High Level Of Quality Assurance Research Articles

Digital twin-enabled quality control through deep learning in industry 4.0: a framework for enhancing manufacturing performance

ABSTRACT In the context of Industry 4.0, integrating Digital Twin (DT) technology stands out as a critical challenge for enhancing manufacturing processes and productivity. The combination of DT and Artificial Intelligence (AI) provides a significant benefit for improving processes in real-time. Industries are actively researching these technologies to keep pace with the rapid evolution of technology, utilizing virtual representations for efficient real-time monitoring and control. The present paper proposes a new approach that relies on DT technology for monitoring, optimizing manufacturing processes and enabling quality control through Deep learning (DL). The proposed methodology involves creating a digital replica of the physical system and utilizing DL models for quality control purposes. This approach improves automation and productivity while maintaining high levels of quality assurance in factories. DL is deployed within the DT for gathering data from the physical system and making predictions regarding product quality. The approach is illustrated by considering an experimental industrial prototype. The results obtained are particularly intriguing, demonstrating heightened predictive accuracy in assessing product quality and real-time issue resolution. Overall, the findings underscore the significant and interesting impact of DT technology with DL on manufacturing processes in the context of Industry 4.0.

Development and Evaluation of "The Delta Plus-Minus Even Distribution Check": A Novel Patient-Based Real-Time Quality Control Method for Laboratory Tests.

Laboratory testing of large sample numbers necessitates high-volume rapid processing, and these test results require immediate validation and a high level of quality assurance. Therefore, real-time quality control including delta checking is an important issue. Delta checking is a process of identifying errors in individual patient results by reviewing differences from previous results of the same patient (Δ value). Under stable analytical conditions, Δ values are equally positively and negatively distributed. The previous 20 Δ values from 3 tests (cholesterol, albumin, and urea nitrogen) were analyzed by calculating the R-value: "the positive Δ value ratio minus 0.5." This method of monitoring optimized R-values is referred to as the even-check method (ECM) and was compared with quality control (QC) testing in terms of error detection. Bias was observed on 4 of the 120 days for the 3 analytes measured. When QC detected errors, the ECM captured the same systematic errors and more rapidly. In contrast, the ECM did not generate an alarm for the one random error that occurred in QC. While QC did not detect any errors, the percentage of R-values exceeding the acceptable range was under 2%, the number of days generating alarms was between 16 and 21 days, with short alarm periods, and a median number of samples per alarm period between 7 and 9 samples. The ECM is a practical real-time QC method, controlled by setting R-value conditions, that quickly detects bias values.

About the Issue 2 of 2023

In this edition of our journal, we are delighted to showcase a compelling collection of articles that delve into diverse facets of the ongoing war in Ukraine. These thought-provoking contributions shed light on critical issues and offer valuable insights for policymakers, legal practitioners, and researchers alike. We are proud to announce that our journal has achieved an incredible milestone by securing a place in Quartile 2 of Scimago, a prestigious recognition in the academic community. This accomplishment reflects the exceptional quality of the research published in our journal and the dedication and expertise of our esteemed contributors. We are committed to promoting excellence in scholarship and advancing knowledge in our field. I would like to express my sincere gratitude to the entire team of our esteemed journal. Your dedication, hard work, and commitment to excellence have been instrumental in our success. Each member has played a vital role in ensuring the smooth operation and continuous improvement of our publication. From the editors and reviewers to the production team and administrative staff, your tireless efforts have been invaluable in maintaining the high standards of our journal. I deeply appreciate your passion, expertise, and unwavering support. Together, we are making a significant impact in the academic community and advancing knowledge in our field. Thank you for your outstanding contributions and for being an integral part of our journal's success. We are excited to announce our collaboration with Scholastica, a renowned platform for academic publishing and peer review. This partnership aims to further enhance the quality and rigor of the review process for our journal. By leveraging Scholastica's cutting-edge technology and robust peer review tools, we are confident in providing an even higher level of quality assurance and ensuring a thorough evaluation of all submitted manuscripts. This collaboration reaffirms our commitment to excellence and our dedication to fostering a rigorous and constructive scholarly review process. We look forward to the continued growth and success of our journal.

Consistency in the transabdominal ultrasound measurement of cervical length in mid-pregnancy.

The Western Australian Preterm Birth Prevention Initiative recommends a transabdominal cervical length (TACL) measurement at the mid-pregnancy ultrasound to screen low-risk women for preterm birth risk. In view of this recommendation, we assessed the inter-observer consistency of TACL screening in mid-pregnancy. Routinely collected mid-pregnancy TACL ultrasound images were graded from 0 to 4 according to the anatomical landmarks identified by a single expert. A random selection of 10 images of each grade were disseminated in an electronic survey to determine inter- and intra-observer variations in the classification of the cervical image. A total of 244 participants graded 50 TACL images. Six participants repeated the grading. Overall agreement to the exact initial grade for all images was 49.6%, highest for images at both ends of the spectrum (83% Grade 0 and 70.4% for Grade 4). Overall agreement to the initial diagnostic Grades 3 and 4 was 75.3% (95% CI 74.5-76.0%) and was higher when the maternal bladder was empty. There was moderate inter-rater agreement (κ = 0.42) for Grades 3 and 4 (diagnostic) or Grades 1 and 2 (non-diagnostic). The intra-rater agreement was fair to good (κ = 0.59, 95% CI 0.49-0.70) for those who repeated the assessment (including the expert grader). Sonographic CL screening is considered an important tool for the identification of women at high risk of preterm birth. Image classification of TACL performed poorly compared with previous studies assessing transvaginal cervical length. Improved reliability and measurement consistency may be achieved through high levels of quality assurance, ongoing training and image audit.

Cardiovascular risk factors, living and ageing in Halle: the CARLA study

The CARLA study (Cardiovascular Disease, Living and Ageing in Halle) is a longitudinal population-based cohort study of the general population of the city of Halle (Saale), Germany. The primary aim of the cohort was to investigate risk factors for cardiovascular diseases based on comprehensive cardiological phenotyping of study participants and was extended to study factors associated with healthy ageing. In total, 1779 probands (812 women and 967 men, aged 45–83 years) were examined at baseline (2002–2005), with a first and second follow-up performed 4 and 8 years later. The response proportion at baseline was 64.1% and the reparticipation proportion for the first and second follow-up was 86% and 77% respectively. Sixty-four percent of the study participants were in retirement while 25% were full- or partially-employed and 11% were unemployed at the time of the baseline examination. The currently running third follow-up focuses on the assessment of physical and mental health, with an intensive 4 h examination program, including measurement of cardiovascular, neurocognitive, balance and gait parameters. The data collected in the CARLA Study resulted in answering various research questions in over 80 publications, of which two thirds were pooled analyses with other similar population-based studies. Due to the extensiveness of information on risk factors, subclinical conditions and evident diseases, the biobanking concept for the biosamples, the cohort representativeness of an elderly population, and the high level of quality assurance, the CARLA cohort offers a unique platform for further research on important indicators for healthy ageing.

A TQM Implementation in Higher Education Institutions: A Review

The implementation of overall quality management is being applied to every educational institution, including TVET MARA, to enhance the quality of educational services. In this situation, management tasks must be carried out in each educational establishment. Implementing TQM in TVET MARA to increase the overall quality of education and achieve a high level of academic achievement is the subject of this article. Every educational institution should strive to improve its quality and ability to compete with others. This is done for educational institutions to continue to earn the general public's trust and other stakeholders in their work. Therefore, it must be continuously improved, both physically and non-physically, to maintain this level of performance to create a high-quality educational institution with a high level of quality assurance. When implementing TQM in the field of education, there are several important factors to consider, including continuous quality improvement; determining quality standards; cultural change; changes in the organisation; and maintaining relationships with other agencies and customers, as well as evaluating the system if anything is not working as it should.

Paving the way for sustainable remanufacturing in Southeast Asia: An analysis of auto parts markets

The consumption of products, including automobiles, has been increasing rapidly in Asian developing and transition (D&T) countries, and appropriate diffusion of remanufacturing in the region is necessary to achieve sustainable consumption and production. This paper presents analyses of consumer perceptions of remanufactured auto parts (RAPs) in three Southeast Asian D&T countries: Malaysia, Thailand, and Vietnam. The authors conducted internet questionnaire surveys, targeting 500 respondents in each country, and examined consumers' knowledge of RAPs, perceptions of the benefits and risks, and consumers' purchase intentions of RAPs. Our study reveals that consumers' knowledge and perceived benefits of RAPs positively affect consumers' purchase intentions of RAPs in all three countries, but the influence of the perceived risks is not found. The cross-comparison of the perceptions in the countries reveals that knowledge of RAPs and the perceived benefits and risks are relatively high in Vietnam compared to those in Malaysia and Thailand. This study analyzes if consumers have a higher preference for certified RAPs than uncertified ones. A higher level of quality assurance in a country is critical for product diffusion in the market. The study clarifies that the purchasing decisions are also influenced by the country-of-origin (COO) of RAPs. Drawing on our study results, we suggest measures to promote markets for remanufactured products in D&T countries and provide policy options to accelerate the promotion of resource efficiency practices.

Characterization of electrochemical flow cell configurations with implemented disposable electrodes for the direct coupling to mass spectrometry

Abstract The characterization of the redox behavior of analytes is a very important aspect for many applications. Pure electrochemical approaches can provide useful information on electroactive species, but are of limited use regarding the identification of generated species. The hyphenation of electrochemistry and mass spectrometry (EC-MS) is a powerful method to investigate redox systems. In the present work, we show a simple approach to on-line EC-MS based on the application of electrochemical flow cells with implemented disposable electrodes. They are connected to electrospray ionization mass spectrometry (ESI-MS) via fused silica capillary tubing. The modularity of the flow cells offers a high flexibility of experimental setup and settings, so that a fast detection of oxidation or reduction products can be achieved. The usage of disposable electrodes guarantees a high level of quality assurance for EC-MS measurements.

Twisted deep hole drilling tools for hard machining

The availability of high performance twisted deep hole drilling tools has been a significant innovation achieved some years ago. The use of these tools in machining centres permits substantially higher productivity and flexibility compared to existing deep hole drilling tools or alternative manufacturing processes for holes with a high aspect ratio. The aim of the present work is the systematic consideration of twisted deep hole drilling tools for reliable and economical hard cutting operations with a high level of quality assurance. In particular, a detailed analysis of manufacturing flaws and tolerances in tool making as well as their influences on the tooĺs performance and the dynamic process behaviour has been conducted. It is shown that twisted deep hole drilling tools can be successfully applied not only with a high productivity but also for a high quality production of hardened components. A prerequisite to this, however, are holistic and precisely controlled process steps including appropriate clamping devices and a suitable high pressure lubrication strategy as well as the availability of high performance tools manufactured with high precision and low tolerances. In this context the symmetry of the tool shown to be of vital importance for the tooĺs performance and the quality of the drilled holes.

Sequential derivatization of polar organic compounds in cloud water using O-(2,3,4,5,6-pentafluorobenzyl)hydroxylamine hydrochloride, N,O-bis(trimethylsilyl)trifluoroacetamide, and gas-chromatography/mass spectrometry analysis

Cloud water samples from Whiteface Mountain, NY were used to develop a combined sampling and gas chromatography–mass spectrometric (GCMS) protocol for evaluating the complex mixture of highly polar organic compounds (HPOC) present in this atmospheric medium. Specific HPOC of interest were mono- and di keto-acids which are thought to originate from photochemical reactions of volatile unsaturated hydrocarbons from biogenic and manmade emissions and be a major fraction of atmospheric carbon. To measure HPOC mixtures and the individual keto-acids in cloud water, samples first must be derivatized for clean elution and measurement, and second, have low overall background of the target species as validated by GCMS analysis of field and laboratory blanks. Here, we discuss a dual derivatization method with PFBHA and BSTFA which targets only organic compounds that contain functional groups reacting with both reagents. The method also reduced potential contamination by minimizing the amount of sample processing from the field through the GCMS analysis steps. Once derivatized only gas chromatographic separation and selected ion monitoring (SIM) are needed to identify and quantify the polar organic compounds of interest. Concentrations of the detected total keto-acids in individual cloud water samples ranged from 27.8 to 329.3ngmL−1 (ppb). Method detection limits for the individual HPOC ranged from 0.17 to 4.99ngmL−1 and the quantification limits for the compounds ranged from 0.57 to 16.64ngmL−1. The keto-acids were compared to the total organic carbon (TOC) results for the cloud water samples with concentrations of 0.607–3.350mgL−1 (ppm). GCMS analysis of all samples and blanks indicated good control of the entire collection and analysis steps. Selected ion monitoring by GCMS of target keto-acids was essential for screening the complex organic carbon mixtures present at low ppb levels in cloud water. It was critical for ensuring high levels of quality assurance and quality control and for the correct identification and quantification of key marker compounds.

Secondary doses to healthy tissues during proton therapy treatments: influence of irradiation parameters

Secondary doses to healthy tissues during proton therapy treatments: influence of irradiation parameters

Masters of Radiology Panel Discussion: Maintaining Maintenance of Certification in the Field of Radiology

AJR:198, April 2012 Larson: Board certification provides a vital service to our profession. Traditionally, the purpose of professional certification has been to assure regulators and the public that professionals are at least meeting minimum professional standards. However, although it is important to have a “floor” for competence, stakeholders are increasingly demanding mechanisms that promote excellence, not just adequacy. Some of the four components of MOC are more geared toward ensuring that radiologists meet the minimum standard and others are better at promoting excellence. I would say that, as they currently exist, components one and two (professional standing, and lifelong learning and self-assessment) probably serve more as minimum standards. Interestingly, although component three (cognitive expertise), including the initial certifying examinations, is structured to serve as a minimum standard, in reality it also promotes excellence. For example, although the 4 hours spent in Louisville might help to screen out the least qualified candidates, that is not the true value of the examination. Rather, far greater value lies in the thousands of hours of deliberate practice candidates spend preparing for the examination. Specifically, the evidence shows that such practice is dramatically more effective at improving performance than work experience alone [1]. Component four (PQI) is a departure from the traditional concept of professional certification. It is completely focused on promoting excellence rather than enforcing minimum standards of competence or compliance. It is going to be an interesting experiment to see whether professional certification can be a vehicle for promoting excellence and innovation. In more market-driven industries, it is typically competition that incentivizes for the high levels of quality assurance and improvement that we are accustomed to. I would say that Masters of Radiology Panel Discussion: Maintaining Maintenance of Certification in the Field of Radiology

Quality assurance of ethical issues and regulatory aspects relating to good clinical practices in the HELENA Cross-Sectional Study

Research involving humans is regulated by regulatory authorities through their specific requirements and controls. The Healthy Life Style in Europe by Nutrition in Adolescence Cross-Sectional Study (HELENA-CSS) is a multicenter biomedical research study of adolescents in several representative European cities, which requires satisfying medico-regulatory requirements including Independent Ethics Committee (IEC) approval and agreement by the national or local regulatory authorities. To achieve a high level of quality assurance relating to ethical issues, we followed the good clinical practices (GCP) described at the International Conference on Harmonisation (ICH), which we adapted to the national and local situations of each of the 11 participating cities in 10 European countries. The main objective of the HELENA-CSS is to evaluate reliable and comparable data of nutritional habits and lifestyle in a representative sample of European adolescents. The aim of this paper is to present the methods relating to the ethical and regulatory issues of this study and to describe the current state of the medico-regulatory requirements involved in conducting this kind of study in each country. Following the GCP-ICH guidelines, a protocol describing the HELENA-CSS was written and approved by all partners. In the pilot study, a case report form adapted to the study objectives and its manual of operation was constructed and used by all partners. All information letters to adolescents and their parents and consent forms were first written in English, then translated into the local language, and adapted to each local situation. All documents were then checked centrally for any deviation and corrected if required. An operation manual relating to ethical issues and other medico-regulatory requirements was also developed. This paper presents the current status of the medico-regulatory requirements from each HELENA-CSS participant country. Before the beginning of the study, most centers had satisfied the medico-regulatory requirements of IEC approval and agreement with other national or local regulatory authorities/organizations. For a few centers, some problems were detected and corrective actions were taken to improve missing information to reach a high level of quality assurance of ethical issues. The GCP-ICH guidelines about nontherapeutic biomedical research are interpreted and applied differently across Europe. This study shows that high-quality nontherapeutic biomedical research can address the ethical issues included in the GCP-ICH regulations and can be harmonized among the HELENA European partners.

Marine Stone Columns to Prevent Earthquake Induced Soil Liquefaction

With ports and other near shore structures expanding, and regions previously not considered prone to earthquakes being re-classified after recent earthquake events, ground improvement by stone columns is increasingly considered to improve loose or soft in situ soils. The Dry Bottom Feed Stone Column construction technique can be used under water if a double-lock stone delivery system is attached to the vibroprobe. The use of pneumatic stone transport from the barge into the vibroprobe receiver tank makes it possible to reach large water and treatment depths. Digital recording of all relevant operation parameters provides a very high level of quality assurance, including a diameter-over-depth profile for each stone column. An introduction to earthquake-resistant design of stone columns and guidelines for specifying Marine Stone Columns are given.

施工管理に活用できる道路構造物の基本設計情報の構造化

This research proposes a model of basic design information for more correct, flexible and compact representation of road structures. Using basic design information based on this model, we can not only improve the efficiency of design works of road and the construction management, but decrease mistakes and achieve higher level of quality assurance. The basic design information can also allow using of the coordinate data developed in design phase effectively for the construction works. In addition, coordinate data can be exchanged, together with the definition of coordinate reference system. It makes possible to exchange complex design information between CAD systems and the surveying equipments. To use the data in surveying equipments, the model can make the data size small.

ANALYSIS OF RANDOM AND SYSTEMATIC ERROR EFFECTS ON UNCERTAINTY PROPAGATION IN PROCESS DESIGN AND SIMULATION USING DISTRIBUTION TAIL CHARACTERIZATION

An exponential and heavy tail analysis method is presented to study the effect of systematic and random errors present in thermodynamic data on chemical process design and simulation. The true distribution tail characteristics (important for high levels of quality assurance) can be far from the estimates obtained with typical Gaussian distribution analysis. Pareto (heavy) or exponential distributions may represent the tail behavior better under many circumstances. Heavy tails diminish at an algebraic rate rather than at an exponential rate. Different error types such as random and systematic error can potentially cause different effects in the behavior of probability distributions, particularly in the tails. In this work, we use the tail behavior of cumulative frequency distributions produced from uncertainty analyses to characterize the error propagation in process design and simulation. The diminishing rate of the tail of a given distribution can be related to the error types involved in the process and also can be used to determine which error exhibits stochastic dominance. Case studies of process performance evaluations for liquid-liquid extraction operations are presented to illustrate the approach. It is observed that random and systematic errors (coupled with typical nonlinear chemical engineering models) can cause the tails of the uncertainty probability distributions to be exponential.

The Biophile Sample Process Management System — Automated Sample Access at Ultra Low Temperatures

The genomics, proteomics, clinical, and drug discovery laboratories have a growing need to maintain valuable samples at ultra-low (−80°C) temperatures in a validated, secure environment. Automated sample processing systems have until now required manual (off-line) storage of samples at −80°C, reducing system reliability and speed. Both of these important needs are addressed by the Sample Process Management System being introduced by BIOPHILE Inc. Conventional sample management processes, such as storage, retrieval, and cataloging, are increasingly strained by the growing sample populations. There are variable sample types, access requirements and storage requirements. Security and inventory procedures are implemented manually. The evolving technologies present in the laboratory cannot interface with conventional manual storage techniques. Addressing these limitations, the primary benefits of BIOPHILE's solutions are: Fully validated sample management process that coordinates the life-cycles of samples and their related data. Robotic technology to securely store and retrieve samples, improving their accessibility and stability. Thermal shock is reduced, improving sample longevity and quality. The robotic technology allows integration with larger automation systems. A process program to develop a Sample Management Strategy. This strategy is developed by analyzing long-term research goals, current baseline processes, and identification of current sample life cycles. A full validation documentation package can be generated, providing a high level of quality assurance. Improved sample visibility and quality assurance — auto mated sample population cataloging; controlled sample management access and security.

The Madurai Intraocular Lens Study I: A Randomized Clinical Trial Comparing Complications and Vision Outcomes of Intracapsular Cataract Extraction and Extracapsular Cataract Extraction With Posterior Chamber Intraocular Lens

The Madurai Intraocular Lens Study (MIOLS) was designed to compare safety, efficacy, and quality of life outcomes after either intracapsular cataract extraction with aphakic glasses (ICCE-AG) or extracapsular cataract extraction with posterior chamber intraocular lens (ECCE/ PC-IOL). The Madurai Intraocular Lens Study was a nonmasked randomized controlled clinical trial conducted at a single hospital. Thirty-four hundred patients with age-related cataracts and having a best-corrected visual acuity less than or equal to 20/120 in the better eye were randomly assigned to either of the two cataract operative procedures. The main clinical outcomes were safety (complication rates) and efficacy (best-corrected visual acuity at 1 year equal to or better than 20/40). In addition, a subset of 1,700 trial participants received questionnaires before surgery, at 6 months after surgery, and at 1 year after surgery to measure visual functioning and vision-related quality of life. Details of study design, study organization, clinical and quality of life outcome variables, sample size calculations, patient eligibility criteria and recruitment, randomization and masking, participant flow, adherence to follow-up, quality assurance, and statistical methods are presented. The Madurai Intraocular Lens Study has sufficient power to detect clinically significant differences between the treatment options. There were no statistically significant differences between the two treatment groups for any of the major study variables at baseline. A high level of quality assurance was maintained throughout the October 1993 to June 1996 study period. The results should be applicable to all settings where the requisite expertise and resources are present.

Computerised parts traceability: An implementation case study

This case study examines the planning and implementation of a computerised parts traceability system at Nippondenso (Australia), a large automotive parts manufacturer located in Melbourne, Australia. The paper discusses the associated planning and training, hardware and software selection, implementation problems and benefits achieved from the implementation. Factors critical to successful implementation are also identified. In early 1990 the Australian car manufacturers demanded that Nippondenso fully identify and trace every component to assure product quality. A five-year plan for computer integrated manufacture (CIM) was developed by Nippondenso (Australia), with an initial emphasis on gaining full traceability of products. The computerised system put in place enables the identification of all incoming goods, direct requisition of those goods from computer terminals at the shop floor and recording of all work and processes used in manufacture. The manufacturing history of every finished product is then stored and is both precise and complete. In addition to a higher level of quality assurance through traceability of faulty parts, Nippondenso (Australia) has gained significant savings from better stock handling and production management. Accurate information regarding work-in-progress and inventory levels greatly aids decision making and has reduced lead times.

Maintaining the integrity of human immunodeficiency virus sequence databases

Human immunodeficiency virus type 1 (HIV-1) sequences are accumulating in the literature at a rapid pace. For this ever-expanding resource to be maximally useful, it is critical that researchers strive to maintain a high level of quality assurance, both in experimental design and conduct and in analyses. Here we present detailed analyses of problematic sets of HIV-1 sequences in the database that include sequence anomalies suggestive of mislabeling or sample contamination problems. These data are examined in the context of currently available HIV-1 sequence information to provide an example of how to identify potentially flawed data. Indicators of potential problems with sequences are (i) sequences that are nearly identical that are supposed to be derived from unlinked individuals and that are markedly distinct from other sequences from the putative source or (ii) sequences that are nearly identical to those of laboratory strains. We provide an outline of methods that researchers can use to perform preliminary laboratory and computational analyses that could help identify problematic data and thus help ensure the integrity of sequence databases.