WorldWideScience

Sample records for assurance system eqas

  1. External quality assurance system (EQAS) for identification of mastitis pathogens in Denmark from 2006 to 2011

    DEFF Research Database (Denmark)

    Karlsmose, Susanne; Kunstmann, L.; Rundsten, Carsten Friis

    2013-01-01

    Bovine mastitis is the most common and costly dairy cattle disease. Mastitis is most frequently caused by bacterial species, and to ensure optimal treatment and control strategies, proper quality assured diagnosis and identification of the causative agent is important. With the aim to assess...... the capacity to isolate and identify mastitis pathogens at veterinary clinics, an external quality assurance system (EQAS) was annually (from 2006 to 2011) provided for the identification of mastitis pathogens. This study presents the setup of the proficiency test and the obtained results that enabled...... the organizers to pinpoint areas for improvement and thereby to assist veterinary practices at strengthening their mastitis diagnostics.The proficiency test consisted of 15 milk samples spiked with a pure culture of a mastitis pathogen and distributed to veterinary practices for identification. Applying...

  2. WHO global salm-surv external quality assurance system (EQAS): an important step toward improving the quality of Salmonella serotyping and antimicrobial susceptibility testing worldwide

    DEFF Research Database (Denmark)

    Petersen, A.; Aarestrup, Frank Møller; Angulo, F. J.

    2002-01-01

    % of the results were correct. For susceptibility testing, 92% of the results were in agreement with the expected results. However, only 78% of the performed tests with the E. coli ATCC 25922 reference strain were within the quality control range specified by National Committee for Clinical Laboratory Standards...... susceptibility testing through international training courses and an External Quality Assurance System (EQAS). In 2000, 44 WHO Global Salm-Surv member laboratories from 35 countries determined the serotype and antimicrobial susceptibility pattern for eight "blinded" Salmonella isolates. For serotyping, 73...... (NCCLS) guidelines. These EQAS results demonstrate the need for further training to improve the performance of some of the laboratories. WHO Global Salm-Surv activities, including international training courses and EQAS, represent an important step toward improving the quality of Salmonella serotyping...

  3. Novel artificial stool material for external quality assurance (EQA) on a fecal immunochemical test for hemoglobin (FIT): The confirmed utility of stable hemoglobin and an internal standard material.

    Science.gov (United States)

    Yasui, Ryota; Yamada, Miyu; Takehara, Shizuka; Sakurabayashi, Ikunosuke; Watanabe, Katsunori

    2018-04-16

    The fecal immunochemical test for hemoglobin (FIT), which detects lower gastrointestinal bleeding, is widely accepted for population-based colorectal cancer (CRC) screening programs. However, the FIT screening process has not been standardized yet, and standardizing the pre-analytical phase and establishing an external quality assurance (EQA) program compliant with ISO requirements is urgently needed. Although there have been various attempts to establish EQA materials suitable for FIT, no materials have yet been reported to have sufficient uniformity and acceptable immunochemical stability of hemoglobin (Hb). The Health Care Technology Foundation (HECTEF; Tokyo Japan) is now developing a ready-to-use artificial stool containing Hb and an internal standard, glycerol. Accordingly, we verified the adaptability and efficacy of this material for the evaluation of the specimen collection phase of FIT. This material uniformly contained both Hb and glycerol. The glycerol allowed us to estimate the weight of the collected artificial stool and to correct the Hb concentration with the estimated weight. Furthermore, the stability of both Hb and glycerol were confirmed to be sufficient for an EQA material under appropriate storage, in-use, repeated freeze-thaw, and heated conditions. These in-house performance characteristics suggest that HECTEF artificial stool is acceptable as an EQA material for FIT. Copyright © 2018 Elsevier B.V. All rights reserved.

  4. Quality assurance in diabetic retinal screening in South Africa | Cook ...

    African Journals Online (AJOL)

    ... external quality assurance (EQA) on graders registered in the Ophthalmological Society of South Africa DR screening programme. Methods. Graders registered on the South African (SA) Diabetic Register website were invited to participate in the study. The Scottish EQA software system was used to enable on-line grading ...

  5. Electronic laboratory quality assurance program: A method of enhancing the prosthodontic curriculum and addressing accreditation standards.

    Science.gov (United States)

    Moghadam, Marjan; Jahangiri, Leila

    2015-08-01

    An electronic quality assurance (eQA) program was developed to replace a paper-based system and to address standards introduced by the Commission on Dental Accreditation (CODA) and to improve educational outcomes. This eQA program provides feedback to predoctoral dental students on prosthodontic laboratory steps at New York University College of Dentistry. The purpose of this study was to compare the eQA program of performing laboratory quality assurance with the former paper-based format. Fourth-year predoctoral dental students (n=334) who experienced both the paper-based and the electronic version of the quality assurance program were surveyed about their experiences. Additionally, data extracted from the eQA program were analyzed to identify areas of weakness in the curriculum. The study findings revealed that 73.8% of the students preferred the eQA program to the paper-based version. The average number of treatments that did not pass quality assurance standards was 119.5 per month. This indicated a 6.34% laboratory failure rate. Further analysis of these data revealed that 62.1% of the errors were related to fixed prosthodontic treatment, 27.9% to partial removable dental prostheses, and 10% to complete removable dental prostheses in the first 18 months of program implementation. The eQA program was favored by dental students who have experienced both electronic and paper-based versions of the system. Error type analysis can yield the ability to create customized faculty standardization sessions and refine the didactic and clinical teaching of the predoctoral students. This program was also able to link patient care activity with the student's laboratory activities, thus addressing the latest requirements of the CODA regarding the competence of graduates in evaluating laboratory work related to their patient care. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  6. HPV testing for primary cervical screening: Laboratory issues and evolving requirements for robust quality assurance.

    Science.gov (United States)

    Carozzi, Francesca Maria; Del Mistro, Annarosa; Cuschieri, Kate; Frayle, Helena; Sani, Cristina; Burroni, Elena

    2016-03-01

    This review aims to highlight the importance of Quality Assurance for Laboratories performing HPV test for Cervical Cancer Screening. An HPV test, to be used as primary screening test, must be validated according to international criteria, based on comparison of its clinical accuracy to HC2 or GP5+/6+ PCR-EIA tests. The number of validated platforms is increasing and appropriate Quality Assurance Programs (QAPs) which can interrogate longitudinal robustness and quality are paramount. This document describes the following topics: (1) the characteristics of an HPV laboratory and the personnel training needs, to ensure an elevated quality of the entire process and the optimal use of the resources; (2) the Quality Assurance, as both internal (IQA) and external quality assessment (EQA) systems, to be implemented and performed, and the description of the existing EQAs, including limitations; (3) general considerations for an optimal EQA program for hrHPV primary screening Due to the importance of Quality Assurance for this field, international efforts are necessary to improve QA International Collaboration. Copyright © 2015 Elsevier B.V. All rights reserved.

  7. The WHO AFRO external quality assessment programme (EQAP): Linking laboratory networks through EQA programmes.

    Science.gov (United States)

    Boeras, Debrah I; Peeling, Rosanna W; Onyebujoh, Philip; Yahaya, Ali A; Gumede-Moeletsi, Hieronyma N; Ndihokubwayo, Jean B

    2016-01-01

    External Quality Assessment (EQA) surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO) revealed the need for the strengthening of public health microbiology laboratories, particularly for testing of epidemic-prone diseases in the African Region. These surveys revealed common issues such as supply chain management, skilled personnel, logistical support and overall lack of quality standards. For sustainable improvements to health systems as well as global health security, deficiencies identified need to be actively corrected through robust quality assurance programmes and implementation of laboratory quality management systems. Given all the pathogens of public health importance, an external quality assessment programme with a focus on vaccine-preventable diseases and emerging and re-emerging dangerous pathogens is important, and should not be stand-alone, but integrated within laboratory networks as seen in polio, measles, yellow fever and rubella. In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Prevention, the London School of Hygiene & Tropical Medicine and partners in a series of consultations with countries and national and regional EQA providers for the development of quality assurance models to support HIV point-of-care testing and monitoring. These consultations revealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forth its experience in implementing quality standards for health programmes, and also opened discussions on how lessons learned through such established programmes can be utilised to supporting and strengthening the introduction of early infant diagnosis of HIV and viral load point-of-care testing. An optimised external quality assessment programme will impact the ability of countries to meet core capacities, providing improved quality management systems, improving the confidence of diagnostic network services in Africa, and including capacities to detect events

  8. Quality assurance for HIV point-of-care testing and treatment monitoring assays

    Directory of Open Access Journals (Sweden)

    Adrienne F.A. Meyers

    2016-10-01

    Full Text Available In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of peopleinfected with HIV to become aware of their status, access antiretroviral therapies and ultimatelybe virally suppressed. To achieve these goals, countries may need to scale up point-of-care (POC testing in addition to strengthening central laboratory services. While decentralisingtesting increases patient access to diagnostics, it presents many challenges with regard totraining and assuring the quality of tests and testing. To ensure synergies, the London Schoolof Hygiene & Tropical Medicine held a series of consultations with countries with an interestin quality assurance and their implementing partners, and agreed on an external qualityassessment (EQA programme to ensure reliable results so that the results lead to the bestpossible care for HIV patients. As a result of the consultations, EQA International wasestablished, bringing together EQA providers and implementers to develop a strategic planfor countries to establish national POC EQA programmes and to estimate the cost of setting upand maintaining the programme. With the dramatic increase in the number of proficiencytesting panels required for thousands of POC testing sites across Africa, it is important tofacilitate technology transfer from global EQA providers to a network of regional EQA centresin Africa for regional proficiency testing panel production. EQA International will continue toidentify robust and cost-effective EQA technologies for quality POC testing, integrating noveltechnologies to support sustainable country-owned EQA programmes in Africa.

  9. Assessing the Organisational Impact of External Quality Assurance: Hypothesising Key Dimensions and Mechanisms

    Science.gov (United States)

    Stensaker, Bjørn; Leiber, Theodor

    2015-01-01

    The aim of the article is to provide a framework in which the organisational impact of external quality assurance (EQA) can be assessed. Based on existing studies of the impact of EQA in universities and colleges it is suggested that greater systematisation of how impact is measured is needed for a better understanding of how EQA can be used as a…

  10. Quality assurance for HIV point-of-care testing and treatment monitoring assays

    Science.gov (United States)

    Sandstrom, Paul; Denny, Thomas N.; Hurlston, Mackenzie; Ball, Terry B.; Peeling, Rosanna W.; Boeras, Debrah I.

    2016-01-01

    In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of people infected with HIV to become aware of their status, access antiretroviral therapies and ultimately be virally suppressed. To achieve these goals, countries may need to scale up point-of-care (POC) testing in addition to strengthening central laboratory services. While decentralising testing increases patient access to diagnostics, it presents many challenges with regard to training and assuring the quality of tests and testing. To ensure synergies, the London School of Hygiene & Tropical Medicine held a series of consultations with countries with an interest in quality assurance and their implementing partners, and agreed on an external quality assessment (EQA) programme to ensure reliable results so that the results lead to the best possible care for HIV patients. As a result of the consultations, EQA International was established, bringing together EQA providers and implementers to develop a strategic plan for countries to establish national POC EQA programmes and to estimate the cost of setting up and maintaining the programme. With the dramatic increase in the number of proficiency testing panels required for thousands of POC testing sites across Africa, it is important to facilitate technology transfer from global EQA providers to a network of regional EQA centres in Africa for regional proficiency testing panel production. EQA International will continue to identify robust and cost-effective EQA technologies for quality POC testing, integrating novel technologies to support sustainable country-owned EQA programmes in Africa. PMID:28879133

  11. Thoughts on Internal and External Quality Assurance

    Science.gov (United States)

    Zhang, Jianxin

    2012-01-01

    Quality assurance of higher education is made up of two parts: internal quality assurance (IQA) and external quality assurance (EQA). Both belong to a union of the coexistence and balance of yin and yang. But in reality there exists a paradox of "confusion of quality assurance (QA) subject consciousness, singularity of social QA and lack of QA…

  12. External quality assurance programme for enzymatic analysis of lysosomal storage diseases : A pilot study

    NARCIS (Netherlands)

    Ruijter, G.J.G.; Boer, M.; Weykamp, C. W.; de Vries, R.; van den Berg, I.; Janssens-Puister, J.; Niezen-Koning, K.; Wevers, R. A.; Poorthuis, B. J. H. M.; van Diggelen, O. P.

    2005-01-01

    Inborn errors of metabolism are rare and laboratories performing diagnostic tests in this field must participate in external quality assurance (EQA) schemes to demonstrate their competence and also to maintain sufficient experience with patient material. EQA schemes for metabolite analyses are

  13. Harmonisation of seven common enzyme results through EQA.

    Science.gov (United States)

    Weykamp, Cas; Franck, Paul; Gunnewiek, Jacqueline Klein; de Jonge, Robert; Kuypers, Aldy; van Loon, Douwe; Steigstra, Herman; Cobbaert, Christa

    2014-11-01

    Equivalent results between different laboratories enable optimal patient care and can be achieved with harmonisation. We report on EQA-initiated national harmonisation of seven enzymes using commutable samples. EQA samples were prepared from human serum spiked with human recombinant enzymes. Target values were assigned with the IFCC Reference Measurement Procedures. The same samples were included at four occasions in the EQA programmes of 2012 and 2013. Laboratories were encouraged to report IFCC traceable results. A parallel study was done to confirm commutability of the samples. Of the 223 participating laboratories, 95% reported IFCC traceable results, ranging from 98% (ASAT) to 87% (amylase). Users of Roche and Siemens (97%) more frequently reported in IFCC traceable results than users of Abbott (91%), Beckman (90%), and Olympus (87%). The success of harmonisation, expressed as the recovery of assigned values and the inter-laboratory CV was: ALAT (recovery 100%; inter-lab CV 4%), ASAT (102%; 4%), LD (98%; 3%), CK (101%; 5%), GGT (98%; 4%), AP (96%; 6%), amylase (99%; 4%). There were no significant differences between the manufacturers. Commutability was demonstrated in the parallel study. Equal results in the same sample in the 2012 and 2013 EQA programmes demonstrated stability of the samples. The EQA-initiated national harmonisation of seven enzymes, using stable, commutable human serum samples, spiked with human recombinant enzymes, and targeted with the IFCC Reference Measurement Procedures, was successful in terms of implementation of IFCC traceable results (95%), recovery of the target (99%), and inter-laboratory CV (4%).

  14. Quality assurance in diabetic retinal screening in South Africa.

    Science.gov (United States)

    Cook, Steve; Staff, Roger T; Goatman, Keith A; Olson, John A

    2014-09-03

    Diabetic retinopathy (DR) is an important biomarker for microvascular disease and blindness. Digital fundus photography is a cost-effective way of screening for DR. Access to DR screening is difficult for many South Africans with diabetes. To perform external quality assurance (EQA) on graders registered in the Ophthalmological Society of South Africa DR screening programme. Graders registered on the South African (SA) Diabetic Register website were invited to participate in the study. The Scottish EQA software system was used to enable on-line grading of 100 retinal photographs. Expert National Health Service graders provided the consensus expert grading for the image set. Two hundred and sixty-one participants completed the EQA process, including nine ophthalmologists, 243 optometrists, and nine other graders. A wide range of outcomes were demonstrated, with a mean sensitivity of 0.905 (range 0.286 - 1.000) and mean specificity of 0.507 (0.000 - 0.935). The mean diagnostic odds ratio was calculated to be 12.3 (range 0.147 - 148.2). This is the first quality assurance study conducted with SA healthcare professionals. The outcomes are of interest to all stakeholders dealing with the diabetes epidemic. The disparity in grader performance indicates room for improvement. The results demonstrate a high referral rate to ophthalmology, suggesting that on average graders are performing safely, but with a high number of inappropriate referrals.

  15. The WHO AFRO external quality assessment programme (EQAP: Linking laboratory networks through EQA programmes

    Directory of Open Access Journals (Sweden)

    Debrah I. Boeras

    2016-10-01

    Full Text Available External Quality Assessment (EQA surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO revealed the need for the strengthening of publichealth microbiology laboratories, particularly for testing of epidemic-prone diseases in theAfrican Region. These surveys revealed common issues such as supply chain managementskilled personnel, logistical support and overall lack of quality standards. For sustainableimprovements to health systems as well as global health security, deficiencies identified needto be actively corrected through robust quality assurance programmes and implementation oflaboratory quality management systems. Given all the pathogens of public health importance, an external quality assessment programmewith a focus on vaccine-preventable diseases and emerging and re-emerging dangerouspathogens is important, and should not be stand-alone, but integrated within laboratorynetworks as seen in polio, measles, yellow fever and rubella. In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Preventionthe London School of Hygiene & Tropical Medicine and partners in a series of consultationswith countries and national and regional EQA providers for the development of qualityassurance models to support HIV point-of-care testing and monitoring. These consultationsrevealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forthits experience in implementing quality standards for health programmes, and also openeddiscussions on how lessons learned through such established programmes can be utilised tosupporting and strengthening the introduction of early infant diagnosis of HIV and viralload point-of-care testing. An optimised external quality assessment programme will impact the ability of countries tomeet core capacities, providing improved quality management systems, improving theconfidence of diagnostic network services in Africa, and including capacities to detect eventsof

  16. Results of Use of WHO Global Salm-Surv External Quality Assurance System for Antimicrobial Susceptibility Testing of Salmonella Isolates from 2000 to 2007

    DEFF Research Database (Denmark)

    Hendriksen, Rene S.; Seyfarth, Anne Mette; Jensen, Arne Bent

    2009-01-01

    laboratories in 102 countries participated in at least one EQAS iteration. A large number of laboratories reported results for the E. coli ATCC 25922 reference strain which were outside the quality control ranges. Critical deviations for susceptibility testing of the Salmonella isolates varied from 4% in 2000......An international External Quality Assurance System (EQAS) for antimicrobial susceptibility testing of Salmonella was initiated in 2000 by the World Health Organization (WHO) Global Salm-Surv in order to enhance the capacities of national reference laboratories to obtain reliable data....... In particular, further training and dissemination of information on quality control, appropriate interpretive criteria (breakpoints), and harmonization of the methodology worldwide through WHO Global Salm-Surv and other programs will contribute to the generation of comparable and reliable antimicrobial...

  17. External quality assurance performance of clinical research laboratories in sub-saharan Africa.

    Science.gov (United States)

    Amukele, Timothy K; Michael, Kurt; Hanes, Mary; Miller, Robert E; Jackson, J Brooks

    2012-11-01

    Patient Safety Monitoring in International Laboratories (JHU-SMILE) is a resource at Johns Hopkins University that supports and monitors laboratories in National Institutes of Health-funded international clinical trials. To determine the impact of the JHU-SMILE quality assurance scheme in sub-Saharan African laboratories, we reviewed 40 to 60 months of external quality assurance (EQA) results of the College of American Pathologists (CAP) in these laboratories. We reviewed the performance of 8 analytes: albumin, alanine aminotransferase, creatinine, sodium, WBC, hemoglobin, hematocrit, and the human immunodeficiency virus antibody rapid test. Over the 40- to 60-month observation period, the sub-Saharan laboratories had a 1.63% failure rate, which was 40% lower than the 2011 CAP-wide rate of 2.8%. Seventy-six percent of the observed EQA failures occurred in 4 of the 21 laboratories. These results demonstrate that a system of remote monitoring, feedback, and audits can support quality in low-resource settings, even in places without strong regulatory support for laboratory quality.

  18. Expressing analytical performance from multi-sample evaluation in laboratory EQA.

    Science.gov (United States)

    Thelen, Marc H M; Jansen, Rob T P; Weykamp, Cas W; Steigstra, Herman; Meijer, Ron; Cobbaert, Christa M

    2017-08-28

    To provide its participants with an external quality assessment system (EQAS) that can be used to check trueness, the Dutch EQAS organizer, Organization for Quality Assessment of Laboratory Diagnostics (SKML), has innovated its general chemistry scheme over the last decade by introducing fresh frozen commutable samples whose values were assigned by Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed reference laboratories using reference methods where possible. Here we present some important innovations in our feedback reports that allow participants to judge whether their trueness and imprecision meet predefined analytical performance specifications. Sigma metrics are used to calculate performance indicators named 'sigma values'. Tolerance intervals are based on both Total Error allowable (TEa) according to biological variation data and state of the art (SA) in line with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Milan consensus. The existing SKML feedback reports that express trueness as the agreement between the regression line through the results of the last 12 months and the values obtained from reference laboratories and calculate imprecision from the residuals of the regression line are now enriched with sigma values calculated from the degree to which the combination of trueness and imprecision are within tolerance limits. The information and its conclusion to a simple two-point scoring system are also graphically represented in addition to the existing difference plot. By adding sigma metrics-based performance evaluation in relation to both TEa and SA tolerance intervals to its EQAS schemes, SKML provides its participants with a powerful and actionable check on accuracy.

  19. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

    Science.gov (United States)

    Murphy, Sean C; Hermsen, Cornelus C; Douglas, Alexander D; Edwards, Nick J; Petersen, Ines; Fahle, Gary A; Adams, Matthew; Berry, Andrea A; Billman, Zachary P; Gilbert, Sarah C; Laurens, Matthew B; Leroy, Odile; Lyke, Kristen E; Plowe, Christopher V; Seilie, Annette M; Strauss, Kathleen A; Teelen, Karina; Hill, Adrian V S; Sauerwein, Robert W

    2014-01-01

    Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

  20. External quality assessment in gynaecological cytology: The Trent Region experience. The Trent Regional Gynaecological Pathology Quality Assurance Group for the National Health Service Cervical Screening Programme.

    Science.gov (United States)

    Slater, D N; Hewer, E M; Melling, S E; Rice, S

    2002-08-01

    A Department of Health Executive Letter stated in 1998 that the principal function of external quality assessment (EQA) is educational. Subsequently, in England, it has no longer been acceptable to assess performance in gynaecological cytology by proficiency testing. This paper describes the EQA scheme in gynaecological cytology that has been run by the Trent Regional Gynaecological Pathology Quality Assurance Group for the NHS Cervical Screening Programme (NHSCSP) since 1998. It conforms as closely as possible to the recommendations published by the Department of Health Working Group on Histopathology EQA Accreditation, and replaced the national proficiency testing protocol. The educational value of the scheme is derived predominantly from a numerical score which provides confidential and quantitative feedback to all participants. Personal performance monitoring occurs as a secondary function. For primary screeners and checkers, this is based purely on the distinction between negative, inadequate and abnormal smears. For pathologists, personal performance monitoring also includes grading of abnormalities. The EQA has been designed so that all professional groups participate in a manner that closely mimics normal practice. Only slides that have achieved an 80% consensus amongst participants are used in the EQA. Substandard performance has been defined as those participants with scores falling below the 2.5%ile. The paper describes the EQA in detail and illustrates its use by means of the second round results. The EQA protocol developed within Trent and described in this paper has contributed to proposals contained in the current national EQA in gynaecological cytology for the NHSCSP. In particular this paper highlights the effectiveness of the scoring system contained within the Trent and National EQA protocols.

  1. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

    Directory of Open Access Journals (Sweden)

    Sean C Murphy

    Full Text Available Nucleic acid testing (NAT for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

  2. Pilot Experience with an External Quality Assurance Scheme for Acylcarnitines in Plasma/Serum

    NARCIS (Netherlands)

    Sala, P Ruiz; Ruijter, G; Acquaviva, C; Chabli, A; de Sain-van der Velden, M G M; Garcia-Villoria, J; Heiner-Fokkema, M R; Jeannesson-Thivisol, E; Leckstrom, K; Franzson, L; Lynes, G; Olesen, J; Onkenhout, W; Petrou, P; Drousiotou, A; Ribes, A; Vianey-Saban, C; Merinero, B

    2016-01-01

    The analysis of acylcarnitines (AC) in plasma/serum is established as a useful test for the biochemical diagnosis and the monitoring of treatment of organic acidurias and fatty acid oxidation defects. External quality assurance (EQA) for qualitative and quantitative AC is offered by ERNDIM and CDC

  3. Evaluation of the Correlation Coefficient of Polyethylene Glycol Treated and Direct Prolactin Results and Comparability with Different Assay System Results.

    Science.gov (United States)

    Pal, Shyamali

    2017-12-01

    The presence of Macro prolactin is a significant cause of elevated prolactin resulting in misdiagnosis in all automated systems. Poly ethylene glycol (PEG) pretreatment is the preventive process but such process includes the probability of loss of a fraction of bioactive prolactin. Surprisingly, PEG treated EQAS & IQAS samples in Cobas e 411 are found out to be correlating with direct results of at least 3 immunoassay systems and treated and untreated Cobas e 411 results are comparable by a correlation coefficient. Comparison of EQAS, IQAS and patient samples were done to find out the trueness of such correlation factor. Study with patient's results have established the correlation coefficient is valid for very small concentration of prolactin also. EQAS, IQAS and 150 patient samples were treated with PEG and prolactin results of treated and untreated samples obtained from Roche Cobas e 411. 25 patient's results (treated) were compared with direct results in Advia Centaur, Architect I & Access2 systems. Correlation coefficient was obtained from trend line of the treated and untreated results. Two tailed p-value obtained from regression coefficient(r) and sample size. The correlation coefficient is in the range (0.761-0.771). Reverse correlation range is (1.289-1.301). r value of two sets of calculated results were 0.995. Two tailed p- value is zero approving dismissal of null hypothesis. The z-score of EQAS does not always assure authenticity of resultsPEG precipitation is correlated by the factor 0.761 even in very small concentrationsAbbreviationsGFCgel filtration chromatographyPEGpolyethylene glycolEQASexternal quality assurance systemM-PRLmacro prolactinPRLprolactinECLIAelectro-chemiluminescence immunoassayCLIAclinical laboratory improvement amendmentsIQASinternal quality assurance systemrregression coefficient.

  4. Quality assurance practices in Europe: a survey of molecular genetic testing laboratories

    Science.gov (United States)

    Berwouts, Sarah; Fanning, Katrina; Morris, Michael A; Barton, David E; Dequeker, Elisabeth

    2012-01-01

    In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. A total of 22% of laboratories did not participate in external quality assessment (EQA) and 28% did not use reference materials (RMs). The main motivations given for accreditation were to improve laboratory profile (85%) and national recognition (84%). Nearly all respondents (95%) would prefer working in an accredited laboratory. In accredited laboratories, participation in EQA (Pquality assurance (Pquality implementation score (QIS), we showed that accredited laboratories (average score 92) comply better than certified laboratories (average score 69, Pquality indicators. We conclude that quality practices vary widely in European genetic testing laboratories. This leads to a potentially dangerous situation in which the quality of genetic testing is not consistently assured. PMID:22739339

  5. Point-of-care urine albumin in general practice offices: effect of participation in an external quality assurance scheme.

    Science.gov (United States)

    Bukve, Tone; Røraas, Thomas; Riksheim, Berit Oddny; Christensen, Nina Gade; Sandberg, Sverre

    2015-01-01

    The Norwegian Quality Improvement of Primary Care Laboratories (Noklus) offers external quality assurance (EQA) schemes (EQASs) for urine albumin (UA) annually. This study analyzed the EQA results to determine how the analytical quality of UA analysis in general practice (GP) offices developed between 1998 (n=473) and 2012 (n=1160). Two EQA urine samples were distributed yearly to the participants by mail. The participants measured the UA of each sample and returned the results together with information about their instrument, the profession and number of employees at the office, frequency of internal quality control (IQC), and number of analyses per month. In the feedback report, they received an assessment of their analytical performance. The number of years that the GP office had participated in Noklus was inversely related to the percentage of "poor" results for quantitative but not semiquantitative instruments. The analytical quality improved for participants using quantitative instruments who received an initial assessment of "poor" and who subsequently changed their instrument. Participants using reagents that had expired or were within 3 months of the expiration date performed worse than those using reagents that were expiring in more than 3 months. Continuous participation in the Noklus program improved the performance of quantitative UA analyses at GP offices. This is probably in part attributable to the complete Noklus quality system, whereby in addition to participating in EQAS, participants are visited by laboratory consultants who examine their procedures and provide practical advice and education regarding the use of different instruments.

  6. ANALISIS PERBANDINGAN PENGHARGAAN KUALITAS MALCOLM BALDRIGE NATIONAL QUALITY AWARD DENGAN EUROPEAN QUALITY AWARD (MBNQA vs EQA

    Directory of Open Access Journals (Sweden)

    Arfan Bakhtiar Amalia

    2012-02-01

    Full Text Available Persaingan bisnis global saat ini makin ketat. Dengan adanya Malcolm Baldrige National Quality Award (MBNQA dan juga European Quality Award (EQA diharapkan mampu mendorong dan memotivasi perusahaan-perusahaan, baik yang sudah sukses maupun yang sedang berkembang, untuk selalu meningkatkan mutu dan kinerja, serta sebagai kunci daya saing. Dalam makalah ini, kita akan membahas penghargaan kualitas mengenai tujuan, manfaat dan perkembangan, dan trend saat ini, terutama untuk MBNQA dan EQM (European Quality Model. Kita akan membandingkan antara MBNQA dan EQM melalui pengertian, latar belakang, metode-metode, dan kriteria-kriteria, serta aplikasinya, sehingga dapat kita lakukan analisa perbandingan untuk keduanya. Kata Kunci  : Penghargaan Kualitas, Malcolm Baldrige National Quality Award (MBNQA, European Quality Award (EQA   Emulation of global business in this time more and more to tighten. With existence of Malcolm Baldrige National Quality Award (MBNQA as well as European Quality Award (EQA expected can push and motivate companies, both for have successful and also which is expanding, to always increase the quality and performance, and also as competitiveness key. In this paper, we will discuss about national quality award concerning target, benefit, growth, and trend in this time, especially MBNQA and EQM (European Quality Model. We will compare between MBNQA and EQM through congeniality, background, method, and criterions, and also its application,  so that earn us to analyse comparison to both of its. Keyword        : Quality Award, Malcolm Baldrige National Quality Award (MBNQA, European Quality Award (EQA

  7. The Royal College of Pathologists of Australasia Quality Assurance Program: Immunohistochemistry Breast Marker Audit Overview 2005-2015.

    Science.gov (United States)

    Haffajee, Zenobia Ayesha Mohamed; Kumar, Beena; Francis, Glenn; Peck, Martyn; Badrick, Tony

    2017-11-20

    The Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP) Anatomical Pathology provides a comprehensive External Quality Assurance (EQA) exercise to review the reporting of immunohistochemistry (IHC) and in-situ hybridization (ISH) breast markers through an audit of clinical results. The aim of this exercise was to provide information regarding the quality of breast marker testing within clinical laboratories from 2005 to 2015. This comprehensive audit included estrogen, progesterone, and HER2 marker reporting. This was an important quality assurance activity established in response to ongoing difficulties experienced in laboratories in this area of testing.

  8. Nova laser assurance-management system

    International Nuclear Information System (INIS)

    Levy, A.J.

    1983-01-01

    In a well managed project, Quality Assurance is an integral part of the management activities performed on a daily basis. Management assures successful performance within budget and on schedule by using all the good business, scientific, engineering, quality assurance, and safety practices available. Quality assurance and safety practices employed on Nova are put in perspective by integrating them into the overall function of good project management. The Nova assurance management system was developed using the quality assurance (QA) approach first implemented at LLNL in early 1978. The LLNL QA program is described as an introduction to the Nova assurance management system. The Nova system is described pictorially through the Nova configuration, subsystems and major components, interjecting the QA techniques which are being pragmatically used to assure the successful completion of the project

  9. The external quality assurance programme (EQAP) for the FAO/IAEA antibody FMD ELISA in Southeast Asia

    International Nuclear Information System (INIS)

    Colling, A.

    2000-01-01

    The external quality assurance programme (EQAP) consists of three equally important items: the questionnaire, the monitoring of the internal quality control data and the external quality control test panel. The EQAP is conducted twice per year. The first round of the EQAP for the FAO/IAEA liquid phase blocking ELISA being used in Southeast Asia was carried out in 1995-1996. A total of 10 laboratories from Asia participated. The round consisted of three FMD sero-types (O, A and Asia) for both, the antigen and antibody ELISA. No interim report was produced, but results were communicated on an individual basis. The second round was initiated in late 1998. Participating laboratories were the same as in 1996. This time the EQA proficiency exercise consisted only of one sero-type (O 1 Manisa) for the FMD Antibody ELISA. The results of this round are presented in this report. All participants replied to this EQA exercise. Out of ten participants six laboratories returned all EQA components (EQC results, IQC data and questionnaire). Four laboratories did not return the complete set of the EQA panel. Three out of five EQC samples achieved an overall agreement of 100%. Two EQC samples were excluded from the evaluation because a minimum of 80% of agreement between participants was not achieved. In comparison to the reference values for the EQC samples as established by the World Reference Center (WRC), UK, the participating laboratories produced lower PI values for the three positive samples 2, 8 and 5 and higher PI values for the negative samples 10 and 9 resulting in a decreased binding ratio. Nevertheless results show that all laboratories are able to detect a strong positive sample and no equivocally result was obtained for the two negative samples. Weak positive sera close to the cut-off are problematical for a minority of the laboratories, which tested these samples negative. The closer the sample comes to the cut-off the less agreement between laboratories is reached

  10. RAS screening in colorectal cancer: a comprehensive analysis of the results from the UK NEQAS colorectal cancer external quality assurance schemes (2009-2016).

    Science.gov (United States)

    Richman, Susan D; Fairley, Jennifer; Butler, Rachel; Deans, Zandra C

    2017-12-01

    Evidence strongly indicates that extended RAS testing should be undertaken in mCRC patients, prior to prescribing anti-EGFR therapies. With more laboratories implementing testing, the requirement for External Quality Assurance schemes increases, thus ensuring high standards of molecular analysis. Data was analysed from 15 United Kingdom National External Quality Assessment Service (UK NEQAS) for Molecular Genetics Colorectal cancer external quality assurance (EQA) schemes, delivered between 2009 and 2016. Laboratories were provided annually with nine colorectal tumour samples for genotyping. Information on methodology and extent of testing coverage was requested, and scores given for genotyping, interpretation and clerical accuracy. There has been a sixfold increase in laboratory participation (18 in 2009 to 108 in 2016). For RAS genotyping, fewer laboratories now use Roche cobas®, pyrosequencing and Sanger sequencing, with more moving to next generation sequencing (NGS). NGS is the most commonly employed technology for BRAF and PIK3CA mutation screening. KRAS genotyping errors were seen in ≤10% laboratories, until the 2014-2015 scheme, when there was an increase to 16.7%, corresponding to a large increase in scheme participants. NRAS genotyping errors peaked at 25.6% in the first 2015-2016 scheme but subsequently dropped to below 5%. Interpretation and clerical accuracy scores have been consistently good throughout. Within this EQA scheme, we have observed that the quality of molecular analysis for colorectal cancer has continued to improve, despite changes in the required targets, the volume of testing and the technologies employed. It is reassuring to know that laboratories clearly recognise the importance of participating in EQA schemes.

  11. Improvement of the quality of BRAF testing in melanomas with nationwide external quality assessment, for the BRAF EQA group

    International Nuclear Information System (INIS)

    Emile, Jean-François; Hofman, Paul; Sabourin, Jean-Christophe; Laurent-Puig, Pierre; Tisserand, Julie; Bergougnoux, Loic; Nowak, Frédérique; Faucher, Gladwys; Surel, Sylvie; Lamy, Aude; Lecorre, Delphine; Helias-Rodzewicz, Zofia

    2013-01-01

    Knowledge about tumour gene mutation status is essential for the treatment of increasing numbers of cancer patients, and testing quality has a major impact on treatment response and cost. In 2012, 4,629 tests for BRAF p.V600 were performed in France, in patients with melanomas. Two batches of unstained melanoma sections were sent, in May and November 2012, to the 46 laboratories supported by the French National Institute of Cancer (INCa). An external quality assessment (EQA) evaluated mutation status, response times and compliance with INCa recommendations. All the French laboratories involved in testing participated in the EQA. Fourteen different methods were used to detect BRAF mutations, most consisting of combinations of in-house techniques. False responses were noted in 25/520 cases (4.8%), 11 of which concerned confusion between p.V600E and p.V600K. Thus, 2.7% of responses would have led to inappropriate treatment. Within six months, mean response times decreased from 22 to 12 days (P<0.001), and the percentage of samples evaluated by a pathologist for tumour cell content increased, from 75.2% to 96.9% (P<0.001). Despite the use of non-certified methods, the false response rate was low. Nationwide EQA can improve the quality of molecular pathology tests on tumours

  12. First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease.

    Directory of Open Access Journals (Sweden)

    Juan C Ramírez

    Full Text Available Real-Time PCR (qPCR testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD, but no external quality assurance (EQA program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228, a pro-drug of ravuconazole; the Sampling Study (NCT01678599, that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967, that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq./mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement and concordance (between laboratory agreement for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of

  13. Lack of grading agreement among international hemostasis external quality assessment programs

    OpenAIRE

    Olson, John D.; Jennings, Ian; Meijer, Piet; Bon, Chantal; Bonar, Roslyn; Favaloro, Emmanuel J.; Higgins, Russell A.; Keeney, Michael; Mammen, Joy; Marlar, Richard A.; Meley, Roland; Nair, Sukesh C.; Nichols, William L.; Raby, Anne; Reverter, Joan C.

    2018-01-01

    Laboratory quality programs rely on internal quality control and external quality assessment (EQA). EQA programs provide unknown specimens for the laboratory to test. The laboratory's result is compared with other (peer) laboratories performing the same test. EQA programs assign target values using a variety of methods statistical tools and performance assessment of ‘pass’ or ‘fail’ is made. EQA provider members of the international organization, external quality assurance in thrombosis and h...

  14. Results from EQAS 2002

    DEFF Research Database (Denmark)

    Petersen, A.; Aarestrup, Frank Møller; Jensen, A.B.

    An international external quality assurance program on serotyping and antimicrobial susceptibility testing of eight Salmonella enterica strains was performed to enhance the capacity of national and regional reference laboratories in WHO Global Salm-Surv (WHO GSS). In 2002 a total of 117 laborator......An international external quality assurance program on serotyping and antimicrobial susceptibility testing of eight Salmonella enterica strains was performed to enhance the capacity of national and regional reference laboratories in WHO Global Salm-Surv (WHO GSS). In 2002 a total of 117...... laboratories from 67 countries participated. For serotyping, almost 90 % of the results were correct. For susceptibility testing, 91 % of the results were in agreement with the expected results, and 86 % of the performed tests with the reference strain E. coli ATCC 25922 were inside the quality control range...

  15. Hungary Higher Education Quality Assurance System

    Directory of Open Access Journals (Sweden)

    Che Ru-shan

    2013-07-01

    Full Text Available Higher education quality assurance system has drawn much attention since 1980s. Most countries are committed to build the higher education quality assurance system to meet international standards. Under such an international trend, Hungary also actively promotes higher education reform, and established Hungarian Accreditation Committee and in order to ensure the quality of higher education.

  16. Model Based Mission Assurance: Emerging Opportunities for Robotic Systems

    Science.gov (United States)

    Evans, John W.; DiVenti, Tony

    2016-01-01

    The emergence of Model Based Systems Engineering (MBSE) in a Model Based Engineering framework has created new opportunities to improve effectiveness and efficiencies across the assurance functions. The MBSE environment supports not only system architecture development, but provides for support of Systems Safety, Reliability and Risk Analysis concurrently in the same framework. Linking to detailed design will further improve assurance capabilities to support failures avoidance and mitigation in flight systems. This also is leading new assurance functions including model assurance and management of uncertainty in the modeling environment. Further, the assurance cases, a structured hierarchal argument or model, are emerging as a basis for supporting a comprehensive viewpoint in which to support Model Based Mission Assurance (MBMA).

  17. 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.

  18. Quality assurance system in nuclear engineering

    International Nuclear Information System (INIS)

    Adams, H.W.; Hoensch, V.

    1985-01-01

    Due to the close connection between the German Atomic Energy Law and the nuclear control regulations, quality systems in nuclear engineering have taken on a special form. Quality assurance systems as a stipulated organisation of structure and procedure to assure quality have implications for the organisation of the electric supply company at the planning, erection and commissioning stage and for the organisation of the nuclear power station facility. To supervise the application and effectiveness of the stipulated organisation of structure and procedure internally and externally among contractors, special organisation units have been set up at the plant suppliers, manufactures, electric supply companies and nuclear power station facilities, which in the electric supply field go by the name of Quality Assurance Supervision. (orig.) [de

  19. Quality assurance records system

    International Nuclear Information System (INIS)

    1979-01-01

    This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the IAEA Code of Practice on Quality Assurance for Safety in Nuclear Power Plants (IAEA Safety Series No.50-C-QA), which requires that for each nuclear power plant a system for the generation, identification, collection, indexing, filing, storing, maintenance and disposition of quality assurance records shall be established and executed in accordance with written procedures and instructions. The purpose of this Safety Guide is to provide assistance in the establishment and operation of such a system. An orderly established and maintained records system is considered to be part of the means of providing a basis for an appropriate level of confidence that the activities which affect the quality of a nuclear power plant have been performed in accordance with the specific requirements and that the required quality has been achieved and is maintained

  20. Characteristics quality system assurance of university programs

    Directory of Open Access Journals (Sweden)

    Lucian Ion Medar

    2011-03-01

    Full Text Available Quality assurance program of study requires time, dedication, effort, innovative thinking and creativity. Competitive research programs monitored by quality assurance system to create the desired results on the relationship between learning and teaching methods and assessment.

  1. Quality assurance manual for the development of digital systems

    International Nuclear Information System (INIS)

    Lee, Cheol Kwon; Kwon, Kee Choon; You, Young Eun; Kim, Kwan Hyun; Park, Jung Woo; Park, Chan Seok

    2001-12-01

    A digital safety system is being developed by three companies under the Korea Nuclear I and C System R and D Program. This Quality Assurance Manual (QAM) is written to ensure the safety and reliability of the system and to meet the regulatory requirements associated with quality assurance. This QAM describes eighteen elements of quality assurance criteria required for the development of the system, which are coincident with the criteria specified in Nuclear Energy Laws and Enforcement Regulations of Nuclear Energy Laws and 10CFR50 Appendix B. This QAM is submitted to the regulatory body with other documents related to the quality assurance activities performed during the system development. And its safety, validity and fulfillment are reviewed and audited in the review process of topical report of the digital safety system

  2. Basic Study of Establishment of Quality Assurance Processes to Develop an Integrated Quality Assurance System for Nuclear Power Plant Construction

    International Nuclear Information System (INIS)

    Lim, Byungki; Moon, Byeongsuk; Lee, Jae Kyoung

    2014-01-01

    An integrated quality assurance system has necessitated carrying out quality assurance programs in a systematic manner because the opportunities to expand business in overseas markets have increased since the export of a nuclear power plant to UAE in 2009. In this study, we use PDCA method to systematically analyze the quality assurance procedures that were used in previous projects for constructing nuclear power plants. We reached a classification system of quality assurance processes at each phase of nuclear power plant construction by integrating similar work related to quality such as planning, design, equipment manufacturing, construction and start-up. We also established a hierarchy of quality assurance processes to develop an integrated quality assurance system as a technology goal to be developed later. To obtain most updated quality assurance activities, a quality assurance process is structured by integrating similar works analyzed from quality assurance procedures through PDCA cycle method. At the implementation phase of Hierarchy of quality processes and sequence of processes for constructing nuclear power plant are established in this study. Integrated quality assurance system is to be developed by connecting organizations as well as stakeholders such as owners, Architect engineering, suppliers, contractors, and sub-contractors to carry out assigned work efficiently

  3. Basic Study of Establishment of Quality Assurance Processes to Develop an Integrated Quality Assurance System for Nuclear Power Plant Construction

    Energy Technology Data Exchange (ETDEWEB)

    Lim, Byungki; Moon, Byeongsuk; Lee, Jae Kyoung [Korea Hydro and Nuclear Power Co. Ltd., Daejeon (Korea, Republic of)

    2014-05-15

    An integrated quality assurance system has necessitated carrying out quality assurance programs in a systematic manner because the opportunities to expand business in overseas markets have increased since the export of a nuclear power plant to UAE in 2009. In this study, we use PDCA method to systematically analyze the quality assurance procedures that were used in previous projects for constructing nuclear power plants. We reached a classification system of quality assurance processes at each phase of nuclear power plant construction by integrating similar work related to quality such as planning, design, equipment manufacturing, construction and start-up. We also established a hierarchy of quality assurance processes to develop an integrated quality assurance system as a technology goal to be developed later. To obtain most updated quality assurance activities, a quality assurance process is structured by integrating similar works analyzed from quality assurance procedures through PDCA cycle method. At the implementation phase of Hierarchy of quality processes and sequence of processes for constructing nuclear power plant are established in this study. Integrated quality assurance system is to be developed by connecting organizations as well as stakeholders such as owners, Architect engineering, suppliers, contractors, and sub-contractors to carry out assigned work efficiently.

  4. System management and quality assurance

    International Nuclear Information System (INIS)

    Sastry, A.M.

    1989-01-01

    This paper describes the principles of system management and shows the relationship to quality assurance. It discusses the need for balanced attention to all the project management controls required for project success

  5. Quality assurance: Importance of systems and standard operating procedures.

    Science.gov (United States)

    Manghani, Kishu

    2011-01-01

    It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

  6. Quality assurance: Importance of systems and standard operating procedures

    Directory of Open Access Journals (Sweden)

    Kishu Manghani

    2011-01-01

    Full Text Available It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

  7. quality assurance systems in nuclear fuel procurement and manufacturing

    International Nuclear Information System (INIS)

    Can, S.

    1997-01-01

    Quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. Quality control is activities and techniques used to fulfill the requirements of quality. Quality assurance is a system and its main components are requirements. QA program, organization and responsibilities, design and verification, material and its control, manufacturing and process control, inspections, audits and documents: manuals, specifications, instructions. Quality assurance systems are largely based on ISO 9000 series of the International Standards Organization. ISO 9000 series has been adopted and published by Turkish Standards Institute as TS-ISO 9000. International Atomic Energy Agency also published a guide (50-SG-QA11) ''Quality Assurance in the Procurement, Design and Manufacture of Nuclear Fuel Assemblies'' in the safety guide series. In this study the role of quality control in quality assurance systems, inspection and test plans and acceptance and nonconformance quality levels will be explained in relation to nuclear fuel production. Examples of applications in quality assurance systems based on ISO 9000 will be given

  8. Quality assurance systems at SKODA JS

    International Nuclear Information System (INIS)

    Janecek, P.

    2000-01-01

    In addition to technical requirements put upon the design, manufacture, installation and commissioning of equipment for nuclear power plants, emphasis is laid upon quality assurance of such activities so as to secure nuclear safety of installations over the world. As the technical level of nuclear safety assurance is being enhanced continuously, the requirements are becoming more and more stringent, which is mirrored by the relevant standards and legislation. SKODA JS has always been pursuing the quality goal and has been contributing to this aspect markedly. The quality assurance system at SKODA JS helps the company to satisfy all the appropriate requirements of its customers as well as the applicable standards and regulations. (author)

  9. Tritium systems test assembly quality assurance program

    International Nuclear Information System (INIS)

    Kerstiens, F.L.; Wilhelm, R.C.

    1986-07-01

    A quality assurance program should establish the planned and systematic actions necessary to provide adequate confidence that fusion facilities and their subsystems will perform satisfactorily in service. The Tritium Systems Test Assembly (TSTA) Quality Assurance Program has been designed to assure that the designs, tests, data, and interpretive reports developed at TSTA are valid, accurate, and consistent with formally specified procedures and reviews. The quality consideration in all TSTA activities is directed toward the early detection of quality problems, coupled with timely and positive disposition and corrective action

  10. NIF Projects Controls and Information Systems Software Quality Assurance Plan

    Energy Technology Data Exchange (ETDEWEB)

    Fishler, B

    2011-03-18

    Quality achievement for the National Ignition Facility (NIF) and the National Ignition Campaign (NIC) is the responsibility of the NIF Projects line organization as described in the NIF and Photon Science Directorate Quality Assurance Plan (NIF QA Plan). This Software Quality Assurance Plan (SQAP) is subordinate to the NIF QA Plan and establishes quality assurance (QA) activities for the software subsystems within Controls and Information Systems (CIS). This SQAP implements an activity level software quality assurance plan for NIF Projects as required by the LLNL Institutional Software Quality Assurance Program (ISQAP). Planned QA activities help achieve, assess, and maintain appropriate quality of software developed and/or acquired for control systems, shot data systems, laser performance modeling systems, business applications, industrial control and safety systems, and information technology systems. The objective of this SQAP is to ensure that appropriate controls are developed and implemented for management planning, work execution, and quality assessment of the CIS organization's software activities. The CIS line organization places special QA emphasis on rigorous configuration control, change management, testing, and issue tracking to help achieve its quality goals.

  11. NIF Projects Controls and Information Systems Software Quality Assurance Plan

    International Nuclear Information System (INIS)

    Fishler, B.

    2011-01-01

    Quality achievement for the National Ignition Facility (NIF) and the National Ignition Campaign (NIC) is the responsibility of the NIF Projects line organization as described in the NIF and Photon Science Directorate Quality Assurance Plan (NIF QA Plan). This Software Quality Assurance Plan (SQAP) is subordinate to the NIF QA Plan and establishes quality assurance (QA) activities for the software subsystems within Controls and Information Systems (CIS). This SQAP implements an activity level software quality assurance plan for NIF Projects as required by the LLNL Institutional Software Quality Assurance Program (ISQAP). Planned QA activities help achieve, assess, and maintain appropriate quality of software developed and/or acquired for control systems, shot data systems, laser performance modeling systems, business applications, industrial control and safety systems, and information technology systems. The objective of this SQAP is to ensure that appropriate controls are developed and implemented for management planning, work execution, and quality assessment of the CIS organization's software activities. The CIS line organization places special QA emphasis on rigorous configuration control, change management, testing, and issue tracking to help achieve its quality goals.

  12. QUALITY ASSURANCE SYSTEMS IN POLISH AND UKRAINIAN HIGHER EDUCATION. A COMPARATIVE ANALYSIS

    Directory of Open Access Journals (Sweden)

    Marta Tutko

    2015-02-01

    Full Text Available The article deals with the progress made to develop external and internal quality assurance systems in Polish and Ukrainian higher education in the European Higher Education Area background. The focus of the paper is on the extent to which quality assurance systems in these countries are following the Standards and Guidelines for Quality Assurance in the European Higher Education Area. Furthermore, internal and external quality assur-ance in the European context is presented in the article. The authors of the article also conducted a comparative analysis of quality assurance systems in Polish and Ukrainian higher education.

  13. Quality assurance systems – the difficulties in providing a global unified system for Surveyors

    OpenAIRE

    Goodhead, Tim

    2012-01-01

    This paper will analyse the difficulties in providing a global quality assurance system for Surveyors. Using case studies from the United Kingdom and elsewhere opportunities for harmonising Quality Assurance systems will be explored. The difficulties in moving towards common quality assurance systems will be analysed. Possible alternatives in the form of the development a knowledge bank of mutual agreements and top up qualifications will be investigated. The paper also looks at the role of FI...

  14. Quality Assurance Tracking System - R7 (QATS-R7)

    Data.gov (United States)

    U.S. Environmental Protection Agency — This is metadata documentation for the Quality Assurance Tracking System - R7, an EPA Region 7 resource that tracks information on quality assurance reviews. Also...

  15. Reactor system safety assurance

    International Nuclear Information System (INIS)

    Mattson, R.J.

    1984-01-01

    The philosophy of reactor safety is that design should follow established and conservative engineering practices, there should be safety margins in all modes of plant operation, special systems should be provided for accidents, and safety systems should have redundant components. This philosophy provides ''defense in depth.'' Additionally, the safety of nuclear power plants relies on ''safety systems'' to assure acceptable response to design basis events. Operating experience has shown the need to study plant response to more frequent upset conditions and to account for the influence of operators and non-safety systems on overall performance. Defense in depth is being supplemented by risk and reliability assessment

  16. Application of quality assurance to MC and A systems

    International Nuclear Information System (INIS)

    Skinner, A.J.; Delvin, W.L.

    1986-01-01

    Application of the principles of quality assurance to MC and A has been done at DOE's Savannah River Operations Office. The principles were applied to the functions within the MC and A Branch, including both the functions used to operate the Branch and those used to review the MC and A activities of DOE/SR's contractor. The purpose of this paper is to discuss that application of quality assurance and to show how the principles of quality assurance relate to the functions of a MC and A system, for both a DOE field office and a contractor. The principles (presented as requirements from the NQA-1 standard) are briefly discussed, a method for applying quality assurance is outlined, application at DOE/SR is shown, and application to a contractor's MC and A system is discussed

  17. Reflection on Quality Assurance System of Higher Vocational Education under Big Data Era

    Directory of Open Access Journals (Sweden)

    Jiang Xinlan

    2015-01-01

    Full Text Available Big data has the features like Volume, Variety, Value and Velocity. Here come the new opportunities and challenges for construction of Chinese quality assurance system of higher vocational education under big data era. There are problems in current quality assurance system of higher vocational education, such as imperfect main body, non-formation of internally and externally incorporated quality assurance system, non-scientific security standard and insufficiency in security investment. The construction of higher vocational education under big data era requires a change in the idea of quality assurance system construction to realize the multiple main bodies and multiple layers development trend for educational quality assurance system, and strengthen the construction of information platform for quality assurance system.

  18. Quality assurance considerations for nuclear power system selection

    International Nuclear Information System (INIS)

    Bender, M.

    1977-01-01

    The key quality assurance principle to be applied in nuclear system selection is to establish that the technological basis is understood and used properly. Knowledgeable and capable personnel with experience in the application are needed, and they must have access to appropriate engineering, laboratory, and manufacturing facilities. A suitable balance must be maintained between the responsibilities of the seller-supplier and the purchaser-owner to assure an even-handed treatment of the implementation program. Safety and reliability must be inherent to the regulatory framework. There must be flexibility in the purchaser-owner resources to overcome unanticipated adversity. Given these quality assurance elements, the nuclear system selection process should result in a high probability that the performance objectives will be satisfied

  19. 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

  20. Assurance in Agent-Based Systems

    Energy Technology Data Exchange (ETDEWEB)

    Gilliom, Laura R.; Goldsmith, Steven Y.

    1999-05-10

    Our vision of the future of information systems is one that includes engineered collectives of software agents which are situated in an environment over years and which increasingly improve the performance of the overall system of which they are a part. At a minimum, the movement of agent and multi-agent technology into National Security applications, including their use in information assurance, is apparent today. The use of deliberative, autonomous agents in high-consequence/high-security applications will require a commensurate level of protection and confidence in the predictability of system-level behavior. At Sandia National Laboratories, we have defined and are addressing a research agenda that integrates the surety (safety, security, and reliability) into agent-based systems at a deep level. Surety is addressed at multiple levels: The integrity of individual agents must be protected by addressing potential failure modes and vulnerabilities to malevolent threats. Providing for the surety of the collective requires attention to communications surety issues and mechanisms for identifying and working with trusted collaborators. At the highest level, using agent-based collectives within a large-scale distributed system requires the development of principled design methods to deliver the desired emergent performance or surety characteristics. This position paper will outline the research directions underway at Sandia, will discuss relevant work being performed elsewhere, and will report progress to date toward assurance in agent-based systems.

  1. Assurance in Agent-Based Systems

    International Nuclear Information System (INIS)

    Gilliom, Laura R.; Goldsmith, Steven Y.

    1999-01-01

    Our vision of the future of information systems is one that includes engineered collectives of software agents which are situated in an environment over years and which increasingly improve the performance of the overall system of which they are a part. At a minimum, the movement of agent and multi-agent technology into National Security applications, including their use in information assurance, is apparent today. The use of deliberative, autonomous agents in high-consequence/high-security applications will require a commensurate level of protection and confidence in the predictability of system-level behavior. At Sandia National Laboratories, we have defined and are addressing a research agenda that integrates the surety (safety, security, and reliability) into agent-based systems at a deep level. Surety is addressed at multiple levels: The integrity of individual agents must be protected by addressing potential failure modes and vulnerabilities to malevolent threats. Providing for the surety of the collective requires attention to communications surety issues and mechanisms for identifying and working with trusted collaborators. At the highest level, using agent-based collectives within a large-scale distributed system requires the development of principled design methods to deliver the desired emergent performance or surety characteristics. This position paper will outline the research directions underway at Sandia, will discuss relevant work being performed elsewhere, and will report progress to date toward assurance in agent-based systems

  2. The Quality Assurance System for Ontario Postsecondary Education: 2010-2014

    Science.gov (United States)

    Liu, Qin

    2015-01-01

    The period of 2010 to 2014 marked a relatively stable stage in the evolving quality assurance system for Ontario postsecondary education, particularly following massive changes after 2000. The current system consists of three frameworks overseen respectively by three quality assurance agencies--the Ontario Universities Council on Quality…

  3. Quality assurance program for isotopic power systems

    International Nuclear Information System (INIS)

    Hannigan, R.L.; Harnar, R.R.

    1982-12-01

    This report summarizes the Sandia National Laboratories Quality Assurance Program that applies to non-weapon (reimbursable) Radioisotopic Thermoelectric Generators. The program has been implemented over the past 16 years on power supplies used in various space and terrestrial systems. The quality assurance (QA) activity of the program is in support of the Department of Energy, Office of Space Nuclear Projects. Basic elements of the program are described in the report and examples of program decumentation are presented

  4. Quality assurance program for isotopic power systems

    Energy Technology Data Exchange (ETDEWEB)

    Hannigan, R.L.; Harnar, R.R.

    1982-12-01

    This report summarizes the Sandia National Laboratories Quality Assurance Program that applies to non-weapon (reimbursable) Radioisotopic Thermoelectric Generators. The program has been implemented over the past 16 years on power supplies used in various space and terrestrial systems. The quality assurance (QA) activity of the program is in support of the Department of Energy, Office of Space Nuclear Projects. Basic elements of the program are described in the report and examples of program decumentation are presented.

  5. Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain.

    Science.gov (United States)

    Weykamp, Cas; Secchiero, Sandra; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Thomas, Annette; Jassam, Nuthar; Barth, Julian H; Perich, Carmen; Ricós, Carmen; Faria, Ana Paula

    2017-02-01

    Optimum patient care in relation to laboratory medicine is achieved when results of laboratory tests are equivalent, irrespective of the analytical platform used or the country where the laboratory is located. Standardization and harmonization minimize differences and the success of efforts to achieve this can be monitored with international category 1 external quality assessment (EQA) programs. An EQA project with commutable samples, targeted with reference measurement procedures (RMPs) was organized by EQA institutes in Italy, the Netherlands, Portugal, UK, and Spain. Results of 17 general chemistry analytes were evaluated across countries and across manufacturers according to performance specifications derived from biological variation (BV). For K, uric acid, glucose, cholesterol and high-density density (HDL) cholesterol, the minimum performance specification was met in all countries and by all manufacturers. For Na, Cl, and Ca, the minimum performance specifications were met by none of the countries and manufacturers. For enzymes, the situation was complicated, as standardization of results of enzymes toward RMPs was still not achieved in 20% of the laboratories and questionable in the remaining 80%. The overall performance of the measurement of 17 general chemistry analytes in European medical laboratories met the minimum performance specifications. In this general picture, there were no significant differences per country and no significant differences per manufacturer. There were major differences between the analytes. There were six analytes for which the minimum quality specifications were not met and manufacturers should improve their performance for these analytes. Standardization of results of enzymes requires ongoing efforts.

  6. Next generation diagnostic molecular pathology: critical appraisal of quality assurance in Europe.

    Science.gov (United States)

    Dubbink, Hendrikus J; Deans, Zandra C; Tops, Bastiaan B J; van Kemenade, Folkert J; Koljenović, S; van Krieken, Han J M; Blokx, Willeke A M; Dinjens, Winand N M; Groenen, Patricia J T A

    2014-06-01

    Tumor evaluation in pathology is more and more based on a combination of traditional histopathology and molecular analysis. Due to the rapid development of new cancer treatments that specifically target aberrant proteins present in tumor cells, treatment decisions are increasingly based on the molecular features of the tumor. Not only the number of patients eligible for targeted precision medicine, but also the number of molecular targets per patient and tumor type is rising. Diagnostic molecular pathology, the discipline that determines the molecular aberrations present in tumors for diagnostic, prognostic or predictive purposes, is faced with true challenges. The laboratories have to meet the need of comprehensive molecular testing using only limited amount of tumor tissue, mostly fixed in formalin and embedded in paraffin (FFPE), in short turnaround time. Choices must be made for analytical methods that provide accurate, reliable and cost-effective results. Validation of the test procedures and results is essential. In addition, participation and good performance in internal (IQA) and external quality assurance (EQA) schemes is mandatory. In this review, we critically evaluate the validation procedure for comprehensive molecular tests as well as the organization of quality assurance and assessment of competence of diagnostic molecular pathology laboratories within Europe. Copyright © 2014 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.

  7. Future of Assurance: Ensuring that a System is Trustworthy

    Science.gov (United States)

    Sadeghi, Ahmad-Reza; Verbauwhede, Ingrid; Vishik, Claire

    Significant efforts are put in defining and implementing strong security measures for all components of the comput-ing environment. It is equally important to be able to evaluate the strength and robustness of these measures and establish trust among the components of the computing environment based on parameters and attributes of these elements and best practices associated with their production and deployment. Today the inventory of techniques used for security assurance and to establish trust -- audit, security-conscious development process, cryptographic components, external evaluation - is somewhat limited. These methods have their indisputable strengths and have contributed significantly to the advancement in the area of security assurance. However, shorter product and tech-nology development cycles and the sheer complexity of modern digital systems and processes have begun to decrease the efficiency of these techniques. Moreover, these approaches and technologies address only some aspects of security assurance and, for the most part, evaluate assurance in a general design rather than an instance of a product. Additionally, various components of the computing environment participating in the same processes enjoy different levels of security assurance, making it difficult to ensure adequate levels of protection end-to-end. Finally, most evaluation methodologies rely on the knowledge and skill of the evaluators, making reliable assessments of trustworthiness of a system even harder to achieve. The paper outlines some issues in security assurance that apply across the board, with the focus on the trustworthiness and authenticity of hardware components and evaluates current approaches to assurance.

  8. Study on quality assurance for high-level radioactive waste disposal project (2). Quality assurance system for the site characterization phase in the Yucca Mountain Project

    International Nuclear Information System (INIS)

    Takada, Susumu

    2006-01-01

    The objective of this report is to assist related organizations in the development of quality assurance systems for a high-level radioactive waste disposal system. This report presents detail information with which related organizations can begin the development of quality assurance systems at an initial phase of repository development for a high-level radioactive waste disposal program, including data qualification, model validation, systems and facilities for quality assurance (e.g., technical data management system, sample management facility, etc.), and QA program applicability (items and activities). These descriptions are based on information in QA program for the Yucca Mountain Project (YMP), such as the U.S. Department of Energy (DOE) Quality Assurance Requirements and Description (QARD), DOE/RW-0333P, quality implementing procedures, and reports implemented by the procedures. Additionally, this report includes some brief recommendations for developing of quality assurance systems, such as establishment of quality assurance requirements, measures for establishment of QA system. (author)

  9. Quality assurance tracking and trending system (QATTS)

    International Nuclear Information System (INIS)

    Anderson, W.J.

    1987-01-01

    In 1984, The Philadelphia Electric Company (PECo) Quality Assurance (QA) Division recognized a need to modify the existing quality finding tracking program to generate a nuclear trending program that could detect trends of PECo-initiated findings that were not detectable to a day-to-day observer. Before 1984, each quality organization in PECo had a separate tracking system. An adequate quality trending program demanded that all findings be tracked in a common data base. The Quality Assurance Tracking and Trending System (QATTS) is divided into two parts, an on-line subsystem that provides access to QATTS data via corporate computer data screens and a reports and graphics subsystem that connects commercially available reports and graphic software computer packages to the QATTS data base. The QATTS can be accessed from any terminal connected to the main frame computer at PECo headquarters. The paper discusses the tracking system, report generation, responsible organization commitment tracking system (ROCT), and trending program

  10. Quality control in mutation analysis: the European Molecular Genetics Quality Network (EMQN).

    Science.gov (United States)

    Müller, C R

    2001-08-01

    The demand for clinical molecular genetics testing has steadily grown since its introduction in the 1980s. In order to reach and maintain the agreed quality standards of laboratory medicine, the same internal and external quality assurance (IQA/EQA) criteria have to be applied as for "conventional" clinical chemistry or pathology. In 1996 the European Molecular Genetics Quality Network (EMQN) was established in order to spread QA standards across Europe and to harmonise the existing national activities. EMQN is operated by a central co-ordinator and 17 national partners from 15 EU countries; since 1998 it is being funded by the EU commission for a 3-year period. EMQN promotes QA by two tools: by providing disease-specific best practice meetings (BPM) and EQA schemes. A typical BPM is focussed on one disease or group of related disorders. International experts report on the latest news of gene characterisation and function and the state-of-the-art techniques for mutation detection. Disease-specific EQA schemes are provided by experts in the field. DNA samples are sent out together with mock clinical referrals and a diagnostic question is asked. Written reports must be returned which are marked for genotyping and interpretation. So far, three BPMs have been held and six EQA schemes are in operation at various stages. Although mutation types and diagnostic techniques varied considerably between schemes, the overall technical performance showed a high diagnostic standard. Nevertheless, serious genotyping errors have been occurred in some schemes which underline the necessity of quality assurance efforts. The European Molecular Genetics Quality Network provides a necessary platform for the internal and external quality assurance of molecular genetic testing.

  11. Lack of grading agreement among international hemostasis external quality assessment programs.

    Science.gov (United States)

    Olson, John D; Jennings, Ian; Meijer, Piet; Bon, Chantal; Bonar, Roslyn; Favaloro, Emmanuel J; Higgins, Russell A; Keeney, Michael; Mammen, Joy; Marlar, Richard A; Meley, Roland; Nair, Sukesh C; Nichols, William L; Raby, Anne; Reverter, Joan C; Srivastava, Alok; Walker, Isobel

    2018-01-01

    : Laboratory quality programs rely on internal quality control and external quality assessment (EQA). EQA programs provide unknown specimens for the laboratory to test. The laboratory's result is compared with other (peer) laboratories performing the same test. EQA programs assign target values using a variety of methods statistical tools and performance assessment of 'pass' or 'fail' is made. EQA provider members of the international organization, external quality assurance in thrombosis and hemostasis, took part in a study to compare outcome of performance analysis using the same data set of laboratory results. Eleven EQA organizations using eight different analytical approaches participated. Data for a normal and prolonged activated partial thromboplastin time (aPTT) and a normal and reduced factor VIII (FVIII) from 218 laboratories were sent to the EQA providers who analyzed the data set using their method of evaluation for aPTT and FVIII, determining the performance for each laboratory record in the data set. Providers also summarized their statistical approach to assignment of target values and laboratory performance. Each laboratory record in the data set was graded pass/fail by all EQA providers for each of the four analytes. There was a lack of agreement of pass/fail grading among EQA programs. Discordance in the grading was 17.9 and 11% of normal and prolonged aPTT results, respectively, and 20.2 and 17.4% of normal and reduced FVIII results, respectively. All EQA programs in this study employed statistical methods compliant with the International Standardization Organization (ISO), ISO 13528, yet the evaluation of laboratory results for all four analytes showed remarkable grading discordance.

  12. Lack of grading agreement among international hemostasis external quality assessment programs

    Science.gov (United States)

    Olson, John D.; Jennings, Ian; Meijer, Piet; Bon, Chantal; Bonar, Roslyn; Favaloro, Emmanuel J.; Higgins, Russell A.; Keeney, Michael; Mammen, Joy; Marlar, Richard A.; Meley, Roland; Nair, Sukesh C.; Nichols, William L.; Raby, Anne; Reverter, Joan C.; Srivastava, Alok; Walker, Isobel

    2018-01-01

    Laboratory quality programs rely on internal quality control and external quality assessment (EQA). EQA programs provide unknown specimens for the laboratory to test. The laboratory's result is compared with other (peer) laboratories performing the same test. EQA programs assign target values using a variety of methods statistical tools and performance assessment of ‘pass’ or ‘fail’ is made. EQA provider members of the international organization, external quality assurance in thrombosis and hemostasis, took part in a study to compare outcome of performance analysis using the same data set of laboratory results. Eleven EQA organizations using eight different analytical approaches participated. Data for a normal and prolonged activated partial thromboplastin time (aPTT) and a normal and reduced factor VIII (FVIII) from 218 laboratories were sent to the EQA providers who analyzed the data set using their method of evaluation for aPTT and FVIII, determining the performance for each laboratory record in the data set. Providers also summarized their statistical approach to assignment of target values and laboratory performance. Each laboratory record in the data set was graded pass/fail by all EQA providers for each of the four analytes. There was a lack of agreement of pass/fail grading among EQA programs. Discordance in the grading was 17.9 and 11% of normal and prolonged aPTT results, respectively, and 20.2 and 17.4% of normal and reduced FVIII results, respectively. All EQA programs in this study employed statistical methods compliant with the International Standardization Organization (ISO), ISO 13528, yet the evaluation of laboratory results for all four analytes showed remarkable grading discordance. PMID:29232255

  13. Quality assurance in a cask fleet parts control system

    International Nuclear Information System (INIS)

    Fernandez, C.; McCreery, P.N.; Shappert, L.B.

    1991-01-01

    Applicable portions of the eighteen Quality Assurance criteria of Subpart H, 10 CFR 71 are incorporated into a relational data base system which has been designed to manage the spare parts control system for a fleet of spent nuclear fuel casks. The system includes not only parts in warehouse storage but parts in use in the field plus casks, ancillary equipment, test equipment, support devices, and even personnel. It provides a high degree of assurance that any device for which a condition for certification has expired will be flagged for recertification testing or removal from service well before the critical date

  14. Nursing Quality Assurance: The Wisconsin System

    Science.gov (United States)

    Hover, Julie; Zimmer, Marie J.

    1978-01-01

    Evaluation model guidelines for hospital departments of nursing to use in their nursing quality assurance programs are presented as developed in Wisconsin. Four essential components of the Wisconsin outcome evaluation system are criteria, assessment, standards, and improvement of care. Sample tests and charts are included in the article. (MF)

  15. Comprehensive Lifecycle for Assuring System Safety

    Science.gov (United States)

    Knight, John C.; Rowanhill, Jonathan C.

    2017-01-01

    CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

  16. External Quality Assessment Scheme for Biological Monitoring of Occupational Exposure to Toxic Chemicals

    Directory of Open Access Journals (Sweden)

    Mi-Young Lee

    2011-09-01

    Conclusion: The EQAS has taken a primary role in improving the reliability of analytical data. A total quality assurance scheme is suggested, including the validation of technical documentation for the whole analytical procedure.

  17. Quality assurance in a cask fleet parts control system

    International Nuclear Information System (INIS)

    Fernandez, C.; Shappert, L.B.

    1992-01-01

    This paper discusses applicable portions of the eighteen Quality Assurance criteria of Subpart H, 10 CFR 71 which are incorporated into a relational data base system which has been designed to manage the spare parts control system for a fleet of spent nuclear fuel casks. The system includes not only parts in warehouse storage but parts in use in the field plus casks, ancillary equipment, test equipment, support devices, and even personnel. It provides a high degree of assurance that any device for which a condition for certification has expired will be flagged for recertification testing or removal from service well before the critical date

  18. The study on the quality assurance of performance assessment for the disposal system

    International Nuclear Information System (INIS)

    Fusaeda, Shigeki; Yanagisawa, Ichiro; Katsurai, Kiyomichi; Ueda, Noriaki; Takeishi, Masayuki; Ida, Toshio; Imamura, Naoko

    1999-02-01

    The purpose of performance assessment of the geological disposal system in the second progress report is to quantitatively evaluate the performance in the near-field. For this purpose, validation of performance models and quality assurance of data used in the performance assessment are important technical subjects. To achieve the subjects, the quality of the procedure of analysis work and data acquisition work must be assured in addition to the quality assurance of data, models and analysis codes. In addition, to assure results of the performance assessment by integrating these qualities is an important matter. The following studies have been performed in order to improve the computer environment for controlling the quality information relating to the performance assessment, and to develop the integrated quality assurance system which can give reliability of the results of the performance assessment in the second progress report. (1) The study of quality assurance framework. In order to assure reliability of MESHNOTE3, we have carried out validation analysis based on experimental data and insite data. And we have revised the quality assurance manual in order to be applicable to preparing documents. We have carried out validation analysis/planning based on the experimental data which is acquired from 'Measurement of Apparent Diffusion Coefficient of 99 Tc in Compacted Bentonite with Fe powder', and confirmed validity of MESHNOTE3. We have added a postscript on the management of analysis documents to the quality assurance manual. (2) The development of the quality assurance computer system. In order to improve reliability of the analysis results and to efficiently use the quality assurance program, the quality assurance computer system on the basis of analysis management system CAPASA has been improved as follows. Database for radionuclide transport calculations that can control geometry of engineered barriers, data relating to glass dissolution and dose rate

  19. Technical foundations for quality assurance of systems engineering activities for safety assessment

    International Nuclear Information System (INIS)

    Oren, T.I.; Elzas, M.S.

    1987-01-01

    Basic system design axioms and a framework for design and test derivation based on structural design are presented. Over thirty quality assurance issues are elaborated on. New dimensions to quality assurance issues in the artificial intelligence era are discussed. The last part of the article is a sequel of another one titled: ''Mode reliability and software quality assurance in simulation of nuclear fuel waste management systems'' which was published in the Proceedings of the 1985 Waste Management Conference

  20. Laboratory diagnosis of the rare anaemias: external quality assessment benefits patient care

    Directory of Open Access Journals (Sweden)

    Barbara De La Salle

    2013-03-01

    Full Text Available Since its introduction in the 1960s, external quality assessment has developed to become an essential component of the quality management system of the diagnostic laboratory. External quality assessment provides a long term, retrospective view of laboratory performance, demonstrating the competence of the laboratory to others. The ENERCA project (the European Network for Rare and Congenital Anaemias has established a list of core laboratory tests that are used in the diagnosis of rare and congenital anaemias, which has been used as the basis for questionnaires to laboratories, to establish the use and quality assurance of diagnostic testing in the congenital and rare anaemias, and to European EQA providers for services in this key area. In general, the provision of EQA for rare and congenital anaemias is widely variable with little provision for the very rare disorders. For the more common congenital anaemias, such as the haemoglobinopathies and thalassaemias, provision is better but there is variation in aspects of the scheme design, especially the frequency of distribution. Where laboratories did not take part in EQA for individual tests, or there was no EQA available, a desire to participate was expressed in 66% (102/154 of cases. The provision of external quality assessment (EQA services for rare disorders is a challenge. For many of these conditions, the number of patients in any one member state is very small with only a few laboratories providing diagnostic testing. In these cases, the development of pan-European or cross-border EQA may be the only means by which standardisation of methods and results can be achieved. An EQA survey of 243 laboratories for performance in Hb A2 quantification showed encouraging results in that there was a clear differentiation in the results from a beta Thalassaemia carrier and an individual with no evidence of Thalassaemia; however, a bias was observed between different methods of measurement.

  1. Achieving Quality Assurance in Nigeria University System through ...

    African Journals Online (AJOL)

    This paper examines how quality assurance can be attained through Strategic Human Resources Development in Nigerian University system. The purpose is to ensure quality control and maintenance of acceptable standards in the University system. To seek solution to the problem, three research questions were posed.

  2. [Quality assurance systems and occupational medicine system: an history twenty years along].

    Science.gov (United States)

    Apostoli, Pietro

    2014-01-01

    Along the last tventy years, in our country the quality assurance systems and the occupational medicine deeply interacted both in theoretical and practical fields of interest at three levels: (i) the need of preventive and therefore of occupational medicine in quality assurance systems; (ii) the need on reverse of quality in prevention and occupational mnedicine mainly in qualification and updating process; (iii) the evidence, proofs of efficacy or appropriateness of different preventive procedures and occupational physician activities; (iv) the connection with European and national legal directives and with technical or good practice norms. Finally we discuss about the role of occupational physician as the global consultant for enterprise, as a mandatory strategic technical figure in a typical multidisciplinary processes as the implementation of the quality systems.

  3. Improving accuracy of breast cancer biomarker testing in India

    Directory of Open Access Journals (Sweden)

    Tanuja Shet

    2017-01-01

    Full Text Available There is a global mandate even in countries with low resources to improve the accuracy of testing biomarkers in breast cancer viz. oestrogen receptor (ER, progesterone receptor (PR and human epidermal growth factor receptor 2 (HER2neu given their critical impact in the management of patients. The steps taken include compulsory participation in an external quality assurance (EQA programme, centralized testing, and regular performance audits for laboratories. This review addresses the status of ER/PR and HER2neu testing in India and possible reasons for the delay in development of guidelines and mandate for testing in the country. The chief cause of erroneous ER and PR testing in India continues to be easily correctable issues such as fixation and antigen retrieval, while for HER2neu testing, it is the use of low-cost non-validated antibodies and interpretative errors. These deficiencies can however, be rectified by (i distributing the accountability and responsibility to surgeons and oncologist, (ii certification of centres for testing in oncology, and (iii initiation of a national EQA system (EQAS programme that will help with economical solutions and identifying the centres of excellence and instill a system for reprimand of poorly performing laboratories.

  4. Risk-Significant Adverse Condition Awareness Strengthens Assurance of Fault Management Systems

    Science.gov (United States)

    Fitz, Rhonda

    2017-01-01

    As spaceflight systems increase in complexity, Fault Management (FM) systems are ranked high in risk-based assessment of software criticality, emphasizing the importance of establishing highly competent domain expertise to provide assurance. Adverse conditions (ACs) and specific vulnerabilities encountered by safety- and mission-critical software systems have been identified through efforts to reduce the risk posture of software-intensive NASA missions. Acknowledgement of potential off-nominal conditions and analysis to determine software system resiliency are important aspects of hazard analysis and FM. A key component of assuring FM is an assessment of how well software addresses susceptibility to failure through consideration of ACs. Focus on significant risk predicted through experienced analysis conducted at the NASA Independent Verification Validation (IVV) Program enables the scoping of effective assurance strategies with regard to overall asset protection of complex spaceflight as well as ground systems. Research efforts sponsored by NASA's Office of Safety and Mission Assurance defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs and allowing queries based on project, mission type, domaincomponent, causal fault, and other key characteristics. Vulnerability in off-nominal situations, architectural design weaknesses, and unexpected or undesirable system behaviors in reaction to faults are curtailed with the awareness of ACs and risk-significant scenarios modeled for analysts through this database. Integration within the Enterprise Architecture at NASA IVV enables interfacing with other tools and datasets, technical support, and accessibility across the Agency. This paper discusses the development of an improved workflow process utilizing this

  5. An IEC standard on quality assurance for diagnostic X-ray systems

    International Nuclear Information System (INIS)

    Boer, J.A. den

    1985-01-01

    A presentation is given of some characteristics of the International Electrotechnical Commission (IEC). This is followed by a short discussion of general aspects of quality assurance in the diagnostic department. From this discussion it becomes apparent to which aspects of quality assurance IEC can contribute. Within that framework a working group of Sub-Committee 62 is at present active in developing a standard on quality assurance for diagnostic X-ray systems. The standard will contain a set of constancy tests that is claimed to allow a balanced quality assurance programme. The democratic procedure of IEC should guarantee that the proposed standard gains wide acceptance. (author)

  6. The Assured Storage Integrated Management System: What is it and what will it cost?

    International Nuclear Information System (INIS)

    Kerr, T.A.; Newberry, W.F.

    1996-01-01

    The Assured Storage Integrated Management System for low-level radioactive waste as an alternative to traditional disposal is attracting favorable attention from many states, regulators, processors, and low-level radioactive waste generators. open-quotes Assured storageclose quotes is defined as a management system for safely isolating waste, while preserving options for its long-term management, through: robust, accessible facilities; planned preventive maintenance; and sureties adequate to address contingencies or implement future alternatives. Following introduction of the concept in RADWASTE Magazine, the Connecticut Hazardous Waste Management Service (among several others) requested a briefing on the idea. The Connecticut Hazardous Waste Management Service then requested that the National Low-Level Waste Management Program at the Idaho National Engineering Laboratory evaluate the life cycle costs of the Assured Storage Integrated Management System versus traditional disposal. Building on some of that work, this paper discusses the concept of an Assured Storage Integrated Management System for low-level radioactive waste as well as examines cost elements of the Assured Storage Integrated Management System in comparison to traditional disposal facilities. Further analyses conducted for the Connecticut study will more clearly define and quantify potential differences in life-cycle costs between the Assured Storage Integrated Management System and traditional disposal

  7. Education for All in South Africa: Developing a National System for Quality Assurance.

    Science.gov (United States)

    Smith, William J.; Ngoma-Maema, Wendy Yolisa

    2003-01-01

    Draws on international research, policy, and practice relevant to quality assurance systems to analyze the development of a national framework for educational quality assurance in South Africa. Describes an emerging framework for quality assurance that encompasses evaluation of student achievement, quality audits and reviews, program and service…

  8. Quality assurance for safety in the radioactive waste management: a quality assurance system in Novi Han radioactive waste repository

    International Nuclear Information System (INIS)

    Petrova, A.; Kolev, I.

    2000-01-01

    Novi Han Radioactive Waste Repository (RWR) is still the only place in Bulgaria for storage of low and intermediate level radioactive waste. It is necessary to establish and maintain a Quality Assurance (QA) system to ensure that the RWR can be operated safely with regard to the health and safety of the general public and site personnel. A QA system has to establish the basic requirements for quality assurance in order to enhance nuclear safety by continuously improving the methods employed to achieve quality. It is envisaged that the QA system for the Novi Han RWR will cover the operation and maintenance of the radioactive waste disposal facilities, the radiation protection and monitoring of the site, as well as the scientific and technology development aspects. The functions of the Novi Han RWR presume the availability of an environmental management system. It is appropriate to establish a QA system based on the requirements of the ISO Standards 9001 and 14000, using the recommendations of the IAEA (Quality assurance for safety in NPPs and other nuclear installations, code and safety guides Q1-Q14). (authors)

  9. Surveillance and Datalink Communication Performance Analysis for Distributed Separation Assurance System Architectures

    Science.gov (United States)

    Chung, William W.; Linse, Dennis J.; Alaverdi, Omeed; Ifarraguerri, Carlos; Seifert, Scott C.; Salvano, Dan; Calender, Dale

    2012-01-01

    This study investigates the effects of two technical enablers: Automatic Dependent Surveillance - Broadcast (ADS-B) and digital datalink communication, of the Federal Aviation Administration s Next Generation Air Transportation System (NextGen) under two separation assurance (SA) system architectures: ground-based SA and airborne SA, on overall separation assurance performance. Datalink performance such as successful reception probability in both surveillance and communication messages, and surveillance accuracy are examined in various operational conditions. Required SA performance is evaluated as a function of subsystem performance, using availability, continuity, and integrity metrics to establish overall required separation assurance performance, under normal and off-nominal conditions.

  10. Office of Storage and Transportation Systems quality assurance directive

    International Nuclear Information System (INIS)

    1986-10-01

    This Directive provides policy guidance, defines organizational authorities and responsibilities for quality assurance (QA) and establishes minimum acceptable requirements for assuring the quality of all programs under the overall direction of the OSTS. This directive provides guidance for preparation of subordinate QA documents (e.g., QA plans, procedures) for the major Office of Storage and Transportation Systems programs that support DOE licensing and/or certification objectives. In turn, those highly specific QA documents will amplify the general guidance presented in this Directive

  11. 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

  12. International External Quality Assurance for Laboratory Diagnosis of Diphtheria ▿

    Science.gov (United States)

    Neal, S. E.; Efstratiou, A.

    2009-01-01

    The diphtheria surveillance network (DIPNET) encompassing National Diphtheria Reference Centers from 25 European countries is a Dedicated Surveillance Network recognized by the European Commission. A key DIPNET objective is the quality assessment of microbiological procedures for diphtheria across the European Union and beyond. A detailed questionnaire on the level of reference laboratory services and an external quality assessment (EQA) panel comprising six simulated throat specimens were sent to 34 centers. Twenty-three centers are designated National Diphtheria Reference Centers, with the laboratory in the United Kingdom being the only WHO Collaborating Centre. A variety of screening and identification tests were used, including the cysteinase test (20/34 centers), pyrazinamidase test (17/34 centers), and commercial kits (25/34 centers). The classic Elek test for toxigenicity testing is mostly used (28/34 centers), with variations in serum sources and antitoxin concentrations. Many laboratories reported problems obtaining Elek reagents or media. Only six centers produced acceptable results for all six specimens. Overall, 21% of identification and 13% of toxigenicity reports were unacceptable. Many centers could not isolate the target organism, and most found difficulties with the specimens that contained Corynebacterium striatum as a commensal contaminant. Nineteen centers generated either false-positive or negative toxigenic results, which may have caused inappropriate medical management. The discrepancies in this diphtheria diagnostics EQA alarmingly reflect the urgent need to improve laboratory performance in diphtheria diagnostics in Europe, standardize feasible and robust microbiological methods, and build awareness among public health authorities. Therefore, DIPNET recommends that regular workshops and EQA distributions for diphtheria diagnostics should be supported and maintained. PMID:19828749

  13. Knowledge, Power and Meanings Shaping Quality Assurance in Higher Education: A Systemic Critique

    Science.gov (United States)

    Houston, Don; Paewai, Shelley

    2013-01-01

    Internationally, quality assurance schemes persist despite long-standing dissatisfaction and critique of their impact and outcomes. Adopting a critical systems perspective, the article explores the relationships between the knowledge, power and meanings that stakeholder groups bring to the design and implementation of quality assurance systems.…

  14. System engineering of complex optical systems for mission assurance and affordability

    Science.gov (United States)

    Ahmad, Anees

    2017-08-01

    Affordability and reliability are equally important as the performance and development time for many optical systems for military, space and commercial applications. These characteristics are even more important for the systems meant for space and military applications where total lifecycle costs must be affordable. Most customers are looking for high performance optical systems that are not only affordable but are designed with "no doubt" mission assurance, reliability and maintainability in mind. Both US military and commercial customers are now demanding an optimum balance between performance, reliability and affordability. Therefore, it is important to employ a disciplined systems design approach for meeting the performance, cost and schedule targets while keeping affordability and reliability in mind. The US Missile Defense Agency (MDA) now requires all of their systems to be engineered, tested and produced according to the Mission Assurance Provisions (MAP). These provisions or requirements are meant to ensure complex and expensive military systems are designed, integrated, tested and produced with the reliability and total lifecycle costs in mind. This paper describes a system design approach based on the MAP document for developing sophisticated optical systems that are not only cost-effective but also deliver superior and reliable performance during their intended missions.

  15. Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region, Ethiopia.

    Science.gov (United States)

    Shiferaw, Melashu Balew; Hailu, Hiwot Amare; Fola, Abebe Alemu; Derebe, Mulatu Melese; Kebede, Aimro Tadese; Kebede, Abayneh Admas; Emiru, Manamnot Agegne; Gelaw, Zelalem Dessie

    2015-01-01

    Reliable smear microscopy is an important component of Directly Observed Treatment Scheme (DOTS) strategy for TB control program in countries with limited resources. Despite external quality assessment is established in Ethiopia, there is lower TB detection rate (48%) in Amhara region compared to the World Health Organization (WHO) estimate (70%). This highlights the quality of smear microscopy needs to be evaluated. Therefore, the aim of this study was to assess the quality of sputum smear microscopy performance among health center laboratories in West Amhara region, Ethiopia. A cross sectional study was conducted from July 08, 2013 to July 07, 2014. Data were collected from 201 public health center laboratories using a structured questionnaire. Slides were collected based on Lot Quality Assurance Sampling (LQAS) method and rechecked blindly by trained laboratory technologists. The data were entered into EPI info V.7 and smear quality indicators and AFB results were analyzed by SPSS version 20. Among 201 laboratories enrolled in this study, 47 (23.4%) laboratories had major errors. Forty one (20.4%) laboratories had a total of 67 false negative and 29 (14.4%) laboratories had a total of 68 false positive results. Specimen quality, smear thickness and evenness were found poor in 134 (66.7%), 133 (66.2%) and 126 (62.7%) laboratories, respectively. Unavailability of microscope lens cleaning solution (AOR: 2.90; 95% CI: 1.25-6.75; P: 0.013) and dirty smears (AOR: 2.65; 95% CI: 1.14-6.18; P: 0.024) were correlated with false negative results whereas no previous EQA participation (AOR: 3.43; 95% CI: 1. 39-8.45; P: 0.007) was associated with false positive results. The performance of health facilities for sputum smear microscopy was relatively poor in West Amhara region. Hence, strengthening the EQA program and technical support on sputum smear microscopy are recommended to ensure quality tuberculosis diagnostic service.

  16. Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region, Ethiopia.

    Directory of Open Access Journals (Sweden)

    Melashu Balew Shiferaw

    Full Text Available Reliable smear microscopy is an important component of Directly Observed Treatment Scheme (DOTS strategy for TB control program in countries with limited resources. Despite external quality assessment is established in Ethiopia, there is lower TB detection rate (48% in Amhara region compared to the World Health Organization (WHO estimate (70%. This highlights the quality of smear microscopy needs to be evaluated. Therefore, the aim of this study was to assess the quality of sputum smear microscopy performance among health center laboratories in West Amhara region, Ethiopia.A cross sectional study was conducted from July 08, 2013 to July 07, 2014. Data were collected from 201 public health center laboratories using a structured questionnaire. Slides were collected based on Lot Quality Assurance Sampling (LQAS method and rechecked blindly by trained laboratory technologists. The data were entered into EPI info V.7 and smear quality indicators and AFB results were analyzed by SPSS version 20.Among 201 laboratories enrolled in this study, 47 (23.4% laboratories had major errors. Forty one (20.4% laboratories had a total of 67 false negative and 29 (14.4% laboratories had a total of 68 false positive results. Specimen quality, smear thickness and evenness were found poor in 134 (66.7%, 133 (66.2% and 126 (62.7% laboratories, respectively. Unavailability of microscope lens cleaning solution (AOR: 2.90; 95% CI: 1.25-6.75; P: 0.013 and dirty smears (AOR: 2.65; 95% CI: 1.14-6.18; P: 0.024 were correlated with false negative results whereas no previous EQA participation (AOR: 3.43; 95% CI: 1. 39-8.45; P: 0.007 was associated with false positive results.The performance of health facilities for sputum smear microscopy was relatively poor in West Amhara region. Hence, strengthening the EQA program and technical support on sputum smear microscopy are recommended to ensure quality tuberculosis diagnostic service.

  17. High assurance SPIRAL

    Science.gov (United States)

    Franchetti, Franz; Sandryhaila, Aliaksei; Johnson, Jeremy R.

    2014-06-01

    In this paper we introduce High Assurance SPIRAL to solve the last mile problem for the synthesis of high assurance implementations of controllers for vehicular systems that are executed in today's and future embedded and high performance embedded system processors. High Assurance SPIRAL is a scalable methodology to translate a high level specification of a high assurance controller into a highly resource-efficient, platform-adapted, verified control software implementation for a given platform in a language like C or C++. High Assurance SPIRAL proves that the implementation is equivalent to the specification written in the control engineer's domain language. Our approach scales to problems involving floating-point calculations and provides highly optimized synthesized code. It is possible to estimate the available headroom to enable assurance/performance trade-offs under real-time constraints, and enables the synthesis of multiple implementation variants to make attacks harder. At the core of High Assurance SPIRAL is the Hybrid Control Operator Language (HCOL) that leverages advanced mathematical constructs expressing the controller specification to provide high quality translation capabilities. Combined with a verified/certified compiler, High Assurance SPIRAL provides a comprehensive complete solution to the efficient synthesis of verifiable high assurance controllers. We demonstrate High Assurance SPIRALs capability by co-synthesizing proofs and implementations for attack detection and sensor spoofing algorithms and deploy the code as ROS nodes on the Landshark unmanned ground vehicle and on a Synthetic Car in a real-time simulator.

  18. THE STUDY REGARDING DIFFERENT APPROACHES OF THE QUALITY ASSURANCE SYSTEMS IN EDUCATION

    Directory of Open Access Journals (Sweden)

    Bonca Dana Valeria

    2015-07-01

    Full Text Available One of the key indicators of any society is represented by the assurance of some domestic policies with a high quality level. At the same time, an important role is given to the education system of each state; hence, at the level of each provider of education services, there is a continuous preoccupation in regards to improving the quality of the entire educational system. Therefore, some legislative and institutional basis where established, which were meant to carry up this process, such as to respond to the dynamics of the societies, even through the implementation of a management system of the quality assurance, starting with the need of respecting the principles of a quality culture, including the level of internal processes of the providing entities of education services. The paper points out the importance of the quality assurance system, at the school level, beginning with the theoretical dimensions.

  19. Quality assurance system in gamma spectrometry laboratory

    International Nuclear Information System (INIS)

    Mielnikow, A.; Michalik, B.; Chalupnik, S.; Lebecka, J.

    1996-01-01

    On basis of guidelines for development of QUALITY SYSTEM for a testing laboratory (European Standard Series EN 45000) a quality assurance system was implemented in gamma spectroscopy laboratory, where routine measurements of natural (mainly Ra-226, Ra-228, Ra-224, K-40) and artificial (mainly Cs-137 and Cs-134) isotopes are performed. We measure a variety of samples, but mainly coal, vaste rock, ashe, deposits, vegetation and air filters. Laboratory of gamma spectroscopy in Central Mining Institute has three HPGe detectors. There is one coaxial detector with 45% relative efficiency, one detector for low energy region and one detector with extended range). We have also two Ge(Li) detectors from former Czechoslovakia. Shielding is made mainly of steel (40 cm) with the interior covered with lead and copper. The electronics and software (Genie-PC) was bought at 'Canberra' and 'Silena'. The paper describes not only the system of quality assurance but also main problems met by its implementation and results of intercomparison measurements. The QAS has been introduced in 1992. In 1993 the Accreditation Certificate of Testing Laboratory for our Laboratory has been obtained from the Polish Bureau of Research and Certification as a fifth laboratory in Poland. (author)

  20. Introduction to quality assurance

    International Nuclear Information System (INIS)

    Kaden, W.

    1980-01-01

    In today's interpretation 'quality assurance' means 'good management'. Quality assurance has to cover all phases of a work, but all quality assurance measures must be adapted to the relevance and complexity of the actual task. Examples are given for the preparation of quality classes, the organization of quality assurance during design and manufacturing and for auditing. Finally, efficiency and limits of quality assurance systems are described. (orig.)

  1. The application of quality assurance

    International Nuclear Information System (INIS)

    Lovatt, G.B.

    1988-01-01

    The paper concerns the application of quality assurance to structures, systems and components for the design, construction and operation of nuclear power plant and fuel reprocessing plant. A description is given of:- the requirements for quality assurance, the establishment of quality assurance arrangements, quality assurance documents structure, and quality assurance manuals and programmes. Quality assurance procedures and auditing are also discussed. (U.K.)

  2. Quality assurance of weather data for agricultural system model input

    Science.gov (United States)

    It is well known that crop production and hydrologic variation on watersheds is weather related. Rarely, however, is meteorological data quality checks reported for agricultural systems model research. We present quality assurance procedures for agricultural system model weather data input. Problems...

  3. A Microfluidic Immunostaining System Enables Quality Assured and Standardized Immunohistochemical Biomarker Analysis

    Science.gov (United States)

    Kwon, Seyong; Cho, Chang Hyun; Kwon, Youngmee; Lee, Eun Sook; Park, Je-Kyun

    2017-04-01

    Immunohistochemistry (IHC) plays an important role in biomarker-driven cancer therapy. Although there has been a high demand for standardized and quality assured IHC, it has rarely been achieved due to the complexity of IHC testing and the subjective validation-based process flow of IHC quality control. We present here a microfluidic immunostaining system for the standardization of IHC by creating a microfluidic linearly graded antibody (Ab)-staining device and a reference cell microarray. Unlike conventional efforts, our system deals primarily with the screening of biomarker staining conditions for quantitative quality assurance testing in IHC. We characterized the microfluidic matching of Ab staining intensity using three HER2 Abs produced by different manufacturers. The quality of HER2 Ab was also validated using tissues of breast cancer patients, demonstrating that our system is an efficient and powerful tool for the standardization and quality assurance of IHC.

  4. Support for Quality Assurance in End-User Systems.

    Science.gov (United States)

    Klepper, Robert; McKenna, Edward G.

    1989-01-01

    Suggests an approach that organizations can take to provide centralized support services for quality assurance in end-user information systems, based on the experiences of a support group at Citicorp Mortgage, Inc. The functions of the support group include user education, software selection, and assistance in testing, implementation, and support…

  5. A Concept of Operations for an Integrated Vehicle Health Assurance System

    Science.gov (United States)

    Hunter, Gary W.; Ross, Richard W.; Berger, David E.; Lekki, John D.; Mah, Robert W.; Perey, Danie F.; Schuet, Stefan R.; Simon, Donald L.; Smith, Stephen W.

    2013-01-01

    This document describes a Concept of Operations (ConOps) for an Integrated Vehicle Health Assurance System (IVHAS). This ConOps is associated with the Maintain Vehicle Safety (MVS) between Major Inspections Technical Challenge in the Vehicle Systems Safety Technologies (VSST) Project within NASA s Aviation Safety Program. In particular, this document seeks to describe an integrated system concept for vehicle health assurance that integrates ground-based inspection and repair information with in-flight measurement data for airframe, propulsion, and avionics subsystems. The MVS Technical Challenge intends to maintain vehicle safety between major inspections by developing and demonstrating new integrated health management and failure prevention technologies to assure the integrity of vehicle systems between major inspection intervals and maintain vehicle state awareness during flight. The approach provided by this ConOps is intended to help optimize technology selection and development, as well as allow the initial integration and demonstration of these subsystem technologies over the 5 year span of the VSST program, and serve as a guideline for developing IVHAS technologies under the Aviation Safety Program within the next 5 to 15 years. A long-term vision of IVHAS is provided to describe a basic roadmap for more intelligent and autonomous vehicle systems.

  6. Digital versus traditional: are diagnostic accuracy rates similar for glass slides versus whole slide images in a non-gynaecological external quality assurance setting?

    Science.gov (United States)

    Ross, Jennifer; Greaves, Janelle; Earls, Peter; Shulruf, Boaz; Van Es, Simone L

    2018-04-17

    The Royal College of Pathologists of Australasia Quality Assurance Programs introduced virtual microscopy cases into its cytopathology non-gynaecological program after a short pilot phase, to address the challenges of providing a purely glass slide-based external quality assurance program to multiple participants both locally and internationally. The use of whole slide image (WSI) cases has facilitated a more robust program in relation to standardised material and statistical analysis, with access to a wider variety of specimen types and diagnostic entities. Diagnostic accuracy rates on 56 WSI were assessed against the reference diagnosis. A portion (12) of these WSI slides had been used in glass slide format in previous EQA surveys, and the results of these were compared to the responses received as glass slide cases. Overall diagnostic accuracy for the 56 WSI cases was acceptable in comparison to the reference diagnosis. When these 12 cases were analysed individually, for seven of the twelve cases, virtual format was found to be not inferior to glass slides for diagnostic accuracy. For one case, accuracy using WSI for diagnosis was superior to glass format. Diagnostic accuracy, using WSI for cases in our external quality assurance program is acceptable. As the use of digital microscopy in a large scale external quality assurance program (eQAP) offers extensive advantages over a glass slide-based format, our results encourage future comparison of diagnostic accuracy for virtual compared to glass slide format at a point in time where pathologists are becoming increasingly familiar with virtual microscopy in everyday practice. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  7. Reliability assurance program for operational emergency ac power system

    International Nuclear Information System (INIS)

    Heineman, J.B.; Ragland, W.A.; Mueller, C.J.

    1985-01-01

    A comprehensive review of emergency ac power systems in nuclear generating plants (the vast majority of these plants contain redundant diesel generator systems) delineates several operational areas that can be improved by instituting a reliability assurance program (RAP), which initially upgrades the diesel generator performance and provides for ongoing monitoring and maintenance based upon alert levels

  8. Software quality assurance: in large scale and complex software-intensive systems

    NARCIS (Netherlands)

    Mistrik, I.; Soley, R.; Ali, N.; Grundy, J.; Tekinerdogan, B.

    2015-01-01

    Software Quality Assurance in Large Scale and Complex Software-intensive Systems presents novel and high-quality research related approaches that relate the quality of software architecture to system requirements, system architecture and enterprise-architecture, or software testing. Modern software

  9. [External quality control system in medical microbiology and parasitology in the Czech Republic].

    Science.gov (United States)

    Slosárek, M; Petrás, P; Kríz, B

    2004-11-01

    The External Quality Control System (EQAS) of laboratory activities in medical microbiology and parasitology was implemented in the Czech Republic in 1993 with coded sera samples for diagnosis of viral hepatitis and bacterial strains for identification distributed to first participating laboratories. The number of sample types reached 31 in 2003 and the number of participating laboratories rised from 79 in 1993 to 421 in 2003. As many as 15.130 samples were distributed to the participating laboratories in 2003. Currently, almost all microbiology and parasitology laboratories in the Czech Republic involved in examination of clinical material participate in the EQAS. Based on the 11-year experience gained with the EQAS in the Czech Republic, the following benefits were observed: higher accuracy of results in different tests, standardisation of methods and the use of most suitable test kits.

  10. SAMJ 8678.indd

    African Journals Online (AJOL)

    RESEARCH. 700. October ... Studies estimating the impact of screening programmes in Europe ... DR screening in South Africa (SA) is done on an ad hoc and ... The Scottish External Quality Assurance (EQA) process is an ... ophthalmologists with a high level of proficiency in assessing retinal ..... SA healthcare market.

  11. Sequence Coding and Search System Backfit Quality Assurance Program Plan

    International Nuclear Information System (INIS)

    Lovell, C.J.; Stepina, P.L.

    1985-03-01

    The Sequence Coding and Search System is a computer-based encoding system for events described in Licensee Event Reports. This data system contains LERs from 1981 to present. Backfit of the data system to include LERs prior to 1981 is required. This report documents the Quality Assurance Program Plan that EG and G Idaho, Inc. will follow while encoding 1980 LERs

  12. Quality assurance system for sitting high risk facilities

    International Nuclear Information System (INIS)

    Rodriguez, Aymee; Peralta, Jose L.; Fernandez, Manuel

    1999-01-01

    The paper shows how we have conceived and designed the quality assurance system for the site selection process of an area for sitting the facility of high risk in correspondence with the approved methodology. The results obtained in the implementation of the system have permitted the satisfactory performance of each one the expected stage, defining the most favorable sectors in order to continue the studies of the repository site for the disposal of low and intermedium. (author)

  13. Application of Quality Assurance to MCandA systems

    International Nuclear Information System (INIS)

    Skinner, A.J.; Delvin, W.L.

    1986-01-01

    Quality Assurance has been applied to the MCandA function within the Department of Energy's Savannah River Operations Office. It was applied to both the activities used to operate the MCandA Branch and the activities used by the Branch to overview the MCandA function of DOE/SR's contractor. In this paper, the principles of quality assurance are reviewed and their application at DOE/SR is discussed. In addition, quality assurance can be applied to the broader MCandA functions required of those facilities producing, using, and handling nuclear materials. Application of quality assurance to those broader functions is also discussed

  14. A retrospective evaluation of proficiency testing, and rapid HIV test ...

    African Journals Online (AJOL)

    Background: Proficiency testing (PT) has been implemented as a form of External Quality Assurance (EQA) by the National HIV Reference Laboratory in Kenya since 2007 in order to monitor and improve on the quality of HIV testing and counselling HTC services. Objective: To compare concordance between National HIV ...

  15. Supplier quality assurance systems: a study in the nuclear industry

    International Nuclear Information System (INIS)

    Singer, A.J.; Churchill, G.F.; Dale, B.G.

    1988-01-01

    The results are reported of a study which investigated the impact of quality assurance on 13 suppliers to the nuclear industry. The purpose of the study was to determine the benefits and problems of applying quality assurance in the supply of high risk plant items and material for nuclear installations. The paper discusses the problems facing the industry including: multiple audits and inspections, the irritation with having to contend with two quality system standards (namely BS 5750 and BS 5882) and the cost effectiveness of the more stringent quality system and quality control surveillance requirements imposed by the nuclear industry. It is also pointed out that companies supplying non-nuclear industrial customers were dissatisfied with the qualifications, experience and professional competence of some auditors and many inspectors. (author)

  16. Revitalizing quality assurance

    International Nuclear Information System (INIS)

    Hawkins, F.C.

    1998-01-01

    The image of someone inspecting or auditing often comes to mind when people hear the term quality assurance. Although partially correct, this image is not the complete picture. The person doing the inspecting or auditing is probably part of a traditional quality assurance organization, but that organization is only one aspect of a properly conceived and effectively implemented quality assurance system whose goal is improved facility safety and reliability. This paper introduces the underlying philosophies and basic concepts of the International Atomic Energy Agency's new quality assurance initiative that began in 1991 as part of a broad Agency-wide program to enhance nuclear safety. The first product of that initiative was publication in 1996 of a new Quality Assurance Code 50-C/SG-Q and fourteen related Safety Guides. This new suite of documents provide the technical and philosophical foundation upon which Member States can base their quality assurance programs. (author)

  17. An approach to software quality assurance for robotic inspection systems

    International Nuclear Information System (INIS)

    Kiebel, G.R.

    1993-10-01

    Software quality assurance (SQA) for robotic systems used in nuclear waste applications is vital to ensure that the systems operate safely and reliably and pose a minimum risk to humans and the environment. This paper describes the SQA approach for the control and data acquisition system for a robotic system being developed for remote surveillance and inspection of underground storage tanks (UST) at the Hanford Site

  18. Unilever food safety assurance system for refined vegetable oils and fats

    Directory of Open Access Journals (Sweden)

    van Duijn Gerrit

    2010-03-01

    Full Text Available The Unilever Food Safety Assurance system for refined oils and fats is based on risk assessments for the presence of contaminants or pesticide residues in crude oils, and refining process studies to validate the removal of these components. Crude oil risk assessments were carried out by combining supply chain visits, and analyses of the contaminant and pesticide residue levels in a large number of crude oil samples. Contaminants like poly-aromatic hydrocarbons and hydrocarbons of mineral origin, and pesticide residues can largely be removed by refining. For many years, this Food Safety Assurance System has proven to be effective in controlling contaminant levels in refined vegetable oils and fats.

  19. Quality assurance in central nuclear power plant control systems. (Status report containing proposed enhancements for KTA rules)

    International Nuclear Information System (INIS)

    Gossner, S.

    1985-01-01

    All enterprises investigated observe the requirements laid down in KTA 1401. In most cases, the quality assurance systems and measures applied even go beyond the requirements of KTA 1401, especially in those enterprises working primarily for export and having to meet foreign quality assurance standards. Quality assurance measures in these enterprises are based primarily on 10 CFR 50, App.B and related rules and standards (e.g. ANSI N 54.2; NUREG 75/087). Internal quality assurance in these enterprises is organized on the basis of graphic flow diagrams which are even presented in the quality assurance manuals. These flow diagrams, in contrast to the German KTA rules, meet the international standards for quality assurance. KTA 1401 requirements not sufficiently met are, e.g. the operator audits with plant producers and unit and equipment producer audits with component producers. The report presents hints for improvements of the quality assurance concept in control systems engineering. (orig./HP) [de

  20. Development of Quality Assurance System and Element for Digital I and C

    International Nuclear Information System (INIS)

    Kim, K. H.; Park, C. K.; Ha, J. H.; Kwon, H. I.

    2008-06-01

    The Quality Assurance system should play an importance role in order to create safety operation. And management of KNICS R and D should have strong leadership to build he safety mind and quality mind. Quality assurance system can help to develop safety management system and to create a positive safety culture in operating organization of nuclear development. The establishment and implementation of QA system is prerequisite for achieving goals of the worker's health, quality, environment and public acceptance in operation of nuclear facilities whether they are regulated by the governmental requirements or not. The focus of nuclear QA system is brought on establishment of an appropriate system and assurance of implementation of the system by continuous improvement of quality problems. As for QA activities related to nuclear R and D, we set up QA systems and supported implementation of the system. We conducted periodic audit of KNICS projects related to safety system development and took corrective actions according to the result. Radiation exposure riskiness of the KAERI's nuclear facilities is lower than that of nuclear power plant and they are more safe. But their safety have being supervised by regulatory body in compliance with laws and technical requirements of nuclear power plant. The present QA system should be changed to an integrated safety management system where elements of environment management, safety management and quality management are complimentarily interacting, and thus meet legal requirements. It is necessary to compare subsystems with KNICS QA and management system requirements to improve the effectiveness of existing implementing procedures in other KNICS projects.

  1. Project Specific Quality Assurance Plan Project (QAPP) W-211 Initial Tank Retrieval Systems (ITRS)

    International Nuclear Information System (INIS)

    HALL, L.R.

    2000-01-01

    This Quality Assurance Program Plan (QAPP) provides information on how the Project Hanford Quality Assurance Program is implemented by CH2M HILL Hanford Group Inc (CHG) for managing the Initial Tank Retrieval Systems (ITRS), Project W-211. This QAPP is responsive to the CHG Quality Assurance Program Description (QAPD) (LMH-MP-599) which provides direction for compliance to 10 CFR 830 120, ''Nuclear Safety Management, Quality Assurance Requirements'', and DOE Order 5700 6C, ''Quality Assurance'' Project W-211 modifies existing facilities and provides systems for retrieval of radioactive wastes from selected double-shell tanks (DST). The contents of these tanks are a combination of supernatant liquids and settled solids. To retrieve waste from the tanks, it is first necessary to mix the liquid and solids prior to transferring the slurry to alternative storage or treatment facilities. The ITRS will provide systems to mobilize the settled solids and transfer the wastes out of the tanks. In so doing, ITRS provides feed for future processing plants, allows for consolidation of tank solids to manage space within existing DST storage capacity, and supports continued safe storage of tank waste. This project includes the design, procurement, construction, startup and turnover of these retrieval systems This QAPP identifies organizational structures and responsibilities. Implementing procedures used by CHG project management can be found in the CHG Quality Assurance Program (CHG QAP) Implementation Matrix located in HNF-IP-0842, Volume XI, Attachment Proposed verification and inspection activities for critical items within the scope of project W-211 are identified in Attachment 1 W-211. Project participants will identify the implementing procedures used by their organization within their QAF'Ps. This project specific QAPP is used to identify requirements in addition to the QAPD and provide, by reference, additional information to other project documents

  2. Lessons learned from development and quality assurance of software systems at the Halden Project

    International Nuclear Information System (INIS)

    Bjorlo, T.J.; Berg, O.; Pehrsen, M.; Dahll, G.; Sivertsen, T.

    1996-01-01

    The OECD Halden Reactor Project has developed a number of software systems within the research programmes. These programmes have comprised a wide range of topics, like studies of software for safety-critical applications, development of different operator support systems, and software systems for building and implementing graphical user interfaces. The systems have ranged from simple prototypes to installations in process plants. In the development of these software systems, Halden has gained much experience in quality assurance of different types of software. This paper summarises the accumulated experience at the Halden Project in quality assurance of software systems. The different software systems being developed at the Halden Project may be grouped into three categories. These are plant-specific software systems (one-of-a-kind deliveries), generic software products, and safety-critical software systems. This classification has been found convenient as the categories have different requirements to the quality assurance process. In addition, the experience from use of software development tools and proprietary software systems at Halden, is addressed. The paper also focuses on the experience gained from the complete software life cycle, starting with the software planning phase and ending with software operation and maintenance

  3. Management information system model supporting the quality assurance of schools in Thailand

    Directory of Open Access Journals (Sweden)

    Daoprakai Raso

    2017-07-01

    Full Text Available Management Information Systems are very important tools for Thai Schools in supporting the quality assurance process. This research therefore aimed to develop a Management Information System (MIS model which consisted of two phases. Phase 1 was the design of MIS model used in Thai school quality assurance (QA. Phase 2 was the evaluation of the model which consisted of four parts. There were the MIS circle which consisted of 1 System Investigation, System Analysis, System Design, System Implementation and System Maintenance. 2 The Management Information System, which consisted of data collecting, data processing, information presenting, information saving, and procedure controlling. 3 The factors that support the MIS, which includes information tools and equipment used factor and the information operator’s factor, and 4 the system theory which consisted of input, process, and output. The results showed that the level of opinions in all aspects was at a “high” level.

  4. Quality assurance of the modernized Dukovany I and C safety system software

    International Nuclear Information System (INIS)

    Karpeta, C.

    2005-01-01

    The approach to quality assurance of the software that implements the instrumentation and control functions for safety category A as per IEC 61226, which has been adopted within the 'NPP Dukovany I and C Refurbishment' project, is described. A survey of the requirements for software quality assurance of the systems that initiate protection interventions in the event of anticipated operational occurrences or accident conditions is given. The software development process applied by the system designers and manufacturers, from the software requirements specification phase to the software testing phase, is outlined. Basic information on technical audits of the software development process is also provided. (orig.)

  5. Automatic non-destructive system for quality assurance of welded elements in the aircraft industry

    Science.gov (United States)

    Chady, Tomasz; Waszczuk, Paweł; Szydłowski, Michał; Szwagiel, Mariusz

    2018-04-01

    Flaws that might be a result of the welding process have to be detected, in order to assure high quality thus reliability of elements exploited in aircraft industry. Currently the inspection stage is conducted manually by a qualified workforce. There are no commercially available systems that could support or replace humans in the flaw detection process. In this paper authors present a novel non-destructive system developed for quality assurance purposes of welded elements utilized in the aircraft industry.

  6. Authentication Assurance Level Application to the Inventory Sampling Measurement System

    International Nuclear Information System (INIS)

    Devaney, Mike M.; Kouzes, Richard T.; Hansen, Randy R.; Geelhood, Bruce D.

    2001-01-01

    This document concentrates on the identification of a standardized assessment approach for the verification of security functionality in specific equipment, the Inspection Sampling Measurement System (ISMS) being developed for MAYAK. Specifically, an Authentication Assurance Level 3 is proposed to be reached in authenticating the ISMS

  7. 48 CFR 12.208 - Contract quality assurance.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Contract quality assurance... Items 12.208 Contract quality assurance. Contracts for commercial items shall rely on contractors' existing quality assurance systems as a substitute for Government inspection and testing before tender for...

  8. A new approach to define acceptance limits for hematology in external quality assessment schemes.

    Science.gov (United States)

    Soumali, Mohamed Rida; Van Blerk, Marjan; Akharif, Abdelhadi; Albarède, Stéphanie; Kesseler, Dagmar; Gutierrez, Gabriela; de la Salle, Barbara; Plum, Inger; Guyard, Anne; Favia, Ana Paula; Coucke, Wim

    2017-10-26

    A study performed in 2007 comparing the evaluation procedures used in European external quality assessment schemes (EQAS) for hemoglobin and leukocyte concentrations showed that acceptance criteria vary widely. For this reason, the Hematology working group from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM) decided to perform a statistical study with the aim of establishing appropriate acceptance limits (AL) allowing harmonization between the evaluation procedures of European EQAS organizers. Eight EQAS organizers from seven European countries provided their hematology survey results from 2010 to 2012 for red blood cells (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), white blood cells (WBC), platelets and reticulocytes. More than 440,000 data were collected. The relation between the absolute value of the relative differences between reported EQA results and their corresponding assigned value (U-scores) was modeled by means of an adaptation of Thompson's "characteristic function". Quantile regression was used to investigate the percentiles of the U-scores for each target concentration range. For deriving AL, focus was mainly on the upper percentiles (90th, 95th and 99th). For RBC, hemoglobin, hematocrit and MCV, no relation was found between the U-scores and the target concentrations for any of the percentiles. For WBC, platelets and reticulocytes, a relation with the target concentrations was found and concentration-dependent ALs were determined. The approach enabled to determine state of the art-based ALs, that were concentration-dependent when necessary and usable by various EQA providers. It could also easily be applied to other domains.

  9. Quality Assurance Framework Implementation Guide for Isolated Community Power Systems

    Energy Technology Data Exchange (ETDEWEB)

    Esterly, Sean R. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Baring-Gould, Edward I. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Burman, Kari A. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Greacen, Chris [Independent Consultant (United States)

    2017-08-15

    This implementation guide is a companion document to the 'Quality Assurance Framework for Mini-Grids' technical report. This document is intended to be used by one of the many stakeholder groups that take part in the implementation of isolated power systems. Although the QAF could be applied to a single system, it was designed primarily to be used within the context of a larger national or regional rural electrification program in which many individual systems are being installed. This guide includes a detailed overview of the Quality Assurance Framework and provides guidance focused on the implementation of the Framework from the perspective of the different stakeholders that are commonly involved in expanding energy development within specific communities or regions. For the successful long-term implementation of a specific rural electrification program using mini-grid systems, six key stakeholders have been identified that are typically engaged, each with a different set of priorities 1. Regulatory agency 2. Governmental ministry 3. System developers 4. Mini-utility 5. Investors 6. Customers/consumers. This document is broken into two distinct sections. The first focuses on the administrative processes in the development and operation of community-based mini-grid programs, while the second focuses on the process around the installation of the mini-grid project itself.

  10. QAM: PROPOSED MODEL FOR QUALITY ASSURANCE IN CBSS

    Directory of Open Access Journals (Sweden)

    Latika Kharb

    2015-08-01

    Full Text Available Component-based software engineering (CBSE / Component-Based Development (CBD lays emphasis on decomposition of the engineered systems into functional or logical components with well-defined interfaces used for communication across the components. Component-based software development approach is based on the idea to develop software systems by selecting appropriate off-the-shelf components and then to assemble them with a well-defined software architecture. Because the new software development paradigm is much different from the traditional approach, quality assurance for component-based software development is a new topic in the software engineering research community. Because component-based software systems are developed on an underlying process different from that of the traditional software, their quality assurance model should address both the process of components and the process of the overall system. Quality assurance for component-based software systems during the life cycle is used to analyze the components for achievement of high quality component-based software systems. Although some Quality assurance techniques and component based approach to software engineering have been studied, there is still no clear and well-defined standard or guidelines for component-based software systems. Therefore, identification of the quality assurance characteristics, quality assurance models, quality assurance tools and quality assurance metrics, are under urgent need. As a major contribution in this paper, I have proposed QAM: Quality Assurance Model for component-based software development, which covers component requirement analysis, component development, component certification, component architecture design, integration, testing, and maintenance.

  11. Quality assurance systems of higher education - The case of european institutions: origin, evolution and trends

    Directory of Open Access Journals (Sweden)

    Ángela Corengia

    2014-11-01

    Full Text Available http://dx.doi.org/10.5007/1983-4535.2014v7n3p61 The purpose of this research is to analyze the origin, evolution, performance and trends of higher education quality assurance systems in the following European countries: Denmark, Norway, Sweden, Finland, Austria, Italy, Switzerland, Germany, Netherlands, United Kingdom and France. It also studies the performance and impact of the organizations that join the European Quality Assurance Agencies together. The main sources of data collection were in situ semi-structured interviews to members of these agencies. It was found that in higher education institutions there is a strong trend towards the development of ‘internal quality assurance systems' in response to the public policies known as 'quality audits'. This overview about what is taking place in Europe may provide innovative instruments that could be considered for higher education quality evaluation and accreditation in Latin-American countries: quality audits, disciplinary agencies, evaluation of the quality assurance agencies, among others.

  12. Authentication Assurance Levels

    International Nuclear Information System (INIS)

    Kouzes, Richard T.; Cash, James R.; Devaney, David M.; Geelhood, Bruce D.; Hansen, Randy R.; Melton, Ronald B.; Pitts, W. Karl

    2002-01-01

    This Common Criteria approach has been applied to create a definition of Authentication Assurance Levels that can quantify the level of assurance reached for a system subject to a set of authentication procedures. The arms-control authentication application of the Common Criteria expands on more typical information security evaluations in that it must contend with information barriers and preclude sophisticated intentional subversion attempts.

  13. Quality assurance in nuclear medicine

    International Nuclear Information System (INIS)

    Kaul, A.

    1986-01-01

    'Quality Assurance in Nuclear Medicine' is the title of the English language original that has been translated into German. The manual very extensively deals with quality control of nuclear medical equipment. Tests are explained for checking radioactivity measuring devices, manual and automatic in-vitro sample measuring systems, in-vivo measuring systems with single or multiple detectors, rectlinear scanners, and gamma cameras, including the phantoms required for the methods. Other chapters discuss the quality control of radiopharmaceuticals, or the quality assurance in data recording and evaluation of results. Helpful comments on the organisation of quality assurance programms are given. The book is intended as a practical guide for introducing quality assurance principles in nuclear medicine in the Federal Republic of Germany. With 13 figs., 22 tabs [de

  14. Tool Use Within NASA Software Quality Assurance

    Science.gov (United States)

    Shigeta, Denise; Port, Dan; Nikora, Allen P.; Wilf, Joel

    2013-01-01

    As space mission software systems become larger and more complex, it is increasingly important for the software assurance effort to have the ability to effectively assess both the artifacts produced during software system development and the development process itself. Conceptually, assurance is a straightforward idea - it is the result of activities carried out by an organization independent of the software developers to better inform project management of potential technical and programmatic risks, and thus increase management's confidence in the decisions they ultimately make. In practice, effective assurance for large, complex systems often entails assessing large, complex software artifacts (e.g., requirements specifications, architectural descriptions) as well as substantial amounts of unstructured information (e.g., anomaly reports resulting from testing activities during development). In such an environment, assurance engineers can benefit greatly from appropriate tool support. In order to do so, an assurance organization will need accurate and timely information on the tool support available for various types of assurance activities. In this paper, we investigate the current use of tool support for assurance organizations within NASA, and describe on-going work at JPL for providing assurance organizations with the information about tools they need to use them effectively.

  15. Quality assurance program for prototype stereotactic system developed for neptun 10 Pc linac

    International Nuclear Information System (INIS)

    Khoshbin Khoshnazar, A.R.; Bahreyni Toossi, M.T.; Hashemiyan, A.R.; Bahreyni Toossi, M.T.; Salek, R.

    2005-01-01

    A prototype stereotactic radiosurgery set was designed and constructed for a Neptun 10 Pc linac that is currently being used at Imam Reza hospital in Mashad. Materials and Methods: A complete quality assurance program was designed and performed for the constructed system including isocentric accuracy test, localization accuracy test, dose delivery accuracy test and leakage radiation test. Target simulator, control alignment device and plexiglass phantom which were parts of the developed hardware were used to fulfill quality assurance program. Results: The average isocentric shift resulted from the gantry rotation and couch turning were respectively obtained to be 1.4 and 2 mm. The average localization error in the three coordinates was found to be 2.2 mm. The total treatment uncertainty due to all of the probable errors in the system was equal to 4.32 mm. The dose delivery accuracy test was carried out, the result indicated a 3.7% difference between the given and measured dose. Conclusion: The quality assurance tests showed consistent performance of the constructed system within the accepted limits; however, some inconsistency might exist in certain cases. The safety of stereotactic radiosurgery system method is increased when the overall uncertainty is minimized nd the treatment of the lesions adjacent to critical organs is avoided

  16. Quality assurance procedure for a gamma guided stereotactic breast biopsy system.

    Science.gov (United States)

    Welch, Benjamin L; Brem, Rachel; Black, Rachel; Majewski, Stan

    2006-01-01

    A quality assurance procedure has been developed for a prototype gamma-ray guided stereotactic biopsy system. The system consists of a compact small-field-of-view gamma-ray camera mounted to the rotational arm of a Lorad stereotactic biopsy system. The small-field-of-view gamma-ray camera has been developed for clinical applications where mammographic X-ray localization is not possible. Marker sources that can be imaged with the gamma-camera have been designed and built for quality assurance testing and to provide a fiducial reference mark. An algorithm for determining the three dimensional location of a region of interest, such as a lesion, relative to the fiducial mark has been implemented into the software control of the camera. This system can be used to determine the three-dimensional location of a region of interest from a stereo pair of images and that information can be used to guide a biopsy needle to that site. Point source phantom tests performed with the system have demonstrated that the camera can be used to localize a point of interest to within 1 mm, which is satisfactory for its use in needle localization.

  17. Software quality assurance plan for the National Ignition Facility integrated computer control system

    Energy Technology Data Exchange (ETDEWEB)

    Woodruff, J.

    1996-11-01

    Quality achievement is the responsibility of the line organizations of the National Ignition Facility (NIF) Project. This Software Quality Assurance Plan (SQAP) applies to the activities of the Integrated Computer Control System (ICCS) organization and its subcontractors. The Plan describes the activities implemented by the ICCS section to achieve quality in the NIF Project`s controls software and implements the NIF Quality Assurance Program Plan (QAPP, NIF-95-499, L-15958-2) and the Department of Energy`s (DOE`s) Order 5700.6C. This SQAP governs the quality affecting activities associated with developing and deploying all control system software during the life cycle of the NIF Project.

  18. Software quality assurance plan for the National Ignition Facility integrated computer control system

    International Nuclear Information System (INIS)

    Woodruff, J.

    1996-11-01

    Quality achievement is the responsibility of the line organizations of the National Ignition Facility (NIF) Project. This Software Quality Assurance Plan (SQAP) applies to the activities of the Integrated Computer Control System (ICCS) organization and its subcontractors. The Plan describes the activities implemented by the ICCS section to achieve quality in the NIF Project's controls software and implements the NIF Quality Assurance Program Plan (QAPP, NIF-95-499, L-15958-2) and the Department of Energy's (DOE's) Order 5700.6C. This SQAP governs the quality affecting activities associated with developing and deploying all control system software during the life cycle of the NIF Project

  19. 48 CFR 2453.246 - Quality Assurance.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Quality Assurance. 2453.246 Section 2453.246 Federal Acquisition Regulations System DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT CLAUSES AND FORMS FORMS Prescription of Forms 2453.246 Quality Assurance. ...

  20. Quality assurance program plan for Building 324

    International Nuclear Information System (INIS)

    Tanke, J.M.

    1997-01-01

    This Quality Assurance Program Plan (QAPP) provides an overview of the quality assurance program for Building 324. This plan supersedes the PNNL Nuclear Facilities Quality Management System Description, PNL-NF-QMSD, Revision 2, dated March 1996. The program applies to the facility safety structures, systems, and components and to activities that could affect safety structures, systems, and components. Adherence to the quality assurance program ensures the following: US Department of Energy missions and objectives are effectively accomplished; Products and services are safe, reliable, and meet or exceed the requirements and expectations of the user; Hazards to the public, to Hanford Site and facility workers, and to the environment are minimized. The format of this Quality Assurance Program Plan is structured to parallel that of 10 CFR 83 0.120, Quality Assurance Requirements

  1. 30 CFR 74.9 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 74.9 Section 74.9 Mineral... DUST SAMPLING DEVICES Requirements for Continuous Personal Dust Monitors § 74.9 Quality assurance. (a) General requirements. The applicant shall establish and maintain a quality control system that assures...

  2. KNOWLEDGE AND APPLICATION OF METHODS AND SYSTEMS QUALITY ASSURANCE IN ORCHARD FARMS IN POLAND

    Directory of Open Access Journals (Sweden)

    Eugenia Czernyszewicz

    2013-06-01

    Full Text Available Poland is significant producer of fruits in Europe. After accession to the EU, fruit producers are obligated to comply with operative rules and standards on this market which are related to ensuring commercial and healthcare products of appropriate quality. The quality of fruits available on the market is varied. This results from the fact that in the past, in domestic horticulture, more attention was paid to enlargement of the acreage, the modernization of orchards, increasing the intensity of production and productivity than on issues related to certification and quality management systems. Therefore, the aim of the work was to show the producer's opinion on methods and systems which assure quality of fruits. It was stated that producers have a good knowledge of the methods and systems of fruit quality assurance. Knowledge of these issues is significantly associated with the scale of the fruit production. The knowledge of the principles of integrated fruit production and trading standards GLOBALG.A.P. was declared most often. These methods of quality assurance were also top rated by producers and implemented mostly in farms.

  3. Qualtity assurance in nuclear technology

    International Nuclear Information System (INIS)

    Roesler, U.

    1977-01-01

    The demand for safety in nuclear power plants is rooted in the Atomic Energy Act of the Federal Republic of Germany, under which 'preplanned safety' is a licensing condition. Moreover, the safety of nuclear power plants is outlined in more precise terms in the guidelines of the German Advisory Committee for Reactor Safeguards (Reaktorsicherheitskommission). The usual approach taken in this country, i.e., to establish quality assurance for each specific product, with supplementary quality assurance measures geared to systems requirements being implemented by industry, has proved to work satisfactorily. Product-based quality assurance mainly stems from the classical quality control concept, whereas systems-based quality assurance primarily is to ensure that both manufacturers and systems suppliers take all measures in advance which are needed for the satisfactory processing of an order and to achieve the quality level required. The special features and the advantages of the joint action of manufacturers, systems suppliers and experts, which are characteristic of the German approach, very clearly emerge from a comparison with practices in the United States. In the further refinement of the quality assurance concept as practised in Germany, qhich will have a particularly great impact on costs and schedules because of the manpower requirement involved, it should be carefully weighed where there are exaggerations and unnecessary complications which can no longer be justified by the demand for more safety. (orig.) [de

  4. Chapter 8: Quality assurance

    International Nuclear Information System (INIS)

    2001-01-01

    The main efforts of Nuclear Regulatory Authority of the Slovak Republic (UJD) have been focused on inspection of quality assurance programmes of Slovak Power Stations, plc. and its daughter companies at Bohunice and Mochovce. Two quality assurance inspections in the area of periodical in service inspections (V-2 units) and tests of selected equipment (NPP V-2 units) and operation control (V-1 units) has been performed at NPPs Bohunice. One violation of decree on quality assurance of selected equipment has been found in the area of documentation archiving. The inspection concerning the implementation of quality assurance programme for operation of NPP Mochovce in the area of operation control has been performed focused on safety aspects of operation, operational procedures, control of operational events and feedback from operational experience. The results of this inspection were positive. Inspection of implementation of quality assurance programme for operation of radioactive waste repository (RU RAW) at the Mochovce location has been performed focused on receiving of containers, with radioactive wastes, containers handling, radiation monitoring, activities of documentation control and radiation protection at the repository site. No serious deficiencies have been found out. Also one inspection of experimental nuclear installations of VUJE Trnava at Jaslovske Bohunice site has been performed focused on procurement control, quality audits, documentation and quality records control when performing activities at experimental nuclear installations. The activity on development of internal quality assurance system continued. The implementation of this system will assure quality and effective fulfilment enlarged tasks of UJD with limited resources for its activity. The analyses of possible use of existing internal administrative control documentation as a basis for future quality system procedures was performed in co-operation with an external specialised organisation. The

  5. Software quality assurance and software safety in the Biomed Control System

    International Nuclear Information System (INIS)

    Singh, R.P.; Chu, W.T.; Ludewigt, B.A.; Marks, K.M.; Nyman, M.A.; Renner, T.R.; Stradtner, R.

    1989-01-01

    The Biomed Control System is a hardware/software system used for the delivery, measurement and monitoring of heavy-ion beams in the patient treatment and biology experiment rooms in the Bevalac at the Lawrence Berkeley Laboratory (LBL). This paper describes some aspects of this system including historical background philosophy, configuration management, hardware features that facilitate software testing, software testing procedures, the release of new software quality assurance, safety and operator monitoring. 3 refs

  6. Concepts of nuclear quality assurance

    International Nuclear Information System (INIS)

    Randers, G.; Morris, P.A.; Pomeroy, D.

    1976-01-01

    While the safety record of the nuclear industry continues to be excellent, the forced outage rates for recent years continue to be 15% or more. Quality assurance, therefore, needs to be applied not only to nuclear safety matters, but to the goals of increased productivity and reduced construction and operating costs. Broadening the application of the general concept of quality assurance in this way leads to the introduction of reliability technology. The total activity might better be called reliability assurance. That effective quality assurance systems do pay off is described by examples from the utility industry, from a manufacturer of instruments and systems and from the experience of Westinghouse Electric Company's manufacturing divisions. The special situation of applying quality assurance to nuclear fuel is discussed. Problems include the lack of a fully developed regulatory policy in this area, incomplete understanding of the mechanism for pellet-clad interaction failures, incomplete access to manufacturers design and process information, inability to make desirable changes on a timely basis and inadequate feedback of irradiation experience. (author)

  7. Calibration and quality assurance for rounded leaf-end MLC systems

    International Nuclear Information System (INIS)

    Graves, Maria N.; Thompson, Antoinette V.; Martel, Mary K.; McShan, Daniel L.; Fraass, Benedick A.

    2001-01-01

    Multileaf collimator (MLC) systems are available on most commercial linear accelerators, and many of these MLC systems utilize a design with rounded leaf ends and linear motion of the leaves. In this kind of system, the agreement between the digital MLC position readouts and the light field or radiation field edges must be achieved with software, since the leaves do not move in a focused motion like that used for most collimator jaw systems. In this work we address a number of the calibration and quality assurance issues associated with the acceptance, commissioning, and routine clinical use of this type of MLC system. These issues are particularly important for MLCs used for various types of intensity modulated radiation therapy (IMRT) and small, conformal fields. For rounded leaf end MLCs, it is generally not possible to make both the light and radiation field edges agree with the digital readout, so differences between the two kinds of calibrations are illustrated in this work using one vendor's MLC system. It is increasingly critical that the MLC leaf calibration be very consistent with the radiation field edges, so in this work a methodology for performing accurate radiation field size calibration is discussed. A system external to the vendor's MLC control system is used to correct or handle limitations in the MLC control system. When such a system of corrections is utilized, it is found that the MLC radiation field size can be defined with an accuracy of approximately 0.3 mm, much more accurate than most vendor's specifications for MLC accuracy. Quality assurance testing for such a calibration correction system is also demonstrated

  8. Quality assurance of fuel elements

    International Nuclear Information System (INIS)

    Hoerber, J.

    1980-01-01

    The quality assurance activities for reactor fuel elements are based on a quality assurance system which implies the requirements resulting from the specifications, regulations of the authorities, national standards and international rules and regulations. The quality assurance related to production of reactor fuel will be shown for PWR fuel elements in all typical fabrication steps as conversion into UO 2 -powder, pelletizing, rodmanufacture and assembling. A wide range of destructive and nondestructive techniques is applied. Quality assurance is not only verified by testing techniques but also by process monitoring by means of parameter control in production and testing procedures. (RW)

  9. Commissioning and quality assurances of the CMS XIO radiotherapy treatment planning system for external beam photons

    International Nuclear Information System (INIS)

    Muralidhar, K.R.; Anurupa; Soubhagya; Sudhakar; Shiva; Krishnam Raju, A.; Narayana Murthy, P.

    2008-01-01

    The commissioning of XIO treatment planning system (TPS) was carried out by Computerized Medical Devices, USA for Siemens and Elekta linear accelerators. The Commissioning and quality assurance of the CMS XIO radiotherapy treatment planning system involves many steps, beginning from beam data acquisition and entry into the computerized TPS, through patient data acquisition, to treatment plan generation and the final transfer of data to the treatment machine and quality assurance of TPS

  10. Quality assurance systems - a means for an integrating organization of nuclear power plants

    International Nuclear Information System (INIS)

    Adams, H.W.

    1984-01-01

    The operators of nuclear power plants are in the process of introducing quality assurance systems of the type required in Rule 1401 by the German Kerntechnischer Ausschuss (Nuclear Technology Committee). These systems as a cross sectional function cover most of the organizational areas of a nuclear power plant. Their introduction offers an opportunity to harmonize and supplement existing systems where necessary. Integrated quality assurance systems built up on a data base allow existing DP data and other logical data to be organized in such a way that certain sequences of events can be managed by enforced control. This relieves the personnel responsible for the safety of a nuclear power plant of routine jobs and routine decisions. Greater flexibility is created for personal decisions. Organized sequences of events can be monitored by having lists printed out in which the necessary data are combined into data sets. (orig.) [de

  11. 22 CFR 141.4 - Assurances required.

    Science.gov (United States)

    2010-04-01

    ... of the United States for the desegregation of such school or school system, and provides an assurance... other participants. Any such assurance shall include provisions which give the United States a right to... system which the responsible official of the Department of Health, Education, and Welfare determines is...

  12. Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the System-Wide Safety and Assurance Technologies Project

    Science.gov (United States)

    Withrow, Colleen A.; Reveley, Mary S.

    2015-01-01

    The Aviation Safety Program (AvSP) System-Wide Safety and Assurance Technologies (SSAT) Project asked the AvSP Systems and Portfolio Analysis Team to identify SSAT-related trends. SSAT had four technical challenges: advance safety assurance to enable deployment of NextGen systems; automated discovery of precursors to aviation safety incidents; increasing safety of human-automation interaction by incorporating human performance, and prognostic algorithm design for safety assurance. This report reviews incident data from the NASA Aviation Safety Reporting System (ASRS) for system-component-failure- or-malfunction- (SCFM-) related and human-factor-related incidents for commercial or cargo air carriers (Part 121), commuter airlines (Part 135), and general aviation (Part 91). The data was analyzed by Federal Aviation Regulations (FAR) part, phase of flight, SCFM category, human factor category, and a variety of anomalies and results. There were 38 894 SCFM-related incidents and 83 478 human-factorrelated incidents analyzed between January 1993 and April 2011.

  13. PECULIARITIES OF DESIGN OF CURTAIN WALL SYSTEMS TO ASSURE THERMAL INSULATION

    Directory of Open Access Journals (Sweden)

    Golunov Sergej Anatolevich

    2012-10-01

    The results of laboratory tests (given the adjustments for permissible tolerances may be regarded as the principal criteria in the assessment of applicability of a curtain wall system in the course of a major building repair project or a new construction to assure the required reliability and durability.

  14. Software Quality Assurance for Nuclear Safety Systems

    International Nuclear Information System (INIS)

    Sparkman, D R; Lagdon, R

    2004-01-01

    The US Department of Energy has undertaken an initiative to improve the quality of software used to design and operate their nuclear facilities across the United States. One aspect of this initiative is to revise or create new directives and guides associated with quality practices for the safety software in its nuclear facilities. Safety software includes the safety structures, systems, and components software and firmware, support software and design and analysis software used to ensure the safety of the facility. DOE nuclear facilities are unique when compared to commercial nuclear or other industrial activities in terms of the types and quantities of hazards that must be controlled to protect workers, public and the environment. Because of these differences, DOE must develop an approach to software quality assurance that ensures appropriate risk mitigation by developing a framework of requirements that accomplishes the following goals: (sm b ullet) Ensures the software processes developed to address nuclear safety in design, operation, construction and maintenance of its facilities are safe (sm b ullet) Considers the larger system that uses the software and its impacts (sm b ullet) Ensures that the software failures do not create unsafe conditions Software designers for nuclear systems and processes must reduce risks in software applications by incorporating processes that recognize, detect, and mitigate software failure in safety related systems. It must also ensure that fail safe modes and component testing are incorporated into software design. For nuclear facilities, the consideration of risk is not necessarily sufficient to ensure safety. Systematic evaluation, independent verification and system safety analysis must be considered for software design, implementation, and operation. The software industry primarily uses risk analysis to determine the appropriate level of rigor applied to software practices. This risk-based approach distinguishes safety

  15. Quality assurance procedures for the IAEA Department of Safeguards Twin Minolta Camera Surveillance System

    International Nuclear Information System (INIS)

    Geoffrion, R.R.; Bussolini, P.L.; Stark, W.A.; Ahlquist, A.J.; Sanders, K.E.; Rubinstein, G.

    1986-01-01

    The International Atomic Energy Agency (IAEA) safeguards program provides assurance to the international community that nations are complying with nuclear safeguards treaties. In one aspect of the program, the Department of Safeguards has developed a twin Minolta camera photo surveillance systems program to assure itself and the international community that material handling is accomplished according to safeguards treaty regulations. The camera systems are positioned in strategic locations in facilities such that objective evidence can be obtained for material transactions. The films are then processed, reviewed, and used to substantiate the conclusions that nuclear material has not been diverted. Procedures have been developed to document and aid in: 1) the performance of activities involved in positioning of the camera system; 2) installation of the systems; 3) review and use of the film taken from the cameras

  16. Quality assurance and evaluation system in japanese higher education

    Directory of Open Access Journals (Sweden)

    Ana Mami Yamaguchi

    2016-03-01

    Full Text Available Abstract In this paper we aim to contribute to the debate over accountability and assessment of higher education (HE by introducing the Japanese system. We first discuss the circumstances and issues surrounding Japanese HE and then examine the historical development of the quality assurance and evaluation system. Since the 1990s, with the implementation of policies that focused on liberalization, deregulation and increased institutional autonomy, the role of the government has shifted from setting strict regulations and quality standards to organizing an evaluation system for assessing the learning outcomes and improving accountability of the HE institutions. Finally, we suggest how Japan may take hints from Brazil in organizing an evaluation system on a national level that can more efficiently support and assess HE institutions

  17. Quality assurance in plant engineering

    International Nuclear Information System (INIS)

    Ohsumi, Morimichi

    1977-01-01

    Quality assurance is defined as the intentional and systematic activity carried out to obtain such reliability that the functions of nuclear power generating plants are demonstrated during the plant operation, and the section in charge has the role to organize, adjust and communicate so that the related sections can work smoothly. There are many documents concerning the quality assurance, such as quality assurance basic program, quality assurance manual, quality control plan and its manual and many specifications, etc. The content of the quality assurance is different for every step of plant planning such as at inquiry and order receiving, and prior to manufacturing, for example, inspection specification being decided for the material and the welded parts of classified pipings at the step of order receiving. Document management, engineering schedule and the custody of quality records are also quality assurance activities. Design management is controlled step by step; plant planning including safety analysis, overall layout plan, conceptual design of buildings, aseismatic design guide, heat balance and so on, system design mainly with system description, piping design including piping specification, standard dimensions of edge preparation, piping and valve lists, inspection manual, etc., detailed design, standardization of piping and design review, etc. are explained. The management of the intermediate between soft and hard parts consists of the quality check for material manufacturers and shipment inspection, etc. (Nakai, Y.)

  18. Information Assurance for Enterprise Resource Planning Systems: Risk Considerations in Public Sector Organizations

    International Nuclear Information System (INIS)

    Naeem, S.; Islam, M.H.

    2016-01-01

    ERP (Enterprise Resource Planning) systems reveal and pose non-typical risks due to its dependencies of interlinked business operations and process reengineering. Understanding of such type of risks is significant conducting and planning assurance involvement of the reliability of these complicated computer systems. Specially, in case of distributed environment where data reside at multiple sites and risks are of unique nature. Until now, there are brief pragmatic grounds on this public sector ERP issue. To analyze this subject, a partially organized consultation study was carried out with 15 skilled information systems auditors who are specialists in evaluating ERP systems risks. This methodology permitted to get more elaborated information about stakeholder's opinions and customer experiences. In addition, interviewees mentioned a numerous basic execution troubles (e.g. inadequately skilled human resource and insufficient process reengineering attempts) that lead into enhanced hazards. It was also reported by the interviewees that currently risks vary across vendors and across applications. Eventually, in offering assurance with ERP systems participants irresistibly stresses examining the process instead of system end product. (author)

  19. Information Assurance for Enterprise Resource Planning Systems: Risk Considerations in Public Sector Organizations

    Directory of Open Access Journals (Sweden)

    SHAHZAD NAEEM

    2016-10-01

    Full Text Available ERP (Enterprise Resource Planning systems reveal and pose non-typical risks due to its dependencies of interlinked business operations and process reengineering. Understanding of such type of risks is significant conducting and planning assurance involvement of the reliability of these complicated computer systems. Specially, in case of distributed environment where data reside at multiple sites and risks are of unique nature. Until now, there are brief pragmatic grounds on this public sector ERP issue. To analyze this subject, a partially organized consultation study was carried out with 15 skilled information systems auditors who are specialists in evaluating ERP systems risks. This methodology permitted to get more elaborated information about stakeholder?s opinions and customer experiences. In addition, interviewees mentioned a numerous basic execution troubles (e.g. inadequately skilled human resource and insufficient process reengineering attempts that lead into enhanced hazards. It was also reported by the interviewees that currently risks vary across vendors and across applications. Eventually, in offering assurance with ERP systems participants irresistibly stresses examining the process instead of system end product.

  20. Development of the supply chain oriented quality assurance system for aerospace manufacturing SMEs and its implementation perspectives

    Science.gov (United States)

    Hussein, Abdullahi; Cheng, Kai

    2016-10-01

    Aerospace manufacturing SMEs are continuously facing the challenge on managing their supply chain and complying with the aerospace manufacturing quality standard requirement due to their lack of resources and the nature of business. In this paper, the ERP system based approach is presented to quality control and assurance work in light of seamless integration of in-process production data and information internally and therefore managing suppliers more effectively and efficiently. The Aerospace Manufacturing Quality Assurance Standard (BS/EN9100) is one of the most recognised and essential protocols for developing the industry-operated-and-driven quality assurance systems. The research investigates using the ERP based system as an enabler to implement BS/EN9100 quality management system at manufacturing SMEs and the associated implementation and application perspectives. An application case study on a manufacturing SME is presented by using the SAP based implementation, which helps further evaluate and validate the approach and application system development.

  1. GSFC Safety and Mission Assurance Organization

    Science.gov (United States)

    Kelly, Michael P.

    2010-01-01

    This viewgraph presentation reviews NASA Goddard Space Flight Center's approach to safety and mission assurance. The contents include: 1) NASA GSFC Background; 2) Safety and Mission Assurance Directorate; 3) The Role of SMA-D and the Technical Authority; 4) GSFC Mission assurance Requirements; 5) GSFC Systems Review Office (SRO); 6) GSFC Supply Chain Management Program; and 7) GSFC ISO9001/AS9100 Status Brief.

  2. Current status of quality assurance of treatment planning systems

    International Nuclear Information System (INIS)

    Mijnheer, B.J.

    1997-01-01

    A review is given of the current status of quality assurance of treatment planning systems. At this moment only one comprehensive report is available. In order to review national activities a questionnaire has been distributed amongst national societies of medical physicists. From the 23 responding countries, 8 indicated that only limited efforts are underway, 8 answered that a working group is evaluating their specific national requirements while in 5 countries a document is drafted. The highlights of these reports have been summarized. (author)

  3. Quality Assurance of Ultrasound Imaging Systems for Target Localization and Online Setup Corrections

    International Nuclear Information System (INIS)

    Tome, Wolfgang A.; Orton, Nigel P.

    2008-01-01

    We describe quality assurance paradigms for ultrasound imaging systems for target localization (UISTL). To determine the absolute localization accuracy of a UISTL, an absolute coordinate system can be established in the treatment room and spherical targets at various depths can be localized. To test the ability of such a system to determine the magnitude of internal organ motion, a phantom that mimics the human male pelvic anatomy can be used to simulate different organ motion ranges. To assess the interuser variability of ultrasound (US) guidance, different experienced users can independently determine the daily organ shifts for the same patients for a number of consecutive fractions. The average accuracy for a UISTL for the localization of spherical targets at various depths has been found to be 0.57 ± 0.47 mm in each spatial dimension for various focal depths. For the phantom organ motion test it was found that the true organ motion could be determined to within 1.0 mm along each axis. The variability between different experienced users who localized the same 5 patients for five consecutive fractions was small in comparison to the indicated shifts. In addition to the quality assurance tests that address the ability of a UISTL to accurately localize a target, a thorough quality assurance program should also incorporate the following two aspects to ensure consistent and accurate localization in daily clinical use: (1) adequate training and performance monitoring of users of the US target localization system, and (2) prescreening of patients who may not be good candidates for US localization

  4. ACHIEVING MISSION ASSURANCE AGAINST A CYBER THREAT WITH THE DEFENSE ACQUISITION SYSTEM

    Science.gov (United States)

    2016-02-13

    assurance to be “ baked in” to system design. Second, FMAs and vulnerability assessments should be conducted prior to every acquisition milestone...Before this guidance, most direction seemed to be biased toward addressing network IT rather than the systems and software characteristic of weapon...vulnerability assessments, it failed to mandate three important characteristics . First, the requirement for execution of an FMA was missing. The

  5. Quality assurance manual: Volume 2, Appendices

    Energy Technology Data Exchange (ETDEWEB)

    Oijala, J.E.

    1988-06-01

    This paper contains quality assurance information on departments of the Stanford Linear Accelerator Center. Particular quality assurance policies and standards discussed are on: Mechanical Systems; Klystron and Microwave Department; Electronics Department; Plant Engineering; Accelerator Department; Purchasing; and Experimental Facilities Department. (LSP)

  6. Quality assurance manual: Volume 2, Appendices

    International Nuclear Information System (INIS)

    Oijala, J.E.

    1988-06-01

    This paper contains quality assurance information on departments of the Stanford Linear Accelerator Center. Particular quality assurance policies and standards discussed are on: Mechanical Systems; Klystron and Microwave Department; Electronics Department; Plant Engineering; Accelerator Department; Purchasing; and Experimental Facilities Department

  7. Quality assurance in NDT

    International Nuclear Information System (INIS)

    Krishnamoorthy, K.

    2010-01-01

    The importance of Nondestructive Testing (NDT) as a Quality Control/Quality Assurance tool in the industrial domain cannot be over-emphasized. With the rapid advancement in research and technology, the NDT field is becoming larger and more sophisticated day by day. Innovative research in materials science and digital technology is paving the way for more and more new methods in NDT technology. Although the NDT technology has improved over the years, the basic 'human factor' underlying the success of the NDT field remains the same. There are two major factors that influence the 'Quality Assurance in NDT'. First, knowledgeable and skilled NDT Operators are the most important factor in assuring the reliable test results. Second, the Management oversight of the NDT operations plays a major role in assuring the overall quality of NDT. Management responsibilities include the implementation of a Quality Management System (QMS) that focuses on the NDT operations and apply all the elements of Quality Assurance relevant to NDT. Whether the NDT operations are performed in-house or by a contractor, periodic Management Self-assessments should include the following question: How can the Management assess and improve the 'Quality Assurance in NDT'? This paper attempts to answer the above question. Some practical examples are provided to illustrate the potential quality incidents that could lead to costly failures, and the role of NDT Operator and the Management in preventing such quality incidents. Also, some guidelines are provided on how the Management can apply the elements of Quality Assurance to NDT in order to assess and improve the 'Quality Assurance in NDT'. (author)

  8. Quality assurance program plan fuel supply shutdown project

    International Nuclear Information System (INIS)

    Metcalf, I.L.

    1998-01-01

    This Quality Assurance Program plan (QAPP) describes how the Fuel Supply Shutdown (FSS) project organization implements the quality assurance requirements of HNF-MP-599, Project Hanford Quality Assurance Program Description (QAPD) and the B and W Hanford Company Quality Assurance Program Plan (QAPP), FSP-MP-004. The QAPP applies to facility structures, systems, and components and to activities (e.g., design, procurement, testing, operations, maintenance, etc.) that could affect structures, systems, and components. This QAPP also provides a roadmap of applicable Project Hanford Policies and Procedures (PHPP) which may be utilized by the FSS project organization to implement the requirements of this QAPP

  9. Application of Quality Assurance Mechanisms for Effective Library ...

    African Journals Online (AJOL)

    The main strategy used for implementation of quality assurance was integration of the library` services quality assurance agenda into the university structures and the quality assurance mechanisms available and used in Nigerian university libraries were programme accreditation and benchmarking of library systems.

  10. Authentication Sensing System Using Resonance Evaluation Spectroscopy (ASSURES)

    Science.gov (United States)

    Trolinger, James D.; Dioumaev, Andrei K.; Lal, Amit K.; Dimas, Dave

    2017-08-01

    This paper describes an ongoing instrument development project to distinguish genuine manufactured components from counterfeit components; we call the instrument ASSURES (Authentication Sensing System Using Resonance Evaluation Spectroscopy). The system combines Laser Doppler Vibrometry with acoustical resonance spectroscopy, augmented with finite element analysis. Vibrational properties of components, such as resonant modes, damping, and spectral frequency response to various forcing functions depend strongly upon the mechanical properties of the material, including its size, shape, internal hardness, tensile strength, alloy/composite compositions, flaws, defects, and other internal material properties. Although acoustic resonant spectroscopy has seen limited application, the information rich signals in the vibrational spectra of objects provide a pathway to many new applications. Components with the same shape but made of different materials, different fatigue histories, damage, tampering, or heat treatment, will respond differently to high frequency stimulation. Laser Doppler Vibrometry offers high sensitivity and frequency bandwidth to measure the component's frequency spectrum, and overcomes many issues that limit conventional acoustical resonance spectroscopy, since the sensor laser beam can be aimed anywhere along the part as well as to multiple locations on a part in a non-contact way. ASSURES is especially promising for use in additive manufacturing technology by providing signatures as digital codes that are unique to specific objects and even to specific locations on objects. We believe that such signatures can be employed to address many important issues in the manufacturing industry. These include insuring the part meets the often very rigid specifications of the customer and being able to detect non-visible internal manufacturing defects or non-visible damage that has occurred after manufacturing.

  11. Quality assurance during site construction

    International Nuclear Information System (INIS)

    Dommke, J.; Jurgutat, H.

    1980-01-01

    During the time of planing and construction of a nuclear power plant, the following proceeding is approved: - the deliverer of a nuclear power plant provides the reports fixing the quality assurance program, it means that he is responsible to write the safety analysis report, the specifications for the erection of the components, the working manuals and specifications for testing (eg nondestr. testing) - the manufacturing of components or systems will be controlled by an own independent quality assurance group, provided that this group was checked by the quality assurance group of the applicant - the TUeV with its independent assessors will fix the requirements relating to quality assurance in its assessment. On this basis the examination of the applicants specifications, working manuals, testing specifications will be done. The efficiency of quality assurance at the manufacturer and at the applicant will be checked by the TUeV specialists by considering specifications of modifications, repairs or tolerances. A mean point of the quality assurance in Germany is the dynamic adjustment, of an action on the latest state of engineering or science. If there exists a change of rules or guidelines, the quality assurance requirements have to be fit on this state in so far as it is feasible from the technical point of view. (orig./RW)

  12. Nuclear fuel quality assurance

    International Nuclear Information System (INIS)

    1976-01-01

    the full application of the quality assurance concept in the purchase of fuel and fuel manufacturing services will depend to a large extent on the availability of fuel specification data. On the part of fuel purchasers, there is an obvious interest in getting as many details of fuel specification as possible in order to be able to establish a proper level of control over the quality of their purchases. On the other hand, if such specifications are set up in advance by the purchasers, there are often complaints by the manufacturers that the specifications were set up without proper regard for the latest technical information on fuel performance and for the realities of manufacturing processes and technical capabilities. This problem may be resolved when fuel design activities are properly meshed with a full quality assurance system. Discussions during the seminar showed that the operation of acceptable quality assurance systems is a well-established practice at most of the fuel manufacturers. The fuel purchaser may monitor such a system through quality assurance programme auditing as agreed to the individual vendor-purchaser contracts. In this way confidence may be obtained in the quality of the purchased product. However, it is considered that the further improvement of the relations between fuel manufacturers and purchasers could be achieved through the following actions undertaken at the international level: (1) standardization of fuel specifications and testing procedures; (2) dissemination of information on fuel specifications and their connections with observed fuel failure rate; (3) Establishment of a standardized quality assurance programme for fuel fabrication; (4) establishment of a central information service to assist utility groups in preparing documents and procedures to be used in quality assurance activities

  13. Commissioning quality assurance for nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1986-09-01

    This standard contains the requirements for the quality assurance program applicable to the commissioning phase of a nuclear power plant. This standard embodies the relevant quality assurance requirements of CSA Standard CAN3-N286.0, and is the governing Standard for commissioning quality assurance activities in the event of any conflicting requirements. This Standard applies to the commissioning of safety-related equipment, systems, and structures as identified by the owner. It may be applied to other equipment, systems, and structures at the discretion of the owner. 1 fig.

  14. Commissioning quality assurance for nuclear power plants

    International Nuclear Information System (INIS)

    1986-09-01

    This standard contains the requirements for the quality assurance program applicable to the commissioning phase of a nuclear power plant. This standard embodies the relevant quality assurance requirements of CSA Standard CAN3-N286.0, and is the governing Standard for commissioning quality assurance activities in the event of any conflicting requirements. This Standard applies to the commissioning of safety-related equipment, systems, and structures as identified by the owner. It may be applied to other equipment, systems, and structures at the discretion of the owner. 1 fig

  15. Power supplies for space systems quality assurance by Sandia Laboratories

    International Nuclear Information System (INIS)

    Hannigan, R.L.; Harnar, R.R.

    1976-07-01

    The Sandia Laboratories' participation in Quality Assurance programs for Radioisotopic Thermoelectric Generators which have been used in space systems over the past 10 years is summarized. Basic elements of this QA program are briefly described and recognition of assistance from other Sandia organizations is included. Descriptions of the various systems for which Sandia has had the QA responsibility are presented, including SNAP 19 (Nimbus, Pioneer, Viking), SNAP 27 (Apollo), Transit, Multi-Hundred Watt (LES 8/9 and MJS), and a new program, High-Performance Generator Mod 3. The outlook for Sandia participation in RTG programs for the next several years is noted

  16. Quality assurance system in electric power companies in Japan, (2)

    International Nuclear Information System (INIS)

    Hamaguchi, Shun-ichi

    1980-01-01

    The organization for the quality assurance in nuclear power plants of Kansai Electric Power Co., Inc. is introduced. It is still in investigation stage what quality assurance (QA) organization and system is the best. The QA investigation project team was organized in the form directly supervised by the Office of President. The purpose of QA in operation is to maintain the functions of power plants in good condition over the lifetime of the power plants after starting the operation, and the QA is divided into the following five items: (1) running operation, (2) check-up and maintenance, (3) in-service testing and inspection, (4) regular inspection, (5) general application control. The purposes and works to be implemented for these items are listed in a table, and explained in detail. The quality control in regular inspection is described about 4 stages is purchase order and contract, design, construction, and adjusting operation. Also further improvement of QA in operating nuclear power plants by implementing the next items has been decided to make the most of the teachings in the accident of Three Mile Island plant. (1) Reinforcement of operation management system, (2) completion of the training for operators, (3) clarification of the command system for operational control, and (4) change of installations and review of application. As seen in the above description, the important tasks in QA activities are the matching to the existing installations and the adjustment of interfaces with the equipments in operation. (Wakatsuki, Y.)

  17. Quality assurance in the design

    International Nuclear Information System (INIS)

    Edelmann, J.

    1980-01-01

    System- and product-related quality assurance measures are completing one another. Certainly it is possible to detect a lot of defects in the single technical document by well controlled product related quality inspections and to avoid the consequences of these defects; but also a not unimportant part of defects and deviations has its origin in system linked deficiencies. The latter can be detected more easily and more securely by means of system related reviews (System audit, Product audit). But also the sole implementation of system related quality assurance measures keeps the danger to get stuck only in formality and to loose all references to the specific characteristics of the product. (orig./RW)

  18. Development of a quality assurance system for radiotherapy

    International Nuclear Information System (INIS)

    Vroome, I.H. de; Leer, J.W.H.; Corver, R.

    1997-01-01

    Due to 1996 legislation in the Netherlands, every health care facility should have a quality assurance program. Because it is difficult to measure the quality of the product of care, a choice is made to focus on the process of care. For this purpose PACE was founded. (PACE is a Dutch acronym for Project ACcreditation) with as founding members: Public Health Insurance Council, TNO health research, 4 university hospitals and 4 large general hospitals. For in total 19 services and disciplines quality assurance standards where developed by groups in six of the hospitals. (author)

  19. National Program of Quality Assurance in Radiotherapy in Cuba

    International Nuclear Information System (INIS)

    Alonso Samper, J. L.; Dominguez Hung, L.; Morales Lopez, J. L.; Alfonso Laguardia, R.; Garcia Yip, F.

    2001-01-01

    It tries on the establishment of a Quality Assurance Nacional System, a Quality Assurance Committee implemented in Cuba, and a Quality Auditory National Program implemented in Cuba to control and assure radiotherapy quality

  20. The quality assurance liaison: Combined technical and quality assurance support

    International Nuclear Information System (INIS)

    Bolivar, S.L.; Day, J.L.

    1993-01-01

    This paper describes the role of the quality assurance liaison, the responsibilities of this position, and the evolutionary changes in duties over the last six years. The role of the quality assurance liaison has had a very positive impact on the Los Alamos Yucca Mountain Site Characterization (YW) quality assurance program. Having both technical and quality assurance expertise, the quality assurance liaisons are able to facilitate communications with scientists on quality assurance issues and requirements, thereby generating greater productivity in scientific investigations. The quality assurance liaisons help ensure that the scientific community knows and implements existing requirements, is aware of new or changing regulations, and is able to conduct scientific work within Project requirements. The influence of the role of the quality assurance liaison can be measured by an overall improvement in attitude of the staff regarding quality assurance requirements and improved job performance, as well as a decrease in deficiencies identified during both internal and external audits and surveillances. This has resulted in a more effective implementation of quality assurance requirements

  1. 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.

  2. 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...

  3. Methods of Software Quality Assurance under a Nuclear Quality Assurance Program

    International Nuclear Information System (INIS)

    Kim, Jang Yeol; Lee, Young Jun; Cha, Kyung Ho; Cheon, Se Woo; Lee, Jang Soo; Kwon, Kee Choon

    2005-01-01

    This paper addresses a substantial implementation of a software quality assurance under a nuclear quality assurance program. The relationship of the responsibility between a top-level nuclear quality assurance program such as ASME/NQA-1 and its lower level software quality assurance is described. Software quality assurance activities and software quality assurance procedures during the software development life cycle are also described

  4. Integrating Safety and Mission Assurance into Systems Engineering Modeling Practices

    Science.gov (United States)

    Beckman, Sean; Darpel, Scott

    2015-01-01

    During the early development of products, flight, or experimental hardware, emphasis is often given to the identification of technical requirements, utilizing such tools as use case and activity diagrams. Designers and project teams focus on understanding physical and performance demands and challenges. It is typically only later, during the evaluation of preliminary designs that a first pass, if performed, is made to determine the process, safety, and mission quality assurance requirements. Evaluation early in the life cycle, though, can yield requirements that force a fundamental change in design. This paper discusses an alternate paradigm for using the concepts of use case or activity diagrams to identify safety hazard and mission quality assurance risks and concerns using the same systems engineering modeling tools being used to identify technical requirements. It contains two examples of how this process might be used in the development of a space flight experiment, and the design of a Human Powered Pizza Delivery Vehicle, along with the potential benefits to decrease development time, and provide stronger budget estimates.

  5. Quality assurance plan, Westinghouse Water Reactor Divisions

    Energy Technology Data Exchange (ETDEWEB)

    1976-03-01

    The Quality Assurance Program used by Westinghouse Nuclear Energy Systems Water Reactor Divisions is described. The purpose of the program is to assure that the design, materials, and workmanship on Nuclear Steam Supply System (NSSS) equipment meet applicable safety requirements, fulfill the requirements of the contracts with the applicants, and satisfy the applicable codes, standards, and regulatory requirements.

  6. Quality Assurance: Strategic Choices for Higher Education in Turkey

    Directory of Open Access Journals (Sweden)

    Mahmut ÖZER

    2011-01-01

    Full Text Available As the number of students and higher education institutions in the world increases and there is a growing difficulty in financing the higher education systems, decision-makers have begun to show more interest in quality assurance. As quality assurance is given special attention in European countries, developing countries such as Turkey are interested in importing quality assurance systems. It is not possible to set quality assurance without sensitivity toward quality and without having quality as a cultural practice. The most likely encountered quality assurance approach in the world is that the higher education institution itself is responsible for its quality. In addition, external quality assurance procedures used are based on (academic peer review rather than on bureaucratic evaluations. Moreover, there is a lively debate across the world regarding the bureaucratic regulations of the quality assurance agencies and institutions that restrict the autonomy of higher education institutions. Without taking into consideration of the existing centralized structure of the higher education system in Turkey, of meeting social demands for the higher education, and of current higher education enrollment rates, the possible establishment of a quality assurance mechanism that may have sanctions on universities in Turkey is a threat to already limited autonomy of universities and is having a risk of additional bureaucratic burden. By laying out the roles and responsibilities of Turkish Council of Higher Education, the government and universities, this article discusses policies that should be adopted regarding the quality assurance.

  7. Benchmarking Software Assurance Implementation

    Science.gov (United States)

    2011-05-18

    product The chicken#. (a.k.a. Process Focused Assessment ) – Management Systems ( ISO 9001, ISO 27001 , ISO 2000) – Capability Maturity Models (CMMI...Assurance PRM, RMM, Assurance for CMMI)) – Lifecycle Processes ( ISO /IEEE 15288, ISO /IEEE 12207) – COBIT, ITIL, MS SDL, OSAMM, BSIMM 5 The egg...a.k.a Product Focused Assessments) – SCAP - NIST-SCAP – ISO /OMG W3C – KDM, BPMN, RIF, XMI, RDF – OWASP Top 10 – SANS TOP 25 – Secure Code Check Lists

  8. A Model for Quality Assurance on Acquisition and Registration, Processing, and Dissemination of Theses and Dissertations Systems

    Directory of Open Access Journals (Sweden)

    Mohammad Javad Ershadi

    2017-06-01

    Full Text Available Developments of recent decades shows that for reducing the financial and opportunities costs as well as increasing productivity, it is necessary to improve the quality of components and systems in organization. Information systems based on these rules should be considered and for improving their productivity, user’s satisfaction and effectiveness it is necessary to quality aspects of these systems are considered too. In this research a quality assurance system is developed to all parts of an information system from data gathering, data entry to indexing and dissemination of information for assuring of quality are included. This model based on continual improvement approach of Deming cycle will change all of its systems and processes so that each development in the system with considering current standards and quality guidelines are done

  9. Quality assurance considerations in nuclear waste management

    International Nuclear Information System (INIS)

    Delvin, W.L.

    1982-01-01

    Proper use of quality assurance will provide the basis for an effective management control system for nuclear waste management programs. Control is essential for achieving successful programs free from costly losses and failures and for assuring the public and regulators that the environment and health and safety are being protected. The essence of quality assurance is the conscientious use of planned and systematic actions, based on selecting and applying appropriate requirements from an established quality assurance standard. Developing a quality assurance program consists of using knowledge of the technical and managerial aspects of a project to identify and evaluate risks of loss and failure and then to select appropriate quality assurance requirements that will minimize the risks. Those requirements are integrated into the project planning documents and are carried out as specific actions during the life of the project

  10. Performance assurance for IT systems

    CERN Document Server

    King, Brian

    2004-01-01

    INDIVIDUAL AREAS OF INTERESTPreparing for the ChallengeAbstractIntroductionIn the BeginningThe Need to Address New ApplicationsDefinition of PerformanceThe Required SkillsPerformance Assurance Within a Project LifecycleSummaryCaveat Emptor (Let the Buyer Beware)AbstractSoftware Product LifecycleHardware Product LifecycleMarketingTechnical Reviews of ProductsLies, Damned Lies and BenchmarksAbstractIntroductionIndustry BenchmarksVendor BenchmarksIndependent BenchmarkingIn-House Benchmarking""Tricks of the Trade""Using Benchmarks Non-Functional Requirements and SolutionsAbstractIntroductionThe Pr

  11. ANA IIF Automation: Moving towards Harmonization? Results of a Multicenter Study

    Directory of Open Access Journals (Sweden)

    Stefanie Van den Bremt

    2017-01-01

    Full Text Available Background. Our study aimed to investigate whether the introduction of automated anti-nuclear antibody (ANA indirect immunofluorescence (IIF analysis decreases the interlaboratory variability of ANA titer results. Method. Three serum samples were sent to 10 laboratories using the QUANTA-Lyser® in combination with the NOVA View®. Each laboratory performed the ANA IIF analysis 10x in 1 run and 1x in 10 different runs and determined the endpoint titer by dilution. One of the three samples had been sent in 2012, before the era of ANA IIF automation, by the Belgian National External Quality Assessment (EQA Scheme. Harmonization was evaluated in terms of variability in fluorescence intensity (LIU and ANA IIF titer. Results. The evaluation of the intra- and interrun LIU variability revealed a larger variability for 2 laboratories, due to preanalytical and analytical problems. Reanalysis of the EQA sample resulted in a lower titer variability. Diluted endpoint titers were similar to the estimated single well titer and the overall median titer as reported by the EQA in 2012. Conclusion. The introduction of automated microscopic analysis allows more harmonized ANA IIF reporting, provided that this totally automated process is controlled by a thorough quality assurance program, covering the total ANA IIF process.

  12. Daily quality assurance software for a satellite radiometer system

    Science.gov (United States)

    Keegstra, P. B.; Smoot, G. F.; Bennett, C. L.; Aymon, J.; Backus, C.; Deamici, G.; Hinshaw, G.; Jackson, P. D.; Kogut, A.; Lineweaver, C.

    1992-01-01

    Six Differential Microwave Radiometers (DMR) on COBE (Cosmic Background Explorer) measure the large-angular-scale isotropy of the cosmic microwave background (CMB) at 31.5, 53, and 90 GHz. Quality assurance software analyzes the daily telemetry from the spacecraft to ensure that the instrument is operating correctly and that the data are not corrupted. Quality assurance for DMR poses challenging requirements. The data are differential, so a single bad point can affect a large region of the sky, yet the CMB isotropy requires lengthy integration times (greater than 1 year) to limit potential CMB anisotropies. Celestial sources (with the exception of the moon) are not, in general, visible in the raw differential data. A 'quicklook' software system was developed that, in addition to basic plotting and limit-checking, implements a collection of data tests as well as long-term trending. Some of the key capabilities include the following: (1) stability analysis showing how well the data RMS averages down with increased data; (2) a Fourier analysis and autocorrelation routine to plot the power spectrum and confirm the presence of the 3 mK 'cosmic' dipole signal; (3) binning of the data against basic spacecraft quantities such as orbit angle; (4) long-term trending; and (5) dipole fits to confirm the spacecraft attitude azimuth angle.

  13. Quality assuring measures for pressure vessels - system approaches, certification, accreditation, surveillance

    International Nuclear Information System (INIS)

    Link, M.

    1992-01-01

    Quality assurance measures for pressure vessels in accordance with German codes and standards and with the participation of manufacturers, plant operators and third party inspection agencies represent a high standard in terms of engineering, safety and availability. Technical competence and the autonomous action of German industry in the field of quality assurance set internationally recognized safety standards. The continuous exchange of experience through the active involvement of manufacturers, plant operators and third party inspection agencies in work establishing codes and standards and in th updating of the state of the art give the German system a control loop and feedback function (Technical Committees on Pressure Vessels). Within the framework of European harmonization it is a German concern that technical competence and expertise are not lost in a formally legal, bureaucratic certification procedure. In the course of the European harmonization process, the dual German QA concept should maintain its position by utilizing the specialist knowledge and competence of experts, and permit appropriate adaptation. (orig.)

  14. Software Quality Assurance activities of ITER CODAC

    Energy Technology Data Exchange (ETDEWEB)

    Pande, Sopan, E-mail: sopan.pande@iter.org [ITER Organization, Route de Vinon sur Verdon, 13115 St Paul Lez Durance (France); DiMaio, Franck; Kim, Changseung; Kim, Joohan; Klotz, Wolf-Dieter; Makijarvi, Petri; Stepanov, Denis; Wallander, Anders [ITER Organization, Route de Vinon sur Verdon, 13115 St Paul Lez Durance (France)

    2013-10-15

    Highlights: ► Comprehensive and consistent software engineering and quality assurance of CODAC. ► Applicable to all CODAC software projects executed by ITER DAs and contractors. ► Configurable plans for cost effective application of SQA processes. ► CODAC software plans SQAP, SVVP, SDP, and SCMP. ► CODAC software processes based on IEEE 12207-2008. -- Abstract: Software as an integral part of the plant system I and C is crucial in the manufacturing and integrated operation of ITER plant systems. Software Quality Assurance is necessary to ensure the development and maintenance of consistently high quality I and C software throughout the lifetime of ITER. CODAC decided to follow IEEE 12207-2008 software lifecycle processes for Software Engineering and Software Quality Assurance. Software Development Plan, Software Configuration Management Plan and Software Verification and Validation Plan are the mainstay of Software Quality Assurance which is documented in the Software Quality Assurance Plan. This paper describes the Software Quality Assurance (SQA) activities performed by CODAC. The SQA includes development and maintenance of above plans, processes and resources. With the help of Verification and Validation Teams they gather evidence of process conformance and product conformance, and record process data for quality audits and perform process improvements.

  15. Software Quality Assurance activities of ITER CODAC

    International Nuclear Information System (INIS)

    Pande, Sopan; DiMaio, Franck; Kim, Changseung; Kim, Joohan; Klotz, Wolf-Dieter; Makijarvi, Petri; Stepanov, Denis; Wallander, Anders

    2013-01-01

    Highlights: ► Comprehensive and consistent software engineering and quality assurance of CODAC. ► Applicable to all CODAC software projects executed by ITER DAs and contractors. ► Configurable plans for cost effective application of SQA processes. ► CODAC software plans SQAP, SVVP, SDP, and SCMP. ► CODAC software processes based on IEEE 12207-2008. -- Abstract: Software as an integral part of the plant system I and C is crucial in the manufacturing and integrated operation of ITER plant systems. Software Quality Assurance is necessary to ensure the development and maintenance of consistently high quality I and C software throughout the lifetime of ITER. CODAC decided to follow IEEE 12207-2008 software lifecycle processes for Software Engineering and Software Quality Assurance. Software Development Plan, Software Configuration Management Plan and Software Verification and Validation Plan are the mainstay of Software Quality Assurance which is documented in the Software Quality Assurance Plan. This paper describes the Software Quality Assurance (SQA) activities performed by CODAC. The SQA includes development and maintenance of above plans, processes and resources. With the help of Verification and Validation Teams they gather evidence of process conformance and product conformance, and record process data for quality audits and perform process improvements

  16. Current conceptions of industrial quality assurance

    International Nuclear Information System (INIS)

    Zeller, H.

    1978-01-01

    In the electrical engineering industry quality assurance is mainly oriented in accordance with the customers', users', and consumers' requirements concerning the quality of products (including reliability). These requirements are as manifold as the range of products itself. They do not only comprise functional criteria, but also safety against malfunctions, bodily injury or property damage. Quality assurance is embedded in the overall activities of a company; the peripheral conditions, such as organization, profitability, qualification, and responsibility of staff have to be considered. Thus, quality assurance in the electrical engineering industry proceeds in efficient systems which are adapted to the individual forms of production. These systems may include planning, testing, feedback of quality data, statistical procedures, costs and profitability. Their obvious interaction is based on the system of coordinates of integrated quality control. The paper will illustrate the basic features of this interaction by reference to various examples. (orig.) [de

  17. Improving the Quality of Academic Services through Implementation of Internal Quality Assurance System in State Institute of Islamic Studies STS Jambi

    Science.gov (United States)

    Iskandar

    2017-01-01

    Implementation of quality assurance systems in IAIN STS Jambi implemented in early 2012, through the build system of internal quality assurance based on ISO 9001: 2008, in the process of implementation required strong reasons behind not growing atmosphere of academic standards of accreditation of study programs and institutions that are reflected…

  18. Reinforcing Quality Assurance in Romanian Higher Education

    Directory of Open Access Journals (Sweden)

    Ana-Maria Dima

    2010-07-01

    Full Text Available Since 1993, the quality assurance system in Romania has gained considerable experience. This experience was recently recognized in 2008 by the ENQA: European Association for Quality Assurance in Higher Education through the admission of ARACIS as a full member of EQAR: the European Quality Assurance Register. The Board of ENQA agreed to grant ARACIS’s full membership of ENQA for five years from 2 June 2009. This article explores the benefits of membership for the Romanian Agency for Quality Assurance in Higher Education – ARACIS, comparing to other regional and global quality assurance agencies networks. The common features and differences between ARACIS and other European agencies are questioned through the frameworks of ENQA and INQAAHE as a case study.

  19. Cascade Distillation System Design for Safety and Mission Assurance

    Science.gov (United States)

    Sarguisingh, Miriam; Callahan, Michael R.; Okon, Shira

    2015-01-01

    Per the NASA Human Health, Life Support and Habitation System Technology Area 06 report "crewed missions venturing beyond Low-Earth Orbit (LEO) will require technologies with improved reliability, reduced mass, self-sufficiency, and minimal logistical needs as an emergency or quick-return option will not be feasible".1 To meet this need, the development team of the second generation Cascade Distillation System (CDS 2.0) chose a development approach that explicitly incorporate consideration of safety, mission assurance, and autonomy. The CDS 2.0 preliminary design focused on establishing a functional baseline that meets the CDS core capabilities and performance. The critical design phase is now focused on incorporating features through a deliberative process of establishing the systems failure modes and effects, identifying mitigation strategies, and evaluating the merit of the proposed actions through analysis and test. This paper details results of this effort on the CDS 2.0 design.

  20. Improving Professional Development System through Quality Assurance Practices in the Universities of Pakistan

    Science.gov (United States)

    Shabbir, Muhammad; Khalid, M. Ibrahim; Bakhsh, Khuda; Mohsin, Muhammad Naeem; Rasool, Shafqat; Mohsin, M. Saleem

    2016-01-01

    The rationalization of this research was to investigate about improving professional development system through Quality Assurance Practices (QAP) in the Universities of Pakistan pertaining to the opinions of students, teachers and Directors of Quality Enhancement Cells (QECs) and to differentiate the ideas of students, teachers and Directors of…

  1. Draft consultants' report. Consultants' meeting on requirements regarding the harmonization of laboratory quality assurance systems, 2-5 May 1995, Vienna, Austria

    International Nuclear Information System (INIS)

    2002-01-01

    The consultants were requested to advise the Agency on the realization of a harmonized approach to internationally compatible quality assurance systems. The consultants presented their viewpoint and position papers in relation to initial questions posed, reflecting the international efforts and their own experiences in analytical quality assurance. The consultants made specific recommendations concerning various aspects of the Agency's Analytical Quality Assurance Services Programme

  2. A Review of Function Allocation and En Route Separation Assurance

    Science.gov (United States)

    Lewis, Timothy A.; Aweiss, Arwa S.; Guerreiro, Nelson M.; Daiker, Ronald J.

    2016-01-01

    Today's air traffic control system has reached a limit to the number of aircraft that can be safely managed at the same time. This air traffic capacity bottleneck is a critical problem along the path to modernization for air transportation. The design of the next separation assurance system to address this problem is a cornerstone of air traffic management research today. This report reviews recent work by NASA and others in the areas of function allocation and en route separation assurance. This includes: separation assurance algorithms and technology prototypes; concepts of operations and designs for advanced separation assurance systems; and specific investigations into air-ground and human-automation function allocation.

  3. Quality assurance requirements in various codes and standards

    International Nuclear Information System (INIS)

    Shaaban, H.I.; EL-Sayed, A.; Aly, A.E.

    1987-01-01

    The quality assurance requirements in various countries and according to various international codes and standards are presented, compared and critically discussed. Cases of developing countries are also discussed, and the use of IAEA code of practice and other codes for quality assurance in these countries is reviewed. Recommendations are made regarding the quality assurance system to be applied for Egypt's nuclear power plants

  4. Quality assurance in design: policy adopted by Vickers Barrow Engineering Works

    International Nuclear Information System (INIS)

    Aubrey, J.H.

    1976-01-01

    The quality assurance system operated by the Vickers Barrow Engineering Works is described, with special reference to the design of the reactor shield and above core structure for the first commercial fast reactor. Section headings are: introduction; what is quality assurance of design; attitude of designer; design discipline; customers attitude; Engineering Company system; future application of Design Quality Assurance Record system. (U.K.)

  5. Technology and Tool Development to Support Safety and Mission Assurance

    Science.gov (United States)

    Denney, Ewen; Pai, Ganesh

    2017-01-01

    The Assurance Case approach is being adopted in a number of safety-mission-critical application domains in the U.S., e.g., medical devices, defense aviation, automotive systems, and, lately, civil aviation. This paradigm refocuses traditional, process-based approaches to assurance on demonstrating explicitly stated assurance goals, emphasizing the use of structured rationale, and concrete product-based evidence as the means for providing justified confidence that systems and software are fit for purpose in safely achieving mission objectives. NASA has also been embracing assurance cases through the concepts of Risk Informed Safety Cases (RISCs), as documented in the NASA System Safety Handbook, and Objective Hierarchies (OHs) as put forth by the Agency's Office of Safety and Mission Assurance (OSMA). This talk will give an overview of the work being performed by the SGT team located at NASA Ames Research Center, in developing technologies and tools to engineer and apply assurance cases in customer projects pertaining to aviation safety. We elaborate how our Assurance Case Automation Toolset (AdvoCATE) has not only extended the state-of-the-art in assurance case research, but also demonstrated its practical utility. We have successfully developed safety assurance cases for a number of Unmanned Aircraft Systems (UAS) operations, which underwent, and passed, scrutiny both by the aviation regulator, i.e., the FAA, as well as the applicable NASA boards for airworthiness and flight safety, flight readiness, and mission readiness. We discuss our efforts in expanding AdvoCATE capabilities to support RISCs and OHs under a project recently funded by OSMA under its Software Assurance Research Program. Finally, we speculate on the applicability of our innovations beyond aviation safety to such endeavors as robotic, and human spaceflight.

  6. Quality Assurance - Construction

    DEFF Research Database (Denmark)

    Gaarslev, Axel

    1996-01-01

    Gives contains three main chapters:1. Quality Assurance initiated by external demands2. Quality Assurance initiated by internal company goals3. Innovation strategies......Gives contains three main chapters:1. Quality Assurance initiated by external demands2. Quality Assurance initiated by internal company goals3. Innovation strategies...

  7. 42 CFR 441.474 - Quality assurance and improvement plan.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Quality assurance and improvement plan. 441.474... improvement plan. (a) The State must provide a quality assurance and improvement plan that describes the State... pursue opportunities for system improvement. (b) The quality assurance and improvement plan shall also...

  8. Waste Management Quality Assurance Plan

    International Nuclear Information System (INIS)

    1993-01-01

    Lawrence Berkeley Laboratory's Environment Department addresses its responsibilities through activities in a variety of areas. The need for a comprehensive management control system for these activities has been identified by the Department of Energy (DOE). The WM QA (Waste Management Quality Assurance) Plan is an integral part of a management system that provides controls necessary to ensure that the department's activities are planned, performed, documented, and verified. This WM QA Plan defines the requirements of the WM QA program. These requirements are derived from DOE Order 5700.6C, Quality Assurance, the LBL Operating and Assurance Program Plan (OAP, LBL PUB-3111), and other environmental compliance documents applicable to WM activities. The requirements presented herein, as well as the procedures and methodologies that direct the implementation of these requirements, will undergo review and revisions as necessary. The provisions of this QA Plan and its implementing documents apply to quality-affecting activities performed by and for WM. It is also applicable to WM contractors, vendors, and other LBL organizations associated with WM activities, except where such contractors, vendors, or organizations are governed by their own WM-approved QA programs. References used in the preparation of this document are (1) ASME NQA-1-1989, (2) ANSI/ASQC E4 (Draft), (3) Waste Management Quality Assurance Implementing Management Plan (LBL PUB-5352, Rev. 1), (4) LBL Operating and Assurance Program Plan (OAP), LBL PUB-3111, 2/3/93. A list of terms and definitions used throughout this document is included as Appendix A

  9. Quality assurance standards of nuclear equipment and international cooperation

    International Nuclear Information System (INIS)

    Savanger, J.M.

    1983-01-01

    This paper analyses the quality assurance system; it briefly defines the meaning of this concept and assesses the status of quality assurance in France. The author also reviews the problems and difficulties encountered in the setting up of this system. (NEA) [fr

  10. Model Based Mission Assurance in a Model Based Systems Engineering (MBSE) Framework: State-of-the-Art Assessment

    Science.gov (United States)

    Cornford, Steven L.; Feather, Martin S.

    2016-01-01

    This report explores the current state of the art of Safety and Mission Assurance (S&MA) in projects that have shifted towards Model Based Systems Engineering (MBSE). Its goal is to provide insight into how NASA's Office of Safety and Mission Assurance (OSMA) should respond to this shift. In MBSE, systems engineering information is organized and represented in models: rigorous computer-based representations, which collectively make many activities easier to perform, less error prone, and scalable. S&MA practices must shift accordingly. The "Objective Structure Hierarchies" recently developed by OSMA provide the framework for understanding this shift. Although the objectives themselves will remain constant, S&MA practices (activities, processes, tools) to achieve them are subject to change. This report presents insights derived from literature studies and interviews. The literature studies gleaned assurance implications from reports of space-related applications of MBSE. The interviews with knowledgeable S&MA and MBSE personnel discovered concerns and ideas for how assurance may adapt. Preliminary findings and observations are presented on the state of practice of S&MA with respect to MBSE, how it is already changing, and how it is likely to change further. Finally, recommendations are provided on how to foster the evolution of S&MA to best fit with MBSE.

  11. Nuclear information systems: Forming the hub of quality assurance

    International Nuclear Information System (INIS)

    Shepherd, S.H.

    1990-01-01

    Data processing, storage, and transmission technology has advanced sufficiently that nuclear information system networks are developing at many nuclear power plant sites. The networks offer much promise - repetitive tasks can be eliminated, cross checks and reviews can be implemented, and the user can do a more thorough, more professional job. With the arrival of this new power to analyze, plan, communicate, and simplify work comes a duty to properly harness the power. If the power of the information age is misused, or used carelessly, much damage can be done. When it comes to nuclear applications, there are really only three significant features to an information system: quality, reliability, and security. Put simply, the user must trust the accuracy of the system or it cannot be used. A system that is not available for use on demand will not be in demand for long. Fast processors, video graphics, and laser publishing are worthless if one must back up the system with hand calculations and tedious verification of data. An effective nuclear information system has good quality practices interwoven into the hardware and software, so that the system itself can foster and promote better quality assurance

  12. Creating Quality Assurance and International Transparency for Quality Assurance Agencies

    DEFF Research Database (Denmark)

    Kristoffersen, Dorte; Lindeberg, Tobias

    2004-01-01

    , on the one hand, to advance internationalisation of quality assurance of higher education, and on the other hand, allow for the differences in the national approaches to quality assurance. The paper will focus on two issues: first, the strength and weaknesses of the method employed and of the use of the ENQA......The paper presents the experiences gained in the pilot project on mutual recognition conducted by the quality assurance agencies in the Nordic countries and the future perspective for international quality assurance of national quality assurance agencies. The background of the project was the need...

  13. Quality assurance for health and environmental chemistry: 1989

    International Nuclear Information System (INIS)

    Gautier, M.A.; Gladney, E.S.; Koski, N.L.; Jones, E.A.; Phillips, M.B.; O'Malley, B.T.

    1990-12-01

    This report documents the continuing quality assurance efforts of the Health and Environmental Chemistry Group (HSE-9) at the Los Alamos National Laboratory. The philosophy, methodology, computing resources, and laboratory information management system used by the quality assurance program to encompass the diversity of analytical chemistry practiced in the group are described. Included in the report are all quality assurance reference materials used, along with their certified or consensus concentrations, and all analytical chemistry quality assurance measurements made by HSE-9 during 1989. 38 refs., 8 figs., 3 tabs

  14. A quality assurance system application to the Juragua NPP

    International Nuclear Information System (INIS)

    Quintero Rosello, Ruben; Milian L, Daniel; Soler Iglesias, Belkis I.; Alonso Garcia, Diosdado; Diaz Duenas, Jorge A.; Carbonell, Leonor Turtos; Rodriguez, Manuel Melian; Domech M, Jesus

    1999-01-01

    In the Nuclear Technology Center were developed capabilities to offer scientific-technical services to Nuclear Power Plants with WWER-440 Reactors in neutronic physical calculation topics. To create these capabilities it was necessary to develop, implement, verify and validate with our own 'know how' several methodologies and a calculational code package. A Quality Assurance System (QAS) was also implemented. The QAS was evaluated by the National Regulatory Authority and agreed with the Juragua Nuclear Power Plant (JNPP), the main costumer of our services. In the paper are presented the principal characteristics and application results of core management and Safety Analysis Laboratory's QAS in making the JNPP Preliminary Safety Report. (author)

  15. Quality assurance in Hanford site defense waste operations

    International Nuclear Information System (INIS)

    Wojtasek, R.D.

    1989-01-01

    This paper discusses quality assurance as an integral part of conducting waste management operations. The storage, treatment, and disposal of radioactive and non- radioactive hazardous wastes at Hanford are described. The author reports that quality assurance programs provide confidence that storage, treatment, and disposal facilities and systems perform as intended. Examples of how quality assurance is applied to Hanford defense waste operations are presented

  16. Helical Tomotherapy Quality Assurance

    International Nuclear Information System (INIS)

    Balog, John; Soisson, Emilie

    2008-01-01

    Helical tomotherapy uses a dynamic delivery in which the gantry, treatment couch, and multileaf collimator leaves are all in motion during treatment. This results in highly conformal radiotherapy, but the complexity of the delivery is partially hidden from the end-user because of the extensive integration and automation of the tomotherapy control systems. This presents a challenge to the medical physicist who is expected to be both a system user and an expert, capable of verifying relevant aspects of treatment delivery. A related issue is that a clinical tomotherapy planning system arrives at a customer's site already commissioned by the manufacturer, not by the clinical physicist. The clinical physicist and the manufacturer's representative verify the commissioning at the customer site before acceptance. Theoretically, treatment could begin immediately after acceptance. However, the clinical physicist is responsible for the safe and proper use of the machine. In addition, the therapists and radiation oncologists need to understand the important machine characteristics before treatment can proceed. Typically, treatment begins about 2 weeks after acceptance. This report presents an overview of the tomotherapy system. Helical tomotherapy has unique dosimetry characteristics, and some of those features are emphasized. The integrated treatment planning, delivery, and patient-plan quality assurance process is described. A quality assurance protocol is proposed, with an emphasis on what a clinical medical physicist could and should check. Additionally, aspects of a tomotherapy quality assurance program that could be checked automatically and remotely because of its inherent imaging system and integrated database are discussed

  17. Establishment of quality assurance system for engineering construction of nuclear installations

    International Nuclear Information System (INIS)

    Jing Shilin; Wang Conglin

    2008-01-01

    Considering the tasks undertaken or to take by the organization, the principle to follow and applicable code for the establishment of quality assurance system shall defined, training of related leaders, directors and main staff on the codes shall carried out, its quality principle and objectives shall defined, and the activities to be completed or controlled and their relevancy and the difficulties in implementation and management shall be determined. Once the activities are defined, the organization to implement the activities shall be established and its responsibilities and interfaces shall defined, and its system documentation shall be developed and issued. During the operation of the system, it shall be evaluated, maintained and improved continuously. (authors)

  18. MR imaging system evaluation and quality assurance using a new phantom set

    International Nuclear Information System (INIS)

    Tsui, B.M.W.; Jaszczak, R.J.; Todd-Pokropek, A.E.; Jaszczak, N.J.

    1986-01-01

    A phantom set with interchangeable modular inserts was used in the evaluation of a number of MR imaging systems. The system characteristics measured included uniformity, linearity and distortion of the image field, thickness and profile of an image section, spatial resolution, pixel calibration, signal-to-noise ratio, and variations of contiguous section thicknesses and section-to-section separations in multiple-section imaging. Also evaluated were the accuracy in quantitative measurement of MR imaging parameters and oblique angle measurement capability. Based on these measurements, protocols for MR imaging system evaluation, acceptance testing, and quality assurance were developed

  19. Experience with the european quality assurance guidelines for digital mammography systems in a national screening programme

    International Nuclear Information System (INIS)

    McCullagh, J.; Keavey, E.; Egan, G.; Phelan, N.

    2013-01-01

    The transition to a fully digital breast screening programme, utilising three different full-field digital mammography (FFDM) systems has presented many challenges to the implementation of the European guidelines for physico-technical quality assurance (QA) testing. An analysis of the QA results collected from the FFDM systems in the screening programme over a 2-y period indicates that the three different systems have similar QA performances. Generally, the same tests were failed by all systems and failure rates were low. The findings provide some assurance that the QA guidelines are being correctly implemented. They also suggest that there is more scope for the development of the relevance of the guidelines with respect to modern FFDM systems. This study has also shown that a summary review of the QA data can be achieved by simple organisation of the QA data storage and by automation of data query and retrieval using commonly available software. (authors)

  20. Quality assurance system for conventional island erection of Daya Day Nuclear Power Plant

    Energy Technology Data Exchange (ETDEWEB)

    Zhongliang, Shi; Suozhi, Wu; Xiangke, Meng [Shandong Electric Power Construction Corp. Nuclear Power Construction Company (China)

    1994-12-01

    The process concerning the establishment, operation and perfection of Quality Assurance System (QA system) experienced by Shandong Electric Power Construction Corporation, Nuclear Power Construction Company (SEPC-NPCC) during the implementation of Conventional Island Erection (CIE) in Daya Bay Nuclear Power Plant is introduced. Apart from systematic description of the principle for working out QA programme and QA procedures and their main contents, it is also detailed, on a combination of theory with practice basis, how the major departments constituting the QA system such as Quality Assurance, Quality Control, Construction and Administration and Business Departments have made fruitful efforts as per the individual responsibility for ensuring the work quality and having in mind the principles specified by QA programme and the requirements of QA procedures. As a result of the reasonable combination of the 3 crucial points and the 4 essential elements of the QA system, high quality of CI erection has been realized. The importance of quality supervision and management review by the owner and upper levels of authorities for ensuring effective operation of QA system is affirmed. The practical experience of CIE project proves that the strict inspection/surveillance on all activities and service affecting quality carried out by QA Department independent of project management and QC Dept, independent of construction management are of quite importance for ensuring the project quality. (4 tabs.).

  1. Quality assurance system for conventional island erection of Daya Day Nuclear Power Plant

    International Nuclear Information System (INIS)

    Shi Zhongliang; Wu Suozhi; Meng Xiangke

    1994-12-01

    The process concerning the establishment, operation and perfection of Quality Assurance System (QA system) experienced by Shandong Electric Power Construction Corporation, Nuclear Power Construction Company (SEPC-NPCC) during the implementation of Conventional Island Erection (CIE) in Daya Bay Nuclear Power Plant is introduced. Apart from systematic description of the principle for working out QA programme and QA procedures and their main contents, it is also detailed, on a combination of theory with practice basis, how the major departments constituting the QA system such as Quality Assurance, Quality Control, Construction and Administration and Business Departments have made fruitful efforts as per the individual responsibility for ensuring the work quality and having in mind the principles specified by QA programme and the requirements of QA procedures. As a result of the reasonable combination of the 3 crucial points and the 4 essential elements of the QA system, high quality of CI erection has been realized. The importance of quality supervision and management review by the owner and upper levels of authorities for ensuring effective operation of QA system is affirmed. The practical experience of CIE project proves that the strict inspection/surveillance on all activities and service affecting quality carried out by QA Department independent of project management and QC Dept, independent of construction management are of quite importance for ensuring the project quality. (4 tabs.)

  2. Reliability assurance for regulation of advanced reactors

    International Nuclear Information System (INIS)

    Fullwood, R.; Lofaro, R.; Samanta, P.

    1992-01-01

    The advanced nuclear power plants must achieve higher levels of safety than the first generation of plants. Showing that this is indeed true provides new challenges to reliability and risk assessment methods in the analysis of the designs employing passive and semi-passive protection. Reliability assurance of the advanced reactor systems is important for determining the safety of the design and for determining the plant operability. Safety is the primary concern, but operability is considered indicative of good and safe operation. this paper discusses several concerns for reliability assurance of the advanced design encompassing reliability determination, level of detail required in advanced reactor submittals, data for reliability assurance, systems interactions and common cause effects, passive component reliability, PRA-based configuration control system, and inspection, training, maintenance and test requirements. Suggested approaches are provided for addressing each of these topics

  3. Reliability assurance for regulation of advanced reactors

    International Nuclear Information System (INIS)

    Fullwood, R.; Lofaro, R.; Samanta, P.

    1991-01-01

    The advanced nuclear power plants must achieve higher levels of safety than the first generation of plants. Showing that this is indeed true provides new challenges to reliability and risk assessment methods in the analysis of the designs employing passive and semi-passive protection. Reliability assurance of the advanced reactor systems is important for determining the safety of the design and for determining the plant operability. Safety is the primary concern, but operability is considered indicative of good and safe operation. This paper discusses several concerns for reliability assurance of the advanced design encompassing reliability determination, level of detail required in advanced reactor submittals, data for reliability assurance, systems interactions and common cause effects, passive component reliability, PRA-based configuration control system, and inspection, training, maintenance and test requirements. Suggested approaches are provided for addressing each of these topics

  4. Quality assurance

    International Nuclear Information System (INIS)

    1996-01-01

    The main efforts of Nuclear Regulatory Authority of the Slovak Republic (NRA SR) was focused on support of quality assurance programmes development at responsible organizations Bohunice V-1 and V-v and Mochovce NPPs and their inspection. Development of the level two documentation of a partial quality assurance programme for NPP operation continued at Mochovce NPP. Most of documentation has been submitted to NRA SR for comments and approval. NRA SR invited a mission of French experts to Mochovce NPP to review preparation and performance of internal audits that would be beneficial for improvement in this kind activities at the NPP. Bohunice NPP continued in development of a partial quality assurance programme for operation. The Quality Assurance Programme submitted to NRA SR for approval. Based on a request of Bohunice NPPs, NRA SR consulted the draft quality assurance programme developed by Siemens for stage of the 'Basic Design' of V-1 NPP upgrading. The programme had not been submitted for approval to NRA SR prior to completion of works by Siemens. Based on an internal audit that had been performed, corrective measures were proposed to meet requirements on review and approval of suppliers quality assurance programmes. Requirements related to the quality assurance at nuclear installations were prepared to be incorporated into principles of a act on peaceful use of nuclear power in Slovak Republic

  5. Quality assurance inspections for shipping and storage containers

    Energy Technology Data Exchange (ETDEWEB)

    Stromberg, H.M.; Roberts, G.D.; Bryce, J.H. [Lockheed Idaho Technologies Co., Idaho Falls, ID (United States)

    1996-04-01

    This is a guide for conducting quality assurance inspections of transportation packaging and dry spent fuel storage system suppliers. (Suppliers are defined as designers, fabricators, distributors, users or owners of those packaging and storage systems.) This guide may be used during inspection to determine regulatory compliance with 10 CFR, Part 71, Subpart H; 10 CFR, Part 72, Subpart G; 10 CFR, Part 21; and supplier`s quality assurance program commitments. It was developed to provide a structured, consistent approach to inspections. The guidance therein provides a framework for evaluation of transportation packaging and dry spent fuel storage systems quality assurance programs. Inspectors are provided with the flexibility to adapt the methods and concepts to meet inspection requirements for the particular facility. The method used in the guide treats each activity at a facility as a separate performance element and combines the activities within the framework of an ``inspection tree.``The method separates each performance element into several areas for inspection and identifies guidelines, based on regulatory requirements, to qualitatively evaluate each area. This guide also serves as a field manual to facilitate quality assurance inspection activities. This guide replaces an earlier one, NUREG/CR-5717 (Packing Supplier Inspection Guide). This replacement guide enhances the inspection activities for transportation packagings and adds the dry spent fuel storage system quality assurance inspection activities.

  6. Quality assurance inspections for shipping and storage containers

    International Nuclear Information System (INIS)

    Stromberg, H.M.; Roberts, G.D.; Bryce, J.H.

    1996-04-01

    This is a guide for conducting quality assurance inspections of transportation packaging and dry spent fuel storage system suppliers. (Suppliers are defined as designers, fabricators, distributors, users or owners of those packaging and storage systems.) This guide may be used during inspection to determine regulatory compliance with 10 CFR, Part 71, Subpart H; 10 CFR, Part 72, Subpart G; 10 CFR, Part 21; and supplier's quality assurance program commitments. It was developed to provide a structured, consistent approach to inspections. The guidance therein provides a framework for evaluation of transportation packaging and dry spent fuel storage systems quality assurance programs. Inspectors are provided with the flexibility to adapt the methods and concepts to meet inspection requirements for the particular facility. The method used in the guide treats each activity at a facility as a separate performance element and combines the activities within the framework of an ''inspection tree.''The method separates each performance element into several areas for inspection and identifies guidelines, based on regulatory requirements, to qualitatively evaluate each area. This guide also serves as a field manual to facilitate quality assurance inspection activities. This guide replaces an earlier one, NUREG/CR-5717 (Packing Supplier Inspection Guide). This replacement guide enhances the inspection activities for transportation packagings and adds the dry spent fuel storage system quality assurance inspection activities

  7. Quality Assurance in Asian Distance Education: Diverse Approaches and Common Culture

    Directory of Open Access Journals (Sweden)

    Insung Jung

    2011-10-01

    Full Text Available With the phenomenal expansion of distance education in Asia during the past three decades, there has been growing public demand for quality and accountability in distance education. This study investigates the national quality assurance systems for distance education at the higher education level in Asia with the aim of contributing to a better understanding of the current level of development of quality assurance in Asian distance education and to offer potential directions for policy makers when developing and elaborating quality assurance systems for distance education. The analysis of the existing quality assurance frameworks in the 11 countries/territories selected reveals that the level of quality assurance policy integration in the overall national quality assurance in higher education policy framework varies considerably. The purpose of quality assurance, policy frameworks, methods, and instruments in place are generally tailored to each country’s particular circumstances. There are, however, obvious commonalities that underpin these different quality assurance efforts.

  8. Quality assurance in nuclear medicine

    International Nuclear Information System (INIS)

    Paras, P.

    1978-01-01

    Quality assurance practices must be followed throughout the entire nuclear medicine process, from the initial decision to perform a particular procedure, through the interpretation and reporting of the results. The various parameters that can be defined and measured in each area must be monitored by quality control tests to assure the excellence of the total nuclear medicine process. The presentation will discuss each of the major areas of nuclear medicine quality control and their interaction as a part of the entire system. Quality control testing results and recommendations for measurements of radioactivity distribution will be described with emphasis on imaging equipment and dose calibrating instrumentation. The role of the health physicist in a quality assurance program will be stressed. (author)

  9. Quality Assurance of Ultrasonic Diagnosis in Breast

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Soo Young; Kim, Hong Dae [Hallym University, Kangnam Sacred Heart Hospital, Seoul (Korea, Republic of)

    2006-06-15

    Sonography is a subjective diagnostic method which is highly dependent on the experience of the operator and the equipment quality which requires real-time adjustments. Breast screening examination currently consists of clinical examination and mammography. Breast sonography, either supplementary to mammography or independently, is indicated for the dense breast, especially in younger women. Breast sonography is especially applicable for Korean women because of the denser breast parenchyma and the approximately 10-year younger incidence rate of breast cancer of Korean women compared to western women. To avoid unnecessary breast biopsy because of the high rate of false positive lesions in breast parenchyma, which is different from other body organs such as the liver or the kidney, a quality assurance program for breast sonography is essential. The quality assurance of breast ultrasound involves quality assurance of the equipment, imaging display and acquisition of clinical images, personnel qualifications and other aspects such as unification of lexicon, guideline of diagnostic examination and reporting system; US BI-RAD reporting system, assessment items and organization, education program, medical audit, certification issues, and medicolegal issues. A breast sonographic quality assurance system should be established before a scheme to initiate governmental medical insurance for breast sonography

  10. Quality Assurance of Ultrasonic Diagnosis in Breast

    International Nuclear Information System (INIS)

    Chung, Soo Young; Kim, Hong Dae

    2006-01-01

    Sonography is a subjective diagnostic method which is highly dependent on the experience of the operator and the equipment quality which requires real-time adjustments. Breast screening examination currently consists of clinical examination and mammography. Breast sonography, either supplementary to mammography or independently, is indicated for the dense breast, especially in younger women. Breast sonography is especially applicable for Korean women because of the denser breast parenchyma and the approximately 10-year younger incidence rate of breast cancer of Korean women compared to western women. To avoid unnecessary breast biopsy because of the high rate of false positive lesions in breast parenchyma, which is different from other body organs such as the liver or the kidney, a quality assurance program for breast sonography is essential. The quality assurance of breast ultrasound involves quality assurance of the equipment, imaging display and acquisition of clinical images, personnel qualifications and other aspects such as unification of lexicon, guideline of diagnostic examination and reporting system; US BI-RAD reporting system, assessment items and organization, education program, medical audit, certification issues, and medicolegal issues. A breast sonographic quality assurance system should be established before a scheme to initiate governmental medical insurance for breast sonography

  11. Quality assurance during site construction. Pt. 1

    International Nuclear Information System (INIS)

    Mueller, J.

    1980-01-01

    The first part of the lecture deals with the Quality Assurance system on the construction site in general. Basic site-related problems during contract implementation and the QA system requirements resulting from them are presented. The compilation of these requirements in a QA program and its inclusion in the site manual in written form are explained. Site organization, personnel qualification and procedures are referred to. Whereas the first part shows what is to be done, the second part shows how it can be put into practice on the site. All the essential points for the assurance of quality are addressed. They include, e.g., review of documents, incoming goods control, in-process surveillance, store controls, identification of components and systems, dealing with changes and deviations, documentation control and audits. By means of examples taken form practice the necessity of a well-functioning QA system, and the importance of quality-assuring measures on the site are pointed out. (orig.)

  12. Quality assurance in the manufacture of pressure components

    International Nuclear Information System (INIS)

    Knoedler, D.

    1979-01-01

    New regulations for nuclear power plants emphasize more quality assurance than it was the case in the past. Quality assurance is a management tool. During erection the quality assurance measures of the manufacturer, the main contractor and the required quality and the reliability of the proof of quality. The qualification of processes, equipment and personnel is a significant measure of quality assurance. The proof for quality assurance to be effective needs not only system-oriented audits, but also product audits aimed at quality characteristics of the product itself. The existing problems of examination techniques not optimized according to latest experience and of the large volume of documetation will persist in case the existing regulations are not adjusted according to the results of relevant studies. Furthermore the effectiveness of quality assurance is too often hampered by vague definitions of the safety objectives. (orig.) [de

  13. Quality assurance organization of the plant owner

    International Nuclear Information System (INIS)

    Staebler, K.

    1980-01-01

    It is not the primary task of the plant owner to assure the quality during erection. It is, however, his responsibility to check the quality assurance system established by the plant, the supplier and the subcontractor. In the lecture, it is shown that the plant owners do this control in the best efficient way. The special consideration of the plant owner in deciding questions of quality assurance is demonstrated by special examples. The meaning of basic safety for the plant owner is presented. (orig./RW)

  14. MEMS Reliability Assurance Activities at JPL

    Science.gov (United States)

    Kayali, S.; Lawton, R.; Stark, B.

    2000-01-01

    An overview of Microelectromechanical Systems (MEMS) reliability assurance and qualification activities at JPL is presented along with the a discussion of characterization of MEMS structures implemented on single crystal silicon, polycrystalline silicon, CMOS, and LIGA processes. Additionally, common failure modes and mechanisms affecting MEMS structures, including radiation effects, are discussed. Common reliability and qualification practices contained in the MEMS Reliability Assurance Guideline are also presented.

  15. Assurance management program for the 30 Nova laser fusion project

    International Nuclear Information System (INIS)

    Levy, A.J.

    1983-01-01

    The Nova assurance management program was developed using the quality assurance (QA) approach first implemented at LLNL in early 1978. The LLNL QA program is described as an introduction to the Nova assurance management program. The Nova system is described pictorially through the Nova configuration, subsystems and major components, interjecting the QA techniques which are being pragmatically used to assure the successful completion of the project

  16. Creating Quality Assurance and International Transparency for Quality Assurance Agencies

    DEFF Research Database (Denmark)

    Kristoffersen, Dorte; Lindeberg, Tobias

    2004-01-01

    The paper presents the experiences gained in the pilot project on mutual recognition conducted by the quality assurance agencies in the Nordic countries and the future perspective for international quality assurance of national quality assurance agencies. The background of the project was the nee...

  17. [Integrated quality assurance].

    Science.gov (United States)

    Bögel, K; Stöhr, K

    1994-07-01

    The definition of terms and connotation of "Quality", "Quality Assurance" and "Integration" lead to an analysis and understanding of inhibiting and fostering factors of the "Health Triad" of people, animals and environment. Although "Quality" is largely or ultimately determined by the consumer, there are considerable differences as this term is applied by (a) the individual consumer, (b) the dynamic producer defending or gaining markets, (c) those engaged in traditional product manufacturing, or (d) governments setting (minimum) requirements for the sake of free trade. "Quality Assurance" offers cooperation of partners all along the food chain from "pasture to table". The managerial process turned into a continuum of responsibility and agreement on processes and product characteristics. This overcomes the disadvantages of strategies stressing distinct defense barriers. In practice this philosophy of a predominant role of defence barriers proved largely partnership destructive, in that it permitted to shift responsibilities for failures and to claim administrative competence according to momentary situations and interests. "Integrated Quality Assurance" means mutual agreement of two or more partners along the food chain (e. g. feed producers, farmers, animal health industry, veterinarians and food processors) on product characteristics and production methods. It involves essential system elements including facilities, materials, manpower, information, transport, management etc. Different principles and procedures of quality assurance have been introduced in practice, including agriculture and food processing. These different approaches are not mutually exclusive but largely of complementary nature.(ABSTRACT TRUNCATED AT 250 WORDS)

  18. Quality assurance in tube manufacture

    International Nuclear Information System (INIS)

    Depken, H.

    1976-01-01

    Reliability in service essential for many high-technology products fabricated today. This is particularly the case within the nuclear industry. Here defective materials or components may have diastrous consequences to the safety of human beings and the environment. A new concept - Quality Assurance - originates from this industry. The concept implies that all contractors, fabricators and material manufactures involved must prove that the quality control system used, fulfits particular requirements at all manufacturing, inspection and testing stages. These requirement are laid down in two standards issued by the U.S. Atomic Energy Commission and the American Society of Mechanical Engineers. These standards are discussed in the paper. As a manufacturer of steel products for nuclear applications Sandvik has been forced to establish a quality assurance system according to these principles. The Sandvik approach is briefly described with regard to organisation and other major quality assurance activities. Further the education and training of operators and technicians is touched upon. Finally some viewpoints regarding audits performed by customers of steel manufacturers are expressed. (author)

  19. Cyber-assurance for the Internet of Things

    CERN Document Server

    2017-01-01

    This book discusses the cyber-assurance needs of the IoT environment, highlighting key information assurance (IA) IoT issues and identifying the associated security implications. Through contributions from cyber-assurance, IA, information security and IoT industry practitioners and experts, the text covers fundamental and advanced concepts necessary to grasp current IA issues, challenges, and solutions for the IoT. The future trends in IoT infrastructures, architectures and applications are also examined. Other topics discussed include the IA protection of IoT systems and information being stored, processed or transmitted from unauthorized access or modification of machine-2-machine (M2M) devices, radio-frequency identification (RFID) networks, wireless sensor networks, smart grids, and supervisory control and data acquisition (SCADA) systems. The book also discusses IA measures necessary to detect, rotect, and defend IoT information and networks/systems to ensure their availability, integrity, authentication...

  20. Guidelines for comprehensive quality assurance in brachytherapy

    International Nuclear Information System (INIS)

    Goldson, A.L.; Nibhanupudy, J.R.

    1984-01-01

    Brachytherapy treatment techniques can provide significant improvement in local control and overall survival, but only when quality assurance can be guaranteed. To establish brachytherapy quality assurance, basic requirements for three predetermined subdivisions of clinical institutions will be forwarded. These are: (1) centers having minimum requirements to provide brachytherapy, (2) intermediate centers such as regional or community hospitals, and (3) optimal centers such as university hospital and cancer centers. This presentation will highlight personnel needs, equipment requirements, academic activities, clinical experience with these systems and proposed quality assurance guidelines

  1. 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)

  2. Redefining and expanding quality assurance.

    Science.gov (United States)

    Robins, J L

    1992-12-01

    To meet the current standards of excellence necessary for blood establishments, we have learned from industry that a movement toward organization-wide quality assurance/total quality management must be made. Everyone in the organization must accept responsibility for participating in providing the highest quality products and services. Quality must be built into processes and design systems to support these quality processes. Quality assurance has been redefined to include a quality planning function described as the most effective way of designing quality into processes. A formalized quality planning process must be part of quality assurance. Continuous quality improvement has been identified as the strategy every blood establishment must support while striving for error-free processing as the long-term objective. The auditing process has been realigned to support and facilitate this same objective. Implementing organization-wide quality assurance/total quality management is one proven plan for guaranteeing the quality of the 20 million products that are transfused into 4 million patients each year and for moving toward the new order.

  3. Why Is It Difficult to Grasp the Impacts of the Portuguese Quality Assurance System?

    Science.gov (United States)

    Veiga, Amélia; Rosa, Maria João; Dias, Diana; Amaral, Alberto

    2013-01-01

    This article analyses the impacts of the Portuguese quality assurance system on academic cultures, using the Cultural Theory proposed by Douglas (1970, 1982) and developed by Thompson, Ellis and Wildavsky (1990) as an explanatory framework for Portuguese academics' preference formation in relation to quality assessment. The Portuguese higher…

  4. Improving patient safety through quality assurance.

    Science.gov (United States)

    Raab, Stephen S

    2006-05-01

    Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. To review some of the anatomic pathology laboratory patient safety quality assurance practices. Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.

  5. Ontario's Quality Assurance Framework: A Critical Response

    Science.gov (United States)

    Heap, James

    2013-01-01

    Ontario's Quality Assurance Framework (QAF) is reviewed and found not to meet all five criteria proposed for a strong quality assurance system focused on student learning. The QAF requires a statement of student learning outcomes and a method and means of assessing those outcomes, but it does not require that data on achievement of intended…

  6. [Development of quality assurance/quality control web system in radiotherapy].

    Science.gov (United States)

    Okamoto, Hiroyuki; Mochizuki, Toshihiko; Yokoyama, Kazutoshi; Wakita, Akihisa; Nakamura, Satoshi; Ueki, Heihachi; Shiozawa, Keiko; Sasaki, Koji; Fuse, Masashi; Abe, Yoshihisa; Itami, Jun

    2013-12-01

    Our purpose is to develop a QA/QC (quality assurance/quality control) web system using a server-side script language such as HTML (HyperText Markup Language) and PHP (Hypertext Preprocessor), which can be useful as a tool to share information about QA/QC in radiotherapy. The system proposed in this study can be easily built in one's own institute, because HTML can be easily handled. There are two desired functions in a QA/QC web system: (i) To review the results of QA/QC for a radiotherapy machine, manuals, and reports necessary for routinely performing radiotherapy through this system. By disclosing the results, transparency can be maintained, (ii) To reveal a protocol for QA/QC in one's own institute using pictures and movies relating to QA/QC for simplicity's sake, which can also be used as an educational tool for junior radiation technologists and medical physicists. By using this system, not only administrators, but also all staff involved in radiotherapy, can obtain information about the conditions and accuracy of treatment machines through the QA/QC web system.

  7. 12: Assuring the quality of critical software

    International Nuclear Information System (INIS)

    Jacky, J.; Kalet, I.

    1987-01-01

    The authors recommend quality assurance procedures for radiation therapy software. Software quality assurance deals with preventing, detecting and repairing programming errors. Error detection difficulties are most severe in computer-based control systems, for example therapy machine control systems, because it may be impossible for users to confirm correct operation while treatments are in progress, or to intervene if things go wrong. Software quality assurance techniques observed in other industries in which public safety is at risk are reviewed. In some of these industries software must be approved or certified before it can be used. Approval is subject to technical reviews and audits by experts other than the program authors. The main obstacles to adoption of these techniques in the radiation therapy field are costs, lack of familiarity and doubts regarding efficacy. 18 refs

  8. Quality assurance and applied statistics. Method 3

    International Nuclear Information System (INIS)

    1992-01-01

    This German-Industry-Standards-paperback contains the International Standards from the Series ISO 9000 (or, as the case may be, the European Standards from the Series EN 29000) concerning quality assurance and including the already completed supplementary guidelines with ISO 9000- and ISO 9004-section numbers, which have been adopted as German Industry Standards and which are observed and applied world-wide to a great extent. It also includes the German-Industry-Standards ISO 10011 parts 1, 2 and 3 concerning the auditing of quality-assurance systems and the German-Industry-Standard ISO 10012 part 1 concerning quality-assurance demands (confirmation system) for measuring devices. The standards also include English and French versions. They are applicable independent of the user's line of industry and thus constitute basic standards. (orig.) [de

  9. Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

    Science.gov (United States)

    Guarro, Sergio B.

    2010-01-01

    This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

  10. DoD Nuclear Weapons Personnel Reliability Assurance

    Science.gov (United States)

    2016-04-27

    systems, positive control material (PCM) and equipment, and special nuclear material (SNM) and subject to a nuclear weapons personnel reliability...assurance implementation guidance for consistency and compliance with this issuance. c. Conducts programmatic reviews, manages audits , and directs...personnel reliability assurance education and training materials . 2.4. ASSISTANT SECRETARY OF DEFENSE FOR HEALTH AFFAIRS (ASD(HA)). Under the authority

  11. The Role Of Quality Assurance Program For Safety Operation Of Nuclear Installations

    International Nuclear Information System (INIS)

    Harjanto, N.T.; Purwadi, K.P.; Boru, D.S.; Farida; Suharni

    2000-01-01

    Nuclear installations expose potential hazard of radiation, therefore in their construction, operation and maintenance, it is necessary to consider safety aspect, in which the safety requirements which has been determined must be met. One of the requirements that is absolutely needed is quality assurance, which covers arrangement of quality assurance program, organization and administration of the implementation of quality assurance, and supervision. Quality Assurance program is a guideline containing quality policies and basic determination on the realization of activities that effect the quality of equipment's and items used in the operation of nuclear installations in order that the operation of nuclear installation can run safety and in accordance with their design aims and operation limits. Quality Assurance Program includes document control, design control, supply control, control of equipment s and items, operation/process control, inspection and control of equipment test, and control of nonconformance and corrections. General system of nuclear installation operation is equipped with safety and supporting systems. These systems must apply the quality assurance program that cover control of activities in the systems. In the implementation of the quality assurance program, it is necessary to establish procedures, work guidelines/instructions, and quality recording that constitutes documents of quality system 2 nd , 3 th , and 4 th level after the quality assurance program. To ensure the effectivity and to prove whether the realization of the program has been pursuant to the determined requirements, an internal audit must be conducted accordingly

  12. Waste Management Quality Assurance Plan

    International Nuclear Information System (INIS)

    2006-01-01

    The WMG QAP is an integral part of a management system designed to ensure that WMG activities are planned, performed, documented, and verified in a manner that assures a quality product. A quality product is one that meets all waste acceptance criteria, conforms to all permit and regulatory requirements, and is accepted at the offsite treatment, storage, and disposal facility. In addition to internal processes, this QA Plan identifies WMG processes providing oversight and assurance to line management that waste is managed according to all federal, state, and local requirements for waste generator areas. A variety of quality assurance activities are integral to managing waste. These QA functions have been identified in the relevant procedures and in subsequent sections of this plan. The WMG QAP defines the requirements of the WMG quality assurance program. These requirements are derived from Department of Energy (DOE) Order 414.1C, Quality Assurance, Contractor Requirements Document, the LBNL Operating and Assurance Program Plan (OAP), and other applicable environmental compliance documents. The QAP and all associated WMG policies and procedures are periodically reviewed and revised, as necessary, to implement corrective actions, and to reflect changes that have occurred in regulations, requirements, or practices as a result of feedback on work performed or lessons learned from other organizations. The provisions of this QAP and its implementing documents apply to quality-affecting activities performed by the WMG; WMG personnel, contractors, and vendors; and personnel from other associated LBNL organizations, except where such contractors, vendors, or organizations are governed by their own WMG-approved QA programs

  13. Quality management and quality assurance contracts

    International Nuclear Information System (INIS)

    Teichler, M.

    1991-01-01

    Quality assurance contracts belong to the most important instruments of quality management systems. As a result of such contracts, quality control is to be done not only by the buyer, but is made a task to be fulfilled by the manufacturer. The author of the article shows that quality assurance contracts do change the contractual relationship between supplier and buyer, but have no effect on economic and practical conditions. This is so because quality assurance contracts apply only to warranty claims, which play a subordinate role in the legal relationship between producer and buyer, or producer and consumer, as compared to the claims for damages arising out of the contracts. (orig.) [de

  14. [Quality assurance in oncology: experiences of an ISO certification].

    Science.gov (United States)

    Szentirmay, Zoltán; Cseh, Lujza; Ottó, Szabolcs; Kásler, Miklós

    2002-01-01

    The ISO 9001 quality assurance of the National Institute of Oncology has been achieved successfully. We give an account of the brief history and the structure of the assurance system of the Institute, the process of setting our goals, and also the experience gained from drafting ISO 9001 handbook and flowcharts. Apart from the bureaucratic nature of quality assurance, it is a good opportunity for us to investigate our everyday work, put it into orderly manner and work more reliably. Experience has shown that the introduction of a quality assurance system increases the level of patient care, the documentation helps the Institute or some of its departments, or even individuals prevent law suits, and serves as a sound basis for proposing promotion, salary increases and bonuses, or even honors.

  15. Quality Assurance for Operation of Nuclear Facilities

    International Nuclear Information System (INIS)

    Park, C. G.; Kwon, H. I.; Kim, K. H.; Oh, Y. W.; Lee, Y. G.; Ha, J. H.; Lim, N. J.

    2008-12-01

    This report describes QA activities performed within 'Quality Assurance for Nuclear facility project' and results thereof. Efforts were made to maintain and improve quality system of nuclear facilities. Varification activities whether quality system was implemented in compliance with requirements. QA department assisted KOLAS accredited testing and calibration laboratories, ISO 9001 quality system, establishment of QA programs for R and D, and carried out reviews and surveys for development of quality assurance technologies. Major items of this report are as follows : - Development and Improvement of QA Programs - QA Activities - Assessment of Effectiveness and Adequacy for QA Programs

  16. Development and application of a quality assurance system for waste repositories

    International Nuclear Information System (INIS)

    Beckmerhagen, I.; Berg, H.P.

    1996-01-01

    A large set of requirements are developed for the structures, systems and components of a waste repository. These requirements cover different regulations concerning planning, design, construction, operation and decommissioning of a waste repository as well as nuclear-specific requirements on the design of the plant. The implementation of a quality assurance (QA) system is an essential task in order to ensure that the requirements are fulfilled by systematic means. The QA system for the German repositories for radioactive waste is built up as a hierarchic system and described in more detail in particular covering aspects like maintenance of QA relevant systems, structures and components as well as the procedure in case of changes. For the operational phase of a repository a separate site-specific manual had to be developed. Such a manual has been elaborated for the operation of the Morsleben repository; main topics of this manual are presented

  17. The on-site quality-assurance system for Hyper Suprime-Cam: OSQAH

    Science.gov (United States)

    Furusawa, Hisanori; Koike, Michitaro; Takata, Tadafumi; Okura, Yuki; Miyatake, Hironao; Lupton, Robert H.; Bickerton, Steven; Price, Paul A.; Bosch, James; Yasuda, Naoki; Mineo, Sogo; Yamada, Yoshihiko; Miyazaki, Satoshi; Nakata, Fumiaki; Koshida, Shintaro; Komiyama, Yutaka; Utsumi, Yousuke; Kawanomoto, Satoshi; Jeschke, Eric; Noumaru, Junichi; Schubert, Kiaina; Iwata, Ikuru; Finet, Francois; Fujiyoshi, Takuya; Tajitsu, Akito; Terai, Tsuyoshi; Lee, Chien-Hsiu

    2018-01-01

    We have developed an automated quick data analysis system for data quality assurance (QA) for Hyper Suprime-Cam (HSC). The system was commissioned in 2012-2014, and has been offered for general observations, including the HSC Subaru Strategic Program, since 2014 March. The system provides observers with data quality information, such as seeing, sky background level, and sky transparency, based on quick analysis as data are acquired. Quick-look images and validation of image focus are also provided through an interactive web application. The system is responsible for the automatic extraction of QA information from acquired raw data into a database, to assist with observation planning, assess progress of all observing programs, and monitor long-term efficiency variations of the instrument and telescope. Enhancements of the system are being planned to facilitate final data analysis, to improve the HSC archive, and to provide legacy products for astronomical communities.

  18. A quality assurance phantom for the performance evaluation of volumetric micro-CT systems

    Energy Technology Data Exchange (ETDEWEB)

    Du, Louise Y [Department of Medical Biophysics, University of Western Ontario, London, ON (Canada); Umoh, Joseph [Imaging Research Laboratories, Robarts Research Institute, London, ON (Canada); Nikolov, Hristo N [Imaging Research Laboratories, Robarts Research Institute, London, ON (Canada); Pollmann, Steven I [Imaging Research Laboratories, Robarts Research Institute, London, ON (Canada); Lee, Ting-Yim [Department of Medical Biophysics, University of Western Ontario, London, ON (Canada); Holdsworth, David W [Department of Medical Biophysics, University of Western Ontario, London, ON (Canada)

    2007-12-07

    Small-animal imaging has recently become an area of increased interest because more human diseases can be modeled in transgenic and knockout rodents. As a result, micro-computed tomography (micro-CT) systems are becoming more common in research laboratories, due to their ability to achieve spatial resolution as high as 10 {mu}m, giving highly detailed anatomical information. Most recently, a volumetric cone-beam micro-CT system using a flat-panel detector (eXplore Ultra, GE Healthcare, London, ON) has been developed that combines the high resolution of micro-CT and the fast scanning speed of clinical CT, so that dynamic perfusion imaging can be performed in mice and rats, providing functional physiological information in addition to anatomical information. This and other commercially available micro-CT systems all promise to deliver precise and accurate high-resolution measurements in small animals. However, no comprehensive quality assurance phantom has been developed to evaluate the performance of these micro-CT systems on a routine basis. We have designed and fabricated a single comprehensive device for the purpose of performance evaluation of micro-CT systems. This quality assurance phantom was applied to assess multiple image-quality parameters of a current flat-panel cone-beam micro-CT system accurately and quantitatively, in terms of spatial resolution, geometric accuracy, CT number accuracy, linearity, noise and image uniformity. Our investigations show that 3D images can be obtained with a limiting spatial resolution of 2.5 mm{sup -1} and noise of {+-}35 HU, using an acquisition interval of 8 s at an entrance dose of 6.4 cGy.

  19. A quality assurance phantom for the performance evaluation of volumetric micro-CT systems

    International Nuclear Information System (INIS)

    Du, Louise Y; Umoh, Joseph; Nikolov, Hristo N; Pollmann, Steven I; Lee, Ting-Yim; Holdsworth, David W

    2007-01-01

    Small-animal imaging has recently become an area of increased interest because more human diseases can be modeled in transgenic and knockout rodents. As a result, micro-computed tomography (micro-CT) systems are becoming more common in research laboratories, due to their ability to achieve spatial resolution as high as 10 μm, giving highly detailed anatomical information. Most recently, a volumetric cone-beam micro-CT system using a flat-panel detector (eXplore Ultra, GE Healthcare, London, ON) has been developed that combines the high resolution of micro-CT and the fast scanning speed of clinical CT, so that dynamic perfusion imaging can be performed in mice and rats, providing functional physiological information in addition to anatomical information. This and other commercially available micro-CT systems all promise to deliver precise and accurate high-resolution measurements in small animals. However, no comprehensive quality assurance phantom has been developed to evaluate the performance of these micro-CT systems on a routine basis. We have designed and fabricated a single comprehensive device for the purpose of performance evaluation of micro-CT systems. This quality assurance phantom was applied to assess multiple image-quality parameters of a current flat-panel cone-beam micro-CT system accurately and quantitatively, in terms of spatial resolution, geometric accuracy, CT number accuracy, linearity, noise and image uniformity. Our investigations show that 3D images can be obtained with a limiting spatial resolution of 2.5 mm -1 and noise of ±35 HU, using an acquisition interval of 8 s at an entrance dose of 6.4 cGy

  20. Quality assurance

    International Nuclear Information System (INIS)

    Kunich, M.P.; Vieth, D.L.

    1989-01-01

    This paper provides a point/counterpoint view of a quality assurance director and a project manager. It presents numerous aspects of quality assurance requirements along with analyses as to the value of each

  1. Practical aspects of quality assurance in nuclear power plants in Japan

    International Nuclear Information System (INIS)

    Inoue, Kunio

    1980-01-01

    Based on the occurrence of accidents caused by inappropriateness in quality assurance in nuclear power plants, the nuclear power plant quality assurance investigation committee was organized in January, 1980, to examine comprehensively what the quality assurance should be from designing through operating stages of the equipments and systems of nuclear power stations, in order to prevent the recurrence of such accidents, to secure the safety and to improve the reliability. The committee established three subcommittees: the first is in charge of the investigation of quality assurance system based on the analyses of accidents, failures or abnormal events, the second in charge of the investigation of quality assurance system in nuclear industries, and the third in charge of the investigation by comparing domestic legal control and the organization for implementing inspection with those of foreign countries. In nuclear power plants in Japan, approximately 20 accidents or failures have occurred every year in the last 3 or 4 years. Many of them seem to be caused by quality assurance problems such as the misuse of materials or the inadequacy in machining. In addition, to this paper the tables showing the general quality assurance activity in, and the present status of permission, approval and inspection for Japanese nuclear power plants are attached. (Wakatsuki, Y.)

  2. State-based modeling of continuous human-integrated systems: An application to air traffic separation assurance

    International Nuclear Information System (INIS)

    Landry, Steven J.; Lagu, Amit; Kinnari, Jouko

    2010-01-01

    A method for modeling the safety of human-integrated systems that have continuous dynamics is introduced. The method is intended to supplement more detailed reliability-based methods. Assumptions for the model are defined such that the model is demonstrably complete, enabling it to yield a set of key agent characteristics. These key characteristics identify a sufficient set of characteristics that can be used to establish the safety of particular system configurations. The method is applied for the analysis of the safety of strategic and tactical separation assurance algorithms for the next generation air transportation system. It is shown that the key characteristics for this problem include the ability of agents (human or automated) to identify configurations that can enable intense transitions from a safe to unsafe state. However, the most technologically advanced algorithm for separation assurance does not currently attempt to identify such configurations. It is also discussed how, although the model is in a form that lends itself to quantitative evaluations, such evaluations are complicated by the difficulty of accurately quantifying human error probabilities.

  3. New techniques in quality assurance

    International Nuclear Information System (INIS)

    Fornicola, J.C.

    1987-01-01

    GPU Nuclear Corp. has a multifaceted quality assurance (QA) program. This program includes a comprehensive QA organization to help ensure its implementation. The QA organization employs various techniques in assuring quality at GPU Nuclear. These techniques not only include the typical QA/quality-control verification activities, i.e., QA engineering, quality control, and audits, but also include some new innovative techniques. Several new techniques have been developed for verifying activities. These techniques include monitoring and functional audits of safety systems. Several new techniques for assessing performance and adequacy and effectiveness of plant and QA programs, such as plant assessments and QA systems engineering evaluations, have also been developed. This paper provides an overview of these and other new techniques being employed by GPU Nuclear's QA organization

  4. In-service quality assurance at the Fessenheim nuclear power plant

    International Nuclear Information System (INIS)

    Waller, A.

    1980-01-01

    Quality assurance is a combination of systematic and planned actions applied so as to give the adequate degree of confidence in the effective obtention of quality. Quality assurance is a daily requestioning resulting from systematic inspections and checks. The different principles permitting the in-service quality assurance system to be applied is presented [fr

  5. Multinational Quality Assurance

    Science.gov (United States)

    Kinser, Kevin

    2011-01-01

    Multinational colleges and universities pose numerous challenges to the traditional models of quality assurance that are designed to validate domestic higher education. When institutions cross international borders, at least two quality assurance protocols are involved. To guard against fraud and abuse, quality assurance in the host country is…

  6. Implementation of an assurance system guarantee quality in the hospital radiotherapy department of Lenin Holguin, Cuba

    International Nuclear Information System (INIS)

    Gonzalez Lopez, Nadia; Perez Velasquez, Reytel; Sol Zamora

    2009-01-01

    By the need to develop a simple and effective method of reducing radiation accidents in the present work has as objective the implementation through a manual system assurance quality assurance department of radiotherapy based on ISO 9000 and 14000 , besides the IAEA TECDOC-1151. The Quality Manual is divided into four sessions: general, procedures for the realization of security testing, mechanical and dosimetric the Co-60 machine, procedures for the planning of treatments in gynecology locations, SNC, rectum and breast cancer and those relating to the search and / or simulation of the first patient treatment, all discussed and approved by the Quality Assurance Committee. We conclude that this document is essential in obtaining an increasing quality in conventional radiation treatments, plus must be a reference material in the training of technologists, doctors and medical physicist and the documentary basis for the conformation of the warranty program quality of radiation therapy 3D-CRT. (author)

  7. The role of food quality assurance and product certification systems on marketing aspects

    Science.gov (United States)

    Petrović, Z.; Milićević, D.; Nastasijević, I.; Đorđević, V.; Trbović, D.; Velebit, B.

    2017-09-01

    The level of quality that a product offers to consumers is a fundamental aspect of competition in many markets. Consumers’ confidence in the safety and quality of foods they buy and consume is a significant support to the economic development of production organizations of this type, and therefore the overall economic development. Consumer concerns about food safety as well as the globalization of food production have also led to the existence of a global internationally linked food production and distribution system. The necessity demanded by the consumer population to provide safe food with consistent quality at an attractive price imposes a choice of an appropriate quality assurance model in accordance with the specific properties of the product and the production processes. Modern trends, especially for the last ten years in quality assurance within specific production, such as the food industry, have marked the trend of hyperproduction and a number of production and safety standards, as well as a change of approach in the certification process of organizations according to one or more standards. This can be an additional source of costs for organizations, and can burden the food business operator`s budget in order to ensure their consistent application and maintenance. Quality assurance (QA) standards are considered to be a proven mechanism for delivering quality of product.

  8. Quality assurance program preparation - review of requirements and plant systems - selection of program levels

    International Nuclear Information System (INIS)

    Asmuss, G.

    1980-01-01

    The establishment and implementation for a practicable quality assurance program for a nuclear power plant demands a detailed background in the field of engineering, manufacturing, organization and quality assurance. It will be demonstrated with examples to define and control the achievement of quality related activities during the phases of design, procurement, manufactoring, commissioning and operation. In general the quality assurance program applies to all items, processes and services important to safety of nuclear power plant. The classification for safety related and non-safety related items and services demonstrate the levels of quality assurance requirements. The lecture gives an introduction of QA Program preparation under the following topics: -Basic criteria and international requirements - Interaction of QA activities - Modular and product oriented QA programs - Structuring of organization for the QA program - Identification of the main quality assurance functions and required actions - Quality Assurance Program documentation - Documentation of planning of activities - Control of program documents - Definitions. (orig./RW)

  9. Factors which contributed for low quality sputum smears for the detection of acid fast bacilli (AFB) at selected health centers in Ethiopia: A quality control perspective.

    Science.gov (United States)

    Mekonen, Ayehu; Ayele, Yeshi; Berhan, Yifru; Woldeyohannes, Desalegn; Erku, Woldaregay; Sisay, Solomon

    2018-01-01

    Quality of tuberculosis (TB) microscopy diagnosis is not a guarantee despite implementation of External Quality Assurance (EQA) service in all laboratories of health facilities. Hence, we aimed at evaluating the technical quality and the findings of sputum smear microscopy for acid fast bacilli (AFB) at health centers in Hararge Zone, Oromia Region, Ethiopia. A cross-sectional study was carried out between July 8, 2014 and July 7, 2015.A pre-tested structured questionnaire was used to collect data. Lot Quality Assurance Sampling (LQAS) method was put into practice for collecting all necessary sample slides. Data were analyzed by using SPSS (Statistical Package for Social Sciences) version 20 software. P-value quality, smear size, smear thickness, staining and evenness were indicated in 40 (72.7%), 39 (70.9%), 37 (67.3%), 27(49.1%) and 37 (67.3%) of the collected samples, respectively. False negative AFB findings were significantly associated with lack of Internal Quality Control (IQC) measures (AOR (Adjusted Odds Ratio): 2.90 (95% CI (Confidence Interval): 1.25,6.75) and poor staining procedures (AOR: 2.16(95% CI: 1.01, 5.11). The qualities of AFB smear microscopy reading and smearing were low in most of the laboratories of the health centers. Therefore, it is essential to strength EQA program through building the capacity of laboratory professionals.

  10. Quality assurance of nuclear energy

    International Nuclear Information System (INIS)

    1994-12-01

    It consists of 14 chapters, which are outline of quality assurance of nuclear energy, standard of quality assurance, business quality assurance, design quality assurance, purchase quality assurance, production quality assurance, a test warranty operation warranty, maintenance warranty, manufacture of nuclear power fuel warranty, computer software warranty, research and development warranty and quality audit.

  11. Development of a quality-assurance program for the Tritium Systems Test Assembly

    International Nuclear Information System (INIS)

    Minor, R.C.

    1981-01-01

    A quality assurance program was developed for TSTA with the attempt in mind to satisfy the developmental nature of the project. Numerous reviews replace strict guidelines because guidelines are one of the objectives of the project, not a basis for it. The reviews assure adequate technical consideration and avoid unilateral decisions. Other major requirements of the program plan include interfacing with another quality assurance organization, the assignment of responsibilities, and instructions for the preparation of SDD's. Areas of concern are, in general, budget related, and include receiving inspection and acceptance of items. A software program is only now being established

  12. Manufacture of heavy reactor components with particular considerations to quality assurance

    International Nuclear Information System (INIS)

    Kreppel, H.; Clausmeyer, H.

    1980-01-01

    The use of adequate quality assurance measures is one of the most important prerequisites for the manufacture of reactor components. Nature and extent of the quality assurance system at present adopted in the Federal Republic of Germany are illustrated, using the manufacture of a reactor pressure vessel as an example. The system comprises quality organization, planning of all quality assurance measures, quality surveillance through all stages of manufacture and documentation of quality attained. (orig.)

  13. Manufacture of heavy reactor components with particular consideration to quality assurance

    International Nuclear Information System (INIS)

    Clausmeyer, H.; Kreppel, H.

    1977-01-01

    The use of adequate quality assurance measures is one of the most important prerequisites for the manufacture of reactor components. Nature and extent of the quality assurance system at present adopted in the Federal Republic of Germany are illustrated, using the manufacture of a reactor pressure vessel as an example. The system comprises quality organization, planning of all quality assurance measures, quality surveillance through all stages of manufacture and documentation of quality attained. (orig.) [de

  14. Manufacture of heavy reactor components with particular consideration to quality assurance

    International Nuclear Information System (INIS)

    Kreppel, H.; Clausmeyer, H.

    1981-01-01

    The use of adequate quality assurance measures is one of the most important prerequisites for the manufacture of reactor components. Nature and extent of the quality assurance system at present adopted in the Federal Republic of Germany are illustrated, using the manufacture of a reactor pressure vessel as an example. The system comprises quality organization, planning of all quality assurance measures, quality surveillance through all stages of manufacture and documentation of quality attained. (orig.)

  15. Quality Assurance Training Tracking (QATTS)

    Data.gov (United States)

    U.S. Environmental Protection Agency — This is metadata documentation for the Quality Assurance Training Tracking System (QATTS) which tracks Quality Assurace training given by R7 QA staff to in-house...

  16. Quality assurance feedback as a nursing management strategy.

    Science.gov (United States)

    Brannon, D; Bucher, J A

    1989-01-01

    Quality assurance and effective nurse management can be viewed as intersecting goals. Objective feedback derived from quality assurance data is a potentially powerful means of enhancing nurses' performance and job satisfaction. The use of automated information systems to provide such direct feedback offers the additional advantage of recognizing nurses as self-monitoring, self-correcting professionals. The need, opportunity, and challenge involved in meshing quality assurance with human resource management through computer-generated feedback are discussed in the context of the home health care setting.

  17. Quality assurance in ionizing radiation application

    International Nuclear Information System (INIS)

    Rastkhah; Nasser.

    1995-01-01

    Quality assurance is a mean for controlling all the activities within an organization which affect the quality of the product or service. A series of international standards have been prepared which incorporate the accumulated knowledge and provide guidance on what activities within an organization should be controlled. A proposal on a quality assurance system to be implemented in ionizing radiation application centers is the primary concern of Atomic Energy Organization of Iran is represented. The Objectives were identification of quality related problems ;Comply with national and international requirements ;Controlling all activities within an organization which affects the quality and assurance of maintaining the quality within organization. In performing protection measures, risk, cost, benefit consideration, cause of problems and the classic solution are summarized in four chapters

  18. Evaluation of the reports on the status of quality assurance systems in the power plants. Pt. 1, annex, pt. 2

    International Nuclear Information System (INIS)

    1983-01-01

    The problem required the development of a presentation and evaluation of the overall results based on the results of the systems analysis with regard to: - further development of control equipment, - discovery of overlapping points, gaps and weak points, especially at the boundaries between the systems, - standardized application of the principles of efficient quality assurance systems for all participants. The results of the systems analyses for the status of quality assurance in producers and suppliers of systems can be summarized as follows: 1. Both systems analyses show that the quality assurance systems introduced are operable but that there are also some weak points. 2. Basically, the results of the systems analyses coincide; there are differences in the assessment of single issues or in a more detailed treatment. The weak points identified by the systems analysis can be summarized under the following catchwords: - structural organization; here, a greater formalization of the descriptions of positions and qualifications of personnel as well as the presentation of the structural organization in organization charts are required. - Procedural organization resp. operational modulei; here, improvements of the interfaces between the QA systems, information feedback, information and documentation are dealt with and the revision and improvement of invalid documents (withdrawal/exchange) as well as the qualification mode for auditors are pointed out separately. (orig./HP) [de

  19. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    Energy Technology Data Exchange (ETDEWEB)

    Riddle, Donna L.

    2007-05-03

    S.M. Stoller Corporation is the contractor for the Technical Assistance Contract (TAC) for the U.S. Department of Energy (DOE) Office of Legacy Management (LM) operations. Stoller employs a management system that applies to all programs, projects, and business management systems funded through DOE-LM task orders. The management system incorporates the philosophy, policies, and requirements of health and safety, environmental compliance, and quality assurance (QA) in all aspects of project planning and implementation. Health and safety requirements are documented in the Health and Safety Manual (STO 2), the Radiological Control Manual (STO 3), the Integrated Safety Management System Description (STO 10), and the Drilling Health and Safety Requirements (STO 14). Environmental compliance policy and requirements are documented in the Environmental Management Program Implementation Manual (STO 11). The QA Program is documented in the Quality Assurance Manual (STO 1). The QA Manual (STO 1) implements the specific requirements and philosophy of DOE Order 414.1C, Quality Assurance. This manual also includes the requirements of other standards that are regularly imposed by customers, regulators, or other DOE orders. Title 10 Code of Federal Regulations Part 830, “Quality Assurance Requirements,” ANSI/ASQC E4-2004, “Quality Systems for Environmental Data and Technology Programs – Requirements with Guidance for Use,” and ISO 14001-2004, “Environmental Management Systems,” have been included. These standards are similar in content. The intent of the QA Manual (STO 1) is to provide a QA management system that incorporates the requirements and philosophy of DOE and other customers within the QA Manual. Criterion 1, “Quality Assurance Program,” identifies the fundamental requirements for establishing and implementing the QA management system; QA Instruction (QAI) 1.1, “QA Program Implementation,” identifies the TAC organizations that have responsibility for

  20. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    International Nuclear Information System (INIS)

    2007-01-01

    S.M. Stoller Corporation is the contractor for the Technical Assistance Contract (TAC) for the U.S. Department of Energy (DOE) Office of Legacy Management (LM) operations. Stoller employs a management system that applies to all programs, projects, and business management systems funded through DOE-LM task orders. The management system incorporates the philosophy, policies, and requirements of health and safety, environmental compliance, and quality assurance (QA) in all aspects of project planning and implementation. Health and safety requirements are documented in the Health and Safety Manual (STO 2), the Radiological Control Manual (STO 3), the Integrated Safety Management System Description (STO 10), and the Drilling Health and Safety Requirements (STO 14). Environmental compliance policy and requirements are documented in the Environmental Management Program Implementation Manual (STO 11). The QA Program is documented in the Quality Assurance Manual (STO 1). The QA Manual (STO 1) implements the specific requirements and philosophy of DOE Order 414.1C, Quality Assurance. This manual also includes the requirements of other standards that are regularly imposed by customers, regulators, or other DOE orders. Title 10 Code of Federal Regulations Part 830, 'Quality Assurance Requirements', ANSI/ASQC E4-2004, 'Quality Systems for Environmental Data and Technology Programs - Requirements with Guidance for Use', and ISO 14001-2004, 'Environmental Management Systems', have been included. These standards are similar in content. The intent of the QA Manual (STO 1) is to provide a QA management system that incorporates the requirements and philosophy of DOE and other customers within the QA Manual. Criterion 1, 'Quality Assurance Program', identifies the fundamental requirements for establishing and implementing the QA management system; QA Instruction (QAI) 1.1, 'QA Program Implementation', identifies the TAC organizations that have responsibility for implementing the QA

  1. Quality assurance programs from laboratories offering radiological protection services

    International Nuclear Information System (INIS)

    Marrero Garcia, M.; Prendes Alonso, M.; Jova Sed, L.; Morales Monzon, J.A.

    1998-01-01

    The implementation of an adequate program for quality assurance in institutions servicing radiological protection programs will become an additional tool to achieve security targets included in that program. All scientific and technical services offered by CPHR employ quality assurance systems

  2. Design of a quality assurance system in the nuclear fuel fabrication

    International Nuclear Information System (INIS)

    Garcia Rojas Palacios, L.

    1992-01-01

    A)For the first time a project on nuclear fuel fabrication is going to be lead in this country. For this reason the work is oriented to establish a quality assurance system for the different stages of fuel fabrication. C) The work of this thesis was developed first by means of an analysis of quality philosophies of Deming, Ishikawa, Juran and Crosby from which several important points were stracted to be used in the designed quality system. Metrology and normalization are so important for quality control that a study of them is made considering definitions, unit systems and type of errors (for Metrology) as well as standards for quality systems, qualification, destructive and non destructive tests, shipment, packing for nuclear power plants. With the standards as a basis, the working strategy for the system was reached, as well as the design of control cards and the design of documents for inspection control, personnel and its documentation and finally the diagrams for each one of the fabrication stages

  3. Implementation of a program of quality assurance of image in an imaging system of flat panel portal

    International Nuclear Information System (INIS)

    Gomez Barrado, A.; Sanchez Jimenez, E.; Benitez, J. A.; Sanchez-Reyes, A.

    2013-01-01

    (IGRT) image-guided radiation therapy is the one in which images are used to locate the area of treatment. Modern irradiation systems are equipped with different modalities for obtaining images, such as flat panel systems, systems conebeam, tomoimagen, etc. This paper describes the start-up and the experience of a quality assurance program based on a flat panel portal Imaging System. (Author)

  4. The system of quality assurance of EDF for designing and developing nuclear power plants

    International Nuclear Information System (INIS)

    Vaujour, M.

    As the quality required for a power plant must fulfill at one and the same time, performance, safety and reliability criteria, the quality obtainment needs the establishment of a system of quality assurance: an internal system of arrangement of the organizations involved, measures creating the relations between said organizations, mechanisms of control of the quality organizing, and some statements. The respective roles of EDF and the constructors are defined together with the contractual obligations of the constructors [fr

  5. A Comparative Study for Detection of EGFR Mutations in Plasma Cell-Free DNA in Korean Clinical Diagnostic Laboratories

    Directory of Open Access Journals (Sweden)

    Yoonjung Kim

    2018-01-01

    Full Text Available Liquid biopsies to genotype the epidermal growth factor receptor (EGFR for targeted therapy have been implemented in clinical decision-making in the field of lung cancer, but harmonization of detection methods is still scarce among clinical laboratories. We performed a pilot external quality assurance (EQA scheme to harmonize circulating tumor DNA testing among laboratories. For EQA, we created materials containing different levels of spiked cell-free DNA (cfDNA in normal plasma. The limit of detection (LOD of the cobas® EGFR Mutation Test v2 (Roche Molecular Systems was also evaluated. From November 2016 to June 2017, seven clinical diagnostic laboratories participated in the EQA program. The majority (98.94% of results obtained using the cobas assay and next-generation sequencing (NGS were acceptable. Quantitative results from the cobas assay were positively correlated with allele frequencies derived from digital droplet PCR measurements and showed good reproducibility among laboratories. The LOD of the cobas assay was 5~27 copies/mL for p.E746_A750del (exon 19 deletion, 35~70 copies/mL for p.L858R, 18~36 copies/mL for p.T790M, and 15~31 copies/mL for p.A767_V769dup (exon 20 insertion. Deep sequencing of materials (>100,000X depth of coverage resulted in detection of low-level targets present at frequencies of 0.06~0.13%. Our results indicate that the cobas assay is a reliable and rapid method for detecting EGFR mutations in plasma cfDNA. Careful interpretation is particularly important for p.T790M detection in the setting of relapse. Individual laboratories should optimize NGS performance to maximize clinical utility.

  6. Mixed Waste Integrated Program Quality Assurance requirements plan

    International Nuclear Information System (INIS)

    1994-01-01

    Mixed Waste Integrated Program (MWIP) is sponsored by the US Department of Energy (DOE), Office of Technology Development, Waste Management Division. The strategic objectives of MWIP are defined in the Mixed Waste Integrated Program Strategic Plan, and expanded upon in the MWIP Program Management Plan. This MWIP Quality Assurance Requirement Plan (QARP) applies to mixed waste treatment technologies involving both hazardous and radioactive constituents. As a DOE organization, MWIP is required to develop, implement, and maintain a written Quality Assurance Program in accordance with DOE Order 4700.1 Project Management System, DOE Order 5700.6C, Quality Assurance, DOE Order 5820.2A Radioactive Waste Management, ASME NQA-1 Quality Assurance Program Requirements for Nuclear Facilities and ANSI/ASQC E4-19xx Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. The purpose of the MWIP QA program is to establish controls which address the requirements in 5700.6C, with the intent to minimize risks and potential environmental impacts; and to maximize environmental protection, health, safety, reliability, and performance in all program activities. QA program controls are established to assure that each participating organization conducts its activities in a manner consistent with risks posed by those activities

  7. Mixed Waste Integrated Program Quality Assurance requirements plan

    Energy Technology Data Exchange (ETDEWEB)

    1994-04-15

    Mixed Waste Integrated Program (MWIP) is sponsored by the US Department of Energy (DOE), Office of Technology Development, Waste Management Division. The strategic objectives of MWIP are defined in the Mixed Waste Integrated Program Strategic Plan, and expanded upon in the MWIP Program Management Plan. This MWIP Quality Assurance Requirement Plan (QARP) applies to mixed waste treatment technologies involving both hazardous and radioactive constituents. As a DOE organization, MWIP is required to develop, implement, and maintain a written Quality Assurance Program in accordance with DOE Order 4700.1 Project Management System, DOE Order 5700.6C, Quality Assurance, DOE Order 5820.2A Radioactive Waste Management, ASME NQA-1 Quality Assurance Program Requirements for Nuclear Facilities and ANSI/ASQC E4-19xx Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. The purpose of the MWIP QA program is to establish controls which address the requirements in 5700.6C, with the intent to minimize risks and potential environmental impacts; and to maximize environmental protection, health, safety, reliability, and performance in all program activities. QA program controls are established to assure that each participating organization conducts its activities in a manner consistent with risks posed by those activities.

  8. Kilowatt isotope power system. Phase II plan. Volume V. Safety, quality assurance and reliability

    International Nuclear Information System (INIS)

    1978-01-01

    The development of a Kilowatt Isotope Power System (KIPS) was begun in 1975 for the purpose of satisfying the power requirements of satellites in the 1980's. The KIPS is a 238 PuO 2 -fueled organic Rankine cycle turbine power system to provide a design output of 500 to 2000 W. Included in this volume are: launch and flight safety considerations; quality assurance techniques and procedures to be followed through system fabrication, assembly and inspection; and the reliability program made up of reliability prediction analysis, failure mode analysis and criticality analysis

  9. Westinghouse Water Reactor Divisions quality assurance plan

    International Nuclear Information System (INIS)

    1977-09-01

    The Quality Assurance Program used by Westinghouse Water Reactor Divisions is described. The purpose of the program is to assure that the design, materials, and workmanship on Nuclear Steam Supply System (NSSS) equipment meet applicable safety requirements, fulfill the requirements of the contracts with the applicants, and satisfy the applicable codes, standards, and regulatory requirements. This program satisfies the NRC Quality Assurance Criteria, 10CFR50 Appendix B, to the extent that these criteria apply to safety related NSSS equipment. Also, it follows the regulatory position provided in NRC regulatory guides and the requirements of ANSI Standard N45.2.12 as identified in this Topical Report

  10. Assurance program for remedial action (APRA) microcomputer-operated bibliography management system

    International Nuclear Information System (INIS)

    Stenner, R.D.; Washburn, D.K.; Denham, D.H.

    1985-10-01

    Pacific Northwest Laboratory (PNL) provided technical assistance to the Office of Operational Safety (OOS) in developing their Assurance Program for Remedial Action (APRA). The APRA Bibliography Management System (BMS), a microcomputer-operated system designed to file, locate and retrieve project-specific bibliographic data, was developed to manage the documentation associated with APRA. The BMS uses APRABASE, a PNL-developed computer program written in dBASE II language, which is designed to operate using the commercially available dBASE II database software. The paper describes the APRABASE computer program, its associated subprograms, and the dBASE II APRA file. Although the BMS was designed to manage APRA-associated documents, it could be easily adapted for use in handling bibliographic data associated with any project

  11. Assurance Program for Remedial Action (APRA) microcomputer-operated bibliography management system

    International Nuclear Information System (INIS)

    Stenner, R.D.; Washburn, D.K.; Denham, D.H.

    1986-01-01

    Pacific Northwest Laboratory (PNL) provided technical assistance to the Office of Operational Safety (OOS) in developing their Assurance Program for Remedial Action (APRA). The APRA Bibliography Management System (BMS), a microcomputer-operated system designed to file, locate and retrieve project-specific bibliographic data, was developed to manage the documentation associated with APRA. The BMS uses APRABASE, a PNL-developed computer program written in dBASE II/sup (b)/ language, which is designed to operate using the commercially available dBASE II database software. This paper describes the APRABASE computer program, its associated subprograms, and the dBASE II APRA file. Although the BMS was designed to manage APRA-associated documents, it could be easily adapted for use in handling bibliographic data associated with any project

  12. Quality assurance in radiation processing

    International Nuclear Information System (INIS)

    Noriah Mod Ali

    2002-01-01

    The growth of the radiation processing industries in Malaysia has presented the SSDL-MINT a new set of parameter for the Quality Assurance (QA) programs. The large massive doses of radiation required for commercial application of sterilization, cross-linking etc needs measurement method outside the scope of familiar radiation detection instruments. This requires establishment of proper calibration procedure and selection of appropriate transfer system/technique to assure adequate traceability to an international radiation standard. The benefit of accurate in-plant dosimetry for the operator, approving authority and purchaser are balanced against the extra dosimetric efforts required for good QA is presented. (Author)

  13. Report on Use of a Methodology for Commissioning and Quality Assurance of a VMAT System

    OpenAIRE

    Mayo, Charles; Fong de los Santos, Luis; Kruse, Jon; Blackwell, Charles R.; McLemore, Luke B.; Pafundi, Deanna; Stoker, Joshua; Herman, Michael

    2013-01-01

    INTRODUCTION: Results of use of methodology for VMAT commissioning and quality assurance, utilizing both control point tests and dosimetric measurements are presented. METHODS AND MATERIALS: A generalizable, phantom measurement approach is used to characterize the accuracy of the measurement system. Correction for angular response of the measurement system and inclusion of couch structures are used to characterize the full range gantry angles desirable for clinical plans. A dose based daily Q...

  14. Proactive quality assurance in environmental research

    International Nuclear Information System (INIS)

    Flanagan, J.B.; Kulkarni, S.V.; Wasson, S.J.; Ford, J.S.; Harmon, D.L.

    1991-01-01

    The Quality Assurance policy of the US Environmental Protection Agency (EPA) stipulates that every project involving environmentally related monitoring, measurements, and data collection activities must have a written and approved quality assurance project plan (QAPjP). A QAPjP is a written document which presents, in specific terms, the policies, organizations, objectives, functional activities, and the quality assurance/quality control activities designed to achieve the quality goals for data collection. In the research studies involving novel or non-routine measurements that use unvalidated methods, measurement quality goals are often difficult or impossible to specify at the beginning of the project for which a QAPjP must be written. Furthermore, it may not be possible for the QAPjP reviewers to evaluate the reasonableness of these goals without initial information about the system under study. For the project to evaluate chlorofluorocarbon for recycling from domestic refrigerators, the QAPjP incorporated standard analytical techniques used by industry. These techniques did not provide accuracy and precision or other validation information. For the initial version of the QAPjP, measurement quality goals were assigned based on limited experience. Quality assurance support was called upon to evaluate the performance of the measurement system for this project through a series of audits. The performance evaluation audits necessitated designing novel audit materials and sample delivery techniques. Continued interaction is necessary between the project and QA teams to permit evolution of reasonable data quality indicators for meaningful assessment of data quality. By treating the QAPjP as a living document that is updated and amended as more knowledge of a system is obtained, AQ becomes an integral part of the research program. This results in a greater understanding of the system under study

  15. Quality assurance database for the CBM silicon tracking system

    Energy Technology Data Exchange (ETDEWEB)

    Lymanets, Anton [Physikalisches Institut, Universitaet Tuebingen (Germany); Collaboration: CBM-Collaboration

    2015-07-01

    The Silicon Tracking System is a main tracking device of the CBM Experiment at FAIR. Its construction includes production, quality assurance and assembly of large number of components, e.g., 106 carbon fiber support structures, 1300 silicon microstrip sensors, 16.6k readout chips, analog microcables, etc. Detector construction is distributed over several production and assembly sites and calls for a database that would be extensible and allow tracing the components, integrating the test data, monitoring the component statuses and data flow. A possible implementation of the above-mentioned requirements is being developed at GSI (Darmstadt) based on the FAIR DB Virtual Database Library that provides connectivity to common SQL-Database engines (PostgreSQL, Oracle, etc.). Data structure, database architecture as well as status of implementation are discussed.

  16. Financial assurances

    International Nuclear Information System (INIS)

    Paton, R.F.

    1990-01-01

    US Ecology is a full service waste management company. The company operates two of the nation's three existing low-level radioactive waste (LLRW) disposal facilities and has prepared and submitted license applications for two new LLRW disposal facilities in California and Nebraska. The issue of financial assurances is an important aspect of site development and operation. Proper financial assurances help to insure that uninterrupted operation, closure and monitoring of a facility will be maintained throughout the project's life. Unfortunately, this aspect of licensing is not like others where you can gauge acceptance by examining approved computer codes, site performance standards or applying specific technical formulas. There is not a standard financial assurance plan. Each site should develop its requirements based upon the conditions of the site, type of design, existing state or federal controls, and realistic assessments of future financial needs. Financial assurances at U.S. Ecology's existing sites in Richland, Washington, and Beatty, Nevada, have been in place for several years and are accomplished in a variety of ways by the use of corporate guarantees, corporate capital funds, third party liability insurance, and post closure/long-term care funds. In addressing financial assurances, one can divide the issue into three areas: Site development/operations, third party damages, and long-term care/cleanup

  17. External quality assessment programs in the context of ISO 15189 accreditation.

    Science.gov (United States)

    Sciacovelli, Laura; Secchiero, Sandra; Padoan, Andrea; Plebani, Mario

    2018-05-23

    Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements.

  18. AVLIS Production Plant Preliminary Quality Assurance Plan and Assessment

    International Nuclear Information System (INIS)

    1984-01-01

    This preliminary Quality Assurance Plan and Assessment establishes the Quality Assurance requirements for the AVLIS Production Plant Project. The Quality Assurance Plan defines the management approach, organization, interfaces, and controls that will be used in order to provide adequate confidence that the AVLIS Production Plant design, procurement, construction, fabrication, installation, start-up, and operation are accomplished within established goals and objectives. The Quality Assurance Program defined in this document includes a system for assessing those elements of the project whose failure would have a significant impact on safety, environment, schedule, cost, or overall plant objectives. As elements of the project are assessed, classifications are provided to establish and assure that special actions are defined which will eliminate or reduce the probability of occurrence or control the consequences of failure. 8 figures, 18 tables

  19. PENGEMBANGAN KONSEP SISTEM JAMINAN HALAL DI RUMAH POTONG AYAM (Studi Kasus pada Industri Daging Ayam [Concept Development Of Halal Assurance System In The Chicken Slaughter House (Case Study Of Chicken Meat Industry

    Directory of Open Access Journals (Sweden)

    Wiwit Estuti1

    2005-12-01

    Full Text Available The application of effective halal assurance system model was one of producer's effort to supply halal food for Moslem consumers. The objective Of this research was to develop halal assurance system concept which is consist of halal manual. Halal Standard Operating Procedure, Guideline, and Work Instruction which should be applied at Chicken Slaughter House. flied research used descriptive method by distributing questionnaire, direct observation, on-site verification and halal assurance system assessment on two Chicken Slaughter House. The halal assurance system assessment was conducted based on ISO 9000, 2000 guideline of arrangement of HACCP system. The conclusion of this research was that this Halal Assurance System was suitable to be used as a standard for Chicken Slaughter House. The document change on both industry was that of applied halal assurance system. It was found that there were two kinds of haram Critical Control Point, which were two points at raw material and four point at chicken production process

  20. Quality assurance in the course of fabrication of LWR fuel

    International Nuclear Information System (INIS)

    Dressler, G.; Perry, J.A.

    1982-01-01

    A high quality level of LWR fuel elements can only be assured by a system of Quality Assurance measures purposefully designed, balanced, and appropriately applied. This includes application of and the appropriate balance between both system and product oriented measures. A prerequisite to the establishment of these measures is a precise analysis of the various influences of the individual process steps on the quality characteristics of the starting materials, semi-finished and finished products. In addition, these characteristics require classification criteria relative to their significance. The described classification is used to establish sampling plans and to disposition non-conformances. The EXXON Nuclear Quality Assurance system which is based on these principles is described and illustrated with some examples. (orig.)

  1. Quality assurance for fittings considering nuclear technology

    International Nuclear Information System (INIS)

    Kilian, H.J.

    1987-01-01

    Negative experience made during World War II led to the idea of quality assurance being born in the United States. Thoroughly misunderstood, it came to be incorporated in European mechanical engineering. Quality assurance there was initially considered to be a new term for the oganizational combination of all parts of an enterprise dealing with testing. German manufacturers of heavy-duty and safety fittings represented in the international market were compelled at a relatively early date to properly understand and realize a quality assurance programme. But the multi-fariousness of specifications to be applied and great number of the most different parts made eminent demands on the suitability and variability of the products developed. On the basis of 18 quality criteria the article describes the structure of 'quality' and what its consequences are for an effective quality assurance system - suited for all kinds of specifications. (orig.) [de

  2. Isotopic power supplies for space and terrestrial systems: quality assurance by Sandia National Laboratories

    International Nuclear Information System (INIS)

    Hannigan, R.L.; Harnar, R.R.

    1981-09-01

    The Sandia National Laboratories participation in Quality Assurance (QA) programs for Radioisotopic Thermoelectric Generators which have been used in space and terrestrial systems over the past 15 years is summarized. Basic elements of the program are briefly described and recognition of assistance from other Sandia organizations is included. Descriptions of the various systems for which Sandia has had the QA responsibility are also presented. In addition, the outlook for Sandia participation in RTG programs for the next several years is noted

  3. Research on assurance system of nuclear fuel supply (Contract research)

    International Nuclear Information System (INIS)

    Kobayashi, Naoki; Naoi, Yosuke; Wakabayashi, Shuji; Tazaki, Makiko; Senzaki, Masao

    2010-08-01

    Assurance of supply (AOS) of nuclear fuel is a special arrangement in case of nuclear fuel supply disruption caused by political reasons other than nonproliferation. It aims to support a stable supply of nuclear fuel while avoiding spread of sensitive enrichment technology. Current discussions on AOS have been initiated by the IAEA Director-General's article published in The Economist entitled 'Towards a Safer World' Oct. 2003. Since then, various proposals on AOS have been presented. In order to facilitate international discussions on AOS, authors have conducted studies of AOS system based on Japanese Government's proposal 'IAEA Standby Arrangement System (INFCIRC/683)'. In this paper, we have been able to discuss feasibility of AOS system more specifically by including additional costs and period required for AOS, and to present a system which could work as a practical system. Issues we have tried to tackle here include definitions of AOS, and roles of consumer States, supplier States, IAEA and nuclear industries. We present some solutions including broadening coverage of AOS, declaration by supplier States on AOS, establishing advisory committee in the IAEA on the actual application of AOS, and setting up an IAEA fund for AOS. (author)

  4. Modernization of software quality assurance

    Science.gov (United States)

    Bhaumik, Gokul

    1988-01-01

    The customers satisfaction depends not only on functional performance, it also depends on the quality characteristics of the software products. An examination of this quality aspect of software products will provide a clear, well defined framework for quality assurance functions, which improve the life-cycle activities of software development. Software developers must be aware of the following aspects which have been expressed by many quality experts: quality cannot be added on; the level of quality built into a program is a function of the quality attributes employed during the development process; and finally, quality must be managed. These concepts have guided our development of the following definition for a Software Quality Assurance function: Software Quality Assurance is a formal, planned approach of actions designed to evaluate the degree of an identifiable set of quality attributes present in all software systems and their products. This paper is an explanation of how this definition was developed and how it is used.

  5. Prevalence of antimicrobial resistance among bacterial pathogens isolated from cattle in different European countries: 2002–2004

    DEFF Research Database (Denmark)

    Hendriksen, Rene S.; Mevius, Dik J; Schroeter, Andreas

    2008-01-01

    Background: The project "Antibiotic resistance in bacteria of animal origin - II" (ARBAO-II) was funded by the European Union (FAIR5-QLK2-2002-01146) for the period 2003 - 2005, with the aim to establish a continuous monitoring of antimicrobial susceptibility among veterinary laboratories...... (2002-2004). Each year the participating laboratories were requested to fill in excelfile templates with national summary data on the occurrence of antimicrobial resistance from different bacterial species. A proficiency test (EQAS - external quality assurance system) for antimicrobial susceptibility...... from 13 European countries. For Staphylococcus aureus from bovine mastitis major differences were apparent in the occurrence of resistance between countries and between the different antimicrobial agents tested. The highest frequency of resistance was observed for penicillin. For Mannheimia haemolytica...

  6. Effluent monitoring Quality Assurance Project Plan for radioactive airborne emissions data. Revision 2

    International Nuclear Information System (INIS)

    Frazier, T.P.

    1995-12-01

    This Quality Assurance Project Plan addresses the quality assurance requirements for compiling Hanford Site radioactive airborne emissions data. These data will be reported to the U.S. Environmental Protection Agency, the US Department of Energy, and the Washington State Department of Health. Effluent Monitoring performs compliance assessments on radioactive airborne sampling and monitoring systems. This Quality Assurance Project Plan is prepared in compliance with interim guidelines and specifications. Topics include: project description; project organization and management; quality assurance objectives; sampling procedures; sample custody; calibration procedures; analytical procedures; monitoring and reporting criteria; data reduction, verification, and reporting; internal quality control; performance and system audits; corrective actions; and quality assurance reports

  7. Model for deployment of a Quality Assurance System in the nuclear fuel cycle facilities using Project Management techniques

    International Nuclear Information System (INIS)

    Lage, Ricardo F.; Ribeiro, Saulo F.Q.

    2015-01-01

    The Nuclear Safety is the main goal in any nuclear facility. In this sense the Norm CNEN-NN-1.16 classifies the quality assurance issue as a management system to be deployed and implemented by the organization to achieving security goals. Quality Assurance is a set of systematic and planned actions necessary to provide adequate confidence ensuring that a structure, system, component or installation will work satisfactorily in s. Hence, the Quality Assurance System (QAS) is a complete and comprehensive methodology, going far beyond a management plan quality from the perspective of project management. The fundamental of QAS requirements is all activities that influence the quality, involving organizational, human resources, procurement, nuclear safety, projects, procedures and communication. Coordination of all these elements requires a great effort by the team responsible because it usually involves different areas and different levels of hierarchy within the organization. The objectives and desired benefits should be well set for everyone to understand what it means to be achieved and how to achieve. The support of senior management is critical at this stage, providing guidelines and resources necessary to get the job elapse clearly and efficiently, on time, cost and certain scope. The methodology of project management processes can be applied to facilitate and expedite the implementation of this system. Many of the principles of the QAS are correlated with knowledge areas of project management. The proposed model for implementation of a QAS in the nuclear fuel cycle facilities considered the best project management practices according to the Project Management Book of Knowledge (PMBOK - 5th edition) of the Project Management Institute (PMI). This knowledge is considered very good practices around the world. Since the model was defined, the deployment process becomes more practical and efficient, providing reduction in deployment time, better management of human

  8. Model for deployment of a Quality Assurance System in the nuclear fuel cycle facilities using Project Management techniques

    Energy Technology Data Exchange (ETDEWEB)

    Lage, Ricardo F.; Ribeiro, Saulo F.Q., E-mail: rflage@gmail.com, E-mail: quintao.saulo@gmail.com [Industrias Nucleares do Brasil (INB), Rio de Janeiro, RJ (Brazil)

    2015-07-01

    The Nuclear Safety is the main goal in any nuclear facility. In this sense the Norm CNEN-NN-1.16 classifies the quality assurance issue as a management system to be deployed and implemented by the organization to achieving security goals. Quality Assurance is a set of systematic and planned actions necessary to provide adequate confidence ensuring that a structure, system, component or installation will work satisfactorily in s. Hence, the Quality Assurance System (QAS) is a complete and comprehensive methodology, going far beyond a management plan quality from the perspective of project management. The fundamental of QAS requirements is all activities that influence the quality, involving organizational, human resources, procurement, nuclear safety, projects, procedures and communication. Coordination of all these elements requires a great effort by the team responsible because it usually involves different areas and different levels of hierarchy within the organization. The objectives and desired benefits should be well set for everyone to understand what it means to be achieved and how to achieve. The support of senior management is critical at this stage, providing guidelines and resources necessary to get the job elapse clearly and efficiently, on time, cost and certain scope. The methodology of project management processes can be applied to facilitate and expedite the implementation of this system. Many of the principles of the QAS are correlated with knowledge areas of project management. The proposed model for implementation of a QAS in the nuclear fuel cycle facilities considered the best project management practices according to the Project Management Book of Knowledge (PMBOK - 5th edition) of the Project Management Institute (PMI). This knowledge is considered very good practices around the world. Since the model was defined, the deployment process becomes more practical and efficient, providing reduction in deployment time, better management of human

  9. Software requirements elicitation to support internal monitoring of quality assurance system for higher education in Indonesia

    Science.gov (United States)

    Amalia, A.; Gunawan, D.; Hardi, S. M.; Rachmawati, D.

    2018-02-01

    The Internal Quality Assurance System (in Indonesian: SPMI (Sistem Penjaminan Mutu Internal) is a systemic activity of quality assurance of higher education in Indonesia. SPMI should be done by all higher education or universities in Indonesia based on the Regulation of the Minister of Research, Technology and Higher Education of the Republic of Indonesia Number 62 of 2016. Implementation of SPMI must refer to the principle of SPMI that is independent, standardize, accurate, well planned and sustainable, documented and systematic. To assist the SPMI cycle properly, universities need a supporting software to monitor all the activities of SPMI. But in reality, many universities are not optimal in building this SPMI monitoring system. One of the obstacles is the determination of system requirements in support of SPMI principles is difficult to achieve. In this paper, we observe the initial phase of the engineering requirements elicitation. Unlike other methods that collect system requirements from users and stakeholders, we find the system requirements of the SPMI principles from SPMI guideline book. The result of this paper can be used as a choice in determining SPMI software requirements. This paper can also be used by developers and users to understand the scenario of SPMI so that could overcome the problems of understanding between this two parties.

  10. Using a web-based image quality assurance reporting system to improve image quality.

    Science.gov (United States)

    Czuczman, Gregory J; Pomerantz, Stuart R; Alkasab, Tarik K; Huang, Ambrose J

    2013-08-01

    The purpose of this study is to show the impact of a web-based image quality assurance reporting system on the rates of three common image quality errors at our institution. A web-based image quality assurance reporting system was developed and used beginning in April 2009. Image quality endpoints were assessed immediately before deployment (period 1), approximately 18 months after deployment of a prototype reporting system (period 2), and approximately 12 months after deployment of a subsequent upgraded department-wide reporting system (period 3). A total of 3067 axillary shoulder radiographs were reviewed for correct orientation, 355 shoulder CT scans were reviewed for correct reformatting of coronal and sagittal images, and 346 sacral MRI scans were reviewed for correct acquisition plane of axial images. Error rates for each review period were calculated and compared using the Fisher exact test. Error rates of axillary shoulder radiograph orientation were 35.9%, 7.2%, and 10.0%, respectively, for the three review periods. The decrease in error rate between periods 1 and 2 was statistically significant (p < 0.0001). Error rates of shoulder CT reformats were 9.8%, 2.7%, and 5.8%, respectively, for the three review periods. The decrease in error rate between periods 1 and 2 was statistically significant (p = 0.03). Error rates for sacral MRI axial sequences were 96.5%, 32.5%, and 3.4%, respectively, for the three review periods. The decrease in error rates between periods 1 and 2 and between periods 2 and 3 was statistically significant (p < 0.0001). A web-based system for reporting image quality errors may be effective for improving image quality.

  11. Achievements and Lessons Learned from Vietnam's Higher Education Quality Assurance System after a Decade of Establishment

    Science.gov (United States)

    Nguyen, Huu Cuong; Ta, Thi Thu Hien; Nguyen, Thi Thu Huong

    2017-01-01

    Higher education quality assurance and accreditation were officially implemented in Vietnam over twelve years ago. From a totally centralized model, Vietnam's accreditation system has been becoming more independent, especially with the establishment of accrediting agencies. The first accreditation certificates were also awarded to universities…

  12. System and Experiences in the Area of Radioactive Material Seizure Assurance

    International Nuclear Information System (INIS)

    Svoboda, K.; Podlaha, K.; Sir, D.

    2005-01-01

    In recent years, a number of radioactive seizures have been increased (i.e. the materials that contain one or more radionuclides and their activities from the point of view of radiation protection are not negligible). This is mainly due to newly installed technical equipment that monitors metal scrap resp. communal waste during its entry to metallurgical plants and iron works resp. incinerators or waste dumps. In the Nuclear research Institute Rez plc. (NRI Rez) was established a working group which provides, among other activities, full system of radioactive material seizure assurance. Part of this service contents also transport, storage, treatment, conditioning and disposal of the seizured radioactive source. This service was firstly established for communal waste dump, but other organizations can take advantage of this service not only for the seizures in communal waste dumps. The system of radioactive material seizure assurance is consisted of the following parts: (1) seizure on stationary detection system; (2) 24 hours emergency service of the working group; (3) event classification, detailed counting a tracking of radioactive source; (4) found radioactive source transport to NRI Rez for storage; (5) radioactive source characterization; (6) seizure evaluation and protocol providing; (7) State Office for Nuclear Safety (SONS) decree about next procedure. Stationary detection system ( detection gate ) is usually installed at the entry to dumps area, metallurgical plants, iron works etc. The detection gate traces changes of vehicle dose rate comparing to the average background by vehicle measurement. If the vehicle dose rate is significantly higher then the average background (usual alarm level is 10-30% above background), the vehicle is postponed by the gate operator and put aside on the determined place. Seizure is announced to the police of the Czech republic and to the SONS. Typical examples of the seizured radionuclide sources are: military, devices coated

  13. 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

  14. Quality Assurance In Radioactivity Measurements

    International Nuclear Information System (INIS)

    Riekstina, D.; Veveris, O.; Smilskalne, G.

    2007-01-01

    The credibility of obtained results is ensured by the quality assurance and control. The main requisitions involved in the quality assurance of the laboratory according to the requirements of LVS EN ISO/IEC 17025:2005 are: 1) the use of calibrated equipment only; 2) the regular and long-time use of reference materials in the control of equipment; 3) the estimation of uncertainty sources and determination of uncertainties within the given interval of credibility; 4) the validation and verification. The very important requirement is regular participation in the interlaboratory intercomparison exercises that makes it possible to estimate and find possible error sources and carry out the corrective actions. The measurements of the radioactivity of Cs-137, Co-60, H-3, the natural radioactive nuclides as well as other radionuclides in different environmental (soil, precipitation, different types of water, needles, et al.) samples, and in various radioactive polluted objects are carried out in the Laboratory of Radiation physics. The quality assurance system was implemented in our laboratory in 2000. Since 1999 laboratory is regular participant in the interlaboratory intercomparison exercises, organized by the RISO National Laboratory (Denmark) and IAEA (Vienna). The paper shows the laboratory's system of quality assurance and its implementation. We have the internal quality audit program that takes into account the requirements of LVS EN ISO/IEC 17025: 2005, but the main attention is paid to the intercomparison of the results of analyses of laboratories, their evaluation and interpretation. Only credible and justified results can be the basis for further use in any field, thus making it possible to make legitimate decisions. (Authors)

  15. Quality assurance programme for isotope diagnostic laboratories

    International Nuclear Information System (INIS)

    Krasznai, Istvan

    1987-01-01

    Quality assurance systems are suggested to be introduced in laboratories, in accordance with the recommendations of IAEA and WHO, taking local circumstances into consideration. It is emphasized that a quantitative enhancement of work must not endanger its quality; diagnostic information must be undistorted, reproducible, and gathered with the minimum of radiation burden. National authorities are requested to strengthen their supervision. Recommendations for quality assurance methods are given for medical isotope diagnostic laboratories. (author)

  16. The assurance management program for the Nova laser fusion project

    International Nuclear Information System (INIS)

    Levy, A.J.

    1983-01-01

    In a well managed project, Quality Assurance is an integral part of the management activities performed on a daily basis. Management assures successful performance within budget and on schedule by using all the good business, scientific, engineering, quality assurance, and safety practices available. Quality assurance and safety practices employed on Nova are put in perspective by integrating them into the overall function of good project management. The Inertial Confinement Fusion (ICF) approach is explained in general terms. The laser ICF and magnetic fusion facilities are significantly different in that the laser system is used solely as a highly reliable energy source for performing plasma physics experiments related to fusion target development; by contrast, magnetic fusion facilities are themselves the experiments. The Nova project consists of a 10-beam, 74 cm aperture neodymium-glass laser experimental facility which is being constructed by the Lawrence Livermore National Laboratory (LLNL) for the U.S. Department of Energy. Nova has a total estimated cost of $176M and will become operational in the Fall of 1984. The Nova laser will be used as the high energy driver for studying the regime of ignition for ICF. The Nova assurance management program was developed using the quality assurance (QA) approach first implemented at LLNL in early 1978. The LLNL QA program is described as an introduction to the Nova assurance management program. The Nova system is described pictorially through the Nova configuration, subsystems and major components, interjecting the QA techniques which are being pragmatically used to assure the successful completion of the project

  17. Quality assurance for geologic investigations

    International Nuclear Information System (INIS)

    Delvin, W.L.; Gustafson, L.D.

    1983-01-01

    A quality assurance handbook was written to provide guidance in the application of quality assurance to geologic work activities associated with the National Waste Terminal Storage (NWTS) Program. It is intended to help geoscientists and NWTS program managers in applying quality assurance to their work activities and projects by showing how technical and quality assurance practices are integrated to provide control within those activities and projects. The use of the guidance found in this handbook should help provide consistency in the interpretation of quality assurance requirements across the various geologic activities wihtin the NWTS Program. This handbook also can assist quality assurance personnel in understanding the relationships between technical and quality assurance practices. This paper describes the handbook

  18. Quality assurance for geologic investigations

    International Nuclear Information System (INIS)

    Delvin, W.L.; Gustafson, L.D.

    1983-01-01

    A quality assurance handbook was written to provide guidance in the application of quality assurance to geologic work activities associated with the National Waste Terminal Storage (NWTS) Program. It is intended to help geoscientists and NWTS program managers in applying quality assurance to their work activitie and projects by showing how technical and quality assurance practices are integrated to provide control within those activities and projects. The use of the guidance found in this handbook should help provide consistency in the interpretation of quality assurance requirements across the various geologic activities within the NWTS Program. This handbook also can assist quality assurance personnel in understanding the relationships between technical and quality assurance practices. This paper describes the handbook

  19. Quality Assurance Source Requirements Traceability Database

    International Nuclear Information System (INIS)

    MURTHY, R.; NAYDENOVA, A.; DEKLEVER, R.; BOONE, A.

    2006-01-01

    At the Yucca Mountain Project the Project Requirements Processing System assists in the management of relationships between regulatory and national/industry standards source criteria, and Quality Assurance Requirements and Description document (DOE/R W-0333P) requirements to create compliance matrices representing respective relationships. The matrices are submitted to the U.S. Nuclear Regulatory Commission to assist in the commission's review, interpretation, and concurrence with the Yucca Mountain Project QA program document. The tool is highly customized to meet the needs of the Office of Civilian Radioactive Waste Management Office of Quality Assurance

  20. Nuclear quality assurance: indoctrination and training

    International Nuclear Information System (INIS)

    Sternberg, A.

    1977-01-01

    Quality Assurance is defined as ''all the planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service''. Within Public Service Electric and Gas Company (PSEandG) Quality Assurance, a discipline which involves everyone within the company, is considered. In order to economically and effectively communicate this discipline throughout the concerned areas of the Company so that involved personnel are made fully aware of the complete scope of their tasks, a detailed comprehensive indoctrination and training program has been developed and implemented. 3 refs

  1. Implementing a High-Assurance Smart-Card OS

    Science.gov (United States)

    Karger, Paul A.; Toll, David C.; Palmer, Elaine R.; McIntosh, Suzanne K.; Weber, Samuel; Edwards, Jonathan W.

    Building a high-assurance, secure operating system for memory constrained systems, such as smart cards, introduces many challenges. The increasing power of smart cards has made their use feasible in applications such as electronic passports, military and public sector identification cards, and cell-phone based financial and entertainment applications. Such applications require a secure environment, which can only be provided with sufficient hardware and a secure operating system. We argue that smart cards pose additional security challenges when compared to traditional computer platforms. We discuss our design for a secure smart card operating system, named Caernarvon, and show that it addresses these challenges, which include secure application download, protection of cryptographic functions from malicious applications, resolution of covert channels, and assurance of both security and data integrity in the face of arbitrary power losses.

  2. Final Report of the NASA Office of Safety and Mission Assurance Agile Benchmarking Team

    Science.gov (United States)

    Wetherholt, Martha

    2016-01-01

    To ensure that the NASA Safety and Mission Assurance (SMA) community remains in a position to perform reliable Software Assurance (SA) on NASAs critical software (SW) systems with the software industry rapidly transitioning from waterfall to Agile processes, Terry Wilcutt, Chief, Safety and Mission Assurance, Office of Safety and Mission Assurance (OSMA) established the Agile Benchmarking Team (ABT). The Team's tasks were: 1. Research background literature on current Agile processes, 2. Perform benchmark activities with other organizations that are involved in software Agile processes to determine best practices, 3. Collect information on Agile-developed systems to enable improvements to the current NASA standards and processes to enhance their ability to perform reliable software assurance on NASA Agile-developed systems, 4. Suggest additional guidance and recommendations for updates to those standards and processes, as needed. The ABT's findings and recommendations for software management, engineering and software assurance are addressed herein.

  3. Krsko NPP Quality Assurance Plan Application to Nuclear Safety Upgrade Projects (PCFV System and PAR System)

    International Nuclear Information System (INIS)

    Biscan, Romeo; Fifnja, Igor

    2014-01-01

    Nuklearna Elektrarna Krsko (NEK) has undertaken Nuclear Safety Upgrade Projects as a safety improvement driven by the lessons learned from the Fukushima-Daiichi Accident. Among other projects, new modification 1008-VA-L Passive Containment Filtered Vent (PCFV) System has been installed which acts as the last barrier minimizing the release of radioactive material into the environment in case of failure of all safety systems, and to insure containment integrity during beyond design basis accidents (BDBA). In addition, modification 1002-GH-L Severe Accident Hydrogen Control System (PAR) has been implemented to prevent and mitigate the consequences of explosive gas generation (hydrogen and carbon monoxide) in case of reactor core melting. To ensure containment integrity for all design basis accidents (DBA) and BDBA conditions, NEK has eliminated existing safety-related electrical recombiners, replaced them with two safety-related passive autocatalytic recombiners (PARs) and added 20 new PARs designed for the BDBA conditions. Krsko NPP Quality Assurance Plan has been applied to Nuclear Safety Upgrade Projects (PCFV System and PAR System) through the following activities: · Internal audit of modification process was performed. · Supplier audits were performed to evaluate QA program efficiency of the main design organization and engineering organizations. · Evaluation and approval of Suppliers were performed. · QA engineer was involved in the review and approval of 1008-VA-L and 1002-GH-L modification documentation (Conceptual Design Package, Design Modification Package, Installation Package, Field Design Change Request, Problem/Deficiency Report, and Final Documentation Package). · Purchasing documentation for modifications 1008-VA-L and 1002-GH-L (technical specifications, purchase orders) has been verified and approved by QA. · QA and QC engineers were involved in oversight of production and testing of the new 1008-VA-L and 1002-GH-L plant components.

  4. Evaluation of reliability assurance approaches to operational nuclear safety

    International Nuclear Information System (INIS)

    Mueller, C.J.; Bezella, W.A.

    1984-01-01

    This report discusses the results of research to evaluate existing and/or recommended safety/reliability assurance activities among nuclear and other high technology industries for potential nuclear industry implementation. Since the Three Mile Island (TMI) accident, there has been increased interest in the use of reliability programs (RP) to assure the performance of nuclear safety systems throughout the plant's lifetime. Recently, several Nuclear Regulatory Commission (NRC) task forces or safety issue review groups have recommended RPs for assuring the continuing safety of nuclear reactor plants. 18 references

  5. Develpment of quality assurance manual for fabrication of DUPIC fuel

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Young Gun; Lee, J. W.; Kim, S. S. and others

    2001-09-01

    The Quality Assurance Manual for the fabrication of DUPIC fuel with high quality was developed. The Quality Assurance Policy established by this manual is to assure that the DUPIC fuel element supplied to customer conform to the specified requirements of customer, applicable codes and standards. The management of KAERI is committed to implementation and maintenance of the program described by this manual. This manual describes the quality assurance program for DUPIC fuel fabrication to comply with CAN3-Z299.2-85 to the extent as needed and appropriate. This manual describes the methods which DUPIC Fuel Development Team(DFDT) personnel must follow to achieve and assure high quality of our product. This manual also describes the quality management system applicable to the activities performed at DFDT.

  6. Develpment of quality assurance manual for fabrication of DUPIC fuel

    International Nuclear Information System (INIS)

    Lee, Young Gun; Lee, J. W.; Kim, S. S. and others

    2001-09-01

    The Quality Assurance Manual for the fabrication of DUPIC fuel with high quality was developed. The Quality Assurance Policy established by this manual is to assure that the DUPIC fuel element supplied to customer conform to the specified requirements of customer, applicable codes and standards. The management of KAERI is committed to implementation and maintenance of the program described by this manual. This manual describes the quality assurance program for DUPIC fuel fabrication to comply with CAN3-Z299.2-85 to the extent as needed and appropriate. This manual describes the methods which DUPIC Fuel Development Team(DFDT) personnel must follow to achieve and assure high quality of our product. This manual also describes the quality management system applicable to the activities performed at DFDT

  7. Quality assurance program

    International Nuclear Information System (INIS)

    1977-07-01

    This topical report describes the Gibbs and Hill Quality Assurance Program and sets forth the methods to be followed in controlling quality-related activities performed by Gibbs and Hill and its contractors. The program is based on company experience in nuclear power and related work, and defines a system found effective in providing independent control of quality-related functions and documentation. The scope of the report covers activities involving nuclear safety-related structures, systems, and components covered by Gibbs and Hill' contractual obligation to the Utility Owner for each project

  8. HACCP based quality assurance systems for organic food production systems

    OpenAIRE

    Knight, C.; Stanley, R.

    2007-01-01

    HACCP provides an effective, logical and structured means of assuring food safety. Although first used in food manufacturing operations, HACCP can be – and, increasingly is – applied to food production and handling operations at all stages in the food chain. This includes the primary production sector. The purpose of this paper is to illustrate how the principles of HACCP can be applied to organic production with special reference to the primary sector.

  9. Assurance of Fault Management: Risk-Significant Adverse Condition Awareness

    Science.gov (United States)

    Fitz, Rhonda

    2016-01-01

    Fault Management (FM) systems are ranked high in risk-based assessment of criticality within flight software, emphasizing the importance of establishing highly competent domain expertise to provide assurance for NASA projects, especially as spaceflight systems continue to increase in complexity. Insight into specific characteristics of FM architectures seen embedded within safety- and mission-critical software systems analyzed by the NASA Independent Verification Validation (IVV) Program has been enhanced with an FM Technical Reference (TR) suite. Benefits are aimed beyond the IVV community to those that seek ways to efficiently and effectively provide software assurance to reduce the FM risk posture of NASA and other space missions. The identification of particular FM architectures, visibility, and associated IVV techniques provides a TR suite that enables greater assurance that critical software systems will adequately protect against faults and respond to adverse conditions. The role FM has with regard to overall asset protection of flight software systems is being addressed with the development of an adverse condition (AC) database encompassing flight software vulnerabilities.Identification of potential off-nominal conditions and analysis to determine how a system responds to these conditions are important aspects of hazard analysis and fault management. Understanding what ACs the mission may face, and ensuring they are prevented or addressed is the responsibility of the assurance team, which necessarily should have insight into ACs beyond those defined by the project itself. Research efforts sponsored by NASAs Office of Safety and Mission Assurance defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs, and allowing queries based on project, mission

  10. Quality assurance handbook for measurement laboratories

    International Nuclear Information System (INIS)

    Delvin, W.L.

    1984-10-01

    This handbook provides guidance in the application of quality assurance to measurement activities. It is intended to help those persons making measurements in applying quality assurance to their work activities by showing how laboratory practices and quality assurance requirements are integrated to provide control within those activities. The use of the guidance found in this handbook should help provide consistency in the interpretation of quality assurance requirements across all types of measurement laboratories. This handbook also can assist quality assurance personnel in understanding the relationships between laboratory practices and quality assurance requirements. The handbook is composed of three chapters and several appendices. Basic guidance is provided by the three chapters. In Chapter 1, the role of quality assurance in obtaining quality data and the importance of such data are discussed. Chapter 2 presents the elements of laboratory quality assurance in terms of practices that can be used in controlling work activities to assure the acquisition of quality data. Chapter 3 discusses the implementation of laboratory quality assurance. The appendices provide supplemental information to give the users a better understanding of the following: what is quality assurance; why quality assurance is required; where quality assurance requirements come from; how those requirements are interpreted for application to laboratory operations; how the elements of laboratory quality assurance relate to various laboratory activities; and how a quality assurance program can be developed

  11. Quality assurance of metabolomics.

    Science.gov (United States)

    Bouhifd, Mounir; Beger, Richard; Flynn, Thomas; Guo, Lining; Harris, Georgina; Hogberg, Helena; Kaddurah-Daouk, Rima; Kamp, Hennicke; Kleensang, Andre; Maertens, Alexandra; Odwin-DaCosta, Shelly; Pamies, David; Robertson, Donald; Smirnova, Lena; Sun, Jinchun; Zhao, Liang; Hartung, Thomas

    2015-01-01

    Metabolomics promises a holistic phenotypic characterization of biological responses to toxicants. This technology is based on advanced chemical analytical tools with reasonable throughput, including mass-spectroscopy and NMR. Quality assurance, however - from experimental design, sample preparation, metabolite identification, to bioinformatics data-mining - is urgently needed to assure both quality of metabolomics data and reproducibility of biological models. In contrast to microarray-based transcriptomics, where consensus on quality assurance and reporting standards has been fostered over the last two decades, quality assurance of metabolomics is only now emerging. Regulatory use in safety sciences, and even proper scientific use of these technologies, demand quality assurance. In an effort to promote this discussion, an expert workshop discussed the quality assurance needs of metabolomics. The goals for this workshop were 1) to consider the challenges associated with metabolomics as an emerging science, with an emphasis on its application in toxicology and 2) to identify the key issues to be addressed in order to establish and implement quality assurance procedures in metabolomics-based toxicology. Consensus has still to be achieved regarding best practices to make sure sound, useful, and relevant information is derived from these new tools.

  12. Quality assurance

    International Nuclear Information System (INIS)

    Cante; Feger; Genevray; Hennion; Moneyron; Monneyron; Normand; Rastoin; Silberstein; Vaujour.

    1976-01-01

    The general principles of quality assurance and their applications within the French industrial and commercial regulations are presented. The conditions for the practical application of quality assurance to the different stages of the life of a nuclear power station (design, development, operation) are considered and a special mention is made of nuclear fuels and liquid sodium cooled reactors [fr

  13. The case of sustainability assurance: constructing a new assurance service

    NARCIS (Netherlands)

    O'Dwyer, B.

    2011-01-01

    This paper presents an in-depth longitudinal case study examining the processes through which practitioners in two Big 4 professional services firms have attempted to construct sustainability assurance (independent assurance on sustainability reports). Power’s (1996, 1997, 1999, 2003) theorization

  14. Real-time quality assurance testing using photonic techniques: Application to iodine water system

    Science.gov (United States)

    Arendale, W. F.; Hatcher, Richard; Garlington, Yadilett; Harwell, Jack; Everett, Tracey

    1990-01-01

    A feasibility study of the use of inspection systems incorporating photonic sensors and multivariate analyses to provide an instrumentation system that in real-time assures quality and that the system in control has been conducted. A system is in control when the near future of the product quality is predictable. Off-line chemical analyses can be used for a chemical process when slow kinetics allows time to take a sample to the laboratory and the system provides a recovery mechanism that returns the system to statistical control without intervention of the operator. The objective for this study has been the implementation of do-it-right-the-first-time and just-in-time philosophies. The Environment Control and Life Support Systems (ECLSS) water reclamation system that adds iodine for biocidal control is an ideal candidate for the study and implementation of do-it-right-the-first-time technologies.

  15. Designing and implementing a trust-wide quality assurance programme.

    Science.gov (United States)

    Coope, Sally-Ann

    2018-04-02

    Derbyshire Community Health Services (DCHS) NHS Foundation Trust provides a wide range of community-based health services. After the Care Quality Commission (CQC) found gaps in the trust's assurance process, its board decided to develop a method of continuous quality improvements that could be used as a basis for the trust's quality assurance system. The trust adapted and built on an acute model so it was suitable for community services. The final assurance system, Quality Always, has four elements: the clinical assessment and accreditation scheme; leadership development; 'champions' within clinical teams to support and promote the scheme; and dashboards to record and monitor progress. A system to recognise and reward achievement was essential for success. Quality Always has resulted in better care quality, an improved CQC rating, a sense of achievement among staff, the development of support networks, learning (especially among support staff) and good practice being shared.

  16. Patient-related quality assurance with different combinations of treatment planning systems, techniques, and machines. A multi-institutional survey

    Energy Technology Data Exchange (ETDEWEB)

    Steiniger, Beatrice; Schwedas, Michael; Weibert, Kirsten; Wiezorek, Tilo [University Hospital Jena, Department of Radiation Oncology, Jena (Germany); Berger, Rene [SRH Hospital Gera, Department of Radiation Oncology, Gera (Germany); Eilzer, Sabine [Martin-Luther-Hospital, Radiation Therapy, Berlin (Germany); Kornhuber, Christine [University Hospital Halle, Department of Radiation Oncology, Halle (Saale) (Germany); Lorenz, Kathleen [Hospital of Chemnitz, Department for Radiation Oncology, Chemnitz (Germany); Peil, Torsten [MVZ Center for Radiation Oncology Halle GmbH, Halle (Saale) (Germany); Reiffenstuhl, Carsten [University Hospital Carl Gustav Carus, Department of Radiation Oncology, Dresden (Germany); Schilz, Johannes [Helios Hospital Erfurt, Department of Radiation Oncology, Erfurt (Germany); Schroeder, Dirk [SRH Central Hospital Suhl, Department of Radiation Oncology, Suhl (Germany); Pensold, Stephanie [Community Hospital Dresden-Friedrichstadt, Department of Radiation Oncology, Dresden (Germany); Walke, Mathias [Otto-von-Guericke University Magdeburg, Department of Radiation Oncology, Magdeburg (Germany); Wolf, Ulrich [University Hospital Leipzig, Department of Radiation Oncology, Leipzig (Germany)

    2017-01-15

    This project compares the different patient-related quality assurance systems for intensity-modulated radiation therapy (IMRT) and volumetric-modulated arc therapy (VMAT) techniques currently used in the central Germany area with an independent measuring system. The participating institutions generated 21 treatment plans with different combinations of treatment planning systems (TPS) and linear accelerators (LINAC) for the QUASIMODO (Quality ASsurance of Intensity MODulated radiation Oncology) patient model. The plans were exposed to the ArcCHECK measuring system (Sun Nuclear Corporation, Melbourne, FL, USA). The dose distributions were analyzed using the corresponding software and a point dose measured at the isocenter with an ionization chamber. According to the generally used criteria of a 10 % threshold, 3 % difference, and 3 mm distance, the majority of plans investigated showed a gamma index exceeding 95 %. Only one plan did not fulfill the criteria and three of the plans did not comply with the commonly accepted tolerance level of ±3 % in point dose measurement. Using only one of the two examined methods for patient-related quality assurance is not sufficiently significant in all cases. (orig.) [German] Im Rahmen des Projekts sollten die verschiedenen derzeit im mitteldeutschen Raum eingesetzten patientenbezogenen Qualitaetssicherungssysteme zur intensitaetsmodulierten Radiotherapie (IMRT) und volumenmodulierten Arc-Radiotherapie (VMAT) mit einem unabhaengigen Messsystem verglichen werden. Die teilnehmenden Einrichtungen berechneten insgesamt 21 Bestrahlungsplaene mit verschiedenen Planungssystemen (TPS) und Linearbeschleunigern (LINAC) fuer das Patientenmodell QUASIMODO (Quality ASsurance of Intensity MODulated radiation Oncology), die dann auf das ArcCHECK-Phantom (Sun Nuclear Corporation, Melbourne, FL, USA) uebertragen und abgestrahlt wurden. Zur Auswertung wurde sowohl eine Punktmessung im Isozentrum als auch die Dosisverteilung in der Diodenebene des

  17. Summary of development and recommendations for a quality assurance program for the procurement and manufacture of urban mass transit operating equipment and systems

    Science.gov (United States)

    Witkin, S. A.

    1976-01-01

    A viable quality program for the urban mass transit industry, and a management approach to ensure compliance with the program are outlined. Included are: (1) a set of guidelines for quality assurance to be imposed on transit authorities, and a management approach to ensure compliance with them; (2) a management approach to be used by the transit authorities (properties) for assuring compliance with the QA guidelines; and (3) quality assurance guidelines to be imposed by properties and umta for procurement of hardware and systems.

  18. Quality assurance of computed and digital radiography systems

    International Nuclear Information System (INIS)

    Walsh, C.; Gorman, D.; Byrne, P.; Larkin, A.; Dowling, A.; Malone, J. F.

    2008-01-01

    Computed radiography (CR) and digital radiography (DR) are replacing traditional film screen radiography as hospitals move towards digital imaging and picture archiving and communication systems (PACS). Both IPEM and KCARE have recently published quality assurance and acceptance testing guidelines for DR. In this paper, the performance of a range of CR and DR systems is compared. Six different manufacturers are included. Particular attention is paid to the performance of the systems under automatic exposure control (AEC). The patient is simulated using a range of thicknesses of tissue equivalent material. Image quality assessment was based on detector assessment protocols and includes pixel value measures as well as subjective assessment using Leeds Test Objects. The protocols for detector assessment cover a broad range of tests and in general detectors (whether DR or CR) performed satisfactorily. The chief limitation in performing these tests was that not all systems provided ready access to pixel values. Subjective tests include the use of the Leeds TO20. As part of this work, suggested reference values are provided to calculate the TO20 image quality factor. One consequence of moving from film screen to digital technologies is that the dynamic range of digital detectors is much wider, and increased exposures are no longer evident from changes in image quality. As such, AEC is a key parameter for CR and DR. Dose was measured using a standard phantom as a basic means of comparing systems. In order to assess the AEC performance, exit doses were also measured while varying phantom thickness. Signal-to-noise ratios (SNRs) were calculated on a number of systems where pixel values were available. SNR was affected by the selection of acquisition protocol. Comparisons between different technologies and collation of data will help refine acceptance thresholds and contribute to optimising dose and image quality. (authors)

  19. Evaluation of a Standardized Method of Quality Assurance in Mental Health Records: A Pilot Study

    Science.gov (United States)

    Bradshaw, Kelsey M.; Donohue, Bradley; Fayeghi, Jasmine; Lee, Tiffany; Wilks, Chelsey R.; Ross, Brendon

    2016-01-01

    The widespread adoption of research-supported treatments by mental health providers has facilitated empirical development of quality assurance (QA) methods. Research in this area has focused on QA systems aimed at assuring the integrity of research-supported treatment implementation, while examination of QA systems to assure appropriate…

  20. Implementing hospital quality assurance policies in Iran: balancing licensing, annual evaluation, inspections and quality management systems.

    Science.gov (United States)

    Aghaei Hashjin, Asgar; Delgoshaei, Bahram; Kringos, Dionne S; Tabibi, Seyed Jamaladin; Manouchehri, Jila; Klazinga, Niek S

    2015-01-01

    The purpose of this paper is to provide an overview of applied hospital quality assurance (QA) policies in Iran. A mixed method (quantitative data and qualitative document analysis) study was carried out between 1996 and 2010. The QA policy cycle forms a tight monitoring system to assure hospital quality by combining mandatory and voluntary methods in Iran. The licensing, annual evaluation and grading, and regulatory inspections statutorily implemented by the government as a national package to assure and improve hospital care quality, while implementing quality management systems (QMS) was voluntary for hospitals. The government's strong QA policy legislation role and support has been an important factor for successful QA implementation in Iran, though it may affected QA assessment independency and validity. Increased hospital evaluation independency and repositioning, updating standards, professional involvement and effectiveness studies could increase QA policy impact and maturity. The study highlights the current QA policy implementation cycle in Iranian hospitals. It provides a basis for further quality strategy development in Iranian hospitals and elsewhere. It also raises attention about finding the optimal balance between different QA policies, which is topical for many countries. This paper describes experiences when implementing a unique approach, combining mandatory and voluntary QA policies simultaneously in a developing country, which has invested considerably over time to improve hospital quality. The experiences with a mixed obligatory/voluntary approach and comprehensive policies in Iran may contain lessons for policy makers in developing and developed countries.

  1. Research on assurance system of nuclear fuel supply (Contract research)

    International Nuclear Information System (INIS)

    Kobayashi, Naoki; Naoi, Yosuke; Wakabayashi, Shuji; Tazaki, Makiko; Senzaki, Masao

    2010-03-01

    Assurance of supply (AOS) of nuclear fuel is a special arrangement in case of nuclear fuel supply disruption caused by political reasons other than nonproliferation. It aims to support a stable supply of nuclear fuel while avoiding unnecessary spread of sensitive enrichment technology. Current discussions on AOS have been initiated by the IAEA Director-General's article published in The Economist entitled 'Towards a Safer World' Oct. 2003. Since then, various proposals on AOS have been presented. In order to facilitate international discussions on AOS, authors have conducted studies of AOS system based on Japanese Government's proposal 'IAEA Standby Arrangement System (INFCIRC/683)'. In this paper, we gave an overview of discussions on AOS since World War II, and elaborated on some of current proposals. We have been able to discuss feasibility of AOS system more specifically by including additional costs and period required for AOS, and to present a system which could work as a practical system. Issues we have tried to tackle here include definitions of AOS, and roles of consumer states, supplier states, IAEA and nuclear industries. We present some solutions including broadening coverage of AOS, declaration by supplier states on AOS, establishing advisory committee in the IAEA on the actual application of AOS, and setting up an IAEA fund for AOS. (author)

  2. A Study of Quality Assurance Practices in the Universiti Sains Malaysia (USM, Malaysia

    Directory of Open Access Journals (Sweden)

    Helen KHOO Chooi Sim; Rozhan M. IDRUS

    2004-01-01

    Full Text Available This article looks at the quality assurance practices amongst three (3 groups of staff in the School of Distance Education, Universiti Sains Malaysia, i.e. lecturers, resident tutors and support staff. 9 dimensions of the Quality Assurance Practices i.e. Staff Development, Planning, Work Process, Team Work, Prioritise Customers, Performance Evaluation, System For Sending Of Learning Materials, System For Receiving Of Assignments From Students and Management of Students’ Records are identified in this study. The results show that quality assurances practices amongst three groups are different. Profile Analysis used in this research shows that quality assurance practices amongst lecturers and support staff are parallel. Results also show that quality assurance practices of resident tutors have profiles that differ from the lecturers and support staff.

  3. Present status of quality assurance system for radiation therapy in the national hospital and sanatorium

    International Nuclear Information System (INIS)

    Uno, Takashi; Itami, Jun; Kotaka, Kikuo; Terui, Takashi

    1994-01-01

    In order to improve the precision of radiation therapy and structure of radiation oncology, the state of quality assurance (QA) system for external radiation therapy in Japanese national hospitals and sanatoriums were investigated, by a questionnaire method. The questionnaire included the equipments, the personnel, and a frequency in quality assurance check of each radiation therapy facilities. The results clarified that real photon energy of megavoltage equipment was measured in only 57% of 58% institutions; frequency of the dose monitor calibration was suboptimal; personnel scale was markedly insufficient; some treatment-related apparatus was inappropriately arranged between institutions. Based on these results, it was considered that the precision of radiation therapy and its QA state could not be improved without personnel sufficiency. In the present situation, we should consider the arrangement of treatment facilities in each area and specialization of radiation therapy between institutions. (author)

  4. [Quality assurance in colorectal cancer in Europe AD 2011].

    Science.gov (United States)

    Mroczkowski, P; Hac, S; Lippert, H; Kube, R

    2013-12-01

    Malignant tumours are the second largest cause of death in Europe. Colorectal cancer takes second place within this group and is responsible for every eighth tumour-related death. Surgical quality assurance requires a prospective observational study, any different type of study is not possible. A complete recording of all treated patients is a prerequisite for quality assurance. Currently, there are quality assurance programmes in Sweden, Norway, Denmark, Great Britain, Spain, Belgium, the Netherlands as well as the multinational study for patients from Germany, Poland and Italy. These projects deliver comprehensive information regarding the treatment of colorectal cancer. However, this information is deeply rooted in the organisation of the health-care system in the given country and is not easily transferable into international settings. Also, an interpretation of the collected data is often possible only within the given health-care system. First, unified initial diagnostics is a prerequisite for quality assurance -  for the local extent and exclusion / confirmation of distant metastases. Until these criteria are unified, any comparison is limited, including a comparison of survival. Second, quality-of-life is not recorded in any of the current projects. Third, the main focus of a quality assurance project must be on therapy-dependent factors. The most sensible method of quality control remains within the connection of preoperative diagnostics (estimate of a best-case scenario), the surgical technique (the actual result) and a standardised pathological examination (evaluation of the actual result). These parameters can be recorded and compared within a quality assurance project regardless of the limitations of the national health-care systems. There is no alternative to a unified diagnostics model and unified histopathological evaluation, a complete picture of treatment quality is also not possible without systematic analysis of the quality of life.

  5. Quality Assurance and T&E of Inertial Systems for RLV Mission

    Science.gov (United States)

    Sathiamurthi, S.; Thakur, Nayana; Hari, K.; Peter, Pilmy; Biju, V. S.; Mani, K. S.

    2017-12-01

    This work describes the quality assurance and Test and Evaluation (T&E) activities carried out for the inertial systems flown successfully in India's first reusable launch vehicle technology demonstrator hypersonic experiment mission. As part of reliability analysis, failure mode effect and criticality analysis and derating analysis were carried out in the initial design phase, findings presented to design review forums and the recommendations were implemented. T&E plan was meticulously worked out and presented to respective forums for review and implementation. Test data analysis, health parameter plotting and test report generation was automated and these automations significantly reduced the time required for these activities and helped to avoid manual errors. Further, T&E cycle is optimized without compromising on quality aspects. These specific measures helped to achieve zero defect delivery of inertial systems for RLV application.

  6. Systems Analysis Programs for Hands-on Integrated Reliability Evaluations (SAPHIRE) Quality Assurance Manual

    Energy Technology Data Exchange (ETDEWEB)

    C. L. Smith; R. Nims; K. J. Kvarfordt; C. Wharton

    2008-08-01

    The Systems Analysis Programs for Hands-on Integrated Reliability Evaluations (SAPHIRE) is a software application developed for performing a complete probabilistic risk assessment using a personal computer running the Microsoft Windows operating system. SAPHIRE is primarily funded by the U.S. Nuclear Regulatory Commission (NRC). The role of the INL in this project is that of software developer and tester. This development takes place using formal software development procedures and is subject to quality assurance (QA) processes. The purpose of this document is to describe how the SAPHIRE software QA is performed for Version 6 and 7, what constitutes its parts, and limitations of those processes.

  7. The Practice of a Quality Assurance System in Open and Distance Learning: A case study at Universitas Terbuka Indonesia (The Indonesia Open University

    Directory of Open Access Journals (Sweden)

    Tian Belawati

    2007-03-01

    Full Text Available Quality assurance for distance higher education is one of the main concerns among institutions and stakeholders today. This paper examines the experiences of Universitas Terbuka (UT, which has initiated and implemented an innovative strategy of quality assurance (QA for continuous improvement. The credo of the UT quality assurance system is "We write what we do. We do what we write. We check. We improve continuously!" Implementing a quality management system at the UT, a mega-university with a student body of more than a quarter of a million and which involved a network of participating institutions and regional centres, was a formidable task to accomplish. To achieve its lofty goal, UT adopted and contextualised the draft of the Asian Association of Open Universities (AAOU QA Framework to launch its own quality assurance program. This has taken a great deal of commitment and participation of all staff involved. QA at the UT required systematic and step-by-step processes, including development of the QA framework and job manuals, raising awareness and commitment amongst all staff involved, internal assessment, and integration of QA programs into the university's annual action plans, external assessment and benchmarking. This paper concludes that quality assurance must be developed as institutional policy and strategy for continuous improvement.

  8. New Paradigm in Nuclear Safety from Quality Assurance to Safety Management System

    International Nuclear Information System (INIS)

    Lim, Nam-Jin; Park, Chan-Gook; Nam, Ji-Hee; Kim, Kwan-Hyun; Kwon, Hyuk-il; Lee, Young-Gun Lee

    2006-01-01

    The initial concept of Quality Control (QC) controlling the quality of products is now evolving toward the Management System (MS) achieving safety, through Quality Assurance (QA) ensuring the quality of products and Quality Management (QM) managing the quality by a systematic approach. Nuclear safety can be achieved through an integrated MS that ensures the health, environmental, security, quality and economic requirements being considered together with nuclear safety requirements. MS approach is developed through realizing that most of nuclear accidents had occurred not by the malfunction of hardware or equipment, but by the human error. The MS is a set of inter-related or interacting elements (system) that establishes policies and objectives and which enables those objectives to be achieved in an efficient and effective way

  9. Operating and Assurance Program Plan. Revision 4

    Energy Technology Data Exchange (ETDEWEB)

    1994-07-01

    The LBL Operating and Assurance Program (OAP) is a management system and a set of requirements designed to maintain the level of performance necessary to achieve LBL`s programmatic and administrative objectives effectively and safely through the application of quality assurance and related conduct of operations and maintenance management principles. Implement an LBL management philosophy that supports and encourages continual improvement in performance and quality at the Laboratory. Provide an integrated approach to compliance with applicable regulatory requirements and DOE orders. The OAP is intended to meet the requirements of DOE Order 5700.6C, Quality Assurance. The Program also contains management system elements of DOE Orders 5480.19, Conduct of Operations Requirements for DOE Facilities; 5480.25, Safety of Accelerator Facilities; and 4330.4A, Maintenance Management Program, and is meant to integrate these elements into the overall LBL approach to Laboratory management. The requirements of this program apply to LBL employees and organizations, and to contractors and facility users as managed by their LBL sponsors. They are also applicable to external vendors and suppliers as specified in procurement documents and contracts.

  10. Quality assurance policies and practices in Scandinavian higher education systems: convergence or different paths?

    DEFF Research Database (Denmark)

    Kalpazidou Schmidt, Evanthia

    2017-01-01

    Because there is close cooperation on quality assurance in the Scandinavian countries, one would expect there to be convergence of quality assurance policies and practices in Scandinavian higher education. Few studies have analysed these quality assurance policies and practices from a comparative...... quality assurance. The debate is compelling with regard to the Swedish case in particular, with its ‘one size fits all’ approach and exclusive focus on outcomes which has been heavily criticised by the higher education institutions and has turned out to be controversial from the European viewpoint....... viewpoint. Based on empirical evidence produced in connection with studies of recent quality reforms in Scandinavia and an approach based on linking diffusion and translation theories with institutionalist perspectives focusing on path dependency, the paper contributes to the current debate on Scandinavian...

  11. Quality assurance during operation of nuclear power plants

    International Nuclear Information System (INIS)

    Modemann, G.

    1990-01-01

    The demands of the licensing authorities and the Nuclear Safety Regulations (KTA Rules) on the one hand and the utility's requirements on the other hand have led to the quality assurance system for the operation of nuclear power plants. One part of the system is the organizational structure for the distribution of all tasks and responsibilities to qualified staff members; all checks are carried out by experts who are independent of the executing staff if necessary. The other part of the system comprises the procedural structures for operation, maintenance, inspection, repair and modifications as well as for procurement and preparation of materials and spare parts. The application and efficiency of the quality assurance system is supervised and periodically checked by an independent department. (orig.) [de

  12. On intra-supply chain system with an improved distribution plan, multiple sales locations and quality assurance.

    Science.gov (United States)

    Chiu, Singa Wang; Huang, Chao-Chih; Chiang, Kuo-Wei; Wu, Mei-Fang

    2015-01-01

    Transnational companies, operating in extremely competitive global markets, always seek to lower different operating costs, such as inventory holding costs in their intra- supply chain system. This paper incorporates a cost reducing product distribution policy into an intra-supply chain system with multiple sales locations and quality assurance studied by [Chiu et al., Expert Syst Appl, 40:2669-2676, (2013)]. Under the proposed cost reducing distribution policy, an added initial delivery of end items is distributed to multiple sales locations to meet their demand during the production unit's uptime and rework time. After rework when the remaining production lot goes through quality assurance, n fixed quantity installments of finished items are then transported to sales locations at a fixed time interval. Mathematical modeling and optimization techniques are used to derive closed-form optimal operating policies for the proposed system. Furthermore, the study demonstrates significant savings in stock holding costs for both the production unit and sales locations. Alternative of outsourcing product delivery task to an external distributor is analyzed to assist managerial decision making in potential outsourcing issues in order to facilitate further reduction in operating costs.

  13. Computer software quality assurance

    International Nuclear Information System (INIS)

    Ives, K.A.

    1986-06-01

    The author defines some criteria for the evaluation of software quality assurance elements for applicability to the regulation of the nuclear industry. The author then analyses a number of software quality assurance (SQA) standards. The major extracted SQA elements are then discussed, and finally specific software quality assurance recommendations are made for the nuclear industry

  14. Supply assurance in the nuclear fuel cycle

    International Nuclear Information System (INIS)

    Neff, T.L.; Jacoby, H.D.

    1979-01-01

    Nuclear fuel assurance, in the face of world and political uncertainties, is interrelated with nuclear technology development plans and international safeguards considerations. This has led some countries to accelerate their commitments to nuclear commercialization faster than necessary and has made non-proliferation policies harder to enforce. Fuel assurance is described on a national basis in three time scales: short-term, or resilience to supply interruptions; mid-term, or contract conditions in which governments make commitments to purchase or deliver; and long-term, or resource adequacy. A review of former assurance problems and current trends in the enrichment and uranium markets indicates that supplier concentration is no longer the major problem so much as non-proliferation actions. The present state of unstable equilibrium is expected to move in the direction of less fuel-supply assurance for countries having a small market or not subscribing to non-proliferation criteria. The authors, while generally optimistic that the fuel-supply system will function, express concern that policies for fuel stockpiles and the condition of uranium markets need improvement. 21 references

  15. Assuring Software Reliability

    Science.gov (United States)

    2014-08-01

    technologies and processes to achieve a required level of confidence that software systems and services function in the intended manner. 1.3 Security Example...that took three high-voltage lines out of service and a software fail- ure (a race condition3) that disabled the computing service that notified the... service had failed. Instead of analyzing the details of the alarm server failure, the reviewers asked why the following software assurance claim had

  16. Quality assurance in radiotherapy

    International Nuclear Information System (INIS)

    2003-03-01

    Good radiotherapy results and safety of treatment require the radiation to be optimally applied to a specified target area and the correct dose. According to international recommendations, the average uncertainty in therapeutic dose should not exceed 5%. The need for high precision in therapeutic dose requires quality assurance covering the entire radiotherapy process. Besides the physical and technical characteristics of the therapy equipment, quality assurance must include all radiotherapy equipment and procedures that are significant for the correct magnitude and precision of application of the therapeutic dose. The duties and responsibilities pertaining to various stages of treatment must also be precisely defined. These requirements may be best implemented through a quality system. The general requirements for supervision and quality assurance of medical radiation apparatus are prescribed in section 40 of the Radiation Act (592/1991, amendment 1142/1998) and in sections 18 and 32 of the Decree of the Ministry of Social Affairs and Health on the medical use of radiation (423/2000). Guide ST 2.2 imposes requirements on structural radiation shielding of radiotherapy equipment and the premises in which it is used, and on warning and safety arrangements. Guide ST 1.1 sets out the general safety principles for radiation practices and regulatory control procedure for the use of radiation. Guide ST 1.6 provides general requirements for operational measures in the use of radiation. This Guide sets out the duties of responsible parties (the party running a radiation practice) in respect of arranging and maintaining radiotherapy quality assurance. The principles set out in this Guide and Guide ST 6.3 may be applied to radionuclide therapy

  17. Software Quality Assurance Audits Guidebooks

    Science.gov (United States)

    1990-01-01

    The growth in cost and importance of software to NASA has caused NASA to address the improvement of software development across the agency. One of the products of this program is a series of guidebooks that define a NASA concept of the assurance processes that are used in software development. The Software Assurance Guidebook, NASA-GB-A201, issued in September, 1989, provides an overall picture of the NASA concepts and practices in software assurance. Second level guidebooks focus on specific activities that fall within the software assurance discipline, and provide more detailed information for the manager and/or practitioner. This is the second level Software Quality Assurance Audits Guidebook that describes software quality assurance audits in a way that is compatible with practices at NASA Centers.

  18. From technical quality assurance of radiotherapy to a comprehensive quality of service management system

    International Nuclear Information System (INIS)

    Kehoe, T.; Rugg, L.

    1999-01-01

    A hierarchy of dosimetry, planning and machine performance checks and evaluations of clinical outcomes have been widely used in radiotherapy for decades. Procedures, codes of practice and guidance are readily available on the technical aspects of radiotherapy treatments, maintenance of which is achieved by quality control checks within a quality assurance approach to radiotherapy. Recently a series of high profile, well-publicised treatment accidents resulting in damage to patients have focused the attention of both professionals and the public. There is now pressure to introduce formal quality management systems. Patients and their relatives/carers are having their expectations raised but their definition of a quality service differs from that generally considered by the oncology professionals. Most departmental managers and staff have wide experience of quality control checks. They understand the philosophy of quality assurance. However the idea of formal quality systems/quality management is alien to them. What is a professional/departmental manager to do? This paper addresses that question by discussing the underlying principles of quality management covering service provision as well as technical radiotherapy treatment delivery and by providing some guidance based on experience in the practical implementation of quality management through three stages of development: a QA programme incorporating checks on essential parts of the technical treatment delivery, a formal documented certified QA system focusing on technical treatment delivery, a comprehensive quality management system covering all parts of a service. One possible action plan is provided indicating progress through the three stages of development based on experience in one large Radiation Oncology Department. With planning, resources and commitment. a comprehensive quality of service management system is achievable in radiotherapy. (author.)

  19. Quality assurance programme of Temelin nuclear power plant

    International Nuclear Information System (INIS)

    Eybl, J.; Nowak, O.

    1988-01-01

    The fundamental principle of the system of quality assurance in Czechoslovak nuclear power is quality assurance at all stages of the construction and operation of nuclear power plants and the grading fo measures taken, this in dependence on the impact on nuclear safety of the respective nuclear installation or its part. The system has been made fully operational during the construction of nuclear power plants in Temelin and Mochovce. State surveillance is executed by the Czechoslovak Atomic Energy Commission, and the Czech and Slovak Offices for Work Safety. Briefly discussed are the tasks of the building subcontractor of the Temelin nuclear power plant with regard to the programme of quality assurance as well as the results of the solution of the respective research tasks. The programme of quality assurance classifies the selected sections of the structure of a nuclear power plant into three safety categories. No part of the structure is classified into the first category, the second category includes, e.g., the reactor building, cooling tanks and diesel generator units, the third includes the reactor building and the building of auxiliary workshops. Attention is also paid to the problems of the qualification of personnel and to inspection activity. (Z.M.). 12 refs

  20. Power transformers quality assurance

    CERN Document Server

    Dasgupta, Indrajit

    2009-01-01

    About the Book: With the view to attain higher reliability in power system operation, the quality assurance in the field of distribution and power transformers has claimed growing attention. Besides new developments in the material technology and manufacturing processes of transformers, regular diagnostic testing and maintenance of any engineering product may be ascertained by ensuring: right selection of materials and components and their quality checks. application of correct manufacturing processes any systems engineering. the user`s awareness towards preventive maintenance. The

  1. Data Quality Assurance Governance

    OpenAIRE

    Montserrat Gonzalez; Stephanie Suhr

    2016-01-01

    This deliverable describes the ELIXIR-EXCELERATE Quality Management Strategy, addressing EXCELERATE Ethics requirement no. 5 on Data Quality Assurance Governance. The strategy describes the essential procedures and practices within ELIXIR-EXCELERATE concerning planning of quality management, performing quality assurance and controlling quality. It also depicts the overall organisation of ELIXIR with emphasis on authority and specific responsibilities related to quality assurance.

  2. Quality assurance program

    International Nuclear Information System (INIS)

    Brooks, G.L.

    The concept of levels of quality assurance as applied to CANDU-type nuclear power plant components, i.e. maintaining an appropriate cost/benefit ratio, is introduced. The design process itself has quality assurance features by virtue of multi-level review. (E.C.B.)

  3. Development of Quality Assurance System in Culture and Nation Character Education in Primary Education in Indonesia

    Science.gov (United States)

    Susilana, Rudi; Asra

    2013-01-01

    The purpose of national education is to develop skills and build dignified national character and civilization in educating nation life (Act No. 20, 2003). The paper describes a system of quality assurance in culture and character education in primary education. This study employs the six sigma model which consists of the formula DMAIC (Define,…

  4. MONITORING OF QUALITY ASSURANCE SYSTEMS IN FOREST INDUSTRY (DÜZCE CASE

    Directory of Open Access Journals (Sweden)

    Tarık Gedik

    2005-04-01

    Full Text Available : In this study, forest industry firms in Düzce city centre were researched. The aim of this study is to investigate the quality assurance systems, standards and quality perceptions of forest industry firms. We used a questionnaire that includes 21 questions. First section of the questionnaire covered general features of the firm. Other sections queried quality perceptions of the firms and staff and quality control process in firms. 30 firms were included in this study and data were analyzed with SPSS statistical program. Evaluation of data revealed that most of the firms have been undertaken revision. Firms are actively seeking new quality approaches and considering the views of their customers in planning phase.

  5. Monitoring of performance management using Quality Assurance Indicators and ISO requirement

    Directory of Open Access Journals (Sweden)

    Dargahi H

    2007-06-01

    Full Text Available Background: Quality assurance is a prevention-oriented system that can be used to improve the quality of care, increase productivity and monitor the performance management in clinical laboratories. ISO 9001: 2000 requirements are a collection of management and technical systems designed to implement quality assurance and monitor performance management in organizations. Methods: A checklist was prepared to monitor the preanalytical, analytical and postanalytical stages of laboratory performance management in 16 areas and all laboratory activities in 14 of the clinical laboratories of the Tehran University of Medical Sciences (TUMS hospitals. Collected data were stored and statistically analyzed using SPSS software. Results: The best performance, in which 77.73% of quality assurance indicators were observed, was found in Sina Hospital. However, only 57.56% of these indicators were fulfilled at Farabi Hospital, with the lowest-level performance among the clinical laboratories of TUMS hospitals. The highest level of compliance with quality assurance indicators was in the hematology departments and for facility demands in management areas. Overall, quality assurance indicators were appropriately followed in only 7% of the clinical laboratories. Conclusion: The average quality assurance observation rate in the clinical laboratories studied was 67.22%, which is insufficient and must be remedied with stricter enforcement of the ISO 9001: 2000 regulations.

  6. Commutability of possible external quality assessment materials for cardiac troponin measurement.

    Directory of Open Access Journals (Sweden)

    Shunli Zhang

    Full Text Available The measurement of cardiac troponin is crucial in the diagnosis of myocardial infarction. The performance of troponin measurement is most conveniently monitored by external quality assessment (EQA programs. The commutability of EQA samples is often unknown and the effectiveness of EQA programs is limited.Commutability of possible EQA materials was evaluated. Commercial control materials used in an EQA program, human serum pools prepared from patient samples, purified analyte preparations, swine sera from model animals and a set of patient samples were measured for cTnI with 4 assays including Abbott Architect, Beckman Access, Ortho Vitros and Siemens Centaur. The measurement results were logarithm-transformed, and the transformed data for patient samples were pairwise analyzed with Deming regression and 95% prediction intervals were calculated for each pair of assays. The commutability of the materials was evaluated by comparing the logarithmic results of the materials with the limits of the intervals. Matrix-related biases were estimated for noncommutable materials. The impact of matrix-related bias on EQA was analyzed and a possible correction for the bias was proposed.Human serum pools were commutable for all assays; purified analyte preparations were commutable for 2 of the 6 assay pairs; commercial control materials and swine sera were all noncommutable; swine sera showed no reactivity to Vitros assay. The matrix-related biases for noncommutable materials ranged from -83% to 944%. Matrix-related biases of the EQA materials caused major abnormal between-assay variations in the EQA program and correction of the biases normalized the variations.Commutability of materials has major impact on the effectiveness of EQA programs for cTnI measurement. Human serum pools prepared from patient samples are commutable and other materials are mostly noncommutable. EQA programs should include at least one human serum pool to allow proper interpretation of

  7. Using management information systems to enhance health care quality assurance.

    Science.gov (United States)

    Rosser, L H; Kleiner, B H

    1995-01-01

    Examines how computers and quality assurance are being used to improve the quality of health care delivery. Traditional quality assurance methods have been limited in their ability to effectively manage the high volume of data generated by the health care process. Computers on the other hand are able to handle large volumes of data as well as monitor patient care activities in both the acute care and ambulatory care settings. Discusses the use of computers to collect and analyse patient data so that changes and problems can be identified. In addition, computer models for reminding physicians to order appropriate preventive health measures for their patients are presented. Concludes that the use of computers to augment quality improvement is essential if the quality of patient care and health promotion are to be improved.

  8. Application of NASA Kennedy Space Center System Assurance Analysis methodology to nuclear power plant systems designs

    International Nuclear Information System (INIS)

    Page, D.W.

    1985-01-01

    In May of 1982, the Kennedy Space Center (KSC) entered into an agreement with the NRC to conduct a study to demonstrate the feasibility and practicality of applying the KSC System Assurance Analysis (SAA) methodology to nuclear power plant systems designs. North Carolina's Duke Power Company expressed an interest in the study and proposed the nuclear power facility at CATAWBA for the basis of the study. In joint meetings of KSC and Duke Power personnel, an agreement was made to select two CATAWBA systems, the Containment Spray System and the Residual Heat Removal System, for the analyses. Duke Power provided KSC with a full set of Final Safety Analysis Reports (FSAR) as well as schematics for the two systems. During Phase I of the study the reliability analyses of the SAA were performed. During Phase II the hazard analyses were performed. The final product of Phase II is a handbook for implementing the SAA methodology into nuclear power plant systems designs. The purpose of this paper is to describe the SAA methodology as it applies to nuclear power plant systems designs and to discuss the feasibility of its application. (orig./HP)

  9. In-house quality audit and benefits of some quality control procedures in the quality assurance of TL dosimetry system at NRPB

    International Nuclear Information System (INIS)

    Dutt, J.C.

    1993-01-01

    A number of Quality Control (QC) procedures have been introduced into the running and operation of the NRPB personal monitoring services. Those described here apply to the whole-body TL dosimetry system. These QC procedures comprise Quality Assurance (QA) of incoming raw materials and equipment, reader stabilisation, daily, routine and periodic QA checks on all phases of the service. In-house quality audit, periodic internal and external 'blind QA checks' on the dosimetry system as a whole have assured the continuing high quality and reliability of the NRPB TL dosimetry service for assessing body and skin doses of radiation workers from external photon and beta radiations. (author)

  10. Data mining methods for quality assurance in an environmental monitoring network

    NARCIS (Netherlands)

    Athanasiadis, Ioannis N.; Rizzoli, Andrea Emilio; Beard, Daniel W.

    2010-01-01

    The paper presents a system architecture that employs data mining techniques for ensuring quality assurance in an environmental monitoring network. We investigate how data mining techniques can be incorporated in the quality assurance decision making process. As prior expert decisions are

  11. A Systems Engineering Approach to Quality Assurance for Aerospace Testing

    Science.gov (United States)

    Shepherd, Christena C.

    2015-01-01

    On the surface, it appears that AS91001 has little to say about how to apply a Quality Management System (QMS) to major aerospace test programs (or even smaller ones). It also appears that there is little in the quality engineering Body of Knowledge (BOK)2 that applies to testing, unless it is nondestructive examination (NDE), or some type of lab or bench testing associated with the manufacturing process. However, if one examines: a) how the systems engineering (SE) processes are implemented throughout a test program; and b) how these SE processes can be mapped to the requirements of AS9100, a number of areas for involvement of the quality professional are revealed. What often happens is that quality assurance during a test program is limited to inspections of the test article; what could be considered a manufacturing al fresco approach. This limits the quality professional and is a disservice to the programs and projects, since there are a number of ways that quality can enhance critical processes, and support efforts to improve risk reduction, efficiency and effectiveness.

  12. Quality assurance

    OpenAIRE

    Cauchi, Maurice A.M.

    1993-01-01

    The concept of quality assurance refers more specifically to the process of objectifying and clearly enunciating goals, and providing means of assessing the outcomes. In this article the author mentions four fundamental elements of quality assurance which should be applied in the medical profession in Malta. These elements should relate to professional performance, resource utilisation, risk management and patient satisfaction. The aim of the medical professionals in Malta is to provide the b...

  13. The Development of Evaluation Model for Internal Quality Assurance System of Dramatic Arts College of Bunditpattanasilpa Institute

    Science.gov (United States)

    Sinthukhot, Kittisak; Srihamongkol, Yannapat; Luanganggoon, Nuchwana; Suwannoi, Paisan

    2013-01-01

    The research purpose was to develop an evaluation model for the internal quality assurance system of the dramatic arts College of Bunditpattanasilpa Institute. The Research and Development method was used as research methodology which was divided into three phases; "developing the model and its guideline", "trying out the actual…

  14. Nuclear Technology. Course 31: Quality Assurance Practices. Module 31-7, Auditing for Quality Assurance.

    Science.gov (United States)

    Pritchard, Jim; Espy, John

    This seventh in a series of eight modules for a course titled Quality Assurance Practices describes the key features of an audit system and offers practice in carrying out tasks of the technicians. The module follows a typical format that includes the following sections: (1) introduction, (2) module prerequisites, (3) objectives, (4) notes to…

  15. DOE financial assurance presentation

    International Nuclear Information System (INIS)

    Huck, R.

    1990-01-01

    The presentation topic is California's approach to license application review in meeting financial assurances for the proposed Ward Valley site. The purpose of the presentation is to provide information on specific financial assurance provisions contained in 10 CFR Part 61 and how California intends to satisfy those requirements. Also, as rate setter, California intends to demonstrate how it will assure allowable costs to the rate base though a financial prudency review. The key provisions of financial assurance are: 10 CFR Section 61.61 - This provision requires an applicant to demonstrate its ability to finance licensed activities; 10 CFR Section 61.62 - This provision requires an applicant to provide assurance that sufficient funds will be available for site closure and stabilization; and 10 CFR Section 61.63 - This provision requires an applicant to provide 'a copy of a binding arrangement, such as a lease, between the applicant and the disposal site owner, so that sufficient funds will be available to cover the costs of the institutional control period.' To assist California in its determination of financial assurance compliance to be demonstrated by the applicant for Part 61 requirements, is NUREG guidance document 1199 'Standard Format and Content of a License Application for a Low-Level Radioactive Waste (LLRW) Disposal Facility.' The detailed financial assurance provisions of NUREG 1199 are then embodied in NUREG 1200, 'Standard Review Plant for the Review of a License Application for a LLRW Disposal Facility.'

  16. How Do Quality Assurance Systems Accommodate the Differences between Academic and Applied Higher Education?

    Science.gov (United States)

    Skolnik, Michael L.

    2016-01-01

    Although the literature on institutional diversity suggests that quality assurance practices could affect institutional diversity, there has been little empirical research on this relationship. This article seeks to shed some light on the possible connection between quality assurance practices and institutional diversity by examining the…

  17. Quality assurance of double-sided silicon microstrip sensors for the silicon tracking system in the CBM experiment at FAIR

    Energy Technology Data Exchange (ETDEWEB)

    Larionov, Pavel [Goethe Universitaet, Frankfurt (Germany); Collaboration: CBM-Collaboration

    2015-07-01

    The Silicon Tracking System (STS) is the core tracking detector of the CBM experiment at FAIR. The system's task is to reconstruct the trajectories of the charged particles produced in the beam-target interactions, provide their momentum determination, and enable the detection of decay topologies. The STS will comprise 1220 double-sided silicon microstrip sensors. After production each sensor will go through a number of Quality Assurance procedures to verify their validity for performance in the STS and also to confirm the manufacturer's data. In this talk, results of the quality assurance procedures that are being applied to the latest STS prototype sensors, including detailed tests of the quality of each single strip, long-term stability and preparations for volume tests during series production, are presented.

  18. Risk management and lessons learned solutions for satellite product assurance

    Science.gov (United States)

    Larrère, Jean-Luc

    2004-08-01

    The historic trend of the space industry towards lower cost programmes and more generally a better economic efficiency raises a difficult question to the quality assurance community: how to achieve the same—or better—mission success rate while drastically reducing the cost of programmes, hence the cost and level of quality assurance activities. EADS Astrium Earth Observation and Science (France) Business Unit have experimented Risk Management and Lessons Learned on their satellite programmes to achieve this goal. Risk analysis and management are deployed from the programme proposal phase through the development and operations phases. Results of the analysis and the corresponding risk mitigation actions are used to tailor the product assurance programme and activities. Lessons learned have been deployed as a systematic process to collect positive and negative experience from past and on-going programmes and feed them into new programmes. Monitoring and justification of their implementation in programmes is done under supervision from the BU quality assurance function. Control of the system is ensured by the company internal review system. Deployment of these methods has shown that the quality assurance function becomes more integrated in the programme team and development process and that its tasks gain focus and efficiency while minimising the risks associated with new space programmes.

  19. The effective quality assurance for image guided device using the AMC G-Box

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Chong Mi [Dept. of Radiation Oncology, Asan Medical Center, Seoul (Korea, Republic of)

    2014-12-15

    According to the rapid increase recently in image-guided radiation therapy, It is necessary to control of the image guidance system completely. In particular for the main subject to the accuracy of image guided radiation therapy device to be done essentially the quality assurance. We made efficient phantom in AMC for the management of the accurate and efficient. By setting up of five very important as a quality assurance inventory of the Image guidance system, we made (AMC G-Box) phantom for quality assurance efficient and accurate. Quality assurance list were the Iso-center align, the real measurement, the center align of four direction, the accuracy of table movement and the reproducibility of Hounsfield Unit. The rectangular phantom; acrylic with a thickness of 1 cm to 10 cm × 10 cm × 10 cm was inserted the three materials with different densities respectively for measure the CBCT HU. The phantom was to perform a check of consistency centered by creating a marker that indicates the position of the center fixed. By performing the quality assurance using the phantom of existing, comparing the resulting value to the different resulting value using the AMC G-Box, experiment was analyzed time and problems. Therapy equipment was used Varian device. It was measured twice at 1-week intervals. When implemented quality assurance of an image guidance system using AMC G-Box and a phantom existing has been completed, the quality assurance result is similar in 0.2 mm ± 0.1. In the case of the conventional method, it was 45 minutes at 30 minutes. When using AMC G-Box, it takes 20 minutes 15 minutes, and declined to 50% of the time. The consistency and accurate of image guidance system tend to decline using device. Therefore, We need to perform thoroughly on the quality assurance related. It needs to be checked daily to consistency check especially. When using the AMC G-Box, It is possible to enhance the accuracy of the patient care and equipment efficiently performing

  20. Specified assurance level sampling procedure

    International Nuclear Information System (INIS)

    Willner, O.

    1980-11-01

    In the nuclear industry design specifications for certain quality characteristics require that the final product be inspected by a sampling plan which can demonstrate product conformance to stated assurance levels. The Specified Assurance Level (SAL) Sampling Procedure has been developed to permit the direct selection of attribute sampling plans which can meet commonly used assurance levels. The SAL procedure contains sampling plans which yield the minimum sample size at stated assurance levels. The SAL procedure also provides sampling plans with acceptance numbers ranging from 0 to 10, thus, making available to the user a wide choice of plans all designed to comply with a stated assurance level

  1. A Study on the Software Quality Assurance Plan

    International Nuclear Information System (INIS)

    Kim, Hyun Tae

    2006-01-01

    On 25 August 2006, the CMMI V1.2 (Capability Maturity Model Integration Version 1.2) was released with the new title CMMI-DEV (CMMI for Development) which supersedes the CMMI-SE/SW (CMMI for systems engineering and software engineering) V1.1. This study discusses the application of IEEE Std 730-2002, IEEE Standard for Software Quality Assurance Plans, for the implementation of the Process and Product Quality Assurance (PPQA) process area (PA) of the CMMI-DEV

  2. Quality Assurance Program Plan (QAPP) Waste Encapsulation and Storage Facility (WESF)

    International Nuclear Information System (INIS)

    ROBINSON, P.A.

    2000-01-01

    This Quality Assurance Plan describes how the Waste Encapsulation and Storage Facility (WESF) implements the quality assurance (QA) requirements of the Quality Assurance Program Description (QAPD) (HNF-Mp-599) for Project Hanford activities and products. This QAPP also describes the organizational structure necessary to successfully implement the program. The QAPP provides a road map of applicable Project Hanford Management System Procedures, and facility specific procedures, that may be utilized by WESF to implement the requirements of the QAPD

  3. [Quality assurance concepts in intensive care medicine].

    Science.gov (United States)

    Brinkmann, A; Braun, J P; Riessen, R; Dubb, R; Kaltwasser, A; Bingold, T M

    2015-11-01

    Intensive care medicine (ICM) is characterized by a high degree of complexity and requires intense communication and collaboration on interdisciplinary and multiprofessional levels. In order to achieve good quality of care in this environment and to prevent errors, a proactive quality and error management as well as a structured quality assurance system are essential. Since the early 1990s, German intensive care societies have developed concepts for quality management and assurance in ICM. In 2006, intensive care networks were founded in different states to support the implementation of evidence-based knowledge into clinical routine and to improve medical outcome, efficacy, and efficiency in ICM. Current instruments and concepts of quality assurance in German ICM include core intensive care data from the data registry DIVI REVERSI, quality indicators, peer review in intensive care, IQM peer review, and various certification processes. The first version of German ICM quality indicators was published in 2010 by an interdisciplinary and interprofessional expert commission. Key figures, indicators, and national benchmarks are intended to describe the quality of structures, processes, and outcomes in intensive care. Many of the quality assurance tools have proved to be useful in clinical practice, but nationwide implementation still can be improved.

  4. Hyperthermia quality assurance

    International Nuclear Information System (INIS)

    Shrivastava, P.N.; Paliwal, B.R.

    1984-01-01

    Hyperthermia Physics Center (HPC) operating under contract with the National Cancer Institute is developing a Quality Assurance program for local and regional hyperthermia. The major clinical problem in hyperthermia treatments is that they are extremely difficult to plan, execute, monitor and reproduce. A scientific basis for treatment planning can be established only after ensuring that the performance of heat generating and temperature monitoring systems are reliable. The HPC is presently concentrating on providing uniform NBS traceable calibration of thermometers and evaluation of reproducibility for power generator operation, applicator performance, phanta compositions, system calibrations and personnel shielding. The organizational plan together with recommended evaluation measurements, procedures and criteria are presented

  5. Compliance assurance in the safe transport of radioactive materials in Switzerland

    International Nuclear Information System (INIS)

    Smith, L.

    1994-01-01

    Quality Assurance in the transport of radioactive materials (RAM) has been a legal requirement in Switzerland since 1 January 1990. Some four years later, Switzerland is well on the way to having a comprehensive system of Compliance Assurance covering the transport of RAM. By the end of 1994 Compliance Assurance will be fully operational with regard to nuclear fuel cycle shipments which account for over 90% of all radioactivity transported in Switzerland. Compliance Assurance has been delayed in Switzerland for non-fuel-cycle radioactive material shipments. This has been due to the need to modify the legal infrastructure for the relevant supervisory authorities. Nevertheless, it is hoped to have Compliance Assurance related to Radiation Units (large sources in Type B packages) operational before the end of 1994. Systematic progress is being made regarding Compliance Assurance relating to the movement of smaller sources. This involves a very large number of smaller organisations and will take some time to become routine. (author)

  6. Quality Assurance Project Plan for the HWMA/RCRA Closure Certification of the TRA-731 Caustic and Acid Storage Tank System - 1997 Notice of Violation Consent Order; TOPICAL

    International Nuclear Information System (INIS)

    Evans, S.K.

    2002-01-01

    This Quality Assurance Project Plan for the HWMA/RCRA Closure Certification of the TRA- 731 Caustic and Acid Storage Tank System is one of two documents that comprise the Sampling and Analysis Plan for the HWMA/RCRA closure certification of the TRA-731 caustic and acid storage tank system at the Idaho National Engineering and Environmental Laboratory. This plan, which provides information about the project description, project organization, and quality assurance and quality control procedures, is to be used in conjunction with the Field Sampling Plan for the HWMA/RCRA Closure Certification of the TRA-731 Caustic and Acid Storage Tank System. This Quality Assurance Project Plan specifies the procedures for obtaining the data of known quality required by the closure activities for the TRA-731 caustic and acid storage tank system

  7. Quality Assurance Systems in Open and Distance Learning: A ...

    African Journals Online (AJOL)

    The article has articulated as to why providers, consumers and accreditation agencies are at all levels interested in quality assurance. For the case of Tanzania ... In the same vein quality education for open and distance education has to remain top in the agenda so as to balance both quantity and quality. Lastly the article ...

  8. Anatomy and history of an external quality assessment program for interpretative comments in clinical biochemistry.

    Science.gov (United States)

    Vasikaran, Samuel D

    2015-05-01

    The provision of clinical interpretation of results, either verbally or in the printed report, may be considered an integral part of clinical biochemistry diagnostic service. Proficiency testing or external quality assessment (EQA) of such activity may be useful in education, training, continuing professional development and ensuring the quality of such service. Details of the Patient Report Comments Program (RPCProgram) developed by the Royal College of Pathologists of Australasia (RCPA) Chemical Pathology Quality Assurance Programs Pty Ltd (QAP) is described in this review. The program is aimed at pathologists, clinical scientists and trainees. Registered participants are provided a report with case details and a set of clinical biochemistry results at monthly intervals and submit an interpretative comment for the report. Comments received are broken up into components that are translated into common key phrases. An expert panel evaluates the key phrases, classifies them according to appropriateness and drafts a suggested comment, a case summary and a rationale, which are included in a summary report returned to participants. There is considerable diversity in the quality of interpretative comments received from participants of the PRCProgram. The primary purpose of EQA of interpretative commenting is educational self-assessment, and they are recognized as a continuing professional development activity. Whilst there is some evidence for the utility of interpretative comments in improving patient outcomes, evidence for the utility of EQA in improving quality of comments is awaited. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  9. The external quality assessment scheme: Five years experience as a participating laboratory

    Directory of Open Access Journals (Sweden)

    Chaudhary Rajendra

    2010-01-01

    Full Text Available Background and Aim : Quality assurance in blood banking includes active participation in the external quality program. Such a program offers valuable benefits to patient care, their safety, and an overall quality of laboratory practices. In the year 2002, we participated in the External Quality Assessment Scheme (EQAS under the World Health Organization (WHO, Bureau of Laboratory Quality Standards, Thailand. Materials and Methods: In the current study we evaluated our EQAS test result of the past five years, from 2003 to 2007. Test results of all blood samples such as ABO grouping, D typing, antibody screening, antibody identification, and transfusion transmitted infection (TTI testing were analyzed and documented. Results: Discordant results in one or more instances were observed with antibody identification, weak D testing, and tests for anti-HIV1/2 and HBsAg. Twice we failed to detect the ′anti-Mia′ antibody in the issued sample and that could be attributed to the absence of the corresponding antigen in the used cell panel. HBsAg was missed due to its critically low titer in the serum and the comparatively low sensitivity of our Enzyme-Linked Immunosorbent Assay (ELISA test kit. Conclusion: All these failures in the last five years have helped us to significantly improve our transfusion service in terms of performance evaluation, patient care and safety issues, and the overall quality of laboratory practices. We therefore recommend all laboratories and hospitals to participate in the EQAS program, which will definitely help them to improve from what they learn.

  10. Improvement in the performance of external quality assessment in Korean HIV clinical laboratories using unrecalcified human plasma.

    Science.gov (United States)

    Wang, Jin-Sook; Kee, Mee-Kyung; Choi, Byeong-Sun; Kim, Chan-Wha; Kim, Hyon-Suk; Kim, Sung Soon

    2012-01-01

    The external quality assessment schemes (EQAS) organizer provides a suitable program to monitor and improve the quality of human immunodeficiency virus (HIV) testing laboratories with EQAS panels prepared under various conditions. The aim of the current study was to investigate the effects of human plasma samples on the EQAS results of HIV obtained from hospital-based clinical laboratories. From 2007 to 2009, HIV EQAS panels consisted of four to six samples that consisted of undiluted positive and negative samples and were provided to laboratories twice per year. Up until the first half EQAS in 2008, EQAS panel materials were obtained by converting acid citrate dextrose treated plasma to serum via chemical treatment with CaCl2. Beginning with the second EQAS in 2008, all materials were prepared without the defibrination process. Approximately 300 HIV clinical laboratories participated in this program. The overall performance of clinical laboratories was shown to be improved when using unrecalcified plasma panels compared with recalcified panels. Significant differences were observed in EIA analyses of plasma for both positive (plaboratories.

  11. Results from 15years of quality surveillance for a National Indigenous Point-of-Care Testing Program for diabetes.

    Science.gov (United States)

    Shephard, Mark; Shephard, Anne; McAteer, Bridgit; Regnier, Tamika; Barancek, Kristina

    2017-12-01

    Diabetes is a major health problem for Australia's Aboriginal and Torres Strait Islander peoples. Point-of-care testing for haemoglobin A1c (HbA1c) has been the cornerstone of a long-standing program (QAAMS) to manage glycaemic control in Indigenous people with diabetes and recently, to diagnose diabetes. The QAAMS quality management framework includes monthly testing of quality control (QC) and external quality assurance (EQA) samples. Key performance indicators of quality include imprecision (coefficient of variation [CV%]) and percentage acceptable results. This paper reports on the past 15years of quality testing in QAAMS and examines the performance of HbA1c POC testing at the 6.5% cut-off recommended for diagnosis. The total number of HbA1c EQA results submitted from 2002 to 2016 was 29,093. The median imprecision for EQA testing by QAAMS device operators averaged 2.81% (SD 0.50; range 2.2 to 3.9%) from 2002 to 2016 and 2.44% (SD 0.22; range 2.2 to 2.9%) from 2009 to 2016. No significant difference was observed between the median imprecision achieved in QAAMS and by Australasian laboratories from 2002 to 2016 (p=0.05; two-tailed paired t-test) and from 2009 to 2016 (p=0.17; two-tailed paired t-test). For QC testing from 2009 to 2016, imprecision averaged 2.5% and 3.0% for the two levels of QC tested. Percentage acceptable results averaged 90% for QA testing from 2002 to 2016 and 96% for QC testing from 2009 to 2016. The DCA Vantage was able to measure a patient and an EQA sample with an HbA1c value close to 6.5% both accurately and precisely. HbA1c POC testing in QAAMS has remained analytically sound, matched the quality achieved by Australasian laboratories and met profession-derived analytical goals for 15years. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  12. [Development of image quality assurance support system using image recognition technology in radiography in lacked images of chest and abdomen].

    Science.gov (United States)

    Shibuya, Toru; Kato, Kyouichi; Eshima, Hidekazu; Sumi, Shinichirou; Kubo, Tadashi; Ishida, Hideki; Nakazawa, Yasuo

    2012-01-01

    In order to provide a precise radiography for diagnosis, it is required that we avoid radiography with defects by having enough evaluation. Conventionally, evaluation was performed only by observation of a radiological technologist (RT). The evaluation support system was developed for providing a high quality assurance without depending on RT observation only. The evaluation support system, called as the Image Quality Assurance Support System (IQASS), is characterized in that "image recognition technology" for the purpose of diagnostic radiography of chest and abdomen areas. The technique of the system used in this study. Of the 259 samples of posterior-anterior (AP) chest, lateral chest, and upright abdominal x-rays, the sensitivity and specificity was 93.1% and 91.8% in the chest AP, 93.3% and 93.6% in the chest lateral, and 95.0% and 93.8% in the upright abdominal x-rays. In the light of these results, it is suggested that AIQAS could be applied to practical usage for the RT.

  13. 10 CFR 71.37 - Quality assurance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under consideration...

  14. A survey on auditing, quality assurance systems and legal frameworks in five selected slaughterhouses in Bulawayo, south-western Zimbabwe.

    Science.gov (United States)

    Masanganise, Kaurai E; Matope, Gift; Pfukenyi, Davies M

    2013-01-01

    The purpose of this study was to explore the audits, quality assurance (QA) programmes and legal frameworks used in selected abattoirs in Zimbabwe and slaughterhouse workers' perceptions on their effectiveness. Data on slaughterhouse workers was gathered through a self-completed questionnaire and additional information was obtained from slaughterhouse and government records. External auditing was conducted mainly by the Department of Veterinary Public Health with little contribution from third parties. Internal auditing was restricted to export abattoirs. The checklist used on auditing lacked objective assessment criteria and respondents cited several faults in the current audit system. Most respondents (> 50.0%) knew the purposes and benefits of audit and QA inspections. All export abattoirs had QA programmes such as hazard analysis critical control point and ISO 9001 (a standard used to certify businesses' quality management systems) but their implementation varied from minimal to nil. The main regulatory defect observed was lack of requirements for a QA programme. Audit and quality assurance communications to the selected abattoirs revealed a variety of non-compliances with most respondents revealing that corrective actions to audit (84.3%) and quality assurance (92.3%) shortfalls were not done. A high percentage of respondents indicated that training on quality (76.8%) and regulations (69.8%) was critical. Thus, it is imperative that these abattoirs develop a food safety management system comprising of QA programmes, a microbial assessment scheme, regulatory compliance, standard operating procedures, internal and external auditing and training of workers.

  15. A survey on auditing, quality assurance systems and legal frameworks in five selected slaughterhouses in Bulawayo, south-western Zimbabwe

    Directory of Open Access Journals (Sweden)

    Kaurai E. Masanganise

    2013-06-01

    Full Text Available The purpose of this study was to explore the audits, quality assurance (QA programmes and legal frameworks used in selected abattoirs in Zimbabwe and slaughterhouse workers’ perceptions on their effectiveness. Data on slaughterhouse workers was gathered through a self-completed questionnaire and additional information was obtained from slaughterhouse and government records. External auditing was conducted mainly by the Department of Veterinary Public Health with little contribution from third parties. Internal auditing was restricted to export abattoirs. The checklist used on auditing lacked objective assessment criteria and respondents cited several faults in the current audit system. Most respondents (>50.0% knew the purposes and benefits of audit and QA inspections. All export abattoirs had QA programmes such as hazard analysis critical control point and ISO 9001 (a standard used to certify businesses’ quality management systems but their implementation varied from minimal to nil. The main regulatory defect observed was lack of requirements for a QA programme. Audit and quality assurance communications to the selected abattoirs revealed a variety of non-compliances with most respondents revealing that corrective actions to audit (84.3% and quality assurance (92.3% shortfalls were not done. A high percentage of respondents indicated that training on quality (76.8% and regulations (69.8% was critical. Thus, it is imperative that these abattoirs develop a food safety management system comprising of QA programmes, a microbial assessment scheme, regulatory compliance, standard operating procedures, internal and external auditing and training of workers.

  16. Quality Assurance in Custom Dental Devices: A Technologist's Perspective.

    Science.gov (United States)

    Griffin, Anthony

    2017-12-01

    Manufacturing of custom-made dental devices such as removable dentures, fixed prosthodontics and orthodontics are subject to the requirements of the Medical Devices Directive (MDD). Many dental laboratories often enhance these requirements by implementing quality assurance procedures that then provide enhanced consistency. this paper provides a dental technologist's view of some of the systems currently being used in dental laboratories to provide a quality assured product and associated issues.

  17. Quality Assurance in the Presence of Variability

    Science.gov (United States)

    Lauenroth, Kim; Metzger, Andreas; Pohl, Klaus

    Software Product Line Engineering (SPLE) is a reuse-driven development paradigm that has been applied successfully in information system engineering and other domains. Quality assurance of the reusable artifacts of the product line (e.g. requirements, design, and code artifacts) is essential for successful product line engineering. As those artifacts are reused in several products, a defect in a reusable artifact can affect several products of the product line. A central challenge for quality assurance in product line engineering is how to consider product line variability. Since the reusable artifacts contain variability, quality assurance techniques from single-system engineering cannot directly be applied to those artifacts. Therefore, different strategies and techniques have been developed for quality assurance in the presence of variability. In this chapter, we describe those strategies and discuss in more detail one of those strategies, the so called comprehensive strategy. The comprehensive strategy aims at checking the quality of all possible products of the product line and thus offers the highest benefits, since it is able to uncover defects in all possible products of the product line. However, the central challenge for applying the comprehensive strategy is the complexity that results from the product line variability and the large number of potential products of a product line. In this chapter, we present one concrete technique that we have developed to implement the comprehensive strategy that addresses this challenge. The technique is based on model checking technology and allows for a comprehensive verification of domain artifacts against temporal logic properties.

  18. Quality-Assurance Program Plan

    International Nuclear Information System (INIS)

    Kettell, R.A.

    1981-05-01

    This Quality Assurance Program Plan (QAPP) is provided to describe the Quality Assurance Program which is applied to the waste management activities conducted by AESD-Nevada Operations at the E-MAD Facility located in Area 25 of the Nevada Test Site. The AESD-Nevada Operations QAPP provides the necessary systematic and administrative controls to assure activities that affect quality, safety, reliability, and maintainability during design, procurement, fabrication, inspection, shipments, tests, and storage are conducted in accordance with established requirements

  19. Quality assurance measures in interventional radiology

    International Nuclear Information System (INIS)

    Heuser, L.

    1999-01-01

    The quality assurance of treatment measures is legally required but as yet not generally established in practice. For interventional radiology, the introduction of quality assurance for PTA of arteries of the lower limbs is planned for January 1999. It is reasonable to subject at least the most important and/or most frequently performed interventions to quality management. In the present article, the term quality in the management of diseases is defined and the system of total quality management discussed at the levels structure, process, and results. For its application, parameters of quality measurement in the form of standards, criteria, and characteristic values are necessary and must be laid down by a team of experts on the basis of subjective experience and/or results in the literature. Practical quality assurance takes place not only within a clinic but also externally by comparison with other centers. Data collection and evaluation requires high-performance software that will be continuously improved, expanded, and adapted to current needs during regular meetings between the various users. (orig.) [de

  20. Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems

    Energy Technology Data Exchange (ETDEWEB)

    Sawant, Amit; Dieterich, Sonja; Svatos, Michelle; Keall, Paul [Stanford University, Stanford, California 94394 (United States); Varian Medical Systems, Palo Alto, California 94304 (United States); Stanford University, Stanford, California 94394 (United States)

    2010-12-15

    Purpose: To develop and implement a failure mode and effect analysis (FMEA)-based commissioning and quality assurance framework for dynamic multileaf collimator (DMLC) tumor tracking systems. Methods: A systematic failure mode and effect analysis was performed for a prototype real-time tumor tracking system that uses implanted electromagnetic transponders for tumor position monitoring and a DMLC for real-time beam adaptation. A detailed process tree of DMLC tracking delivery was created and potential tracking-specific failure modes were identified. For each failure mode, a risk probability number (RPN) was calculated from the product of the probability of occurrence, the severity of effect, and the detectibility of the failure. Based on the insights obtained from the FMEA, commissioning and QA procedures were developed to check (i) the accuracy of coordinate system transformation, (ii) system latency, (iii) spatial and dosimetric delivery accuracy, (iv) delivery efficiency, and (v) accuracy and consistency of system response to error conditions. The frequency of testing for each failure mode was determined from the RPN value. Results: Failures modes with RPN{>=}125 were recommended to be tested monthly. Failure modes with RPN<125 were assigned to be tested during comprehensive evaluations, e.g., during commissioning, annual quality assurance, and after major software/hardware upgrades. System latency was determined to be {approx}193 ms. The system showed consistent and accurate response to erroneous conditions. Tracking accuracy was within 3%-3 mm gamma (100% pass rate) for sinusoidal as well as a wide variety of patient-derived respiratory motions. The total time taken for monthly QA was {approx}35 min, while that taken for comprehensive testing was {approx}3.5 h. Conclusions: FMEA proved to be a powerful and flexible tool to develop and implement a quality management (QM) framework for DMLC tracking. The authors conclude that the use of FMEA-based QM ensures

  1. Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems.

    Science.gov (United States)

    Sawant, Amit; Dieterich, Sonja; Svatos, Michelle; Keall, Paul

    2010-12-01

    To develop and implement a failure mode and effect analysis (FMEA)-based commissioning and quality assurance framework for dynamic multileaf collimator (DMLC) tumor tracking systems. A systematic failure mode and effect analysis was performed for a prototype real-time tumor tracking system that uses implanted electromagnetic transponders for tumor position monitoring and a DMLC for real-time beam adaptation. A detailed process tree of DMLC tracking delivery was created and potential tracking-specific failure modes were identified. For each failure mode, a risk probability number (RPN) was calculated from the product of the probability of occurrence, the severity of effect, and the detectibility of the failure. Based on the insights obtained from the FMEA, commissioning and QA procedures were developed to check (i) the accuracy of coordinate system transformation, (ii) system latency, (iii) spatial and dosimetric delivery accuracy, (iv) delivery efficiency, and (v) accuracy and consistency of system response to error conditions. The frequency of testing for each failure mode was determined from the RPN value. Failures modes with RPN > or = 125 were recommended to be tested monthly. Failure modes with RPN < 125 were assigned to be tested during comprehensive evaluations, e.g., during commissioning, annual quality assurance, and after major software/hardware upgrades. System latency was determined to be approximately 193 ms. The system showed consistent and accurate response to erroneous conditions. Tracking accuracy was within 3%-3 mm gamma (100% pass rate) for sinusoidal as well as a wide variety of patient-derived respiratory motions. The total time taken for monthly QA was approximately 35 min, while that taken for comprehensive testing was approximately 3.5 h. FMEA proved to be a powerful and flexible tool to develop and implement a quality management (QM) framework for DMLC tracking. The authors conclude that the use of FMEA-based QM ensures efficient allocation

  2. Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems

    International Nuclear Information System (INIS)

    Sawant, Amit; Dieterich, Sonja; Svatos, Michelle; Keall, Paul

    2010-01-01

    Purpose: To develop and implement a failure mode and effect analysis (FMEA)-based commissioning and quality assurance framework for dynamic multileaf collimator (DMLC) tumor tracking systems. Methods: A systematic failure mode and effect analysis was performed for a prototype real-time tumor tracking system that uses implanted electromagnetic transponders for tumor position monitoring and a DMLC for real-time beam adaptation. A detailed process tree of DMLC tracking delivery was created and potential tracking-specific failure modes were identified. For each failure mode, a risk probability number (RPN) was calculated from the product of the probability of occurrence, the severity of effect, and the detectibility of the failure. Based on the insights obtained from the FMEA, commissioning and QA procedures were developed to check (i) the accuracy of coordinate system transformation, (ii) system latency, (iii) spatial and dosimetric delivery accuracy, (iv) delivery efficiency, and (v) accuracy and consistency of system response to error conditions. The frequency of testing for each failure mode was determined from the RPN value. Results: Failures modes with RPN≥125 were recommended to be tested monthly. Failure modes with RPN<125 were assigned to be tested during comprehensive evaluations, e.g., during commissioning, annual quality assurance, and after major software/hardware upgrades. System latency was determined to be ∼193 ms. The system showed consistent and accurate response to erroneous conditions. Tracking accuracy was within 3%-3 mm gamma (100% pass rate) for sinusoidal as well as a wide variety of patient-derived respiratory motions. The total time taken for monthly QA was ∼35 min, while that taken for comprehensive testing was ∼3.5 h. Conclusions: FMEA proved to be a powerful and flexible tool to develop and implement a quality management (QM) framework for DMLC tracking. The authors conclude that the use of FMEA-based QM ensures efficient allocation

  3. Quality assurance in the Antares laser fusion construction project

    International Nuclear Information System (INIS)

    Reichelt, W.H.

    1984-01-01

    The Antares CO 2 laser facility came on line in November 1983 as an experimental physics facility; it is the world's largest CO 2 laser fusion system. Antares is a major component of the Department of Energy's Inertial Confinement Fusion Program. Antares is a one-of-a-kind laser system that is used in an experimental environment. Given limited project funds and tight schedules, the quality assurance program was tailored to achieve project goals without imposing oppressive constraints. The discussion will review the Antares quality assurance program and the utility of various portions to completion of the project

  4. Experience with quality assurance in fuel design and manufacturing

    International Nuclear Information System (INIS)

    Holzer, R.; Nilson, F.

    1984-01-01

    The Quality Assurance/Quality Control activities for nuclear fuel design and manufacturing described here are coordinated under a common ''Quality Assurance System For Fuel Assemblies and Associated Core Components'' which regulates the QA-functions of the development, design and manufacturing of fuel assemblies independent of the organizational assignment of the contributing technical groups. Some essential characteristics of the system are shown, using examples from design control, procurement, manufacturing and qualification of special processes. The experience is very good, it allowed a flexible and well controlled implementation of design and manufacturing innovations and contributed to the overall good fuel behavior. (orig.)

  5. 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

  6. Repository construction management and quality assurance

    International Nuclear Information System (INIS)

    Hood, F.C.

    1984-01-01

    An emphasis on preventive rather than reactive management is key to an efficient construction management operation. Development of contingency plans to deal with unexpected adverse conditions, e.g., brine pockets during mining operations, are an integral part of the management program to ensure project safety, quality, cost, schedule and environmental objectives are met. A viable quality assurance program with active management support will optimize management effectiveness in reaching project goals. With adequate planning and perceptive application of the proper management controls, Quality Assurance becomes an essential ingredient for efficiently managing a job because it has been built into the management system rather than being an uninvolved peripheral entity. 6 references, 3 figures

  7. Idaho National Laboratory Emergency Readiness Assurance Plan - Fiscal Year 2015

    Energy Technology Data Exchange (ETDEWEB)

    Farmer, Carl J. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-09-01

    Department of Energy Order 151.1C, Comprehensive Emergency Management System requires that each Department of Energy field element documents readiness assurance activities, addressing emergency response planning and preparedness. Battelle Energy Alliance, LLC, as prime contractor at the Idaho National Laboratory (INL), has compiled this Emergency Readiness Assurance Plan to provide this assurance to the Department of Energy Idaho Operations Office. Stated emergency capabilities at the INL are sufficient to implement emergency plans. Summary tables augment descriptive paragraphs to provide easy access to data. Additionally, the plan furnishes budgeting, personnel, and planning forecasts for the next 5 years.

  8. Training, Quality Assurance Factors, and Tools Investigation: a Work Report and Suggestions on Software Quality Assurance

    Science.gov (United States)

    Lee, Pen-Nan

    1991-01-01

    Previously, several research tasks have been conducted, some observations were obtained, and several possible suggestions have been contemplated involving software quality assurance engineering at NASA Johnson. These research tasks are briefly described. Also, a brief discussion is given on the role of software quality assurance in software engineering along with some observations and suggestions. A brief discussion on a training program for software quality assurance engineers is provided. A list of assurance factors as well as quality factors are also included. Finally, a process model which can be used for searching and collecting software quality assurance tools is presented.

  9. Implementing a quality assurance system in the Laboratory of Environmental Radiological Surveillance from the Center of Protection and Hygiene of Radiation

    International Nuclear Information System (INIS)

    Prendes Alosno, M.; Fernandes Gomez, I.M.; Marrero Garcia, M.

    1998-01-01

    This work aimed to design and implement a system for quality assurance. The same describes working experiences, the organization of the registry system, the training and certification of the staff, checking, maintenance and calibration of equipment as well as internal auditing process made

  10. The Status of Quality Assurance and Accreditation Systems within Higher Education Institutions in the Republic of Yemen

    Science.gov (United States)

    Anaam, Mahyoub Ali; Alhammadi, Abdullah Othman; Kwairan, Abdulwahab Awadh

    2009-01-01

    The purpose of this paper is to provide an overview of the status of quality assurance and accreditation systems within higher education institutions in Yemen. The paper initially describes the stages of development and changes that have occurred in the field of quality and accreditation in Yemeni higher education. The paper shows that no formal…

  11. Quality-assurance approach for the Elmo Bumpy Torus Proof-of-Principal experiment

    International Nuclear Information System (INIS)

    Sticksel, F.M.

    1981-01-01

    Components, subsystems and systems will be subjected to inspection and test as necessary to ensure compliance to applicable specifications, Acceptance Test Procedures and/or customer requirements. Quality Assurance will inspect each component, subsystem and system for selected mechanical and electrical defects. In addition, Quality Assurance will either perform, or verify performance of, and analyze, or verify analysis of, all required field and laboratory tests. If hardware is modified, repaired or replaced after final testing, necessary re-inspection and retest must be performed. Insofar as possible the component, subsystem or system will be released as acceptable upon completion of these activities. When nonconformances are detected during the course of site surveillance activities, MDAC or Gilbert/Commonwealth will initiate a Nonconformance Record for review by MDAC Quality Assurance and Project Engineering personnel. These nonconformances will be identified and dispositioned per MDAC Standard Practices with the advice and concurrence of Gilbert/Commonwealth personnel, if deemed appropriate. MDAC Quality Assurance personnel will witness the pre-operational testing and review the test data

  12. Digital radiography for quality assurance

    International Nuclear Information System (INIS)

    Thiele, H.; Friemel, H.J.

    2001-01-01

    The digital radiographic system AMICA-401 is described. It is a mobile system originally developed for wall thickness and diameter measurements of insulated and non-insulated pipes which is also suited for quality assurance in fabrication and maintenance. Its advantages are immediate evaluation of images, very short exposure times with reduced radiation loads, and an efficient integrated image processing software. Further, no chemical substances are required for film processing. The system can be used both in mobile and in stationary applications. Practical examples are presented and discussed. (orig.) [de

  13. 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

  14. A case study in flow assurance of a pipeline-riser system using OLGA

    Energy Technology Data Exchange (ETDEWEB)

    Nemoto, Rafael Horschutz; Balino, Jorge Luis [Nucleo de Dinamica e Fluidos. Dept. de Engenharia Mecanica. Universidade de Sao Paulo (EP/USP), SP (Brazil)], e-mails: rafael.nemoto@usp.br, jlbalino@usp.br; Tanaka, Rafael Loureiro; Godinho, Carlos Alberto [Prysmian Cables and Systems, Cariacica, ES (Brazil)], e-mails: rafael.tanaka@prysmian.com, carlos.godinho@prysmian.com

    2010-07-01

    In this paper, a case study in flow assurance is performed considering an offshore operating system, using the software OLGA. As operating system we consider a pipeline-riser geometry with typical dimensions of offshore oil production systems, and a three-phase flow of oil, gas and water. The model developed in OLGA considers the composition and dimensions of the tubes, heat transfer parameters, process equipment and fluid sources. The fluids properties are calculated using the software PVTsim. Simulations are ran in order to determine the pipeline inner diameter and insulation required to satisfy pressure and temperature requirements. It is also possible to simulate the transient behavior of the system, which allows to evaluate if production instabilities are present. In case instabilities exist, two mitigation alternatives are evaluated: closure of a choke valve before the separator and gas lift. Considering a possible production shutdown, the tubes insulation is calculated in order to avoid hydrate formation. (author)

  15. Quality Assurance in Engineering Education: Comparison of Accreditation Schemes and ISO 9001.

    Science.gov (United States)

    Karapetrovic, Stanislav; Rajamani, Divakar; Willborn, Walter

    1998-01-01

    Outlines quality assurance schemes for distance-education technologies that are based on the ISO 9000 family of international quality-assurance standards. Argues that engineering faculties can establish such systems on the basis of and integrated with accreditation schemes. Contains 34 references. (DDR)

  16. The NASA Commercial Crew Program (CCP) Mission Assurance Process

    Science.gov (United States)

    Canfield, Amy

    2016-01-01

    In 2010, NASA established the Commercial Crew Program in order to provide human access to the International Space Station and low earth orbit via the commercial (non-governmental) sector. A particular challenge to NASA has been how to determine the commercial providers transportation system complies with Programmatic safety requirements. The process used in this determination is the Safety Technical Review Board which reviews and approves provider submitted Hazard Reports. One significant product of the review is a set of hazard control verifications. In past NASA programs, 100 percent of these safety critical verifications were typically confirmed by NASA. The traditional Safety and Mission Assurance (SMA) model does not support the nature of the Commercial Crew Program. To that end, NASA SMA is implementing a Risk Based Assurance (RBA) process to determine which hazard control verifications require NASA authentication. Additionally, a Shared Assurance Model is also being developed to efficiently use the available resources to execute the verifications. This paper will describe the evolution of the CCP Mission Assurance process from the beginning of the Program to its current incarnation. Topics to be covered include a short history of the CCP; the development of the Programmatic mission assurance requirements; the current safety review process; a description of the RBA process and its products and ending with a description of the Shared Assurance Model.

  17. Mission Assurance Modeling and Simulation: A Cyber Security Roadmap

    Science.gov (United States)

    Gendron, Gerald; Roberts, David; Poole, Donold; Aquino, Anna

    2012-01-01

    This paper proposes a cyber security modeling and simulation roadmap to enhance mission assurance governance and establish risk reduction processes within constrained budgets. The term mission assurance stems from risk management work by Carnegie Mellon's Software Engineering Institute in the late 19905. By 2010, the Defense Information Systems Agency revised its cyber strategy and established the Program Executive Officer-Mission Assurance. This highlights a shift from simply protecting data to balancing risk and begins a necessary dialogue to establish a cyber security roadmap. The Military Operations Research Society has recommended a cyber community of practice, recognizing there are too few professionals having both cyber and analytic experience. The authors characterize the limited body of knowledge in this symbiotic relationship. This paper identifies operational and research requirements for mission assurance M&S supporting defense and homeland security. M&S techniques are needed for enterprise oversight of cyber investments, test and evaluation, policy, training, and analysis.

  18. Application of NASA Kennedy Space Center system assurance analysis methodology to nuclear power plant systems designs

    International Nuclear Information System (INIS)

    Page, D.W.

    1985-01-01

    The Kennedy Space Center (KSC) entered into an agreement with the Nuclear Regulatory Commission (NRC) to conduct a study to demonstrate the feasibility and practicality of applying the KSC System Assurance Analysis (SAA) methodology to nuclear power plant systems designs. In joint meetings of KSC and Duke Power personnel, an agreement was made to select to CATAWBA systems, the Containment Spray System and the Residual Heat Removal System, for the analyses. Duke Power provided KSC with a full set a Final Safety Analysis Reports as well as schematics for the two systems. During Phase I of the study the reliability analyses of the SAA were performed. During Phase II the hazard analyses were performed. The final product of Phase II is a handbook for implementing the SAA methodology into nuclear power plant systems designs. The purpose of this paper is to describe the SAA methodology as it applies to nuclear power plant systems designs and to discuss the feasibility of its application. The conclusion is drawn that nuclear power plant systems and aerospace ground support systems are similar in complexity and design and share common safety and reliability goals. The SAA methodology is readily adaptable to nuclear power plant designs because of it's practical application of existing and well known safety and reliability analytical techniques tied to an effective management information system

  19. Treatment of Wastewater From Car Washes Using Natural Coagulation and Filtration System

    Science.gov (United States)

    Al-Gheethi, A. A.; Mohamed, R. M. S. R.; Rahman, M. A. A.; Johari, M. R.; Kassim, A. H. M.

    2016-07-01

    Wastewater generated from carwash is one of the main wastewater resources, which contribute effectively in the increasing of environmental contamination due to the chemical characteristics of the car wastes. The present work aimed to develop an integrated treatment system for carwash wastewater based on coagulation and flocculation using Moringa oleifera and Ferrous Sulphate (FeSO4.7H2O) as well as natural filtration system. The carwash wastewater samples were collected from carwash station located at Parit Raja, Johor, Malaysia. The treatment system of car wash wastewater was designed in the lab scale in four stages included, aeration, coagulation and flocculation, sedimentation and filtration. The coagulation and flocculation unit was carried out using different dosage (35, 70, 105 and 140 mg L-1) of M. oleifera and FeSO4.7H2O, respectively. The efficiency of the integrated treatment system to treat carwash wastewater and to meet Environmental Quality Act (EQA 1974) was evaluated based on the analysis of pH, dissolved oxygen (DO), chemical oxygen demand (COD) and turbidity (NTU). The integrated treatment system was efficient for treatment of raw carwash wastewater. The treated carwash wastewaters meet EQA 1974 regulation 2009 (Standards A) in the term of pH and DO while, turbidity and COD reduced in the wastewater to meet Standards B. The integrated treatment system designed here with natural coagulant (M. oleifera) and filtration unit were effective for primary treatment of carwash wastewater before the final disposal or to be reused again for carwash process.

  20. Metrology's role in quality assurance

    International Nuclear Information System (INIS)

    Zeederberg, L.B.

    1982-01-01

    Metrology, the science of measurement, is playing an increasing role in modern industry as part of an on-going quality assurance programme. At Escom, quality assurance was critical during the construction of the Koeberg nuclear facility, and also a function in controlling services provided by Escom. This article deals with the role metrology plays in quality assurance

  1. Quality assurance in military medical research and medical radiation accident management.

    Science.gov (United States)

    Hotz, Mark E; Meineke, Viktor

    2012-08-01

    The provision of quality radiation-related medical diagnostic and therapeutic treatments cannot occur without the presence of robust quality assurance and standardization programs. Medical laboratory services are essential in patient treatment and must be able to meet the needs of all patients and the clinical personnel responsible for the medical care of these patients. Clinical personnel involved in patient care must embody the quality assurance process in daily work to ensure program sustainability. In conformance with the German Federal Government's concept for modern departmental research, the international standard ISO 9001, one of the relevant standards of the International Organization for Standardization (ISO), is applied in quality assurance in military medical research. By its holistic approach, this internationally accepted standard provides an excellent basis for establishing a modern quality management system in line with international standards. Furthermore, this standard can serve as a sound basis for the further development of an already established quality management system when additional standards shall apply, as for instance in reference laboratories or medical laboratories. Besides quality assurance, a military medical facility must manage additional risk events in the context of early recognition/detection of health risks of military personnel on deployment in order to be able to take appropriate preventive and protective measures; for instance, with medical radiation accident management. The international standard ISO 31000:2009 can serve as a guideline for establishing risk management. Clear organizational structures and defined work processes are required when individual laboratory units seek accreditation according to specific laboratory standards. Furthermore, international efforts to develop health laboratory standards must be reinforced that support sustainable quality assurance, as in the exchange and comparison of test results within

  2. The UKNEQAS scheme for cerebrospinal fluid haem pigments: a paradigm for service improvement.

    Science.gov (United States)

    Beetham, Robert; Egner, William; Patel, Dina

    2011-11-01

    We describe the programme of an established External Quality Assurance (EQA) provider and a Specialist Advisory Group (SAG) to develop a successful EQA scheme for cerebrospinal fluid (CSF) haem pigments as an example of a professionally led, unfunded initiative with the real potential to benefit patients. Within three years, we had assured sample stability, stoichiometry, and published best practice guidelines, enabling both analytical results and interpretation to be assessed and reported with an educative summary of the desired responses. Misclassification scoring of analysis and interpretation was introduced. Following audit, guidelines were modified and republished. The outcomes were as follows: Participant numbers increased from 63 at inception to 150 10 years later; The percentage of participants using visual inspection, a poor practice indicator, decreased from 27% to less than 1%; In all, 94-100% of participants consistently detected minor increases in bilirubin over the last four years of the scheme; More than 93% of participants were able to interpret analytical results linked to straightforward clinical scenarios; Misclassification scoring demonstrated that more complex scenarios repeatedly posed problems and is the next challenge to address. Scheme success is attributed to the experience of the operator and the formation of a voluntary expert advisory group, with both concerned to advance science and patient safety and thus contribute unpaid time and effort in order to succeed. In times of fiscal constraint, such resource may not be so readily available, yet is a vital part of continuous quality improvement for the benefit of patients.

  3. Commissioning and quality assurance for the treatment delivery components of the AccuBoost system.

    Science.gov (United States)

    Iftimia, Ileana; Talmadge, Mike; Ladd, Ron; Halvorsen, Per

    2015-03-08

    The objective for this work was to develop a commissioning methodology for the treatment delivery components of the AccuBoost system, as well as to establish a routine quality assurance program and appropriate guidance for clinical use based on the commissioning results. Various tests were developed: 1) assessment of the accuracy of the displayed separation value; 2) validation of the dwell positions within each applicator; 3) assessment of the accuracy and precision of the applicator localization system; 4) assessment of the combined dose profile of two opposed applicators to confirm that they are coaxial; 5) measurement of the absolute dose delivered with each applicator to confirm acceptable agreement with dose based on Monte Carlo modeling; 6) measurements of the skin-to-center dose ratio using optically stimulated luminescence dosimeters; and 7) assessment of the mammopad cushion's effect on the center dose. We found that the difference between the measured and the actual paddle separation is < 0.1 cm for the separation range of 3 cm to 7.5 cm. Radiochromic film measurements demonstrated that the number of dwell positions inside the applicators agree with the values from the vendor, for each applicator type and size. The shift needed for a good applicator-grid alignment was within 0.2 cm. The dry-run test using film demonstrated that the shift of the dosimetric center is within 0.15 cm. Dose measurements in water converted to polystyrene agreed within 5.0% with the Monte Carlo data in polystyrene for the same applicator type, size, and depth. A solid water-to-water (phantom) factor was obtained for each applicator, and all future annual quality assurance tests will be performed in solid water using an average value of 1.07 for the solid water-to-water factor. The skin-to-center dose ratio measurements support the Monte Carlo-based values within 5.0% agreement. For the treatment separation range of 4 cm to 8cm, the change in center dose would be < 1.0% for all

  4. The Groundwater Performance Assessment Project Quality Assurance Plan

    International Nuclear Information System (INIS)

    Luttrell, Stuart P.

    2006-01-01

    U.S. Department of Energy (DOE) has monitored groundwater on the Hanford Site since the 1940s to help determine what chemical and radiological contaminants have made their way into the groundwater. As regulatory requirements for monitoring increased in the 1980s, there began to be some overlap between various programs. DOE established the Groundwater Performance Assessment Project (groundwater project) in 1996 to ensure protection of the public and the environment while improving the efficiency of monitoring activities. The groundwater project is designed to support all groundwater monitoring needs at the site, eliminate redundant sampling and analysis, and establish a cost-effective hierarchy for groundwater monitoring activities. This document provides the quality assurance guidelines that will be followed by the groundwater project. This QA Plan is based on the QA requirements of DOE Order 414.1C, Quality Assurance, and 10 CFR 830, Subpart A--General Provisions/Quality Assurance Requirements as delineated in Pacific Northwest National Laboratory's Standards-Based Management System. In addition, the groundwater project is subject to the Environmental Protection Agency (EPA) Requirements for Quality Assurance Project Plans (EPA/240/B-01/003, QA/R-5). The groundwater project has determined that the Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD, DOE/RL-96-68) apply to portions of this project and to the subcontractors. HASQARD requirements are discussed within applicable sections of this plan

  5. Software quality assurance handbook

    Energy Technology Data Exchange (ETDEWEB)

    1990-09-01

    There are two important reasons for Software Quality Assurance (SQA) at Allied-Signal Inc., Kansas City Division (KCD): First, the benefits from SQA make good business sense. Second, the Department of Energy has requested SQA. This handbook is one of the first steps in a plant-wide implementation of Software Quality Assurance at KCD. The handbook has two main purposes. The first is to provide information that you will need to perform software quality assurance activities. The second is to provide a common thread to unify the approach to SQA at KCD. 2 figs.

  6. Plutonium stabilization and handling quality assurance program plan

    International Nuclear Information System (INIS)

    Weiss, E.V.

    1998-01-01

    This Quality Assurance Program Plan (QAPP) identifies project quality assurance requirements for all contractors involved in the planning and execution of Hanford Site activities for design, procurement, construction, testing and inspection for Project W-460, Plutonium Stabilization and Handling. The project encompasses procurement and installation of a Stabilization and Packaging System (SPS) to oxidize and package for long term storage remaining plutonium-bearing special nuclear materials currently in inventory at the Plutonium Finishing Plant (PFP), and modification of vault equipment to allow storage of resulting packages of stabilized SNM

  7. Chemical analysis quality assurance at the ICPP

    International Nuclear Information System (INIS)

    Hand, R.L.

    1990-01-01

    This document discusses the chemical analysis quality assurance program at the ICPP which involves records management, analytical methods quality control, analysis procedures and training and qualification. Since 1979, the major portion of the quality assurance program has been implemented on a central analytical computer system. The individual features provided by the system are storage, retrieval, and search capabilities over all general request and sample analysis information, automatic method selection for all process streams, automation of all method calculations, automatic assignment of bias and precision estimates at all analysis levels, with-method-use requalification, untrained or unqualified analyst method lockout, statistical testing of all process stream results for replicate agreement, automatic testing of process results against pre- established operating, safety, or failure limits at varying confidence levels, and automatic transfer and report of all analysis data plus all statistical testing to the Production Department

  8. Application of project design peer review to improve quality assurance

    International Nuclear Information System (INIS)

    McClure, F.E.

    1989-01-01

    DOE ORDER 5481.1B Safety Analysis and Review Systems and DOE ORDER 6430.1A General Design Criteria require that the design of facilities shall incorporate the necessary Quality Assurance review requirements to assure that the established program quality assurance objectives are met in the design criteria and the construction documents. The use of Project Design Peer Review to satisfy these requirements is presented. The University of California manages the Lawrence Berkeley Laboratory, the Lawrence Livermore National Laboratory, and the Los Alamos National Scientific Laboratory. The 1988 University Seismic Safety Policy requires the use of independent Project Design Peer Review in its capital improvement and seismic reconstruction program

  9. Quality assurance measures for spent fuel shipping and storage containers

    International Nuclear Information System (INIS)

    Droste, B.; Roedel, R.

    1987-01-01

    Quality assurance measures are to be applied in production and operation to ensure the approved fuel-element-container design specifications. The authors concentrate on the official regulations pertaining to the application of a quality assurance system, on the compliance with design specifications ensured by certified manufacturing tests and in-service inspections. For nodular-cast-iron container bodies, the authors demonstrate the procedure by presenting the contents of the materials data sheet characterizing the material, and the production and test sequence plan for container casting. In addition, they state the quality assurance requirements for interim-storage containers which transgress those stipulated for shipping containers. (orig.) [de

  10. Design quality assurance for nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1986-07-01

    This Standard contains the requirements for the quality assurance program applicable to the design phase of a nuclear plant, and is applicable to the design of safety-related equipment, systems, and structures, as identified by the owner. 1 fig.

  11. Design quality assurance for nuclear power plants

    International Nuclear Information System (INIS)

    1986-07-01

    This Standard contains the requirements for the quality assurance program applicable to the design phase of a nuclear plant, and is applicable to the design of safety-related equipment, systems, and structures, as identified by the owner. 1 fig

  12. External Quality Assurance System (EQAS) of the WHO Global Salmonella Surveillance and Laboratory Support Project (Global Salm-Surv) Results from 2001

    DEFF Research Database (Denmark)

    Petersen, A.; Aarestrup, Frank Møller; Evans, M.C.

    An international collaborative study on serotyping and antimicrobial susceptibility testing of eight Salmonella enterica strains was performed to enhance the capacity of national and regional reference laboratories in WHO Global Salm-Surv to conduct Salmonella serotyping and antimicrobial suscept...... of the quality control range specified by NCCLS guidelines....

  13. A CEGB system for the assurance of quality in the commissioning of power plant

    International Nuclear Information System (INIS)

    Lake, M.W.

    1984-01-01

    This paper outlines a system of organization, documentation and surveillance which has been fully proven in practice and looks ahead to identify the arrangements for the organization, documentation, and audit which the CEGB proposes to use in the commissioning of the Sizewell 'B' PWR, so that quality may be assured. In the UK between 1967 and 1982, the CEGB commissioned approximately 40,000 M Watts of power plant. This comprised power plants that were coal fired, oil fired, water driven, gas turbine driven and nuclear (both magnox and advanced gas cooled (AGR) reactors)

  14. Labelled agents for PET studies of the dopaminergic system -some quality assurance methods, experience and issues

    International Nuclear Information System (INIS)

    Pike, V.W.; Kensett, M.J.; Turton, D.R.; Waters, S.L.; Silvester, D.J.

    1990-01-01

    Practical methods are described for the quality assurance of three labelled agents (L-6-[ 18 F]fluoro-DOPA, S-[N-methyl- 11 C]nomifensine and [O-methyl- 11 C]raclopride) now produced regularly for PET studies of the dopaminergic system in man. These include indirect methods for the initial determination of label position (e.g. 13 C-NMR spectroscopy) and also direct methods for the assessment of chiral purity (TLC and HPLC) and the routine determination of radiochemical purity, chemical purity and specific activity (HPLC). Mass spectrometry has been used to identify some impurities. L-6-hydroxy-DOPA (a precursor in vivo of the neurotoxin, L-6-hydroxydopamine) has been detected by HPLC in some preparations of L-6-[ 18 F]fluoro-DOPA. Formulated S-[N-methyl- 11 C]nomifensine has been found to be stable. Some quality assurance issues are discussed in relation to experience in the application of the described methods and the obtained results. (author)

  15. Technical Reference Suite Addressing Challenges of Providing Assurance for Fault Management Architectural Design

    Science.gov (United States)

    Fitz, Rhonda; Whitman, Gerek

    2016-01-01

    Research into complexities of software systems Fault Management (FM) and how architectural design decisions affect safety, preservation of assets, and maintenance of desired system functionality has coalesced into a technical reference (TR) suite that advances the provision of safety and mission assurance. The NASA Independent Verification and Validation (IV&V) Program, with Software Assurance Research Program support, extracted FM architectures across the IV&V portfolio to evaluate robustness, assess visibility for validation and test, and define software assurance methods applied to the architectures and designs. This investigation spanned IV&V projects with seven different primary developers, a wide range of sizes and complexities, and encompassed Deep Space Robotic, Human Spaceflight, and Earth Orbiter mission FM architectures. The initiative continues with an expansion of the TR suite to include Launch Vehicles, adding the benefit of investigating differences intrinsic to model-based FM architectures and insight into complexities of FM within an Agile software development environment, in order to improve awareness of how nontraditional processes affect FM architectural design and system health management. The identification of particular FM architectures, visibility, and associated IV&V techniques provides a TR suite that enables greater assurance that critical software systems will adequately protect against faults and respond to adverse conditions. Additionally, the role FM has with regard to strengthened security requirements, with potential to advance overall asset protection of flight software systems, is being addressed with the development of an adverse conditions database encompassing flight software vulnerabilities. Capitalizing on the established framework, this TR suite provides assurance capability for a variety of FM architectures and varied development approaches. Research results are being disseminated across NASA, other agencies, and the

  16. 10 CFR 72.142 - Quality assurance organization.

    Science.gov (United States)

    2010-01-01

    ... activities are performed, the organizational structure for executing the quality assurance program may take... the required authority and organizational freedom. Irrespective of the organizational structure, the... functions of structures, systems, and components which are important to safety. These activities include...

  17. Quality assurance records system for research and development activities in support of geologic repository programs

    International Nuclear Information System (INIS)

    Smith, J.W.; Ryder, D.E.

    1987-01-01

    The Pacific Northwest Laboratory (PNL), which is operated by Battelle Memorial Institute for the Department of Energy, is conducting site-specific research for all three candidate sites for the first geologic high-level waste repository, as well as generic research for the second repository. In conjunction with this effort, PNL has developed a quality assurance (QA) program that is applicable to all organizations that are performing research and development (R and D) activities in support of the repository programs. This QA program meets the basic and supplemental requirements of ANSI/ASME NQA-1-1983 and the Nuclear Regulatory Commission (NRC) Review Plan for QA Programs for Site Characterization of High Level Nuclear Waste Repositories. A key part of this program is the handling of QA records that may ultimately support the licensing process for the repository. This paper describes a QA records system that is flexible enough to accommodate several types of research, such as paper studies, test method development, site characterization studies, software development, and hardware design. In addition, the QA records system is acceptable to a variety of sponsors who have licensing concerns. The QA procedures and their relation to the requirements are described. Most important is the discussion on the approaches used to assure that the records are organized such that the user can readily recreate or defend data, conclusions, and recommendations resulting from the research

  18. Development of quality assurance requirements - an international comparison

    Energy Technology Data Exchange (ETDEWEB)

    Link, M [Siemens AG, Bereich Energieerzeugung (KWU), Erlangen (Germany); Mertz, W [Siemens AG, Bereich Energieerzeugung (KWU), Offenbach am Main (Germany)

    1993-12-01

    Total quality management strategy and the worldwide introduction of the DIN/ISO 9000 (EN 29 000) series of standards have given new impetus to traditional quality assurance. The most important change must surely be seen in the holistic approach of total quality management and its strict orientation towards customer requirements and satisfaction. International codes and standards for the nuclear industry will also have to be brought into line as part of the process of harmonizing quality assurance system standards. One possible approach is simply to specify a supplementary 'delta' of nuclear-specific requirements to be appended to the broad range of conventional requirements. It is a particular feature of quality-assured procedures in Germany that product and/or component related quality requirements and quality verifications are defined in the specifications of the architect engineer so that full implementation of the requirements from the design phase through to the manufacturing phase is assured. Looking at the development of the European Pressurized Water Reactor (EPR) and the elaboration of 'Common Rules', it is to be anticipated that a major step will be made toward international harmonization of safety criteria. (orig.)

  19. Development of quality assurance requirements - an international comparison

    International Nuclear Information System (INIS)

    Link, M.; Mertz, W.

    1993-01-01

    Total quality management strategy and the worldwide introduction of the DIN/ISO 9000 (EN 29 000) series of standards have given new impetus to traditional quality assurance. The most important change must surely be seen in the holistic approach of total quality management and its strict orientation towards customer requirements and satisfaction. International codes and standards for the nuclear industry will also have to be brought into line as part of the process of harmonizing quality assurance system standards. One possible approach is simply to specify a supplementary 'delta' of nuclear-specific requirements to be appended to the broad range of conventional requirements. It is a particular feature of quality-assured procedures in Germany that product and/or component related quality requirements and quality verifications are defined in the specifications of the architect engineer so that full implementation of the requirements from the design phase through to the manufacturing phase is assured. Looking at the development of the European Pressurized Water Reactor (EPR) and the elaboration of 'Common Rules', it is to be anticipated that a major step will be made toward international harmonization of safety criteria. (orig.) [de

  20. Environmental Restoration Remedial Action quality assurance requirements document

    International Nuclear Information System (INIS)

    1991-01-01

    This document defines the quality assurance requirements for the US Department of Energy-Richland Operations Office Environmental Restoration Remedial Action program at the Hanford Site. The Environmental Restoration Remedial Action program implements significant commitments made by the US Department of Energy in the Hanford Federal Facility Agreement and Consent Order entered into with the Washington State Department of Ecology and the US Environmental Protection Agency. This document combines quality assurance requirements from various source documents into one set of requirements for use by the US Department of Energy-Richland Operations Office and other Environmental Restoration Remedial Action program participants. This document will serve as the basis for developing Quality Assurance Program Plans and implementing procedures by the participants. The requirements of this document will be applied to activities affecting quality, using a graded approach based on the importance of the item, service, or activity to the program objectives. The Quality Assurance Program that will be established using this document as the basis, together with other program and technical documents, form an integrated management control system for conducting the Environmental Restoration Remedial Action program activities in a manner that provides safety and protects the environment and public health

  1. Quality assurance of radiation therapy machines

    International Nuclear Information System (INIS)

    Francois, P.

    2002-01-01

    Due to the modifications of components, to unexpected breakage of elements or to electronic dysfunctions, the performance of radiotherapy machines may decrease with age. Quality Assurance procedures and maintenance program are necessary to guarantee the performances. For linear accelerators, modus operandi of control tests and their frequency are based on regulations and recommendations widely published, that are presented here. Concerning accessories, especially those recently developed (multi-leaf collimators, dynamic wedges,...), recommendations remains to be defined. Simple tests are proposed. Concerning numerical imaging systems, widely used for three dimensional dosimetry, image quality and geometry controls must be performed with fantom tests. For portal imaging, a quality assurance program is proposed. A strict and complete Quality Assurance program is essential to guarantee quality and safety of the treatment. A regular control of linear accelerator is one of the important component of this program. It suppose the implementation of permanent tests procedures, periodically modified following technological progresses and treatment techniques. Measurements must be sensible to variations below the tolerance level defined during the installation process. The analysis of the variations of measurements with time are an objective criterion of quality. (author)

  2. Nuclear and radiation safety assurance federal target programme management system

    International Nuclear Information System (INIS)

    Kryukov, O.V.; Vasil'ev, V.A.; Nikishin, D.A.; Linge, I.I.; Obodinskij, A.N.

    2012-01-01

    The Federal Program Nuclear and Radiation Safety Assurance for 2008-2015 is presented. Specifics of Federal target program management as well as changes to program management are discussed. Data on evaluation of management effectiveness is given. Further efforts to resolve the nuclear legacy problem in Russia are also presented [ru

  3. The Columbia River Protection Supplemental Technologies Quality Assurance Project Plan

    International Nuclear Information System (INIS)

    Fix, Anne

    2007-01-01

    The U.S. Department of Energy (DOE) has conducted interim groundwater remedial activities on the Hanford Site since the mid-1990s for several groundwater contamination plumes. DOE established the Columbia River Protection Supplemental Technologies Project (Technologies Project) in 2006 to evaluate alternative treatment technologies. The objectives for the technology project are as follows: develop a 300 Area polyphosphate treatability test to immobilize uranium, design and test infiltration of a phosphate/apatite technology for Sr-90 at 100-N, perform carbon tetrachloride and chloroform attenuation parameter studies, perform vadose zone chromium characterization and geochemistry studies, perform in situ biostimulation of chromium studies for a reducing barrier at 100-D, and perform a treatability test for phytoremediation for Sr-90 at 100-N. This document provides the quality assurance guidelines that will be followed by the Technologies Project. This Quality Assurance Project Plan is based on the quality assurance requirements of DOE Order 414.1C, Quality Assurance, and 10 CFR 830, Subpart A--Quality Assurance Requirements as delineated in Pacific Northwest National Laboratory?s Standards-Based Management System. In addition, the technology project is subject to the Environmental Protection Agency (EPA) Requirements for Quality Assurance Project Plans (EPA/240/B-01/003, QA/R-5). The Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD, DOE/RL-96-68) apply to portions of this project and to the subcontractors. HASQARD requirements are discussed within applicable sections of this plan.

  4. Regulatory inspection of the implementation of quality assurance programmes

    International Nuclear Information System (INIS)

    1989-01-01

    This Manual provides guidance to Member States in the organization and performance of their regulatory inspection functions regarding the implementation of nuclear power plant quality assurance programmes. It addresses the interface between, and is consistent with, the IAEA Nuclear Safety Standards (NUSS programme) documents on quality assurance and governmental organization. The Manual offers a practical model and examples for performing regulatory inspections to ensure that the quality assurance programme is operating satisfactorily in the siting, design, manufacturing, construction, commissioning, operation and decommissioning of nuclear power plants. The primary objective is to confirm that the licensee has the capability to manage and control the effective performance of all quality assurance responsibilities during all phases of a nuclear power project. The guidance provided through this Manual for proper establishment and execution of the regulatory inspections helps to enforce the effective implementation of the quality assurance programme as a management control system that the nuclear industry should establish and use in attaining the safety and reliability objectives for nuclear installations. This enforcement action by national regulatory bodies and the emphasis on the purposes and advantages of quality assurance as an important management tool integrated within the total project task have been recommended by the IAEA International Nuclear Safety Advisory Group (INSAG). The primary intended users of this Manual are the management personnel and high level staff from regulatory bodies but it will also be helpful to management personnel from nuclear utilities and vendors. They all are inevitable partners in a nuclear power project and this document offers all of them valuable information on the better accomplishment of quality assurance activities to ensure the common objective of safe and reliable nuclear power production

  5. Reliability assurance programme guidebook for advanced light water reactors

    International Nuclear Information System (INIS)

    2001-12-01

    To facilitate the implementation of reliability assurance programmes (RAP) within future advanced reactor programmes and to ensure that the next generation of commercial nuclear reactors achieves the very high levels of safety, reliability and economy which are expected of them, in 1996, the International Atomic Energy Agency (IAEA) established a task to develop a guidebook for reliability assurance programmes. The draft RAP guidebook was prepared by an expert consultant and was reviewed/modified at an Advisory Group meeting (7-10 April 1997) and at a consults meeting (7-10 October 1997). The programme for the RAP guidebook was reported to and guided by the Technical Working Group on Advanced Technologies for Light Water Reactors (TWG-LWR). This guidebook will demonstrate how the designers and operators of future commercial nuclear plants can exploit the risk, reliability and availability engineering methods and techniques developed over the past two decades to augment existing design and operational nuclear plant decision-making capabilities. This guidebook is intended to provide the necessary understanding, insights and examples of RAP management systems and processes from which a future user can derive his own plant specific reliability assurance programmes. The RAP guidebook is intended to augment, not replace, specific reliability assurance requirements defined by the utility requirements documents and by individual nuclear steam supply system (NSSS) designers. This guidebook draws from utility experience gained during implementation of reliability and availability improvement and risk based management programmes to provide both written and diagrammatic 'how to' guidance which can be followed to assure conformance with the specific requirements outlined by utility requirements documents and in the development of a practical and effective plant specific RAP in any IAEA Member State

  6. Seeking legitimacy for new assurance forms: The case of assurance on sustainability reporting

    NARCIS (Netherlands)

    O'Dwyer, B.; Owen, D.; Unerman, J.

    2011-01-01

    Based on the development of a more refined conception of legitimacy than has been used in prior audit/assurance and sustainability accounting research, this paper analyses how the legitimation processes adopted by sustainability assurance practitioners in a large professional services firm have

  7. Fault Management Architectures and the Challenges of Providing Software Assurance

    Science.gov (United States)

    Savarino, Shirley; Fitz, Rhonda; Fesq, Lorraine; Whitman, Gerek

    2015-01-01

    The satellite systems Fault Management (FM) is focused on safety, the preservation of assets, and maintaining the desired functionality of the system. How FM is implemented varies among missions. Common to most is system complexity due to a need to establish a multi-dimensional structure across hardware, software and operations. This structure is necessary to identify and respond to system faults, mitigate technical risks and ensure operational continuity. These architecture, implementation and software assurance efforts increase with mission complexity. Because FM is a systems engineering discipline with a distributed implementation, providing efficient and effective verification and validation (VV) is challenging. A breakout session at the 2012 NASA Independent Verification Validation (IVV) Annual Workshop titled VV of Fault Management: Challenges and Successes exposed these issues in terms of VV for a representative set of architectures. NASA's IVV is funded by NASA's Software Assurance Research Program (SARP) in partnership with NASA's Jet Propulsion Laboratory (JPL) to extend the work performed at the Workshop session. NASA IVV will extract FM architectures across the IVV portfolio and evaluate the data set for robustness, assess visibility for validation and test, and define software assurance methods that could be applied to the various architectures and designs. This work focuses efforts on FM architectures from critical and complex projects within NASA. The identification of particular FM architectures, visibility, and associated VVIVV techniques provides a data set that can enable higher assurance that a satellite system will adequately detect and respond to adverse conditions. Ultimately, results from this activity will be incorporated into the NASA Fault Management Handbook providing dissemination across NASA, other agencies and the satellite community. This paper discusses the approach taken to perform the evaluations and preliminary findings from the

  8. Design-reliability assurance program application to ACP600

    International Nuclear Information System (INIS)

    Zhichao, Huang; Bo, Zhao

    2012-01-01

    ACP600 is a newly nuclear power plant technology made by CNNC in China and it is based on the Generation III NPPs design experience and general safety goals. The ACP600 Design Reliability Assurance Program (D-RAP) is implemented as an integral part of the ACP600 design process. A RAP is a formal management system which assures the collection of important characteristic information about plant performance throughout each phase of its life and directs the use of this information in the implementation of analytical and management process which are specifically designed to meet two specific objects: confirm the plant goals and cost effective improvements. In general, typical reliability assurance program have 4 broad functional elements: 1) Goals and performance criteria; 2) Management system and implementing procedures; 3) Analytical tools and investigative methods; and 4) Information management. In this paper we will use the D-RAP technical and Risk-Informed requirements, and establish the RAM and PSA model to optimize the ACP600 design. Compared with previous design process, the D-RAP is more competent for the higher design targets and requirements, enjoying more creativity through an easier implementation of technical breakthroughs. By using D-RAP, the plants goals, system goals, performance criteria and safety criteria can be easier to realize, and the design can be optimized and more rational

  9. 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.

  10. Concrete and steel construction quality control and assurance

    CERN Document Server

    El-Reedy, Mohamed A

    2014-01-01

    Starting with the receipt of materials and continuing all the way through to the final completion of the construction phase, Concrete and Steel Construction: Quality Control and Assurance examines all the quality control and assurance methods involving reinforced concrete and steel structures. This book explores the proper ways to achieve high-quality construction projects, and also provides a strong theoretical and practical background. It introduces information on quality techniques and quality management, and covers the principles of quality control. The book presents all of the quality control and assurance protocols and non-destructive test methods necessary for concrete and steel construction projects, including steel materials, welding and mixing, and testing. It covers welding terminology and procedures, and discusses welding standards and procedures during the fabrication process, as well as the welding codes. It also considers the total quality management system based on ISO 9001, and utilizes numer...

  11. Operations quality assurance for nuclear power plants

    International Nuclear Information System (INIS)

    1987-01-01

    This standard covers the quality assurance of all activities concerned with the operation and maintenance of plant equipment and systems in CANDU-based nuclear power plants during the operations phase, the period between the completion of commissioning and the start of decommissioning

  12. 48 CFR 53.301-1406 - Preaward Survey of Prospective Contractor-Quality Assurance.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Preaward Survey of Prospective Contractor-Quality Assurance. 53.301-1406 Section 53.301-1406 Federal Acquisition Regulations...-1406 Preaward Survey of Prospective Contractor—Quality Assurance. ER09DE97.000 ER09DE97.001 [62 FR...

  13. THE LEGITIMACY OF INCLUDING THE SOCIAL PARAMETERS IN EVALUATING THE HEALTH STATUS IN THE SOCIAL ASSURANCE SYSTEM

    Directory of Open Access Journals (Sweden)

    MIHAI NEDELCU

    2011-04-01

    Full Text Available The social state crisis encouraged a reductionist tendency which had recently developed in the evaluations of the health status in the social assurance system. A holistic, psycho-medical approach, which took in consideration the implications of the social factors regarding disability, was confronted with a strictly medical model, in which the illness is exclusively considered a person’s problem; therefore, the references towards the „social” are irrelevant. In this context, the present paper states the question of the legitimacy of using some sociological concepts, in medical expertise, considered relevant in this area, such as: „occupational access” or the „social functioning of the person”. The present study doesn’t stop at offering as arguments of legitimacy the authority of some recommendations regarding the use of the social-medical model, including the evaluation of the health status, recommendations received from the behalf of OMS and the European Council (see CIF. The paper presents the construction of specific evaluation instruments and tries to identify the sense in which using the references regarding the „social” could influence the pressures in the social assurance system.

  14. 42 CFR 422.210 - Assurances to CMS.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Assurances to CMS. 422.210 Section 422.210 Public...) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Relationships With Providers § 422.210 Assurances to CMS. (a) Assurances to CMS. Each organization will provide assurance satisfactory to the Secretary that the...

  15. 40 CFR 31.45 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 31.45 Section 31.45... Requirements Reports, Records, Retention, and Enforcement § 31.45 Quality assurance. If the grantee's project... quality assurance practices consisting of policies, procedures, specifications, standards, and...

  16. The simplification of quality assurance programmes to suit developing countries

    International Nuclear Information System (INIS)

    French, F.J.

    1978-01-01

    Whilst the need to produce and maintain documentation covering the supply and operation of Nuclear Steam Supply Systems is appreciated, it is felt that there is now a tendency to regard such documentation as more important than the plant itself. This tendency must be corrected if the safety and reliability of nuclear plants is to be maintained. The following paper proposes actions which will bring documentation into its proper perspective and make it more easily understood internationally. In addition, it is proposed that a common international Quality Assurance Programme Standard should be adopted by countries importing and exporting NSSS in order to make the requirements more understandable to all concerned. The proposals cover Quality Assurance Systems Specifications and the training of quality engineers and evaluators, and discuss Quality Assurance Programmes and Quality Plans. Specifically, the paper suggests the actions which could be undertaken now and proposes the bodies which should be responsible for such actions. (author)

  17. Comparative analysis of quality assurance systems which effectively control, review and verify the quality of components manufactured for liquid metal cooled fast breeder reactors within the EEC

    International Nuclear Information System (INIS)

    Benn, L.A.

    1985-01-01

    Comparative analyses are made of Quality Assurance Systems, by techniques and the methodology used, for the manufacture of component parts for the Liquid Metal Cooled Fast Breeder Reactor (LMFBR) within the EEC. Two differing alternative systems are presented in the analysis. First, a tabulated analytical treatment which analyses 14 codes and standards relating to Quality Assurance which can be applied to LMFBR's. The comparison equates equivalent clauses between codes and standards followed by an analysis of individual clauses in tabular form, the International Standard ISO 6215. A statistical summary and recommendations conclude this analysis. The second alternative system used in the comparison is a descriptive analytical method applied to 9 selected codes and standards relating to Quality Assurance based on the 13 criteria of the International IAEA Code of Practice no. 50 C.QA entitled ''Quality Assurance for Safety in Nuclear Power Plants''. An investigation is then made of the state of the art on the subject of classification of component parts bearing generally on Quality Assurance. The method of classification is segregated into General, Safety and Inspection categories. A summary of destructive and non destructive controls that may be applied during the manufacture of LMFBR components is given, together with tests that may be applied to selected components, namely Primary Tank, Secondary Sodium Pump and the Primary Cold Trap allocated to Safety Classes, 1, 2 and 3 respectively. The report concludes with a summary of typical records produced at the delivery of a component

  18. The successful Chief Executive Officer understands quality assurance

    International Nuclear Information System (INIS)

    Hedges, D.

    1984-01-01

    The successful Chief Executive Officer (CEO) will have recognized the benefits of, and have implemented, a total quality assurance program. The quality assurance program will be adequately defined in policies and procedures such that managers and supervisors of each organizational element understand their primary and supporting roles in carrying out an effective quality assurance program. The traditional practice of having all quality assurance activities reside in a quality assurance organization will have been cast aside. Instead, the quality assurance activities necessary to achieve and assure the quality of the desired end product will have been defined and assigned to responsible organization elements. The quality assurance organization's primary role will be to define the total quality assurance program, insure that the achieving and assuring functions are assigned in policies and procedures, conduct training necessary to have management and supervisors understand the total quality assurance program, measure the effectiveness of the program and feedback measurement data for improvements in the program. The successful CEO will have implemented a quality assurance program that provides for a graded approach for application of the program based upon the importance of the intended use of the product or service. The successful CEO will rely heavily on the scheduled progress reports and assessments to measure the pulse of his organization's successes and improvement needs. This paper will describe suggested approaches for the Quality Assurance Manager to implement a quality assurance program which results in his corporation's CEO being a supporter of and a driving force in the implementation of the quality assurance program

  19. Continuously revised assurance cases with stakeholders’ cross-validation: a DEOS experience

    Directory of Open Access Journals (Sweden)

    Kimio Kuramitsu

    2016-12-01

    Full Text Available Recently, assurance cases have received much attention in the field of software-based computer systems and IT services. However, software changes very often, and there are no strong regulations for software. These facts are two main challenges to be addressed in the development of software assurance cases. We propose a method of developing assurance cases by means of continuous revision at every stage of the system life cycle, including in operation and service recovery in failure cases. Instead of a regulator, dependability arguments are validated by multiple stakeholders competing with each other. This paper reported our experience with the proposed method in the case of Aspen education service. The case study demonstrates that continuous revisions enable stakeholders to share dependability problems across software life cycle stages, which will lead to the long-term improvement of service dependability.

  20. Patient dosimetry quality assurance program with a commerical diode system

    International Nuclear Information System (INIS)

    Lee, P.C.; Sawicka, J.M.; Glasgow, G.P.

    1994-01-01

    The purpose was to evaluate a commercial silicone diode dosimeter for a patient dosimetry quality assurance program. The diode dosimeter was calibrated against an ion chamber, and percentage depth dose, linearity, anisotrophy, virtual source position, and field size factor studies were performed. Correction factors for lack of full scatter medium in the diode entrance and exit dose measurements were acquired. Dosimetry equations were proposed for calculation of dose delivered at isocenter. Diode dose accuracy and reproducibility were tested on phantom and on four patients. A patient dosimetry quality assurance program based on diode-measured dose was instituted and patient dose data were collected. Diode measured percentage depth dose and field factors agreed to within 3% with those measured with an ion chamber. The diode exhibited less than 1.7% angular dose anisotrophy and less than 0.5% nonlinearity up to 4 Gy. Diode dose measurements in phantom showed that the calculated doses differed from the prescribed dose by less than 1.%; the diode exhibited a daily dose reproducibility of better than 0.2%. On four selected patients, the measured dose reproducibility was 1.5%; the average calculated doses were all within ± 7% of the prescribed doses. For 33 of 40 patients treated with a 6 MW beam, measured doses were within ± 7% of the prescribed doses. For 11 out of 12 patients, a second repeat measurements yielded doses within ± 7% of the prescribed doses. The proposed diode-based patient dosimetry quality assurance program with dose tolerance at ± 7% is simple and feasible. It is capable of detecting certain serious treatment errors such as incorrect daily dose greater than 7%, incorrect wedge use, incorrect photon energy and patient setup errors involving some incorrect source-to-surface-distance vs. source-to-axis-distance treatments. 13 refs., 5 figs., 5 tabs

  1. 40 CFR 160.35 - Quality assurance unit.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Quality assurance unit. 160.35 Section... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure...

  2. 10 CFR 63.142 - Quality assurance criteria.

    Science.gov (United States)

    2010-01-01

    ... planned and periodic audits to verify compliance with all aspects of the quality assurance program and to... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance criteria. 63.142 Section 63.142 Energy... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.142 Quality assurance criteria. (a) Introduction...

  3. The Phases and Paradoxes of Educational Quality Assurance: The Case of the Singapore Education System

    Science.gov (United States)

    Ng, Pak Tee

    2008-01-01

    Purpose: The purpose of this paper is to highlight three important insights into educational quality assurance, using Singapore as a case study. It is useful to policy makers and practitioners to understand the phases and paradoxes in their educational quality assurance journey so that they may recognise and manage better the complex dynamics of…

  4. 7 CFR 652.7 - Quality assurance.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 6 2010-01-01 2010-01-01 false Quality assurance. 652.7 Section 652.7 Agriculture... assurance. (a) NRCS will review, in consultation with the Farm Service Agency, as appropriate, the quality... information obtained through its quality assurance process, documentation submitted by the technical service...

  5. 10 CFR 76.93 - Quality assurance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

  6. Quality assurance in the construction phase of the Guangdong Daya Bay Nuclear Power Plant

    International Nuclear Information System (INIS)

    Chen Heling; Zou Xiaoshun

    1994-11-01

    The quality assurance system of Guangdong Daya Bay Nuclear Power Plant during construction phase is briefly introduced. It includes the quality assurance organization and multiple quality control system of the owner (GNPJVC) and contractors. The status of the programmes implementation has been also described through presenting of some important quality assurance activities such as quality surveillance, QA audit and nonconformance control. In addition, the effectiveness of GNPP Construction QA Program has been analyzed and evaluated and both positive and negative experience have been summarized which could be used for reference by the nuclear power constructors. (6 figs.)

  7. Quality assurance in the construction phase of the Guangdong Daya Bay Nuclear Power Plant

    Energy Technology Data Exchange (ETDEWEB)

    Heling, Chen; Xiaoshun, Zou [Guangdong Nuclear Power Joint Venture Company (China)

    1994-11-01

    The quality assurance system of Guangdong Daya Bay Nuclear Power Plant during construction phase is briefly introduced. It includes the quality assurance organization and multiple quality control system of the owner (GNPJVC) and contractors. The status of the programmes implementation has been also described through presenting of some important quality assurance activities such as quality surveillance, QA audit and nonconformance control. In addition, the effectiveness of GNPP Construction QA Program has been analyzed and evaluated and both positive and negative experience have been summarized which could be used for reference by the nuclear power constructors. (6 figs.).

  8. Quality assurance when refitting - SUSAN example

    International Nuclear Information System (INIS)

    Gautier, R.

    1992-01-01

    The most important points of quality assurance for the realisation of the SUSAN project (special independent system for the dissipation of post-decay heat) at the Muehleberg nuclear power station are discussed in this article. The periodic controls and function tests which have been performed since August 1989, confirm the quality of the products used

  9. Quality assurance in radiodiagnosis

    International Nuclear Information System (INIS)

    Ghilardi Netto, T.; Sao Paulo Univ., Ribeirao Preto

    1983-01-01

    The following topics are dealt with: 1) the importance of the application of a quality assurance program in radiodiagnosis, with its main consequences : improvement of imaging quality, reduction of the patient expossure rate, cost reduction and 2) how to introduce the quality assurance control in the radiodiagnostic area. (M.A.) [pt

  10. Radiation quality assurance intercomparison studies 1974--1975

    International Nuclear Information System (INIS)

    1975-10-01

    The Quality Assurance Branch of the Monitoring Systems Research and Development Division at the U.S. Environmental Protection Agency's Environmental Monitoring and Support Laboratory-Las Vegas prepares and distributes calibrated low-level radioactive solutions to Federal, State, and private laboratories involved in environmental radiation monitoring and surveillance. These solutions are used for both the calibration of counting instruments and chemical yield determinations. Since the laboratories using these samples must have confidence in their accuracy, the Quality Assurance Branch has instituted intercomparison studies with the National Bureau of Standards and with the Energy Research and Development Administration Health and Service Laboratory. The results of the studies conducted during 1974 and 1975 are described

  11. Design and Evaluation of Nextgen Aircraft Separation Assurance Concepts

    Science.gov (United States)

    Johnson, Walter; Ho, Nhut; Arutyunov, Vladimir; Laue, John-Luke; Wilmoth, Ian

    2012-01-01

    To support the development and evaluation of future function allocation concepts for separation assurance systems for the Next Generation Air Transportation System, this paper presents the design and human-in-the-loop evaluation of three feasible function allocation concepts that allocate primary aircraft separation assurance responsibilities and workload to: 1) pilots; 2) air traffic controllers (ATC); and 3) automation. The design of these concepts also included rules of the road, separation assurance burdens for aircraft of different equipage levels, and utilization of advanced weather displays paired with advanced conflict detection and resolution automation. Results of the human-in-the-loop simulation show that: a) all the concepts are robust with respect to weather perturbation; b) concept 1 (pilots) had highest throughput, closest to assigned spacing, and fewest violations of speed and altitude restrictions; c) the energy of the aircraft during the descent phase was better managed in concepts 1 and 2 (pilots and ATC) than in concept 3 (automation), in which the situation awareness of pilots and controllers was lowest, and workload of pilots was highest. The paper also discusses further development of these concepts and their augmentation and integration with future air traffic management tools and systems that are being considered for NextGen.

  12. Safety Assurance Process for FRMS : EJcase Implementation

    NARCIS (Netherlands)

    Stewart, S.; Koornneef, F.; Akselsson, R.; Barton, P.

    2009-01-01

    Chapter 6: Safety Assurance Process for FRMS - eJcase Implementation The European Commission HILAS project (Human Integration into the Lifecycle of Aviation Systems - a project supported by the European Commission’s 6th Framework between 2005-2009) was focused on using human factors knowledge and

  13. 40 CFR 30.54 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 30.54 Section 30.54... NON-PROFIT ORGANIZATIONS Post-Award Requirements Reports and Records § 30.54 Quality assurance. If the... data generation, the grantee shall develop and implement quality assurance practices consisting of...

  14. Russian Higher Education and European Standards of Quality Assurance

    Science.gov (United States)

    Motova, Galina; Pykko, Ritta

    2012-01-01

    This article considers the relevance and implementation of European approaches to quality assurance in the context of the Russian educational system. It covers the issues of transformation of the higher education system during the post-Soviet period, specific features of the state accreditation system, the impact of the European Standards and…

  15. BYU Food Quality Assurance Laboratory

    Data.gov (United States)

    Federal Laboratory Consortium — The Quality Assurance Lab is located in the Eyring Science Center in the department of Nutrition, Dietetics, and Food Science. The Quality Assurance Lab has about 10...

  16. Evaluation of halal assurance system (HAS) implementation on bakery products processing in small and medium enterprises (case study in X Bakery Batu, East Java)

    Science.gov (United States)

    Perdani, C. G.; Chasanah, N. U.; Sucipto

    2018-03-01

    Small and Medium Enterprises (SMEs) have an important role to catch opportunities in the global halal market. To achieve halal standards, bakery SMEs need to implement Halal Assurance System (HAS). The objective of this research was to evaluate HAS applied by SMEs in bakery product processing. Evaluation was conducted by audit method in accordance to Indonesian Halal Assurance System (a guideline regarding the Fulfillment of Criteria of Halal Assurance System in Processing Industry – namely HAS 23101). The result of the evaluation shows that 44% of HAS criteria have been met. Halal team is the key of HAS management, therefore the team needs to be institutionally established. Halal policy need to be documented and announced to the public. Regular training will improve understanding and awareness of the importance of HAS responsibilities among stakeholders. With regard to bread ingredients, 85% products hold halal certificate from MUI (Indonesian Ulema Council). Halal Control Point (HCP) of production process can be derived from contamination of haram (not permitted by Islamic Law) and najis (dirty according to Islamic Law) in term of material, equipment, and packaging process. It requires top management commitment and cooperation of a good halal team to implement a sustainable halal system.

  17. Model reliability and software quality assurance in simulation of nuclear fuel waste management systems

    International Nuclear Information System (INIS)

    Oeren, T.I.; Elzas, M.S.; Sheng, G.; Wageningen Agricultural Univ., Netherlands; McMaster Univ., Hamilton, Ontario)

    1985-01-01

    As is the case with all scientific simulation studies, computerized simulation of nuclear fuel waste management systems can introduce and hide various types of errors. Frameworks to clarify issues of model reliability and software quality assurance are offered. Potential problems with reference to the main areas of concern for reliability and quality are discussed; e.g., experimental issues, decomposition, scope, fidelity, verification, requirements, testing, correctness, robustness are treated with reference to the experience gained in the past. A list comprising over 80 most common computerization errors is provided. Software tools and techniques used to detect and to correct computerization errors are discussed

  18. Quality assurance tests of the CBM silicon tracking system sensors with an infrared laser

    Energy Technology Data Exchange (ETDEWEB)

    Teklishyn, Maksym [FAIR GmbH, Darmstadt (Germany); KINR, Kyiv (Ukraine); Collaboration: CBM-Collaboration

    2016-07-01

    Double-sided 300 μm thick silicon microstrip sensors are planned to be used in the Silicon Tracking System (STS) of the future CBM experiment. Different tools, including an infrared laser, are used to induce charge in the sensor medium to study the sensor response. We use present installation to develop a procedure for the sensor quality assurance during mass production. The precise positioning of the laser spot allows to make a clear judgment about the sensor interstrip gap response which provides information about the charge distribution inside the sensor medium. Results are compared with the model estimations.

  19. Post-Mission Quality Assurance Procedure for Survey-Grade Mobile Mapping Systems

    Science.gov (United States)

    Kerstinga, A. P.; Friess, P.

    2016-06-01

    Mobile Mapping Systems (MMS) consist of terrestrial-based moving platforms that integrate a set of imaging sensors (typically digital cameras and laser scanners) and a Position and Orientation System (POS), designed to collect data of the surrounding environment. MMS can be classified as "mapping-grade" or "survey-grade" depending on the system's attainable accuracy. Mapping-grade MMS produce geospatial data suitable for GIS applications (e.g., asset management) while survey-grade systems should satisfy high-accuracy applications such as engineering/design projects. The delivered accuracy of an MMS is dependent on several factors such as the accuracy of the system measurements and calibration parameters. It is critical, especially for survey-grade systems, to implement a robust Quality Assurance (QA) procedure to ensure the achievement of the expected accuracy. In this paper, a new post-mission QA procedure is presented. The presented method consists of a fully-automated self-calibration process that allows for the estimation of corrections to the system calibration parameters (e.g., boresight angles and lever-arm offsets relating the lidar sensor(s) to the IMU body frame) as well as corrections to the system measurements (e.g., post-processed trajectory position and orientation, scan angles and ranges). As for the system measurements, the major challenge for MMS is related to the trajectory determination in the presence of multipath signals and GNSS outages caused by buildings, underpasses and high vegetation. In the proposed self-calibration method, trajectory position errors are properly modelled while utilizing an efficient/meaningful trajectory segmentation technique. The validity of the proposed method is demonstrated using a dataset collected under unfavorable GNSS conditions.

  20. [Quality assurance in human genetic testing].

    Science.gov (United States)

    Stuhrmann-Spangenberg, Manfred

    2015-02-01

    Advances in technical developments of genetic diagnostics for more than 50 years, as well as the fact that human genetic testing is usually performed only once in a lifetime, with additional impact for blood relatives, are determining the extraordinary importance of quality assurance in human genetic testing. Abidance of laws, directives, and guidelines plays a major role. This article aims to present the major laws, directives, and guidelines with respect to quality assurance of human genetic testing, paying careful attention to internal and external quality assurance. The information on quality assurance of human genetic testing was obtained through a web-based search of the web pages that are referred to in this article. Further information was retrieved from publications in the German Society of Human Genetics and through a PubMed-search using term quality + assurance + genetic + diagnostics. The most important laws, directives, and guidelines for quality assurance of human genetic testing are the gene diagnostics law (GenDG), the directive of the Federal Medical Council for quality control of clinical laboratory analysis (RiliBÄK), and the S2K guideline for human genetic diagnostics and counselling. In addition, voluntary accreditation under DIN EN ISO 15189:2013 offers a most recommended contribution towards quality assurance of human genetic testing. Legal restraints on quality assurance of human genetic testing as mentioned in § 5 GenDG are fulfilled once RiliBÄK requirements are followed.

  1. A review of the recommendations governing quality assurance of ultrasound systems used for guidance in prostate brachytherapy.

    Science.gov (United States)

    Doyle, Andrea Jane; King, Deirdre M; Browne, Jacinta E

    2017-12-01

    Ultrasound guided brachytherapy for the treatment of prostate cancer has become a routine treatment option, due to many benefits including patient recovery and dose localisation [1]; however it is not clear whether the standards which govern the image quality for these systems are adequate. Upon review of the recommended standards for ultrasound systems used in prostate brachytherapy procedures, the recommended tests do not appear to be specific to the clinical application of ultrasound guided prostate brachytherapy. Rather they are generic and similar to those recommended for other clinical applications such as general abdominal scanning [2]. Furthermore, there is growing evidence that these tests should be specific to the clinical application [3,4] in order to gain meaningful data about the performance of the system for the application, and also to detect clinically relevant changes in quality control results. An additional problem is that there are no clinically relevant test phantom recommended for the quality assurance of ultrasound systems used in prostate brachytherapy. The image quality for this application of ultrasound needs to be monitored to ensure consistent levels of confidence in the procedure. This paper reviews the currently recommended test guidelines and test phantoms for ultrasound systems used in prostate brachytherapy from the different standard bodies and professional organisations. A critical analysis of those tests which are most reflective of the imaging and guidance tasks undertaken in an ultrasound guided prostate brachytherapy procedure will also be presented to inform the design of a TRUS quality assurance protocol. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  2. Quality assurance for screening mammography data collection systems in 22 countries.

    NARCIS (Netherlands)

    Klabunde, C.N.; Sancho-Garnier, H.; Broeders, M.E.A.C.; Thoresen, S.; Rodrigues, V.J.; Ballard-Barbash, R.

    2001-01-01

    OBJECTIVES: To document the mammography data that are gathered by the organized screening programs participating in the International Breast Cancer Screening Network (IBSN), the nature of their procedures for data quality assurance, and the measures used to assess program performance and impact.

  3. Assuring Competency in Nuclear Power Plants: Regulatory Policy and Practice

    International Nuclear Information System (INIS)

    Durbin, Nancy E.; Melber, Barbara

    2004-06-01

    approaches to assuring competency, these include: Implementing new programs; Requiring a systematic approach to training (SAT); Responding to audit findings using the IAEA guidelines on training programs; Anticipating and addressing potential problems; Assuring licensee remains an intelligent customer; Assuring competence after organizational changes; Building a new facility: 'pre-regulation' concerns. Outcomes of proactive inspections: Checking on a new regulation; Checking contractor qualifications before an outage; Checking qualifications of managers: two examples; Checking training after a modification; Checking training as part of a quality system review; Outcomes of reactive inspections: In depth evaluation of incident leads to increased attention to competence; Deteriorating performance traced to poor training program; Licensee needs training in root cause analysis; Two licensees lose function that tracks training in safety related positions; The authors noted the following as concluding remarks: Regulators seem to be moving towards more process based regulations and/or process based inspection methods for the oversight of competency. There is increasing attention to training and qualifications of personnel outside of operations, particularly those in maintenance positions. Competency specialists are concerned about the effects of two trends that seem to be increasing - downsizing, and the increased use of contractors. While there is an increased emphasis on human factors areas in nuclear power regulation, there is still an emphasis on technical systems and hardware by regulators and utilities. There is also concern about inadequate availability of expertise in the area of human factors in nuclear power regulators and industry

  4. The development of quality assurance program in Reactor TRIGA PUSPATI (RTP)

    International Nuclear Information System (INIS)

    Rosli Darmawan; Mohd Rizal Mamat; Mohamad Zaid Mohamad; Mohd Ridzuan Abdul Mutalib

    2007-01-01

    One of the trivial issues in the operation of Nuclear Reactor is the safety of the system. Worldwide publicity on a few nuclear accidents as well as the notorious Hiroshima and Nagasaki bombing has always bring about general public fear on anything related to nuclear. IAEA has always emphasized on the assurance of nuclear safety for all nuclear installations and activities. According to the IAEA safety guides, all research reactors are required to implement quality assurance programs to ensure the conduct of operations are in accordance with the safety standards required. This paper discusses the activities carried out toward the establishment of Quality Assurance Program for Reaktor TRIGA PUSPATI (RTP). (Author)

  5. Investigation on legislation necessity of qualification of quality assurance auditors for civilian nuclear components

    International Nuclear Information System (INIS)

    Zhu Hong

    2004-01-01

    The paper discusses the actual state and legislation necessity of administration for qualification of quality assurance auditors engaging in nuclear component activities in our country, and presents the tentative idea for establishing qualification system of quality assurance auditors. (author)

  6. Quality assurance management policies and requirements

    International Nuclear Information System (INIS)

    1985-10-01

    The purpose of this document is to: set forth overall, integrated quality assurance management policies and requirements for the entire Civilian Radioactive Waste Management Program; define management responsibilities for assuring quality; and provide a general framework for the development of more detailed quality assurance management policies and requirements by program, project, and contractor organizations

  7. Quality assurance in the nuclear industry

    International Nuclear Information System (INIS)

    Knoedler, D.

    1978-01-01

    Quality assurance is the sum of all activities systematically planned, practiced, and controlled with the aim to assure the quality of deliveries and performances. This assurance today covers all phases of activities, from the planning (including a determination of the required and necessary quality characteristics) to the start-up of a plant. (orig./RW) [de

  8. Quality assurance and the sub-contract interface: co-operative evaluations

    International Nuclear Information System (INIS)

    Churchill, G.F.; Rippon, D.J.

    1976-01-01

    A common feature of all contemporary Quality Assurance Standards is the requirement for organisations, when carrying out purchasing activities, to select their suppliers on the basis of either a proven record or demonstrated quality capability. In particular the C.E.G.B. Standard QA42-1 Quality Assurance Programme, which the C.E.G.B. will apply to their future major projects, requires purchasers to establish supplier selection and assessment procedures using one or other of the following methods: (a) a previous continuous record of supplying identical or equivalent material to a satisfactory standard; or (b) an evaluation of the sub-contractor's quality assurance system to determine his ability to satisfy the procurement requirements. Co-operative evaluations, where there are several suppliers, are discussed. (author)

  9. POST-MISSION QUALITY ASSURANCE PROCEDURE FOR SURVEY-GRADE MOBILE MAPPING SYSTEMS

    Directory of Open Access Journals (Sweden)

    A. P. Kerstinga

    2016-06-01

    Full Text Available Mobile Mapping Systems (MMS consist of terrestrial-based moving platforms that integrate a set of imaging sensors (typically digital cameras and laser scanners and a Position and Orientation System (POS, designed to collect data of the surrounding environment. MMS can be classified as “mapping-grade” or “survey-grade” depending on the system’s attainable accuracy. Mapping-grade MMS produce geospatial data suitable for GIS applications (e.g., asset management while survey-grade systems should satisfy high-accuracy applications such as engineering/design projects. The delivered accuracy of an MMS is dependent on several factors such as the accuracy of the system measurements and calibration parameters. It is critical, especially for survey-grade systems, to implement a robust Quality Assurance (QA procedure to ensure the achievement of the expected accuracy. In this paper, a new post-mission QA procedure is presented. The presented method consists of a fully-automated self-calibration process that allows for the estimation of corrections to the system calibration parameters (e.g., boresight angles and lever-arm offsets relating the lidar sensor(s to the IMU body frame as well as corrections to the system measurements (e.g., post-processed trajectory position and orientation, scan angles and ranges. As for the system measurements, the major challenge for MMS is related to the trajectory determination in the presence of multipath signals and GNSS outages caused by buildings, underpasses and high vegetation. In the proposed self-calibration method, trajectory position errors are properly modelled while utilizing an efficient/meaningful trajectory segmentation technique. The validity of the proposed method is demonstrated using a dataset collected under unfavorable GNSS conditions.

  10. IEEE Std 730 Software Quality Assurance: Supporting CMMI-DEV v1.3, Product and Process Quality Assurance

    Science.gov (United States)

    2011-05-27

    frameworks 4 CMMI-DEV IEEE / ISO / IEC 15288 / 12207 Quality Assurance ©2011 Walz IEEE Life Cycle Processes & Artifacts • Systems Life Cycle Processes...TAG to ISO TC 176 Quality Management • Quality: ASQ, work experience • Software: three books, consulting, work experience • Systems: Telecom & DoD...and IEEE 730 SQA need to align. The P730 IEEE standards working group has expanded the scope of the SQA process standard to align with IS 12207

  11. Organization of the Fessenheim works and the quality assurance systems

    International Nuclear Information System (INIS)

    Broch, M.; Rousset, P.

    1978-01-01

    A rapid description is made of the power station which comprises two parts of 900 MW. The general organization of the works and the part played by E.D.F. in coordinating the work and controlling the quality are described. Then it is shown how the quality assurance is obtained during working activities and assembling, and also during trial runs [fr

  12. Definition of a material's quality assurance level

    International Nuclear Information System (INIS)

    Fride, B.

    1990-01-01

    The architecture of expert system COIN (French acronym for classification of Operation Tools) is presented. The system was developed for providing assistance in the determination of the quality level required by the operation tools and their components. Those tools are applied in the maintenance operations in the nuclear power plants and are classified under a Quality Assurance procedure. The characteristics of COIN, its influence on a problem solving method, and the steps of the system's development are summarized [fr

  13. Manual on the selection of appropriate quality assurance programmes for items and services of a nuclear power plant

    International Nuclear Information System (INIS)

    1984-02-01

    This manual provides guidance and illustrative examples for devising a system by which applicable quality assurance activities may be selected and applied to items and services in conformance with the requirements of the Code and the guidance of SG-QA 1. The selective application system described herein contains the following elements: (1) Classification of items and services; (2) Grading of quality assurance activities; (3) Correlation of applicable quality assurance activities with items and services; (4) Adaptation of selected quality assurance activities to the unique needs of the items or services; (5) Specifying of applicable quality assurance activities in bid specifications or in a contract. This selective application system is intended to be used by plant systems designers in the classifying of items (structures, components and materials) and related services; and by the organizations designing, manufacturing, installing and operating items or performing support services for such items in the specifying of applicable quality assurance activities that are to be implemented. The parts of the system should be developed to the degree and sophistication necessary for the particular needs of the project or organization. There are many methods and techniques that may be used effectively and those of one organization may not suit the purposes of another organization. It is important that the methodology of the system is developed with sufficient instructions documented to guide its consistent and disciplined execution

  14. Software quality assurance - seven years experience

    International Nuclear Information System (INIS)

    Malsbury, J.A.

    1987-01-01

    This paper describes seven years experience with software quality assurance at PPPL. It covers the early attempts of 1980 and 1981 to establish software quality assurance; the first attempt of 1982 to develop a complete software quality assurance plan; the significant modifications of this plan in 1985; and the future. In addition, the paper describes the role of the Quality Assurance organization within each plan. The scope of this paper is limited to discussions of the software development procedures used in the seven year period. Other software quality topics, such as configuration control or problem identification and resolution, are not discussed

  15. Quantitative evaluation of patient-specific quality assurance using online dosimetry system

    Science.gov (United States)

    Jung, Jae-Yong; Shin, Young-Ju; Sohn, Seung-Chang; Min, Jung-Whan; Kim, Yon-Lae; Kim, Dong-Su; Choe, Bo-Young; Suh, Tae-Suk

    2018-01-01

    In this study, we investigated the clinical performance of an online dosimetry system (Mobius FX system, MFX) by 1) dosimetric plan verification using gamma passing rates and dose volume metrics and 2) error-detection capability evaluation by deliberately introduced machine error. Eighteen volumetric modulated arc therapy (VMAT) plans were studied. To evaluate the clinical performance of the MFX, we used gamma analysis and dose volume histogram (DVH) analysis. In addition, to evaluate the error-detection capability, we used gamma analysis and DVH analysis utilizing three types of deliberately introduced errors (Type 1: gantry angle-independent multi-leaf collimator (MLC) error, Type 2: gantry angle-dependent MLC error, and Type 3: gantry angle error). A dosimetric verification comparison of physical dosimetry system (Delt4PT) and online dosimetry system (MFX), gamma passing rates of the two dosimetry systems showed very good agreement with treatment planning system (TPS) calculation. For the average dose difference between the TPS calculation and the MFX measurement, most of the dose metrics showed good agreement within a tolerance of 3%. For the error-detection comparison of Delta4PT and MFX, the gamma passing rates of the two dosimetry systems did not meet the 90% acceptance criterion with the magnitude of error exceeding 2 mm and 1.5 ◦, respectively, for error plans of Types 1, 2, and 3. For delivery with all error types, the average dose difference of PTV due to error magnitude showed good agreement between calculated TPS and measured MFX within 1%. Overall, the results of the online dosimetry system showed very good agreement with those of the physical dosimetry system. Our results suggest that a log file-based online dosimetry system is a very suitable verification tool for accurate and efficient clinical routines for patient-specific quality assurance (QA).

  16. Auditing of quality assurance programs for nuclear power plants - September 1980 - (Rev.1)

    International Nuclear Information System (INIS)

    Anon.

    1981-01-01

    Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, establishes overall quality assurance requirements for the design, construction, and operation of structures, systems, and components of nuclear power plants important to safety. Criterion XVIII, Audits, of Appendix B to 10 CFR Part 50 establishes requirements for conducting audits of the quality assurance program. This guide describes a method acceptable to the NRC staff for complying with the Commission's regulations with regard to auditing of quality assurance programs for nuclear power plants. The Advisory Committee on Reactor Safeguards has been consulted concerning this guide and has concurred in the regulatory position

  17. Qinshan Phase III (CANDU) nuclear power project quality assurance

    International Nuclear Information System (INIS)

    Wang Lingen; Du Jinxiang

    2001-01-01

    The completion and implementation of quality assurance system of Qinshan Phase III (CANDU) nuclear power project are presented. Some comments and understanding with consideration of the project characteristics are put forward

  18. An approach to applying quality assurance to nuclear fuel waste disposal

    International Nuclear Information System (INIS)

    Cooper, R.B.; Abel, R.

    1996-12-01

    An approach to developing and applying a quality assurance program for a nuclear fuel waste disposal facility is described. The proposed program would be based on N286-series standards used for quality assurance programs in nuclear power plants, and would cover all aspects of work across all stages of the project, from initial feasibility studies to final closure of the vault. A quality assurance manual describing the overall quality assurance program and its elements would be prepared at the outset. Planning requirements of the quality assurance program would be addressed in a comprehensive plan for the project. Like the QA manual, this plan would be prepared at the outset of the project and updated at each stage. Particular attention would be given to incorporating the observational approach in procedures for underground engineering, where the ability to adapt designs and mining techniques to changing ground conditions would be essential. Quality verification requirements would be addressed through design reviews, peer reviews, inspections and surveillance, equipment calibration and laboratory analysis checks, and testing programs. Regular audits and program reviews would help to assess the state of implementation, degree of conformance to standards, and effectiveness of the quality assurance program. Audits would be particularly useful in assessing the quality systems of contractors and suppliers, and in verifying the completion of work at the end of stages. Since a nuclear fuel waste disposal project would span a period of about 90 years, a key function of the quality assurance program would be to ensure the continuity of knowledge and the transfer of experience from one stage to another This would be achieved by maintaining a records management system throughout the life of the project, by ensuring that work procedures were documented and kept current with new technologies and practices, and by instituting training programs that made use of experience gained

  19. Software quality assurance

    CERN Document Server

    Laporte, Claude Y

    2018-01-01

    This book introduces Software Quality Assurance (SQA) and provides an overview of standards used to implement SQA. It defines ways to assess the effectiveness of how one approaches software quality across key industry sectors such as telecommunications, transport, defense, and aerospace. * Includes supplementary website with an instructor's guide and solutions * Applies IEEE software standards as well as the Capability Maturity Model Integration for Development (CMMI) * Illustrates the application of software quality assurance practices through the use of practical examples, quotes from experts, and tips from the authors

  20. Core components of a comprehensive quality assurance program in anatomic pathology.

    Science.gov (United States)

    Nakhleh, Raouf E

    2009-11-01

    In this article the core components of a comprehensive quality assurance and improvement plan are outlined. Quality anatomic pathology work comes with focus on accurate, timely, and complete reports. A commitment to continuous quality improvement and a systems approach with a persistent effort helps to achieve this end. Departments should have a quality assurance and improvement plan that includes a risk assessment of real and potential problems facing the laboratory. The plan should also list the individuals responsible for carrying out the program with adequate resources, a defined timetable, and annual assessment for progress and future directions. Quality assurance monitors should address regulatory requirements and be organized by laboratory division (surgical pathology, cytology, etc) as well as 5 segments (preanalytic, analytic, postanalytic phases of the test cycle, turn-around-time, and customer satisfaction). Quality assurance data can also be used to evaluate individual pathologists using multiple parameters with peer group comparison.

Some links on this page may take you to non-federal websites. Their policies may differ from this site.