Qualitative and Quantitative Analysis for the Quality Control of Rhizoma Coptidis by HPLC-DAD and HPLC-ESI-MS

For quality control purpose, an approach of fingerprinting and simultaneous quantification of five major bioactive constituents of Rhizoma Coptidis was established via a high-performance liquid chromatograph coupled with a photodiode array UV detector（HPLC-DAD） and an electrospray ionization mass spectrometer（HPLC-ESI/MS） The compounds were identified on the basis of the comparison of their mass spectra with literature data and those of standard samples and quantified by the HPLC-DAD method. Baseline separation was achieved on an XTerra C18 column（5 μm, 250 mm×4.6 mm i. d.） with linear gradient elution of formate buffer（consisting of 0.5% formic acid, adjusted to pH=4.5 with ammonia） and acetonitrile（consisting of 0.2% formic acid and 0.2% triethylamine）. The me- thod was validated for linearity（r^2〉0.9995）, repeatability（RSD〈3.1%）, intra- and inter-day precision（RSD〈1.8%） with recovery（99.9%-105.1%）, limits of detection（0.15-0.35 μg/mL）, and limits of quantification（0.53-0.82 μg/mL）. The similarities of 32 batches of Rhizoma Coptidis and their classification according to their manufacturers were based on the retention time and peak areas of the characteristic compounds. The five compounds were selected for quality assessment ofRhizoma coptidis via partial least squares analysis（PLS）.

QUALITY CONTROL OF SEMICONDUCTOR PACKAGING BASED ON PRINCIPAL COMPONENTS ANALYSIS

5 critical quality characteristics must be controlled in the surface mount and wire-bond process in semiconductor packaging. And these characteristics are correlated with each other. So the principal components analysis（PCA） is used in the analysis of the sample data firstly. And then the process is controlled with hotelling T^2 control chart for the first several principal components which contain sufficient information. Furthermore, a software tool is developed for this kind of problems. And with sample data from a surface mounting device（SMD） process, it is demonstrated that the T^2 control chart with PCA gets the same conclusion as without PCA, but the problem is transformed from high-dimensional one to a lower dimensional one, i.e., from 5 to 2 in this demonstration.

Risk Analysis and Quality Control of Cosmetic Raw Materials

The present situation of cosmetic raw materials has been introduced,mainly including the measures of risk analysis and quality control for cosmetic raw materials.Through the inspection of cosmetic raw materials,the formulation design and development,and the incoming management,the departments in the enterprise have worked together to achieve the risk analysis and quality control of cosmetic raw materials,to ensure the quality and safety of cosmetics.

Seismic Data Quality Control and Interpolation Using Principal Component Analysis

Commonly, seismic data processing procedures, such as stacking and prestack migration, require the ability to detect bad traces/shots and restore or replace them by interpolation, particularly when the seismic observations are noisy or there are malfunctioned components in the recording system. However, currently available trace/shot interpolation methods in the spatial or Fourier domain must deal with requirements such as evenly sampled traces/shots, infinite bandwidth of the signals, and linear seismic events. In this paper, we present a novel method, termed the E-S (eigenspace seismic) method, using principal component analysis (PCA) of the seismic signal to address the issue of reliable detection or interpolation of bad traces/shots. The E-S method assumes the existence of a correlation between the observed seismic entities, such as trace or shot gathers, making it possible to estimate one of these entities from all others for interpolation or seismic quality control. It first transforms a trace (or shot) gather into an eigenspace using PCA. Then in the eigenspace, it treats every trace as a point with its loading scores of PCA as its coordinates. Simple linear, bilinear, or cubic spline 1 dimensional (1D) interpolation is used to determine PCA loading scores for any arbitrary coordinate in the eigenspace, which are then used to construct an interpolated trace for the desired position in physical space. This E-S method works with either regular or irregular sampling and, unlike various other published methods, it is well-suited for band-limited seismic records with curvilinear reflection events. We developed related algorithms and applied these to processed synthetic and offshore seismic survey data with or without simulated noises to demonstrate their performance. By comparing the interpolated and observed seismic traces, we find that the E-S method can effectively assess the quality of the trace, and restore poor quality data by interpolation. The successful processing of synthetic and real data using the E-S method presented in this approach will be widely applicable to seismic trace/shot interpolation and seismic quality control.

Assessing the Awareness and Usage of Quality Control Tools with Emphasis to Statistical Process Control (SPC) in Ethiopian Manufacturing Industries

Introduction: The present work was devoted to assess the awareness and usage of quality control tools with the emphasis on statistical process control in Ethiopian manufacturing industries. Semi structured questionnaire has been employed to executive and technical managers of manufacturing industries of various size and specialism across the country. Stratified random sample method by region was used to select sample industries for the study. The samples used for this study are industries mainly from Oromiya, Addis Ababa, Tigray, Amara, SNNP and Diredawa regions proportional to their size of the available industries. Methods: Exploratory method and descriptive statistics was used for data analysis. Available documents and reports related to quality control policy of the selected companies were investigated. Results and Discussions: The number of manufacturing industries involved in this study was 44. Of the sampled manufacturing industries about 60% are from Oromiya and Addis Ababa regions. It has been reported that 100% of the respondents said that the importance of quality control tools is very important to their organizations’ productivity and quality improvement (Figure 3). Quality control professionals were also asked the extent to which quality control system is working in their industry and majority of the respondents (45%) have indicated that quality control system is working to some extent in their respective industries (Figure 18). Conclusions and Recommendations: Most of the quality department of the industries did not fully recognize the importance of statistical process control as quality control tools. This is mainly due to lack of awareness and motivation of the top managements, shortage of man power in the area, and others together would make it difficult to apply quality control tools in their organization. In general, the industries in Ethiopia are deficient in vigor and found to be stagnant hence less exposed to a highly competitive market and don’t adopt the latest quality control techniques in order to gain knowledge about systems to improve quality and operational performance. We conclude that quality management system has to be established as an independent entity with a real power and hence the quality control department which is responsible for quality can make an irreversible decision with respect to quality of any given product. Moreover, the concerned bodies (government and ministry of industries) should give attention and work together with universities to ensure how these statistical process control techniques could be incorporated in a curriculum of the universities at higher levels in degree and masters programs. Furthermore, different trainings which could improve quality and efficiency of their respective management system should be given as short and long term to the employees including top and middle managers found in various industries relevant to their process.

Quality assurance and quality control in the laboratory andrology

Quality assurance （QA） and quality control （QC） are fundamental aspects of any laboratory measurement. However, in comparison with other medical disciplines, the need for QA and QC in laboratory andrology has been recognized only recently. Furthermore, there is evidence that the effort required to undertake QA and QC has not been wholly welcomed by some clinicians. Nevertheless, accrediting bodies and regulatory authorities increasingly require evidence that laboratories have effective QA and QC measures in place because both are central to the quality management processes. Following the publication of the 5th edition of the World Health Organization Laboratory Manual, existing QA and QC systems will need to be updated to take into account some of the methodological changes recommended by the manual. Three of these are discussed in this commentary; they relate to： （i） the move to infer semen volume from its weight; （ii） the re-classification of sperm motility grades from four to three; and （iii） the publication of a lower reference limit for morphology of 4% （with a corresponding 95% confidence interval of 3%-4%）. The importance of QA and QC in all laboratory tests, including up and coming new tests to assess sperm DNA integrity, is discussed. The need for adequate initial training and continuing professional development programmes to support laboratory scientists performing andrology is also described.

Quality Control on Crimping of Large Diameter Welding Pipe

Crimping is used in production of large diameter submerged-arc welding pipes. Many researches are focused on crimping in certain manufacturing mode of welding pipe. The application scopes of research achievements become limited due to lack of uniformity in theoretical analysis. In order to propose a crimping prediction method in order to control forming quality, the theory model of crimping based on elastic-plastic mechanics is established. The main technical parameters are determined by theoretical analysis, including length of crimping, base radius of punch, terminal angle of punch, base radius of die, terminal angle of die and horizontal distance between punch and die. In addition, a method used to evaluate the forming quality is presented, which investigates the bending angle after springback, forming force, straight edge length and equivalent radius of curvature. In order to investigate the effects of technical parameters on forming quality, a two-dimensional finite element model is established by finite element software ABAQUS. The finite element model is verified in that its shapes error is less than 5% by comparable experiments, which shows that their geometric precision meets demand. The crimping characteristics is obtained, such as the distribution of stress and strain and the changes of forming force, and the relation curves of technical parameters on forming quality are given by simulation analysis. The sensitivity analysis indicates that the effects of length of crimping, technical parameters of punch on forming quality are significant. In particular, the data from simulation analysis are regressed by response surface method （RSM） to establish prediction model. The feasible technical parameters are obtained from the prediction model. This method presented provides a new thought used to design technical parameters of crimping forming and makes a basis for improving crimping forming quality.

Recent advancement of chemical imaging in pharmaceutical quality control:From final product testing to industrial utilization

Chemical imaging(CI)possesses a strong ability of pharmaceutical analysis.Its great strength relies on the integration of traditional spectroscopy(one dimension)and imaging technique(two dimensions)to generate three-dimensional data hypercubes.Data pre-processing or processing methods are proposed to analyze vast data matrixes and thereby realizing different research objectives.In this review paper,various pharmaceutical applications of quality control over the past few years are summed up in two groups of final product test and industrial utilization.The scope of"quality control"here includes traditional analytical use,process understanding and manufactural control.Finally,two major challenges about undesirable sample geometry and lengthy acquisition time are discussed for prospective commercial or industrial application.

Chemical fingerprinting of Su-He-Xiang-Wan and attribution of major characteristic peaks for its quality control by GC-MS

A simple and facile gas chromatography-mass spectrometer （GC-MS） fingerprint of Su-He-Xiang-Wan （SHXW） was developed, the similarity analysis was conducted, and attribution of the major characteristic peaks was identified for SHXW quality control. GC-MS analysis was performed on a QP2010 instrument （Shimadzu, Japan） equipped with a capillary column of RTX-5MS. The column temperature was initiated at 50℃, held for 5 min, increased at the rate of 3 ℃/min to 120 ℃, held for 2 min, and then increased at the rate of 4 ℃/min to 220℃, held for 10 min. Helium carrier gas was used at a constant flow rate of 1.3 mL/min. Mass conditions were ionization voltage, 70 eV; injector temperature, 250℃; ion source temperature, 250 ℃; splitting ratio, 30：1; full scan mode in the 40-500 Da mass ranges with rate of 0.2 s per scan. Attribution of the major characteristic peaks was identified for SHXW by comparing the chemical standards, references of Chinese herbal medicines and the negative controls of prescription samples （NC） of SHXW. With the help of the temperature-programmed retention indices （PTRIs） used together with mass spectra and chemical standards, 25 major characteristic peaks have been identified. Nine volatile medicinal materials were identified in the prescription of SHXW by attributing to the 27 major characteristic peaks. The results demonstrate that the proposed method is a powerful approach to quality control of complex herbal medicines.

Off-Line Quality Control in Bioproducts Processing: A Case Study in Greece

In the present article we study the production of grape molasses. Data drawn from a specified biolaboratory, are properly analyzed in order to detect factors that affect significantly the Brix value and the volatile acidity of the final product. The ground that is used for planting and a variety of grapes have been taken into account. Off-line statistical quality control techniques have been employed and the outcomes are displayed and discussed in detail.

The Role of Blood Station Quality Management System in the Quality Control of Blood Collection

With the continuous development of China’s medical industry in recent years,relevant staff has also paid more attention to the quality management of blood stations,and China has gradually improved during the setting of laws and regulations for blood station quality management.The policies set by the Chinese government have been fully implemented through the reasonable implementation of relevant staff.With the continuous development of China’s medical industry in recent years,relevant staff have also paid more attention to the quality management of blood stations,and China has gradually improved during the setting of laws and regulations for blood station quality management.The policies set by the Chinese government have been fully implemented through the reasonable implementation of relevant staff.On this basis,the management model of the Chinese blood station has been continuously innovated in the application process,and the blood collection work of the Chinese blood station has been greatly developed.However,when the blood station in China is conducting blood collection,its quality control program is still not fully mature.Therefore,in this context,it is necessary to do a good job in the construction of the corresponding blood station quality management system and make effective adjustments,which will give full play to the role of the management system in the quality control process of blood collection.In this paper,the construction plan of the blood station quality management system is analyzed to explore the role of the blood station quality management system in the process of blood collection quality control,aiming to provide assistance for the quality management of blood collection in China.

Evaluation of ICUs and weight of quality control indicators:an exploratory study based on Chinese ICU quality data from 2015 to 2020

This study aimed to explore key quality control factors that affected the prognosis of intensive care unit(ICU)patients in Chinese mainland over six years(2015–2020).The data for this study were from 31 provincial and municipal hospitals(3425 hospital ICUs)and included 2110685 ICU patients,for a total of 27607376 ICU hospitalization days.We found that 15 initially established quality control indicators were good predictors of patient prognosis,including percentage of ICU patients out of all inpatients(%),percentage of ICU bed occupancy of total inpatient bed occupancy(%),percentage of all ICU inpatients with an APACHE II score≥15(%),three-hour(surviving sepsis campaign)SSC bundle compliance(%),six-hour SSC bundle compliance(%),rate of microbe detection before antibiotics(%),percentage of drug deep venous thrombosis(DVT)prophylaxis(%),percentage of unplanned endotracheal extubations(%),percentage of patients reintubated within 48 hours(%),unplanned transfers to the ICU(%),48-h ICU readmission rate(%),ventilator associated pneumonia(VAP)(per 1000 ventilator days),catheter related blood stream infection(CRBSI)(per 1000 catheter days),catheter-associated urinary tract infections(CAUTI)(per 1000 catheter days),in-hospital mortality(%).When exploratory factor analysis was applied,the 15 indicators were divided into 6 core elements that varied in weight regarding quality evaluation:nosocomial infection management(21.35%),compliance with the Surviving Sepsis Campaign guidelines(17.97%),ICU resources(17.46%),airway management(15.53%),prevention of deep-vein thrombosis(14.07%),and severity of patient condition(13.61%).Based on the different weights of the core elements associated with the 15 indicators,we developed an integrated quality scoring system defined as F score=21.35%xnosocomial infection management+17.97%xcompliance with SSC guidelines+17.46%×ICU resources+15.53%×airway management+14.07%×DVT prevention+13.61%×severity of patient condition.This evidence-based quality scoring system will help in assessing the key elements of quality management and establish a foundation for further optimization of the quality control indicator system.

External quality control and training of semen analysis in the Netherlands:starting point for further reduction of outcome variability

Semen analysis is characterized by high levels of intra-and inter-laboratory variability,due to a low level of standardization,high subjectivity of the assessments,and problems with automated procedures.To improve consistency of laboratory results,quality control and training of technicians are important requisites.The goals of this study are to evaluate the results of an external quality control(EQC)program and standardized training by ESHRE Basic Semen Analysis Courses(BSAC)on the variability in manual assessments of semen parameters.We performed retrospective analyses of(1)the interlaboratory variability in the Dutch EQC program and(2)the interobserver variability in BSACs for concentration,motility,and morphology assessments.EQC data showed that the interlaboratory coefficient of variation(CV)for concentration assessment decreased(range from 24.0%–97.5%to 12.7%–20.9%)but not for morphology and motility assessments.Concentration variability was lower if improved Neubauer hemocytometers were used.Morphology assessment showed highest CVs(up to 375.0%),with many outliers in the period of 2007–2014.During BSAC,a significant reduction of interobserver variability could be established for all parameters(P<0.05).The absence of an effect in the EQC program for motility and morphology might be explained by respectively the facts that motility assessment was introduced relatively late in the EQC program(since 2013)and that criteria for morphology assessment changed in time.BSAC results might have been influenced by the pretraining level of participants and the influence of external factors.Both EQC and training show positive effects on reducing variability.Increased willingness by laboratories to change their methods toward standards may lead to further improvements.

AIAP: A Quality Control and Integrative Analysis Package to Improve ATAC-seq Data Analysis

Assay for transposase-accessible chromatin with high-throughput sequencing(ATAC-seq) is a technique widely used to investigate genome-wide chromatin accessibility. The recently published Omni-ATAC-seq protocol substantially improves the signal/noise ratio and reduces the input cell number. High-quality data are critical to ensure accurate analysis.Several tools have been developed for assessing sequencing quality and insertion size distribution for ATAC-seq data;however, key quality control(QC) metrics have not yet been established to accurately determine the quality of ATAC-seq data. Here, we optimized the analysis strategy for ATAC-seq and defined a series of QC metrics for ATAC-seq data,including reads under peak ratio(RUPr), background(BG), promoter enrichment(Pro En), subsampling enrichment(Sub En), and other measurements. We incorporated these QC tests into our recently developed ATAC-seq Integrative Analysis Package(AIAP) to provide a complete ATAC-seq analysis system, including quality assurance, improved peak calling, and downstream differential analysis. We demonstrated a significant improvement of sensitivity(20%–60%) in both peak calling and differential analysis by processing paired-end ATAC-seq datasets using AIAP. AIAP is compiled into Docker/Singularity, and it can be executed by one command line to generate a comprehensive QC report. We used ENCODE ATAC-seq data to benchmark and generate QC recommendations, and developed q ATACViewer for the userfriendly interaction with the QC report. The software, source code, and documentation of AIAP are freely available at https://github.com/Zhang-lab/ATAC-seq_QC_analysis.

Simulation on a Car Interior Aerodynamic Noise Control Based on Statistical Energy Analysis

How to simulate interior aerodynamic noise accurately is an important question of a car interior noise reduction. The unsteady aerodynamic pressure on body surfaces is proved to be the key effect factor of car interior aerodynamic noise control in high frequency on high speed. In this paper, a detail statistical energy analysis （SEA） model is built. And the vibra-acoustic power inputs are loaded on the model for the valid result of car interior noise analysis. The model is the solid foundation for further optimization on car interior noise control. After the most sensitive subsystems for the power contribution to car interior noise are pointed by SEA comprehensive analysis, the sound pressure level of car interior aerodynamic noise can be reduced by improving their sound and damping characteristics. The further vehicle testing results show that it is available to improve the interior acoustic performance by using detailed SEA model, which comprised by more than 80 subsystems, with the unsteady aerodynamic pressure calculation on body surfaces and the materials improvement of sound/damping properties. It is able to acquire more than 2 dB reduction on the central frequency in the spectrum over 800 Hz. The proposed optimization method can be looked as a reference of car interior aerodynamic noise control by the detail SEA model integrated unsteady computational fluid dynamics （CFD） and sensitivity analysis of acoustic contribution.

Effect of Jianpi Bushen formula for colon cancer patients who underwent adjuvant chemotherapy:Statistical analysis plan for a multicenter trial

Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to treatment.As an effective traditional Chinese medicine,the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.Objective:To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy.This statistical analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled trial.Methods:Our study is a multicenter,double-blind,randomized controlled clinical trial.This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula.To attenuate possible selection bias in the final report,we declared the overall trial design,outcome measures,subgroup analyses,and safety measures.Also,we described the data management and statistical analysis methods in detail.Conclusion:The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods.Further post-hoc analyses can be performed by referring to the SAP,and possible selection bias can be attenuated.

Outlier Detection of Air Quality for Two Indian Urban Cities Using Functional Data Analysis

Human living would be impossible without air quality. Consistent advancements in practically every aspect of contemporary human life have harmed air quality. Everyday industrial, transportation, and home activities turn up dangerous contaminants in our surroundings. This study investigated two years’ worth of air quality and outlier detection data from two Indian cities. Studies on air pollution have used numerous types of methodologies, with various gases being seen as a vector whose components include gas concentration values for each observation per-formed. We use curves to represent the monthly average of daily gas emissions in our technique. The approach, which is based on functional depth, was used to find outliers in the city of Delhi and Kolkata’s gas emissions, and the outcomes were compared to those from the traditional method. In the evaluation and comparison of these models’ performances, the functional approach model studied well.

Statistical Analysis and Countermeasures for Specimen Rejection in the Emergency Department

The rejected specimens from the Emergency Department of the Center of Clinical Laboratory from January 1,2022 to January 1,2023 were analyzed to reduce the specimen rejection rates and to improve the quality of inspection.The results showed that there were 1488 samples of rejected specimens and the non-conforming rate was 0.58%.The departments involved were mainly the Emergency Department,the Hematology Department,the Cardiology Department,the Intensive Care Department,and the Brain Surgery Department.Among the reasons for rejection,blood hemolysis accounted for 43.15%,blood coagulation accounted for 26.61%,and the rate of insufficient specimens was 17.14%.Among them,the sample rejection rate for arterial blood gas analysis was the highest,which accounted for 1.74%;followed by specimens for coagulation test,which was 1.18%.These results indicate the main reason for producing rejected specimens is mainly due to not following the standard operating procedure.Specimen rejection can largely be avoided if the standards for specimen collection are strictly followed.

Quality Evaluation of Cardamine macrophylla Willd as an Edible and Medicinal Herb of Tibetan and Qiang Ethnic Groups

[Objectives]To evaluate the quality of Cardamine macrophylla Willd as Tibetan and Qiang medicinal materials,so as to improve its quality standard and evaluate the quality of C.macrophylla Willd in western Sichuan Province.[Methods]C.macrophylla Willd produced from western Sichuan Province was used as the sample,and the contents of moisture,total ash,acid-insoluble ash,extract,total flavonoids and quercetin in the ground part of C.macrophylla Willd were determined in accordance with the methods of Chinese Pharmacopoeia(2020 edition).With the above seven indicators as evaluation indicators,the quality of medicinal materials was comprehensively evaluated by cluster analysis and principal component analysis(PCA).[Results]According to the results of each indicator,the moisture content of C.macrophylla Willd sample should not exceed 11.00%,the total ash content should not exceed 18%,the acid-insoluble ash content should not exceed 6%,the extract content should not be less than 19%,the total flavone content(calculated by quercetin)should not be less than 2%,and the quercetin content should not be less than 0.15%.[Conclusions]The sample S7 has the best quality and S6 has the worst quality.In this study,the quantitative analysis method of total flavonoids(quercetin)and quercetin in C.macrophylla Willd was established,and the limits of each indicator were preliminarily formulated.

Study on Quality and Safety Trust Early Warning of Dairy Products Based on Statistical Process Control

In order to solve such problems as lack of dynamic evaluation system in evaluation of quality and safety trust of dairy products,and weak awareness of prevention,it is necessary to introduce the statistical process control into the quality and safety trust evaluation system of dairy products,and establish quality and safety trust early warning model for dairy products,so as to determine the control limit of control chart and carry out early warning according to eight criteria. According to the empirical results,the statistical process control is helpful for finding the hidden process risks and providing the necessary basis for enterprises taking positive measures to raise the confidence of consumers.