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Multivariate Statistical Process Monitoring and Control: Recent Developments and Applications to Chemical Industry 被引量:39
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作者 梁军 钱积新 《Chinese Journal of Chemical Engineering》 SCIE EI CAS CSCD 2003年第2期191-203,共13页
Multivariate statistical process monitoring and control (MSPM&C) methods for chemical process monitoring with statistical projection techniques such as principal component analysis (PCA) and partial least squares ... Multivariate statistical process monitoring and control (MSPM&C) methods for chemical process monitoring with statistical projection techniques such as principal component analysis (PCA) and partial least squares (PLS) are surveyed in this paper. The four-step procedure of performing MSPM&C for chemical process, modeling of processes, detecting abnormal events or faults, identifying the variable(s) responsible for the faults and diagnosing the source cause for the abnormal behavior, is analyzed. Several main research directions of MSPM&C reported in the literature are discussed, such as multi-way principal component analysis (MPCA) for batch process, statistical monitoring and control for nonlinear process, dynamic PCA and dynamic PLS, and on-line quality control by inferential models. Industrial applications of MSPM&C to several typical chemical processes, such as chemical reactor, distillation column, polymerization process, petroleum refinery units, are summarized. Finally, some concluding remarks and future considerations are made. 展开更多
关键词 multivariate statistical process monitoring and control (MSPM&C) fault detection and isolation (FDI) principal component analysis (PCA) partial least squares (PLS) quality control inferential model
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Multivariate Statistical Process Monitoring of an Industrial Polypropylene Catalyzer Reactor with Component Analysis and Kernel Density Estimation 被引量:16
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作者 熊丽 梁军 钱积新 《Chinese Journal of Chemical Engineering》 SCIE EI CAS CSCD 2007年第4期524-532,共9页
Abstract Data-driven tools, such as principal component analysis (PCA) and independent component analysis (ICA) have been applied to different benchmarks as process monitoring methods. The difference between the t... Abstract Data-driven tools, such as principal component analysis (PCA) and independent component analysis (ICA) have been applied to different benchmarks as process monitoring methods. The difference between the two methods is that the components of PCA are still dependent while ICA has no orthogonality constraint and its latentvariables are independent. Process monitoring with PCA often supposes that process data or principal components is Gaussian distribution. However, this kind of constraint cannot be satisfied by several practical processes. To ex-tend the use of PCA, a nonparametric method is added to PCA to overcome the difficulty, and kernel density estimation (KDE) is rather a good choice. Though ICA is based on non-Gaussian distribution intormation, .KDE can help in the close monitoring of the data. Methods, such as PCA, ICA, PCA.with .KDE(KPCA), and ICA with KDE,(KICA), are demonstrated and. compared by applying them to a practical industnal Spheripol craft polypropylene catalyzer reactor instead of a laboratory emulator. 展开更多
关键词 multivariate statistical process monitoring principal comPonent analysis kermel density estimation POLYPROPYLENE catalyzer reactor fault detection data-driven tools
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New Method for Multivariate Statistical Process Monitoring 被引量:1
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作者 裴旭东 陈祥光 刘春涛 《Journal of Beijing Institute of Technology》 EI CAS 2010年第1期92-98,共7页
A new method using discriminant analysis and control charts is proposed for monitoring multivariate process operations more reliably.Fisher discriminant analysis (FDA) is used to derive a feature discriminant direct... A new method using discriminant analysis and control charts is proposed for monitoring multivariate process operations more reliably.Fisher discriminant analysis (FDA) is used to derive a feature discriminant direction (FDD) between each normal and fault operations,and each FDD thus decided constructs the feature space of each fault operation.Individuals control charts (XmR charts) are used to monitor multivariate processes using the process data projected onto feature spaces.Upper control limit (UCL) and lower control limit (LCL) on each feature space from normal process operation are calculated for XmR charts,and are used to distinguish fault from normal.A variation trend on an XmR chart reveals the type of relevant fault operation.Applications to Tennessee Eastman simulation processes show that this proposed method can result in better monitoring performance than principal component analysis (PCA)-based methods and can better identify step type faults on XmR charts. 展开更多
关键词 Fisher discriminant analysis individuals control chart multivariate statistical process monitoring
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A novel Q-based online model updating strategy and its application in statistical process control for rubber mixing 被引量:2
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作者 Chunying Zhang Sun Chen +1 位作者 Fang Wu Kai Song 《Chinese Journal of Chemical Engineering》 SCIE EI CAS CSCD 2015年第5期796-803,共8页
To overcome the large time-delay in measuring the hardness of mixed rubber, rheological parameters were used to predict the hardness. A novel Q-based model updating strategy was proposed as a universal platform to tra... To overcome the large time-delay in measuring the hardness of mixed rubber, rheological parameters were used to predict the hardness. A novel Q-based model updating strategy was proposed as a universal platform to track time-varying properties. Using a few selected support samples to update the model, the strategy could dramat- ically save the storage cost and overcome the adverse influence of low signal-to-noise ratio samples. Moreover, it could be applied to any statistical process monitoring system without drastic changes to them, which is practical for industrial practices. As examples, the Q-based strategy was integrated with three popular algorithms (partial least squares (PIE), recursive PIE (RPLS), and kernel PIE (KPIE)) to form novel regression ones, QPLS, QRPIE and QKPLS, respectively. The applications for predicting mixed rubber hardness on a large-scale tire plant in east China prove the theoretical considerations. 展开更多
关键词 Online model updating Rubber mixingQ statistic Hardness Rheological parameters statistical process control
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Study on Quality and Safety Trust Early Warning of Dairy Products Based on Statistical Process Control
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作者 Xiao FAN 《Asian Agricultural Research》 2017年第10期63-67,71,共6页
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 co... 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. 展开更多
关键词 statistical process control Dairy products Quality and safety trust Early warning
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Application of Statistical Process Control for Setting Action Thresholds as Quality Assurance of Dose Verifications in External Beam Radiotherapy
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作者 Philip Kioko Ndonye Samuel Nii Adu Tagoe 《International Journal of Medical Physics, Clinical Engineering and Radiation Oncology》 2022年第1期22-35,共14页
Purpose: To test the concept of Statistical Process Control (SPC) as a Quality Assurance (QA) procedure for dose verifications in external beam radiation therapy in conventional and 3D Conformal Radiotherapy (3D-CRT) ... Purpose: To test the concept of Statistical Process Control (SPC) as a Quality Assurance (QA) procedure for dose verifications in external beam radiation therapy in conventional and 3D Conformal Radiotherapy (3D-CRT) treatment of cervical cancer. Materials and Methods: A study of QA verification of target doses of 198 cervical cancer patients undergoing External Beam Radiotherapy (EBRT) treatments at two different cancer treatment centers in Kenya was conducted. The target doses were determined from measured entrance doses by the diode in vivo dosimetry. Process Behavior Charts (PBC) developed by SPC were applied for setting Action Thresholds (AT) on the target doses. The AT set was then proposed as QA limits for acceptance or rejection of verified target doses overtime of the EBRT process. Result and Discussion: Target doses for the 198 patients were calculated and SPC applied to test whether the action limits set by the Process Behavior Charts could be applied as QA for verified doses in EBRT. Results for the two sub-groups of n = 3 and n = 4 that were tested produced action thresholds which are within clinical dose specifications for both conventional AP/PA and 3D-CRT EBRT treatment techniques for cervical cancer. Conclusion: Action thresholds set by SPC were within the clinical dose specification of ±5% uncertainty for both conventional AP/PA and 3D-CRT EBRT treatment techniques for cervical cancer. So the concept of SPC could be applied in setting QA action limits for dose verifications in EBRT. 展开更多
关键词 Quality Assurance statistical process Control Action Thresholds Dose Verification External Beam Radiation Therapy
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Assessing the Awareness and Usage of Quality Control Tools with Emphasis to Statistical Process Control (SPC) in Ethiopian Manufacturing Industries
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作者 Leakemariam Berhe Tesfay Gidey 《Intelligent Information Management》 2016年第6期143-169,共27页
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 questionnai... 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. 展开更多
关键词 Quality Products AWARENESS USAGE statistical process Control Ethiopia
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Statistical Monitoring of Chemical Processes Based on Sensitive Kernel Principal Components 被引量:10
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作者 JIANG Qingchao YAN Xuefeng 《Chinese Journal of Chemical Engineering》 SCIE EI CAS CSCD 2013年第6期633-643,共11页
The kernel principal component analysis (KPCA) method employs the first several kernel principal components (KPCs), which indicate the most variance information of normal observations for process monitoring, but m... The kernel principal component analysis (KPCA) method employs the first several kernel principal components (KPCs), which indicate the most variance information of normal observations for process monitoring, but may not reflect the fault information. In this study, sensitive kernel principal component analysis (SKPCA) is proposed to improve process monitoring performance, i.e., to deal with the discordance of T2 statistic and squared prediction error SVE statistic and reduce missed detection rates. T2 statistic can be used to measure the variation di rectly along each KPC and analyze the detection performance as well as capture the most useful information in a process. With the calculation of the change rate of T2 statistic along each KPC, SKPCA selects the sensitive kernel principal components for process monitoring. A simulated simple system and Tennessee Eastman process are employed to demonstrate the efficiency of SKPCA on online monitoring. The results indicate that the monitoring performance is improved significantly. 展开更多
关键词 statistical process monitoring kernel principal component analysis sensitive kernel principal compo-nent Tennessee Eastman process
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Integrated Statistical and Engineering Process Control Based on Smooth Transition Autoregressive Model 被引量:1
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作者 张晓蕾 何桢 《Transactions of Tianjin University》 EI CAS 2013年第2期147-156,共10页
Traditional studies on integrated statistical process control and engineering process control (SPC-EPC) are based on linear autoregressive integrated moving average (ARIMA) time series models to describe the dynamic n... Traditional studies on integrated statistical process control and engineering process control (SPC-EPC) are based on linear autoregressive integrated moving average (ARIMA) time series models to describe the dynamic noise of the system.However,linear models sometimes are unable to model complex nonlinear autocorrelation.To solve this problem,this paper presents an integrated SPC-EPC method based on smooth transition autoregressive (STAR) time series model,and builds a minimum mean squared error (MMSE) controller as well as an integrated SPC-EPC control system.The performance of this method for checking the trend and sustained shift is analyzed.The simulation results indicate that this integrated SPC-EPC control method based on STAR model is effective in controlling complex nonlinear systems. 展开更多
关键词 statistical process control engineering process control time series STAR model AUTOCORRELATION
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Machining Error Control by Integrating Multivariate Statistical Process Control and Stream of Variations Methodology 被引量:4
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作者 WANG Pei ZHANG Dinghua LI Shan CHEN Bing 《Chinese Journal of Aeronautics》 SCIE EI CAS CSCD 2012年第6期937-947,共11页
For aircraft manufacturing industries, the analyses and prediction of part machining error during machining process are very important to control and improve part machining quality. In order to effectively control mac... For aircraft manufacturing industries, the analyses and prediction of part machining error during machining process are very important to control and improve part machining quality. In order to effectively control machining error, the method of integrating multivariate statistical process control (MSPC) and stream of variations (SoV) is proposed. Firstly, machining error is modeled by multi-operation approaches for part machining process. SoV is adopted to establish the mathematic model of the relationship between the error of upstream operations and the error of downstream operations. Here error sources not only include the influence of upstream operations but also include many of other error sources. The standard model and the predicted model about SoV are built respectively by whether the operation is done or not to satisfy different requests during part machining process. Secondly, the method of one-step ahead forecast error (OSFE) is used to eliminate autocorrelativity of the sample data from the SoV model, and the T2 control chart in MSPC is built to realize machining error detection according to the data characteristics of the above error model, which can judge whether the operation is out of control or not. If it is, then feedback is sent to the operations. The error model is modified by adjusting the operation out of control, and continually it is used to monitor operations. Finally, a machining instance containing two operations demonstrates the effectiveness of the machining error control method presented in this paper. 展开更多
关键词 machining error multivariate statistical process control stream of variations error modeling one-step ahead forecast error error detection
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Ultrasonic attenuation spectroscopy for multivariate statistical process control in nanomaterial processing 被引量:2
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作者 Bundit Boonkhao 《Particuology》 SCIE EI CAS CSCD 2012年第2期196-202,共7页
Ultrasonic attenuation spectroscopy (UAS) is an attractive process analytical technology (PAT) for on-line real-time characterisation of slurries for particle size distribution (PSD) estimation. It is however on... Ultrasonic attenuation spectroscopy (UAS) is an attractive process analytical technology (PAT) for on-line real-time characterisation of slurries for particle size distribution (PSD) estimation. It is however only applicable to relatively low solid concentrations since existing instrument process models still cannot fully take into account the phenomena of particle-particle interaction and multiple scattering, leading to errors in PSD estimation. This paper investigates an alternative use of the raw attenuation spectra for direct multivariate statistical process control (MSPC). The UAS raw spectra were processed using principal component analysis. The selected principal components were used to derive two MSPC statistics, the Hotelling's T2 and square prediction error (SPE). The method is illustrated and demonstrated by reference to a wet milling process for processinR nanoparticles. 展开更多
关键词 Ultrasonic attenuation spectraParticle sizeMultivariate statistical process contro(MSPC)Wet milling processNanoparticle processing
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A Robust Statistical Batch Process Monitoring Framework and Its Application 被引量:4
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作者 谢磊 张建明 王树青 《Chinese Journal of Chemical Engineering》 SCIE EI CAS CSCD 2004年第5期682-687,共6页
In order to reduce the variations of the product quality in batch processes, multivariate statistical process control methods according to multi-way principal component analysis (MPCA) or multi-way projection to laten... In order to reduce the variations of the product quality in batch processes, multivariate statistical process control methods according to multi-way principal component analysis (MPCA) or multi-way projection to latent structure (MPLS) were proposed for on-line batch process monitoring. However, they are based on the decomposition of relative covariance matrix and strongly affected by outlying observations. In this paper, in view of an efficient projection pursuit algorithm, a robust statistical batch process monitoring (RSBPM) framework,which is resistant to outliers, is proposed to reduce the high demand for modeling data. The construction of robust normal operating condition model and robust control limits are discussed in detail. It is evaluated on monitoring an industrial streptomycin fermentation process and compared with the conventional MPCA. The results show that the RSBPM framework is resistant to possible outliers and the robustness is confirmed. 展开更多
关键词 robust statistical batch process monitoring robust principal componentanalysis streptomycin fermentation robust multi-way principal component analysis
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Investigation of Dynamic Multivariate Chemical Process Monitoring 被引量:3
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作者 谢磊 张建明 王树青 《Chinese Journal of Chemical Engineering》 SCIE EI CAS CSCD 2006年第5期559-568,共10页
Chemical process variables are always driven by random noise and disturbances. The closed-loop con-trol yields process measurements that are auto and cross correlated. The influence of auto and cross correlations on s... Chemical process variables are always driven by random noise and disturbances. The closed-loop con-trol yields process measurements that are auto and cross correlated. The influence of auto and cross correlations on statistical process control (SPC) is investigated in detail by Monte Carlo experiments. It is revealed that in the sense of average performance, the false alarms rates (FAR) of principal component analysis (PCA), dynamic PCA are not affected by the time-series structures of process variables. Nevertheless, non-independent identical distribution will cause the actual FAR to deviate from its theoretic value apparently and result in unexpected consecutive false alarms for normal operating process. Dynamic PCA and ARMA-PCA are demonstrated to be inefficient to remove the influences of auto and cross correlations. Subspace identification-based PCA (SI-PCA) is proposed to improve the monitoring of dynamic processes. Through state space modeling, SI-PCA can remove the auto and cross corre-lations efficiently and avoid consecutive false alarms. Synthetic Monte Carlo experiments and the application in Tennessee Eastman challenge process illustrate the advantages of the proposed approach. 展开更多
关键词 multivariate statistical processes control subspace identification false alarms rate dynamic processes
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Real-time monitoring of weld penetration quality in robotic arc welding process
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作者 武传松 贾传宝 段晓宁 《China Welding》 EI CAS 2008年第1期40-43,共4页
It is of great significance to develop an intelligent monitoring system for weld penetration defects such as incomplete penetration and burn-through in real-time during robotic arc welding process. In this paper, robo... It is of great significance to develop an intelligent monitoring system for weld penetration defects such as incomplete penetration and burn-through in real-time during robotic arc welding process. In this paper, robotic gas metal arc welding experiments are carried out on the mild steel test pieces with Vee-type groove. Through-the-arc sensing method is used to capture the transient values of the welding voltage and current. The raw data of the captured welding current and voltage are processed statistically, and the feature vector SIO is extracted to correlate the welding conditions to the weld penetration information. It lays foundation for intelligent monitoring of weld quality in robotic arc welding. 展开更多
关键词 real-time monitoring statistical processing weld penetration robotic arc welding
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Monitoring Saccharification Process in Brewery Industry Using Quality Control Charts
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作者 Samwel Manyele Nyakorema Rioba 《Engineering(科研)》 2016年第7期481-498,共18页
The aim of this study was to establish a control system for saccharification process using quality control charts. To achieve this goal, temperature, pH and brix were measured at 12 minutes intervals for 15 consecutiv... The aim of this study was to establish a control system for saccharification process using quality control charts. To achieve this goal, temperature, pH and brix were measured at 12 minutes intervals for 15 consecutive batches which took 2 hours each. The time variations for three process parameters were assessed to establish a good understanding of the saccharification process. The temperature varied between 58℃ and 62℃ while the pH decreased slowly due to oxidation, values of which varied between 5.7 and 5.0. Brix values increased linearly with time. The initial and final values of the three parameters varied from one batch to another. Of the three parameters, brix was not well represented on the quality control charts due to wide difference between initial and final values during saccharification. The final brix values varied between batches, from 10.6% to 11.6%. The control charts used in this study were X-bar and Range charts. The rules for interpreting control charts were implemented for both X-bar and R charts, results of which showed that the process was out of control, although some rules were not violated due to little number of batches studied. The values of for temperature and pH data (2.27℃ and 0.35, respectively) were lower compared to brix data (11.2%). The corresponding values of span between control limits, SP<sub>x</sub> and SP<sub>R</sub> for temperature and pH were also comparatively lower than those established from brix data. Due to larger values of for brix measurements, the corresponding control charts for brix were insensitive in identifying out-of-control points during saccharification process. 展开更多
关键词 SACCHARIFICATION Batch processing statistical process Control Control Charts Control Limits Number of Subgroups
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Graph-based Lexicalized Reordering Models for Statistical Machine Translation
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作者 SU Jinsong LIU Yang +1 位作者 LIU Qun DONG Huailin 《China Communications》 SCIE CSCD 2014年第5期71-82,共12页
Lexicalized reordering models are very important components of phrasebased translation systems.By examining the reordering relationships between adjacent phrases,conventional methods learn these models from the word a... Lexicalized reordering models are very important components of phrasebased translation systems.By examining the reordering relationships between adjacent phrases,conventional methods learn these models from the word aligned bilingual corpus,while ignoring the effect of the number of adjacent bilingual phrases.In this paper,we propose a method to take the number of adjacent phrases into account for better estimation of reordering models.Instead of just checking whether there is one phrase adjacent to a given phrase,our method firstly uses a compact structure named reordering graph to represent all phrase segmentations of a parallel sentence,then the effect of the adjacent phrase number can be quantified in a forward-backward fashion,and finally incorporated into the estimation of reordering models.Experimental results on the NIST Chinese-English and WMT French-Spanish data sets show that our approach significantly outperforms the baseline method. 展开更多
关键词 natural language processing statistical machine translation lexicalized reordering model reordering graph
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A Study of Detection of Outliers for Working and Non-Working Days Air Quality in Kolkata, India: A Case Study
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作者 Mohammad Ahmad Weihu Cheng +1 位作者 Zhao Xu Abdul Kalam 《Journal of Environmental Protection》 2023年第8期685-709,共22页
A variety of factors affect air quality, making it a difficult issue. The level of clean air in a certain area is referred to as air quality. It is challenging for conventional approaches to correctly discover aberran... A variety of factors affect air quality, making it a difficult issue. The level of clean air in a certain area is referred to as air quality. It is challenging for conventional approaches to correctly discover aberrant values or outliers due to the significant fluctuation of this sort of data, which is influenced by Climate change and the environment. With accelerating industrial expansion and rising population density in Kolkata City, air pollution is continuously rising. This study involves two phases, in the first phase imputation of missing values and second detection of outliers using Statistical Process Control (SPC), and Functional Data Analysis (FDA), studies to achieve the efficacy of the outlier identification methodology proposed with working days and Nonworking days of the variables NO<sub>2</sub>, SO<sub>2</sub>, and O<sub>3</sub>, which were used for a year in a row in Kolkata, India. The results show how the functional data approach outshines traditional outlier detection methods. The outcomes show that functional data analysis vibrates more than the other two approaches after imputation, and the suggested outlier detector is absolutely appropriate for the precise detection of outliers in highly variable data. 展开更多
关键词 statistical process Control Functional Data Analysis Fuzzy C Means OUTLIERS Air Quality
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低能中子引起的核反应中γ产生数据的计算
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作者 刘建峰 聂家瑞 《郑州大学学报(理学版)》 CAS 1987年第2期34-41,共8页
一、引言理论研究和大量实验表明,(n,Υ)反应中存在丰富的反应机制,如果按照波函数的成份分类,目前已经提出并在一定程度上被证实的辐射俘获反应机制有:位阱俘获和阶俘获、复合核弹性道及非弹性道中的俘获、半直接俘获、门态俘获以及复... 一、引言理论研究和大量实验表明,(n,Υ)反应中存在丰富的反应机制,如果按照波函数的成份分类,目前已经提出并在一定程度上被证实的辐射俘获反应机制有:位阱俘获和阶俘获、复合核弹性道及非弹性道中的俘获、半直接俘获、门态俘获以及复合核过程。复合核过程又称统计过程,与其相对应,所有其它过程称为非统计过程。非统计过程中,半直接俘获可看作和初态波函数中三个准粒子组态有关的门态过程,只有在中子能量大于3~5Mev时才变得重要。其他门态过程目前了解得很少,也没有成熟的计算方法。价俘获是一种单粒子的共振俘获过程。因此,如果研究对能量平均的辐射俘获,并且限于中子能量小于3Mev,则只需要考虑复合核统计过程和位阱俘获。 展开更多
关键词 statistical process non-statistical process
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Nonparametric Control Scheme for Monitoring Phase Ⅱ Nonlinear Profiles with Varied Argument Values 被引量:6
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作者 ZHANG Yang HE Zhen +1 位作者 FANG Juntao ZHANG Min 《Chinese Journal of Mechanical Engineering》 SCIE EI CAS CSCD 2012年第3期587-597,共11页
Profile monitoring is used to check the stability of the quality of a product over time when the product quality is best represented by a function at each time point.However,most previous monitoring approaches have no... Profile monitoring is used to check the stability of the quality of a product over time when the product quality is best represented by a function at each time point.However,most previous monitoring approaches have not considered that the argument values may vary from profile to profile,which is common in practice.A novel nonparametric control scheme based on profile error is proposed for monitoring nonlinear profiles with varied argument values.The proposed scheme uses the metrics of profile error as the statistics to construct the control charts.More details about the design of this nonparametric scheme are also discussed.The monitoring performance of the combined control scheme is compared with that of alternative nonparametric methods via simulation.Simulation studies show that the combined scheme is effective in detecting parameter error and is sensitive to small shifts in the process.In addition,due to the properties of the charting statistics,the out-of-control signal can provide diagnostic information for the users.Finally,the implementation steps of the proposed monitoring scheme are given and applied for monitoring the blade manufacturing process.With the application in blade manufacturing of aircraft engines,the proposed nonparametric control scheme is effective,interpretable,and easy to apply. 展开更多
关键词 statistical process control profile monitoring nonparametric metric profile error
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A strategy for population pharmaceutical quality assessment based on quality by design 被引量:2
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作者 Yu Zhao Changqin Hu +2 位作者 Shangchen Yao Lihui Yin Xiaomei Ling 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2021年第5期588-595,共8页
From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for populatio... From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide databased information for approval.Not only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation. 展开更多
关键词 Population pharmaceutical quality Quality by design(QbD) Crucial evaluation attributes(CEAs) process indicators(PIs) Improved statistical process control(SPC) Risk assessment
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