Quality Assurance Applications Research Articles

Adapting to Changes: A Novel Framework for Continual Machine Learning in Industrial Applications

This paper is dedicated to solving the problem of concept drift in industrial plants using artificial intelligence methods. For this purpose, methodological approaches and procedures are considered and analyzed. Based on the findings, reference architectures were developed at different abstraction levels that can be used in an industrial environment and enable continuous machine learning. Continuous machine learning offers the possibility of adapting to dynamic changes in the production environment, which are reflected in constantly changing data sets. Through a combination of machine learning techniques, a novel and practical framework for continuous learning, also known as lifelong learning, is presented. The integration of problem-focused machine learning methods is advancing in production, e.g., predictive maintenance, process optimization or fault detection. Thereby, fully or semi-automated adaptations to changing environments requiring continuous improvements are less often explored, although practical use cases often require adaptive capabilities as the physical data distribution may change over time. In this paper, the application was continuously improved based on case studies and empirical results, and finally validated with a quality assurance application. Various methods and approaches for detecting concept and data deviations, retraining, packaging and model updating had to be investigated, which led to the question of what a real industry-oriented implementation could look like. The result is a reference architecture that can run on cloud and edge computing resources. This reference architecture is validated in real-world application in the parquet production sector, proving its feasibility and efficiency.

Novel Bragg peak characterization method using proton flux measurements on plastic scintillators

Objective. Bragg peak measurements play a key role in the beam quality assurance in proton therapy. Used as base data for the treatment planning softwares, the accuracy of the data is crucial when defining the range of the protons in the patient.Approach. In this paper a protocol to reconstruct a Pristine Bragg Peak exploring the direct correlation between the particle flux and the dose deposited by particles is presented. Proton flux measurements at the HollandPTC and FLUKA Monte Carlo simulations are used for this purpose. This new protocol is applicable to plastic scintillator detectors developed for Quality Assurance applications. In order to obtain the Bragg curve using a plastic fiber detector, a PMMA phantom with a decoupled and moveable stepper was designed. The step phantom allows to change the depth of material in front of the fiber detector during irradiations. The Pristine Bragg Peak reconstruction protocol uses the measured flux of particles at each position and multiplies it by the average dose obtained from the Monte Carlo simulation at each position.Main results. The results show that with this protocol it is possible to reconstruct the Bragg Peak with an accuracy of about 470µm, which is in accordance with the tolerances set by the AAPM.Significance. It has the advantage to be able to overcome the quenching problem of scintillators in the high ionization density region of the Bragg peak.

Synergizing Ai and ERP for Predictive Supply Chain Management and Quality Assurance in Healthcare

This article explores the transformative potential of integrating Artificial Intelligence (AI) with Enterprise Resource Planning (ERP) systems in healthcare, focusing on applications in predictive supply chain management and quality assurance. The healthcare industry faces increasing pressure to improve efficiency while maintaining high-quality care, and AI-ERP integration offers a compelling solution. By combining ERP's comprehensive data management capabilities with AI's predictive and analytical power, healthcare organizations can enhance operational efficiency, improve decision-making, and ultimately deliver better patient outcomes. The article examines current implementations, case studies, and future projections to provide a comprehensive overview of how this technological synergy can help healthcare providers navigate the complex challenges of modern healthcare delivery, from optimizing inventory levels to ensuring regulatory compliance and proactive risk management.

A 3D imaging system for dosimetry in FLASH radiotherapy

This study examines the feasibility of reconstructing the spatial dose distribution delivered by a 9 MeV electron beam within a plastic scintillator block using optical tomography. The system is designed for use in 3D-dosimetry for clinical applications in quality assurance and beam characterization, especially with FLASH-beam sources. The proposed detector reconstructs the 3D dose distribution map employing a monolith with 10 cm side, imaged in four different projections by scientific cameras. The 3D dose distribution simulated with Geant4 was reconstructed using a maximum likelihood expectation maximization algorithm applied to the lateral projection, resulting in a longitudinal image with a standard deviation of 0.2 Gy. Furthermore, a preliminary experimental test has been performed.

Limitations in next-generation sequencing-based genotyping of breast cancer polygenic risk score loci

Considering polygenic risk scores (PRSs) in individual risk prediction is increasingly implemented in genetic testing for hereditary breast cancer (BC) based on next-generation sequencing (NGS). To calculate individual BC risks, the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm (BOADICEA) with the inclusion of the BCAC 313 or the BRIDGES 306 BC PRS is commonly used. The PRS calculation depends on accurately reproducing the variant allele frequencies (AFs) and, consequently, the distribution of PRS values anticipated by the algorithm. Here, the 324 loci of the BCAC 313 and the BRIDGES 306 BC PRS were examined in population-specific database gnomAD and in real-world data sets of five centers of the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC), to determine whether these expected AFs can be reproduced by NGS-based genotyping. Four PRS loci were non-existent in gnomAD v3.1.2 non-Finnish Europeans, further 24 loci showed noticeably deviating AFs. In real-world data, between 11 and 23 loci were reported with noticeably deviating AFs, and were shown to have effects on final risk prediction. Deviations depended on the sequencing approach, variant caller and calling mode (forced versus unforced) employed. Therefore, this study demonstrates the necessity to apply quality assurance not only in terms of sequencing coverage but also observed AFs in a sufficiently large cohort, when implementing PRSs in a routine diagnostic setting. Furthermore, future PRS design should be guided by the technical reproducibility of expected AFs across commonly used genotyping methods, especially NGS, in addition to the observed effect sizes.

Proton beam spot size and position measurements using a multi-strip ionization chamber

PurposeTo develop and characterize a large-area multi-strip ionization chamber (MSIC) for efficient measurement of proton beam spot size and position at a synchrotron-based proton therapy facility. Methods and MaterialsA 420 mm x 320 mm MSIC was designed with 240 vertical strips and 180 horizontal strips at 1.75 mm pitch. The MSIC was characterized by irradiating a grid of proton spots across 17 energies from 73.5 MeV to 235 MeV and comparing to simultaneous measurements made with a reference Gafchromic EBT3 film. Beam profiles, spot sizes, and positions were analyzed. Short term measurement stability and sensitivity were evaluated. ResultsExcellent agreement was demonstrated between the MSIC and EBT3 film for both spot size and position measurements. Spot sizes agreed within ± 0.18 mm for all energies tested. Measured beam spot positions agreed within ± 0.17 mm. The detector showed good short term measurement stability and low noise performance. ConclusionThe large-area MSIC enables efficient and accurate proton beam spot characterization across the clinical energy range. The results indicate the MSIC is suitable for pencil beam scanning proton therapy commissioning and quality assurance applications requiring fast spot size and position quantification.

Real-time quality assurance and quality control for a high frequency radar network

This paper recommends end to end quality assurance methods and quality control tests for High Frequency Radar Networks. We focus on the network that is operated by the Mid Atlantic Regional Association Coastal Ocean Observing System (MARACOOS). The network currently consists of 38 radars making real-time measurements of the surface currents over the continental shelf for a variety of applications including search and rescue planning, oil spill trajectory modelling and providing a transport context for marine biodiversity observing networks. MARACOOS has been delivering surface current measurements to the United States Coast Guard (USCG) since May 2009. Data quality is important for all applications; however, since the USCG uses this surface current information to plan life-saving missions, delivery of the best quality data is crucial. We have mapped the components of the HF radar data processing chain onto the data levels presented in the NASA Earth Science Reference Handbook and have applied quality assurance and quality control techniques at each data level to achieve the highest quality data. There are approximately 400 High Frequency radars (HFRs) deployed globally and the presented techniques can provide a foundation for data quality checks and standardization of the data collected by the large number of systems operating today.

An improved approach to determine aerosol properties from all-sky camera imagery: Sensitivity to the partially cloud scenes

We present a new approach to determine aerosol properties from radiometrically calibrated images provided by an all-sky camera. It is designed to be used regardless of the sky conditions. However, we especially focus on partially cloudy scenes, which is the main novelty of this work. Our methodology is based on using a small sector of the image that contains the principal plane of the Sun. The RGB principal plane radiances are associated to the aerosol optical depth (AOD) and Angstrom exponent (AE) AERONET observations through a Gaussian Process Regression (GPR) machine learning (ML) model. We identify the cloudy points within our working sector and the principal plane signal for the RGB radiances is averaged and smoothed. Then, we use the Pérez model to synthesize the principal plane signal in the cloudy spots. Finally, 2-year dataset has been used to test the method considering different atmospheric conditions related to the presence of clouds and aerosols, according to their amount and type. In addition, we have developed a method to evaluate the quality of predictions based on the standard deviation of the GPR. This quality assurance method may be fine-tuned according to the desired accuracy based on the application for which it is intended. Our AOD and AE predictions show an excellent overall agreement with AERONET measurements that substantially improves when our quality assurance method is applied. In that case, we obtain a high degree of correlation (R2 ¿ 0.97) and an overall MAE lower than the nominal uncertainty of AERONET measurements (0.006 and 0.05 for AOD and AE, respectively). Moreover, more than 83% and 77% of the predictions fall within the nominal uncertainty associated with AERONET measurements for AOD and AE, respectively. A comprehensive sensitivity analysis of the factors affecting the performance of the proposed methodology confirms that our method is stable and not very sensitive to external and methodological factors, especially when we apply quality assurance criteria. All this supports that our methodology is a reliable alternative to retrieve the optical properties of aerosols independently of the cloud conditions. Our results may contribute to the operational use of all-sky cameras, which may be an interesting complement regarding the study of aerosol-cloud interactions in partially cloud scenarios.

Digital Technologies for Quality Assurance in the Construction Industry: Current Trend and Future Research Directions towards Industry 4.0

Despite the growing rich and fragmented literature focusing on quality assurance (QA) and Industry 4.0, the implementation of associated individual digital technologies has not been fully evaluated and synthesised to achieve adequate QA in the construction industry; hence, it has received limited focus. This study, thus, aimed to organise, evaluate, and synthesise the current literature on individual digital technology applications in QA in the construction industry and propose future research directions. A literature review approach was adopted for this study along with Deming’s cycle framework to address four research questions: (1) What is the status of the state-of-the-art in the literature? (2) What digital technologies have been applied for QA in the construction industry? (3) Which areas in QA processes have experienced digital technology applications, and what are the applications? (4) What are the limitations of the existing studies and future research directions of digital technologies for QA in the construction industry? The findings showed an increasing trend of research on digital technology for QA in construction since 2017. This cuts across 23 countries with six different research methods published across 18 different publication sources. Four categories of digital technologies were revealed to have been adopted for QA in construction based on the functionality of the technologies: data collection technologies, decision-oriented technologies, collaborative technologies, and transparency and security-related technologies. Evaluation with Deming’s cycle framework revealed that digital technologies have a high level of application at the “do” phase, improving the quality management process during construction towards achieving pre-stated quality requirements. This includes mostly collaborative technologies, consisting of BIM technologies. Limitations of the existing studies were further identified, and this led to five research directions: interoperability of technology development, integrated digital technologies for QA of prefabricated and modular construction, integrated digital technologies for QA of cross-border construction logistics and supply chain, digital innovation for sustainable QA, and moving beyond the technical solution. The study showed a significant contribution to both academia and the industry in the built environment.

The The Influence of Auditor Competence and Integrity on Audit Quality with the Implementation of Quality Assurance as a Moderating Variable (Study at the Audit Unit of the Regional Office of DJBC East Java I)

This research aims to test and analyze the influence of auditor competence and integrity on audit quality by applying quality assurance as a moderating variable, research at the audit unit of the East Java I Regional Office of the Directorate General of Customs and Excise. This type of research is quantitative research. The population of this study are functional auditors and executive examiners who are tasked with assisting the implementation of audits. The sampling technique uses a saturated sample, namely the entire population of 47 people as the research sample. The data analysis technique for testing hypotheses uses Partial Least Square – Structural Equation Modeling with the SmartPLS program. The research results show that: 1) auditor competency has a significant and positive effect on audit quality, 2) auditor integrity has a significant and positive effect on audit quality, 3) the application of quality assurance has a significant and positive effect on audit quality, 4) the application of quality assurance does not moderate the effect auditor competency on audit quality, 5) implementation of quality assurance does not moderate the influence of auditor integrity on audit quality

Systems and Mechanisms of Applying Quality Assurance in Higher Education.

Systems and Mechanisms of Applying Quality Assurance in Higher Education.

ICH Q14-inspired novel approach to establish an SFC-based purity method for carbamazepine.

The proposed ICH Q14 guideline "Analytical procedure development" describes science and risk-based approaches for development and maintenance of analytical procedures suitable for the assessment of the quality of drug substances and drug products. As a case study, the systematic development and validation of a supercritical fluid chromatography (SFC)-based purity method for carbamazepine is presented. Systematic analytical quality by design (AQbD) principles were applied using the software package Fusion QbD to the method development approach. The relationship between chromatographic parameters and the responses of interest were examined to improve the reliability of the method by understanding, reducing, and controlling sources of variability. Method performance qualification in terms of method robustness was finally carried out with the parameters that were classified as critical after method development and a validation study met previously set acceptance criteria. The developed SFC purity method for carbamazepine demonstrated readiness as a viable alternative to the official HPLC method published in the Ph.Eur. with improved peak resolution, improved peak symmetry, and faster analysis times (3min vs. 80 min for the official method). Its inherent reliability illustrates the superiority of AQbD in method development and application for drug quality assurance.

Leveraging AI and Machine Learning in Six-Sigma Documentation for Pharmaceutical Quality Assurance.

The pharmaceutical industry must maintain stringent quality assurance standards to ensure product safety and regulatory compliance. A key component of the well-known Six Sigma methodology for process improvement and quality control is precise and comprehensive documentation. However, there are a number of significant issues with traditional documentation procedures, including as slowness, human error, and difficulties with regulatory standards. This review research looks at innovative ways to employ machine learning (ML) and artificial intelligence (AI) to enhance Six Sigma documentation processes in the pharmaceutical sector. AI and ML provide cutting-edge technologies that have the potential to drastically alter documentation processes by automating data entry, collection, and analysis. Natural language processing (NLP) and computer vision technologies have the potential to significantly reduce human error rates and increase the efficacy of documentation processes. By applying machine learning algorithms to support real-time data analysis, predictive analytics, and proactive quality management, pharmaceutical organizations may be able to identify potential quality issues early on and take proactive efforts to address them. Combining AI and ML improves documentation accuracy and reliability while also strengthening compliance with stringent regulatory criteria. The primary barriers and limitations to the current state of Six Sigma documentation in the pharmaceutical industry are identified in this study. It examines the fundamentals of AI and ML with an emphasis on their specific applications in quality assurance and potential benefits for Six Sigma processes. The report includes extensive case studies that highlight notable developments and explain how AI/ML enhanced documentation is used in the real world.

Scaling up the task-sharing of psychological therapies: A formative study of the PEERS smartphone application for supervision and quality assurance in rural India.

Measurement-based peer supervision is one strategy to assure the quality of psychological treatments delivered by non-mental health specialist providers. In this formative study, we aimed to 1) describe the development and 2) examine the acceptability and feasibility of PEERS (Promoting Effective mental healthcare through peER Supervision)-a novel smartphone app that aims to facilitate registering and scheduling patients, collecting patient outcomes, rating therapy quality and assessing supervision quality-among frontline treatment providers delivering behavioral activation treatment for depression. The PEERS prototype was developed and tested in 2021, and version 1 was launched in 2022. To date, 215 treatment providers (98% female; ages 30-35) in Madhya Pradesh and Goa, India, have been trained to use PEERS and 65.58% have completed the supplemental, virtual PEERS course. Focus group discussions with 98 providers were examined according to four themes-training and education, app effectiveness, user experience and adherence and data privacy and safety. This yielded commonly endorsed facilitators (e.g., collaborative learning through group supervision, the convenience of consolidated patient data), barriers (e.g., difficulties with new technologies) and suggested changes (e.g., esthetic improvements, suicide risk assessment prompt). The PEERS app has the potential to scale measurement-based peer supervision to facilitate quality assurance of psychological treatments across contexts.

إجراءات تطبيق عمليات ضمان وضبط الجودة في الجامعات اليمنية من وجهة نظر القيادات الاكاديمية وأعضاء هيئة التدريس

This study displays the Yemen experience in the field of quality assurance and academic accreditation for post secondary institutions to build on when constructing quality assurance and academic accreditation for general education. It aims at identifying the implementation level of postsecondary institutions of evaluation activities required for quality assurance and academic accreditation through the opinions of those who are in charge of this process and others involved in it. It also aims at identifying needs that help in applying quality assurance in post-secondary institutions in Yemen Arabia، hurdles faced، and proposing suitable solutions at the individual، institutional، and system levels. The two researchers have applied a questionnaire at purposeful sample consisting of those who are in charge of evaluation and quality assurance activates and those interested in it at their universities. Interviews were also conducted to specify the practicing level of evaluation for individuals، programs، and institutions، and its barriers. Results showed that there are differences amongst the universities in regard to implementing evaluation and tools for quality assurance and accreditation purposes. The main implementation barriers were the lack of sufficient knowledge and training. The researchers stressed the necessity of adopting capacity building model to assess training needs for individuals، programs، and institutions. This model can be used to design graded and detailed training programs that fit each university، and the implementation and monitoring of it should happen at each university site.

Object-Oriented Approach: Applying ISO 21001 at Vietnamese Higher Education Institutions

To evaluate whether an educational institution has quality or not, requires standards that reflect all the requirements of the complex relationships operating within the educational institution. At the same time, this standard must be recognized by all nations for it to apply widely. It is in this context that the ISO 21001:2018 series of standards was published. This standard mentioned three areas of activities that an educational organization must pay attention to: training, scientific research, and community service. They are also the main activities that the educational accreditation standards refer to. To meet the requirement of quality guarantee and enhancement, a higher education institution has to apply quality assurance norms in general and quality criteria on management systems. Putting the ISO 21001 quality standard into practice is the choice of Vietnamese educational institutions to ensure they meet the requirements for improving management system quality. There are a set of quality system standards for educational organizations to satisfy their specific needs. Not following the traditional approach as they apply other ISO standard systems, Vietnamese educational institutions have chosen an object-base approach, where the beneficiaries are related to the management system of the university. They then approach the PDCA cycle to build and implement an ISO 21001 quality management system. We found that, according to this orientation, the implementation processes might be ensured given that the quality thresholds set by the university are met in order to satisfy the demands of the learners and related stakeholders. The paper aims to analyze the approach of Vietnamese educational institutions in implementing ISO 21001 standards, and at the same time identify advantages and disadvantages in developing policies in the quality management system at educational institutions. The paper also gives recommendations that can be adjusted by management at other higher education institutions to improve quality assurance activities towards sustainable development.
 Keywords: ISO 21001:2018, quality assurance, quality management system, PDCA (Plan-Do-Check-Act), sustainable development

Delineation of prototypical degradation mechanism, characterization of unknown degradation impurities by liquid chromatography-quadrupole-time-of-flight-tandem mass spectrometry and stability-indicating analytical method of selumetinib.

Selumetinib (SELU) was recently approved by the US Food and Drug Administration (US FDA) in 2020. However, the degradation impurities of SELU have not been characterized or identified to date. The mechanism for impurity formation and the degradation behavior have not been previously studied. This study aims to elucidate the prototypical degradation mechanism of SELU. Furthermore, the degradation impurities have been identified using LC-quadrupole-time-of-flight tandem mass spectrometry and are reported in this article for the first time. In addition, a stability-indicating analytical method (SIAM) has been developed for this drug. Forced degradation studies revealed the degradation of SELU under various stress conditions, including hydrolytic stress (acid and base), oxidative stress, and photolytic stress (ultraviolet and visible). Three degradation impurities were identified. This article presents the first validated SIAM, capable of accurately quantifying SELU in the presence of its degradation impurities. Furthermore, we have proposed the degradation pathway for SELU and its degradation impurities, a first in the field. The developed SIAM can find applications in process development and quality assurance of SELU in both research laboratories and pharmaceutical industries. Moreover, the identified degradation impurities may serve as impurity standards for quality control testing in pharmaceutical industries.

From Protons to Picasso: Recreating Famous Paintings Using Proton Beams as a “Paintbrush”

To many, medicine is just as much an artform as it is a science. From the colorful stains used in diagnostic pathology, to the tactile sculpting of surgery, to the dose painting in radiation oncology, there is beauty and art to be found across all disciplines. In pencil-beam-scanning proton therapy, the dose is painted layer-by-layer, spot-by-spot, allowing for significantly more control compared to conventional radiation. This work intends to showcase the immense capability of intensity-modulated proton therapy (IMPT) through the recreation of some of the most renowned artworks throughout history, and has potential applications in patient education, medical/physics education, and quality assurance. Five (5) well-recognized paintings spanning from the Golden Age to the modern era were recreated as treatment plans in the Eclipse (version 16.1) External Beam Planning environment. For each "painting" (treatment plan), clinical protons within the range of 70-250 MeV were used to deposit "paint" (radiation dose) onto a "canvas" (water phantom) to a prescription of 100 Gy. The individual elements of each artwork were first delineated as separate structures. Colors were then assigned to appropriate isodose lines to mimic the corresponding palettes found in the original artworks. For each treatment plan, a single field was used along with inverse optimization to deposit the different doses at a depth of 10 centimeters. The resulting dose distribution was calculated with the proton convolution-superposition algorithm used in clinical practice. The dose distributions of the "paintings" demonstrated a marked semblance to the original artworks with sufficient resolution to elucidate fine details. The "paintings" varied in dimension from 20-30 cm at isocenter and on average took between 5-6 hours to complete. The number of structures used for planning ranged from 6-65 depending on the style and complexity of the original artwork. For a fractional dose of 200 cGy, the number of monitor units ranged from 73,145-269,970. With the advent of IMPT and modern planning techniques, we can now realize increasingly complex treatment plans, allowing for the creation of dose distributions that are highly targeted and specific. This is demonstrated by the capability to create recognizable works of art using proton beams as a "paintbrush".

A QbD Based RP-HPLC Method for Stability Indicating Impurity Profiling of Pyridoxine: Method Development, Validation, and Application

Pyridoxine impurity profiling in bulk and formulations was devised and validated using a reversed-phase high-performance liquid chromatography (RP-HPLC) strategy. The technique was fine-tuned using an Analytical quality by design (QbD) approach, ensuring its dependability and sturdiness. Linearity, accuracy, and precision were carefully examined as key performance indicators. With a relative standard deviation (RSD) < 2%, the approach showed exceptional precision, excellent recovery rates (100 and, 101.2%), and a strong correlation value (R2 = 0.9990). The technique has been used successfully for impurity profiling, and because it indicates stability, it can be used for long-term stability studies. The work contributes to the body of knowledge and has applications for pharmaceutical quality assurance.

Evaluation of a Scintillating Plastic Optical Fiber Device for Measuring kV-Cone Beam Computed Tomography Dose.

Justification of imaging procedures such as cone beam computed tomography (CBCT) in radiotherapy makes no doubt. However, the CBCT composite dose is rarely reported or optimized, even though the repeated CBCT cumulative dose can be up to 3% of the prescription dose. This study aimed to evaluate the performance and utility of a new plastic scintillating optical fiber dosimeter for CBCT dosimetric quality assurance (QA) applications before a potential application in patient composite CBCT dosimetry. The dosimeter, made of 1 mm diameter plastic fiber, was installed under a linear accelerator treatment table and linked to photodetectors. The fiber impact on the fluence and dose delivered was respectively assessed with an electronic portal imaging device (EPID) and EBT3 Gafchromic® film. The presence of artifacts was visually evaluated on kV images. The dosimeter performances were determined for various acquisition parameters by comparison with ionization chamber values. The maximum impact of the fiber on the fluence measured by the EPID was -1.2% for the 6 MV flattening filter-free beam. However, the fiber did not alter the film dose profile when measured for all the beams tested. The fiber was not visible at energies ≥ 80 kV and was merely visible on the CBCT images. When the rate of images per second or mA was changed, the maximum relative difference between the device and the ionization chamber CTDIs was <5%. Changing collimation led to a -7.2% maximum relative difference with an absolute dose difference that was insignificant (-0.3 mGy). Changing kV was associated with a -8.7% maximum relative difference, as published in the literature. The dosimeter may be a promising device for CBCT recurrent dosimetry quality control or dose optimization. According to these results, further developments are in progress in order to adapt the solution to the measurement of patient composite CBCT doses.