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A systematic approach to nonconformity management and continuous improvements are the key elements of the quality management system. The objective of this paper is to present quality improvement for a manufacturing company producing forgings through the combination of several statistical methods and quality control techniques. First, Pareto analysis was applied, followed by the 8D (eight disciplines) methodology using a structured eight-step approach to problem solving following the PDCA (plan-do-check-act) method. The aim was to identify the problem and discover the critical causes of failures in the management system that allowed the problem to occur, by modifying and combining appropriate quality management methods and tools. The paper introduces a case study considering the forging process in the production of gearboxes, where customer complaints were identified in the last year, demanding the need to eliminate failures. Using the mentioned methods, the root cause of the problem was identified and permanent corrective action was planned and implemented according to the recommendations of the 8D report, which made it possible to reduce the likelihood of a recurrence of this problem and increase customer satisfaction.

Masalah: PT. Djohartex adalah perusahaan pengolahan benang menjadi kain gray atau tekstil. Pada bulan September 2022 didapatkan jumlah produksi sebanyak 1.792.208 yard dengan jumlah cacat produk sebanyak 309.747 yard atau 17,28%. dalam implementasinya, jumlah cacat melebihi batas toleransi produk cacat yang ditentukan. Bagian produksi dan quality control berusaha menekan pada cacat tertentu, jumlah jenis cacat lain meningkat. Hal ini menyebabkan kualitas menjadi permasalahan berlarut-larut yang tidak segera terselesaikan. Tujuan: Tujuan dari penelitian ini adalah untuk meminimasi cacat produk. Metodologi: Salah satu metode yang digunakan untuk meminimasi produk cacat adalah metode Lean Six Sigma. Lean Six Sigma lebih difokuskan kepada perbaikan proses dengan menggunakan data yang diperoleh kemudian diolah sesuai dengan langkah-langkah DMAIC, kemudian akan didapatkan masalah pada system kerja perusahaan, sehingga dapat diidentifikasi permasalahan serta penyebab masalah, dan segera diambil tindakan perbaikan. Temuan/Hasil Penelitian: Pada bulan September 2022 didapat jenis cacat paling banyak adalah rapat/renggang sebanyak 88.502 dengan presentasi sebesar 31,44% dan yang paling sedikit adalah netting sebanyak 0 dengan presentasi sebesar 0% dari keseluruhan jenis defect. Faktor penyebab terjadinya cacat ada 5 faktor penyebab Manusia, Mesin, Metode, Material, Lingkungan. Perbaikan dapat diusulkan menggunakan metode 5W+1H dan metode Poka Yoke. perbaikan harus dilakukan, dengan melakukan penjadwalan ulang dalam pengecekan mesin dan proses produksi, memberikan pengarahan standarisasri mesin, memberikan edukasi kepada operator produksi untuk lebih mengutamakan kualitas kain yaitu menguraung faktor penyebab defect, dan melakukan perbaikan pada ruang kerja agar dapat mengurangi dampak kebisingan, kotor, kurangnya pencahayaan dan panas ruangan. Jenis penelitian: pengendalian kualitas produk. Kata kunci DMAIC, Lean Six Sigma, dan Pengendalian Kualitas

We present guidelines by the European Association of Nuclear Medicine (EANM) for routine quality control (QC) of PET-CT and PET-MR systems. These guidelines are partially based on the current EANM guidelines for routine quality control of Nuclear Medicine instrumentation but focus more on the inherent multimodal aspect of the current, state-of-the-art PET-CT and PET-MR scanners. We briefly discuss the regulatory context put forward by the International Electrotechnical Commission (IEC) and European Commission (EC) and consider relevant guidelines and recommendations by other societies and professional organizations. As such, a comprehensive overview of recommended quality control procedures is provided to ensure the optimal operational status of a PET system, integrated with either a CT or MR system. In doing so, we also discuss the rationale of the different tests, advice on the frequency of each test and present the relevant MR and CT tests for an integrated system. In addition, we recommend a scheme of preventive actions to avoid QC tests from drifting out of the predefined range of acceptable performance values such that an optimal performance of the PET system is maintained for routine clinical use. ispartof: Z Med Phys vol:33 issue:1 pages:103-113 ispartof: location:Germany status: published

The analysis of pharmaceuticals is fundamental in both human and veterinary medicine. In this context, quality control must accompany the process from the acquisition of raw material to the transformation into a finished product, since its goal is to ensure safe and effective drugs for human or animal consumption. Considering the significant increase in veterinary prescriptions containing antimicrobial drugs, the present work carried out a search for information about the qualification of veterinary preparations available in the national market, highlighting, through legislation, the quality parameters applied to pharmaceutical products for veterinary use. The quality of solid pharmaceutical preparations containing cephalexin, acquired in the national veterinary pharmaceutical market, was also evaluated. The six different brands of cephalexin tablets and coated tablets analyzed in this study were approved with regard to identification, average weight, determination of mechanical strength in tablets, disintegration test, and content. The results of the determination of the content varied between 94.9% and 103%, being within the limits indicated for preparations for human use, as recommended by USP 44 and the Brazilian Pharmacopeia 6th edition. Even so, it is important to emphasize the need for improvement in the legislation that regulates the quality control of medicines for veterinary use, since the norms are not very specific, with an absence of parameters, specifications, and release procedures that ensure which tests should be performed. This study is a perspective that can bring subsidies for investigations of other therapeutic classes, considering the large number of formulations available in the Brazilian market of veterinary medicines.

The purpose of this study was to investigate and evaluate the current technical performance of ultrasound imaging device displays. Altogether 53 ultrasound device displays were evaluated in two hospital districts of Finland. The performance of the displays was evaluated with tests and test patterns developed by American Association of Physicists in Medicine (AAPM). Minimum, maximum and ambient luminances (L

Background: Cannabis plants and their seed have been used in many cultures as a source of medicine and feeding during history. Today, there is an increasing demand for cannabis seeds for medical use. Moreover, a seed sales market with no legal regulations has also grown. This may pose some issues if a quality control is not set in place. Identification of cannabis strains is important for quality control purposes in a nonregulated growing market and in cases of illegal traffic and medical use. Owing to the high price as a pharmacological drug, commercial products of cannabis plants and seeds for medical users are often subjected to adulterations, either when packing or distributing certified seeds in the market. Materials and Methods: Cannabis commercial seeds and cannabis seeds for medical use were analyzed with high-resolution melting (HRM) analysis using barcoding markers. Humulus lupulus L. plants from a local market were used as outgroup control. DNA barcoding uses specific regions of the genome to identify differences in the genetic sequence of conserved regions such as internal transcribed spacer (ITS) and rbcL. DNA barcoding data can be generated with real-time polymerase chain reaction combined with HRM analysis to distinguish specific conserved DNA regions of closely related species. HRM analysis is the method of choice for rapid analysis of sequence variation. Results: The melting temperature (Tm) of homogeneous packages was consistent with single genotypes. However, packages containing contaminating seeds showed Tm differences of 0.2°C on average. Conclusions: An effective, rapid, and low-cost method based on ITS nuclear DNA and on chloroplast rbcL regions for screening and detection of contamination in commercial cannabis seeds was developed and applied for the analysis of different samples. This approach can be used as a quality control tool for cannabis seeds or other plant material.

A brief idea

Introduction: The poor quality of medicines represents a threat to public health. However, the causes come from a variety of factors such as the use of an active ingredient of insufficient quality, inadequate manufacturing processes, or even unsuitable packaging, insufficient quality control measures. Thus, this study aims to assess the quality of injectable ampicillin in the formal and informal circuit in the city of Yaoundé. Methodology: Thirty (30) batches of injectable ampicillin collected in the city of Yaoundé were the subject of an experimental study. The European and American Pharmacopoeia (USP) standards were used to assess pharmaco-technical and physicochemical compliance. Results: According to the parameters including respect for the mass, the pH, the labeling and the dosage of the active ingredient were found non-compliant on 02 batches (7%), 01 batch (3%), 25 batches (83% ) and 01 lot (3%). However, of the 30 batches analyzed, 53% were non-compliant, including 13%, 3%, and 37% respectively from the private, public and informal sectors. Conclusion: More than half of the batches of ampicillin injection analyzed in this study had corrupted qualities. Strict measures are necessary on the quality of badly needed drugs such as ampicillin from the first people in charge of drug control in the city of Yaoundé in order to improve the quality of treatment for pathologies.

In December 2019, the World Health Organization was informed of an outbreak of pneumonia of unknown etiology in Wuhan, Hubei Province, China. On January 7, 2020, a new type of coronavirus was isolated, with the WHO later officially calling it “COVID-19” and the International Committee on Taxonomy of Viruses naming the virus “SARS-CoV-2”. On January 30, 2020, the WHO declared the severe acute respiratory syndrome coronavirus 2 outbreak a public health emergency of international concern, making it an unprecedented global public health challenge. From a scientific and literary reference, it was established that the main drugs in the therapy with Covid-19 are Dexamethasone and Levofluoxetine. For this reason, we pay attention to the analysis of these two medicinal products. In the literature, we did not find an analysis of a combination of Dexamethasone and Levofloxacin. Development and validation of a highperformance liquid chromatographic analytical procedure for simultaneously determining Dexamethasone and Levofloxacin in a synthetic mixture is described in this paper. The separation was made with a LiChrosorb RP 18 (250 × 4.6 mm) column, at 25 °C temperature,with isocratic mode andmobile phase,containingt acetonitrile and woter (70-30v/v). Eluent was monitored at 254 nm and the flow rate was 1.0 ml/min. Dexamethasone and Levofluoxetine were effectively separated with retention time (tr) of 4.69 min and 14.51 min,respectively,with in the selected chromatographic conditions.The method was validated for analytical parameters: specificity, linearity, precision, accuracy,andlimits of detection and quantitation. The calibration curves were linear inthe concentration range of 12.5 to 100.0 μg/ml for Dexamethasone and Levofloxacin, and the regression coefficientswere more than 0.999. For Dexamethasone and Levofloxacin the recovery was 100.01% and 100.04%, respectively. This analytical procedure is applicable for the quality control of drug formulations.

Generating big-data is becoming imperative with the advent of machine learning. RIN-Neuroimaging Network addresses this need by developing harmonized protocols for multisite studies to identify quantitative MRI (qMRI) biomarkers for neurological diseases. In this context, image quality control (QC) is essential. Here, we present methods and results of how the RIN performs intra- and inter-site reproducibility of geometrical and image contrast parameters, demonstrating the relevance of such QC practice.American College of Radiology (ACR) large and small phantoms were selected. Eighteen sites were equipped with a 3T scanner that differed by vendor, hardware/software versions, and receiver coils. The standard ACR protocol was optimized (in-plane voxel, post-processing filters, receiver bandwidth) and repeated monthly. Uniformity, ghosting, geometric accuracy, ellipse's ratio, slice thickness, and high-contrast detectability tests were performed using an automatic QC script.Measures were mostly within the ACR tolerance ranges for both T1- and T2-weighted acquisitions, for all scanners, regardless of vendor, coil, and signal transmission chain type. All measurements showed good reproducibility over time. Uniformity and slice thickness failed at some sites. Scanners that upgraded the signal transmission chain showed a decrease in geometric distortion along the slice encoding direction. Inter-vendor differences were observed in uniformity and geometric measurements along the slice encoding direction (i.e. ellipse's ratio).Use of the ACR phantoms highlighted issues that triggered interventions to correct performance at some sites and to improve the longitudinal stability of the scanners. This is relevant for establishing precision levels for future multisite studies of qMRI biomarkers.

In this work, a novel environment-friendly stability indicating capillary zone electrophoresis (CZE) method has been developed and validated for assaying the aripiprazole (ARP) in tablet dosage form. The separation of ARP from its degradation products and internal standard was achieved using a fused silica capillary column (30.2 cm x 75 μm ID), a background electrolyte containing 6 mmol L

Gametogenesis is a conserved developmental program whereby a diploid progenitor cell differentiates into haploid gametes, the precursors for sexually reproducing organisms. In addition to ploidy reduction and extensive organelle remodeling, gametogenesis naturally rejuvenates the ensuing gametes, leading to resetting of life span. Excitingly, ectopic expression of the gametogenesis-specific transcription factor Ndt80 is sufficient to extend life span in mitotically dividing budding yeast, suggesting that meiotic rejuvenation pathways can be repurposed outside of their natural context. In this review, we highlight recent studies of gametogenesis that provide emerging insight into natural quality control, organelle remodeling, and rejuvenation strategies that exist within a cell. These include selective inheritance, programmed degradation, and de novo synthesis, all of which are governed by the meiotic gene expression program entailing many forms of noncanonical gene regulation. Finally, we highlight critical questions that remain in the field and provide perspective on the implications of gametogenesis research on human health span.

Monoclonal antibody (mAb) coformulation containing two therapeutic proteins provides benefits of improved therapeutic efficacy and better patient compliance. Monitoring of the individual mAb stability in the coformulation is critical to ensure its quality and safety. Among post-translational modifications (PTMs), oxidation is often considered as one of the critical quality attributes (CQAs) as it potentially affects the structure and potency. Although hydrophobic interaction chromatography (HIC) and reversed phase liquid chromatography (RPLC) have been used to monitor overall protein oxidation, mass spectrometry of peptide digests resolved by LC methods can afford superior selectivity and sensitivity for specific PTMs. With the advent of the Quadrupole Dalton (QDa) mass spectrometer as an affordable add-on detector, implementation of targeted oxidation assays in development and quality control (QC) laboratories is now feasible. In this study, as the first effort to implement MS-based methods for antibody coformulation in QC laboratories, we developed and validated a high-throughput and robust focused peptide mapping method using QDa for simultaneous site-specific monitoring of oxidation of methionine and tryptophan residues in heavy-chain (HC) complementary determining regions (CDRs) of two co-formulated mAbs. The method was validated in terms of accuracy, precision, linearity, range, quantitation limit (QL), specificity, and solution stability per recommendations in ICH Q2. The method robustness was systematically assessed involving multiple sample preparation and instrument method parameters. The method met the validation criteria in GMP laboratories with excellent robustness and was implemented in both GMP and development environments.

Origanum compactum Benth (O. compactum) is widely used traditionally in Morocco to treat a broad range of illnesses, including infectious diseases. The aim of this study was to evaluate the phytochemical composition, quality control, and antibacterial activity of O. compactum leaf and flower essential oil. First, a quality control study on soil and irrigation water was performed to determine whether there was any risk of heavy metals endangering human health or causing stress to the plants studied. Laboratory examination of the environmental quality of the researched species revealed an almost absolute absence of metals that could endanger human health or any abiotic stressor. The essential oil was extracted by hydrodistillation. Chemical characterization was performed using gas chromatography-mass spectrometry (GC/MS). The yield of essential oil (EO) obtained by hydrodistillation of O. compactum leaves and flowers and moisture content were 4.27% and 12.20%, respectively. GC/MS identified 35 volatile compounds in the studied EO majorly composed of thymol (38.59%) followed by carvacrol (26.65%), o-cymene (14.33), and γ-terpinene (11.22%). The antibacterial activity of O. compactum leaf and flower essential oil was evaluated using the solid-state diffusion method against five Gram-negative bacterial strains and a Gram-positive strain. The results show that the essential oil of O. compactum leaves and flowers has a considerable inhibitory effect against E. coli with an MIC = 0.35 µg/mL, E. pseudocoloides (MIC = 0.35 µg/mL), E. vekanda (MIC = 0.35 µg/mL), K. pneumoniae (MIC = 0.7 µg/mL), P. aeruginosa (MIC = 0.35 µg/mL), and S. aureus (MIC = 0.35 µg/mL).

The Italian Neuroimaging Network Initiative (INNI) is an expanding repository of brain MRI data from multiple sclerosis (MS) patients recruited at four Italian MRI research sites. We describe the raw data quality of resting-state functional MRI (RS-fMRI) time-series in INNI and the inter-site variability in functional connectivity (FC) features after unified automated data preprocessing. MRI datasets from 489 MS patients and 246 healthy control (HC) subjects were retrieved from the INNI database. Raw data quality metrics included temporal signal-to-noise ratio (tSNR), spatial smoothness (FWHM), framewise displacement (FD), and differential variation in signals (DVARS). Automated preprocessing integrated white-matter lesion segmentation (SAMSEG) into a standard fMRI pipeline (fMRIPrep). FC features were calculated on pre-processed data and harmonized between sites (Combat) prior to assessing general MS-related alterations. Across centers (both groups), median tSNR and FWHM ranged from 47 to 84 and from 2.0 to 2.5, and median FD and DVARS ranged from 0.08 to 0.24 and from 1.06 to 1.22. After preprocessing, only global FC-related features were significantly correlated with FD or DVARS. Across large-scale networks, age/sex/FD-adjusted and harmonized FC features exhibited both inter-site and site-specific inter-group effects. Significant general reductions were obtained for somatomotor and limbic networks in MS patients (vs. HC). The implemented procedures provide technical information on raw data quality and outcome of fully automated preprocessing that might serve as reference in future RS-fMRI studies within INNI. The unified pipeline introduced little bias across sites and appears suitable for multisite FC analyses on harmonized network estimates.

The proliferation of counterfeit and poor-quality drugs is a major public health problem, especially in developing countries such as Ghana where there are inadequate resources to effectively monitor their prevalence. Most of these drugs, which are counterfeited, are drugs, which are in high demand and will reap huge profits for the unscrupulous people who engage in such activities. The introduction of Omeprazole as one of the first-line therapies in the management of peptic and duodenal ulcers in the treatment guidelines of Ghana has resulted in many generics being introduced onto the market. The pharmaceutical quality of fifteen randomly sampled Omeprazole capsule brands in the Kumasi metropolis was assessed using the innovator brand as a comparator to confirm their suitability for patient use and to provide data for drug regulatory agencies in Ghana concerning poor quality omeprazole brands. All the sampled brands complied with the official specifications for identification with good primary and secondary packaging characteristics. Ninety-four (94%) of the sampled brands passed the uniformity of weight test. All the brands (n = 16) representing 100% passed the disintegration tests. Sixty percent (60%) of the sampled brands passed the drug content test. Ten brands (66.7%) met the specification for in vitro dissolution test. From f2 analysis, the dissolution profiles of only five brands (31%) were similar to that of the reference brand which indicated that they could be used interchangeably in clinical practice. Conclusively, ten out of the fifteen sampled brands were of good quality and only five could be used as a substitute for the innovator. Thus, regulatory agencies will need to strengthen their postmarket surveillance to ensure that generic brands of good quality are allowed onto the market.

As testing for infectious diseases moves from manual, biological testing such as complement fixation to high throughput automated autoanalyzer, the methods for controlling these assays have also changed to reflect those used in clinical chemistry. However, there are many differences between infectious disease serology and clinical chemistry testing, and these differences have not been considered when applying traditional quality control methods to serology. Infectious disease serology, which is highly regulated, detects antibodies of varying classes and to multiple and different antigens that change according to the organisms’ genotype/serotype and stage of disease. Although the tests report a numerical value (usually signal to cut-off), they are not measuring an amount of antibodies, but the intensity of binding within the test system. All serology assays experience lot-to-lot variation, making the use of quality control methods used in clinical chemistry inappropriate. In many jurisdictions, the use of the manufacturer-provided kit controls is mandatory to validate the test run. Use of third-party controls, which are highly recommended by ISO 15189 and the World Health Organization, must be manufactured in a manner whereby they have minimal lot-to-lot variation and at a level where they detect exceptional variation. This paper outlines the differences between clinical chemistry and infectious disease serology and offers a range of recommendations when addressing the quality control of infectious disease serology.

To analyze quality control in urodynamic studies, using a proportion control chart (p-chart) for statistical process control.This single-center study was conducted at the Urodynamic Center of West China Hospital, Sichuan University. We randomly selected 15 samples from each month in 2020, and 180 urodynamic traces were finally enrolled. We used the p-chart of statistical process control for analysis. We calculated the proportion of the incidence of a selected set of artefacts in the monthly urodynamic study process, including non-standard zero setting, no cough test, incomplete records of all measurements by urodynamicists, catheter displacement, and baseline drift. Through the specific calculation formula of statistical process control, we obtained the values of the center line, lower control limit, and upper control limit.All data points of each artefact were within zone A. However, one outlier was found in the p-chart of all artefacts in October, which might have been caused by inexperienced operators.Statistical process control may play an important role in the process control of urodynamic studies and guide us in identifying the cause of poor quality in process management.

The top-down (TD) approach using internal quality control (IQC) data is regarded a practical method for estimating measurement uncertainty (MU) in clinical laboratories. We estimated the MU of 14 clinical chemistry analytes using the TD approach and evaluated the effect of lot changes on the MU.MU values were estimated using subgrouping by reagent lot changes or using the data as a whole, and both methods were compared. Reagent lot change was simulated using randomly generated data, and the mean values and MU for two IQC datasets (different QC material lots) were compared using statistical methods.All MU values calculated using subgrouping were lower than the total values; however, the average differences were minimal. The simulation showed that the greater the increase in the extent of the average shift, the larger the difference in MU. In IQC data comparison, the mean values and MU exhibited statistically significant differences for most analytes. The MU calculation methods gave rise to minimal differences, suggesting that IQC data in clinical laboratories show no significant shift. However, the simulation results demonstrated that notable differences in the MU can arise from significant variations in IQC results before and after a reagent lot change. Additionally, IQC material lots should be treated separately when IQC data are collected for MU estimation.Lot changes in IQC data are a key factor affecting MU estimation and should not be overlooked during MU estimation.

Background: Determination of the radiochemical purity of [99mTc]NANOCIS® was performed using the procedure described in the Summary of Product Characteristics (SPC). In contrast to the clinical findings of thyroid gland accumulation indicating free [99mTc] pertechnetate, the QC results showed no free [99mTc]pertechnetate. This discrepancy prompted us to further investigate the described QC procedure. The aim of our study is to develop a correct QC procedure for [99mTc]NANOCIS®. Method and materials: After 99mTc-labelling performed in accordance with the SPC, QC was performed on two stationary phases (Whatman No. 1 and ITLC-SA) with both wet and dry application spots. Results: All QC samples prepared using the method described in the SPC (Whatman No. 1 with dry application spot) indicated an acceptable labelling with a radiochemical purity over 99 %. The QC methods performed using non-SPC described methods (Whatman No. 1 with wet application spot, ITLC-SA with wet and dry application spot), show more impurities, resulting in radiochemical purity ranging between 68 % and 99 %. All results from the three QC procedures not outlined in the SPC resulted in comparable results. When comparing the QC results with imaging of the thyroid gland, if the correct TLC method is used, a clear connection was observed between low radiochemical purity, as a result of free [99mTc]pertechnetate present in the prepared radiopharmaceutical, and visualisation of the thyroid gland, due to thyroid uptake of the free [99mTc]pertechnetate. Conclusion: Drying the application spot on Whatman No. 1 paper indicates erroneous high labelling. To obtain a correct QC result, either an analytical method using Whatman No. 1 papers without drying of the application spot or a method using instant thin layer chromatography with a silica acid coating (ITLC-SA) should be used.

Article presents the general assumptions and the mechanical design of the new device for measuring the friction torque of rolling bearings, as well as preliminary evaluation of the indications on the basis of which further detailed analyses and corrections of the prototype will be made. The device presented in the manuscript is dedicated to quality control as part of its support for rolling bearing plants.

The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have been published, there is no industry standard established that is based on empirical data or that has a justifiable scientific rationale. This article provides a review of the scientific literature in the public domain and most importantly, a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry. Using this information we recommend a best practice for the lyophilizer leak rate test which includes detailing necessary preparation activities following Steam-In-Place (SIP) sterilization, defining a period of stabilization to eliminate pressure and temperature fluctuations and details of the test conditions and the test period. We conclude that for routine manufacturing practice the operational leak rate should not exceed 20 µbar L/s and we provide additional guidance for large volume and older lyophilisation equipment.

RNA-based products have emerged as one of the most promising and strategic technologies for global vaccination, infectious disease control, and future therapy development. The assessment of critical quality attributes (CQAs), product-process interactions, relevant process analytical technologies, and process modeling capabilities can feed into a robust Quality by Design (QbD) framework for future development, design, and control of manufacturing processes. QbD implementation will help the RNA technology reach its full potential and will be central to the development, pre-qualification, and regulatory approval of rapid response, disease-agnostic RNA platform production processes.

Enterprises request the product they produce in a competitive environment to be constantly demanded. One of the most important factors in the continuous demand for the produced product is that it is a quality product. It is the quality control throughout the production process in order to have the desired quality product. The main purpose of Quality Control is to identify and prevent production defects and to produce standard goods. Quality control is important in the industry, as well as in natural stone production. Especially the measurable characteristics of the tiles produced in natural stone factories, such as thickness, width, length, square and surface properties, are the first thing that the customer pays attention to. The tile features that cannot be measured but important in terms of quality are corner cracks, surface filling gaps and defects caused by edge processing features. In the marble processing factory, after the semi-finished product produced in each operation, measurement control, vein-crack-fracture and color homogeneity control should be performed before the next operation. It is important in terms of establishing the quality standards of the final products offered to the customer in the marble sector and ensuring the continuity in quality. Quality control studies should be carried out at certain stages in slabs and tiles in marble factories. In this study,beige marble tiles of 30,5x30,5x1,25 cm sizes taken as an example from the tile production line of a marble factory in Isparta are marbles coming out of the same production line, which shows the quality characteristic of stone in general. After measuring the measurable characteristics of the samples taken such as width, height, thickness, miter and surface brightness, Shewhart control graphs were applied to these obtained data. As a result of X-S control graphs, some deviations in production have been observed. In the marble sector, which is important in terms of customer satisfaction, the reasons should be investigated taking into account these deviations in quality control, customer satisfaction should be brought to the maximum level., İşletmeler, rekabet ortamında ürettikleri ürünün devamlı talep edilmesini isterler. Üretilen ürünün devamlı talep görmesindeki en önemli unsurlardan biri de kaliteli ürün olmasıdır. İstenilen kalitede ürün olması için de üretim süreci boyunca kalite kontrol olmasıdır. Kalite kontrol’ün temel amacı, üretim kusurlarının belirlenip önlenmesi ve standart mal üretilmesidir. Endüstride kalite kontrol önemli olduğu gibi doğaltaş üretimlerinde de kalite kontrol önemli olmaktadır. Özellikle doğaltaş fabrikalarında üretilen fayansların ölçülebilir karakteristikleri olan kalınlıkları, eni, boyu, gönyesi ve yüzey özelliği müşterinin ilk etap da dikkat ettiği kısımdır. Ölçülemeyen fakat kalite açısından önemli olan fayans özellikleri ise, köşe kırığı, yüzey dolgu boşlukları ve kenar işleme özelliklerinden kaynaklanan kusurlardır. Mermer işleme tesisinde, her operasyonda üretilen yarı mamulden sonra ölçü kontrolünün, damar-çatlak-kırık ve renk homojenliği kontrolünün, bir sonraki işlemden önce yapılması gerekmektedir. Mermer sektöründe müşteriye sunulan nihai ürünlerin kalite standartlarının oluşturulması ve kalitedeki sürekliliğin sağlanması önemlidir. Mermer fabrikalarında levha ve fayanslara belirli aşamalarda kalite kontrol çalışmaları yapılmalıdır. Bu çalışmada Isparta’da bulunan bir mermer fabrikasının fayans üretim hattından örnek olarak alınan 30,5x30,5x1,25 cm boyutlarındaki bej mermer fayanslar, genel olarak taşın kalite karakteristiğini ortaya koyan, aynı üretim hattından çıkan mermerlerdir. Alınan örneklerin en, boy, kalınlık, gönye ve yüzey parlaklığı gibi ölçülebilir karakteristikleri ölçüldükten sonra, elde edilen verilere Shewhart kontrol grafikleri uygulanmıştır. X-S kontrol grafikleri sonucunda üretimde bazı sapmaların olduğu gözlemlenmiştir. Müşteri memnuniyeti açısından önemli olan mermer sektöründe, kalite kontrolde yaşanan bu sapmalar göz önünde bulundurarak nedenleri araştırılmalı, müşteri memnuniyeti maksimum düzeye getirilmelidir.

It has long been known that biological species can be identified from mass spectrometry data alone. Ten years ago, we described a method and software tool, compareMS2, for calculating a distance between sets of tandem mass spectra, as routinely collected in proteomics. This method has seen use in species identification and mixture characterization in food and feed products, as well as other applications. Here, we present the first major update of this software, including a new metric, a graphical user interface and additional functionality. The data have been deposited to ProteomeXchange with dataset identifier PXD034932.

IntroductionTo ensure the quality of the new-born screening (NBS), our laboratory reviewed the analytical procedure to detect subjective steps that may represent a risk to the patient. Two subjective activities were identified in the extra-analytical phases: the classification of dried blood spots (DBS) according to their quality and the assignment of haemoglobin patterns. To keep these activities under control, inter-rater studies were implemented. This study aimed to evaluate the inter-rater reliability and the effectiveness of the measures taken to improve the agreement between observers, to assure NBS results’ quality. Materials and methodsDried blood spots specimens were used for the inter-rater studies. Ten studies were performed to assess DBS quality classification, and four to assess the assignment of haemoglobin patterns. Krippendorff’s alpha test was used to estimate inter-rater reliability. Causes were investigated when alpha values were below 0.80. ResultsFor both activities, the reliability obtained in the first studies was inadequate. After investigation, we detected that the criterion to classify a DBS as scant was not consolidated, and also a lack of consensus on whether or not to report Bart’s haemoglobin depending on its percentage. Alpha estimates became higher once the training was reinforced and a consensus about the appropriate criteria to be applied was reached. ConclusionInter-rater reliability assessment helped us to ensure the quality of subjective activities that could add variability to NBS results. Furthermore, the evolution of the alpha value over time allowed us to verify the effectiveness of the measures adopted.

Critical quality control on the determination of boron using ICP-EOS with gravimetric method is carried out. This study was conducted to examine the critical aspects which include linearity, LOD, LOQ, precision, and accuracy. Based on the results of the study showed that the determination of boron with the ICP-OES method was following the critical aspects of quality control test results. The linearity of the calibration curve with a concentration range of 0 - 10 mg/L has linearity with a correlation coefficient of 0.9998 and a determination coefficient of 0.9996. The standard solution calibration curve follows the linear regression equation y = 2567.5 x + 23.043. This method has a LOD of 1.24 mg/L and a LOQ of 4.13 mg/L. The ICP-OES method has high precision and accuracy at low, medium, and high concentration levels. The testing precision of low, medium and high concentration levels is 0.44, 0.54, and 0.14%. The accuracy obtained for the three concentration levels was 98.03, 95.05, and 98.61%. Based on the ANOVA test, it was shown that the precision and accuracy at all concentration levels were not significantly different.

The total lignans from Fructus arctii (TLFA) is a mixture of a series of lignans isolated from dried ripe fruit of Arctium lappa L. We previously reported on the pharmacological activity of TLFA that is related to diabetes. An accurate and practical TLFA quantitative analysis method for utilising it needs to be established.This study aimed to develop an effective quantitative analysis method for assessing the TLFA quality.A total of 11 marker components were confirmed by analysing the high-performance liquid chromatography fingerprints of 24 batches of TLFA samples. The samples were prepared from TLFA and structurally identified as lappaol H, lappaol C, arctiin, arctignan D, arctignan E, matairesinol, arctignan G, isolappaol A, lappaol A, arctigenin, and lappaol F. In the quantitative analysis of multi-components by the single-marker (QAMS) method and with arctiin as an internal reference substance, the content of these lignans in TLFA was simultaneously determined according to their relative correction factors with arctiin.There was no significant difference between results measured by the QAMS and traditional external standard methods. Hierarchical cluster and principal component analyses were performed to evaluate 24 TLFA batches based on the contents of 10 marker components. The results revealed that QAMS method combined with chemometric analyses could accurately measure and clearly distinguish the different quality samples of TLFA.The QAMS method is a reliable and promising quality control method for TLFA. It can provide a reference for promoting quality control of complex multi-component systems, especially for traditional Chinese medicine.

According to the current food legislation in Bulgaria the dried herbs are classified under the large group of food supplements and their trade is allowed in pharmacies, drugstores and grocery stores. The aim of this study is to assess the morphological pharmacognostic characteristics of the content and the additional information on the labels of food supplements containing dried herbs in Bulgaria, in the light of key standard and regulatory documents related to the quality of herbal substances and food supplements. 91 herbal substances of 10 main groups were studied, which included 103 commercial products from 8 companies. The authenticity of the herbal substances was confirmed with macro-and microscopic tests. The macroscopic morphological indicators which were used as elements of trade-commodity analysis were changes in color, presence of other parts of the same or different plants, organic and mineral impurities, evidences of diseases and pest infestations. The phenological phase in which the herbal substances had been collected was determined also. We found that very small part of the studied products meet the standards for all of the selected criteria according to the considered documents which implies the need of strengthening control.

Biomedical science is rapidly developing in terms of more transparency, openness and reproducibility of scientific publications. This is even more important for all studies that are based on results from basic semen examination. Recently two concordant documents have been published: the 6th edition of the WHO Laboratory Manual for the Examination and Processing of Human Semen, and the International Standard ISO 23162:2021. With these tools, we propose that authors should be instructed to follow these laboratory methods in order to publish studies in peer-reviewed journals, preferable by using a checklist as suggested in an Appendix to this article.

The influence of rolling bearing contamination on the level of generated vibrations is ignored in many cases. The influence is clearly visible in the theoretical and experimental works on the mathematical modelling of rolling bearing vibration. The authors of the most recent works in this field use substantial simplifications, often ignoring the presence of solid particles between the rolling bearing mating surfaces. However, bearing in mind the continuous improvement of the rolling bearings production processes, a series of exploratory tests in industrial conditions should be carried out, taking into account the factors affecting the bearing vibrations that are crucial in terms of quality control of the manufactured bearings. The analysis presented in this paper show that the cleanliness of the bearings is a critical factor that determines whether the rolling bearings meet quality requirements.

Specifications for durability that are based on performance tests on concrete during the early stages of construction are finding acceptance throughout the world. In South Africa the durability index (DI) approach has been accepted into local specifications. This raises a challenge in the design of a concrete mixture for a construction project that takes account of the variability in materials and test conditions to ensure that the concrete will achieve the specification requirements when subjected to DI testing on in-situ samples. This paper proposes a statistical approach to accounting for this variability in concrete mixture design with oxygen permeability index (OPI) testing, in a manner that acknowledges the variability of both laboratory-based and in-situ sample testing for compliance. The OPI test results obtained on nominally similar concretes on actual construction projects undertaken by the South African National Roads Agency Limited (SANRAL), which included the DI-based specifications, were used to illustrate the operation of the proposed approach. The results show that the target value of OPI to be achieved in the design of concrete mixtures is influenced by the level of quality control on construction sites but that this can be managed through an appropriate statistical approach.

Ground Truth Data is data that comes from a known source, where the truth about the data is known and not inferred (FSR, 2021). The Forensic Science Regulator requires forensic units (that carry out certain forensic processes) to undertake tests against ground truth data for the purposes of quality assurance/quality control processes such as accreditation. However, the data collected must form a meaningful dataset that will enable relevant tests to be performed that inform the end-user. This technical note discusses how a forensic unit in the UK planned and developed a method for collecting ground truth data for footwear mark evidence. It discusses the materials and variables that were considered when developing the method and the evidence-based, decision-making processes that enabled its creation. Recommendations and considerations are provided to assist other forensic units collect data relevant to their jurisdiction. Whilst the method is not prescriptive, if it is used as a guide, it may facilitate the development of a large and relevant national dataset.

BACKGROUND: This project is the first formal usability review of the hybrid electronic medical registry (HEMR) since its implementation in 2012 METHODS: A synchronous usability evaluation by novice operators was followed by a survey of veteran users. The usability evaluation was done by moderated think-aloud interview while completing tasks for a mock patient. The veteran survey was paper-based and focused on satisfaction of the system RESULTS: A total of 141 comments on system errors were identified by the novice doctors. These consisted of 123 unique problems, of which three were hardware faults and were thus excluded. The identified issues were categorised into errors of control (27%), minimalist (21%), error (17%), match (13%), flexibility, visibility and consistency (9% each), and history (4%). Every unique usability violation was evaluated by the three experts who agreed that 82 of the 141 errors (58%) were valid and applicable. The other 59 items were rejected, not only because of the inability to reproduce some errors or programme shortcomings, but also because a series of "hurdles" were purposely included in the software to decrease cognitive dissonance and reduce error by the users. The survey of veteran users showed high levels of contentment with the system with regards to efficiency, satisfaction and preference CONCLUSION: Despite many usability complaints by novices, almost half of them were rejected. Although usability in electronic health systems is important, it can often be sacrificed for more imperative aims such as safety, error filtering and clinical decision support

This study sets out to investigate the utility of exponentially weighted moving average (EWMA) as patient-based real-time quality control (PBRTQC) by conducting a simulation study and subsequent real-patient data implementation to determine optimal EWMA features (weighting factors, control limits, and truncation methods) based on the Youden index.A simulation experiment was conducted in the first stage to investigate optimal EWMA features for the tests, including aspartate aminotransferase, blood urea nitrogen, and glucose, calcium, creatinine, potassium, sodium, triglycerides, thyroid - stimulating hormone (TSH), and vitamin B12 tests. In the second stage of the study, EWMA was applied to real patient data to elucidate practical utility and achieve final optimal EWMA features. Different degrees of systematic errors (SE) including total allowable error (TEa) as a maximum error level were added to both simulation and patient results, and then the EWMA performance was assessed for different EWMA features. We calculated Youden's index for each combination of EWMA features to find their optimal features to achieve minimum false positive rate (FPR) and maximum error detection rate at the SE level corresponding to TEa.EWMA implementation on real patient data revealed optimal EWMA features for each test. FPR values of creatinine and glucose were 18.48% and 10.17%, respectively, which exceeded the acceptable criteria for FPR (10%). The remaining six analytes showed acceptable FPR.We showed the implementation of EWMA as PBRTQC, and optimization of its features based on the Youden index by conducting extensive performance evaluations and simulations in this study.

Inhibition of chaperone-mediated autophagy (CMA), a selective type of lysosomal degradation for intracellular proteins, may contribute to pathogenesis in neurodegenerative diseases including Parkinson disease (PD). Pathogenic variants of PD-related proteins that reside in the cytosol, including SNCA/alpha-synuclein, LRRK2 (leucine rich repeat kinase 2), UCHL1 (ubiquitin Cterminal hydrolase 1) and VPS35 (VPS35 retromer complex component), exert inhibitory effects on CMA. Decreased CMA activity has also been reported in sporadic PD patients, consistent with an association between CMA inhibition and PD. We have now reported the first example of CMA dysfunction caused by a non-cytosolic PD-related protein, GBA/β-glucocerebrosidase, the most common genetic risk factor for PD, which uncovers a new role for CMA in endoplasmic reticulum (ER) quality control.

Lithium metal battery (LMB) has the potential to be the next-generation battery system because of its high theoretical energy density. However, defects known as dendrites are formed by heterogeneous lithium (Li) plating, which hinders the development and utilization of LMBs. Non-destructive techniques to observe the dendrite morphology often use X-ray computed tomography (XCT) to provide cross-sectional views. To retrieve three-dimensional structures inside a battery, image segmentation becomes essential to quantitatively analyze XCT images. This work proposes a new semantic segmentation approach using a transformer-based neural network called TransforCNN that is capable of segmenting out dendrites from XCT data. In addition, we compare the performance of the proposed TransforCNN with three other algorithms, U-Net, Y-Net, and E-Net, consisting of an ensemble network model for XCT analysis. Our results show the advantages of using TransforCNN when evaluating over-segmentation metrics, such as mean intersection over union (mIoU) and mean Dice similarity coefficient (mDSC), as well as through several qualitatively comparative visualizations.

Recombinant adeno-associated virus virus-derived vectors (rAAVs) are among the most used viral delivery system for in vivo gene therapies with a good safety profile. However, rAAV production methods often lead to a heterogeneous vector population, in particular with the presence of undesired empty particles. Analytical ultracentrifugation sedimentation velocity (AUC-SV) is considered as the gold analytical technique allowing the measurement of relative amounts of each vector subpopulation and components like particle aggregates, based on their sedimentation coefficients. This letter presents the principle and practice of AUC experiments for rAAVs characterization. We discuss our results in the framework of previously published works. In addition to classical detection at 260 nm, using interference optics in the ultracentrifuge can provide an independent estimate of weight percentages of the different populations of capsids, and of the genome size incorporated in rAAV particles.

Purpose: Automated treatment planning strategies are being widely implemented in clinical routines to reduce inter-planner variability, speed up the optimization process, and improve plan quality. This study aims to evaluate the feasibility and quality of intensity-modulated proton therapy (IMPT) plans generated with four different knowledge-based planning (KBP) pipelines fully integrated into a commercial treatment planning system (TPS). Materials/Methods: A data set containing 60 oropharyngeal cancer patients was split into 11 folds, each containing 47 patients for training, five patients for validation, and five patients for testing. A dose prediction model was trained on each of the folds, resulting in a total of 11 models. Three patients were left out in order to assess if the differences introduced between models were significant. From voxel-based dose predictions, we analyze the two steps that follow the dose prediction: post-processing of the predicted dose and dose mimicking (DM). We focused on the effect of post-processing (PP) or no post-processing (NPP) combined with two different DM algorithms for optimization: the one available in the commercial TPS RayStation (RSM) and a simpler isodose-based mimicking (IBM). Using 55 test patients (five test patients for each model), we evaluated the quality and robustness of the plans generated by the four proposed KBP pipelines (PP-RSM, PP-IBM, NPP-RSM, NPP-IBM). After robust evaluation, dose-volume histogram (DVH) metrics in nominal and worst-case scenarios were compared to those of the manually generated plans. Results: Nominal doses from the four KBP pipelines showed promising results achieving comparable target coverage and improved dose to organs at risk (OARs) compared to the manual plans. However, too optimistic post-processing applied to the dose prediction (i.e. important decrease of the dose to the organs) compromised the robustness of the plans. Even though RSM seemed to partially compensate for the lack of robustness in the PP plans, still 65% of the patients did not achieve the expected robustness levels. NPP-RSM plans seemed to achieve the best trade-off between robustness and OAR sparing. Discussion/Conclusions: PP and DM strategies are crucial steps to generate acceptable robust and deliverable IMPT plans from ML-predicted doses. Before the clinical implementation of any KBP pipeline, the PP and DM parameters predefined by the commercial TPS need to be modified accordingly with a comprehensive feedback loop in which the robustness of the final dose calculations is evaluated. With the right choice of PP and DM parameters, KBP strategies have the potential to generate IMPT plans within clinically acceptable levels comparable to plans manually generated by dosimetrists. © 2023 American Association of Physicists in Medicine.

The ICOS Central Analytical Laboratories (CALs) play a central role in assuring the accuracy of atmospheric observations within ICOS. This involves the central provision of reference gases to the ICOS atmospheric network and calibrating these standards based on the World Meteorological Organization (WMO) calibration scales. A quality control strategy for the ICOS atmospheric measurements has been described within the Atmospheric Station Specification document [ATC 2020]. In this report the quality control measures are described that are made by the ICOS-CAL Flask and Calibration Laboratory (FCL) to characterize the performance of their calibration of ICOS reference gases. It updates and replaces the QC 2020 report following the same assessment scheme with only minor changes and some few corrections. The results of these activities of the recent years are presented in detail for each of the ICOS core components for in-situ observations (CO2, CH4, CO) and N2O. The results are then assessed and used to substantiate estimates of the measurement uncertainties of the different tracers and to quantify different uncertainty contributions. This involves an evaluation of the uncertainty of the reference values of calibration standard gases ("scale link uncertainty") and the measurement uncertainty related to the respective analyzer’s precision or response stability over time. Based on further evidence obtained in 2022 the assumption of a Primary Standard gas set with stable CO2 appears justified. This report is a deliverable (D7) of Annex 2 to the Cooperation Agreement between ICOS ERIC and the Max-Planck-Society that is the host organization for the ICOS Flask and Calibration Laboratory (FCL).

Traditional peer review is undergoing increasing questioning, given the increase in scientific fraud detected and the replication crisis biomedical research is currently going through. Researchers, academic institutions, and research funding agencies actively promote scientific record analysis, and multiple tools have been developed to achieve this. Different biomedical journals were founded with post-publication peer review as a feature, and there are several digital platforms that make this process possible. In addition, an increasing number biomedical journals allow commenting on articles published on their websites, which is also possible in preprint repositories. Moreover, publishing houses and researchers are largely using social networks for the dissemination and discussion of articles, which sometimes culminates in refutations and retractions. La revision por pares tradicional atraviesa por crecientes cuestionamientos, dado el aumento en el fraude cientifico detectado y la crisis de replicacion que recientemente se ha presentado en la investigacion biomedica. Investigadores, instituciones academicas y agencias de financiamiento activamente promueven el analisis del registro cientifico y se han desarrollado multiples herramientas para lograrlo. Diferentes revistas biomedicas se fundaron con la revision por pares pospublicacion como caracteristica; existen varias plataformas digitales que hacen posible este proceso. Asimismo, cada vez hay mas revistas biomedicas que permiten comentar articulos publicados en sus sitios web, lo cual tambien es posible en repositorios de preimpresiones. Sumado a esto, las casas editoriales y los investigadores estan usando ampliamente las redes sociales para la difusion y discusion de articulos, lo cual a veces culmina en refutaciones y retracciones.

[ES] ¿Cuántas veces hemos realizado o participado en una repoblación forestal y pasados los años no hemos encontrado rastro de los árboles plantados? Y en muchas ocasiones nos habremos preguntado por qué e incluso sentido frustración de creer que no lo hemos cuidado adecuadamente. La respuesta no es sencilla como veremos en este trabajo. En las últimas décadas, las repoblaciones forestales o reforestaciones, enmarcadas dentro de planes de restauración, han experimentado altas tasas de mortalidad, sobre todo en nuestro ámbito mediterráneo donde predominan las tierras secas. Esta tasa alta de mortalidad en numerosas ocasiones se relaciona con las condiciones meteorológicas, pero existen multitud de aspectos que pueden influir en alcanzar o no el objetivo final de la repoblación. Para poder conocer cuáles son los aspectos que influyen en mayor o menor medida en la supervivencia y crecimiento adecuado de las plántulas puedas en campo, se plantea la puesta en marcha de un protocolo de control holístico o integral de repoblaciones y el estudio y seguimiento de la puesta en práctica en una repoblación real durante 10 años. El control de calidad en sí mismo se ha contemplado sobre las distintas fases de la repoblación: desde la revisión de las decisiones tomadas en proyecto, pasando por la ejecución en obra, la evaluación de los lotes de planta empleados, la caracterización de sitio o estación, hasta la realización del seguimiento climatológico, ambiental y de la propia repoblación (en términos de supervivencia y crecimiento). En base a distintos planteamientos experimentales y de toma de muestras dentro de una repoblación real, en condiciones cambiantes y con sequias extremas, se ha podido estudiar pormenorizadamente la calidad de planta o stock y la idoneidad de las especies utilizadas (Pinus sp., Quercus sp., Arbutus Unedo, Juniperus phoenicea y Fraxinus ornus) para posteriormente evaluar la repoblación tras 10 años en conjunto y por tanto, los demás aspectos y sus interacciones que influyen en el establecimiento, como: la calidad de ejecución, la calidad de sitio o estación, la idoneidad del tubo protector, etc. A grandes rasgos, los resultados tanto en las parcela experimental como en la repoblación, siendo en ellas las condiciones meteorológicas las mismas, no ha sido muy satisfactoria tras los 10 años. Al margen de conocer que las sequias extremas acontecidas han tenido gran influencia e interaccionan demás factores (acrecentando los efectos negativos), se ha podido evaluar que existen especies de dudosa idoneidad para determinados sitios; que la correcta ejecución juega un papel importante; que se requiere de una mejor zonificación; y que cuidados culturales post plantación como el tubo protector, pueden influir notablemente en la consecución de la repoblación. Así, además de identificar cuáles son los aspectos más influyentes en esta repoblación en particular, se han adquirido cuestiones prácticas tanto a la hora de aplicar el control de calidad como a la hora de como plantearnos, desde la redacción del proyecto, las nuevas repoblaciones, teniendo muy en cuenta el nuevo contexto de cambio climático., [CAT] Quantes vegades hem realitzat o participat en una repoblació forestal i passats els anys no hem trobat cap rastre dels arbres plantats? I moltes vegades ens haurem preguntat per què i fins i tot, sentit frustració de creure que els hem cuidat adequadament. La resposta no és senzilla com veurem en aquest treball. En les darreres dècades, les repoblacions forestals o reforestacions, emmarcades dins de plans de restauració, han experimentat altes taxes de mortalitat, sobretot al nostre àmbit mediterrani on predominen les zones àrides. Aquesta taxa alta de mortalitat normalment es relaciona amb les condicions meteorològiques, però hi ha multitud d'aspectes que poden influir en assolir o no l'objectiu final de la repoblació. Per poder conèixer quins són els aspectes que influeixen en major o menor mesura en la supervivència i el creixement adequat de les plàntules posades camp, es fica en marxa un protocol de control holístic o integral de repoblacions, i l'estudi i el seguiment de la posada en pràctica en una repoblació real durant 10 anys. El control de qualitat en si mateix s'ha contemplat sobre les diferents fases de la repoblació: des de la revisió de les decisions preses en projecte, passant per l'execució en l'obra, l'avaluació dels lots de planta emprats, la caracterització de lloc o estació, fins a la realització del seguiment climatològic, ambiental i de la pròpia repoblació (en termes de supervivència i creixement). En base a diferents plantejaments experimentals i de presa de mostres dins una repoblació real, en condicions canviants i amb sequeres extremes, s'ha pogut estudiar detalladament la qualitat de planta i la idoneïtat de les espècies utilitzades (Pinus sp., Quercus sp., Arbutus Unedo, Juniperus phoenicea i Fraxinus ornus) per posteriorment avaluar la repoblació després de 10 anys en conjunt i per tant, els altres aspectes i les seves interaccions que influeixen en l'establiment, com ara: la qualitat d'execució, la qualitat de lloc o estació, la idoneïtat del tub protector, etc. A grans trets, els resultats tant a les parcel·les experimentals com a la repoblació, sent en elles les condicions meteorològiques les mateixes, no ha estat gaire satisfactòria després dels 10 anys. Al marge de saber que les sequeres extremes esdevingudes han tingut gran influència i interaccionen altres factors (augmentant els efectes negatius), s'ha pogut avaluar que hi ha espècies de dubtosa idoneïtat per a determinats llocs; que la correcta execució juga un paper important; que es requereix una millor zonificació; i que els tractaments culturals postplantació com el tub protector, poden influir notablement en la consecució de la repoblació. Així, a mes a més de conèixer quins són els aspectes més influents en aquesta repoblació en particular, s'han adquirit qüestions pràctiques tant a l'hora d'aplicar el control de qualitat com a l'hora de plantejar-nos, des de la redacció del projecte, les noves repoblacions, tenint molt en compte el nou context de canvi climàtic., [EN] How many times have we carried out or participated in a reforestation and over the years we have not found a trace of the planted trees? On many occasions, we will have wondered why and even felt frustrated to believe that we have not taken care of it properly. The answer is not simple as we will see in this work. In recent decades reforestations, framed within restoration plans, have experienced high mortality rates, especially in our Mediterranean area where drylands predominate. This high mortality rate is often related to weather conditions, but there are many aspects that can influence the final objective of the reforestation. In order to know which are the aspects that influence the survival and adequate growth of seedlings in the field, the implementation of a holistic control protocol for reforestation is proposed, as well as the study and monitoring of the put into practice in a real reforestation for 10 years. The quality control itself has been contemplated on the different phases of the reforestation: from the review of the decisions taken in the project, through the execution on site, the evaluation of the stock quality of plant used, the site characterization, until climatological, environmental and reforestation monitoring (in terms of survival and growth). Based on different experimental approaches and sampling within a real reforestation, with changing conditions and extreme droughts, it has been possible to study in detail the quality of the plant and the suitability of the species used (Pinus sp., Quercus sp., Arbutus Unedo, Juniperus phoenicea and Fraxinus ornus). Then has been evaluated the repopulation after 10 years as a whole, knowing the other aspects and their interactions that influence the establishment, such as: the quality of execution, the site quality, the suitability of shelter tube, etc. Broadly speaking, the results in the experimental plot and in the reforestation, being the same the weather conditions, have not been very satisfactory after 10 years. Apart from knowing that the extreme droughts that have occurred have had a great influence and their interactions with other factors (increasing the negative effects), it has been possible to evaluate that there are species of doubtful suitability for certain site conditions; that correct execution plays an important role; that better zoning is required; and post-planting cultural treatment, such as the protective tube, can significantly influence the establishment of reforestation. Thus, apart from identify which are the most influential aspects in this particular reforestation, practical questions have been acquired when applying quality control from the project drafting of the new reforestations taking into account the new context, the climate change.

AI and Optical Data Sciences IV; Paper 12438-50 The power of artificial neural networks to determine the quality and properties of olive oil was proven by several studies in the last years. Less clear is, however, how the neural network is able to extract useful information from the input data. This work investigates the learning mechanism of one-dimensional convolutional neural networks (1D-CNNs) trained to predict the physicochemical properties of olive oil from single fluorescence spectra. Such a 1D-CNN can successfully predict the parameters relevant to the quality assessment: acidity, peroxide value, and UV absorbance. To go beyond a simple quality assessment algorithm, it is important to identify which spectral features in the measured spectra are correlated with each chemical parameter and therefore with the quality of olive oil. To obtain this information, explainability techniques can be used by studying the latent feature space generated by the intermediate layers of the one-dimensional trained convolutional neural network. This work analyses in detail the common features that are used by the 1D-CNN to predict the two physicochemical parameters: acidity and K232.

Mucopolysaccharidoses (MPSs) are complex lysosomal storage disorders that result in the accumulation of glycosaminoglycans (GAGs) in urine, blood, and tissues. Lysosomal enzymes responsible for GAG degradation are defective in MPSs. GAGs including chondroitin sulfate (CS), dermatan sulfate (DS), heparan sulfate (HS), and keratan sulfate (KS) are disease-specific biomarkers for MPSs. This unit describes a stable isotope dilution-tandem mass spectrometric method for quantifying CS, DS, and HS in urine samples. The GAGs are methanolyzed to uronic or iduronic acid-N-acetylhexosamine or iduronic acid-N-sulfo-glucosamine dimers and mixed with internal standards derived from deuteriomethanolysis of GAG standards. Specific dimers derived from HS, DS, and CS are separated by ultra-performance liquid chromatography (UPLC) and analyzed by electrospray ionization tandem mass spectrometry (MS/MS) using selected reaction monitoring for each targeted GAG product and its corresponding internal standard. This new GAG assay is useful for identifying patients with MPS types I, II, III, VI, and VII.

Objectives Westgard Sigma Rules is a statistical tool available for quality control. Biological variation (BV) can be used to set analytical performance specifications (APS). The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) regularly updates BV data. However, few studies have used robust BV data to determine quality goals and design a quality control strategy for tumor markers. The aim of this study was to derive APS for tumor markers from EFLM BV data and apply Westgard Sigma Rules to establish internal quality control (IQC) rules. Methods Precision was calculated from IQC data, and bias was obtained from the relative deviation of the External quality assurance scheme (EQAS) group mean values and laboratory-measured values. Total allowable error (TEa) was derived using EFLM BV data. After calculating sigma metrics, the IQC strategy for each tumor marker was determined according to Westgard Sigma Rules. Results Sigma metrics achieved for each analyte varied with the level of TEa. Most of these tumor markers except neuron-specific enolase reached 3σ or better based on TEamin. With TEades and TEaopt set as the quality goals, almost all analytes had sigma values below 3. Set TEamin as quality goal, each analyte matched IQC muti rules and numbers of control measurements according to sigma values. Conclusions Quality goals from the EFLM BV database and Westgard Sigma Rules can be used to develop IQC strategy for tumor markers.

The multi-attribute method (MAM) was conceived as a single assay to potentially replace multiple single-attribute assays that have long been used in process development and quality control (QC) for protein therapeutics. MAM is rooted in traditional peptide mapping methods; it leverages mass spectrometry (MS) detection for confident identification and quantitation of many types of protein attributes that may be targeted for monitoring. While MAM has been widely explored across the industry, it has yet to gain a strong foothold within QC laboratories as a replacement method for established orthogonal platforms. Members of the MAM consortium recently undertook an interlaboratory study to evaluate the industry-wide status of MAM. Here we present the results of this study as they pertain to the targeted attribute analytics component of MAM, including investigation into the sources of variability between laboratories and comparison of MAM data to orthogonal methods. These results are made available with an eye toward aiding the community in further optimizing the method to enable its more frequent use in the QC environment.

Even though surgery has remained a key component within multi-disciplinary cancer care, the expectations have changed. Instead of serving as a modality to free a patient of a mass at all means and at the risk of high morbidity, modern cancer surgery is expected to provide adequate tumor clearance with lowest invasiveness. This review summarizes the evidence on quality assurance in surgical oncology and gives a comprehensive overview of quality improvement tools.

Quality assurance and quality control (or QAQC) plays a key role in safeguarding the level of confidence of the data generated during mineral exploration and mine development, and is also part of the reporting code requirements for resource estimation and reporting, as well as mining investment. Implementation of good policies and working protocols in quality management will result in the generation of reliable information, which is critical for decision-making on the future of the mining project. The use of certified reference materials, i.e., standard, blank, and duplicate samples, proves effective and efficient for ensuring the level of data confidence in terms of precision, accuracy, and sample contamination. This is well demonstrated by the practice of QC in the exploration programme for the chrysotile tailings storage facilities of Havelock Mine, using 1254 samples from 53 drill-holes. Different statistical tools were applied to analyse the assay results from these samples. The outcome substantiates that the QC practice established during the Havelock exploration project is aligned to best practice guidelines in the industry. The resource delineated indicates that the tailings material at Havelock could potentially become a significant source of supply to the global magnesium market.