Aigner, H.; Doherty, P.; Donohue, D.; Kuno, Y.

2001-01-01

Full text: In the year 2000, SAL'S quality management system was certified for conforming with the requirements of the international standard ISO-9002: 1994. The certification incurred considerable efforts, both in manpower and capital investments. The expected benefits of a formal quality management system do not directly target the correctness and reliability of analytical results. SAL believes that it was already performing well in this respect, even before re-shaping its quality system according to the reference model. Systematic QA and QC procedures have been applied since the begin of SAL'S operations in the mid-70's. The management framework specified in ISO-9002: 1994 complements these technical measures. Besides its value of being internationally recognised and thus enhancing perhaps the credibility in the quality of SAL'S services, the quality management system in this form provides additional advantages for the customer of the services of SAL, i.e. the Department of Safeguards of the IAEA, but also for the control and management of SAL'S internal 'business' processes. The paper discusses if these expected additional benefits are indeed obtained and whether or not their value is in balance with operational and initial investment costs. (author)

Micro-homogeneity of candidate reference materials: Results from an intercomparison study for the Analytical Quality Control Services (AQCS) of the IAEA

International Nuclear Information System (INIS)

Rossbach, M.; Kniewald, G.

2002-01-01

The IAEA Analytical Quality Control Services (AQCS) has made available two single cell algae materials IAEA-392 and IAEA-393 as well as an urban dust IAEA-396 to study their use for analytical sample sizes in the milligram range and below. Micro-analytical techniques such as PIXE and μ-PIXE, solid sampling AAS, scanning electron microprobe X-ray analysis and INAA were applied to the determination of trace elements on the basis of μg to mg amounts of the selected materials. The comparability of the mean values as well as the reproducibility of successive measurements is being evaluated in order to compare relative homogeneity factors for many elements in the investigated materials. From the reported results it seems that the algae materials IAEA-392 and IAEA-393 are extremely homogeneous biological materials for a number of elements with an extraordinary sharp particle size distribution below 10 μm. A similar situation seems to hold for the urban dust material IAEA-396 which had been air-jet milled to a particle size distribution around 4 μm. The introduction of these materials as CRMs with very small amounts needed to determine the certified concentrations will help to meet the needs of micro-analytical techniques for natural matrix reference materials. (author)

Pre-analytical and post-analytical evaluation in the era of molecular diagnosis of sexually transmitted diseases: cellularity control and internal control

Directory of Open Access Journals (Sweden)

Loria Bianchi

2014-06-01

Full Text Available Background. Increase of molecular tests performed on DNA extracted from various biological materials should not be carried out without an adequate standardization of the pre-analytical and post-analytical phase. Materials and Methods. Aim of this study was to evaluate the role of internal control (IC to standardize pre-analytical phase and the role of cellularity control (CC in the suitability evaluation of biological matrices, and their influence on false negative results. 120 cervical swabs (CS were pre-treated and extracted following 3 different protocols. Extraction performance was evaluated by amplification of: IC, added in each mix extraction; human gene HPRT1 (CC with RT-PCR to quantify sample cellularity; L1 region of HPV with SPF10 primers. 135 urine, 135 urethral swabs, 553 CS and 332 ThinPrep swabs (TP were tested for C. trachomatis (CT and U. parvum (UP with RT-PCR and for HPV by endpoint-PCR. Samples were also tested for cellularity. Results. Extraction protocol with highest average cellularity (Ac/sample showed lowest number of samples with inhibitors; highest HPV positivity was achieved by protocol with greatest Ac/PCR. CS and TP under 300.000 cells/sample showed a significant decrease of UP (P<0.01 and HPV (P<0.005 positivity. Female urine under 40.000 cells/mL were inadequate to detect UP (P<0.05. Conclusions. Our data show that IC and CC allow optimization of pre-analytical phase, with an increase of analytical quality. Cellularity/sample allows better sample adequacy evaluation, crucial to avoid false negative results, while cellularity/PCR allows better optimization of PCR amplification. Further data are required to define the optimal cut-off for result normalization.

A simple method for the quality control of [F-18]FDG

DEFF Research Database (Denmark)

Koziorowski, J.

2010-01-01

Most automated synthesis modules produce [F-18]FDG within half an hour, but the quality control involving up to three separate methods and three different analytical systems is time consuming. The use of HPLC, TLC, and GC for the quality control of [F-18]FDG is both time consuming and expensive...

A simple method for the quality control of [(18)F]FDG

DEFF Research Database (Denmark)

Koziorowski, J

2010-01-01

Most automated synthesis modules produce [(18)F]FDG within half an hour, but the quality control involving up to three separate methods and three different analytical systems is time consuming. The use of HPLC, TLC, and GC for the quality control of [(18)F]FDG is both time consuming and expensive...

Quality control for measurement of soil samples containing 237Np and 241Am as radiotracer

International Nuclear Information System (INIS)

Sha Lianmao; Zhang Caihong; Song Hailong; Ren Xiaona; Han Yuhu; Zhang Aiming; Chu Taiwei

2003-01-01

This paper reports quality control (QC) for the measurement of soil samples containing 237 Np and 241 Am as radiotracers in migration test of transuranic nuclides. All of the QC were done independently by the QA members of analytical work. It mainly included checking 5%-10% of the total analyzed samples; preparing blank samples, blind replicate sample and spiked samples used as quality control samples to check the quality of analytical work

Study of the analytic quality in the determinations of Cr, Fe, Mn, Cu, Zn, Pb and Hg through conventional and nuclear analytical techniques in mosses of the MATV

International Nuclear Information System (INIS)

Caballero S, B.

2013-01-01

To evaluate the environmental risks of air pollution and to facilitate the decision-making for control, is necessary to have the capacity to generate data with analytical quality. A comparison between nuclear (Neutron activation analysis and total reflection X-ray fluorescence spectrometry) and no nuclear analytical techniques (atomic absorption spectrometry and inductively coupled plasma optical emission spectrometry) for simultaneous determination of metal content (Cr, Cu, Fe, Hg, Mn, Pb and Zn) in mosses from Metropolitan Area of the Toluca Valley (MATV) was performed. Epiphytic mosses (Fabriona ciliaris and Leskea angustata) were sampled in two campaigns, 16 sites (urban, transition and natural) and were prepared for each technique. The biological certified reference materials were used for the quality control and to evaluate accuracy, precision, linearity, detection and quantification limits. Results show that nuclear analytical techniques and no nuclear applied in chemical analysis of Cr, Cu, Fe, Hg, Mn, Pb and Zn in moss from MATV are comparable and therefore all of these can potentially be used for this purpose. However, if its considered both, the performance parameters and economic/operational characteristics is widely recommended inductively coupled plasma optical emission spectrometry, conventional analytical technique, which showed the highest analytical grade quality. Also were observed spatial and temporal variations in the concentrations of Cr, Cu, Fe, Hg, Mn, Pb and Zn in mosses from MATV and was discussed its potential origin. The urban sites had the highest concentration of anthropogenic elements as Cr, Cu, Fe, Hg, Pb and Zn because are strongly impacted by roads with high vehicle traffic. (Author)

Quality control and analysis of radiotracer compounds

International Nuclear Information System (INIS)

Sheppard, G.; Thomson, R.

1977-01-01

Special emphasis was on the problems and errors possible in quality control and analysis. The principles underlying quality control were outlined, and analytical techniques applicable to radiotracers were described. Chapter concluded with a selection of examples showing the effects of impurities on the use of radiotracers. The subject of quality control and analysis was treated from the viewpoint of the user and those research workers who need to synthesize and analyze their own radiochemicals. The quality characteristics for radiotracers are of two kinds, valuable or attributive. These were discussed in the chapter. For counting low radioactive concentration, scintillation techniques are in general use, whereas ionization techniques are now used mainly for the measurement of high radioactive concentrations or large quantities of radioactivity, for scanning chromatograms, and a number of very specific purposes. Determination of radionuclidic purity was discussed. Use of radiotracers in pharmaceuticals were presented. 4 figures, 6 tables

Regional programme on quality control of radioimmunoassay: Development of human resources and external quality assessments

International Nuclear Information System (INIS)

Quiroga, S.; Torres, M.; Mendizabal, A.F.; Farinati, Z.; Galanternik, A.

1986-01-01

Since 1978 the authors have been concerned with helping to standardize radioimmunoassay (RIA) methodology in Argentina and other Latin American countries by: (1) developing human resources through courses on quality control of RIA and training of fellows, and (2) developing four external quality assessment (EQA) schemes to evaluate the performance of laboratories in determining several analytes by RIA. The number of collaborating laboratories increased between the first and fourth schemes. The average analytical performance achieved by the participants in each scheme was estimated by the average between-laboratory variation. Thyroxine, cortisol and tri-iodothyronine were measured the most accurately. Different problems were evident in the RIAs of thyrotrophin, luteinizing hormone, follicle stimulating hormone, prolactin, testosterone, progesterone, cortisol, immunoglobulin E and human growth hormone. RIA of oestradiol showed the worst accuracy. Analysis of the results showed an increasing interest in RIA quality control as it was found to improve the reliability of RIA. (author)

Process Analytical Technology and On-Line Spectroscopic Measurements of Chemical Meat Quality

DEFF Research Database (Denmark)

Sørensen, Klavs Martin

This thesis deals with process analytical technology and how it can be implemented in the meat industry through on-line grading of chemical meat quality. The focus will be on two applications, namely the rapid quality control of fat quality and the development of a method for on-line detection...... of nano-molar quantification in few seconds, in addition to an accelerated extraction-free GC-MS method that through automation can deliver results much faster than other similar methods. The implementation of these high tech methods will provide the meat industry with a leading edge not only with product...... of boar taint. The chemical makeup of fat has a large effect on meat cut quality. Fat quality has traditionally been determined by methylation of a tissue sample followed by chromatography on a GC-MS system, elucidating the composition of the individual fatty acids. As this procedure typically takes far...

New Analytical Monographs on TCM Herbal Drugs for Quality Proof.

Science.gov (United States)

Wagner, Hildebert; Bauer, Rudolf; Melchart, Dieter

2016-01-01

Regardless of specific national drug regulations there is an international consensus that all TCM drugs must meet stipulated high quality standards focusing on authentication, identification and chemical composition. In addition, safety of all TCM drugs prescribed by physicians has to be guaranteed. During the 25 years history of the TCM hospital Bad Kötzting, 171 TCM drugs underwent an analytical quality proof including thin layer as well as high pressure liquid chromatography. As from now mass spectroscopy will also be available as analytical tool. The findings are compiled and already published in three volumes of analytical monographs. One more volume will be published shortly, and a fifth volume is in preparation. The main issues of the analytical procedure in TCM drugs like authenticity, botanical nomenclature, variability of plant species and parts as well as processing are pointed out and possible ways to overcome them are sketched. © 2016 S. Karger GmbH, Freiburg.

Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities.

Science.gov (United States)

Orlandini, Serena; Pasquini, Benedetta; Caprini, Claudia; Del Bubba, Massimo; Pinzauti, Sergio; Furlanetto, Sandra

2015-11-01

A fast and selective CE method for the determination of zolmitriptan (ZOL) and its five potential impurities has been developed applying the analytical Quality by Design principles. Voltage, temperature, buffer concentration, and pH were investigated as critical process parameters that can influence the critical quality attributes, represented by critical resolution values between peak pairs, analysis time, and peak efficiency of ZOL-dimer. A symmetric screening matrix was employed for investigating the knowledge space, and a Box-Behnken design was used to evaluate the main, interaction, and quadratic effects of the critical process parameters on the critical quality attributes. Contour plots were drawn highlighting important interactions between buffer concentration and pH, and the gained information was merged into the sweet spot plots. Design space (DS) was established by the combined use of response surface methodology and Monte Carlo simulations, introducing a probability concept and thus allowing the quality of the analytical performances to be assured in a defined domain. The working conditions (with the interval defining the DS) were as follows: BGE, 138 mM (115-150 mM) phosphate buffer pH 2.74 (2.54-2.94); temperature, 25°C (24-25°C); voltage, 30 kV. A control strategy was planned based on method robustness and system suitability criteria. The main advantages of applying the Quality by Design concept consisted of a great increase of knowledge of the analytical system, obtained throughout multivariate techniques, and of the achievement of analytical assurance of quality, derived by probability-based definition of DS. The developed method was finally validated and applied to the analysis of ZOL tablets. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Program Performance Assessment System (PPAS). External reviewers' report of the consultants' meeting on analytical quality control services

International Nuclear Information System (INIS)

2001-01-01

In reviewing the recommendations of previous Consultants' Meetings concerning the AQCS program, it is apparent that there has been a clear and consistent agreement on what the objectives of the AQCS activities should be. The mission statement as given in the Agency's 'Blue Book 1997-1998' states 'To assist analytical laboratories in Member States in maintaining/improving the quality of their analytical measurements, to achieve internationally acceptable levels of quality assurance and to develop and supply appropriate reference standards to achieve these objectives'. In concert with this mission statement, the consultants have endorsed an elaboration of these objectives for both the Agency' s laboratories and Member State laboratories as outlined in the 1994 Consultants' Report (KONA, HI, USA) which includes: the improvement of the reliability of results for the intended purposes; the enhancement of the comparability of results from one measurement laboratory to another; the attainment of compatibility of results in physical and chemical sciences with specific coverage of international standards for food and agriculture, human health, environment, industry, earth sciences, radiation safety, and safeguards activities; the demonstration of quality measurement systems sufficient for laboratory/analyst accreditation or acceptance, and; the establishment of traceability of radioactivity measurements and chemical analyses to the international SI system of measurements

Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control.

Science.gov (United States)

Westgard, James O; Westgard, Sten A

2017-03-01

Six sigma concepts provide a quality management system (QMS) with many useful tools for managing quality in medical laboratories. This Six Sigma QMS is driven by the quality required for the intended use of a test. The most useful form for this quality requirement is the allowable total error. Calculation of a sigma-metric provides the best predictor of risk for an analytical examination process, as well as a design parameter for selecting the statistical quality control (SQC) procedure necessary to detect medically important errors. Simple point estimates of sigma at medical decision concentrations are sufficient for laboratory applications. Copyright © 2016 Elsevier Inc. All rights reserved.

The Effects of Mindfulness-Based Interventions on Diabetes-Related Distress, Quality of Life, and Metabolic Control Among Persons with Diabetes: A Meta-Analytic Review.

Science.gov (United States)

Bogusch, Leah M; O'Brien, William H

2018-04-04

Mindfulness-based interventions (MBIs) have improved psychological outcomes for multiple chronic health conditions, including diabetes. A meta-analytic review of the literature was conducted on all located studies (n = 14) investigating MBIs that targeted diabetes-related distress (DRD) and diabetes-related outcomes among people with Type 1 and Type 2 diabetes. PsychInfo, PubMed, Medline, and Web of Science were searched for MBIs that were designed to improve DRD and other secondary outcomes, including quality of life and measures of metabolic control. A meta-analysis of these outcomes uncovered small-to-moderate effect sizes for intervention studies measuring pretreatment to posttreatment changes in DRD and metabolic control among treatment group participants. However, the pretreatment to follow-up comparisons for DRD and metabolic control were small and unreliable. For control groups, all pre-treatment to post-treatment and pre-treatment to follow-up comparisons were unreliable for all outcomes. A moderate effect size for treatment-control comparisons was found for intervention studies measuring quality of life outcomes at posttreatment, but not at follow-up comparisons. All other effect sizes for treatment-control comparisons were unreliable. Limitations and implications for MBIs among individuals with diabetes are discussed.

Analytical performance specifications for external quality assessment - definitions and descriptions.

Science.gov (United States)

Jones, Graham R D; Albarede, Stephanie; Kesseler, Dagmar; MacKenzie, Finlay; Mammen, Joy; Pedersen, Morten; Stavelin, Anne; Thelen, Marc; Thomas, Annette; Twomey, Patrick J; Ventura, Emma; Panteghini, Mauro

2017-06-27

External Quality Assurance (EQA) is vital to ensure acceptable analytical quality in medical laboratories. A key component of an EQA scheme is an analytical performance specification (APS) for each measurand that a laboratory can use to assess the extent of deviation of the obtained results from the target value. A consensus conference held in Milan in 2014 has proposed three models to set APS and these can be applied to setting APS for EQA. A goal arising from this conference is the harmonisation of EQA APS between different schemes to deliver consistent quality messages to laboratories irrespective of location and the choice of EQA provider. At this time there are wide differences in the APS used in different EQA schemes for the same measurands. Contributing factors to this variation are that the APS in different schemes are established using different criteria, applied to different types of data (e.g. single data points, multiple data points), used for different goals (e.g. improvement of analytical quality; licensing), and with the aim of eliciting different responses from participants. This paper provides recommendations from the European Federation of Laboratory Medicine (EFLM) Task and Finish Group on Performance Specifications for External Quality Assurance Schemes (TFG-APSEQA) and on clear terminology for EQA APS. The recommended terminology covers six elements required to understand APS: 1) a statement on the EQA material matrix and its commutability; 2) the method used to assign the target value; 3) the data set to which APS are applied; 4) the applicable analytical property being assessed (i.e. total error, bias, imprecision, uncertainty); 5) the rationale for the selection of the APS; and 6) the type of the Milan model(s) used to set the APS. The terminology is required for EQA participants and other interested parties to understand the meaning of meeting or not meeting APS.

Analytical control in metallurgical processes

International Nuclear Information System (INIS)

Coedo, A.G.; Dorado, M.T.; Padilla, I.

1998-01-01

This paper illustrates the role of analysis in enabling metallurgical industry to meet quality demands. For example, for the steel industry the demands by the automotive, aerospace, power generation, tinplate packaging industries and issue of environment near steel plants. Although chemical analysis technology continues to advance, achieving improved speed, precision and accuracy at lower levels of detection, the competitiveness of manufacturing industry continues to drive property demands at least at the same rate. Narrower specification ranges, lower levels of residual elements and economic pressures prescribe faster process routes, all of which lead to increased demands on the analytical function. These damands are illustrated by examples from several market sectors in which customer issues are considered together with ther analytical implications. (Author) 5 refs

ANALYTICAL SYNTHESIS OF CHEMICAL REACTOR CONTROL SYSTEM

Directory of Open Access Journals (Sweden)

Alexander Labutin

2017-02-01

Full Text Available The problem of the analytical synthesis of the synergetic control system of chemical reactor for the realization of a complex series-parallel exothermal reaction has been solved. The synthesis of control principles is performed using the analytical design method of aggregated regulators. Synthesized nonlinear control system solves the problem of stabilization of the concentration of target component at the exit of reactor and also enables one to automatically transfer to new production using the equipment.

[Discussion on Quality Evaluation Method of Medical Device During Life-Cycle in Operation Based on the Analytic Hierarchy Process].

Science.gov (United States)

Zheng, Caixian; Zheng, Kun; Shen, Yunming; Wu, Yunyun

2016-01-01

The content related to the quality during life-cycle in operation of medical device includes daily use, repair volume, preventive maintenance, quality control and adverse event monitoring. In view of this, the article aims at discussion on the quality evaluation method of medical devices during their life cycle in operation based on the Analytic Hierarchy Process (AHP). The presented method is proved to be effective by evaluating patient monitors as example. The method presented in can promote and guide the device quality control work, and it can provide valuable inputs to decisions about purchase of new device.

Internal quality control: planning and implementation strategies.

Science.gov (United States)

Westgard, James O

2003-11-01

The first essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating specifications. Finally, a total QC strategy is formulated to minimize cost and maximize quality. A general strategy for IQC implementation is recommended that employs a three-stage design in which the first stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.

Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?--A pilot study and a proposal.

Science.gov (United States)

Jassam, Nuthar; Yundt-Pacheco, John; Jansen, Rob; Thomas, Annette; Barth, Julian H

2013-08-01

The implementation of national and international guidelines is beginning to standardise clinical practice. However, since many guidelines have decision limits based on laboratory tests, there is an urgent need to ensure that different laboratories obtain the same analytical result on any sample. A scientifically-based quality control process will be a pre-requisite to provide this level of analytical performance which will support evidence-based guidelines and movement of patients across boundaries while maintaining standardised outcomes. We discuss the finding of a pilot study performed to assess UK clinical laboratories readiness to work to a higher grade quality specifications such as biological variation-based quality specifications. Internal quality control (IQC) data for HbA1c, glucose, creatinine, cholesterol and high density lipoprotein (HDL)-cholesterol were collected from UK laboratories participating in the Bio-Rad Unity QC programme. The median of the coefficient of variation (CV%) of the participating laboratories was evaluated against the CV% based on biological variation. Except creatinine, the other four analytes had a variable degree of compliance with the biological variation-based quality specifications. More than 75% of the laboratories met the biological variation-based quality specifications for glucose, cholesterol and HDL-cholesterol. Slightly over 50% of the laboratories met the analytical goal for HBA1c. Only one analyte (cholesterol) had a performance achieving the higher quality specifications consistent with 5σ. Our data from IQC do not consistently demonstrate that the results from clinical laboratories meet evidence-based quality specifications. Therefore, we propose that a graded scale of quality specifications may be needed at this stage.

Application of quality improvement analytic methodology in emergency medicine research: A comparative evaluation.

Science.gov (United States)

Harries, Bruce; Filiatrault, Lyne; Abu-Laban, Riyad B

2018-05-30

Quality improvement (QI) analytic methodology is rarely encountered in the emergency medicine literature. We sought to comparatively apply QI design and analysis techniques to an existing data set, and discuss these techniques as an alternative to standard research methodology for evaluating a change in a process of care. We used data from a previously published randomized controlled trial on triage-nurse initiated radiography using the Ottawa ankle rules (OAR). QI analytic tools were applied to the data set from this study and evaluated comparatively against the original standard research methodology. The original study concluded that triage nurse-initiated radiographs led to a statistically significant decrease in mean emergency department length of stay. Using QI analytic methodology, we applied control charts and interpreted the results using established methods that preserved the time sequence of the data. This analysis found a compelling signal of a positive treatment effect that would have been identified after the enrolment of 58% of the original study sample, and in the 6th month of this 11-month study. Our comparative analysis demonstrates some of the potential benefits of QI analytic methodology. We found that had this approach been used in the original study, insights regarding the benefits of nurse-initiated radiography using the OAR would have been achieved earlier, and thus potentially at a lower cost. In situations where the overarching aim is to accelerate implementation of practice improvement to benefit future patients, we believe that increased consideration should be given to the use of QI analytic methodology.

Visual analytics in medical education: impacting analytical reasoning and decision making for quality improvement.

Science.gov (United States)

Vaitsis, Christos; Nilsson, Gunnar; Zary, Nabil

2015-01-01

The medical curriculum is the main tool representing the entire undergraduate medical education. Due to its complexity and multilayered structure it is of limited use to teachers in medical education for quality improvement purposes. In this study we evaluated three visualizations of curriculum data from a pilot course, using teachers from an undergraduate medical program and applying visual analytics methods. We found that visual analytics can be used to positively impacting analytical reasoning and decision making in medical education through the realization of variables capable to enhance human perception and cognition on complex curriculum data. The positive results derived from our evaluation of a medical curriculum and in a small scale, signify the need to expand this method to an entire medical curriculum. As our approach sustains low levels of complexity it opens a new promising direction in medical education informatics research.

Mussel tissue (T-31) - A new analytical quality control material for the determination of mercury and arsenic in mussels

Energy Technology Data Exchange (ETDEWEB)

Gawlik, B. [Joint Research Centre Ispra, Ispra, Varese (Italy). Environment Institute]|[Muenchen, Technische Universitaet (Germany). Lehrstuhl fuer Oekologische Chemie und Umweltanalytik; Druges, M. [Thomson Microelectronics, Crolles (France); Bianchi, M.; Muntau, H. [Joint Research Centre Ispra, Ispra, Varese (Italy). Environment Institute; Bortoli, A. [ULSS 12, Venice (Italy). Presidio Multizonale di Prevenzione; Kettrup, A. [Muenchen, Technische Universitaet (Germany). Lehrstuhl fur Oekologische Chemie und Umweltanalytik]|[GSF Forschungszentrum fuer Umwelt und Gesundheit, Oberschleissheim (Germany). Inst. fuer Oekologische Chemie

1998-05-01

The use of filter-feeding molluscs for the monitoring of selected contaminant levels in the marine environment is well-known in the scientific community. In the order to assure the quality of those analysis and to prepare laboratories for accreditation procedures certified reference materials and proficiency testing campaigns were introduced. However, there is still a need for the introduction of suitable analytical quality materials of high quality which can be used on a daily basis. This paper therefore describes the preparation of a mussel tissue material for the internal quality control of Hg and As analysis in bivalves, as well as the principle of preparation and the analytical characterisation of such a material. The total concentration for arsenic (8.98 {+-} 0.67 {mu}g/g) and mercury (0.169 {+-} 0.005 {mu}g/g) was determined by the use of different techniques. Additionally, indicative values for major constituents (C, H, N, Na, Cl, P, S, K, Mg, Ca, Si, Fe, Al, Br, Zn, Sr) and some trace elements (Cu, Cd, Pb, Ni) were measured. [Italiano] L`uso di molluschi filtratori nel monitoraggio dei livelli di contaminazione in ambiente marino e` ben noto in ambito scientifico. Per assicurare la qualita` di queste analisi e preparare i laboratori alle procedure di accreditamento e stato introdotto l`uso di materiali di riferimento certificati accoppiato alla partecipazione a campagne di controllo interlaboratoriale. Attualmente non sono ancora disponibili materiali di riferimento appropriati e di alta qualita`, che possano essere usati su base quotidiana. Questo lavoro descrive la preparazione di un materiale di riferimanto di cozze da usare come mezzo di controllo di qualita` interna e i principi di preparazione e di caratterizzazione analitica di un materiale di questo tipo. La concentrazione totale dell`arsenico (8.98 {+-} 0.67 {mu}g/g) e del mercurio (0.169 {+-} 0.005 {mu}g/g) sono state determinati mediante l`uso di differenti tecniche. Sono stati in oltre misurati

Development of Quality Control Method for Glucofarmaka Antidiabetic Jamu by HPLC Fingerprint Analysis

Directory of Open Access Journals (Sweden)

Hanifullah Habibie

2017-04-01

Full Text Available Herbal medicines become increasingly popular all over the world for preventive and therapeutic purposes. Quality control of herbal medicines is important to make sure their safety and efficacy. Chromatographic fingerprinting has been accepted by the World Health Organization as one reliable strategy for quality control method in herbal medicines. In this study, high-performance liquid chromatography fingerprint analysis was developed as a quality control method for glucofarmaka antidiabetic jamu. The optimum fingerprint chromatogram were obtained using C18 as the stationary phase and linear gradient elution using 10–95% acetonitrile:water as the mobile phase within 60 minutes of elution and detection at 210 nm. About 20 peaks were detected and could be used as fingerprint of glucofarmaka jamu. To evaluate the analytical performance of the method, we determined the precision, reproducibility, and stability. The result of the analytical performance showed reliable results. The proposed method could be used as a quality control method for glucofarmaka antidiabetic jamu and also for its raw materials.

HPTLC Fingerprint Analysis: A Quality Control for Authentication of Herbal Phytochemicals

Science.gov (United States)

Ram, Mauji; Abdin, M. Z.; Khan, M. A.; Jha, Prabhakar

Authentication and consistent quality are the basic requirement for Indian traditional medicine (TIM), Chinese traditional herbal medicine (TCHM), and their commercial products, regardless of the kind of research conducted to modernize the TIM and TCHM. The complexities of TIM and TCHM challenge the current official quality control mode, for which only a few biochemical markers were selected for identification and quantitative assay. Referring too many unknown factors existed in TIM and TCHM, it is impossible and unnecessary to pinpoint qualitatively and quantitatively every single component contained in the herbal drug. Chromatographic fingerprint is a rational option to meet the need for more effective and powerful quality assessment to TIM and TCHM. The optimized chromatographic fingerprint is not only an alternative analytical tool for authentication, but also an approach to express the various pattern of chemical ingredients distribution in the herbal drugs and preserve such "database" for further multifaced sustainable studies. Analytical separation techniques, for example, high-performance liquid chromatography (HPLC), gas chromatography (GC) and mass spectrometry (MS) were among the most popular methods of choice used for quality control of raw material and finished herbal product. Fingerprint analysis approach using high-performance thin-layer chromatography (HPTLC) has become the most potent tool for quality control of herbal medicines because of its simplicity and reliability. It can serve as a tool for identification, authentication, and quality control of herbal drugs. In this chapter, attempts are being made to expand the use of HPTLC and at the same time create interest among prospective researcher in herbal analysis. The developed method can be used as a quality control tool for rapid authentication from a wide variety of herbal samples. Some examples demonstrated the role of fingerprinting in quality control and assessment.

Analytical performance, reference values and decision limits. A need to differentiate between reference intervals and decision limits and to define analytical quality specifications

DEFF Research Database (Denmark)

Petersen, Per Hyltoft; Jensen, Esther A; Brandslund, Ivan

2012-01-01

of the values of analytical components measured on reference samples from reference individuals. Decision limits are based on guidelines from national and international expert groups defining specific concentrations of certain components as limits for decision about diagnosis or well-defined specific actions....... Analytical quality specifications for reference intervals have been defined for bias since the 1990s, but in the recommendations specified in the clinical guidelines analytical quality specifications are only scarcely defined. The demands for negligible biases are, however, even more essential for decision...... limits, as the choice is no longer left to the clinician, but emerge directly from the concentration. Even a small bias will change the number of diseased individuals, so the demands for negligible biases are obvious. A view over the analytical quality as published gives a variable picture of bias...

Assurance and control of quality in trace element analysis

International Nuclear Information System (INIS)

Heinonen, J.

1979-01-01

The study demonstrates in practice the assurance and control of the quality of results from trace analysis in biological materials. The performance of three analytical methods is studied: one involving the determination of Cs and two the determination of As by neutron activation techniques in biological materials at the natural background level. In the case of Cs, the validity of the analytical procedure was investigated by the means available in the laboratory of the Institute and by utilizing the specific properties of the determinant. In the establishment and control of accuracy, the analysis of precision was essential. The investigation of the two different methods applied for the determination of arsenic demonstrates the many problems connected with trace analysis. For the control of accuracy a number of different kinds of reference materials (RMs) were used, namely four former intercomparison materials of the IAEA and two certified RMs of the NBS. The various tests performed revealed two different types of systematic errors. The scheme applied for the long-term surveillance of systematic and random errors is found to be suitable for the continuous control of quality of results from routine analysis. (author)

A Visual Analytics Approach for Station-Based Air Quality Data

Directory of Open Access Journals (Sweden)

Yi Du

2016-12-01

Full Text Available With the deployment of multi-modality and large-scale sensor networks for monitoring air quality, we are now able to collect large and multi-dimensional spatio-temporal datasets. For these sensed data, we present a comprehensive visual analysis approach for air quality analysis. This approach integrates several visual methods, such as map-based views, calendar views, and trends views, to assist the analysis. Among those visual methods, map-based visual methods are used to display the locations of interest, and the calendar and the trends views are used to discover the linear and periodical patterns. The system also provides various interaction tools to combine the map-based visualization, trends view, calendar view and multi-dimensional view. In addition, we propose a self-adaptive calendar-based controller that can flexibly adapt the changes of data size and granularity in trends view. Such a visual analytics system would facilitate big-data analysis in real applications, especially for decision making support.

A Visual Analytics Approach for Station-Based Air Quality Data.

Science.gov (United States)

Du, Yi; Ma, Cuixia; Wu, Chao; Xu, Xiaowei; Guo, Yike; Zhou, Yuanchun; Li, Jianhui

2016-12-24

With the deployment of multi-modality and large-scale sensor networks for monitoring air quality, we are now able to collect large and multi-dimensional spatio-temporal datasets. For these sensed data, we present a comprehensive visual analysis approach for air quality analysis. This approach integrates several visual methods, such as map-based views, calendar views, and trends views, to assist the analysis. Among those visual methods, map-based visual methods are used to display the locations of interest, and the calendar and the trends views are used to discover the linear and periodical patterns. The system also provides various interaction tools to combine the map-based visualization, trends view, calendar view and multi-dimensional view. In addition, we propose a self-adaptive calendar-based controller that can flexibly adapt the changes of data size and granularity in trends view. Such a visual analytics system would facilitate big-data analysis in real applications, especially for decision making support.

A tiered analytical approach for investigating poor quality emergency contraceptives.

Directory of Open Access Journals (Sweden)

María Eugenia Monge

Full Text Available Reproductive health has been deleteriously affected by poor quality medicines. Emergency contraceptive pills (ECPs are an important birth control method that women can use after unprotected coitus for reducing the risk of pregnancy. In response to the detection of poor quality ECPs commercially available in the Peruvian market we developed a tiered multi-platform analytical strategy. In a survey to assess ECP medicine quality in Peru, 7 out of 25 different batches showed inadequate release of levonorgestrel by dissolution testing or improper amounts of active ingredient. One batch was found to contain a wrong active ingredient, with no detectable levonorgestrel. By combining ultrahigh performance liquid chromatography-ion mobility spectrometry-mass spectrometry (UHPLC-IMS-MS and direct analysis in real time MS (DART-MS the unknown compound was identified as the antibiotic sulfamethoxazole. Quantitation by UHPLC-triple quadrupole tandem MS (QqQ-MS/MS indicated that the wrong ingredient was present in the ECP sample at levels which could have significant physiological effects. Further chemical characterization of the poor quality ECP samples included the identification of the excipients by 2D Diffusion-Ordered Nuclear Magnetic Resonance Spectroscopy (DOSY 1H NMR indicating the presence of lactose and magnesium stearate.

The Significance of Attachment Quality for Obesity : A Meta-Analytic Review

NARCIS (Netherlands)

Diener, Marc J.; Geenen, Rinie; Koelen, Jurrijn A.; Aarts, Floor; Gerdes, Victor E. A.; Brandjes, Dees P. M.; Hinnen, Chris

2016-01-01

Theoretical considerations and empirical results suggest that attachment quality is relevant to obesity. This study used meta-analytic methods to systematically examine the empirical, peer-reviewed evidence regarding the relationship between attachment quality and body mass index (BMI) in separate

Application of Six Sigma Model to Evaluate the Analytical Quality of Four HbA1c Analyzers.

Science.gov (United States)

Maesa, Jos Eacute M; Fern Aacute Ndez-Riejos, Patricia; S Aacute Nchez-Mora, Catalina; Toro-Crespo, Mar Iacute A De; Gonz Aacute Lez-Rodriguez, Concepci Oacute N

2017-01-01

The Six Sigma Model is a global quality management system applicable to the determination of glycated hemoglobin (HbA1c). In addition, this model can ensure the three characteristics influencing the patient risk: the correct performance of the analytical method with low inaccuracy and bias, the quality control strategy used by the laboratory, and the necessary quality of the analyte. The aim of this study is to use the Six Sigma Model for evaluating quality criteria in the determination of glycated hemoglobin HbA1c and its application to assess four different HbA1c analyzers. Four HbA1c analyzers were evaluated: HA-8180V®, D-100®, G8®, and Variant II Turbo®. For 20 consecutive days, two levels of quality control (high and low) provided by the manufacturers were measured in each of the instruments. Imprecision (CV), bias, and Sigma values (σ) were calculated with the data obtained and a method decision chart was developed considering a range of quality requirements (allowable total error, TEa). For a TEa = 3%, HA-8180V = 1.54 σ, D-100 = 1.63 σ, G8 = 2.20 σ, and Variant II Turbo = -0.08 σ. For a TEa = 4%, HA-8180V = 2.34 σ, D-100 = 2.32 σ, G8 = 3.74 σ, and Variant II Turbo = 0.16 σ. For a TEa = 10%, HA8180V = 7.12 σ, D-100 = 6.46 σ, G8 = 13.0 σ, and Variant II Turbo = 1.56 σ. Applying the Stockholm consensus and its subsequent Milan review to the results: the maximum level in quality requirements for HbA1c is an allowable total error (TEa) = 3%, G8 is located in region 2 σ (2.20), which is a poor result, and HA-8180V and D-100 are both in region 1 σ (1.54 and 1.63, respectively), which is an unacceptable analytical performance.

Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing.

Science.gov (United States)

Lester, Sally; Harr, K E; Rishniw, Mark; Pion, Paul

2013-01-15

Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

MapReduce Based Parallel Bayesian Network for Manufacturing Quality Control

Science.gov (United States)

Zheng, Mao-Kuan; Ming, Xin-Guo; Zhang, Xian-Yu; Li, Guo-Ming

2017-09-01

Increasing complexity of industrial products and manufacturing processes have challenged conventional statistics based quality management approaches in the circumstances of dynamic production. A Bayesian network and big data analytics integrated approach for manufacturing process quality analysis and control is proposed. Based on Hadoop distributed architecture and MapReduce parallel computing model, big volume and variety quality related data generated during the manufacturing process could be dealt with. Artificial intelligent algorithms, including Bayesian network learning, classification and reasoning, are embedded into the Reduce process. Relying on the ability of the Bayesian network in dealing with dynamic and uncertain problem and the parallel computing power of MapReduce, Bayesian network of impact factors on quality are built based on prior probability distribution and modified with posterior probability distribution. A case study on hull segment manufacturing precision management for ship and offshore platform building shows that computing speed accelerates almost directly proportionally to the increase of computing nodes. It is also proved that the proposed model is feasible for locating and reasoning of root causes, forecasting of manufacturing outcome, and intelligent decision for precision problem solving. The integration of bigdata analytics and BN method offers a whole new perspective in manufacturing quality control.

Median of patient results as a tool for assessment of analytical stability

DEFF Research Database (Denmark)

Jørgensen, Lars Mønster; Hansen, Steen Ingemann; Petersen, Per Hyltoft

2015-01-01

BACKGROUND: In spite of the well-established external quality assessment and proficiency testing surveys of analytical quality performance in laboratory medicine, a simple tool to monitor the long-term analytical stability as a supplement to the internal control procedures is often needed. METHOD......: Patient data from daily internal control schemes was used for monthly appraisal of the analytical stability. This was accomplished by using the monthly medians of patient results to disclose deviations from analytical stability, and by comparing divergences with the quality specifications for allowable...... analytical bias based on biological variation. RESULTS: Seventy five percent of the twenty analytes achieved on two COBASs INTEGRA 800 instruments performed in accordance with the optimum and with the desirable specifications for bias. DISCUSSION: Patient results applied in analytical quality performance...

How to conduct External Quality Assessment Schemes for the pre-analytical phase?

Science.gov (United States)

Kristensen, Gunn B B; Aakre, Kristin Moberg; Kristoffersen, Ann Helen; Sandberg, Sverre

2014-01-01

In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.

Application of Sigma Metrics Analysis for the Assessment and Modification of Quality Control Program in the Clinical Chemistry Laboratory of a Tertiary Care Hospital.

Science.gov (United States)

Iqbal, Sahar; Mustansar, Tazeen

2017-03-01

Sigma is a metric that quantifies the performance of a process as a rate of Defects-Per-Million opportunities. In clinical laboratories, sigma metric analysis is used to assess the performance of laboratory process system. Sigma metric is also used as a quality management strategy for a laboratory process to improve the quality by addressing the errors after identification. The aim of this study is to evaluate the errors in quality control of analytical phase of laboratory system by sigma metric. For this purpose sigma metric analysis was done for analytes using the internal and external quality control as quality indicators. Results of sigma metric analysis were used to identify the gaps and need for modification in the strategy of laboratory quality control procedure. Sigma metric was calculated for quality control program of ten clinical chemistry analytes including glucose, chloride, cholesterol, triglyceride, HDL, albumin, direct bilirubin, total bilirubin, protein and creatinine, at two control levels. To calculate the sigma metric imprecision and bias was calculated with internal and external quality control data, respectively. The minimum acceptable performance was considered as 3 sigma. Westgard sigma rules were applied to customize the quality control procedure. Sigma level was found acceptable (≥3) for glucose (L2), cholesterol, triglyceride, HDL, direct bilirubin and creatinine at both levels of control. For rest of the analytes sigma metric was found control levels (8.8 and 8.0 at L2 and L3, respectively). We conclude that analytes with the sigma value quality control procedure. In this study application of sigma rules provided us the practical solution for improved and focused design of QC procedure.

Assessment report for Hanford analytical services quality assurance plan

International Nuclear Information System (INIS)

Taylor, L.H.

1994-11-01

This report documents the assessment results of DOE/RL-94-55, Hanford Analytical Services Quality Assurance Plan. The assessment was conducted using the Requirement and Self-Assessment Database (RSAD), which contains mandatory and nonmandatory DOE Order statements for the relevant DOE orders

IAEA analytical quality assurance programmes to meet the present and future needs of developing countries

International Nuclear Information System (INIS)

Parr, R.M.; Fajgelj, A.; Dekner, R.; Vera Ruiz, H.; Carvalho, F.P.; Povinec, P.P.

1998-01-01

For many years the International Atomic Energy Agency (IAEA) has been promoting analytical quality assurance and quality control in its Member States with emphasis on measurands that are amenable to analysis by nuclear and related techniques, i.e. radionuclides, trace elements, and stable isotopes. This paper reviews briefly the rationale for some of these activities, particularly in relation to the needs of participants in developing countries arising out of co-ordinated research programmes, technical co-operation projects and global and regional networks. Emphasis is given to biological and environmental reference materials with a matrix of natural origin. Also described are some activities arising out of the requirements of ISO-25 and other relevant international quality standards. (orig.)

Quality specification and status of internal quality control of cardiac biomarkers in China from 2011 to 2016.

Science.gov (United States)

Li, Tingting; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2017-09-07

This study aimed to investigate the status of internal quality control (IQC) for cardiac biomarkers from 2011 to 2016 so that we can have overall knowledge of the precision level of measurements in China and set appropriate precision specifications. Internal quality control data of cardiac biomarkers, including creatinine kinase MB (CK-MB) (μg/L), CK-MB(U/L), myoglobin (Mb), cardiac troponin I (cTnI), cardiac troponin T (cTnT), and homocysteines (HCY), were collected by a web-based external quality assessment (EQA) system. Percentages of laboratories meeting five precision quality specifications for current coefficient of variations (CVs) were calculated. Then, appropriate precision specifications were chosen for these six analytes. Finally, the CVs and IQC practice were further analyzed with different grouping methods. The current CVs remained nearly constant for 6 years. cTnT had the highest pass rates every year against five specifications, whereas HCY had the lowest pass rates. Overall, most analytes had a satisfactory performance (pass rates >80%), except for HCY, if one-third TEa or the minimum specification were employed. When the optimal specification was applied, the performance of most analytes was frustrating (pass rates < 60%) except for cTnT. The appropriate precision specifications of Mb, cTnI, cTnT and HCY were set as current CVs less than 9.20%, 9.90%, 7.50%, 10.54%, 7.63%, and 6.67%, respectively. The data of IQC practices indicated wide variation and substantial progress. The precision performance of cTnT was already satisfying, while the other five analytes, especially HCY, were still frustrating; thus, ongoing investigation and continuous improvement for IQC are still needed. © 2017 Wiley Periodicals, Inc.

Report on the NAT-9 quality control exercise on uranium isotopes in two soil samples

International Nuclear Information System (INIS)

Bleise, Andreas

2001-04-01

The International Atomic Energy Agency (IAEA) section of Nutritional and Health related Environmental Studies (NAHRES) organized a quality control study for laboratories analysing samples from the UNEP field mission to Kosovo. Quality control was the major responsibility of the IAEA in the UN field assessment team. The NAT-9 quality control study consists of two soil materials from the IAEA Laboratories in Seibersdorf. The scope of this exercise was to determine the content of the uranium isotopes U-234, U-235 and U-238. The IAEA did not provide specific instructions, the participants were encouraged to apply their established analytical procedures to the samples. Five laboratories were invited to participate, four laboratories submitted results. For each soil sample 10 laboratory mean values were reported, using ICP-MS (3 laboratories) and α-spectrometry (1 laboratory). The participating laboratories were capable to distinguish the different uranium isotopes. All laboratories obtained the natural uranium ratio between U-235 and U-238. However, the results highlight a particular analytical weak spot. Although the methods of measuring the analytical signals are highly dependable, the sample preparation steps, in particular the sample dissolution procedure, appears to be lacking total quality control and has contributed to the deviations from the reported target values. One laboratory has documented evidence that extensive and well-controlled digestion methods can yield measurement results close to the target values. (author)

Median of patient results as a tool for assessment of analytical stability.

Science.gov (United States)

Jørgensen, Lars Mønster; Hansen, Steen Ingemann; Petersen, Per Hyltoft; Sölétormos, György

2015-06-15

In spite of the well-established external quality assessment and proficiency testing surveys of analytical quality performance in laboratory medicine, a simple tool to monitor the long-term analytical stability as a supplement to the internal control procedures is often needed. Patient data from daily internal control schemes was used for monthly appraisal of the analytical stability. This was accomplished by using the monthly medians of patient results to disclose deviations from analytical stability, and by comparing divergences with the quality specifications for allowable analytical bias based on biological variation. Seventy five percent of the twenty analytes achieved on two COBASs INTEGRA 800 instruments performed in accordance with the optimum and with the desirable specifications for bias. Patient results applied in analytical quality performance control procedures are the most reliable sources of material as they represent the genuine substance of the measurements and therefore circumvent the problems associated with non-commutable materials in external assessment. Patient medians in the monthly monitoring of analytical stability in laboratory medicine are an inexpensive, simple and reliable tool to monitor the steadiness of the analytical practice. Copyright © 2015 Elsevier B.V. All rights reserved.

Automated Deployment of Advanced Controls and Analytics in Buildings

Science.gov (United States)

Pritoni, Marco

Buildings use 40% of primary energy in the US. Recent studies show that developing energy analytics and enhancing control strategies can significantly improve their energy performance. However, the deployment of advanced control software applications has been mostly limited to academic studies. Larger-scale implementations are prevented by the significant engineering time and customization required, due to significant differences among buildings. This study demonstrates how physics-inspired data-driven models can be used to develop portable analytics and control applications for buildings. Specifically, I demonstrate application of these models in all phases of the deployment of advanced controls and analytics in buildings: in the first phase, "Site Preparation and Interface with Legacy Systems" I used models to discover or map relationships among building components, automatically gathering metadata (information about data points) necessary to run the applications. During the second phase: "Application Deployment and Commissioning", models automatically learn system parameters, used for advanced controls and analytics. In the third phase: "Continuous Monitoring and Verification" I utilized models to automatically measure the energy performance of a building that has implemented advanced control strategies. In the conclusions, I discuss future challenges and suggest potential strategies for these innovative control systems to be widely deployed in the market. This dissertation provides useful new tools in terms of procedures, algorithms, and models to facilitate the automation of deployment of advanced controls and analytics and accelerate their wide adoption in buildings.

Structural modeling of the production quality as a multidimensional object of measurement and control

OpenAIRE

Зубрецкая, Наталья Анатольевна

2015-01-01

The structural-analytical models of product quality as a multidimensional process of evaluation, measurement and control are developed. The product quality is represented as a multi-factor, multi-criteria and multi-parameter estimation object. This structural formalization of quality demonstrates the multidimensional qualities: comprehensiveness due to a set of environmental factors; multicriteriality due collectively evaluated quality criteria; multiparameter information models that describe...

Analytical one parameter method for PID motion controller settings

NARCIS (Netherlands)

van Dijk, Johannes; Aarts, Ronald G.K.M.

2012-01-01

In this paper analytical expressions for PID-controllers settings for electromechanical motion systems are presented. It will be shown that by an adequate frequency domain oriented parametrization, the parameters of a PID-controller are analytically dependent on one variable only, the cross-over

Control of Bank Consolidated Financial Statements Quality

Directory of Open Access Journals (Sweden)

Margarita S. Ambarchyan

2013-01-01

Full Text Available The author presents the multiple linear regression model of bank consolidated financial statements quality. The article considers six characteristics that can be used to estimate the level of bank consolidated financial statements quality. The multiple linear regression model was developed, using the results of point-based system of consolidated financial statements of thirty European bank and financial groups on the basis of the developed characteristics. The author offers to use the characteristic significance factor in the process of consolidated financial statements appraisal by points. The constructed regression model is checked on accuracy and statistical significance. The model can be used by internal auditors and financial analytics as an instrument for bank and non-bank consolidated financial statements quality control

Analytical quality assurance in laboratories using tracers for biological and environmental studies

International Nuclear Information System (INIS)

Melaj, Mariana; Martin, Olga; Lopez, Silvia; Rojas de Tramontini, Susana

1999-01-01

This work describe the way we are organizing a quality assurance system to apply in the analytical measurements of the relation 14 N/ 15 N in biological and soil material. The relation 14 / 15 is measured with a optic emission spectrometer (NOI6PC), which distinguish the differences in wave length of electromagnetic radiation emitted by N-28, N-29 and N-30. The major problem is the 'cross contamination' of samples with different enrichments. The elements that are been considered to reach satisfactory analytical results are: 1) A proper working area; 2) The samples must be homogeneous and the samples must represent the whole sampled system; 3) The use of reference materials. In each digestion, a known reference sample must be added; 4) Adequate equipment operation; 5) Standard operating procedures; 6) Control charts, laboratory and equipment books. All operations using the equipment is registered in a book; 7) Training of the operators. (author)

Evaluating supplier quality performance using analytical hierarchy process

Science.gov (United States)

Kalimuthu Rajoo, Shanmugam Sundram; Kasim, Maznah Mat; Ahmad, Nazihah

2013-09-01

This paper elaborates the importance of evaluating supplier quality performance to an organization. Supplier quality performance evaluation reflects the actual performance of the supplier exhibited at customer's end. It is critical in enabling the organization to determine the area of improvement and thereafter works with supplier to close the gaps. Success of the customer partly depends on supplier's quality performance. Key criteria as quality, cost, delivery, technology support and customer service are categorized as main factors in contributing to supplier's quality performance. 18 suppliers' who were manufacturing automotive application parts evaluated in year 2010 using weight point system. There were few suppliers with common rating which led to common ranking observed by few suppliers'. Analytical Hierarchy Process (AHP), a user friendly decision making tool for complex and multi criteria problems was used to evaluate the supplier's quality performance challenging the weight point system that was used for 18 suppliers'. The consistency ratio was checked for criteria and sub-criteria. Final results of AHP obtained with no overlap ratings, therefore yielded a better decision making methodology as compared to weight point rating system.

Considerations of critical quality attributes in the analytical comparability assessment of biosimilar products.

Science.gov (United States)

Kwon, Ohseok; Joung, Jeewon; Park, Younjoo; Kim, Chan Wha; Hong, Seung Hwa

2017-07-01

Based on experience in clinical trial approvals and marketing authorizations for biosimilar products in Korea, we suggest principles for the analytical comparability assessment of biosimilar products with respect to regulatory considerations. The composition and manufacturing processes of biosimilar products can differ from those of the reference product depending on the information available for the reference product and the time of product development; however, the analytical characteristics of biosimilar products should be highly similar to those of the reference product. Although manufacturing an identical product in terms of the quality profile is nearly impossible due to the high molecular weight and complex structure of biological products, the developer of the biosimilar product should attempt to establish a quality level as similar to that of the reference product as possible. When comparing the similarity of quality attributes, the criticality of the quality attributes and the characteristics of orthogonal quality attributes need to be considered carefully. Based on the results from the analytical comparability assessment, the comparability results of non-clinical and clinical studies should be evaluated before claiming biosimilarity to the reference product. In this review, we focus on quality attribute evaluation based on our regulatory experience. Copyright © 2017 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

[Raman spectroscopy applied to analytical quality control of injectable drugs: analytical evaluation and comparative economic versus HPLC and UV / visible-FTIR].

Science.gov (United States)

Bourget, P; Amin, A; Vidal, F; Merlette, C; Troude, P; Corriol, O

2013-09-01

In France, central IV admixture of chemotherapy (CT) treatments at the hospital is now required by law. We have previously shown that the shaping of Therapeutic Objects (TOs) could profit from an Analytical Quality Assurance (AQA), closely linked to the batch release, for the three key parameters: identity, purity, and initial concentration of the compound of interest. In the course of recent and diversified works, we showed the technical superiority of non-intrusive Raman Spectroscopy (RS) vs. any other analytical option and, especially for both HPLC and vibrational method using a UV/visible-FTIR coupling. An interconnected qualitative and economic assessment strongly helps to enrich these relevant works. The study compares in operational situation, the performance of three analytical methods used for the AQC of TOs. We used: a) a set of evaluation criteria, b) the depreciation tables of the machinery, c) the cost of disposables, d) the weight of equipment and technical installations, e) the basic accounting unit (unit of work) and its composite costs (Euros), which vary according to the technical options, the weight of both human resources and disposables; finally, different combinations are described. So, the unit of work can take 12 different values between 1 and 5.5 Euros, and we provide various recommendations. A qualitative evaluation grid constantly places the SR technology as superior or equal to the 2 other techniques currently available. Our results demonstrated: a) the major interest of the non-intrusive AQC performed by RS, especially when it is not possible to analyze a TO with existing methods e.g. elastomeric portable pumps, and b) the high potential for this technique to be a strong contributor to the security of the medication circuit, and to fight the iatrogenic effects of drugs especially in the hospital. It also contributes to the protection of all actors in healthcare and of their working environment.

Implementing self sustained quality control procedures in a clinical laboratory.

Science.gov (United States)

Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

2013-01-01

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

Automated statistical modeling of analytical measurement systems

International Nuclear Information System (INIS)

Jacobson, J.J.

1992-01-01

The statistical modeling of analytical measurement systems at the Idaho Chemical Processing Plant (ICPP) has been completely automated through computer software. The statistical modeling of analytical measurement systems is one part of a complete quality control program used by the Remote Analytical Laboratory (RAL) at the ICPP. The quality control program is an integration of automated data input, measurement system calibration, database management, and statistical process control. The quality control program and statistical modeling program meet the guidelines set forth by the American Society for Testing Materials and American National Standards Institute. A statistical model is a set of mathematical equations describing any systematic bias inherent in a measurement system and the precision of a measurement system. A statistical model is developed from data generated from the analysis of control standards. Control standards are samples which are made up at precise known levels by an independent laboratory and submitted to the RAL. The RAL analysts who process control standards do not know the values of those control standards. The object behind statistical modeling is to describe real process samples in terms of their bias and precision and, to verify that a measurement system is operating satisfactorily. The processing of control standards gives us this ability

Irregular analytical errors in diagnostic testing - a novel concept.

Science.gov (United States)

Vogeser, Michael; Seger, Christoph

2018-02-23

In laboratory medicine, routine periodic analyses for internal and external quality control measurements interpreted by statistical methods are mandatory for batch clearance. Data analysis of these process-oriented measurements allows for insight into random analytical variation and systematic calibration bias over time. However, in such a setting, any individual sample is not under individual quality control. The quality control measurements act only at the batch level. Quantitative or qualitative data derived for many effects and interferences associated with an individual diagnostic sample can compromise any analyte. It is obvious that a process for a quality-control-sample-based approach of quality assurance is not sensitive to such errors. To address the potential causes and nature of such analytical interference in individual samples more systematically, we suggest the introduction of a new term called the irregular (individual) analytical error. Practically, this term can be applied in any analytical assay that is traceable to a reference measurement system. For an individual sample an irregular analytical error is defined as an inaccuracy (which is the deviation from a reference measurement procedure result) of a test result that is so high it cannot be explained by measurement uncertainty of the utilized routine assay operating within the accepted limitations of the associated process quality control measurements. The deviation can be defined as the linear combination of the process measurement uncertainty and the method bias for the reference measurement system. Such errors should be coined irregular analytical errors of the individual sample. The measurement result is compromised either by an irregular effect associated with the individual composition (matrix) of the sample or an individual single sample associated processing error in the analytical process. Currently, the availability of reference measurement procedures is still highly limited, but LC

Validation of the quality control methods for active ingredients of Fungirex cream

International Nuclear Information System (INIS)

Perez Navarro, Maikel; Rodriguez Hernandez, Yaslenis; Suarez Perez, Yania

2014-01-01

Fungirex cream is a two-drug product, that is, undecylenic acid and zinc undecylenate over a suitable basis. Since this is a product not documented in the official monographs of the pharmacopoeia, simple analytical methods were suggested for quantitation of analytes of interest in the cream, which are useful for release of newly prepared cream batches. To validate two volumetric methods for the quality control of active ingredients in Fungirex cream

Revisit of analytical methods for the process and plant control analyses during reprocessing of fast reactor fuels

International Nuclear Information System (INIS)

Subba Rao, R.V.

2016-01-01

CORAL (COmpact facility for Reprocessing of Advanced fuels in Lead cell) is an experimental facility for demonstrating the reprocessing of irradiated fast reactor fuels discharged from the Fast Breeder Test Reactor (FBTR). The objective of the reprocessing plant is to achieve nuclear grade plutonium and uranium oxides with minimum process waste volumes. The process flow sheet for the reprocessing of spent Fast Reactor Fuel consists of Transport of spent fuel, Chopping, Dissolution, Feed conditioning, Solvent Extraction cycle, Partitioning Cycle and Re-conversion of Plutonium nitrate and uranium nitrate to respective oxides. The efficiency and performance of the plant to achieve desired objective depends on the analyses of various species in the different steps adopted during reprocessing of fuels. The analytical requirements in the plant can be broadly classified as 1. Process control Analyses (Analyses which effect the performance of the plant- PCA); 2. Plant control Analyses (Analyses which indicates efficiency of the plant-PLCA); 3. Nuclear Material Accounting samples (Analyses which has bearing on nuclear material accounting in the plant - NUMAC) and Quality control Analyses (Quality of the input bulk chemicals as well as products - QCA). The analytical methods selected are based on the duration of analyses, precision and accuracies required for each type analytical requirement classified earlier. The process and plant control analyses requires lower precision and accuracies as compared to NUMAC analyses, which requires very high precision accuracy. The time taken for analyses should be as lower as possible for process and plant control analyses as compared to NUMAC analyses. The analytical methods required for determining U and Pu in process and plant samples from FRFR will be different as compared to samples from TRFR (Thermal Reactor Fuel Reprocessing) due to higher Pu to U ratio in FRFR as compared TRFR and they should be such that they can be easily

Computer graphics for quality control in the INAA of geological samples

International Nuclear Information System (INIS)

Grossman, J.N.; Baedecker, P.A.

1987-01-01

A data reduction system for the routine instrumental activation analysis of samples is described, with particular emphasis on interactive graphics capabilities for evaluating analytical quality. Graphics procedures were developed to interactively control the analysis of selected photopeaks during spectral analysis, and to evaluate detector performance during a given counting cycle. Graphics algorithms are also used to compare the data on reference samples with accepted values, to prepare quality control charts to evaluate long term precision and to search for systematic variations in data on reference samples as a function of time. (author)

Implementation of quality control systems in laboratories in Paraguay by the participants of ARCAL LXXVI project

International Nuclear Information System (INIS)

Villanueva, Z.

2004-12-01

In the Project ARCAL LXXVII, was realized the National Course of Control of Quality of Analytic Laboratories, from 12 to 16 of April in the CNEA, Paraguay, as a result of the one mentioned course was elaborated this project whose purpose is to elaborate the necessary documentation to fulfill the requirements of administration in the Analytic Laboratories to be adapted to the system of quality according to the ISO 17025 [es

Developing an Evaluation Framework of Quality Indicators for Learning Analytics

NARCIS (Netherlands)

Scheffel, Maren; Drachsler, Hendrik; Specht, Marcus

2017-01-01

This paper presents results from the continuous process of developing an evaluation framework of quality indicators for learning analytics (LA). Building on a previous study, a group concept mapping approach that uses multidimensional scaling and hierarchical clustering, the study presented here

Quality assurance

Energy Technology Data Exchange (ETDEWEB)

Gillespie, B.M.; Gleckler, B.P.

1995-06-01

This section of the 1994 Hanford Site Environmental Report summarizes the quality assurance and quality control practices of Hanford Site environmental monitoring and surveillance programs. Samples are analyzed according to documented standard analytical procedures. This section discusses specific measures taken to ensure quality in project management, sample collection, and analytical results.

Quality assurance

International Nuclear Information System (INIS)

Gillespie, B.M.; Gleckler, B.P.

1995-01-01

This section of the 1994 Hanford Site Environmental Report summarizes the quality assurance and quality control practices of Hanford Site environmental monitoring and surveillance programs. Samples are analyzed according to documented standard analytical procedures. This section discusses specific measures taken to ensure quality in project management, sample collection, and analytical results

An Analytical Hierarchy Process Model for the Evaluation of College Experimental Teaching Quality

Science.gov (United States)

Yin, Qingli

2013-01-01

Taking into account the characteristics of college experimental teaching, through investigaton and analysis, evaluation indices and an Analytical Hierarchy Process (AHP) model of experimental teaching quality have been established following the analytical hierarchy process method, and the evaluation indices have been given reasonable weights. An…

Development and use of reference materials and quality control materials

International Nuclear Information System (INIS)

2003-04-01

Current knowledge is summarized on correct use of commercially available certified reference materials (CRMs) and reference materials (RMs). Acknowledged are also the limitations and restrictions analysts have to face if they want to apply quality control. The concept of in-house RMs or quality control materials (QCMs) is advocated to supplement the use of CRMs for quality control purposes. On hand advice on how to select, prepare, characterize and use these QCMs is given from the experts' perspective. Several scenarios are described to make this concept widely applicable to: advanced laboratories with CRMs with validated analytical techniques available, laboratories with less experience and facilities, as well as cases were labile compounds and unstable matrices are involved. Each scenario considers different approaches to overcome the lack of appropriate CRMs and advise on the preparation of QCMs, which might fit the particular purpose

Development and use of reference materials and quality control materials

Energy Technology Data Exchange (ETDEWEB)

NONE

2003-04-01

Current knowledge is summarized on correct use of commercially available certified reference materials (CRMs) and reference materials (RMs). Acknowledged are also the limitations and restrictions analysts have to face if they want to apply quality control. The concept of in-house RMs or quality control materials (QCMs) is advocated to supplement the use of CRMs for quality control purposes. On hand advice on how to select, prepare, characterize and use these QCMs is given from the experts' perspective. Several scenarios are described to make this concept widely applicable to: advanced laboratories with CRMs with validated analytical techniques available, laboratories with less experience and facilities, as well as cases were labile compounds and unstable matrices are involved. Each scenario considers different approaches to overcome the lack of appropriate CRMs and advise on the preparation of QCMs, which might fit the particular purpose.

Evaluation of analytical results on DOE Quality Assessment Program Samples

International Nuclear Information System (INIS)

Jaquish, R.E.; Kinnison, R.R.; Mathur, S.P.; Sastry, R.

1985-01-01

Criteria were developed for evaluating the participants analytical results in the DOE Quality Assessment Program (QAP). Historical data from previous QAP studies were analyzed using descriptive statistical methods to determine the interlaboratory precision that had been attained. Performance criteria used in other similar programs were also reviewed. Using these data, precision values and control limits were recommended for each type of analysis performed in the QA program. Results of the analysis performed by the QAP participants on the November 1983 samples were statistically analyzed and evaluated. The Environmental Measurements Laboratory (EML) values were used as the known values and 3-sigma precision values were used as control limits. Results were submitted by 26 participating laboratories for 49 different radionuclide media combinations. The participants reported 419 results and of these, 350 or 84% were within control limits. Special attention was given to the data from gamma spectral analysis of air filters and water samples. both normal probability and box plots were prepared for each nuclide to help evaluate the distribution of the data. Results that were outside the expected range were identified and suggestions made that laboratories check calculations, and procedures on these results

Improving of Quality Control and Quality Assurance in 14C and 3H Laboratory; Participation in the IAEA Model Project

International Nuclear Information System (INIS)

Obelic, B.

2001-01-01

Full text: Users of laboratory's analytical results are increasingly requiring demonstrable proofs of the reliability and credibility of the results using internationally accepted standards, because the economic, ecological, medical and legal decisions based on laboratory results need to be accepted nationally and internationally. Credibility, respect and opportunities of the laboratories are improved when objective evidence on the reliability and quality of the results can be given. This is achieved through inculcation of a quality culture through definition of well-defined procedures and controls and operational checks characteristic of quality assurance and quality control (Q A/QC). IAEA launched in 1999 a two-and-a-half year model project entitled Quality Control and Quality Assurance of Nuclear Analytical Techniques with participation of laboratories using alpha, beta and/or gamma spectrometry from CEE and NIS countries. The project started to introduce and implement QA principles in accordance with the ISO-17025 guide, leading eventually to a level at which the QA system is self-sustainable and might be appropriate for formal accreditation or certification by respective national authorities. Activities within the project consist of semi-annual reports, two training workshops, two inspection visits of the laboratories by IAEA experts and proficiency tests. The following topics were considered: organisation requirements, acceptance criteria and non-conformance management of QC, internal and external method validation, statistical analyses and uncertainty evaluation, standard operation procedures and quality manual documentation. 14 C and 3 H Laboratory of the Rudjer Boskovic Institute has been one of ten laboratories participating in the Project. In the Laboratory all the procedures required in the quality control were included implicitly, while during the Model Project much effort has been devoted to elaboration of explicit documentation. Since the beginning

AMAZON RAINFOREST COSMETICS: CHEMICAL APPROACH FOR QUALITY CONTROL

Directory of Open Access Journals (Sweden)

Mariko Funasaki

2016-02-01

Full Text Available The market for natural cosmetics featuring ingredients derived from Amazon natural resources is growing worldwide. However, there is neither enough scientific basis nor quality control of these ingredients. This paper is an account of the chemical constituents and their biological activities of fourteen Amazonian species used in cosmetic industry, including açaí (Euterpe oleracea, andiroba (Carapa guianensis, bacuri (Platonia insignis, Brazil nut (Bertholletia excelsa, buriti (Mauritia vinifera or M. flexuosa, cumaru (Dipteryx odorata, cupuaçu (Theobroma grandiflorum, guarana (Paullinia cupana, mulateiro (Calycophyllum spruceanum, murumuru (Astrocaryum murumuru, patawa (Oenocarpus bataua or Jessenia bataua, pracaxi (Pentaclethra macroloba, rosewood (Aniba rosaeodora, and ucuuba (Virola sebifera. Based on the reviewed articles, we selected chemical markers for the quality control purpose and evaluated analytical methods. Even though chromatographic and spectroscopic methods are major analytical techniques in the studies of these species, molecular approaches will also be important as used in food and medicine traceability. Only a little phytochemical study is available about most of the Amazonian species and some species such as açaí and andiroba have many reports on chemical constituents, but studies on biological activities of isolated compounds and sampling with geographical variation are limited.

Development of Process Analytical Technology (PAT) methods for controlled release pellet coating.

Science.gov (United States)

Avalle, P; Pollitt, M J; Bradley, K; Cooper, B; Pearce, G; Djemai, A; Fitzpatrick, S

2014-07-01

This work focused on the control of the manufacturing process for a controlled release (CR) pellet product, within a Quality by Design (QbD) framework. The manufacturing process was Wurster coating: firstly layering active pharmaceutical ingredient (API) onto sugar pellet cores and secondly a controlled release (CR) coating. For each of these two steps, development of a Process Analytical Technology (PAT) method is discussed and also a novel application of automated microscopy as the reference method. Ultimately, PAT methods should link to product performance and the two key Critical Quality Attributes (CQAs) for this CR product are assay and release rate, linked to the API and CR coating steps respectively. In this work, the link between near infra-red (NIR) spectra and those attributes was explored by chemometrics over the course of the coating process in a pilot scale industrial environment. Correlations were built between the NIR spectra and coating weight (for API amount), CR coating thickness and dissolution performance. These correlations allow the coating process to be monitored at-line and so better control of the product performance in line with QbD requirements. Copyright © 2014 Elsevier B.V. All rights reserved.

Role of modern analytical techniques in the production of uranium metal

International Nuclear Information System (INIS)

Hareendran, K.N.; Roy, S.B.

2009-01-01

Production of nuclear grade uranium metal conforming to its stringent specification with respect to metallic and non metallic impurities necessitates implementation of a comprehensive quality control regime. Founding members of Uranium Metal Plant realised the importance of this aspect of metal production and a quality control laboratory was set up as part of the production plant. In the initial stages of its existence, the laboratory mainly catered to the process control analysis of the plant process samples and Spectroscopy Division and Analytical Division of BARC provided analysis of trace metallic impurities in the intermediates as well as in the product uranium metal. This laboratory also provided invaluable R and D support for the optimization of the process involving both calciothermy and magnesiothermy. Prior to 1985, analytical procedures used were limited to classical methods of analysis with minimal instrumental procedures. The first major analytical instrument, a Flame AAS was installed in 1985 and a beginning to the trace analysis was made. However during the last 15 years the Quality Control Section has modernized the analytical set up by acquiring appropriate instruments. Presently the facility has implemented a complete quality control and quality assurance program required to cover all aspects of uranium metal production viz analysis of raw materials, process samples, waste disposal samples and also determination of all the specification elements in uranium metal. The current analytical practices followed in QCS are presented here

Student Writing Accepted as High-Quality Responses to Analytic Text-Based Writing Tasks

Science.gov (United States)

Wang, Elaine; Matsumura, Lindsay Clare; Correnti, Richard

2018-01-01

Literacy standards increasingly emphasize the importance of analytic text-based writing. Little consensus exists, however, around what high-quality student responses should look like in this genre. In this study, we investigated fifth-grade students' writing in response to analytic text-based writing tasks (15 teachers, 44 writing tasks, 88 pieces…

At-line validation of a process analytical technology approach for quality control of melamine-urea-formaldehyde resin in composite wood-panel production using near infrared spectroscopy.

Science.gov (United States)

Meder, Roger; Stahl, Wolfgang; Warburton, Paul; Woolley, Sam; Earnshaw, Scott; Haselhofer, Klaus; van Langenberg, Ken; Ebdon, Nick; Mulder, Roger

2017-01-01

The reactivity of melamine-urea-formaldehyde resins is of key importance in the manufacture of engineered wood products such as medium density fibreboard (MDF) and other wood composite products. Often the MDF manufacturing plant has little available information on the resin reactivity other than details of the resin specification at the time of batch manufacture, which often occurs off-site at a third-party resin plant. Often too, fresh resin on delivery at the MDF plant is mixed with variable volume of aged resin in storage tanks, thereby rendering any specification of the fresh resin batch obsolete. It is therefore highly desirable to develop a real-time, at-line or on-line, process analytical technology to monitor the quality of the resin prior to MDF panel manufacture. Near infrared (NIR) spectroscopy has been calibrated against standard quality methods and against 13 C nuclear magnetic resonance (NMR) measures of molecular composition in order to provide at-line process analytical technology (PAT), to monitor the resin quality, particularly the formaldehyde content of the resin. At-line determination of formaldehyde content in the resin was made possible using a six-factor calibration with an R 2 (cal) value of 0.973, and R 2 (CV) value of 0.929 and a root-mean-square error of cross-validation of 0.01. This calibration was then used to generate control charts of formaldehyde content at regular four-hourly periods during MDF panel manufacture in a commercial MDF manufacturing plant.

Computer graphics for quality control in the INAA of geological samples

Science.gov (United States)

Grossman, J.N.; Baedecker, P.A.

1987-01-01

A data reduction system for the routine instrumental activation analysis of samples is described, with particular emphasis on interactive graphics capabilities for evaluating analytical quality. Graphics procedures have been developed to interactively control the analysis of selected photopeaks during spectral analysis, and to evaluate detector performance during a given counting cycle. Graphics algorithms are also used to compare the data on reference samples with accepted values, to prepare quality control charts to evaluate long term precision and to search for systematic variations in data on reference samples as a function of time. ?? 1987 Akade??miai Kiado??.

Quality assurance in microbiology

OpenAIRE

Arora D

2004-01-01

Quality assurance (QA) is the total process whereby the quality of laboratory reports can be guaranteed. The term quality control covers that part of QA, which primarily concerns the control of errors in the performance of tests and verification of test results. All materials, equipment and procedures must be adequately controlled. Culture media must be tested for sterility and performance. Each laboratory must have standard operating procedures (SOPs). QA of pre-analytical, analytical and po...

Enhancing Treatment Outcome of Patients at Risk of Treatment Failure: Meta-Analytic and Mega-Analytic Review of a Psychotherapy Quality Assurance System

Science.gov (United States)

Shimokawa, Kenichi; Lambert, Michael J.; Smart, David W.

2010-01-01

Objective: Outcome research has documented worsening among a minority of the patient population (5% to 10%). In this study, we conducted a meta-analytic and mega-analytic review of a psychotherapy quality assurance system intended to enhance outcomes in patients at risk of treatment failure. Method: Original data from six major studies conducted…

Design of a Clean Room for Quality Control of an Environmental Sampling in KINAC

International Nuclear Information System (INIS)

Yoon, Jongho; Ahn, Gil Hoon; Seo, Hana; Han, Kitek; Park, Il Jin

2014-01-01

The objective of environmental sampling and analysis for safeguards is to characterize the nuclear materials handled and the activities conducted at the specific locations. The KINAC is responsible for the conclusions drawn from the analytical results provided by the analytical laboratories. To assure the KINAC of the continuity of the quality of the analytical results provided by the laboratories, the KINAC will implement a quality control(QC) programme. One of the QC programme is to prepare QC samples. The establishment of a clean room is needed to handle QC samples due to stringent control of contamination. The KINAC designed a clean facility with cleanliness of ISO Class 6, the Clean Room for Estimation and Assay of trace Nuclear materials(CREAN) to meet conflicting requirements of a clean room and for handling of nuclear materials according to Korean laws. The clean room will be expected to acquire of a radiation safety license under these conditions in this year and continue to improve it. The construction of the CREAN facility will be completed by the middle of 2015. In terms of QC programme, the establishment of a clean room is essential and will be not only very helpful for setting of quality control system for the national environmental sampling programme but also be applied for the environmental sample analysis techniques to the nuclear forensics

Application of capability indices and control charts in the analytical method control strategy.

Science.gov (United States)

Oliva, Alexis; Llabres Martinez, Matías

2017-08-01

In this study, we assessed the usefulness of control charts in combination with the process capability indices, C pm and C pk , in the control strategy of an analytical method. The traditional X-chart and moving range chart were used to monitor the analytical method over a 2-year period. The results confirmed that the analytical method is in-control and stable. Different criteria were used to establish the specifications limits (i.e. analyst requirements) for fixed method performance (i.e. method requirements). If the specification limits and control limits are equal in breadth, the method can be considered "capable" (C pm  = 1), but it does not satisfy the minimum method capability requirements proposed by Pearn and Shu (2003). Similar results were obtained using the C pk index. The method capability was also assessed as a function of method performance for fixed analyst requirements. The results indicate that the method does not meet the requirements of the analytical target approach. A real-example data of a SEC with light-scattering detection method was used as a model whereas previously published data were used to illustrate the applicability of the proposed approach. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Application of Metabolomics to Quality Control of Natural Product Derived Medicines.

Science.gov (United States)

Lee, Kyung-Min; Jeon, Jun-Yeong; Lee, Byeong-Ju; Lee, Hwanhui; Choi, Hyung-Kyoon

2017-11-01

Metabolomics has been used as a powerful tool for the analysis and quality assessment of the natural product (NP)-derived medicines. It is increasingly being used in the quality control and standardization of NP-derived medicines because they are composed of hundreds of natural compounds. The most common techniques that are used in metabolomics consist of NMR, GC-MS, and LC-MS in combination with multivariate statistical analyses including principal components analysis (PCA) and partial least squares-discriminant analysis (PLS-DA). Currently, the quality control of the NP-derived medicines is usually conducted using HPLC and is specified by one or two indicators. To create a superior quality control framework and avoid adulterated drugs, it is necessary to be able to determine and establish standards based on multiple ingredients using metabolic profiling and fingerprinting. Therefore, the application of various analytical tools in the quality control of NP-derived medicines forms the major part of this review. Veregen ® (Medigene AG, Planegg/Martinsried, Germany), which is the first botanical prescription drug approved by US Food and Drug Administration, is reviewed as an example that will hopefully provide future directions and perspectives on metabolomics technologies available for the quality control of NP-derived medicines.

Association between product quality control and process quality control of bulk milk

NARCIS (Netherlands)

Velthuis, A.; Asseldonk, van M.A.P.M.

2010-01-01

Assessment of dairy-milk quality is based on product quality control (testing bulk-milk samples) and process quality control (auditing dairy farms). It is unknown whether process control improves product quality. To quantify possible association between product control and process control a

Quality Control Applications

CERN Document Server

Chorafas, Dimitris N

2013-01-01

Quality control is a constant priority in electrical, mechanical, aeronautical, and nuclear engineering – as well as in the vast domain of electronics, from home appliances to computers and telecommunications. Quality Control Applications provides guidance and valuable insight into quality control policies; their methods, their implementation, constant observation and associated technical audits. What has previously been a mostly mathematical topic is translated here for engineers concerned with the practical implementation of quality control. Once the fundamentals of quality control are established, Quality Control Applications goes on to develop this knowledge and explain how to apply it in the most effective way. Techniques are described and supported using relevant, real-life, case studies to provide detail and clarity for those without a mathematical background. Among the many practical examples, two case studies dramatize the importance of quality assurance: A shot-by-shot analysis of the errors made ...

X-ray quality control using TLD-100

International Nuclear Information System (INIS)

Rojas S, D. A.; Garcia V, E.; Azorin N, J.; Gaona, E.

2017-10-01

The use of thermoluminescent dosimeters in the area of medical physics and especially in radiology is of great importance to guarantee the quality of a given study, for this reason the need to verify by means of measurements for quality control in X-rays using thermoluminescent dosimeters of LiF:Mg,Ti was raised. For this, measurements of air Kerma, beam efficiency (reproducibility and linearity) and determination of the hemi-reductive layer were carried out, where previously the dosimeters were used, the graphs of the linear equation were used to obtain the absorbed dose of each dosimeter and thus the results of the absorbed dose calculated analytically against the value estimated by an electronic dosimeter were compared; it was found that the values of the absorbed dose are quantities similar to those stipulated by the electronic dosimeter. These measurements made it possible to verify the quality of the equipment that was used in the comparison. (Author)

Regulatory quality control in the metal and semi metal environmental monitoring program at IPEN/CNEN-SP

International Nuclear Information System (INIS)

Faustino, Mainara G.; Silva, Doulgas Batista; Monteiro, Lucilena R.; Dantas, Elizabeth S.K.; Pires, Maria Aparecida F.; Cotrim, Marycel E.B.

2013-01-01

The CONAMA's Resolution 430 recently published in May 13 th of 2011, that completes and modifies the Resolution 357/2005, defined new quality standards to perform liquid effluent monitoring essays in order to allow the release in the public sewer system. This Resolution has established that the essay laboratories must be certified by Brazilian National Metrology, Normalization and Industrial Quality Institute - INMETRO and also count with an implemented quality control system. Thereby this publication affected directly IPEN's Environmental Monitoring Program of Stables Chemical Compound (PMA-Q), performed since 2007. In this program, 20 parameters related to the metallic and non-metallic chemical elements content are monitored by using sensitive analytical techniques such as graphite furnace atomic absorption spectrometry - GF-AAS or inductively coupled plasma spectrometry - ICP-OES. Therefore this paper presents improvements to determine the laboratory individual performance performed by GF-AAS and ICP-OES. To achieve the legislation compliance for these parameters, the following actions were implemented: the construction of control charts (internal quality control) and the participation of the laboratory in interlaboratory proficiency tests (external quality control). These actions are presented and discussed with the results of elements such as Arsenic and Lead that are analyzed through GF-AAS as well as Chromium, Cooper, Zinc, Iron and Nickel, that are analyzed through ICP-OES. These actions of quality control allowed the continuous monitoring of laboratory performance, the identification and resolution of analytic problems and interlaboratory differences, provide additional confidence to monitoring program. (author)

Improved quality control of [18F]fluoromethylcholine

International Nuclear Information System (INIS)

Nader, Michael; Reindl, Dietmar; Eichinger, Reinhard; Beheshti, Mohsen; Langsteger, Werner

2011-01-01

Objectives: With respect to the broad application of [ 18 F-methyl]fluorocholine (FCH), there is a need for a safe, but also efficient and convenient way for routine quality control of FCH. Therefore, a GC- method should be developed and validated which allows the simultaneous quantitation of all chemical impurities and residual solvents such as acetonitrile, ethanol, dibromomethane and N,N-dimethylaminoethanol. Methods: Analytical GC has been performed with a GC-capillary column Optima 1701 (50 m×0.32 mm), and a pre-column deactivated capillary column phenyl-Sil (10 m×0.32) in line with a flame ionization detector (FID) was used. The validation includes the following tests: specificity, range, accuracy, linearity, precision, limit of detection (LOD) and limit of quantitation (LOQ) of all listed substances. Results: The described GC method has been successfully used for the quantitation of the listed chemical impurities. The specificity of the GC separation has been proven by demonstrating that the appearing peaks are completely separated from each other and that a resolution R≥1.5 for the separation of the peaks could be achieved. The specified range confirmed that the analytical procedure provides an acceptable degree of linearity, accuracy and precision. For each substance, a range from 2% to 120% of the specification limit could be demonstrated. The corresponding LOD values were determined and were much lower than the specification limits. Conclusions: An efficient and convenient GC method for the quality control of FCH has been developed and validated which meets all acceptance criteria in terms of linearity, specificity, precision, accuracy, LOD and LOQ.

Final draft consultants report. Consultants' meeting on requirements for reference materials and intercomparison runs - IAEA programme on Analytical Quality Control Services (AQCS), 17-21 April 1994, Kona, HI, USA

International Nuclear Information System (INIS)

2002-01-01

The purpose of the meeting was to define the aims of the Agency's Analytical Quality Control Services (AQCS) programme in view of its uniqueness as an international programme and to establish objectives for the organization of intercomparison runs and production of reference materials and the Agency's services to Member States in future years. This draft report contains the meeting agenda and recommendations made by the consultants. The recommendations are grouped as follows: Mission Statement; Laboratory Qualification; Training and Development; Resources and Technical Concepts; Standing Group of Experts

Potential sources of analytical bias and error in selected trace element data-quality analyses

Science.gov (United States)

Paul, Angela P.; Garbarino, John R.; Olsen, Lisa D.; Rosen, Michael R.; Mebane, Christopher A.; Struzeski, Tedmund M.

2016-09-28

Potential sources of analytical bias and error associated with laboratory analyses for selected trace elements where concentrations were greater in filtered samples than in paired unfiltered samples were evaluated by U.S. Geological Survey (USGS) Water Quality Specialists in collaboration with the USGS National Water Quality Laboratory (NWQL) and the Branch of Quality Systems (BQS).Causes for trace-element concentrations in filtered samples to exceed those in associated unfiltered samples have been attributed to variability in analytical measurements, analytical bias, sample contamination either in the field or laboratory, and (or) sample-matrix chemistry. These issues have not only been attributed to data generated by the USGS NWQL but have been observed in data generated by other laboratories. This study continues the evaluation of potential analytical bias and error resulting from matrix chemistry and instrument variability by evaluating the performance of seven selected trace elements in paired filtered and unfiltered surface-water and groundwater samples collected from 23 sampling sites of varying chemistries from six States, matrix spike recoveries, and standard reference materials.Filtered and unfiltered samples have been routinely analyzed on separate inductively coupled plasma-mass spectrometry instruments. Unfiltered samples are treated with hydrochloric acid (HCl) during an in-bottle digestion procedure; filtered samples are not routinely treated with HCl as part of the laboratory analytical procedure. To evaluate the influence of HCl on different sample matrices, an aliquot of the filtered samples was treated with HCl. The addition of HCl did little to differentiate the analytical results between filtered samples treated with HCl from those samples left untreated; however, there was a small, but noticeable, decrease in the number of instances where a particular trace-element concentration was greater in a filtered sample than in the associated

European specialist porphyria laboratories: diagnostic strategies, analytical quality, clinical interpretation, and reporting as assessed by an external quality assurance program.

Science.gov (United States)

Aarsand, Aasne K; Villanger, Jørild H; Støle, Egil; Deybach, Jean-Charles; Marsden, Joanne; To-Figueras, Jordi; Badminton, Mike; Elder, George H; Sandberg, Sverre

2011-11-01

The porphyrias are a group of rare metabolic disorders whose diagnosis depends on identification of specific patterns of porphyrin precursor and porphyrin accumulation in urine, blood, and feces. Diagnostic tests for porphyria are performed by specialized laboratories in many countries. Data regarding the analytical and diagnostic performance of these laboratories are scarce. We distributed 5 sets of multispecimen samples from different porphyria patients accompanied by clinical case histories to 18-21 European specialist porphyria laboratories/centers as part of a European Porphyria Network organized external analytical and postanalytical quality assessment (EQA) program. The laboratories stated which analyses they would normally have performed given the case histories and reported results of all porphyria-related analyses available, interpretative comments, and diagnoses. Reported diagnostic strategies initially showed considerable diversity, but the number of laboratories applying adequate diagnostic strategies increased during the study period. We found an average interlaboratory CV of 50% (range 12%-152%) for analytes in absolute concentrations. Result normalization by forming ratios to the upper reference limits did not reduce this variation. Sixty-five percent of reported results were within biological variation-based analytical quality specifications. Clinical interpretation of the obtained analytical results was accurate, and most laboratories established the correct diagnosis in all distributions. Based on a case-based EQA scheme, variations were apparent in analytical and diagnostic performance between European specialist porphyria laboratories. Our findings reinforce the use of EQA schemes as an essential tool to assess both analytical and diagnostic processes and thereby to improve patient care in rare diseases.

222-S laboratory quality assurance plan

International Nuclear Information System (INIS)

Meznarich, H.K.

1995-01-01

This document provides quality assurance guidelines and quality control requirements for analytical services. This document is designed on the basis of Hanford Analytical Services Quality Assurance Plan (HASQAP) technical guidelines and is used for governing 222-S and 222-SA analytical and quality control activities. The 222-S Laboratory provides analytical services to various clients including, but not limited to, waste characterization for the Tank Waste Remediation Systems (TWRS), waste characterization for regulatory waste treatment, storage, and disposal (TSD), regulatory compliance samples, radiation screening, process samples, and TPA samples. A graded approach is applied on the level of sample custody, QC, data verification, and data reporting to meet the specific needs of the client

Preanalytical quality improvement : in quality we trust

OpenAIRE

Lippi, Giuseppe; Becan-McBride, Kathleen; Behulova, Darina; Bowen, Raffick A.; Church, Stephen; Delanghe, Joris; Grankvist, Kjell; Kitchen, Steve; Nybo, Mads; Nauck, Matthias; Nikolac, Nora; Palicka, Vladimir; Plebani, Mario; Sandberg, Sverre; Simundic, Ana-Maria

2013-01-01

Total quality in laboratory medicine should be defined as the guarantee that each activity throughout the total testing process is correctly performed, providing valuable medical decision-making and effective patient care. In the past decades, a 10-fold reduction in the analytical error rate has been achieved thanks to improvements in both reliability and standardization of analytical techniques, reagents, and instrumentation. Notable advances in information technology, quality control and qu...

IAEA Reference Materials for Quality Assurance: A Study in the Quality Control of Marine Radioactivity

International Nuclear Information System (INIS)

Pham Mai Khanh; Bartocci, J.; Gastaud, J.; Nies, H.; Vasileva, E.; Betti, M.; Chamizo, E.; Gomez-Guzman, J.-M.

2013-01-01

The IAEA's Marine Environment Laboratories has assisted laboratories in Analytical Quality Control Services (AQCS) for the analysis of radionuclides in the marine environment since the early seventies. The AQCS programme, now named Reference Products for Environment and Trade, is recognized as an essential component of quality assurance and control and for the development and validation of analytical methods, through its worldwide and regional interlaboratory comparisons and the provision of reference methods and Reference Materials/Certified Reference Materials (RMs/CRMs). A total of 49 interlaboratory exercises were organized and 42 RMs/CRMs were produced for marine radioactivity studies. Different techniques such as radiometric methods with X ray, gamma spectrometry, alpha spectrometry, beta counter, liquid scintillation counter as well as mass spectrometry (ICP-MS, AMS, TIMS) are applied for the characterization during certification process. An overview of prepared Certified Reference Materials (CRMs) for radionuclides in marine matrices will be presented as well as lessons learned from interlaboratory comparisons (ICs) and Proficiency Tests (PTs). A characterization of a new CRM for radionuclides in IAEA-446, Baltic Sea seaweed (Fucus vesiculosus), as well as a specific case of using Accelerator Mass Spectrometry (AMS) technique to characterize I-129 in sea water (IAEA-418) and seaweed sample (IAEA-446), will be discussed. Available RMs/CRMs are listed and can be ordered and purchased through the IAEA website http://nucleus.iaea.org/rpst/. (author)

IAEA Reference Materials for Quality Assurance: A Study in the Quality Control of Marine Radioactivity

Energy Technology Data Exchange (ETDEWEB)

Khanh, Pham Mai; Bartocci, J.; Gastaud, J.; Nies, H.; Vasileva, E.; Betti, M. [International Atomic Energy Agency, Environment Laboratory (Monaco); Chamizo, E.; Gomez-Guzman, J. -M. [Centro Nacional de Aceleradores, Seville (Spain)

2013-07-15

The IAEA's Marine Environment Laboratories has assisted laboratories in Analytical Quality Control Services (AQCS) for the analysis of radionuclides in the marine environment since the early seventies. The AQCS programme, now named Reference Products for Environment and Trade, is recognized as an essential component of quality assurance and control and for the development and validation of analytical methods, through its worldwide and regional interlaboratory comparisons and the provision of reference methods and Reference Materials/Certified Reference Materials (RMs/CRMs). A total of 49 interlaboratory exercises were organized and 42 RMs/CRMs were produced for marine radioactivity studies. Different techniques such as radiometric methods with X ray, gamma spectrometry, alpha spectrometry, beta counter, liquid scintillation counter as well as mass spectrometry (ICP-MS, AMS, TIMS) are applied for the characterization during certification process. An overview of prepared Certified Reference Materials (CRMs) for radionuclides in marine matrices will be presented as well as lessons learned from interlaboratory comparisons (ICs) and Proficiency Tests (PTs). A characterization of a new CRM for radionuclides in IAEA-446, Baltic Sea seaweed (Fucus vesiculosus), as well as a specific case of using Accelerator Mass Spectrometry (AMS) technique to characterize I-129 in sea water (IAEA-418) and seaweed sample (IAEA-446), will be discussed. Available RMs/CRMs are listed and can be ordered and purchased through the IAEA website http://nucleus.iaea.org/rpst/. (author)

Approximate analytical relationships for linear optimal aeroelastic flight control laws

Science.gov (United States)

Kassem, Ayman Hamdy

1998-09-01

This dissertation introduces new methods to uncover functional relationships between design parameters of a contemporary control design technique and the resulting closed-loop properties. Three new methods are developed for generating such relationships through analytical expressions: the Direct Eigen-Based Technique, the Order of Magnitude Technique, and the Cost Function Imbedding Technique. Efforts concentrated on the linear-quadratic state-feedback control-design technique applied to an aeroelastic flight control task. For this specific application, simple and accurate analytical expressions for the closed-loop eigenvalues and zeros in terms of basic parameters such as stability and control derivatives, structural vibration damping and natural frequency, and cost function weights are generated. These expressions explicitly indicate how the weights augment the short period and aeroelastic modes, as well as the closed-loop zeros, and by what physical mechanism. The analytical expressions are used to address topics such as damping, nonminimum phase behavior, stability, and performance with robustness considerations, and design modifications. This type of knowledge is invaluable to the flight control designer and would be more difficult to formulate when obtained from numerical-based sensitivity analysis.

Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories.

Science.gov (United States)

Chen, Ming-Shu; Wu, Ming-Hsun; Lin, Chih-Ming

2014-04-30

The traditional criteria for acceptability of analytic quality may not be objective in clinical laboratories. To establish quality control procedures intended to enhance Westgard multi-rules for improving the quality of clinical biochemistry tests, we applied the Cp and Cpk quality-control indices to monitor tolerance fitting and systematic variation of clinical biochemistry test results. Daily quality-control data of a large Taiwanese hospital in 2009 were analyzed. The test items were selected based on an Olympus biochemistry machine and included serum albumin, aspartate aminotransferase, cholesterol, glucose and potassium levels. Cp and Cpk values were calculated for normal and abnormal levels, respectively. The tolerance range was estimated with data from 50 laboratories using the same instruments and reagents. The results showed a monthly trend of variation for the five items under investigation. The index values of glucose were lower than those of the other items, and their values were usually quality control, but also for revealing inter-laboratory qualitycontrol capability differences.

Hybrid Analytical and Data-Driven Modeling for Feed-Forward Robot Control.

Science.gov (United States)

Reinhart, René Felix; Shareef, Zeeshan; Steil, Jochen Jakob

2017-02-08

Feed-forward model-based control relies on models of the controlled plant, e.g., in robotics on accurate knowledge of manipulator kinematics or dynamics. However, mechanical and analytical models do not capture all aspects of a plant's intrinsic properties and there remain unmodeled dynamics due to varying parameters, unmodeled friction or soft materials. In this context, machine learning is an alternative suitable technique to extract non-linear plant models from data. However, fully data-based models suffer from inaccuracies as well and are inefficient if they include learning of well known analytical models. This paper thus argues that feed-forward control based on hybrid models comprising an analytical model and a learned error model can significantly improve modeling accuracy. Hybrid modeling here serves the purpose to combine the best of the two modeling worlds. The hybrid modeling methodology is described and the approach is demonstrated for two typical problems in robotics, i.e., inverse kinematics control and computed torque control. The former is performed for a redundant soft robot and the latter for a rigid industrial robot with redundant degrees of freedom, where a complete analytical model is not available for any of the platforms.

Analytical Chemistry Division annual progress report for period ending December 31, 1992

Energy Technology Data Exchange (ETDEWEB)

Shults, W.D.

1993-04-01

This report is divided into: Analytical spectroscopy (optical spectroscopy, organic mass spectrometry, inorganic mass spectrometry, secondary ion mass spectrometry), inorganic and radiochemistry (transuranium and activation analysis, low-level radiochemical analysis, inorganic analysis, radioactive materials analysis, special projects), organic chemistry (organic spectroscopy, separations and synthesis, special projects, organic analysis, ORNL/UT research program), operations (quality assurance/quality control, environmental protection, safety, analytical improvement, training, radiation control), education programs, supplementary activities, and presentation of research results. Tables are included for articles reviewed or refereed for periodicals, analytical service work, division manpower and financial summary, and organization chart; a glossary is also included.

Establishment of a quality control system of coals; Establecimiento de una Metodologia de Aseguramiento de Calidad en el Analisis de Carbones

Energy Technology Data Exchange (ETDEWEB)

1999-09-01

The pain propose of this project is the establishment of a quality control system in order to assure the feasibility of analytic data used in commercial valorization coals. The programme of quality assurement takes into account the following concepts: - Normalization of analytic methods. - Maintenance and measurements of analysis equipment - Standardization of analysis process. - Quality control inside of laboratory - Standardization of measurement systems between laboratories - External audits of quality process. - Accreditation of alternative systems. - Personnel education necessities. In order to be an useful tool, the programme has been consider under this three aspects: reliableness, rapidness, and simpleness. The process is based in: validation of method, validation of origin, and validation by coherence. All that is integrated in an informatic system. (Author)

Analytical Model-based Fault Detection and Isolation in Control Systems

DEFF Research Database (Denmark)

Vukic, Z.; Ozbolt, H.; Blanke, M.

1998-01-01

The paper gives an introduction and an overview of the field of fault detection and isolation for control systems. The summary of analytical (quantitative model-based) methodds and their implementation are presented. The focus is given to mthe analytical model-based fault-detection and fault...

Can a combination of average of normals and "real time" External Quality Assurance replace Internal Quality Control?

Science.gov (United States)

Badrick, Tony; Graham, Peter

2018-03-28

Internal Quality Control and External Quality Assurance are separate but related processes that have developed independently in laboratory medicine over many years. They have different sample frequencies, statistical interpretations and immediacy. Both processes have evolved absorbing new understandings of the concept of laboratory error, sample material matrix and assay capability. However, we do not believe at the coalface that either process has led to much improvement in patient outcomes recently. It is the increasing reliability and automation of analytical platforms along with improved stability of reagents that has reduced systematic and random error, which in turn has minimised the risk of running less frequent IQC. We suggest that it is time to rethink the role of both these processes and unite them into a single approach using an Average of Normals model supported by more frequent External Quality Assurance samples. This new paradigm may lead to less confusion for laboratory staff and quicker responses to and identification of out of control situations.

A Process Analytical Technology (PAT) approach to control a new API manufacturing process: development, validation and implementation.

Science.gov (United States)

Schaefer, Cédric; Clicq, David; Lecomte, Clémence; Merschaert, Alain; Norrant, Edith; Fotiadu, Frédéric

2014-03-01

Pharmaceutical companies are progressively adopting and introducing Process Analytical Technology (PAT) and Quality-by-Design (QbD) concepts promoted by the regulatory agencies, aiming the building of the quality directly into the product by combining thorough scientific understanding and quality risk management. An analytical method based on near infrared (NIR) spectroscopy was developed as a PAT tool to control on-line an API (active pharmaceutical ingredient) manufacturing crystallization step during which the API and residual solvent contents need to be precisely determined to reach the predefined seeding point. An original methodology based on the QbD principles was designed to conduct the development and validation of the NIR method and to ensure that it is fitted for its intended use. On this basis, Partial least squares (PLS) models were developed and optimized using chemometrics methods. The method was fully validated according to the ICH Q2(R1) guideline and using the accuracy profile approach. The dosing ranges were evaluated to 9.0-12.0% w/w for the API and 0.18-1.50% w/w for the residual methanol. As by nature the variability of the sampling method and the reference method are included in the variability obtained for the NIR method during the validation phase, a real-time process monitoring exercise was performed to prove its fit for purpose. The implementation of this in-process control (IPC) method on the industrial plant from the launch of the new API synthesis process will enable automatic control of the final crystallization step in order to ensure a predefined quality level of the API. In addition, several valuable benefits are expected including reduction of the process time, suppression of a rather difficult sampling and tedious off-line analyses. © 2013 Published by Elsevier B.V.

Web Analytics

Science.gov (United States)

EPA’s Web Analytics Program collects, analyzes, and provides reports on traffic, quality assurance, and customer satisfaction metrics for EPA’s website. The program uses a variety of analytics tools, including Google Analytics and CrazyEgg.

Quality Assurance of Chemical Measurements.

Science.gov (United States)

Taylor, John K.

1981-01-01

Reviews aspects of quality control (methods to control errors) and quality assessment (verification that systems are operating within acceptable limits) including an analytical measurement system, quality control by inspection, control charts, systematic errors, and use of SRMs, materials for which properties are certified by the National Bureau…

Quality Management, Quality Assurance and Quality Control in Blood Establishments

OpenAIRE

Bolbate, N

2008-01-01

Quality terms and the roots of the matter are analyzed according to European Committee’s recommendations. Essence of process and product quality control as well as essence of quality assurance is described. Quality system’s structure including quality control, quality assurance and management is justified in the article.

A device for automatic photoelectric control of the analytical gap for emission spectrographs

Science.gov (United States)

Dietrich, John A.; Cooley, Elmo F.; Curry, Kenneth J.

1977-01-01

A photoelectric device has been built that automatically controls the analytical gap between electrodes during excitation period. The control device allows for precise control of the analytical gap during the arcing process of samples, resulting in better precision of analysis.

Analytical verification and quality assessment of the Tosoh HLC-723GX HbA1c analyzer

Directory of Open Access Journals (Sweden)

Marko Ris

2017-04-01

Full Text Available Objectives: Ion-exchange high-performance liquid chromatography (IE-HPLC has long been used as a reproducible and versatile analytical tool for HbA1c measurement.In this study, we performed analytical verification and quality assessment of the recently introduced small IE-HPLC Tosoh HLC-723GX HbA1c analyzer, and a comparison of results to immunoassay (IA and capillary electrophoresis (CE. Design and methods: The total imprecision of Tosoh HLC-723GX was verified according to CLSI EP15-A2 protocol using commercial control materials (C-QC and pooled human whole blood samples (HWB. The Sigma metric was used for the evaluation of quality targets. HbA1c results were compared to automated CE (MiniCap Flex Piercing, Sebia, France and IA (Tina-quant HbA1c Gen 2, Cobas Integra 400+, Roche Diagnostics, USA procedures. Results: The total imprecision of Tosoh HLC-723GX-HbA1c for IFCC(mmol/mol and NGSP(% units was: 1.91/1.25% (HbA1c=31 mmol/mol/5.0% and 0.51/0.63% (HbA1c=84 mmol/mol/9.8% for C-QC, and 0.39/0.2% (HbA1c=47 mmol/mol/6.5% and 0.77/0.46% (HbA1c=94 mmol/mol/10.8% in HWB samples, respectively. Bland-Altman analysis did not reveal any deviation of the results between Tosoh HLC-723GX and CE: mean difference 0.0% (95%CI: −0.02927 to 0.02653%, while the mean HbA1c difference against IA was −0.07% (95%CI: −0.1039 to −0.02765. At the selected HbA1c clinical decision level (48 mmol/mol/6,5%, six sigma analysis gave σ value of 3.91, within a desirable classification of performance. Conclusion: The analytical performance of the Tosoh HLC-723GX complies with the rigorous quality criteria for clinical use of HbA1c, with the results comparable to the CE procedure. Tosoh HLC-723GX provides a plausible analytical choice for reliable HbA1c measurement in low-volume laboratories. Keywords: HbA1c, Quality targets, Six sigma, Tosoh HLC-723GX analyzer

Express quality control of chicken eggs by machine vision

Science.gov (United States)

Gorbunova, Elena V.; Chertov, Aleksandr N.; Peretyagin, Vladimir S.; Korotaev, Valery V.; Arbuzova, Evgeniia A.

2017-06-01

The urgency of the task of analyzing the foodstuffs quality is determined by the strategy for the formation of a healthy lifestyle and the rational nutrition of the world population. This applies to products, such as chicken eggs. In particular, it is necessary to control the chicken eggs quality at the farm production prior to incubation in order to eliminate the possible hereditary diseases, as well as high embryonic mortality and a sharp decrease in the quality of the bred young. Up to this day, in the market there are no objective instruments of contactless express quality control as analytical equipment that allow the high-precision quality examination of the chicken eggs, which is determined by the color parameters of the eggshell (color uniformity) and yolk of eggs, and by the presence in the eggshell of various defects (cracks, growths, wrinkles, dirty). All mentioned features are usually evaluated only visually (subjectively) with the help of normalized color standards and ovoscopes. Therefore, this work is devoted to the investigation of the application opportunities of contactless express control method with the help of technical vision to implement the chicken eggs' quality analysis. As a result of the studies, a prototype with the appropriate software was proposed. Experimental studies of this equipment on a representative sample of eggs from chickens of different breeds have been carried out (the total number of analyzed samples exceeds 300 pieces). The correctness of the color analysis was verified by spectrophotometric studies of the surface of the eggshell.

High perfomance liquid chromatography fingerprint analysis for quality control of brotowali (Tinospora crispa)

Science.gov (United States)

Syarifah, V. B.; Rafi, M.; Wahyuni, W. T.

2017-05-01

Brotowali (Tinospora crispa) is widely used in Indonesia as ingredient of herbal medicine formulation. To ensure the quality, safety, and efficacy of herbal medicine products, its chemical constituents should be continuously evaluated. High performance liquid chromatography (HPLC) fingerprint is one of powerful technique for this quality control process. In this study, HPLC fingerprint analysis method was developed for quality control of brotowali. HPLC analysis was performed in C18 column and detection was performed using photodiode array detector. The optimum mobile phase for brotowali fingerprint was acetonitrile (ACN) and 0.1% formic acid in gradient elution mode at a flow rate of 1 mL/min. The number of peaks detected in HPLC fingerprint of brotowali was 32 peaks and 23 peaks for stems and leaves, respectively. Berberine as marker compound was detected at retention time of 20.525 minutes. Evaluation of analytical performance including precision, reproducibility, and stability prove that this HPLC fingerprint analysis was reliable and could be applied for quality control of brotowali.

Modelling quality dynamics on business value and firm performance in big data analytics environment

OpenAIRE

Ji-fan Ren, S; Fosso Wamba, S; Akter, S; Dubey, R; Childe, SJ

2017-01-01

Big data analytics have become an increasingly important component for firms across advanced economies. This paper examines the quality dynamics in big data environment that are linked with enhancing business value and firm performance. The study identifies that system quality (i.e., system reliability, accessibility, adaptability, integration, response time and privacy) and information quality (i.e., completeness, accuracy, format and currency) are key to enhance business value and firm perf...

Evaluation of controls for the assurance of quality data in a radiochemistry laboratory

International Nuclear Information System (INIS)

Morton, J.S.

1993-01-01

The paper describes the controls implemented by the U.S. Department of Energy (DOE) at the Radiological and Environmental Sciences Laboratory (RESL) to secure data quality. A description of the analytical instrumentation and methodology employed by RESL is provided. The results of the intercomparison program with the National Institute of Standards and Technology (NIST) are provided to demonstrate traceability to a primary source. A description of the methods and techniques used to ensure quality control on a daily basis is given. The techniques used to evaluate the sources of uncertainty are reviewed and specific examples cited. The intercomparison programs operated by RESL are discussed

Evaluation of controls for the assurance of quality data in a radiochemistry laboratory

Energy Technology Data Exchange (ETDEWEB)

Morton, J.S. [Radiological and Environmental Sciences Lab., Idaho Falls, ID (United States)

1993-12-31

The paper describes the controls implemented by the U.S. Department of Energy (DOE) at the Radiological and Environmental Sciences Laboratory (RESL) to secure data quality. A description of the analytical instrumentation and methodology employed by RESL is provided. The results of the intercomparison program with the National Institute of Standards and Technology (NIST) are provided to demonstrate traceability to a primary source. A description of the methods and techniques used to ensure quality control on a daily basis is given. The techniques used to evaluate the sources of uncertainty are reviewed and specific examples cited. The intercomparison programs operated by RESL are discussed.

Analytical optimization of active bandwidth and quality factor for TOCSY experiments in NMR spectroscopy

Energy Technology Data Exchange (ETDEWEB)

Coote, Paul, E-mail: paul-coote@hms.harvard.edu [Harvard Medical School (United States); Bermel, Wolfgang [Bruker BioSpin GmbH (Germany); Wagner, Gerhard; Arthanari, Haribabu, E-mail: hari@hms.harvard.edu [Harvard Medical School (United States)

2016-09-15

Active bandwidth and global quality factor are the two main metrics used to quantitatively compare the performance of TOCSY mixing sequences. Active bandwidth refers to the spectral region over which at least 50 % of the magnetization is transferred via a coupling. Global quality factor scores mixing sequences according to the worst-case transfer over a range of possible mixing times and chemical shifts. Both metrics reward high transfer efficiency away from the main diagonal of a two-dimensional spectrum. They can therefore be used to design mixing sequences that will function favorably in experiments. Here, we develop optimization methods tailored to these two metrics, including precise control of off-diagonal cross peak buildup rates. These methods produce square shaped transfer efficiency profiles, directly matching the desirable properties that the metrics are intended to measure. The optimization methods are analytical, rather than numerical. The two resultant shaped pulses have significantly higher active bandwidth and quality factor, respectively, than all other known sequences. They are therefore highly suitable for use in NMR spectroscopy. We include experimental verification of these improved waveforms on small molecule and protein samples.

Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory.

Science.gov (United States)

Kumar, B Vinodh; Mohan, Thuthi

2018-01-01

Six Sigma is one of the most popular quality management system tools employed for process improvement. The Six Sigma methods are usually applied when the outcome of the process can be measured. This study was done to assess the performance of individual biochemical parameters on a Sigma Scale by calculating the sigma metrics for individual parameters and to follow the Westgard guidelines for appropriate Westgard rules and levels of internal quality control (IQC) that needs to be processed to improve target analyte performance based on the sigma metrics. This is a retrospective study, and data required for the study were extracted between July 2015 and June 2016 from a Secondary Care Government Hospital, Chennai. The data obtained for the study are IQC - coefficient of variation percentage and External Quality Assurance Scheme (EQAS) - Bias% for 16 biochemical parameters. For the level 1 IQC, four analytes (alkaline phosphatase, magnesium, triglyceride, and high-density lipoprotein-cholesterol) showed an ideal performance of ≥6 sigma level, five analytes (urea, total bilirubin, albumin, cholesterol, and potassium) showed an average performance of sigma level and for level 2 IQCs, same four analytes of level 1 showed a performance of ≥6 sigma level, and four analytes (urea, albumin, cholesterol, and potassium) showed an average performance of sigma level. For all analytes sigma level, the quality goal index (QGI) was 1.2 indicated inaccuracy. This study shows that sigma metrics is a good quality tool to assess the analytical performance of a clinical chemistry laboratory. Thus, sigma metric analysis provides a benchmark for the laboratory to design a protocol for IQC, address poor assay performance, and assess the efficiency of existing laboratory processes.

Moving standard deviation and moving sum of outliers as quality tools for monitoring analytical precision.

Science.gov (United States)

Liu, Jiakai; Tan, Chin Hon; Badrick, Tony; Loh, Tze Ping

2018-02-01

An increase in analytical imprecision (expressed as CV a ) can introduce additional variability (i.e. noise) to the patient results, which poses a challenge to the optimal management of patients. Relatively little work has been done to address the need for continuous monitoring of analytical imprecision. Through numerical simulations, we describe the use of moving standard deviation (movSD) and a recently described moving sum of outlier (movSO) patient results as means for detecting increased analytical imprecision, and compare their performances against internal quality control (QC) and the average of normal (AoN) approaches. The power of detecting an increase in CV a is suboptimal under routine internal QC procedures. The AoN technique almost always had the highest average number of patient results affected before error detection (ANPed), indicating that it had generally the worst capability for detecting an increased CV a . On the other hand, the movSD and movSO approaches were able to detect an increased CV a at significantly lower ANPed, particularly for measurands that displayed a relatively small ratio of biological variation to CV a. CONCLUSION: The movSD and movSO approaches are effective in detecting an increase in CV a for high-risk measurands with small biological variation. Their performance is relatively poor when the biological variation is large. However, the clinical risks of an increase in analytical imprecision is attenuated for these measurands as an increased analytical imprecision will only add marginally to the total variation and less likely to impact on the clinical care. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

National Survey on Internal Quality Control for HbA(1c) Analytical Instruments in 331 Hospital Laboratories of China.

Science.gov (United States)

Zeng, Rong; Wang, Wei; Zhao, Haijian; Fei, Yang; Wang, Zhiguo

2015-01-01

The narrow gap of HbA1 value of mass fraction between "normal" (control of inter-assay standardization, assay precision, and trueness. This survey was initiated to obtain knowledge of the current situation of internal quality control (IQC) practice for HbA(1c) in China and find out the most appropriate quality specifications. Data of IQC for HbA(1c) in 331 institutions participating in the national proficiency testing (PT) programs in China were evaluated using four levels of quality specifications, and the percentages of laboratories meeting the quality requirement were calculated to find out the most appropriate quality specifications for control materials of HbA(1c) in China. The IQC data varied vastly among 331 clinical laboratories in China. The measurement of control materials covered a wide range from 4.52% to 12.24% (inter-quartile range) and there were significant differences among the CVs of different methods, including LPLC, CE-HPLC, AC-HPLC, immunoturbidimetry, and others. Among the four main methods, CE-HPLC and AC-HPLC achieved a better precision. As we can see, the performance of laboratories for HbA(1c) has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.

Service Quality of Online Shopping Platforms: A Case-Based Empirical and Analytical Study

Directory of Open Access Journals (Sweden)

Tsan-Ming Choi

2013-01-01

Full Text Available Customer service is crucially important for online shopping platforms (OSPs such as eBay and Taobao. Based on the well-established service quality instruments and the scenario of the specific case on Taobao, this paper focuses on exploring the service quality of an OSP with an aim of revealing customer perceptions of the service quality associated with the provided functions and investigating their impacts on customer loyalty. By an empirical study, this paper finds that the “fulfillment and responsiveness” function is significantly related to the customer loyalty. Further analytical study is conducted to reveal that the optimal service level on the “fulfillment and responsiveness” function for the risk averse OSP uniquely exists. Moreover, the analytical results prove that (i if the customer loyalty is more positively correlated to the service level, it will lead to a larger optimal service level, and (ii the optimal service level is independent of the profit target, the source of uncertainty, and the risk preference of the OSP.

Evaluating supplier quality performance using fuzzy analytical hierarchy process

Science.gov (United States)

Ahmad, Nazihah; Kasim, Maznah Mat; Rajoo, Shanmugam Sundram Kalimuthu

2014-12-01

Evaluating supplier quality performance is vital in ensuring continuous supply chain improvement, reducing the operational costs and risks towards meeting customer's expectation. This paper aims to illustrate an application of Fuzzy Analytical Hierarchy Process to prioritize the evaluation criteria in a context of automotive manufacturing in Malaysia. Five main criteria were identified which were quality, cost, delivery, customer serviceand technology support. These criteria had been arranged into hierarchical structure and evaluated by an expert. The relative importance of each criteria was determined by using linguistic variables which were represented as triangular fuzzy numbers. The Center of Gravity defuzzification method was used to convert the fuzzy evaluations into their corresponding crisps values. Such fuzzy evaluation can be used as a systematic tool to overcome the uncertainty evaluation of suppliers' performance which usually associated with human being subjective judgments.

Using complaints to enhance quality improvement: developing an analytical tool.

Science.gov (United States)

Hsieh, Sophie Yahui

2012-01-01

This study aims to construct an instrument for identifying certain attributes or capabilities that might enable healthcare staff to use complaints to improve service quality. PubMed and ProQuest were searched, which in turn expanded access to other literature. Three paramount dimensions emerged for healthcare quality management systems: managerial, operational, and technical (MOT). The paper reveals that the managerial dimension relates to quality improvement program infrastructure. It contains strategy, structure, leadership, people and culture. The operational dimension relates to implementation processes: organizational changes and barriers when using complaints to enhance quality. The technical dimension emphasizes the skills, techniques or information systems required to achieve successfully continuous quality improvement. The MOT model was developed by drawing from the relevant literature. However, individuals have different training, interests and experiences and, therefore, there will be variance between researchers when generating the MOT model. The MOT components can be the guidelines for examining whether patient complaints are used to improve service quality. However, the model needs testing and validating by conducting further research before becoming a theory. Empirical studies on patient complaints did not identify any analytical tool that could be used to explore how complaints can drive quality improvement. This study developed an instrument for identifying certain attributes or capabilities that might enable healthcare professionals to use complaints and improve service quality.

Analytical method development and validation for quantification of uranium by Fourier Transform Infrared Spectroscopy (FTIR) for routine quality control analysis

International Nuclear Information System (INIS)

Pereira, Elaine; Silva, Ieda de S.; Gomide, Ricardo G.; Pires, Maria Aparecida F.

2015-01-01

This work presents a low cost, simple and new methodology for direct determination uranium in different matrices uranium: organic phase (UO 2 (NO 3 ) 2 .2TBP - uranyl nitrate complex) and aqueous phase (UO 2 (NO 3 ) 2 - NTU - uranyl nitrate), based on Fourier Transform Infrared spectroscopy (FTIR) using KBr pellets technique. The analytical validation is essential to define if a developed methodology is completely adjusted to the objectives that it is destined and is considered one of the main instruments of quality control. The parameters used in the validation process were: selectivity, linearity, limits of detection (LD) and quantitation (LQ), precision (repeatability and intermediate precision), accuracy and robustness. The method for uranium in organic phase (UO 2 (NO 3 ) 2 .2TBP in hexane/embedded in KBr) was linear (r=0.9989) over the range of 1.0 g L -1 a 14.3 g L -1 , LD were 92.1 mg L -1 and LQ 113.1 mg L -1 , precision (RSD < 1.6% and p-value < 0.05), accurate (recovery of 100.1% - 102.9%). The method for uranium aqueous phase (UO 2 (NO 3 )2/embedded in KBr) was linear (r=0.9964) over the range of 5.4 g L -1 a 51.2 g L -1 , LD were 835 mg L -1 and LQ 958 mg L -1 , precision (RSD < 1.0% and p-value < 0.05), accurate (recovery of 99.1% - 102.0%). The FTIR method is robust regarding most of the variables analyzed, as the difference between results obtained under nominal and modified conditions were lower than the critical value for all analytical parameters studied. Some process samples were analyzed in FTIR and compared with gravimetric and x ray fluorescence (XRF) analyses showing similar results in all three methods. The statistical tests (Student-t and Fischer) showed that the techniques are equivalent. (author)

Results of quality control surveys of radioimmunological determinations of thyrotropin in newborns

International Nuclear Information System (INIS)

Roehle, G.; Kruse, R.; Voigt, U.; Torresani, T.

1983-01-01

Within the quality control scheme of the Deutsche Gesellschaft fuer Klinische Chemie, seven quality control surveys of thyrotropin (TSH) determinations in blood dried on filter paper have been carried out since 1980. Ninety-six screening laboratories from 12 European countries took part in these surveys. In a single survey each participant usually analysed four different samples; each of these consisted of three spots of dried blood spiked with defined amounts of thyrotropin. For the evaluations of the surveys the participants were asked to give information about their analytical results, and from these, their diagnostic classifications. The medians of the analytical results correlated well with the given thyrotropin concentrations, but the individual estimations from different laboratories varied greatly. Major discrepancies of classification were also apparent, both in the given thyrotropin concentrations and in the individual estimations. Two special collaborative studies with nine selected laboratories showed on the one hand that analysis of the largest possible part of the dried blood sample can help to optimize the precision of the results; on the other hand, considerable drawbacks related to the reagents and the methods were sometimes observed. (orig.) [de

Principles and Practices for Quality Assurance and Quality Control

Science.gov (United States)

Jones, Berwyn E.

1999-01-01

Quality assurance and quality control are vital parts of highway runoff water-quality monitoring projects. To be effective, project quality assurance must address all aspects of the project, including project management responsibilities and resources, data quality objectives, sampling and analysis plans, data-collection protocols, data quality-control plans, data-assessment procedures and requirements, and project outputs. Quality control ensures that the data quality objectives are achieved as planned. The historical development and current state of the art of quality assurance and quality control concepts described in this report can be applied to evaluation of data from prior projects.

Checking quality control?

DEFF Research Database (Denmark)

Brodersen, Lars

2005-01-01

How is quality control doing within the community of GIS, web-services based on geo-information, GI etc.?......How is quality control doing within the community of GIS, web-services based on geo-information, GI etc.?...

Minimum analytical quality specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers.

Science.gov (United States)

Ricós, Carmen; Ramón, Francisco; Salas, Angel; Buño, Antonio; Calafell, Rafael; Morancho, Jorge; Gutiérrez-Bassini, Gabriella; Jou, Josep M

2011-11-18

Four Spanish scientific societies organizing external quality assessment programs (EQAP) formed a working group to promote the use of common minimum quality specifications for clinical tests. Laboratories that do not meet the minimum specifications are encouraged to make immediate review of the analytical procedure affected and to implement corrective actions if necessary. The philosophy was to use the 95th percentile of results sent to EQAP (expressed in terms of percentage deviation from the target value) obtained for all results (except the outliers) during a cycle of 1 year. The target value for a number of analytes of the basic biochemistry program was established as the overall mean. However, because of the substantial discrepancies between routine methods for basic hematology, hormones, proteins, therapeutic drugs and tumor markers, the target in these cases was the peer group mean. The resulting specifications were quite similar to those established in the US (CLIA), and Germany (Richtlinie). The proposed specifications stand for the minimum level of quality to be attained for laboratories, to assure harmonized service performance. They have nothing to do with satisfying clinical requirements, which are the final level of quality to be reached, and that is strongly recommended in our organizations by means of documents, courses, symposiums and all types of educational activities.

Hybrid Analytical and Data-Driven Modeling for Feed-Forward Robot Control †

Directory of Open Access Journals (Sweden)

René Felix Reinhart

2017-02-01

Full Text Available Feed-forward model-based control relies on models of the controlled plant, e.g., in robotics on accurate knowledge of manipulator kinematics or dynamics. However, mechanical and analytical models do not capture all aspects of a plant’s intrinsic properties and there remain unmodeled dynamics due to varying parameters, unmodeled friction or soft materials. In this context, machine learning is an alternative suitable technique to extract non-linear plant models from data. However, fully data-based models suffer from inaccuracies as well and are inefficient if they include learning of well known analytical models. This paper thus argues that feed-forward control based on hybrid models comprising an analytical model and a learned error model can significantly improve modeling accuracy. Hybrid modeling here serves the purpose to combine the best of the two modeling worlds. The hybrid modeling methodology is described and the approach is demonstrated for two typical problems in robotics, i.e., inverse kinematics control and computed torque control. The former is performed for a redundant soft robot and the latter for a rigid industrial robot with redundant degrees of freedom, where a complete analytical model is not available for any of the platforms.

Hybrid Analytical and Data-Driven Modeling for Feed-Forward Robot Control †

Science.gov (United States)

Reinhart, René Felix; Shareef, Zeeshan; Steil, Jochen Jakob

2017-01-01

Feed-forward model-based control relies on models of the controlled plant, e.g., in robotics on accurate knowledge of manipulator kinematics or dynamics. However, mechanical and analytical models do not capture all aspects of a plant’s intrinsic properties and there remain unmodeled dynamics due to varying parameters, unmodeled friction or soft materials. In this context, machine learning is an alternative suitable technique to extract non-linear plant models from data. However, fully data-based models suffer from inaccuracies as well and are inefficient if they include learning of well known analytical models. This paper thus argues that feed-forward control based on hybrid models comprising an analytical model and a learned error model can significantly improve modeling accuracy. Hybrid modeling here serves the purpose to combine the best of the two modeling worlds. The hybrid modeling methodology is described and the approach is demonstrated for two typical problems in robotics, i.e., inverse kinematics control and computed torque control. The former is performed for a redundant soft robot and the latter for a rigid industrial robot with redundant degrees of freedom, where a complete analytical model is not available for any of the platforms. PMID:28208697

Extra-analytical quality indicators and laboratory performances.

Science.gov (United States)

Sciacovelli, Laura; Aita, Ada; Plebani, Mario

2017-07-01

In the last few years much progress has been made in raising the awareness of laboratory medicine professionals about the effectiveness of quality indicators (QIs) in monitoring, and improving upon, performances in the extra-analytical phases of the Total Testing Process (TTP). An effective system for management of QIs includes the implementation of an internal assessment system and participation in inter-laboratory comparison. A well-designed internal assessment system allows the identification of critical activities and their systematic monitoring. Active participation in inter-laboratory comparison provides information on the performance level of one laboratory with respect to that of other participating laboratories. In order to guarantee the use of appropriate QIs and facilitate their implementation, many laboratories have adopted the Model of Quality Indicators (MQI) proposed by Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of IFCC, since 2008, which is the result of international consensus and continuous experimentation, and updating to meet new, constantly emerging needs. Data from participating laboratories are collected monthly and reports describing the statistical results and evaluating laboratory data, utilizing the Six Sigma metric, issued regularly. Although the results demonstrate that the processes need to be improved upon, overall the comparison with data collected in 2014 shows a general stability of quality levels and that an improvement has been achieved over time for some activities. The continuous monitoring of QI data allows identification all possible improvements, thus highlighting the value of participation in the inter-laboratory program proposed by WG-LEPS. The active participation of numerous laboratories will guarantee an ever more significant State-of-the-Art, promote the reduction of errors and improve quality of the TTP, thus guaranteeing patient safety. Copyright © 2017. Published by Elsevier Inc.

Recent applications of Chemical Imaging to pharmaceutical process monitoring and quality control.

Science.gov (United States)

Gowen, A A; O'Donnell, C P; Cullen, P J; Bell, S E J

2008-05-01

Chemical Imaging (CI) is an emerging platform technology that integrates conventional imaging and spectroscopy to attain both spatial and spectral information from an object. Vibrational spectroscopic methods, such as Near Infrared (NIR) and Raman spectroscopy, combined with imaging are particularly useful for analysis of biological/pharmaceutical forms. The rapid, non-destructive and non-invasive features of CI mark its potential suitability as a process analytical tool for the pharmaceutical industry, for both process monitoring and quality control in the many stages of drug production. This paper provides an overview of CI principles, instrumentation and analysis. Recent applications of Raman and NIR-CI to pharmaceutical quality and process control are presented; challenges facing CI implementation and likely future developments in the technology are also discussed.

Gradient Optimization for Analytic conTrols - GOAT

Science.gov (United States)

Assémat, Elie; Machnes, Shai; Tannor, David; Wilhelm-Mauch, Frank

Quantum optimal control becomes a necessary step in a number of studies in the quantum realm. Recent experimental advances showed that superconducting qubits can be controlled with an impressive accuracy. However, most of the standard optimal control algorithms are not designed to manage such high accuracy. To tackle this issue, a novel quantum optimal control algorithm have been introduced: the Gradient Optimization for Analytic conTrols (GOAT). It avoids the piecewise constant approximation of the control pulse used by standard algorithms. This allows an efficient implementation of very high accuracy optimization. It also includes a novel method to compute the gradient that provides many advantages, e.g. the absence of backpropagation or the natural route to optimize the robustness of the control pulses. This talk will present the GOAT algorithm and a few applications to transmons systems.

Quality control and quality assurance of nuclear analytical techniques. Thematic planning of QC/QA in technical co-operations. Report of the external participants

International Nuclear Information System (INIS)

Innes, R.W.; Bode, P.; Brickenkamp, C.S.; Casa, A.; Abdul Khalik Haji Wood

1998-02-01

In areas of trade, health, safety, and environmental protection users of a laboratory's analytical results, for example by governments and private institutions, are increasingly requiring demonstrable proof of the reliability and credibility of the laboratory's analytical results using internationally accepted standards. This is so that the products and the decisions based on these laboratory results will be accepted in the respective national and international communities. These requirements are being imposed, for example by the European Community and others, for products to be imported and can be a significant barrier to trade, especially for developing nations. In addition to this there is a growing need for these laboratories to operate efficiently and effectively to reduce internal waste, to provide reports on time in an economical manner and to become self supporting. The need for change is global and this proposal is for the Agency to pursue a thematic plan for the implementation of quality assurance as partners in development with the selected laboratories using nuclear analytical techniques. This report describes a model project for this thematic approach to confirm the models immediate benefits as well as facilitating long-term sustainability of member states' laboratories. The model is thematic in that it is also applicable to all other projects for which the credibility and reliability of the results of a laboratory's processes and results must be demonstrated. This model project provides a cost effective approach for protecting the Agency's investment in these laboratories and strengthening the ability of these national institutions to define, organize, and manage the application of nuclear technology in their respective countries. This pilot project consists of (1) determining the general levels of knowledge and application of quality assurance principles (as delineated in ISO Guide 25) in the responding laboratories; (2) selecting a trail group of

Direct analysis in real time mass spectrometry and multivariate data analysis: a novel approach to rapid identification of analytical markers for quality control of traditional Chinese medicine preparation.

Science.gov (United States)

Zeng, Shanshan; Wang, Lu; Chen, Teng; Wang, Yuefei; Mo, Huanbiao; Qu, Haibin

2012-07-06

The paper presents a novel strategy to identify analytical markers of traditional Chinese medicine preparation (TCMP) rapidly via direct analysis in real time mass spectrometry (DART-MS). A commonly used TCMP, Danshen injection, was employed as a model. The optimal analysis conditions were achieved by measuring the contribution of various experimental parameters to the mass spectra. Salvianolic acids and saccharides were simultaneously determined within a single 1-min DART-MS run. Furthermore, spectra of Danshen injections supplied by five manufacturers were processed with principal component analysis (PCA). Obvious clustering was observed in the PCA score plot, and candidate markers were recognized from the contribution plots of PCA. The suitability of potential markers was then confirmed by contrasting with the results of traditional analysis methods. Using this strategy, fructose, glucose, sucrose, protocatechuic aldehyde and salvianolic acid A were rapidly identified as the markers of Danshen injections. The combination of DART-MS with PCA provides a reliable approach to the identification of analytical markers for quality control of TCMP. Copyright © 2012 Elsevier B.V. All rights reserved.

Aroma analysis and quality control of food using highly sensitive analytical methods

International Nuclear Information System (INIS)

Mayr, D.

2003-02-01

This thesis deals with the development of quality control methods for food based on headspace measurements by Proton-Transfer-Reaction Mass-Spectrometry (PTR-MS) and with aroma analysis of food using PTR-MS and Gas Chromatography-Olfactometry (GC-O). An objective method was developed for the determination of a herb extract's quality; this quality was checked by a sensory analysis until now. The concentrations of the volatile organic compounds (VOCs) in the headspace of 81 different batches were measured by PTR-MS. Based on the sensory judgment of the customer, characteristic differences in the emissions of 'good' and 'bad' quality samples were identified and a method for the quality control of this herb extract was developed. This novel method enables the producing company to check and ensure that they are only selling high-quality products and therefore avoid complaints of the customer. Furthermore this method can be used for controlling, optimizing and automating the production process. VOCs emitted by meat were investigated using PTR-MS to develop a rapid, non-destructive and quantitative technique for determination of the microbial contamination of meat. Meat samples (beef, pork and poultry) that were wrapped into different kinds of packages (air and vacuum) were stored in at 4 o C for up to 13 days. The emitted VOCs were measured as a function of storage time and identified partly. The concentration of many of the measured VOCs, e.g. sulfur compounds like methanethiol, dimethylsulfide and dimethyldisulfide, largely increased over the storage time. There were big differences in the emissions of normal air- and vacuum-packed meat. VOCs typically emitted by air-packaged meat were methanethiol, dimethylsulfide and dimethyldisulfide, while ethanol and methanol were found in vacuum-packaged meat. A comparison of the PTR-MS results with those obtained by a bacteriological examination performed at the same time showed strong correlations (up to 99 %) between the

Evaluation and quality control of radiometric and spectrometric methods used in LVRA of Cuba CPHR

International Nuclear Information System (INIS)

Perez, Danyl; Prendes, Miguel; Fernandez, Isis M.; Gonzalez, Leidy

1997-01-01

The Surveillance Radiological Environmental Laboratory of the Center for Hygiene and Radiation Protection of Cuba, has developed a quality assurance system for the analytical services that it offers. The laboratory has designed and implemented a statistical control program for some measurements of standard samples and certificate reference materials. Statistical tests were used to determine the deviation of experimental results from the certificates ones. The results statistical analysis showed that the used methods are precise and exact in agreement with the requirements demanded for the measurements currently made in the laboratory. As a result a methodology for quality assurance of described methods was established and this experience is applicable to other analytical methods in the laboratory. (author). 15 refs., fig., 3 tabs

Contextual and Analytic Qualities of Research Methods Exemplified in Research on Teaching

Science.gov (United States)

Svensson, Lennart; Doumas, Kyriaki

2013-01-01

The aim of the present article is to discuss contextual and analytic qualities of research methods. The arguments are specified in relation to research on teaching. A specific investigation is used as an example to illustrate the general methodological approach. It is argued that research methods should be carefully grounded in an understanding of…

The National Shipbuilding Research Program, Analytical Quality Circles

Science.gov (United States)

1986-09-01

standard tools for quality control, in English, see “Guide to Quality Control” by Dr. Kaoru Ishikawa , Asian Productivity Organization, Aoyama Dai-ichi...factors affect work evaluation is shown schemati- cally by Characteristic-Factor Diagrams (also called Fishbone or Ishikawa Diagrams), see Figure 2-5

Analytic Model Predictive Control of Uncertain Nonlinear Systems: A Fuzzy Adaptive Approach

Directory of Open Access Journals (Sweden)

Xiuyan Peng

2015-01-01

Full Text Available A fuzzy adaptive analytic model predictive control method is proposed in this paper for a class of uncertain nonlinear systems. Specifically, invoking the standard results from the Moore-Penrose inverse of matrix, the unmatched problem which exists commonly in input and output dimensions of systems is firstly solved. Then, recurring to analytic model predictive control law, combined with fuzzy adaptive approach, the fuzzy adaptive predictive controller synthesis for the underlying systems is developed. To further reduce the impact of fuzzy approximation error on the system and improve the robustness of the system, the robust compensation term is introduced. It is shown that by applying the fuzzy adaptive analytic model predictive controller the rudder roll stabilization system is ultimately uniformly bounded stabilized in the H-infinity sense. Finally, simulation results demonstrate the effectiveness of the proposed method.

Quality control of intelligence research

International Nuclear Information System (INIS)

Lu Yan; Xin Pingping; Wu Jian

2014-01-01

Quality control of intelligence research is the core issue of intelligence management, is a problem in study of information science This paper focuses on the performance of intelligence to explain the significance of intelligence research quality control. In summing up the results of the study on the basis of the analysis, discusses quality control methods in intelligence research, introduces the experience of foreign intelligence research quality control, proposes some recommendations to improve quality control in intelligence research. (authors)

Interaction between production control and quality control

NARCIS (Netherlands)

Bij, van der J.D.; Ekert, van J.H.W.

1999-01-01

Describes a qualitative study on interaction between systems for production control and quality control within industrial organisations. Production control and quality control interact in a sense. Good performance for one aspect often influences or frustrates the performance of the other. As far as

Environmental analytical laboratory setup operation and QA/QC

International Nuclear Information System (INIS)

Hsu, J.P.; Boyd, J.A.; DeViney, S.

1991-01-01

Environmental analysis requires precise and timely measurements. The required precise measurement is ensured with quality control and timeliness through an efficient operation. The efficiency of the operation also ensures cost-competitiveness. Environmental analysis plays a very important role in the environmental protection program. Due to the possible litigation involvement, most environmental analyses follow stringent criteria, such as the U.S. EPA Contract Laboratory Program procedures with analytical results documented in an orderly manner. The documentation demonstrates that all quality control steps are followed and facilitates data evaluation to determine the quality and usefulness of the data. Furthermore, the tedious documents concerning sample checking, chain-of-custody, standard or surrogate preparation, daily refrigerator and oven temperature monitoring, analytical and extraction logbooks, standard operation procedures, etc., also are an important part of the laboratory documentation. Quality control for environmental analysis is becoming more stringent, required documentation is becoming more detailed and turnaround time is shorter. However, the business is becoming more cost-competitive and it appears that this trend will continue. In this paper, we discuss what should be done to deal this high quality, fast-paced and tedious environmental analysis process at a competitive cost. The success of environmental analysis is people. The knowledge and experience of the staff are the key to a successful environmental analysis program. In order to be successful in this new area, the ability to develop new methods is crucial. In addition, the laboratory information system, laboratory automation and quality assurance/quality control (QA/QC) are major factors for laboratory success. This paper concentrates on these areas

Quality control in radiotherapy

International Nuclear Information System (INIS)

Batalla, A.

2009-01-01

The authors discuss the modalities and periodicities of internal quality control on radiotherapy installations. They indicate the different concerned systems and the aspects and items to be controlled (patient and personnel security, apparatus mechanical characteristics, beam quality, image quality, isodose and irradiation duration calculation, data transfer). They present the measurement instruments and tools used for the mechanical controls, dose measurement, beam homogeneity and symmetry, anatomic data acquisition systems, and dose distribution and control imagery calculation

Quality control and stability study of 100 mg/ml paracetamol oral drops

International Nuclear Information System (INIS)

Garcia Penna, Caridad M.; Montes de Oca Porto, Yanet; Salomon Izquierdo, Suslebys

2013-01-01

Paracetamol is an effective analgesic and antipyretic drug of the non-steroidal anti-inflammatory drug group. Paracetamol oral drops are indicated for use in infant population aged up to 5 years to relieve fever, headache, toothache and symptomatic relief of common cold. To validate two analytical methods for the quality control and the stability study and to study the stability of 100 mg/ml Paracetamol oral drops made in Cuba

Long story short: an introduction to the short-term and long-term Six Sigma quality and its importance in the laboratory medicine for the management of extra-analytical processes.

Science.gov (United States)

Ialongo, Cristiano; Bernardini, Sergio

2018-06-18

There is a compelling need for quality tools that enable effective control of the extra-analytical phase. In this regard, Six Sigma seems to offer a valid methodological and conceptual opportunity, and in recent times, the International Federation of Clinical Chemistry and Laboratory Medicine has adopted it for indicating the performance requirements for non-analytical laboratory processes. However, the Six Sigma implies a distinction between short-term and long-term quality that is based on the dynamics of the processes. These concepts are still not widespread and applied in the field of laboratory medicine although they are of fundamental importance to exploit the full potential of this methodology. This paper reviews the Six Sigma quality concepts and shows how they originated from Shewhart's control charts, in respect of which they are not an alternative but a completion. It also discusses the dynamic nature of process and how it arises, concerning particularly the long-term dynamic mean variation, and explains why this leads to the fundamental distinction of quality we previously mentioned.

[Analytical quality in biological monitoring of workers exposed to chemicals: experience of the Prevention and Safety at the Workplace Service in Modena].

Science.gov (United States)

Alpaca, R I Paredes; Migliore, A; Di Rico, R; Canali, Claudia; Rota, Cristina; Trenti, T; Cariani, Elisabetta

2010-01-01

The quality of laboratory data is one of the main factors in guaranteeing efficacy of biological monitoring. To analyze the quality of laboratory data used for biological monitoring of exposed workers. A survey involving 18 companies employing 945 workers in the area of Modena, Italy, was carried out in 2008. Most of the 9 private laboratories receiving biological samples did not perform directly part or all of the laboratory assessments requested, but this was not indicated in the final report. Major problems were observed in the application of internal quality control, and only one laboratory participated in external quality assessment for blood lead measurements. Our results raise major concerns on the traceability and reliability of laboratory assessments performed for biomonitoring of exposed workers. Systematic evaluation of the quality of analytical data would be highly recommendable.

Quality Control in Screening for Infectious Diseases at Blood Banks. Rationale and Methodology.

Science.gov (United States)

Sáez-Alquezar, Amadeo; Albajar-Viñas, Pedro; Guimarães, André Valpassos; Corrêa, José Abol

2015-11-01

Quality control procedures are indispensable to ensure the reliability of the results provided by laboratories responsible for serological screening in blood banks. International recommendations on systems of quality management classify as a top component the inclusion of two types of control: (a) internal quality control (IQC) and (b) external quality control (EQC). In EQC it is essential to have, at least, a monthly frequency of laboratory assessment. On the other hand, IQC involves the daily use of low-reactivity control sera, which should be systematically added in all run, carried out in the laboratory for each parameter. Through the IQC analysis some variations in the criteria of run acceptance and rejection may be revealed, but it is of paramount importance to ensure the previous definition of these criteria and even more importantly, the adherence to them; and that corresponds to the validation of analytical runs of each test. Since 2010 this has been, for instance, the experience of the PNCQ*, developing external quality control programmes on serology for blood banks. These programmes use samples of lyophilized sera well-characterized for the reactivity related to the parameters used for the serological screening of blood donors. The programmes have used blind panels of six samples for monthly assessments. In the last 50 assessments, which involved 68 blood banks in Brazil, a significant number of instances of non-compliance were observed in all monthly assessments. These results provide strong support to the recommendation of systematic monthly assessments. (*) National Quality Control Programme (PNCQ).

Quality control of Cordyceps sinensis, a valued traditional Chinese medicine.

Science.gov (United States)

Li, S P; Yang, F Q; Tsim, Karl W K

2006-08-28

Cordyceps sinensis, a well-known and valued traditional Chinese medicine, is also called DongChongXiaCao (winter worm summer grass) in Chinese. It is commonly used to replenish the kidney and soothe the lung for the treatment of fatigue, night sweating, hyposexualities, hyperglycemia, hyperlipidemia, asthemia after severe illness, respiratory disease, renal dysfunction and renal failure, arrhythmias and other heart disease, and liver disease. As the rarity and upstanding curative effects of natural Cordyceps, several mycelial strains have been isolated from natural Cordyceps and manufactured in large quantities by fermentation technology, and they are commonly sold as health food products in Asia. In addition, some substitutes such as Cordyceps militaris also have been used and adulterants also confused the market. Therefore, quality control of C. sinensis and its products is very important to ensure their safety and efficacy. Herein, markers and analytical methods for quality control of Cordyceps were reviewed and discussed.

Role of analytical chemistry in environmental monitoring

International Nuclear Information System (INIS)

Kayasth, S.; Swain, K.

2004-01-01

Basic aspects of pollution and the role of analytical chemistry in environmental monitoring are highlighted and exemplified, with emphasis on trace elements. Sources and pathways of natural and especially man-made polluting substances as well as physico-chemical characteristics are given. Attention is paid to adequate sampling in various compartments of the environment comprising both lithosphere and biosphere. Trace analysis is dealt with using a variety of analytical techniques, including criteria for choice of suited techniques, as well as aspects of analytical quality assurance and control. Finally, some data on trace elements levels in soil and water samples from India are presented. (author)

Interlaboratory analytical performance studies; a way to estimate measurement uncertainty

Directory of Open Access Journals (Sweden)

El¿bieta £ysiak-Pastuszak

2004-09-01

Full Text Available Comparability of data collected within collaborative programmes became the key challenge of analytical chemistry in the 1990s, including monitoring of the marine environment. To obtain relevant and reliable data, the analytical process has to proceed under a well-established Quality Assurance (QA system with external analytical proficiency tests as an inherent component. A programme called Quality Assurance in Marine Monitoring in Europe (QUASIMEME was established in 1993 and evolved over the years as the major provider of QA proficiency tests for nutrients, trace metals and chlorinated organic compounds in marine environment studies. The article presents an evaluation of results obtained in QUASIMEME Laboratory Performance Studies by the monitoring laboratory of the Institute of Meteorology and Water Management (Gdynia, Poland in exercises on nutrient determination in seawater. The measurement uncertainty estimated from routine internal quality control measurements and from results of analytical performance exercises is also presented in the paper.

Quality assurance and quality control

International Nuclear Information System (INIS)

Anon.

1987-01-01

The practice of nuclear diagnostic imaging requires an appropriate quality assurance program to attain high standards of efficiency and reliability. The International Atomic Energy Agency defines the term quality assurance as ''the closeness with which the outcome of a given procedure approaches some ideal, free from all errors and artifacts.'' The term quality control is used in reference to the specific measures taken to ensure that one particular aspect of the procedure is satisfactory. Therefore, quality assurance is a hospital-wide concept that should involve all aspects of clinical practice. Quality control is concerned with the submission of requests for procedures; the scheduling of patients; the preparation and dispensing of radiopharmaceuticals; the protection of patients, staff, and the general public against radiation hazards and accidents caused by radioactive materials or by faulty equipment; the setting up, use, and maintenance of electronic instruments; the methodology of the actual procedures; the analysis and interpretation of data; the reporting of results; and, finally, the keeping of records. The chapter discusses each of these areas

An overview of analytical activities of control laboratory in NFC

International Nuclear Information System (INIS)

Balaji Rao, Y.; Subba Rao, Y.; Saibaba, N.

2015-01-01

As per the mandate of Department of Atomic Energy (DAE), Nuclear Fuel Complex (NFC) was established in 1971 for manufacturing Fuel Sub-assemblies for both PHWRs and BWRs operating in India on industrial scale. Control Laboratory (C.Lab) was envisaged as a centralized analytical facility to achieve the objectives of NFC on the similar lines of its predecessor, Analytical Chemistry Division at BARC. With highest ever production of 1200 MT of PHWR Fuel and 16 lakhs PHWR Fuel Tubes achieved during production year of 2014-15 and with increase in demand further for fuel requirements, NFC has got demanding situation in next year and accordingly, C. Lab has also geared up to meet the challenging demands of all the production plant. The average annual analytical load comes around 5 Lakhs estimations and to manage such a massive analytical load a proper synergy between good chemistry, process conditions and analytical methods is a necessity and laboratory is able to meet this important requirement consistently

Analytical design of proportional-integral controllers for the optimal control of first-order processes with operational constraints

Energy Technology Data Exchange (ETDEWEB)

Thu, Hien Cao Thi; Lee, Moonyong [Yeungnam University, Gyeongsan (Korea, Republic of)

2013-12-15

A novel analytical design method of industrial proportional-integral (PI) controllers was developed for the optimal control of first-order processes with operational constraints. The control objective was to minimize a weighted sum of the controlled variable error and the rate of change in the manipulated variable under the maximum allowable limits in the controlled variable, manipulated variable and the rate of change in the manipulated variable. The constrained optimal servo control problem was converted to an unconstrained optimization to obtain an analytical tuning formula. A practical shortcut procedure for obtaining optimal PI parameters was provided based on graphical analysis of global optimality. The proposed PI controller was found to guarantee global optimum and deal explicitly with the three important operational constraints.

Recent developments in analytical detection methods for radiation processed foods

International Nuclear Information System (INIS)

Wu Jilan

1993-01-01

A short summary of the programmes of 'ADMIT' (FAO/IAEA) and the developments in analytical detection methods for radiation processed foods has been given. It is suggested that for promoting the commercialization of radiation processed foods and controlling its quality, one must pay more attention to the study of analytical detection methods of irradiated food

[On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

Science.gov (United States)

Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

2014-02-01

To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

Quality assurance in biomarker measurement.

Science.gov (United States)

Aitio, A; Apostoli, P

1995-05-01

Quality assurance (QA) concerns the validity of all the analytical processes (from collection of the samples to interpretation of the results). It is not an abstract concept but must be adapted to the different situations such as the different exposure levels, the different analytical methods, and the context of use (risk assessment procedures, research, routine determinations). The main requirements in QA programmes regard the control of all the known sources of preanalytical and analytical variations, while the instruments with which adequate QA can be implemented are the certified materials and the quality control programmes (quality manual, internal and external quality controls). Another important concept in QA is that measurements must be placed a different metrological levels: at the highest there are the methods (definitive, reference) to be used for assessing accuracy of routine methods. QA programmes should enable a grading of biomarkers (from experimental only to full evaluated) and of the laboratories in order to identify the significance of the test and to assess the level at which a laboratory could operate.

Laboratory quality assurance

International Nuclear Information System (INIS)

Delvin, W.L.

1977-01-01

The elements (principles) of quality assurance can be applied to the operation of the analytical chemistry laboratory to provide an effective tool for indicating the competence of the laboratory and for helping to upgrade competence if necessary. When used, those elements establish the planned and systematic actions necessary to provide adequate confidence in each analytical result reported by the laboratory (the definition of laboratory quality assurance). The elements, as used at the Hanford Engineering Development Laboratory (HEDL), are discussed and they are qualification of analysts, written methods, sample receiving and storage, quality control, audit, and documentation. To establish a laboratory quality assurance program, a laboratory QA program plan is prepared to specify how the elements are to be implemented into laboratory operation. Benefits that can be obtained from using laboratory quality assurance are given. Experience at HEDL has shown that laboratory quality assurance is not a burden, but it is a useful and valuable tool for the analytical chemistry laboratory

Comparative analysis of methods for real-time analytical control of chemotherapies preparations.

Science.gov (United States)

Bazin, Christophe; Cassard, Bruno; Caudron, Eric; Prognon, Patrice; Havard, Laurent

2015-10-15

Control of chemotherapies preparations are now an obligation in France, though analytical control is compulsory. Several methods are available and none of them is presumed as ideal. We wanted to compare them so as to determine which one could be the best choice. We compared non analytical (visual and video-assisted, gravimetric) and analytical (HPLC/FIA, UV/FT-IR, UV/Raman, Raman) methods thanks to our experience and a SWOT analysis. The results of the analysis show great differences between the techniques, but as expected none us them is without defects. However they can probably be used in synergy. Overall for the pharmacist willing to get involved, the implementation of the control for chemotherapies preparations must be widely anticipated, with the listing of every parameter, and remains according to us an analyst's job. Copyright © 2015 Elsevier B.V. All rights reserved.

Quality management and accreditation in a mixed research and clinical hair testing analytical laboratory setting-a review.

Science.gov (United States)

Fulga, Netta

2013-06-01

Quality management and accreditation in the analytical laboratory setting are developing rapidly and becoming the standard worldwide. Quality management refers to all the activities used by organizations to ensure product or service consistency. Accreditation is a formal recognition by an authoritative regulatory body that a laboratory is competent to perform examinations and report results. The Motherisk Drug Testing Laboratory is licensed to operate at the Hospital for Sick Children in Toronto, Ontario. The laboratory performs toxicology tests of hair and meconium samples for research and clinical purposes. Most of the samples are involved in a chain of custody cases. Establishing a quality management system and achieving accreditation became mandatory by legislation for all Ontario clinical laboratories since 2003. The Ontario Laboratory Accreditation program is based on International Organization for Standardization 15189-Medical laboratories-Particular requirements for quality and competence, an international standard that has been adopted as a national standard in Canada. The implementation of a quality management system involves management commitment, planning and staff education, documentation of the system, validation of processes, and assessment against the requirements. The maintenance of a quality management system requires control and monitoring of the entire laboratory path of workflow. The process of transformation of a research/clinical laboratory into an accredited laboratory, and the benefits of maintaining an effective quality management system, are presented in this article.

The behavior-analytic approach to emotional self-control

Directory of Open Access Journals (Sweden)

Jussara Rocha Batista

2012-12-01

Full Text Available Some psychological approaches distinguish behavioral self-control from emotional self-control, the latter being approached with the reference to inside events controlled by the individual himself. This paper offers some directions to a behavior-analytic approach of what has been referred to as emotional self-control. According to Behavior Analysis, no new process is found in emotional self-control, but components that are additional to those found in behavioral self-control, which require appropriate treatment. The paper highlights some determinants of behavioral repertoires taken as instances of emotional self-control: the social context in which self-control is produced and maintained; the conflicts between consequences for the individual and for the group; and the degree of participation of the motor apparatus in the emission of emotional responses. Keywords: emotional self-control; emotional responses; inner world; behavior analysis.

Validation of a liquid chromatographic method for the pharmaceutical quality control of products containing elacridar

Directory of Open Access Journals (Sweden)

Emilia Sawicki

2016-08-01

Full Text Available Many anticancer drugs have an impaired bioavailability and poor brain penetration because they are substrates to drug efflux pumps such as P-glycoprotein and Breast Cancer Resistance Protein. Elacridar is a strong inhibitor of these two drug efflux pumps and therefore has great potential to improve oral absorption and brain penetration of many anticancer drugs. Currently, a clinical formulation of elacridar is unavailable and therefore the pharmaceutical development of a drug product is highly warranted. This also necessitates the availability of an analytical method for its quality control. A reverse-phase high-performance liquid chromatographic method with ultraviolet detection was developed for the pharmaceutical quality control of products containing elacridar as the active pharmaceutical ingredient. The analytical method was validated for linearity, accuracy, precision, selectivity, carry-over, stability of stock and reference solutions, stability of the final extract, stability-indicating capability and impurity testing. We found that elacridar is unstable in aqueous solutions that are exposed to light because a hydroxylation product of elacridar is formed. Therefore, sample solutions with elacridar must be protected from light.

Software product quality control

CERN Document Server

Wagner, Stefan

2013-01-01

Quality is not a fixed or universal property of software; it depends on the context and goals of its stakeholders. Hence, when you want to develop a high-quality software system, the first step must be a clear and precise specification of quality. Yet even if you get it right and complete, you can be sure that it will become invalid over time. So the only solution is continuous quality control: the steady and explicit evaluation of a product's properties with respect to its updated quality goals.This book guides you in setting up and running continuous quality control in your environment. Star

An analytical quality framework for learning cities and regions

Science.gov (United States)

Preisinger-Kleine, Randolph

2013-09-01

There is broad agreement that innovation, knowledge and learning have become the main source of wealth, employment and economic development of cities, regions and nations. Over the past two decades, the number of European cities and regions which label themselves as "learning city" or "learning region" has constantly grown. However, there are also pitfalls and constraints which not only hinder them in unlocking their full potential, but also significantly narrow their effects and their wider impact on society. Most prominently, learning cities and regions manifest serious difficulties in rendering transparent the surplus value they generate, which is vital for attracting investment into lifelong learning. While evaluation and quality management are still perceived as being a bureaucratic necessity rather than a lesson one could learn from or an investment in the future, it is also true that without evaluation and quality assurance local networks do not have the means to examine their strengths and weaknesses. In order to design strategies to maximise the strengths and effectively address the weaknesses it is necessary to understand the factors that contribute to success and those that pose challenges. This article proposes an analytical quality framework which is generic and can be used to promote a culture of quality in learning cities and regions. The proposed framework builds on the findings and results of the R3L+ project, part-funded by the European Commission under the Grundtvig (adult education) strand of the Lifelong Learning programme 2007-2013.

Introduction to Quality Management for EDXRF Practice

International Nuclear Information System (INIS)

2012-01-01

The accelerated development of analytical methodologies during the last decades makes the analytical practice a field where competitiveness is ultimately defined by the confidence of the customers, based on their acceptance of the services provided. The IAEA assists its Member States laboratories to effectively utilize nuclear spectrometries for analytical services in environmental monitoring and other applications including nuclear energy systems-related needs. To support the IAEA Member States efforts the Agency implements various types of activities including production and distribution of reference materials, development of standardized analytical methods, conducting interlaboratory comparisons and proficiency tests as tools for quality control and provision of specialized training in Quality Management and Quality Control topics. This learning module was developed within the IAEA Project 1.4.3.4 (D.3.03) Nuclear Spectrometry for Analytical Applications, under the Nuclear Science Programme. The main objective of the Project is to enhance capability of interested Member States in effective utilization of nuclear spectrometries and analytical services in industry, human health, agriculture, and monitoring and evaluation of environmental pollution. The module aims at providing practical guidelines for the organization of work and quality management practice in x-ray fluorescence laboratories in IAEA Member States. The target users include the managers and technical staff of the analytical laboratories.

Evaluation of quality assurance/quality control data collected by the U.S. Geological Survey for water-quality activities at the Idaho National Engineering and Environmental Laboratory, Idaho, 1994 through 1995

International Nuclear Information System (INIS)

Williams, L.M.

1997-03-01

More than 4,000 water samples were collected by the US Geological Survey (USGS) from 179 monitoring sites for the water-quality monitoring program at the Idaho National Engineering Laboratory from 1994 through 1995. Approximately 500 of the water samples were replicate or blank samples collected for the quality assurance/quality control program. Analyses were performed to determine the concentrations of major ions, nutrients, trace elements, gross radioactivity and radionuclides, total organic carbon, and volatile organic compounds in the samples. To evaluate the precision of field and laboratory methods, analytical results of the replicate pairs of samples were compared statistically for equivalence on the basis of the precision associated with each result. In all, the statistical comparison of the data indicated that 95% of the replicate pairs were equivalent. Within the major ion analyses, 97% were equivalent; nutrients, 88%; trace elements, 95%; gross radioactivity and radionuclides, 93%; and organic constituents, 98%. Ninety percent or more of the analytical results for each constituent were equivalent, except for nitrite, orthophosphate, phosphorus, aluminum, iron, strontium-90, and total organic carbon

Quality control of technetium-99m DTPA: correlation of analytic tests with in vivo protein binding in man

International Nuclear Information System (INIS)

Russell, C.D.; Rowell, K.; Scott, J.W.

1986-01-01

When [/sup 99m/Tc]DTPA is administered, a small fraction of the activity (presumably an impurity) is bound to plasma proteins. This causes an error in the calculation of glomerular filtration rate from plasma clearance. This paper presents two methods of laboratory quality control for measuring the fraction that binds to plasma proteins. One method involves in vitro binding to human serum albumin followed by gel filtration. The other method involves descending paper chromatography on wet pre-equilibrated anion exchange paper. In a series of 80 patients, correlation was demonstrated between laboratory characteristics and actual clinical performance of the [/sup 99m/Tc]DTPA preparation. Both laboratory methods appear suitable for routine quality control

Quality assurance and quality control

International Nuclear Information System (INIS)

Kaden, W.

1986-01-01

General preconditions and methods for QA work in the nuclear field are analysed. The application of general QA principles to actual situations is illustrated by examples in the fields of engineering and of the manufacturing of mechanical and electrical components. All QA measures must be fitted to the complexity and relevance of the work steps, which are under consideration. The key to good product quality is the control of working processes. The term 'controlled process' is discussed in detail and examples of feed back systems are given. The main QA measures for the operation of nuclear power plants include the establishment of a Quality Assurance Program, training and qualification of personnel, procurement control, inspection and tests, reviews and audits. These activities are discussed. (orig.)

Pre-analytical and analytical aspects affecting clinical reliability of plasma glucose results.

Science.gov (United States)

Pasqualetti, Sara; Braga, Federica; Panteghini, Mauro

2017-07-01

The measurement of plasma glucose (PG) plays a central role in recognizing disturbances in carbohydrate metabolism, with established decision limits that are globally accepted. This requires that PG results are reliable and unequivocally valid no matter where they are obtained. To control the pre-analytical variability of PG and prevent in vitro glycolysis, the use of citrate as rapidly effective glycolysis inhibitor has been proposed. However, the commercial availability of several tubes with studies showing different performance has created confusion among users. Moreover, and more importantly, studies have shown that tubes promptly inhibiting glycolysis give PG results that are significantly higher than tubes containing sodium fluoride only, used in the majority of studies generating the current PG cut-points, with a different clinical classification of subjects. From the analytical point of view, to be equivalent among different measuring systems, PG results should be traceable to a recognized higher-order reference via the implementation of an unbroken metrological hierarchy. In doing this, it is important that manufacturers of measuring systems consider the uncertainty accumulated through the different steps of the selected traceability chain. In particular, PG results should fulfil analytical performance specifications defined to fit the intended clinical application. Since PG has tight homeostatic control, its biological variability may be used to define these limits. Alternatively, given the central diagnostic role of the analyte, an outcome model showing the impact of analytical performance of test on clinical classifications of subjects can be used. Using these specifications, performance assessment studies employing commutable control materials with values assigned by reference procedure have shown that the quality of PG measurements is often far from desirable and that problems are exacerbated using point-of-care devices. Copyright © 2017 The Canadian

Quality control in nuclear medicine

International Nuclear Information System (INIS)

Leme, P.R.

1983-01-01

The following topics are discussed: objectives of the quality control in nuclear medicine; the necessity of the quality control in nuclear medicine; guidelines and recommendations. An appendix is given concerning the guidelines for the quality control and instrumentation in nuclear medicine. (M.A.) [pt

Biodiesel Analytical Methods: August 2002--January 2004

Energy Technology Data Exchange (ETDEWEB)

Van Gerpen, J.; Shanks, B.; Pruszko, R.; Clements, D.; Knothe, G.

2004-07-01

Biodiesel is an alternative fuel for diesel engines that is receiving great attention worldwide. The material contained in this book is intended to provide the reader with information about biodiesel engines and fuels, analytical methods used to measure fuel properties, and specifications for biodiesel quality control.

Deriving and Analyzing Analytical Structures of a Class of Typical Interval Type-2 TS Fuzzy Controllers.

Science.gov (United States)

Zhou, Haibo; Ying, Hao

2017-09-01

A conventional controller's explicit input-output mathematical relationship, also known as its analytical structure, is always available for analysis and design of a control system. In contrast, virtually all type-2 (T2) fuzzy controllers are treated as black-box controllers in the literature in that their analytical structures are unknown, which inhibits precise and comprehensive understanding and analysis. In this regard, a long-standing fundamental issue remains unresolved: how a T2 fuzzy set's footprint of uncertainty, a key element differentiating a T2 controller from a type-1 (T1) controller, affects a controller's analytical structure. In this paper, we describe an innovative technique for deriving analytical structures of a class of typical interval T2 (IT2) TS fuzzy controllers. This technique makes it possible to analyze the analytical structures of the controllers to reveal the role of footprints of uncertainty in shaping the structures. Specifically, we have mathematically proven that under certain conditions, the larger the footprints, the more the IT2 controllers resemble linear or piecewise linear controllers. When the footprints are at their maximum, the IT2 controllers actually become linear or piecewise linear controllers. That is to say the smaller the footprints, the more nonlinear the controllers. The most nonlinear IT2 controllers are attained at zero footprints, at which point they become T1 controllers. This finding implies that sometimes if strong nonlinearity is most important and desired, one should consider using a smaller footprint or even just a T1 fuzzy controller. This paper exemplifies the importance and value of the analytical structure approach for comprehensive analysis of T2 fuzzy controllers.

Quality assurance for analitical dairy laboratories

Directory of Open Access Journals (Sweden)

Šimun Zamberlin

2005-04-01

Full Text Available Quality evaluation of analytical laboratories must be estimated through accuracy, precision and traceability of measurement results. In European countries, acceptable analytical results are those which come from accredited laboratories (EN ISO/IEC 17025:2000. This paper presents examples of traceability, measurement uncertainty, inner quality control and control through the interlaboratory proficiency testing of results for milk fat. Also it demonstrates proficiency testing organization of results for fat, protein, lactose and somatic cells in milk.

PubFocus: semantic MEDLINE/PubMed citations analytics through integration of controlled biomedical dictionaries and ranking algorithm

Directory of Open Access Journals (Sweden)

Chuong Cheng-Ming

2006-10-01

Full Text Available Abstract Background Understanding research activity within any given biomedical field is important. Search outputs generated by MEDLINE/PubMed are not well classified and require lengthy manual citation analysis. Automation of citation analytics can be very useful and timesaving for both novices and experts. Results PubFocus web server automates analysis of MEDLINE/PubMed search queries by enriching them with two widely used human factor-based bibliometric indicators of publication quality: journal impact factor and volume of forward references. In addition to providing basic volumetric statistics, PubFocus also prioritizes citations and evaluates authors' impact on the field of search. PubFocus also analyses presence and occurrence of biomedical key terms within citations by utilizing controlled vocabularies. Conclusion We have developed citations' prioritisation algorithm based on journal impact factor, forward referencing volume, referencing dynamics, and author's contribution level. It can be applied either to the primary set of PubMed search results or to the subsets of these results identified through key terms from controlled biomedical vocabularies and ontologies. NCI (National Cancer Institute thesaurus and MGD (Mouse Genome Database mammalian gene orthology have been implemented for key terms analytics. PubFocus provides a scalable platform for the integration of multiple available ontology databases. PubFocus analytics can be adapted for input sources of biomedical citations other than PubMed.

Experience of quality control for material accountancy analysis in Pu fuel facility

International Nuclear Information System (INIS)

Sumi, Mika; Satoh, Mitsuhiro; Ohnishi, Sumitaka; Suzuki, Toru

2003-01-01

Destructive analysis for material accountancy purpose should maintain higher precision referring the International Target Value (ITV). Quality control for the analysis is effective tool to maintain the analytical precision in routine analysis as well as to improve its performance. Since isotope dilution mass spectrometry for the determination of Plutonium and Uranium content and its isotopic composition has launched in the laboratory of Plutonium Fuel Center (PFC) of JNC, comprehensive quality control system has gradually growing up, which currently consists of bias detecting, random error monitoring and human error preventing system. Preventing analysis bias is the most important to maintain long-term performance of measurement. To make bias detecting capability robust, PFC is participating to several intercomparison programs regarding DA samples. Random error monitoring system is another important system to maintain high performance of each routine analysis operation, which composes functions to detect abnormal dispersion of each result and to confirm the state of health of operation of mass spectrometers by measurement of standard materials. To avoid human error during operation process, introduction of computer control system as much extent as possible is practical approach. In this paper, the comprehensive quality control system is introduced and the experiences gained so far are summarized for discussion. (author)

Olive oil authentication: A comparative analysis of regulatory frameworks with especial emphasis on quality and authenticity indices, and recent analytical techniques developed for their assessment. A review.

Science.gov (United States)

Bajoub, Aadil; Bendini, Alessandra; Fernández-Gutiérrez, Alberto; Carrasco-Pancorbo, Alegría

2018-03-24

Over the last decades, olive oil quality and authenticity control has become an issue of great importance to consumers, suppliers, retailers, and regulators in both traditional and emerging olive oil producing countries, mainly due to the increasing worldwide popularity and the trade globalization of this product. Thus, in order to ensure olive oil authentication, various national and international laws and regulations have been adopted, although some of them are actually causing an enormous debate about the risk that they can represent for the harmonization of international olive oil trade standards. Within this context, this review was designed to provide a critical overview and comparative analysis of selected regulatory frameworks for olive oil authentication, with special emphasis on the quality and purity criteria considered by these regulation systems, their thresholds and the analytical methods employed for monitoring them. To complete the general overview, recent analytical advances to overcome drawbacks and limitations of the official methods to evaluate olive oil quality and to determine possible adulterations were reviewed. Furthermore, the latest trends on analytical approaches to assess the olive oil geographical and varietal origin traceability were also examined.

40 CFR 75.21 - Quality assurance and quality control requirements.

Science.gov (United States)

2010-07-01

... quality assurance audit or any other audit, the system is out-of-control. The owner or operator shall... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Quality assurance and quality control... assurance and quality control requirements. (a) Continuous emission monitoring systems. The owner or...

Analytical Model for LLC Resonant Converter With Variable Duty-Cycle Control

DEFF Research Database (Denmark)

Shen, Yanfeng; Wang, Huai; Blaabjerg, Frede

2016-01-01

are identified and discussed. The proposed model enables a better understanding of the operation characteristics and fast parameter design of the LLC converter, which otherwise cannot be achieved by the existing simulation based methods and numerical models. The results obtained from the proposed model......In LLC resonant converters, the variable duty-cycle control is usually combined with a variable frequency control to widen the gain range, improve the light-load efficiency, or suppress the inrush current during start-up. However, a proper analytical model for the variable duty-cycle controlled LLC...... converter is still not available due to the complexity of operation modes and the nonlinearity of steady-state equations. This paper makes the efforts to develop an analytical model for the LLC converter with variable duty-cycle control. All possible operation models and critical operation characteristics...

Validated spectroscopic methods for determination of anti-histaminic drug azelastine in pure form: Analytical application for quality control of its pharmaceutical preparations

Science.gov (United States)

El-Masry, Amal A.; Hammouda, Mohammed E. A.; El-Wasseef, Dalia R.; El-Ashry, Saadia M.

2018-02-01

Two simple, sensitive, rapid, validated and cost effective spectroscopic methods were established for quantification of antihistaminic drug azelastine (AZL) in bulk powder as well as in pharmaceutical dosage forms. In the first method (A) the absorbance difference between acidic and basic solutions was measured at 228 nm, whereas in the second investigated method (B) the binary complex formed between AZL and Eosin Y in acetate buffer solution (pH 3) was measured at 550 nm. Different criteria that have critical influence on the intensity of absorption were deeply studied and optimized so as to achieve the highest absorption. The proposed methods obeyed Beer's low in the concentration range of (2.0-20.0 μg·mL- 1) and (0.5-15.0 μg·mL- 1) with % recovery ± S.D. of (99.84 ± 0.87), (100.02 ± 0.78) for methods (A) and (B), respectively. Furthermore, the proposed methods were easily applied for quality control of pharmaceutical preparations without any conflict with its co-formulated additives, and the analytical results were compatible with those obtained by the comparison one with no significant difference as insured by student's t-test and the variance ratio F-test. Validation of the proposed methods was performed according the ICH guidelines in terms of linearity, limit of quantification, limit of detection, accuracy, precision and specificity, where the analytical results were persuasive. The absorption spectrum of AZL (16 μg·mL- 1) in 0.1 M HCl. The absorption spectrum of AZL (16 μg·mL- 1) in 0.1 M NaOH. The difference absorption spectrum of AZL (16 μg·mL- 1) in 0.1 M NaOH vs 0.1 M HCl. The absorption spectrum of eosin binary complex with AZL (10 μg·mL- 1).

Commercial jet fuel quality control

Energy Technology Data Exchange (ETDEWEB)

Strauss, K.H.

1995-05-01

The paper discusses the purpose of jet fuel quality control between the refinery and the aircraft. It describes fixed equipment, including various types of filters, and the usefulness and limitations of this equipment. Test equipment is reviewed as are various surveillance procedures. These include the Air Transport Association specification ATA 103, the FAA Advisory Circular 150/5230-4, the International Air Transport Association Guidance Material for Fuel Quality Control and Fuelling Service and the Guidelines for Quality Control at Jointly Operated Fuel Systems. Some past and current quality control problems are briefly mentioned.

SPECT quality control tests

International Nuclear Information System (INIS)

Robilotta, C.C.; Rebelo, M.F.S.; Oliveira, M.A.; Abe, R.

1987-01-01

Quality control tests of tomographic system composed by a rotatory chamber (CGR Gammatomome T-9000) and a microcomputer are presented. Traditional quality control tests for scintilation chambers and specific tests for tomographic systems are reported. (M.A.C.) [pt

Activities at Forschungszentrum Juelich in Safeguards Analytical Techniques and Measurements

International Nuclear Information System (INIS)

Duerr, M.; Knott, A.; Middendorp, R.; Niemeyer, I.; Kueppers, S.; Zoriy, M.; Froning, M.; Bosbach, D.

2015-01-01

The application of safeguards by the IAEA involves analytical measurements of samples taken during inspections. The development and advancement of analytical techniques with support from the Member States contributes to strengthened and more efficient verification of compliance with non-proliferation obligations. Since recently, a cooperation agreement has been established between Forschungszentrum Juelich and the IAEA in the field of analytical services. The current working areas of Forschungszentrum Juelich are: (i) Production of synthetic micro-particles as calibration standard and reference material for particle analysis, (ii) qualification of the Forschungszentrum Juelich as a member of the IAEA network of analytical laboratories for safeguards (NWAL), and (iii) analysis of impurities in nuclear material samples. With respect to the synthesis of particles, a dedicated setup for the production of uranium particles is being developed, which addresses the urgent need for material tailored for its use in quality assurance and quality control measures for particle analysis of environmental swipe samples. Furthermore, Forschungszentrum Juelich has been nominated as a candidate laboratory for membership in the NWAL network. To this end, analytical capabilities at Forschungszentrum Juelich have been joined to form an analytical service within a dedicated quality management system. Another activity is the establishment of analytical techniques for impurity analysis of uranium-oxide, mainly focusing on inductively coupled mass spectrometry. This contribution will present the activities at Forschungszentrum Juelich in the area of analytical measurements and techniques for nuclear verification. (author)

Quality control aspects of herbs and botanicals in developing countries: Coleus forskohlii Briq a case study

Directory of Open Access Journals (Sweden)

Ennus Tajuddin Tamboli

2015-01-01

Full Text Available Objective: Current trend of commercialization of herbal medicines draw a huge need of maintaining their quality. The declaration of quality, safety and efficacy of medicinal plants as well as poly-herbal formulations has become an important issue. Hence, qualitative and quantitative analysis of herbal drugs and formulations viz., fingerprint profiles and quantification of the various markers become key factors of quality control. Materials and Methods: Present investigation is a detailed report for quality control of well-known herb Coleus forskohlii Briq, which includes physicochemical parameter determination, safety evaluation, microscropical evaluation, and chromatographic fingerprinting as well. Results: Physico-chemical characters were evaluated according to Indian Pharmacopoeia, further microscopic evaluation of transverse section of Coleus reveals that periderm, secondary phloem, and wide secondary xylem cylinder, which occupies major portion of the root fragmentary. Chromatographic fingerprint profiles of Coleus have been generated, and a marker based standardization strategy was adopted; using different analytical technique like high-performance thin layer chromatography, high-performance liquid chromatography and gas chromatography-mass spectroscopy to maintain quality and ensure safety as well as efficacy. Conclusion: These advancements in modern techniques of analysis can lead to effective quality control of Coleus as well as other herbs. Present report can act as pioneer for quality control of modern herbal medicine.

Organization of a system of guarantee of quality for the control of specifications of chemical reagents

International Nuclear Information System (INIS)

Bustamante Gutierrez, M. G.

2000-01-01

Analytic methods were implemented based on valuations acid-base and redox for the quantitative determination of sodium hidroxid, iodine and iron chloride III, like part of a system of quality for the technical specifications of these reagents. The planning of its system of quality includes two fundamental parts: insurance and control of quality. In the insurance part the state of operation of the team that you uses settled down, gauges the one that achieve to maintain under the supervision of a single operator (electronic equip and glassware) and the design of the appropriate documents settled down to carry out the periodic supervision of the acting of the same ones and other aspects characteristic of the system (experimental results). Also protocolized and validated the analytic methods to use following the approaches of precision given by ASTM, organism whose methodologies are recognized in the country like official; other procedures, as that of calibration of the volumetric equipments, they were also protocolized. In the part of control of quality, the limits settled down and procedures were applied the scales and used other, to the necessary distilled water to carry out the determinations and to the used chemical reagents. With base in the obtained results you determines that the analyzed reagents fulfill the specifications of ACS (and with those reported by the maker) at the same time settled down that the laboratory 09 of the Chemistry School, used in a large part of development of this project, it didn't fulfill the necessary requirements so that it works as laboratory of control of quality. As an alternative, the administration of the School outlines as solution the use of the Laboratory of Insurance of the Quality from the Unit of Service to the Industry for such end [es

The information system of learning quality control in higher education institutions: achievements and problems of European universities

Directory of Open Access Journals (Sweden)

Orekhova Elena

2016-01-01

Full Text Available The article deals with the main trends in the development of the system of learning quality control connected with the European integration of higher education and the democratization of education. The authors analyze the state of information systems of learning quality control existing in European higher education and identify their strong and weak points. The authors show that in the learning process universities actively use innovative analytic methods as well as modern means of collecting, storing and transferring information that ensure the successful management of such a complex object as the university of the 21st century.

Quality control analysis of imported fertilizers used in Ghana

International Nuclear Information System (INIS)

Enti-Brown, S.

2010-01-01

Twenty three (23) imported fertilizer samples of 5 fertilizer types have been analysed to determine their quality. The main objective of this research was to validate specifications indicated by manufacturers' on their fertilizer products. To achieve this objective, the fertilizer samples were analysed using five analytical techniques (INAA, AAS, flame photometer, kjeldahl method and UV-visible spectroscopy) to determine the concentrations of macronutrients (N, P, K, Mg, Ca and S), micronutrients (Cu, Na, Fe, Mn, Mo and Zn) and heavy metals (As, Cd, Co, Hg and Pd) in the fertilizer samples. Results obtained from analysis were compared with certified values obtained from the companies and with standard values obtained from MOFA to establish whether the imported fertilizers met standards. Two reference materials (IAEA Soil-7 and SRM 1646a Estuarine Sediment) were used to validate the quantitative methods employed in the INAA and AAS techniques. Good agreements (98%) were obtained between the measured and verified concentrations for most of the elements. Analytical results revealed that the concentrations of the primary macronutrients (N, P and K) claimed by the manufacturers were valid. In contrast, manufacturers' claims for micronutrient concentrations did not agree with analytical results. The concentrations recorded were far below the minimum plant nutrient guarantees. For instance, the highest values recorded for Cu and Zn were 0.0265% and 0.00305% respectively, whiles the minimum guaranteed values were set at 0.05%. Heavy metal levels recorded in the fertilizers were insignificant and therefore do not present possible contamination problems during fertilizer application. In conclusion, not all the nutrient requirements expected of imported fertilizers were met. There is therefore the need for a good quality control system to monitor the chemical compositions of fertilizers imported into Ghana (au).

Genetic variation at loci controlling quality traits in spring wheat

International Nuclear Information System (INIS)

Ali, N.; Iqbal, M.; Asif, M.

2013-01-01

Selection for quality traits in bread wheat (Triticum aestivum L.) during early breeding generations requires quick analytical methods that need small grain samples. Marker assisted selection can be useful for the improvement of quality traits in wheat. The present study was conducted to screen 117 Pakistani adapted spring wheat varieties with DNA markers linked with genes controlling composition of low and high molecular weight glutenin subunits (LMW-GS and HMW-GS, respectively), starch viscosity, Polyphenol oxidase (PPO) activity and grain hardness. DNA fragments associated with the presence/absence of quality related genes were amplified using Polymerase chain reaction (PCR) and detected using agarose gel electrophoresis. Positive allele of beta-secalin, which indicates presence of 1B.1R translocation, was found in 77 (66%) varieties. The marker PPO05 was found in 30 (26%) varieties, indicating lower PPO activity. Grain hardness controlled by Pinb-D1b allele was present in 49 (42%) varieties. Allele Wx-B1b which confers superior noodle quality was found in 48 (41%) varieties. HMW-GS encoded by Glu-D1d allele that exerts a positive effect on dough strength was present in 115 (98%) varieties. LMW-GS alleles Glu-A3d and Glu-B3 were observed in 21 (18%) and 76 (65%) varieties, respectively. Results of the present study may help wheat breeders in selecting parents for improving desirable quality attributes of future wheat varieties. The varieties, identified having desirable quality genes, in this study can be used in the wheat breeding programs aiming to improve quality traits. Early generation marker assisted selection can help to efficiently utilize resources of a breeding program. (author)

Quality assurance and quality control of nuclear engineering during construction phase

International Nuclear Information System (INIS)

Zhang Zhihua; Deng Yue; Liu Yaoguang; Xu Xianqi; Zhou Shan; Qian Dazhi; Zhang Yang

2007-01-01

The quality assurance (QA) and quality control (QC) is a very important work in the nuclear engineering. This paper starts with how to establish quality assurance system of nuclear engineering construction phase, then introduces several experiments and techniques such as the implementation of quality assurance program, the quality assurance and quality control of contractors, the quality surveillance and control of supervisory companies, quality assurance audit and surveillance of builders. (authors)

Applying fuzzy analytic network process in quality function deployment model

Directory of Open Access Journals (Sweden)

Mohammad Ali Afsharkazemi

2012-08-01

Full Text Available In this paper, we propose an empirical study of QFD implementation when fuzzy numbers are used to handle the uncertainty associated with different components of the proposed model. We implement fuzzy analytical network to find the relative importance of various criteria and using fuzzy numbers we calculate the relative importance of these factors. The proposed model of this paper uses fuzzy matrix and house of quality to study the products development in QFD and also the second phase i.e. part deployment. In most researches, the primary objective is only on CRs to implement the quality function deployment and some other criteria such as production costs, manufacturing costs etc were disregarded. The results of using fuzzy analysis network process based on the QFD model in Daroupat packaging company to develop PVDC show that the most important indexes are being waterproof, resistant pill packages, and production cost. In addition, the PVDC coating is the most important index in terms of company experts’ point of view.

Programs and analytical methods for the U.S. Geological Survey acid-rain quality-assurance project. Water Resources Investigation

International Nuclear Information System (INIS)

See, R.B.; Willoughby, T.C.; Brooks, M.H.; Gordon, J.D.

1990-01-01

The U.S. Geological Survey operates four programs to provide external quality-assurance of wet deposition monitoring by the National Atmospheric Deposition Program and the National Trends Network. An intersite-comparison program assesses the precision and bias of onsite determinations of pH and specific conductance made by site operators. A blind-audit program is used to assess the effect of routine sample-handling procedures and transportation on the precision and bias of wet-deposition data. An interlaboratory-comparison program is used to assess analytical results from three or more laboratories, which routinely analyze wet-deposition samples from the major North American networks, to determine if comparability exists between laboratory analytical results and to provide estimates of the analytical precision of each laboratory. A collocated-sampler program is used to estimate the precision of wet/dry precipitation sampling throughout the National Atmospheric Deposition Program and the National Trends Network, to assess the variability of diverse spatial arrays, and to evaluate the impact of violations of specific site criteria. The report documents the procedures and analytical methods used in these four quality-assurance programs

The Hazardous-Drums Project: A Multiweek Laboratory Exercise for General Chemistry Involving Environmental, Quality Control, and Cost Evaluation

Science.gov (United States)

Hayes, David; Widanski, Bozena

2013-01-01

A laboratory experiment is described that introduces students to "real-world" hazardous waste management issues chemists face. The students are required to define an analytical problem, choose a laboratory analysis method, investigate cost factors, consider quality-control issues, interpret the meaning of results, and provide management…

Report on the analysis of the quality assurance and quality control data for the petroleum refining sector

International Nuclear Information System (INIS)

Thorton, N.; Michajluk, S.; Powell, T.; Lee, G.

1992-07-01

The Ontario Municipal-Industrial Strategy for Abatement (MISA) program has the ultimate goal of virtual elimination of persistent toxic contaminants from all discharges to provincial waterways. MISA effluent monitoring regulations, first promulgated for the petroleum refining sector, require direct dischargers to monitor their effluents for a specified number of contaminants and a specified frequency over a one-year period. The refineries were also required to carry out a quality control program on all process effluent streams and for specified analytical test groups. Two types of quality assurance/quality control (QA/QC) data were required: field QA/QC, which would indicate problems with field contamination or sampling, and laboratory QA/QC, which would indicate problems with the laboratory. The objectives of QA/QC analysis are to identify the significance of biases, chronic contamination, data variability, and false results, to assess data validity, and to allow data comparability among companies and laboratories. Of the 149 parameters monitored in the petroleum refining sector, 34 qualified as candidates for setting effluent limits. The QA/QC evaluation of monitoring data for the 34 parameters confirmed the presence of 18 parameters at such levels that they could be used to set statistically valid quantitative limits. 50 tabs

Quality assurance and quality control at the joint IAEA NMCC On-Site Laboratory at RRP as a contribution to the inspectorate's review of near real time accountancy of nuclear material

International Nuclear Information System (INIS)

Ludwig, R.; Duhamel, G.; Raptis, K.; Mayorov, V.; Sato, Y.; Hara, S.; Itoh, Y.; Hayakawa, T.

2011-01-01

This paper provides updates on the elements of the quality management system (QMS) of the On-Site Laboratory for nuclear safeguards at the Rokkasho Reprocessing Plant. Representative examples of the OSL's quality control levels are discussed, such as analytical method performance review, method inter-comparison and participation in Laboratory inter-comparison exercises. It also highlights quality assurance measures to continuously improve the data quality within the boundary conditions of a high throughput industrial laboratory operating according to the guidelines of ISO 17025 and to meet the requirements of the ITV's on method uncertainties. (author)

Validación de método analítico para el control de la calidad de vitamina B12 10 000 inyección Validation of analytical method for quality control of B12 Vitamin-10 000 injection

Directory of Open Access Journals (Sweden)

Martha Botet García

2009-12-01

Full Text Available Se validó el método analítico reportado en la Farmacopea de los Estados Unidos, para el control de la calidad de vitamina B12 10 000 U (cianocobalamina inyectable, por espectrofotometría ultravioleta, por ser este un método más sencillo, económico y que permite controlar la calidad del producto terminado. La curva de calibración se realizó en el intervalo de 60 al 140 %, donde fue lineal con un coeficiente de correlación igual a 0,9999; la prueba estadística para el intercepto y la pendiente se consideró no significativa. Se obtuvo un recobrado del 99,97 % en el intervalo de concentraciones estudiado, y las pruebas de Cochran (G y Student (t resultaron no significativas. El coeficiente de variación en el estudio de la repetibilidad fue igual a 0,59 % para las 6 réplicas ensayadas, mientras que en los análisis de la precisión intermedia las pruebas de Fischer y Student no significativas. El método analítico resultó lineal, preciso, específico y exacto en el intervalo de concentraciones estudiadas.Analytical method reported by USA Pharmacopeia was validated for quality control of injectable B12 Vitamin (10 000 U by UV spectrophotometry because this is a simpler and low-cost method allowing quality control of finished product. Calibration curve was graphed at 60 to 140 % interval, where it was linear with a correlation coefficient similar to 0, 9999; statistical test for interception and slope was considered non-significant. There was a recovery of 99.7 % in study concentrations interval where the Cochran (G and Student(t test were not significant too. Variation coefficient in repetition study was similar to 0.59 % for the 6 assayed replies, whereas in intermediate precision analysis, the Fisher and Student tests were not significant. Analytical method was linear, precise, specific and exact in study concentrations interval.

Assessment of shrimp farming impact on groundwater quality using analytical hierarchy process

Science.gov (United States)

Anggie, Bernadietta; Subiyanto, Arief, Ulfah Mediaty; Djuniadi

2018-03-01

Improved shrimp farming affects the groundwater quality conditions. Assessment of shrimp farming impact on groundwater quality conventionally has less accuracy. This paper presents the implementation of Analytical Hierarchy Process (AHP) method for assessing shrimp farming impact on groundwater quality. The data used is the impact data of shrimp farming in one of the regions in Indonesia from 2006-2016. Criteria used in this study were 8 criteria and divided into 49 sub-criteria. The weighting by AHP performed to determine the importance level of criteria and sub-criteria. Final priority class of shrimp farming impact were obtained from the calculation of criteria's and sub-criteria's weights. The validation was done by comparing priority class of shrimp farming impact and water quality conditions. The result show that 50% of the total area was moderate priority class, 37% was low priority class and 13% was high priority class. From the validation result impact assessment for shrimp farming has been high accuracy to the groundwater quality conditions. This study shows that assessment based on AHP has a higher accuracy to shrimp farming impact and can be used as the basic fisheries planning to deal with impacts that have been generated.

40 CFR 51.359 - Quality control.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

Science.gov (United States)

Smith, D.B.; Woodruff, L.G.; O'Leary, R. M.; Cannon, W.F.; Garrett, R.G.; Kilburn, J.E.; Goldhaber, M.B.

2009-01-01

In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The Ca, Fe, K, Mg, Na, S, Ti, Ag, As, Ba, Be, Bi, Cd, Ce, Co, Cr, Cs, Cu, Ga, In, La, Li, Mn, Mo, Nb, Ni, P, Pb, Rb, Sb, Sc, Sn, Sr, Te, Th, Tl, U, V, W, Y, and Zn by inductively coupled plasma-mass spectrometry and inductively coupled plasma-atomic emission spectrometry following a near-total digestion in a mixture of HCl, HNO3, HClO4, and HF. Separate methods were used for Hg, Se, total C, and carbonate-C on this same size fraction. Only Ag, In, and Te had a large percentage of concentrations below the detection limit. Quality control (QC) of the analyses was monitored at three levels: the laboratory performing the analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset of 73 of these samples was analyzed for a suite of

What cost quality assurance

International Nuclear Information System (INIS)

Tikkanen, M.W.; Starek, R.; Liddel, P.R.; Grey, R.G.; Peile, R.C.

1991-01-01

This paper reports that the increased awareness of global environmental pollution has meant that analytical laboratories are faced with an increasing number of samples to analyze and a greater demand for quality control for their applications. In answer to these demands, more laboratory managers are turning to automation for analytical procedures and automated routines to perform quality control on individual samples. Atomic Absorption analysis, particularly by graphite furnace and hydride generation technique has proved to be adaptable to automated analysis to determine low concentrations of elements such as As, Co, Cd, Hg, Ag, Ba, Cr and Pb. Although highly sensitive, both techniques are time consuming and highly matrix dependent. They may also require extensive sample preparation prior to analysis. Additionally, government imposed methodologies e.g. those used for the USA EPA, Contract Laboratory Program, RCRA and SDWA programs, require very specific time consuming quality control measures

Microbiological quality control of single-walled carbon-nanotubes-coated surfaces experimentally contaminated

International Nuclear Information System (INIS)

Natalizi, T.; Frioni, A.; Passeri, D.; Pantanella, F.

2013-01-01

The emergence of new nanotechnologies involves the spreading of nanoparticles in various fields of human life. Nanoparticles in general and, more specifically, carbon nanotubes have been adopted for many practical approaches i.e.: coatings for medical devices, food process industry and drug delivery. Humans will be increasingly exposed to nanoparticles but the susceptibility of nanostructured materials to microbial colonization in process of manufacturing and storage has not been thoroughly considered. Therefore, the microbiological quality control of nanoparticles plays a pivotal role. Different analytical methods have been attempted for detecting bacterial population contaminating a surface, but no one can be considered fully appropriate. Here, BioTimer Assay (BTA) and conventional sonication followed by colony forming units method (S-CFU) were applied for microbiological quality control of single-walled carbon nanotubes (SWCNTs)-coated surfaces experimentally contaminated with Streptococcus mutans and Pseudomonas aeruginosa. Our results demonstrated that S-CFU is unreliable to actually determine the number of bacteria, contaminating abiotic surfaces, as it does not detach all adherent bacteria and kills part of the bacterial population. Instead, BTA is a reliable method to enumerate bacteria colonizing SWCNTs-coated surfaces and can be considered a useful tool for microbiological quality control of nanomaterials for human use.

Evaluating the service quality of third-party logistics service providers using the analytic hierarchy process

Directory of Open Access Journals (Sweden)

Soon-hoo So

2006-12-01

Full Text Available In this study we apply the analytic hierarchy process (AHP to evaluate the service quality of third-party logistics (3PL service providers. We first conceptualize five dimensions of 3PL service quality (i.e. tangibles, reliability, responsiveness, assurance and empathy. We then apply the AHP method to determine the relative weights of the five service quality dimensions and eventually select the best 3PL service provider. To implement this idea in practice, we conduct an empirical case study on four companies providing 3PL services in Korea. The results indicate that Responsiveness out of the five service quality dimensions is the most important factor in the perception of 3PL customers.

Machine learning and predictive data analytics enabling metrology and process control in IC fabrication

Science.gov (United States)

Rana, Narender; Zhang, Yunlin; Wall, Donald; Dirahoui, Bachir; Bailey, Todd C.

2015-03-01

Integrate circuit (IC) technology is going through multiple changes in terms of patterning techniques (multiple patterning, EUV and DSA), device architectures (FinFET, nanowire, graphene) and patterning scale (few nanometers). These changes require tight controls on processes and measurements to achieve the required device performance, and challenge the metrology and process control in terms of capability and quality. Multivariate data with complex nonlinear trends and correlations generally cannot be described well by mathematical or parametric models but can be relatively easily learned by computing machines and used to predict or extrapolate. This paper introduces the predictive metrology approach which has been applied to three different applications. Machine learning and predictive analytics have been leveraged to accurately predict dimensions of EUV resist patterns down to 18 nm half pitch leveraging resist shrinkage patterns. These patterns could not be directly and accurately measured due to metrology tool limitations. Machine learning has also been applied to predict the electrical performance early in the process pipeline for deep trench capacitance and metal line resistance. As the wafer goes through various processes its associated cost multiplies. It may take days to weeks to get the electrical performance readout. Predicting the electrical performance early on can be very valuable in enabling timely actionable decision such as rework, scrap, feedforward, feedback predicted information or information derived from prediction to improve or monitor processes. This paper provides a general overview of machine learning and advanced analytics application in the advanced semiconductor development and manufacturing.

Sea Empress hydrocarbon data review and quality control

International Nuclear Information System (INIS)

1997-11-01

Three laboratories (Ministry of Agriculture, Fisheries and Food (MAFF), Environment Agency (Agency), and the National Environmental Technology Centre (NETCEN) of AEA Technology plc.), were heavily involved with hydrocarbon analytical chemistry during the response to the Sea Empress oil spill from February 1996. Arthur D. Little was asked by the Sea Empress Environmental Evaluation Committee (SEEEC) to review the laboratories to provide extra quality assurance for the data gathered and for future oil spill responses in the U.K. The objective of the review was to evaluate the general quality, technical defensibility, and interpretative value of analytical chemistry data generated as part of the Sea Empress oil spill response and monitoring programmes. The objectives of each of the three organisations within the overall spill response were different, and as a result the respective analytical programmes were designed to meet quite specific goals. Consequently, our comments on each group's performance are not intended to invite direct comparison between the three laboratories. The review was not a formal compliance audit, but rather is aimed at the U.K. government in an attempt to assist their preparations for future oil spills. (author)

The application of analytical methods to the study of Pareto - optimal control systems

Directory of Open Access Journals (Sweden)

I. K. Romanova

2014-01-01

; for Pareto - tasks in the presence touch formed the system of algebraic equations whose solution yields the equation of the line Pareto in the parameter space. Display space criteria provides the required Pareto - border; in the absence touch analyzes the property of monotonicity. Analysis of derivatives enables you to define two borders in the parameter space (abscissa and the ordinate axis or at the borders, their parallel.The obtained analytical results are applied to the problem of parametric synthesis of control systems. In the framework of the given structure of double-circuit system suitable made use of a system of differential equations instead of the traditional structural schemes. The formula that shows the change dynamic coefficients of unmanaged system after applying the correction. The choice of direct quality criteria, calculated according to the transition process, made the decision problem is most visible and effective. As quality criteria selected rise time and overshoot. As parameters used the gains of the sensors of angular velocity and linear accelerations. Isolated in the space of parameters of stability and oscillatory. Given the author's conclusion formulas for gradients of direct quality criteria - and rise time overshoot. Built fields antigradient and the level lines of the criteria. The analysis of the properties of contramonotonicity all of the criteria specified parameters. In accordance with the claims put forward by tradeoff line in the space of parameters and displaying them in the form of lines of Pareto on space criteria. The use of traditional means of sensing space parameters showed the reliability of the obtained analytical manner. The calculation results for the synthesis of double-circuit motion control systems of flying devices can be used for selection of possible directions of improvement of conflicting criteria. The proposed method is able to replace traditional methods of synthesis of the systems under consideration on the

Network-based production quality control

Science.gov (United States)

Kwon, Yongjin; Tseng, Bill; Chiou, Richard

2007-09-01

This study investigates the feasibility of remote quality control using a host of advanced automation equipment with Internet accessibility. Recent emphasis on product quality and reduction of waste stems from the dynamic, globalized and customer-driven market, which brings opportunities and threats to companies, depending on the response speed and production strategies. The current trends in industry also include a wide spread of distributed manufacturing systems, where design, production, and management facilities are geographically dispersed. This situation mandates not only the accessibility to remotely located production equipment for monitoring and control, but efficient means of responding to changing environment to counter process variations and diverse customer demands. To compete under such an environment, companies are striving to achieve 100%, sensor-based, automated inspection for zero-defect manufacturing. In this study, the Internet-based quality control scheme is referred to as "E-Quality for Manufacturing" or "EQM" for short. By its definition, EQM refers to a holistic approach to design and to embed efficient quality control functions in the context of network integrated manufacturing systems. Such system let designers located far away from the production facility to monitor, control and adjust the quality inspection processes as production design evolves.

Towards an analytical framework linking institutions and quality: theory and evidence from the Beninese Pineapple Sector

NARCIS (Netherlands)

Royer, A.; Bijman, J.

2012-01-01

Improving non-traditional agricultural product quality is challenging for smallholder farmers in developing countries since they often lack the resources and an adequate enabling institutional environment. Based on an extensive literature review, this paper develops an analytical framework

Meeting report on third regional workshop on quality assurance and quality control of nuclear analytical techniques

International Nuclear Information System (INIS)

2002-01-01

Over the last 20 years, the Agency, through its Technical Co-operation Programme, has helped to establish many nuclear analytical laboratories in nuclear institutions and universities of Member States. The project RER/2/004 has been approved in 1999 for a period of two years aiming at the implementation of a comprehensive QA/QC protocol in laboratories of Member States following the ISO guide 17025. The project involved 13 laboratories from 12 countries. This report presents the project setup, intended outputs and outcomes, achievements and conclusions. It also contains reports from participating laboratories. Each of the reports has been provided with an abstract and indexed separately

Validation of the ultraviolet spectrophotometry method for the quality control of ciprofloxacin chlorhydrate in Ciprecu tablets

International Nuclear Information System (INIS)

Perez Navarro, Maikel; Rodriguez Hernandez, Yaslenis; Suarez Perez, Yania

2014-01-01

Quinolones are a group of antimicrobials of high clinical significance. Ciprofloxacin hydrochloride monohydrate is a second-generation antibacterial fluoroquinolone for treatment of several infections and is marketed as eye drops, injections, capsule and tablets. To develop and to validate an ultraviolet spectrophotometric analytical method to be used in the quality control of ciprofloxacin hydrochloride monohydrate in newly manufactured Ciprecu tablets

Process analytical technology (PAT) for biopharmaceuticals

DEFF Research Database (Denmark)

Glassey, Jarka; Gernaey, Krist; Clemens, Christoph

2011-01-01

Process analytical technology (PAT), the regulatory initiative for building in quality to pharmaceutical manufacturing, has a great potential for improving biopharmaceutical production. The recommended analytical tools for building in quality, multivariate data analysis, mechanistic modeling, novel...

Intercalibration of analytical methods on marine environmental samples

International Nuclear Information System (INIS)

1988-06-01

The pollution of the seas by various chemical substances constitutes nowadays one of the principal concerns of mankind. The International Atomic Energy Agency has organized in past years several intercomparison exercises in the framework of its Analytical Quality Control Service. The present intercomparison had a double aim: first, to give laboratories participating in this intercomparison an opportunity for checking their analytical performance. Secondly, to produce on the basis of the results of this intercomparison a reference material made of fish tissue which would be accurately certified with respect to many trace elements. Such a material could be used by analytical chemists to check the validity of new analytical procedures. In total, 53 laboratories from 29 countries reported results (585 laboratory means for 48 elements). 5 refs, 52 tabs

Analytical and Experimental Evaluation of Digital Control Systems for the Semi-Span Super-Sonic Transport (S4T) Wind Tunnel Model

Science.gov (United States)

Wieseman, Carol D.; Christhilf, David; Perry, Boyd, III

2012-01-01

An important objective of the Semi-Span Super-Sonic Transport (S4T) wind tunnel model program was the demonstration of Flutter Suppression (FS), Gust Load Alleviation (GLA), and Ride Quality Enhancement (RQE). It was critical to evaluate the stability and robustness of these control laws analytically before testing them and experimentally while testing them to ensure safety of the model and the wind tunnel. MATLAB based software was applied to evaluate the performance of closed-loop systems in terms of stability and robustness. Existing software tools were extended to use analytical representations of the S4T and the control laws to analyze and evaluate the control laws prior to testing. Lessons were learned about the complex windtunnel model and experimental testing. The open-loop flutter boundary was determined from the closed-loop systems. A MATLAB/Simulink Simulation developed under the program is available for future work to improve the CPE process. This paper is one of a series of that comprise a special session, which summarizes the S4T wind-tunnel program.

Radiopharmaceutical quality control-Pragmatic approach

International Nuclear Information System (INIS)

Barbier, Y.

1994-01-01

The quality control must be considered in a practical manner. The radiopharmaceuticals are drugs. They must satisfy the quality assurance control. These products are then conform to Pharmacopeia. But sometimes the user must control some data especially radiochemical purity and pH value. On all the administered solutions four controls are compulsory: radionuclide identity, administered radioactivity, organoleptic character and pH

7 CFR 981.42 - Quality control.

Science.gov (United States)

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

Quality control of dosemeters

International Nuclear Information System (INIS)

Mendes, L.

1984-01-01

Nuclear medicine laboratories are required to assay samples of radioactivity to be administered to patients. Almost universally, these assays are acomplished by use of a well ionization chamber isotope calibrator. The Instituto de Radioprotecao e Dosimetria (Institute for Radiological Protection and Dosimetry) of the Comissao Nacional de Energia Nuclear (National Commission for Nuclear Energy) is carrying out a National Quality Control Programme in Nuclear Medicine, supported by the International Atomic Energy Agency. The assessment of the current needs and practices of quality control in the entire country of Brazil includes Dose Calibrators and Scintilation Cameras, but this manual is restricted to the former. Quality Control Procedures for these Instruments are described in this document together with specific recommendations and assessment of its accuracy. (Author) [pt

Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars.

Science.gov (United States)

Vandekerckhove, Kristof; Seidl, Andreas; Gutka, Hiten; Kumar, Manish; Gratzl, Gyöngyi; Keire, David; Coffey, Todd; Kuehne, Henriette

2018-05-10

Leading regulatory agencies recommend biosimilar assessment to proceed in a stepwise fashion, starting with a detailed analytical comparison of the structural and functional properties of the proposed biosimilar and reference product. The degree of analytical similarity determines the degree of residual uncertainty that must be addressed through downstream in vivo studies. Substantive evidence of similarity from comprehensive analytical testing may justify a targeted clinical development plan, and thus enable a shorter path to licensing. The importance of a careful design of the analytical similarity study program therefore should not be underestimated. Designing a state-of-the-art analytical similarity study meeting current regulatory requirements in regions such as the USA and EU requires a methodical approach, consisting of specific steps that far precede the work on the actual analytical study protocol. This white paper discusses scientific and methodological considerations on the process of attribute and test method selection, criticality assessment, and subsequent assignment of analytical measures to US FDA's three tiers of analytical similarity assessment. Case examples of selection of critical quality attributes and analytical methods for similarity exercises are provided to illustrate the practical implementation of the principles discussed.

Evaluation of capillary zone electrophoresis for the quality control of complex biologic samples: Application to snake venoms.

Science.gov (United States)

Kpaibe, André P S; Ben-Ameur, Randa; Coussot, Gaëlle; Ladner, Yoann; Montels, Jérôme; Ake, Michèle; Perrin, Catherine

2017-08-01

Snake venoms constitute a very promising resource for the development of new medicines. They are mainly composed of very complex peptide and protein mixtures, which composition may vary significantly from batch to batch. This latter consideration is a challenge for routine quality control (QC) in the pharmaceutical industry. In this paper, we report the use of capillary zone electrophoresis for the development of an analytical fingerprint methodology to assess the quality of snake venoms. The analytical fingerprint concept is being widely used for the QC of herbal drugs but rarely for venoms QC so far. CZE was chosen for its intrinsic efficiency in the separation of protein and peptide mixtures. The analytical fingerprint methodology was first developed and evaluated for a particular snake venom, Lachesis muta. Optimal analysis conditions required the use of PDADMAC capillary coating to avoid protein and peptide adsorption. Same analytical conditions were then applied to other snake venom species. Different electrophoretic profiles were obtained for each venom. Excellent repeatability and intermediate precision was observed for each batch. Analysis of different batches of the same species revealed inherent qualitative and quantitative composition variations of the venoms between individuals. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Control cards as a statistical quality control resource

Directory of Open Access Journals (Sweden)

Aleksandar Živan Drenovac

2013-02-01

Full Text Available Normal 0 false false false MicrosoftInternetExplorer4 This paper proves that applying of statistical methods can significantly contribute increasing of products and services quality, as well as increasing of institutions rating. Determining of optimal, apropos anticipatory and limitary values, is based on sample`s statistical analyze. Control cards represent very confident instrument, which is simple for use and efficient for control of process, by which process is maintained in set borders. Thus, control cards can be applied in quality control of procesess of weapons and military equipment production, maintenance of technical systems, as well as for seting of standards and increasing of quality level for many other activities.

7 CFR 930.44 - Quality control.

Science.gov (United States)

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

Study of the analytic quality in the determinations of Cr, Fe, Mn, Cu, Zn, Pb and Hg through conventional and nuclear analytical techniques in mosses of the MATV; Estudio de la calidad analitica en las determinaciones de Cr, Fe, Mn, Cu, Zn, Pb y Hg a traves de tecnicas analiticas nucleares y convencionales en musgos de la ZMVT

Energy Technology Data Exchange (ETDEWEB)

Caballero S, B.

2013-07-01

To evaluate the environmental risks of air pollution and to facilitate the decision-making for control, is necessary to have the capacity to generate data with analytical quality. A comparison between nuclear (Neutron activation analysis and total reflection X-ray fluorescence spectrometry) and no nuclear analytical techniques (atomic absorption spectrometry and inductively coupled plasma optical emission spectrometry) for simultaneous determination of metal content (Cr, Cu, Fe, Hg, Mn, Pb and Zn) in mosses from Metropolitan Area of the Toluca Valley (MATV) was performed. Epiphytic mosses (Fabriona ciliaris and Leskea angustata) were sampled in two campaigns, 16 sites (urban, transition and natural) and were prepared for each technique. The biological certified reference materials were used for the quality control and to evaluate accuracy, precision, linearity, detection and quantification limits. Results show that nuclear analytical techniques and no nuclear applied in chemical analysis of Cr, Cu, Fe, Hg, Mn, Pb and Zn in moss from MATV are comparable and therefore all of these can potentially be used for this purpose. However, if its considered both, the performance parameters and economic/operational characteristics is widely recommended inductively coupled plasma optical emission spectrometry, conventional analytical technique, which showed the highest analytical grade quality. Also were observed spatial and temporal variations in the concentrations of Cr, Cu, Fe, Hg, Mn, Pb and Zn in mosses from MATV and was discussed its potential origin. The urban sites had the highest concentration of anthropogenic elements as Cr, Cu, Fe, Hg, Pb and Zn because are strongly impacted by roads with high vehicle traffic. (Author)

Quality control analysis at the hospital

International Nuclear Information System (INIS)

Kristensen, K.

1979-01-01

Quality control analysis is an integral part of quality assurance. In a system as with radiopharmaceuticals where part of the finishing of the product takes place at individual hospitals, the need for quality control analysis at the hospital can be discussed. Data are presented that stresses the importance of quality control by the manufacturer as a basis for limitation of such work at hospitals. A simplified programme is proposed

14 CFR 21.139 - Quality control.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which he...

33 CFR 385.21 - Quality control.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

Road Transportable Analytical Laboratory system

International Nuclear Information System (INIS)

Finger, S.M.; Keith, V.F.; Spertzel, R.O.; De Avila, J.C.; O'Donnell, M.; Vann, R.L.

1993-09-01

This developmental effort clearly shows that a Road Transportable Analytical Laboratory System is a worthwhile and achievable goal. The RTAL is designed to fully analyze (radioanalytes, and organic and inorganic chemical analytes) 20 samples per day at the highest levels of quality assurance and quality control. It dramatically reduces the turnaround time for environmental sample analysis from 45 days (at a central commercial laboratory) to 1 day. At the same time each RTAL system will save the DOE over $12 million per year in sample analysis costs compared to the costs at a central commercial laboratory. If RTAL systems were used at the eight largest DOE facilities (at Hanford, Savannah River, Fernald, Oak Ridge, Idaho, Rocky Flats, Los Alamos, and the Nevada Test Site), the annual savings would be $96,589,000. The DOE's internal study of sample analysis needs projects 130,000 environmental samples requiring analysis in FY 1994, clearly supporting the need for the RTAL system. The cost and time savings achievable with the RTAL system will accelerate and improve the efficiency of cleanup and remediation operations throughout the DOE complex

Process Analytical Technology (PAT): batch-to-batch reproducibility of fermentation processes by robust process operational design and control.

Science.gov (United States)

Gnoth, S; Jenzsch, M; Simutis, R; Lübbert, A

2007-10-31

The Process Analytical Technology (PAT) initiative of the FDA is a reaction on the increasing discrepancy between current possibilities in process supervision and control of pharmaceutical production processes and its current application in industrial manufacturing processes. With rigid approval practices based on standard operational procedures, adaptations of production reactors towards the state of the art were more or less inhibited for long years. Now PAT paves the way for continuous process and product improvements through improved process supervision based on knowledge-based data analysis, "Quality-by-Design"-concepts, and, finally, through feedback control. Examples of up-to-date implementations of this concept are presented. They are taken from one key group of processes in recombinant pharmaceutical protein manufacturing, the cultivations of genetically modified Escherichia coli bacteria.

Descriptive and analytic epidemiology. Bridges to cancer control

International Nuclear Information System (INIS)

Mettlin, C.

1988-01-01

Epidemiology serves as a bridge between basic science and cancer control. The two major orientations of epidemiology are descriptive and analytic. The former is useful in assessing the scope and dimensions of the cancer problem and the latter is used to assess environmental and lifestyle sources of cancer risk. A recent development in descriptive epidemiology is the use of functional measures of disease such as lost life expectancy. In analytical epidemiology, there is new or renewed interest in several lifestyle factors including diet and exercise as well as environmental factors such as involuntary tobacco exposure and radon in dwellings. Review of the evidence should consider the strengths and weaknesses of different research procedures. Each method is inconclusive by itself but, the different research designs of epidemiology collectively may represent a hierarchy of proof. Although the roles of many factors remain to be defined, the aggregate epidemiologic data continue to demonstrate the special importance of personal behavior and lifestyle in affecting cancer risk

Related regulation of quality control of industrial products

International Nuclear Information System (INIS)

1983-04-01

This book introduce related regulation of quality control of industrial products, which includes regulations of industrial products quality control, enforcement ordinance of industrial products quality control, enforcement regulation of quality control of industrial products, designated items with industrial production quality indication, industrial production quality test, and industrial production quality test organization and management tips of factory quality by grade.

Application of quality function deployment (QFD and analytic hierarchy process (AHP techniques to improve the quality of postgraduate training

Directory of Open Access Journals (Sweden)

Antonio Pastor Sanmillán

2016-05-01

Full Text Available The importance of ensuring quality in higher education is evident in the number of local, national and transnational organizations dedicated to this end. The impressive volume of works published on quality in education is further testimony to its importance. All university, traditional or on-line, has a department dedicated to the study of quality, and the academic literature in this area is extremely broad in scope. Yet in this abundant wealth of studies, methodologies, techniques, fantasies and realities in which professors and university administrators, teachers, psychologists, marketing experts and quality professionals focus their attention, there is in our opinion something basic and elemental which is frequently forgotten: to ask the student, the end user (who should be the fundamental object of our interest what aspects of postgraduate study he truly values. The goal of the present study will be to verify the usefulness of multi-criteria analysis, and of the analytic hierarchy process (AHP in particular, attached to quality function deployment (QFD, for performing this task in multicultural environments. The population chosen for our study is comprised of the students enrolled in on-site postgraduate programs at the CEF School of Business.

Quality control guarantees the safety of radiotherapy

International Nuclear Information System (INIS)

Aaltonen, P.

1994-01-01

While radiotherapy equipment has seen some decisive improvements in the last few decades, the technology has also become more complicated. The advanced equipment produces increasingly good treatment results, but the condition of the equipment must be controlled efficiently so as to eliminate any defects that might jeopardise patient safety. The quality assurance measures that are taken to show that certain equipment functions as required are known as quality control. The advanced equipment and stricter requirements set for the precision of radiotherapy have meant that more attention must be paid to quality control. The present radiation legislation stipulates that radiotherapy equipment must undergo regular quality control. The implementation of the quality control is supervised by the Finnish Centre for Radiation and Nuclear Safety (STUK). Hospitals carry out quality control in accordance with a programme approved by STUK, and STUK inspectors periodically visit hospitals to check the results of quality control. (orig.)

The quality of veterinary in-clinic and reference laboratory biochemical testing.

Science.gov (United States)

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

Quality assurance and quality control of geochemical data—A primer for the research scientist

Science.gov (United States)

Geboy, Nicholas J.; Engle, Mark A.

2011-01-01

Geochemistry is a constantly expanding science. More and more, scientists are employing geochemical tools to help answer questions about the Earth and earth system processes. Scientists may assume that the responsibility of examining and assessing the quality of the geochemical data they generate is not theirs but rather that of the analytical laboratories to which their samples have been submitted. This assumption may be partially based on knowledge about internal and external quality assurance and quality control (QA/QC) programs in which analytical laboratories typically participate. Or there may be a perceived lack of time or resources to adequately examine data quality. Regardless of the reason, the lack of QA/QC protocols can lead to the generation and publication of erroneous data. Because the interpretations drawn from the data are primary products to U.S. Geological Survey (USGS) stakeholders, the consequences of publishing erroneous results can be significant. The principal investigator of a scientific study ultimately is responsible for the quality and interpretation of the project's findings, and thus must also play a role in the understanding, implementation, and presentation of QA/QC information about the data. Although occasionally ignored, QA/QC protocols apply not only to procedures in the laboratory but also in the initial planning of a research study and throughout the life of the project. Many of the tenets of developing a sound QA/QC program or protocols also parallel the core concepts of developing a good study: What is the main objective of the study? Will the methods selected provide data of enough resolution to answer the hypothesis? How should samples be collected? Are there known or unknown artifacts or contamination sources in the sampling and analysis methods? Assessing data quality requires communication between the scientists responsible for designing the study and those collecting samples, analyzing samples, treating data, and

Preanalytical quality improvement: in quality we trust.

Science.gov (United States)

Lippi, Giuseppe; Becan-McBride, Kathleen; Behúlová, Darina; Bowen, Raffick A; Church, Stephen; Delanghe, Joris; Grankvist, Kjell; Kitchen, Steve; Nybo, Mads; Nauck, Matthias; Nikolac, Nora; Palicka, Vladimir; Plebani, Mario; Sandberg, Sverre; Simundic, Ana-Maria

2013-01-01

Total quality in laboratory medicine should be defined as the guarantee that each activity throughout the total testing process is correctly performed, providing valuable medical decision-making and effective patient care. In the past decades, a 10-fold reduction in the analytical error rate has been achieved thanks to improvements in both reliability and standardization of analytical techniques, reagents, and instrumentation. Notable advances in information technology, quality control and quality assurance methods have also assured a valuable contribution for reducing diagnostic errors. Nevertheless, several lines of evidence still suggest that most errors in laboratory diagnostics fall outside the analytical phase, and the pre- and postanalytical steps have been found to be much more vulnerable. This collective paper, which is the logical continuum of the former already published in this journal 2 years ago, provides additional contribution to risk management in the preanalytical phase and is a synopsis of the lectures of the 2nd European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)-Becton Dickinson (BD) European Conference on Preanalytical Phase meeting entitled "Preanalytical quality improvement: in quality we trust" (Zagreb, Croatia, 1-2 March 2013). The leading topics that will be discussed include quality indicators for preanalytical phase, phlebotomy practices for collection of blood gas analysis and pediatric samples, lipemia and blood collection tube interferences, preanalytical requirements of urinalysis, molecular biology hemostasis and platelet testing, as well as indications on best practices for safe blood collection. Auditing of the preanalytical phase by ISO assessors and external quality assessment for preanalytical phase are also discussed.

Quality and reliability control on assemblies

International Nuclear Information System (INIS)

Mueller, H.

1976-01-01

Taking as an example electronic assemblies in printed circuit board engineering, quality control during manufacture is dealt with. After giving a survey of four phases of quality and reliability control, some specific methods of quality control are dealt with by means of a flowchart, and by some examples the necessity and the success of these measures are shown. (RW) [de

Quality Control in Mammography: Image Quality and Patient Doses

International Nuclear Information System (INIS)

Ciraj Bjelac, O.; Arandjic, D.; Boris Loncar, B.; Kosutic, D.

2008-01-01

Mammography is method of choice for early detection of breast cancer. The purpose of this paper is preliminary evaluation the mammography practice in Serbia, in terms of both quality control indicators, i.e. image quality and patient doses. The survey demonstrated considerable variations in technical parameters that affect image quality and patients doses. Mean glandular doses ranged from 0.12 to 2.8 mGy, while reference optical density ranged from 1.2 to 2.8. Correlation between image contrast and mean glandular doses was demonstrated. Systematic implementation of quality control protocol should provide satisfactory performance of mammography units and maintain satisfactory image quality and keep patient doses as low as reasonably practicable. (author)

Analytical study of flow instability behaviour in a boiling two-phase natural circulation loop under low quality conditions

International Nuclear Information System (INIS)

Nayak, A.K.; Kumar, N.; Vijayan, P.K.; Saha, D.; Sinha, R.K.

2002-01-01

Analytical investigations have been carried out to study the flow instability behaviour in a boiling two-phase natural circulation loop under low quality conditions. For this purpose, the computer code TINFLO-S has been developed. The code solves the conservation equations of mass, momentum and energy and equation of state for homogeneous equilibrium twophase flow using linear analytical technique. The results of the code have been validated with the experimental data of the loop for both the steady state and stability. The study reveals that the stability behaviour of low quality flow oscillations is different from that of the high quality flow oscillations. The instability reduces with increase in power and throttling at the inlet of the heater. The instability first increases and then reduces with increase in pressure at any subcooling. The effects of diameter of riser pipe, heater and the height of the riser on this instability are also investigated. (orig.) [de

VGI QUALITY CONTROL

Directory of Open Access Journals (Sweden)

C. C. Fonte

2015-08-01

Full Text Available This paper presents a framework for considering quality control of volunteered geographic information (VGI. Different issues need to be considered during the conception, acquisition and post-acquisition phases of VGI creation. This includes items such as collecting metadata on the volunteer, providing suitable training, giving corrective feedback during the mapping process and use of control data, among others. Two examples of VGI data collection are then considered with respect to this quality control framework, i.e. VGI data collection by National Mapping Agencies and by the most recent Geo-Wiki tool, a game called Cropland Capture. Although good practices are beginning to emerge, there is still the need for the development and sharing of best practice, especially if VGI is to be integrated with authoritative map products or used for calibration and/or validation of land cover in the future.

7 CFR 58.928 - Quality control tests.

Science.gov (United States)

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be...

Trends in Process Analytical Technology: Present State in Bioprocessing.

Science.gov (United States)

Jenzsch, Marco; Bell, Christian; Buziol, Stefan; Kepert, Felix; Wegele, Harald; Hakemeyer, Christian

2017-08-04

Process analytical technology (PAT), the regulatory initiative for incorporating quality in pharmaceutical manufacturing, is an area of intense research and interest. If PAT is effectively applied to bioprocesses, this can increase process understanding and control, and mitigate the risk from substandard drug products to both manufacturer and patient. To optimize the benefits of PAT, the entire PAT framework must be considered and each elements of PAT must be carefully selected, including sensor and analytical technology, data analysis techniques, control strategies and algorithms, and process optimization routines. This chapter discusses the current state of PAT in the biopharmaceutical industry, including several case studies demonstrating the degree of maturity of various PAT tools. Graphical Abstract Hierarchy of QbD components.

Expert database system for quality control

Science.gov (United States)

Wang, Anne J.; Li, Zhi-Cheng

1993-09-01

There are more competitors today. Markets are not homogeneous they are fragmented into increasingly focused niches requiring greater flexibility in the product mix shorter manufacturing production runs and above allhigher quality. In this paper the author identified a real-time expert system as a way to improve plantwide quality management. The quality control expert database system (QCEDS) by integrating knowledge of experts in operations quality management and computer systems use all information relevant to quality managementfacts as well as rulesto determine if a product meets quality standards. Keywords: expert system quality control data base

Quantitative Evaluation of Acetaminophen in Oral Solutions by Dispersive Raman Spectroscopy for Quality Control

OpenAIRE

Borio, Viviane G.; Vinha, RubensJr.; Nicolau, Renata A.; de Oliveira, Hueder Paulo M.; de Lima, Carlos J.; Silveira, LandulfoJr.

2012-01-01

This work used dispersive Raman spectroscopy to evaluate acetaminophen in commercially available formulations as an analytical methodology for quality control in the pharmaceutical industry. Raman spectra were collected using a near-infrared dispersive Raman spectrometer (830 nm, 50 mW, 20 s exposure time) coupled to a fiber optic probe. Solutions of acetaminophen diluted in excipient (70 to 120% of the commercial concentration of 200 mg/mL) were used to develop a calibration model based on p...

Analytical chemistry department. Annual report, 1977

International Nuclear Information System (INIS)

Knox, E.M.

1978-09-01

The annual report describes the analytical methods, analyses and equipment developed or adopted for use by the Analytical Chemistry Department during 1977. The individual articles range from a several page description of development and study programs to brief one paragraph descriptions of methods adopted for use with or without some modification. This year, we have included a list of the methods incorporated into our Analytical Chemistry Methods Manual. This report is organized into laboratory sections within the Department as well as major programs within General Atomic Company. Minor programs and studies are included under Miscellaneous. The analytical and technical support activities for GAC include gamma-ray spectroscopy, radiochemistry, activation analysis, gas chromatography, atomic absorption, spectrophotometry, emission spectroscopy, x-ray diffractometry, electron microprobe, titrimetry, gravimetry, and quality control. Services are provided to all organizations throughout General Atomic Company. The major effort, however, is in support of the research and development programs within HTGR Generic Technology Programs ranging from new fuel concepts, end-of-life studies, and irradiated capsules to fuel recycle studies

LASL computerized quality assurance record-keeping system for analytical chemistry

International Nuclear Information System (INIS)

Dahlby, J.W.; Phillips, J.R.

1976-06-01

Research programs requiring quality assurance surveillance, certification procedures, and associated record keeping have increased markedly at the Los Alamos Scientific Laboratory. A computer-based system, accessible through time-sharing terminals, performs many routine operations, including continued records updating for equipment calibration, personnel certification, quality assurance procedure listings, and controlled-document distribution lists. The system described has operated successfully for more than a year, resulting in a significant savings in man-hours required to keep quality assurance records

The effect of statistical analytical measurement variations on the plant control parameters and production costs in cement manufacturing – a case study

Directory of Open Access Journals (Sweden)

A. D. Love

2010-01-01

Full Text Available Raw materials used in cement manufacturing normally have varying chemical compositions and require regular analyses for plant control purposes. This is achieved by using several analytical instruments, such as XRF and ICP. The values obtained for the major elements Ca, Si, Fe and Al, are used to calculate the plant control parameters Lime Saturation Factor (LSF, Silica Ratio (SR and Alumina Modulus (AM. These plant control parameters are used to regulate the mixing and blending of various raw meal components and to operate the plant optimally. Any errors and large fluctuations in these plant parameters not only influence the quality of the cement produced, but also have a major effect on the cost of production of cement clinker through their influence on the energy consumption and residence time in the kiln. This paper looks at the role that statistical variances in the analytical measurements of the major elements Ca, Si, Fe and Al can have on the ultimate LSF, SR and AM values calculated from these measurements. The influence of too high and too low values of the LSF, SR and AM on clinker quality and energy consumption is discussed, and acceptable variances in these three parameters, based on plant experiences, are established. The effect of variances in the LSF, SR and AM parameters on the production costs is then analysed, and it is shown that variations of as large as 30% and as little as 5% can potentially occur. The LSF calculation incorporates most chemical elements and therefore is prone to the largest number of variations due to statistical variances in the analytical determinations of the chemical elements. Despite all these variations in LSF values they actually produced the smallest influence on the production cost of the clinker. It is therefore concluded that the LSF value is the most practical parameter for plant control purposes.

Intercalibration study. Net of quality control of waters of the Department of Antioquia

International Nuclear Information System (INIS)

Parra M, C.M; Mejia Z, G.M.

1999-01-01

The norm ISO 5725 has set a series of statistical procedures for the evaluation of results for an intercalibration study which of course is a fundamental support for the setting of a quality control program that must be implement by every laboratory seeking accreditation. In the present paper the implementation of such procedures is shown for an exercise classified to be as of a uniform level. The chosen parameter was suspended solids which is included in the fees of the retributive rates set by the Ministerio del Medio Ambiente in Colombia. The exercise was done by the laboratories that are members of the Analytical Control of Water Web in the Department of Antioquia

7 CFR 58.335 - Quality control tests.

Science.gov (United States)

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality control tests. 58.335 Section 58.335... Procedures § 58.335 Quality control tests. All milk, cream and related products are subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be made on flow...

Quality control of radiopharmaceuticals

International Nuclear Information System (INIS)

Verdera, E.S.

1994-01-01

The quality control of radiopharmaceuticals is based in physics, physics-chemical and biological controls. Between the different controls can be enumerated the following: visual aspect,side, number of particle beams,activity,purity,ph,isotonicity,sterility,radioinmunoessay,toxicity,stability and clinical essay

7 CFR 58.642 - Quality control tests.

Science.gov (United States)

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality control tests. 58.642 Section 58.642... Procedures § 58.642 Quality control tests. All mix ingredients shall be subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be made on flow line samples as...

Comparative mass spectrometry & nuclear magnetic resonance metabolomic approaches for nutraceuticals quality control analysis: a brief review.

Science.gov (United States)

Farag, Mohamed A

2014-01-01

The number of botanical dietary supplements in the market has recently increased primarily due to increased health awareness. Standardization and quality control of the constituents of these plant extracts is an important topic, particularly when such ingredients are used long term as dietary supplements, or in cases where higher doses are marketed as drugs. The development of fast, comprehensive, and effective untargeted analytical methods for plant extracts is of high interest. Nuclear magnetic resonance spectroscopy and mass spectrometry are the most informative tools, each of which enables high-throughput and global analysis of hundreds of metabolites in a single step. Although only one of the two techniques is utilized in the majority of plant metabolomics applications, there is a growing interest in combining the data from both platforms to effectively unravel the complexity of plant samples. The application of combined MS and NMR in the quality control of nutraceuticals forms the major part of this review. Finally I will look at the future developments and perspectives of these two technologies for the quality control of herbal materials.

Desarrollo y validación de los métodos analíticos para el control de calidad del micocilén polvo Development and validation of analytical methods for quality control of Micocilen powder

Directory of Open Access Journals (Sweden)

Yania Suárez Pérez

2011-06-01

Full Text Available El micocilén es un medicamento que se presenta en forma de polvo. Contiene 2 ingredientes farmacéuticos activos: el ácido undecilénico y el undecilinato de zinc. Por su acción fungistática, se ha convertido en un producto de alta demanda en Cuba, ya que las micosis se favorecen en climas cálidos y húmedos. Se realizó el desarrollo y la validación de 2 métodos analíticos para el control de calidad sobre la base de la cuantificación de cada analito presente en la formulación. Se seleccionaron técnicas volumétricas por neutralización acuosa y complejometría. Los resultados fueron satisfactorios, ya que en ambos casos se obtuvo adecuada especificidad, linealidad, exactitud, precisión y robustez. Los métodos propuestos se compararon con los aplicados anteriormente y se obtuvieron resultados mucho más confiables, según resultados del análisis estadístico aplicado, sin diferencias significativas entre las réplicas de un mismo lote.The undecylenic acid (Micocilen is a drug in powder presentation containing two active pharmaceutical ingredients: undecylenic acid and zinc undecylenate. By its fungistatic action becames a first line product in Cuba because of mycoses are typical of wet and warm climates. Development and validation of two analytical methods for the quality control on the base of the quantification of each symbol present in the formula. Volumetric techniques were selected by aqueous neutralization and complexometric. Results were satisfactory since in both cases an appropriate specificity, linearity, accuracy, precision and robustness were obtained. Methods proposed were compared to those previously applied obtaining more reliable results, according to results of analytical analysis applied, without significant differences among replica of a same batch.

Quality control of nuclear medicine instrumentation

International Nuclear Information System (INIS)

Mould, R.F.

1983-09-01

The proceedings of a conference held by the Hospital Physicists' Association in London 1983 on the quality control of nuclear medicine instrumentation are presented. Section I deals with the performance of the Anger gamma camera including assessment during manufacture, acceptance testing, routine testing and long-term assessment of results. Section II covers interfaces, computers, the quality control problems of emission tomography and the quality of software. Section III deals with radionuclide measurement and impurity assessment and Section IV the presentation of images and the control of image quality. (U.K.)

Control quality and performance measurement of gamma cameras. S.F.P.M. report nr 28. Updating of S.F.P.H. reports Performance assessment and quality control of scintillation cameras: plane mode (1992), tomographic mode (1996) whole-body mode (1997)

International Nuclear Information System (INIS)

Petegnief, Yolande; Barrau, Corinne; Coulot, Jeremy; Guilhem, Marie Therese; Hapdey, Sebastien; Vrigneaud, Jean-Marc; Metayer, Yann; Picone, Magali; Ricard, Marcel; Salvat, Cecile; Bouchet, Francis; Ferrer, Ludovic; Murat, Caroline

2012-01-01

This report aims at providing students and professionals with a comprehensive guide related to quality control and to performance measurement on gamma cameras. It completes and updates three previous reports published by the SFPM during the 1990's related to the different acquisition modes for this modality of medical imagery: plane imagery, whole-body scanning, and tomography. The authors present the operation principle of scintillation cameras, the characteristics of a scintillation camera, analytic and algebraic algorithms of tomographic reconstruction, and the various software corrections applied in mono-photonic imagery (corrections of the attenuation effect, of the scattering effect, of the collimator response effect, and of the partial volume effect). In the next part, the present the various characteristics, parameters and issues related to performance measurement for the three addressed modes (plane, whole body, tomographic). The last part presents various aspects of the organisation of quality control and of performance follow-up: regulatory context, reference documents, internal quality control program

Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls - A review.

Science.gov (United States)

Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J Pablo; Garcia-Jares, Carmen

2016-04-07

Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005-2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. Copyright © 2016

Control by quality: proposition of a typology.

Science.gov (United States)

Pujo, P; Pillet, M

The application of Quality tools and methods in industrial management has always had a fundamental impact on the control of production. It influences the behavior of the actors concerned, while introducing the necessary notions and formalizations, especially for production systems with little or no automation, which constitute a large part of the industrial activity. Several quality approaches are applied in the workshop and are implemented at the level of the control. In this paper, the authors present a typology of the various approaches that have successively influenced control, such as statistical process control, quality assurance, and continuous improvement. First the authors present a parallel between production control and quality organizational structure. They note the duality between control, which is aimed at increasing productivity, and quality, which aims to satisfy the needs of the customer. They also note the hierarchical organizational structure of these two systems of management with, at each level, the notion of a feedback loop. This notion is fundamental to any kind of decision making. The paper is organized around the operational, tactical, and strategic levels, by describing for each level the main methods and tools for control by quality. The overview of these tools and methods starts at the operational level, with the Statistical Process Control, the Taguchi technique, and the "six sigma" approach. On the tactical level, we find a quality system approach, with a documented description of the procedures introduced in the firm. The management system can refer here to Quality Assurance, Total Productive Maintenance, or Management by Total Quality. The formalization through procedures of the rules of decision governing the process control enhances the validity of these rules. This leads to the enhancement of their reliability and to their consolidation. All this counterbalances the human, intrinsically fluctuating, behavior of the control

INFORMATION SYSTEM QUALITY CONTROL KNOWLEDGE

Directory of Open Access Journals (Sweden)

Vladimir Nikolaevich Babeshko

2017-02-01

Full Text Available The development of the educational system is associated with the need to control the quality of educational services. Quality control knowledge is an important part of the scientific process. The penetration of computers into all areas of activities changing approaches and technologies that previously they were used.

HPLC-MS technique in radiopharmaceutical research (the quality control of 18F-2-fluorodeoxyglucose as an example)

International Nuclear Information System (INIS)

Macasek, F.

2001-01-01

Application of radiopharmaceuticals puts increasing demands on their quality control, considering the short half-times, high specific activities (auto-radiolytic effects), and general quality (chemical purity, apyrogenity and sterility) of pharmacy. Mostly, the radioanalytical control consists of application of several separation and instrumental analytical techniques. In this paper, perspective of the hyphenated HPLC and MS techniques is demonstrated on the example of one of the most spread radiopharmaceutical, 2-[ 18 F]fluoro-2-deoxy-D-glucose (further as FDG). In this work, a liquid chromatography/refractive index detector/radiometric detector/mass spectrometric detector combination (HPLC/RID/RAD/MSD) was used for development of a complex routine technique. Optimization of HPLC/MS analysis was performed investigating the electrospray ionization (ESI) analytical signal of mass spectrometer as a function of various eluent composition (see this book, p. 39). Some results, illustrating the glucose and FDG ESI-MS, and also composition of FDG after autoradiolysis, which were obtained either by a TOF Mariner (Perkin Elmer) mass-spectrometer and Agilent 1100 HPLC-MS equipment with quadrupole MS detector are discussed. They give evidence of admixtures and radiolytic formation of deoxyglucose, deoxychloroglucose, erythrose, erytritol, gluconic acid, lactose, raffinose, saccharic acid, sorbitol/[ 19 F]FDG, xylitol, and also univalent ions of C 6 H 10 O 7 F.H 2 O and C 6 H 12 O 8 compounds. The results indicate that the emerging demands on radiopharmaceuticals quality control can be fulfilled in-time only by the radio-HPLC technique developed by the help of a tandem mass-spectrometric detector. (authors)

2. Product quality control and assurance system

International Nuclear Information System (INIS)

1990-01-01

Product quality control and assurance are dealt with in relation to reliability in nuclear power engineering. The topics treated include product quality control in nuclear power engineering, product quality assurance of nuclear power plant equipment, quality assurance programs, classification of selected nuclear power equipment, and standards relating to quality control and assurance and to nuclear power engineering. Particular attention is paid to Czechoslovak and CMEA standards. (P.A.). 2 figs., 1 tab., 12 refs

Review of experience gained in fabricating nuclear grade uranium and thorium compounds and their analytical quality control at the Instituto de Energia Atomica, Sao Paulo, Brazil

International Nuclear Information System (INIS)

Abrao, A.; Franca, J.M. Jr.; Ikuta, A.; Pueschel, C.R.; Federgruen, L.; Lordello, A.R.; Tomida, E.K.; Moraes, S.; Brito, J. de; Gomes, R.P.; Araujo, J.A.; Floh, B.; Matsuda, H.T.

1977-01-01

This paper summarizes the main activities dealing with the fabrication of nuclear grade uranium and thorium compounds at the Instituto de Energia Atomica, Sao Paulo. Identification of problems and their resolutions, the experience gained in plant operation, the performance characteristics of an ion-exchange facility and a solvent extraction unit (a demonstration plant based on pulsed columns for purification of uranium and production of ammonium diuranate) are described. A moving-bed facility for UF 4 preparation and its operation is discussed. A pilot plant for uranium and thorium oxide microsphere preparation based on internal gelation for HTGR fuel type is also described. A solvent extraction pilot plant for thorium purification based on a compound extraction-scrubbing column and a mixer-settler battery and the involved technology for thorium purification are commented. The main products, namely ammonium diuranate, uranyl amonium tricarbonate, uranium trioxide, uranium tetrafluoride, thorium nitrate and thorium oxalate and their quality are commented. The development of necessary analytical procedures for the quality control of the mentioned nuclear grade products is summarized. A great majority of such procedures was particularly suitable for analyzing traces impurities. Designed for installation are the units for denitration of uranyl nitrate solutions and pilot plants for elemental fluorine and UF 6 . The installation of a laboratory-scale plant designed for reprocessing irradiated uranium and an experimental unit for the recovery of protactinium from irradiated thorium is in progress

Determination and evaluation of air quality control. Manual of ambient air quality control in Germany

Energy Technology Data Exchange (ETDEWEB)

Lahmann, E.

1997-07-01

Measurement of air pollution emissions and ambient air quality are essential instruments for air quality control. By undertaking such measurements, pollutants are registered both at their place of origin and at the place where they may have an effect on people or the environment. Both types of measurement complement each other and are essential for the implementation of air quality legislation, particularly, in compliance with emission and ambient air quality limit values. Presented here are similar accounts of measurement principles and also contains as an Appendix a list of suitability-tested measuring devices which is based on information provided by the manufacturers. In addition, the guide of ambient air quality control contains further information on discontinuous measurement methods, on measurement planning and on the assessment of ambient air quality data. (orig./SR)

Analytical performance evaluation of a high-volume hematology laboratory utilizing sigma metrics as standard of excellence.

Science.gov (United States)

Shaikh, M S; Moiz, B

2016-04-01

Around two-thirds of important clinical decisions about the management of patients are based on laboratory test results. Clinical laboratories are required to adopt quality control (QC) measures to ensure provision of accurate and precise results. Six sigma is a statistical tool, which provides opportunity to assess performance at the highest level of excellence. The purpose of this study was to assess performance of our hematological parameters on sigma scale in order to identify gaps and hence areas of improvement in patient care. Twelve analytes included in the study were hemoglobin (Hb), hematocrit (Hct), red blood cell count (RBC), mean corpuscular volume (MCV), red cell distribution width (RDW), total leukocyte count (TLC) with percentages of neutrophils (Neutr%) and lymphocytes (Lymph %), platelet count (Plt), mean platelet volume (MPV), prothrombin time (PT), and fibrinogen (Fbg). Internal quality control data and external quality assurance survey results were utilized for the calculation of sigma metrics for each analyte. Acceptable sigma value of ≥3 was obtained for the majority of the analytes included in the analysis. MCV, Plt, and Fbg achieved value of performed poorly on both level 1 and 2 controls with sigma value of <3. Despite acceptable conventional QC tools, application of sigma metrics can identify analytical deficits and hence prospects for the improvement in clinical laboratories. © 2016 John Wiley & Sons Ltd.

30 CFR 74.6 - Quality control.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality control. 74.6 Section 74.6 Mineral... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality...

Droplet digital PCR-based EGFR mutation detection with an internal quality control index to determine the quality of DNA.

Science.gov (United States)

Kim, Sung-Su; Choi, Hyun-Jeung; Kim, Jin Ju; Kim, M Sun; Lee, In-Seon; Byun, Bohyun; Jia, Lina; Oh, Myung Ryurl; Moon, Youngho; Park, Sarah; Choi, Joon-Seok; Chae, Seoung Wan; Nam, Byung-Ho; Kim, Jin-Soo; Kim, Jihun; Min, Byung Soh; Lee, Jae Seok; Won, Jae-Kyung; Cho, Soo Youn; Choi, Yoon-La; Shin, Young Kee

2018-01-11

In clinical translational research and molecular in vitro diagnostics, a major challenge in the detection of genetic mutations is overcoming artefactual results caused by the low-quality of formalin-fixed paraffin-embedded tissue (FFPET)-derived DNA (FFPET-DNA). Here, we propose the use of an 'internal quality control (iQC) index' as a criterion for judging the minimum quality of DNA for PCR-based analyses. In a pre-clinical study comparing the results from droplet digital PCR-based EGFR mutation test (ddEGFR test) and qPCR-based EGFR mutation test (cobas EGFR test), iQC index ≥ 0.5 (iQC copies ≥ 500, using 3.3 ng of FFPET-DNA [1,000 genome equivalents]) was established, indicating that more than half of the input DNA was amplifiable. Using this criterion, we conducted a retrospective comparative clinical study of the ddEGFR and cobas EGFR tests for the detection of EGFR mutations in non-small cell lung cancer (NSCLC) FFPET-DNA samples. Compared with the cobas EGFR test, the ddEGFR test exhibited superior analytical performance and equivalent or higher clinical performance. Furthermore, iQC index is a reliable indicator of the quality of FFPET-DNA and could be used to prevent incorrect diagnoses arising from low-quality samples.

Costs of Quality: Exploratory Analysis of Hidden Elements and Prioritization using Analytic Hierarchy Process

Directory of Open Access Journals (Sweden)

Sailaja A

2015-02-01

Full Text Available Cost of Quality analysis is emerged as an effective tool for the industrial managers for pinpointing the deficiencies in the system as well as for identifying the improvement areas by highlighting the cost reduction opportunities. However , this analysis will be fully effective only if it is further extended to identify the cost incurred in ensuring quality in all areas of the supply chain including the hidden costs and costs of missed out opportunities. Most of the hidden elements of quality costs are difficult to track and not accounted by the traditional accounting tools. An exploratory analysis is made in this research to identify the hidden elements of quality costs in manufacturing industry. Further, the identified cost elements are classified into various groups for better analysis and, finally, prioritized to identify the vital few among them. Analytic Hierarchy Process (AHP technique which is one of the most popular Multi Criteria Decision Method (MCDM and Pareto analysis were used in this study for prioritizing the hidden quality cost elements based on their degree of impact on overall cost of quality. By this analysis, the key cost elements which are to be addressed to reduce the overall cost of quality are identified.

Microplastics in the environment: Challenges in analytical chemistry - A review.

Science.gov (United States)

Silva, Ana B; Bastos, Ana S; Justino, Celine I L; da Costa, João P; Duarte, Armando C; Rocha-Santos, Teresa A P

2018-08-09

Microplastics can be present in the environment as manufactured microplastics (known as primary microplastics) or resulting from the continuous weathering of plastic litter, which yields progressively smaller plastic fragments (known as secondary microplastics). Herein, we discuss the numerous issues associated with the analysis of microplastics, and to a less extent of nanoplastics, in environmental samples (water, sediments, and biological tissues), from their sampling and sample handling to their identification and quantification. The analytical quality control and quality assurance associated with the validation of analytical methods and use of reference materials for the quantification of microplastics are also discussed, as well as the current challenges within this field of research and possible routes to overcome such limitations. Copyright © 2018 Elsevier B.V. All rights reserved.

[Quality control in herbal supplements].

Science.gov (United States)

Oelker, Luisa

2005-01-01

Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

Number of Clusters and the Quality of Hybrid Predictive Models in Analytical CRM

Directory of Open Access Journals (Sweden)

Łapczyński Mariusz

2014-08-01

Full Text Available Making more accurate marketing decisions by managers requires building effective predictive models. Typically, these models specify the probability of customer belonging to a particular category, group or segment. The analytical CRM categories refer to customers interested in starting cooperation with the company (acquisition models, customers who purchase additional products (cross- and up-sell models or customers intending to resign from the cooperation (churn models. During building predictive models researchers use analytical tools from various disciplines with an emphasis on their best performance. This article attempts to build a hybrid predictive model combining decision trees (C&RT algorithm and cluster analysis (k-means. During experiments five different cluster validity indices and eight datasets were used. The performance of models was evaluated by using popular measures such as: accuracy, precision, recall, G-mean, F-measure and lift in the first and in the second decile. The authors tried to find a connection between the number of clusters and models' quality.

Distributed sensor architecture for intelligent control that supports quality of control and quality of service.

Science.gov (United States)

Poza-Lujan, Jose-Luis; Posadas-Yagüe, Juan-Luis; Simó-Ten, José-Enrique; Simarro, Raúl; Benet, Ginés

2015-02-25

This paper is part of a study of intelligent architectures for distributed control and communications systems. The study focuses on optimizing control systems by evaluating the performance of middleware through quality of service (QoS) parameters and the optimization of control using Quality of Control (QoC) parameters. The main aim of this work is to study, design, develop, and evaluate a distributed control architecture based on the Data-Distribution Service for Real-Time Systems (DDS) communication standard as proposed by the Object Management Group (OMG). As a result of the study, an architecture called Frame-Sensor-Adapter to Control (FSACtrl) has been developed. FSACtrl provides a model to implement an intelligent distributed Event-Based Control (EBC) system with support to measure QoS and QoC parameters. The novelty consists of using, simultaneously, the measured QoS and QoC parameters to make decisions about the control action with a new method called Event Based Quality Integral Cycle. To validate the architecture, the first five Braitenberg vehicles have been implemented using the FSACtrl architecture. The experimental outcomes, demonstrate the convenience of using jointly QoS and QoC parameters in distributed control systems.

Distributed Sensor Architecture for Intelligent Control that Supports Quality of Control and Quality of Service

Directory of Open Access Journals (Sweden)

Jose-Luis Poza-Lujan

2015-02-01

Full Text Available This paper is part of a study of intelligent architectures for distributed control and communications systems. The study focuses on optimizing control systems by evaluating the performance of middleware through quality of service (QoS parameters and the optimization of control using Quality of Control (QoC parameters. The main aim of this work is to study, design, develop, and evaluate a distributed control architecture based on the Data-Distribution Service for Real-Time Systems (DDS communication standard as proposed by the Object Management Group (OMG. As a result of the study, an architecture called Frame-Sensor-Adapter to Control (FSACtrl has been developed. FSACtrl provides a model to implement an intelligent distributed Event-Based Control (EBC system with support to measure QoS and QoC parameters. The novelty consists of using, simultaneously, the measured QoS and QoC parameters to make decisions about the control action with a new method called Event Based Quality Integral Cycle. To validate the architecture, the first five Braitenberg vehicles have been implemented using the FSACtrl architecture. The experimental outcomes, demonstrate the convenience of using jointly QoS and QoC parameters in distributed control systems.

Quality control education in the community college

Science.gov (United States)

Greene, J. Griffen; Wilson, Steve

1966-01-01

This paper describes the Quality Control Program at Daytona Beach Junior College, including course descriptions. The program in quality control required communication between the college and the American Society for Quality Control (ASQC). The college has machinery established for certification of the learning process, and the society has the source of teachers who are competent in the technical field and who are the employers of the educational products. The associate degree for quality control does not have a fixed program, which can serve all needs, any more than all engineering degrees have identical programs. The main ideas which would be common to all quality control programs are the concept of economic control of a repetitive process and the concept of developing individual potentialities into individuals who are needed and productive.

TRAINING SYSTEM OF FUTURE SPECIALISTS: QUALITY CONTROL

Directory of Open Access Journals (Sweden)

Vladimir A. Romanov

2015-01-01

Full Text Available The aim of the investigation is development of innovative strategy of quality control training of engineers and skilled workers (hereinafter – future specialists in educational professional organizations on the principles of social partnership.Methods. Theoretic: theoretic and methodological analysis, polytheoretic synthesis, modeling. Empirical: research and generalization of the system, process and competence – based approaches experience, experiment, observation, surveys, expert evaluation, SWOT-analysis as a method of strategic planning which is to identify the internal and external factors (socio-cultural of the organization surrounding.Results. The strategy of the development of the process of quality control training in educational professional organizations and a predictive model of the system of quality control training for future engineers and workers have been created on the analysis and synthesis of a quantitative specification of the quality, the obtained experience and success in control training of future specialists in educational professional organizations in recent economic and educational conditions.Scientific novelty. There has been built a predicative model of quality control training of future specialists to meet modern standards and the principles of social partnership; the control algorithm of the learning process, developed in accordance with the standards (international of quality ISO in the implementation of the quality control systems of the process approach (matrix-based responsibility, competence and remit of those responsible for the education process in the educational organization, the «problem» terms and diagnostic tools for assessing the quality of professional training of future specialists. The perspective directions of innovation in the control of the quality of future professionals training have been determined; the parameters of a comprehensive analysis of the state of the system to ensure the

14 CFR 145.211 - Quality control system.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Quality control system. 145.211 Section 145...) SCHOOLS AND OTHER CERTIFICATED AGENCIES REPAIR STATIONS Operating Rules § 145.211 Quality control system. (a) A certificated repair station must establish and maintain a quality control system acceptable to...

18 CFR 12.40 - Quality control programs.

Science.gov (United States)

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Quality control... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a... meeting any requirements or standards set by the Regional Engineer. If a quality control program is...

Developing methods of controlling quality costs

Directory of Open Access Journals (Sweden)

Gorbunova A. V.

2017-01-01

Full Text Available The article examines issues of managing quality costs, problems of applying economic methods of quality control, implementation of progressive methods of quality costs management in enterprises with the view of improving the efficiency of their evaluation and analysis. With the aim of increasing the effectiveness of the cost management mechanism, authors introduce controlling as a tool of deviation analysis from the standpoint of the process approach. A list of processes and corresponding evaluation criteria in the quality management system of enterprises is introduced. Authors also introduce the method of controlling quality costs and propose it for the practical application, which allows them to determine useful and unnecessary costs at the existing operating plant. Implementing the proposed recommendations in the system of cost management at an enterprise will allow to improve productivity of processes operating and reduce wasted expense on the quality of the process on the basis of determining values of useful and useless costs of quality according to criteria of processes functioning in the system of quality management.

Quality in laboratory medicine: 50years on.

Science.gov (United States)

Plebani, Mario

2017-02-01

The last 50years have seen substantial changes in the landscape of laboratory medicine: its role in modern medicine is in evolution and the quality of laboratory services is changing. The need to control and improve quality in clinical laboratories has grown hand in hand with the growth in technological developments leading to an impressive reduction of analytical errors over time. An essential cause of this impressive improvement has been the introduction and monitoring of quality indicators (QIs) such as the analytical performance specifications (in particular bias and imprecision) based on well-established goals. The evolving landscape of quality and errors in clinical laboratories moved first from analytical errors to all errors performed within the laboratory walls, subsequently to errors in laboratory medicine (including errors in test requesting and result interpretation), and finally, to a focus on errors more frequently associated with adverse events (laboratory-associated errors). After decades in which clinical laboratories have focused on monitoring and improving internal indicators of analytical quality, efficiency and productivity, it is time to shift toward indicators of total quality, clinical effectiveness and patient outcomes. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

International Nuclear Information System (INIS)

Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

2016-01-01

Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights: �

Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

Energy Technology Data Exchange (ETDEWEB)

Lores, Marta, E-mail: marta.lores@usc.es; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

2016-04-07

Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights: �

Quality assurance, quality control and quality audit in diagnostic radiology

International Nuclear Information System (INIS)

Vassileva, J.

2009-01-01

Full text:The lecture aims to present contemporary view of quality assurance in X-Ray diagnosis and its practical realization in Bulgaria. In the lecture the concepts of quality assurance, quality control and clinical audit will be defined and their scope will be considered. An answer of the following questions will be given: why is it necessary to determine the dose of patient in X-ray studies, what is the reference dose level and how it is used for dosimetric quantity which characterized the patient's exposure in X-ray, mammography and CT scans and how they are measured, who conducted the measurement and how to keep the records, what are the variations of doses in identical tests and what defines them? The findings from a national survey of doses in diagnostic radiology, conducted in 2008-2009 and the developed new national reference levels will be presented. The main findings of the first tests of radiological equipment and the future role of quality control as well as the concept of conducting clinical audit and its role in quality assurance are also presented. Quality assurance of the diagnostic process with minimal exposure of patients is a strategic goal whose realization requires understanding, organization and practical action, both nationally and in every hospital. To achieve this the important role of education and training of physicians, radiological technicians and medical physicists is enhanced

Employee quality, monitoring environment and internal control

Directory of Open Access Journals (Sweden)

Chunli Liu

2017-03-01

Full Text Available We investigate the effect of internal control employees (ICEs on internal control quality. Using special survey data from Chinese listed firms, we find that ICE quality has a significant positive influence on internal control quality. We examine the effect of monitoring on this result and find that the effect is more pronounced for firms with strict monitoring environments, especially when the firms implement the Chinese internal control regulation system (CSOX, have higher institutional ownership or attach greater importance to internal control. Our findings suggest that ICEs play an important role in the design and implementation of internal control systems. Our study should be of interest to both top managers who wish to improve corporate internal control quality and regulators who wish to understand the mechanisms of internal control monitoring.

Problems of quality assurance and quality control in diagnostic radiology

International Nuclear Information System (INIS)

Angerstein, W.

1986-01-01

Topical problems of quality assurance and quality control in diagnostic radiology are discussed and possible solutions are shown. Complex units are differentiated with reference to physicians, technicians, organization of labour, methods of examination and indication. Quality control of radiologic imaging systems should involve three stages: (1) simple tests carried out by radiologic technicians, (2) measurements by service technicians, (3) testing of products by the manufacturer and independent governmental or health service test agencies. (author)

Behavioural effects of advanced cruise control use : a meta-analytic approach.

NARCIS (Netherlands)

Dragutinovic, N. Brookhuis, K.A. Hagenzieker, M.P. & Marchau, V.A.W.J.

2006-01-01

In this study, a meta-analytic approach was used to analyse effects of Advanced Cruise Control (ACC) on driving behaviour reported in seven driving simulator studies. The effects of ACC on three consistent outcome measures, namely, driving speed, headway and driver workload have been analysed. The

Quality Control in construction.

Science.gov (United States)

1984-01-01

behavioral scientists. In 1962, Dr. Kaoru Ishikawa gave shape to the form of training which featured intradepartmental groups of ten or so workers seated...and Japanese circles bears closer scrutiny. 4.3.1 Japanese Ingredients of Quality The founder of quality circles, Dr. Kaoru Ishikawa , gives six...around 51 a table; hence the name Quality Control Circle. 4 Dr. 0 Ishikawa was an engineering professor at Tokyo University, and the circles were

Establishment for quality control of experimental animal

International Nuclear Information System (INIS)

Kim, Tae Hwan; Kim, Soo Kwan; Kim, Tae Kyoung

1999-06-01

Until now, because we have imported experimental animal from foreign experimental animal corporation, we could have saved money by establishing the quality control of animal in barrier system. In order to improve the quality of animal experiment and efficiency of biomedical study, it is indispensable to control many factors that effect in the experiment. Therefore, it is essential to organize the system of laboratory animal care for enhancing reliability and revivability of experimental results. The purpose of the present investigation was to establish the quality control system of experimental animals that we can provide good quality animals according to the experimental condition of each investigator although the exact quality control system to estimate the infection of bacteria and virus easily remains ill-defined yet. Accordingly, we established the useful quality control system for microbiologic monitoring and environmental monitoring to protect experimental animal from harmful bacteria and virus

Establishment for quality control of experimental animal

Energy Technology Data Exchange (ETDEWEB)

Kim, Tae Hwan; Kim, Soo Kwan; Kim, Tae Kyoung

1999-06-01

Until now, because we have imported experimental animal from foreign experimental animal corporation, we could have saved money by establishing the quality control of animal in barrier system. In order to improve the quality of animal experiment and efficiency of biomedical study, it is indispensable to control many factors that effect in the experiment. Therefore, it is essential to organize the system of laboratory animal care for enhancing reliability and revivability of experimental results. The purpose of the present investigation was to establish the quality control system of experimental animals that we can provide good quality animals according to the experimental condition of each investigator although the exact quality control system to estimate the infection of bacteria and virus easily remains ill-defined yet. Accordingly, we established the useful quality control system for microbiologic monitoring and environmental monitoring to protect experimental animal from harmful bacteria and virus.

Quality control for dose calibrators

International Nuclear Information System (INIS)

Mendes, L.C.G.

1984-01-01

Nuclear medicine laboratories are required to assay samples of radioactivity to be administered to patients. Almost universally, these assays are accomplished by use of a well ionization chamber isotope calibrator. The Instituto de Radioprotecao e Dosimetria (Institute for Radiological Protection and Dosimetry) of the Comissao Nacional de Energia Nuclear (National Commission for Nuclear Energy) is carrying out a National Quality Control Programme in Nuclear Medicine, supported by the International Atomic Energy Agency. The assessment of the current needs and practices of quality control in the entire country of Brazil includes Dose Calibrators and Scintillation Cameras, but this manual is restricted to the former. Quality Control Procedures for these Instruments are described in this document together with specific recommendations and assessment of its accuracy. (author)

Validación de métodos analíticos para el control de calidad de naproxeno supositorios Validation of analytical methods for the quality control of Naproxen suppositories

Directory of Open Access Journals (Sweden)

Yaslenis Rodríguez Hernández

2011-09-01

Full Text Available En el presente trabajo se desarrollaron por primera vez, los métodos de análisis que serán utilizados para el control de calidad de las futuras formulaciones de supositorios de naproxeno, para uso infantil y adulto de producción nacional. Se propuso un método por espectrofotometría ultravioleta directa, el cual resultó específico, lineal, exacto y preciso para su aplicación en el control de calidad del naproxeno en supositorios, teniendo en cuenta la presencia de grupos cromóforos en su estructura. Se modificó el método por volumetría ácido-base semiacuosa directa reportado para control de calidad de la materia prima de naproxeno y se adaptó al control de calidad en los supositorios. A partir del proceso de validación realizado, se demostró la adecuada especificidad frente a los componentes de la formulación, así como su linealidad, exactitud y precisión en el rango de 1 a 3 mg/mL. Se compararon los resultados obtenidos por ambos métodos sin detectar diferencias estadísticamente significativas entre las réplicas analizadas por cada dosis, por lo que cualquiera de ellos pueden aplicarse al control de calidad de los supositorios.The analysis methods that will be used for the quality control of the future Cuban-made Naproxen suppositories for adults and children were developed for the first time in this paper. One method based on direct ultraviolet spectrophotometry was put forward, which proved to be specific, linear, accurate and precise for the quality control of Naproxen suppositories, taking into account the presence of chromophore groups in their structure. Likewise, the direct semi-aqueous acid-base volumetry method aimed at the quality control of the Naproxen raw material was changed and adapted to the quality control of suppositories. On the basis of the validation process, there was demonstrated the adequate specificity of this method with respect to the formulation components, as well as its linearity, accuracy and

42 CFR 84.256 - Quality control requirements.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

Role of analytical chemistry in the development of nuclear fuels

International Nuclear Information System (INIS)

Ramakumar, K.L.

2012-01-01

Analytical chemistry is indispensable and plays a pivotal role in the entire gamut of nuclear fuel cycle activities starting from ore refining, conversion, nuclear fuel fabrication, reactor operation, nuclear fuel reprocessing to waste management. As the fuel is the most critical component of the reactor where the fissions take place to produce power, extreme care should be taken to qualify the fuel. For example, in nuclear fuel fabrication, depending upon the reactor system, selection of nuclear fuel has to be made. The fuel for thermal reactors is normally uranium oxide either natural or slightly enriched. For research reactors it can be uranium metal or alloy. The fuel for FBR can be metal, alloy, oxide, carbide or nitride. India is planning an advanced heavy water reactor for utilization of vast resources of thorium in the country. Also research is going on to identify suitable metallic/alloy fuels for our future fast reactors and possible use in fast breeder test reactor. Other advanced fuel materials are also being investigated for thermal reactors for realizing increased performance levels. For example, advanced fuels made from UO 2 doped with Cr 2 O 3 and Al 2 O 3 are being suggested in LWR applications. These have shown to facilitate pellet densification during sintering and enlarge the pellet grain size. The chemistry of these materials has to be understood during the preparation to the stringent specification. A number of analytical parameters need to be determined as a part of chemical quality control of nuclear materials. Myriad of analytical techniques starting from the classical to sophisticated instrumentation techniques are available for this purpose. Insatiable urge of the analytical chemist enables to devise and adopt new superior methodologies in terms of reduction in the time of analysis, improvement in the measurement precision and accuracy, simplicity of the technique itself etc. Chemical quality control provides a means to ensure that the

Improved quality control of carbon-14 labelled compounds

International Nuclear Information System (INIS)

Leonhardt, J.W.; Fuchs, P.; Standtke, K.

1997-01-01

IUT Ltd is a producer of carbon-14 labelled organic compounds like benzene, methanol, phenol, formaldehyde, Na-acetates and also special ordered compounds. The quality control of these compounds is carried out by means of HPLC and GC-MS due to chemical purity. Molar activity was determined by Liquid Scintillation Counting and HPLC being equipped by a radioactivity detector. Unfortunately the accuracy of the activity determination was arrived only ±4% relatively. This error is too high because of the large dilution factors. In respect of the IUT accreditation as an analytical laboratory in Germany the accuracy had to be improved remarkably. Therefore the GC-MS-determination of molar activities of labelled compounds is used as the 14 C-labelled compound. A special evaluation code is used to determine the enrichment values relative to the unlabelled molecules. Taking into account the results of GC-MS the accuracy of molar activity determination is improved to ±2%. The spectra evaluation is demonstrated and some examples are discussed

Assembly and Quality Control of the LHC Cryostats at CERN Motivations, Means, Results and Lessons Learnt

CERN Document Server

Poncet, A; Parma, V; Strubin, P; Tock, JP; Tommasini, D

2007-01-01

In 2001, the project management decided to perform at CERN the final assembly of the LHC superconducting magnets with cryostat parts and cold masses produced by European Industry in large series. This industrial-like production has required a very significant investment in tooling, production facilities, engineering and quality control efforts, in contractual partnership with a consortium of firms. This unusual endeavour of a limited lifetime represented more than 850,000 working hours spanning over five years, the work being done on a result-oriented basis by the contractor. This paper presents the reasons for having conducted this project at CERN, summarizes the work breakdown structure, the production means and methods, the infrastructure specially developed, the tooling, logistics and quality control aspects of the work performed and the results achieved, in analytical form. Finally, the lessons learnt are outlined.

Quality assurance/quality control summary report for Phase 1 of the Clinch River remedial investigation. Environmental Restoration Program

International Nuclear Information System (INIS)

Holladay, S.K.; Bevelhimer, M.S.; Brandt, C.C.

1994-07-01

The Clinch River Remedial Investigation (CRRI) is designed to address the transport, fate, and distribution of waterborne contaminants released from the US Department of Energy Oak Ridge Reservation and to assess potential risks to human health and the environment associated with these contaminants. Primary areas of investigation are Melton Hill Reservoir, the Clinch River from Melton Hill Dam to its confluence with the Tennessee River, Poplar Creek, and Watts Bar Reservoir. Phase 1 of the CRRI was a preliminary study in selected areas of the Clinch River/Watts Bar Reservoir. Fish, sediment, and water samples were collected and analyzed for inorganic, organic, and radiological parameters. Phase 1 was designed to (1) obtain high-quality data to confirm existing historical data for contaminant levels; (2) determine the range of contaminant concentrations present in the river-reservoir system; (3) identify specific contaminants of concern; and (4) establish the reference (background) concentrations for those contaminants. Quality assurance (QA) objectives for Phase I were that (1) scientific data generated would withstand scientific scrutiny; (2) data would be gathered using appropriate procedures for field sampling, chain-of-custody, laboratory analyses, and data reporting; and (3) data would be of known precision and accuracy. These objectives were met through the development and implementation of (1) a QA oversight program of audits and surveillances; (2) standard operating procedures accompanied by a training program; (3) field sampling and analytical laboratory quality control requirements; (4) data and records management systems; and (5) validation of the data by an independent reviewer. Approximately 1700 inorganic samples, 1500 organic samples, and 2200 radiological samples were analyzed and validated. The QA completeness objective for the project was to obtain valid analytical results for at least 95% of the samples collected

Quality assurance techniques for activation analysis

International Nuclear Information System (INIS)

Becker, D.A.

1984-01-01

The principles and techniques of quality assurance are applied to the measurement method of activation analysis. Quality assurance is defined to include quality control and quality assessment. Plans for quality assurance include consideration of: personnel; facilities; analytical design; sampling and sample preparation; the measurement process; standards; and documentation. Activation analysis concerns include: irradiation; chemical separation; counting/detection; data collection, and analysis; and calibration. Types of standards discussed include calibration materials and quality assessment materials

42 CFR 493.1250 - Condition: Analytic systems.

Science.gov (United States)

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Analytic systems. 493.1250 Section 493.1250 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and...

An analytic-numerical method for the construction of the reference law of operation for a class of mechanical controlled systems

Science.gov (United States)

Mizhidon, A. D.; Mizhidon, K. A.

2017-04-01

An analytic-numerical method for the construction of a reference law of operation for a class of dynamic systems describing vibrations in controlled mechanical systems is proposed. By the reference law of operation of a system, we mean a law of the system motion that satisfies all the requirements for the quality and design features of the system under permanent external disturbances. As disturbances, we consider polyharmonic functions with known amplitudes and frequencies of the harmonics but unknown initial phases. For constructing the reference law of motion, an auxiliary optimal control problem is solved in which the cost function depends on a weighting coefficient. The choice of the weighting coefficient ensures the design of the reference law. Theoretical foundations of the proposed method are given.

Role of thermo-analytical techniques in compositional characterization of nuclear materials

International Nuclear Information System (INIS)

Raje, Naina

2015-01-01

The study of heat effects on different materials has a long history. Extraction of metals from the ores, pottery production, glasses making etc. are the examples, where the performance of products obtained from raw materials depends on the processing temperatures. Concrete, pottery, bricks etc., are severely damaged due to uncontrolled high temperatures. Therefore, the heating of raw materials in controlled manner is of pivotal importance to get products of the desired quality. Thermo-analytical techniques provide the information on the effect of heat under controlled heating conditions. In thermo-analytical techniques, physical properties of materials are measured as a function of temperature. Simultaneous thermo-analytical techniques are beneficial in comparison to any single thermo-analytical technique. Simultaneous techniques refer to the measurement of two or more signals on the same sample at the same time in the same instrument. Nowadays, simultaneous thermo-analytical technique are extensively in use for the analysis of materials. Ammonium diuranate (ADU) and magnesium diuranate (MDU), also known as yellowcake, are intermediate precursors in fuel fabrication process, with stringent specifications along with the need to understand its thermal behavior. In the processing of lowgrade ores, higher levels of impurities are being encountered in the leach solution that affects the properties of ADU/MDU. In order to meet the fuel specifications, quality assurance of these nuclear materials is essential. Current studies describe the application of simultaneous Thermogravimetry (TG) - differential thermal analysis (DTA) - evolved gas analysis (EGA) techniques for the compositional characterization of ADU/MDU with respect to the impurities present in the matrices

Employee quality, monitoring environment and internal control

OpenAIRE

Chunli Liu; Bin Lin; Wei Shu

2017-01-01

We investigate the effect of internal control employees (ICEs) on internal control quality. Using special survey data from Chinese listed firms, we find that ICE quality has a significant positive influence on internal control quality. We examine the effect of monitoring on this result and find that the effect is more pronounced for firms with strict monitoring environments, especially when the firms implement the Chinese internal control regulation system (CSOX), have higher institutional ow...

Development of analytical techniques in support of waste and effluent characterization

International Nuclear Information System (INIS)

Reed, W.J.

1991-01-01

The Analytical Services Group within Sellafield Technical Department has been established for >40 yr and employs >150 analysts. The group operates >400 analytical methods across a wide range of techniques and has a yearly workload of ∼250,000 determinations. The group operates under a quality system based on statistical process control that has achieved national recognition through the accreditation of its mass spectrometry and radiochemical services to the standard of national testing laboratories. The group offers services ranging from the characterization of highly active wastes to trace elemental and radiochemical measurements in environmental, biological, and effluent streams. The group has vast experience in the management of analytical services to tight time scales and has pioneered developments not only in analytical instrumentation, but also in the adaptation of equipment to radioactive environments and the design of dedicated analytical facilities

Multispectral UV imaging for fast and non-destructive quality control of chemical and physical tablet attributes

DEFF Research Database (Denmark)

Klukkert, Marten; Wu, Jian X; Rantanen, Jukka

2016-01-01

Monitoring of tablet quality attributes in direct vicinity of the production process requires analytical techniques that allow fast, non-destructive, and accurate tablet characterization. The overall objective of this study was to investigate the applicability of multispectral UV imaging...... as a reliable, rapid technique for estimation of the tablet API content and tablet hardness, as well as determination of tablet intactness and the tablet surface density profile. One of the aims was to establish an image analysis approach based on multivariate image analysis and pattern recognition to evaluate...... the potential of UV imaging for automatized quality control of tablets with respect to their intactness and surface density profile. Various tablets of different composition and different quality regarding their API content, radial tensile strength, intactness, and surface density profile were prepared using...

Quality of Public Hospitals Websites: A Cross-Sectional Analytical Study in Iran.

Science.gov (United States)

Salarvand, Shahin; Samadbeik, Mahnaz; Tarrahi, Mohammad Javad; Salarvand, Hamed

2016-04-01

Nowadays, hospitals have turned increasingly towards the Internet and develop their own web presence. Hospital Websites could be operating as effective web resources of information and interactive communication mediums to enhance hospital services to the public. Therefore, the aim of this study was to assess the quality of websites in Tehran's public hospitals. This cross-sectional analysis involved all public hospitals in Iran's capital city, Tehran, with a working website or subsites between April and June, 2014 (N=59). The websites were evaluated using three validated instruments: a localized checklist, Google page rank, and the Alexa traffic ranking. The mentioned checklist consisted of 112 items divided into five sections: technical characteristics, hospital information and facilities, medical services, interactive on-line services and external activities. Data were analyzed using descriptive and analytical statistics. The mean website evaluation score was 45.7 out of 224 for selected public hospitals. All the studied websites were in the weak category based on the earned quality scores. There was no statistically significant association between the website evaluation score with Google page rank (P=0.092), Alexa global traffic rank and Alexa traffic rank in Iran (P>0.05). The hospital websites had a lower quality score in the interactive online services and external activities criteria in comparing to other criteria. Due to the low quality level of the studied websites and the importance of hospital portals in providing information and services on the Internet, the authorities should do precise planning for the appreciable improvement in the quality of hospital websites.

An analytical investigation on the valve and centrifugal pump speed control with a constant differential pressure across the valve

International Nuclear Information System (INIS)

Jung, B. R.; Joo, K. I.; Lee, B. J.; Baek, S. J.; Noh, T. S.

2003-01-01

A valve opening and centrifugal pump speed control was investigated analytically in a simple pumping system where the differential pressure across the control valve is maintained constant over the required flow range. The valve control program was derived analytically only as a function of the required flow rate to maintain the constant differential pressure across the valve. The centrifugal pump speed control program was also derived analytically for the required flow rate for the constant differential pressure across the control valve. These derivations theoretically show that the independent control is possible between the valve and pump speed in a system with a constant valve pressure drop. In addition, it was shown that a linear pump speed control is impossible in maintaining the constant valve pressure drop

An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes.

Science.gov (United States)

Padoan, Andrea; Antonelli, Giorgia; Aita, Ada; Sciacovelli, Laura; Plebani, Mario

2017-10-26

The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU). The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015-2016 were used to estimate bias and bias uncertainty. A total of 263 measurement procedures (MPs) were analyzed. On the basis of test purpose, in 51 MPs imprecision only was used to estimate MU; in the remaining MPs, the bias component was not estimable for 22 MPs because EQAs results did not provide reliable statistics. For a total of 28 MPs, two or more MU values were calculated on the basis of analyte concentration levels. Overall, results showed that uncertainty of bias is a minor factor contributing to MU, the bias component being the most relevant contributor to all the studied sample matrices. The model chosen for MU estimation allowed us to derive a standardized approach for bias calculation, with respect to the fitness-for-purpose of test results. Measurement uncertainty estimation could readily be implemented in medical laboratories as a useful tool in monitoring the analytical quality of test results since they are calculated using a combination of both the long-term imprecision IQC results and bias, on the basis of EQAs results.

Quality control with R an ISO standards approach