Comprehensive Quality Control System Research Articles

Up-to-date quality survey and evaluation of neonatal screening programs in China

AimsTo thoroughly evaluate the quality of the entire process of neonatal screening (NBS) in China.MethodsWe collected survey questionnaires from 54.4% (135/248) of NBS institutions in China and conducted on-site visits to 20 of these facilities to validate the data. The quality performance of the institutions was evaluated, and differences across various factors were analysed.ResultsMerely 62.5% of the provinces had acceptable performance in neonatal screening. Institutions with limited staff were more prone to organizational management shortcomings. Institutions in provinces with a per capita GDP below 10,000 USD exhibited lower quality control levels than those with a per capita GDP between 10,000 and 15,000 USD. Obstetrics departments have a lower awareness of quality control compared to other blood collection facilities.ConclusionsA nationwide, comprehensive quality control system for continuous enhancements in quality management, screening, diagnosis, and treatment is imperative to ensure prompt diagnosis and intervention.

Quality evaluation of Fufang Jinqiancao granules based on ultra performance liquid chromatography-ultraviolet detection quantitative fingerprint combined with chemical pattern recognition

Fufang Jinqiancao granules have a large market demand due to the fact that they contain diuretics, inhibit urinary calculi formation, and exhibit both anti-inflammatory and antioxidant effects. In the current study, a fast and efficient quantitative ultra performance liquid chromatography-ultraviolet detection (UPLC-UV) fingerprinting method was established to analyze the Fufang Jinqiancao granules, while a chemical pattern recognition technology was used to evaluate the quality of the granules over different years. More specifically, the UPLC-UV system consisted of a Waters Acquity UPLC BEH C18 column (100 mm×2.1 mm, 1.7 μm), acetonitrile (mobile phase A), and a 0.1% formic acid aqueous solution (mobile phase B), wherein a gradient elution protocol was followed. Ultra performance liquid chromatography-quadrupole-time of flight-mass spectrometry (UPLC-Q-TOF-MS, Agilent Infinity Ⅱ 1290-6545) was used in combination with reference substances and literature comparisons to identify the common peaks present in the quantitative fingerprint. The fingerprints of 35 batches of Fufang Jinqiancao granules were established by means of the quantitative UPLC-UV fingerprinting method, and the fingerprint data obtained for these samples were further analyzed by chemical pattern recognition techniques, including hierarchical cluster analysis (HCA) and principal component analysis (PCA). The quality difference markers, namely mangiferin and isomangiferin, were screened, and their contents were determined. It was found that 12 common peaks existed in the fingerprint of the Fufang Jinqiancao granules, and the similarities of all 35 batches of samples were greater than 0.952. In addition, for the purpose of HCA, the 35 batches were divided into two categories, of which sample years 2018 and 2019 belonged to one category, and sample years 2020 and 2021 belonged to another category. Notably, PCA gave the same clustering trends as HCA. Based on the obtained results, the mangiferin and isomangiferin components responsible for the differences between the 2018, 2019 and 2020, 2021 samples were further screened by orthogonal partial least squares discriminant analysis (OPLS-DA). Moreover, the contents of the 35 batches of samples were determined using the two differential markers mangiferin and isomangiferin as indicators. The obtained results indicated that the chromatographic peaks of all 35 batches had acceptable resolutions, with mangiferin exhibiting a good linear relationship in the range of 5.3291-133.2276 mg/L, and isomangiferin exhibiting a similar linear relationship in the range of 4.1847-104.6170 mg/L. The average recovery of mangiferin was 101.7%-105.6%, with a relative standard deviation (RSD) of 0.63%-1.43%, while that of isomangiferin was 103.4%-105.5%, with an RSD of 0.60%-1.18%. Importantly, all RSD values were less than 1.43%, thereby indicating that our method meets the requirements of the Chinese Pharmacopoeia (2020 Edition). Among the 35 batches of samples, the contents of mangiferin and isomangiferin were higher in the 2020 and 2021 samples, and the content fluctuation range was smaller. Overall, the development of an accurate and reliable quality control method for Fufang Jinqiancao granules, and a reasonable and effective quality evaluation of Fufang Jinqiancao granule samples from different years was realized. We therefore expect that this study will provide a reference for establishing a more systematic and comprehensive quality control system.

Strengthening the quality of clinical trials of acupuncture: a guideline protocol

IntroductionAcupuncture has been accepted in many Western countries and clinical trials have been increasing recently. However, the problems of insufficient and low-quality evidence remain, and substantially hinder the development of...

3D Reconstruction and Measurement of Surface Defects in Prefabricated Elements Using Point Clouds

Due to higher efficiency and lower cost, prefabricated construction is gradually gaining acceptance within the market. Laser scanning has already been adopted in civil engineering to reconstruct 3D model of structure and monitoring the deformation and so on. This paper seeks to explore a more automated and accurate quality control process focusing on the surface defects in prefabricated elements. Laser scanning is adopted for data collection and the 3D reconstruction of the prefabricated components. Besides, a new point cloud pre-processing, involving the KNN algorithm, reduction of data dimension and data gridding, is developed to improve the efficiency and accuracy of subsequent algorithms. The Delaunay triangle is used to extract the contour of the point cloud, then the contour is fitted to further determine the geometric data. Meanwhile, a comprehensive quality control system of prefabricated components based on relevant specifications is proposed, and the quality of prefabricated components is monitored intuitively by the values of indicators. In order to integrate into the BIM platform and better store the obtained quality information, the production quality information is designed to be extended to the IFC standard. The proposed approach will be applied to analyze the causes of quality problems in the production process and strengthen the quality control. This study designs a more efficient and accurate quality evaluation process, including data collection, data processing, indicator calculation and quality evaluation. Moreover, the results forward can feedback to the cause of the quality issues, and further improve the production quality of prefabricated elements.

A comprehensive quality control system suitable for academic research: application in a pediatric study.

Aim: Clinical research in pediatrics is progressively initiated by academia. As the reliability of pharmacodynamic measures is closely linked to the quality of bioanalytical data, bioanalytical quality assurance is crucial. However, clear guidance on comprehensive bioanalytical quality monitoring in the academic environment is lacking. Methods & results: By applying regulatory guidelines, international recommendations and scientific discussions, a five-step quality control system for monitoring the bioanalysis of aldosterone by immunoassay was developed. It comprised performance qualification, calibration curve evaluation, analysis of the intra- and inter-run performance via quality control samples, incurred sample reanalysis and external quality assessment by interlaboratory testing. A total of 55 out of 70 runs were qualified for the quantification of aldosterone in the study sample enabling the evaluation of 954 pediatric samples and demonstrating reliability over the 29-month bioanalysis period. Conclusion: The bioanalytical quality control system successfully monitored the aldosterone assay performance and proved its applicability in the academic environment.

Factors that limit customer value in touristic facilities, as perceived by managers and specialists

Due to the increased change rate and high competitiveness of today’s world market, it is of the utmost importance to identify the non-value activities in every organization. This research analysis on organizational change management covers between 2017 and 2018 in sixteen touristic facilities of the Holguín territory, in Cuba. Its main objectives were to verify whether waste occurs and to analyze the main changes that took place in these entities. The methods used in order to conduct this research were: theoretical methods, such as synthesis and analysis and inductive-deductive; empiric methods, such as surveys and statistic methods, such as factor analysis. The main conclusion of the research was that waste occurs in all of the facilities that were included in the research. This waste can be grouped according to five factors, of which the most significant one is waiting time. The research also shows that the main change-driving initiatives taking place are linked to the implementation of a comprehensive quality control system and to cost reduction, and that the objectives of these initiatives are to increase incomes, to reduce costs and to boost customer satisfaction.

DNA Mini-Barcoding: A Derived Barcoding Method for Herbal Molecular Identification.

In recent years, the demand for natural herbal products (NHP) has increased; however, the quality of these products is difficult to confirm due to the lack of a comprehensive quality control system. Traditional methods are not effective in detecting processed ingredients. DNA barcoding is an established technique that has been used for more than 10 years. This technique uses short standard sequences (generally 200–600 bp) to identify species. While a complete DNA barcode is difficult to obtain from NHP due to DNA degradation, mini-barcoding is a complementary tool to identify species in NHP. DNA mini-barcoding uses smaller DNA segments for polymerase chain reaction amplification and can be applied to identify species rapidly. The present review summarizes the development and application of DNA mini-barcodes over recent years and discusses the limitations of this technique. This review also compares mini-barcoding and meta-barcoding, a technique using universal polymerase chain reaction primers to simultaneously amplify multiple DNA barcodes and identify many species in a single environmental sample. Additionally, other detection methods that can be combined with mini-barcodes, such as nucleotide signatures, high-resolution DNA melting analysis, and gold nanoparticles, are discussed. DNA mini-barcoding can fill the gaps left by other methods in the field of herbal molecular identification.

Establishing a Quality Control System of Hedyotis corymbosa

ABSTRACT Objective Hedyotis corymbosa (Shui Xian Cao, 水线草, HC) is the main antitumor medicine in China and other southeast Asian countries. A comprehensive quality control system of HC was established in this study, as the current system was ineffective. Methods Microscopy was used to observe the characteristics of the powder and cross-sectional tissue. Thin layer chromatography (TLC) was employed to separate HC from Hedyotis diffusa (Bai Hua She She Cao, 白花蛇舌草, HD). Simultaneously, high-performance liquid chromatography (HPLC) was used to establish the characteristic spectrum of HC and determine the concentrations of hedyotiscone A. Regarding the issue of systematicness, concentrations of water, total ash, acid-insoluble ash, heavy metals (including lead, arsenic, mercury, cadmium and copper) and pesticide residue were measured by the methods described in the 2015 edition of Chinese Pharmacopoeia. Results Calcium oxalate needle crystal bundles and oil drops were observed in the cross-sectional tissue. Three characteristic blue fluorescent spots were observed in the HC samples by TLC. There were five distinct characteristic peaks in HC but not in HD, and hedyotiscone A was the sharpest characteristic peak. The generated linear equation of hedyotiscone A was Y = 3.15 × 108X + 312.04 (r2 = 1.000) between 0.00005270 and 0.002108 mg/mL, and the average recovery was 100.42%. Precision [relative standard deviation (RSD) 0.92%], repeatability (RSD 0.14%), and recovery (RSD 0.85%) met the requirements for quantitative analysis. Hedyotiscone A concentrations ranged from 0.00017%∼0.00113% across different habitats. Concentrations of water, ash and acid-insoluble ash were 8.80%∼11.2%, 7.00%∼15.3% and 0.440%∼7.70%, respectively. Concentrations of Pb, As, Hg, Cd and Cu were 1.60∼4.60, 0.650∼1.60, 0.0300∼0.100, 0.240∼0.690 and 10.1∼16.6 µg/g, respectively. Pesticide residues were less than 0.00100 ppm. Conclusion The quality control system can effectively distinguish HC from HD, so as to comprehensively control the quality of HC, to provide references for the clinical use of HC.

A Look Back at the Incurred Sample Reanalysis

BioanalysisVol. 10, No. 21 EditorialA look back at the incurred sample reanalysisFaye VazvaeiFaye Vazvaei*Author for correspondence: E-mail Address: faye.vazvaei@roche.com Pharmaceutical Research & Early Development Roche Innovation Center, Roche Innovation Center New York, New York, NY 10016, USASearch for more papers by this authorPublished Online:6 Nov 2018https://doi.org/10.4155/bio-2018-0263AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: bioanalysisBMV guidancefailureincurred sample reanalysisISRReferences1 US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM). Guidance for Industry Bioanalytical Method Validation (2001).Google Scholar2 Viswanathan CT, Bansal S, Booth B et al. 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AAPS J. 16(6), 1167–1174 (2014).Crossref, Medline, CAS, Google Scholar10 FDA: early stage drug development costs trigger higher drug costs. http://www.pharmtech.com/fda-early-stage-drug-development-costs-trigger-higher-drug-costs.Google ScholarFiguresReferencesRelatedDetailsCited ByIs Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?5 May 2022 | The AAPS Journal, Vol. 24, No. 3Sensitive and rapid simultaneous quantitation of leucovorin and its major active metabolite 5‐methyl‐tetrahydrofolate in human plasma using a liquid chromatography coupled with triple quadruple mass spectrometry23 January 2022 | Biomedical Chromatography, Vol. 36, No. 4Enantiomeric separation and estimation of stiripentol by liquid chromatography mass spectrometer in human plasma28 June 2020 | SEPARATION SCIENCE PLUS, Vol. 3, No. 8A comprehensive quality control system suitable for academic research: application in a pediatric studyNina Makowski, Agnes M Ciplea, Mohsin Ali, Ilja Burdman, Anke Bartel & Bjoern B Burckhardt Stephanie LäerJörg BreitkreutzIngrid KlingmannFlorian LaglerJan de HoonMichel DalinghausMilica BajceticSaskia de WildtAnne Keatley ClarkeJohannes BreurChristoph MaleLaslo AblonczyThomas MirVladislav VukomanovicMilan DukicIda JovanovicBjoern BurckhardtWilli CawelloKarl KleineAngelika ModerEmina ObarcaninPeter WagnerJennifer WalshAnne van HeckenLucie SpatenkovaAli MohsinBojana BožićMaja BijelićIlja BurdmanAgnes CipleaMuhammed FaisalSamieh FarahaniMartin FeickertTanja GangnusMilica LazicNina MakowskiFabian SüssenbachMarijke van der MeulenSaša PopovićMiro ParezanovićNori SmeetsVanessa SwobodaDragana BojaninStefan ĐorđevićJasminka DragićAnn-Kathrin HolleBosiljka JovičićJovan KošutićGordana KozomaraHaidara MajidJadranka MitrovićSanja NinićMiro ParezanovicVojislav ParezanovicAndrija PavlovićSergej PrijićBranislava RebićIgor StefanovićDaniel TordasIrena VulićevićAnke BartelAndjelka čekoMarissa HerbortsAnnelies HenninkBosiljka KosanovićSanja KosticLjiljana IsailovićJasmina MaksimovicBadies ManaiNada MartinovićGyöngyi MátéMiloš PerišićJelena ReljićRegina PirkerMarta SalamomovicClaudia SchlesnerJutta TinsEva Wissmann4 March 2020 | Bioanalysis, Vol. 12, No. 5A review of the bioanalytical methods for the quantitative determination of capecitabine and its metabolites in biological matrices8 January 2020 | Biomedical Chromatography, Vol. 34, No. 1Incurred sample reproducibilityFaye Vazvaei & Philip Timmerman13 November 2018 | Bioanalysis, Vol. 10, No. 21 Vol. 10, No. 21 Follow us on social media for the latest updates Metrics Downloaded 127 times History Received 16 September 2018 Accepted 5 October 2018 Published online 6 November 2018 Published in print November 2018 Information© 2018 Newlands PressKeywordsbioanalysisBMV guidancefailureincurred sample reanalysisISRFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

The Impact Of Senior Management In The Application Of Quality Management

Since the emergence of the world in the era of the first industrial revolution, and since the human relations took the nature of dealing between companies of different nationality from the countries of the world, and with the intensity of dealing with various facilities and technologies, and the resulting enormity of the quality and quality of different products, and with the intensification of competition between companies and countries, And the growing desire to dominate the local and global markets, which increased its motto, the world witnessed the economic crises and the repercussions of some advanced industrial countries, and the emergence of new centers of gravity of the industrial technology countries were Japan, Korea and Southeast Asian countries and other countries that have added an element For innovation in industrial technology to the global competition circuit.
 Hence, the factors and conditions of quality were reviewed and accelerated in accordance with the tastes of customers and the economic price, which imposed its importance based on many data. And the emergence of the comprehensive quality control system or the so-called international standards ISO 9000, all aimed at the liberalization of trade and the development of specific standards for trade, service and commodity.
 Taking into consideration all of the above, as well as the growing interest in industry in developing countries, including the Arab countries, and their attempts to innovate in industrial catching up, the international standards have become very important in all developing countries.
 Therefore, quality management in educational institutions has been addressed in some of its systems in order to shed light on this issue and to link it with the role of senior management. The concept of TQM has become an effective administrative approach adopted by most organizations. Since TQM in its essence and philosophy, Of its main and important tools and because it is the cornerstone in the management of the quality of the educational service, in which the service was received and developed following scientific methods based on the objective basis for both continuous improvement and quality management service.

Continuous Renal Replacement Therapy Quality Control and Performance Measures.

Continuous renal replacement therapy (CRRT) is one of the most predominant forms of renal replacement therapy (RRT) currently in use now, this therapy being the initial RRT modality in most critically ill patients. However, in general, the quality of CRRT is still suboptimal. The quality of CRRT is affected by many factors, including the optimal prescription and precision delivery, the CRRT providers' professional level, and the CRRT device used. Establishment of a comprehensive quality control system covering all the aspects and procedures of CRRT is essential. Quality measures for structure, process, and outcome of CRRT need to be developed, evaluated, and implemented to ensure the high quality of CRRT. Some CRRT quality improvement methods such as the professional education and specialized team and the application of citrate anticoagulation to extend filter lifespan have been found to be potentially beneficial but need further validation. After all, much work is needed in this field because of the heterogeneity in CRRT practice. More evidence is needed to improve the CRRT quality control system. These are challenges that will need to be addressed in the future.

The development of quality control system providing road-building services

Determined that the effectiveness of the management of enterprise road construction, largely determined by the quality of road works. Over the past 15 years in the industry made a lot of work to improve quality control system, which was due to a change in the economic model of the national economy. A great amount of work on a mechanism of quality control, based on compliance with existing regulations and design documentation. This could substantially improve the quality of road works to reduce the number of deviations from the requirements. However, if you switch from road works quality indicators to the indicators of the state of the road network, it must be noted that the volume of outstanding problems in recent years is growing. An approach to the development of a comprehensive quality control system of road-construction services, based on the model of the formation of the relationship of constructive, technological and organizational parameters of road works, which analyzes the control parameters listed in the production stage and assess their impact on the quality and reliability of road construction at an appropriate stage operation, which enables integrated control: the quality of the individual types of road works; materials used in road construction; preparation and adoption of constructive-technological and organizational decisions during the road construction.

Metrological support to a comprehensive quality-control system at the Riga ?Kompressor? plant

Metrological support to a comprehensive quality-control system at the Riga ?Kompressor? plant

Certification of metal products and a comprehensive quality control system at the Zlatoust Metallurgical Plant

Certification of metal products and a comprehensive quality control system at the Zlatoust Metallurgical Plant