ABSTRACT
Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.
Subject(s)
Tablets/analysis , Zidovudine/agonists , HIV/pathogenicity , Lamivudine/agonists , Patients/classification , Total Quality Management/organization & administration , Fees and Charges/statistics & numerical data , Laboratories/classification , Manufactured Materials/supply & distributionABSTRACT
【Objective】 To explore the analytical methods for detecting data in the process of quality inspection of blood component samples. 【Methods】 The quality inspection data of blood component samples from 2018 to 2022 in our center were collected. Based on the principles of statistical process control, control charts were created using Minitab software to analyze key test items. 【Results】 The P control chart was used to analyze the pass rate of platelet content and revealed one out-of-control point. The normality test was performed on plasma protein content to analyze the causes of data fluctuations for further improvement. The mean and range control chart was utilized for hematocrit measurement, with abnormal data trends detected. Further analysis of the normality test and process capability analysis was conducted, resulting in a Cpk value of 0.67. 【Conclusion】 By applying statistical process control methods, the study employed P control charts to analyze count data in the quality inspection of blood component samples, conducted normality tests for measurement data, and utilized mean and range control charts to identify abnormal data trends. For data conforming to a normal distribution, the process capability index (Cpk) was calculated to explore effective monitoring methods for ensuring stability in the blood supply process.
ABSTRACT
Harvesting is one of the most important stages of the agricultural production process. However, the lack of monitoring during this operation and the absence of efficient methodologies to quantify losses have contributed to the decline in the quality of the operation. The objective of this study was to monitor mechanized soybean harvest by quantifying losses through two methodologies using statistical process control. The study was conducted in March 2016 in an agricultural area in the municipality of Ribeirão Preto, SP, using a John Deere harvester model 1470 with a tangential-type track system and separation by a straw-blower. The experimental design followed the standards established by statistical process control, and every 8 min of harvest, the total losses by the circular framework and rectangular framework methodologies were simultaneously quantified, totaling 40 points. Data were analyzed using descriptive statistics and statistical process control. The averages of the circular methodology framework were values above those found in the rectangular methodology framework, presenting greater representativeness of losses. The process was considered unable to maintain losses of soybeans at acceptable levels during mechanical harvest throughout the operation of the two frameworks. The circular framework for collecting samples at different locations resulted in higher reliability of data.
Subject(s)
Automation , Soybeans , Crop Production , StatisticsABSTRACT
En el control de enfermedades infecciosas resulta esencial usar modelos epidemiológicos, sin embargo, existen herramientas que permiten el monitoreo y control estadístico de la transmisión de este tipo de enfermedad en el tiempo. El objetivo de este trabajo de investigación fue proporcionar un análisis de la dinámica diaria de transmisión de la COVID-19 en Cuba mediante dos cartas de control, basadas en un modelo probabilístico fundamentado en las distribuciones binomial y Poisson. Los dos métodos se aplicaron, utilizando los reportes diarios publicados por el Ministerio de Salud Pública, a un proceso cuya variable en estudio es de atributos y con poca información sobre su estabilidad. Las cartas aplicadas fueron clave para mejorar la estabilidad del proceso, en la medida en que se detectaron, identificaron y sugirió la eliminación de causas especiales para reducir la variación; y en el monitoreo para asegurar que las mejoras a generarse se puedan conservar(AU)
In the control of infectious diseases it is essential to use epidemiological models; however, there are tools that allow monitoring and statistical control of the transmission of this type of disease over time. The objective of this research work was to provide an analysis of the daily dynamics of COVID-19 transmission in Cuba through two control charts, based on a probabilistic model based on the binomial and Poisson distributions. The two methods were applied, using the daily reports published by the Ministry of Public Health, to a process whose variable under study is attributes type and with little information on its stability. The applied charts were key to improve the stability of the process, insofar as they were detected, identified and suggested the elimination of special causes to reduce the variation; and in monitoring to ensure that the improvements to be generated can be preserved(AU)
Subject(s)
Humans , Male , Female , Communicable Disease Control , Models, Statistical , COVID-19/transmission , CubaABSTRACT
Resumo No contexto de crise e restrições de recursos é razoável supor o agravamento de fragilidades do Sistema Único de Saúde (SUS), como desigualdades regionais, subfinanciamento e problemas na qualidade do cuidado. Este estudo explorou a aplicação de indicadores de acesso e efetividade, facilmente compreensíveis e calculados, passíveis de refletir a crise na rede hospitalar. Cinco indicadores extraídos do Sistema de Informações Hospitalares, relativos ao Brasil e a estados da Região Sudeste, foram analisados no período de 2009-2018: internações resultantes em morte; internações cirúrgicas resultantes em morte; cirurgias eletivas no total das internações cirúrgicas; próteses de quadril na população de idosos; e angioplastias na população de 20 anos ou mais. Utilizaram-se gráficos de controle estatístico para a comparação dos indicadores entre estados, antes e a partir de 2014. No Brasil, as mortes hospitalares tiveram um leve crescimento enquanto que as mortes cirúrgicas uma queda; as cirurgias eletivas e próteses de quadril também diminuíram. No Sudeste, o Rio de Janeiro apresentou os piores resultados, em especial a queda de cirurgias eletivas. Os resultados ilustram o potencial dos indicadores para monitorar efeitos da crise sobre o cuidado hospitalar.
Abstract In the context of crisis and resource constraints, it is reasonable to assume the deteriorated weaknesses of the Unified Health System (SUS), such as regional inequalities, underfinancing, and care quality issues. This study explored the application of easily comprehensible and calculated access and effectiveness indicators that could reflect the hospital network crisis. Five indicators extracted from the Hospital Information System, related to Brazil and states of the Southeastern region, were analyzed in the 2009-2018 period: hospitalizations resulting in death; surgical hospitalizations resulting in death; elective surgeries in the total of surgical hospitalizations; hip prostheses in the senior population; and angioplasties in the population aged 20 years and over. Statistical control charts were used to compare indicators between states, before and from 2014. In Brazil, overall hospital deaths had a slight increase while surgical deaths declined; elective surgeries and hipprosthesis also decreased. In Southeastern Brazil, Rio de Janeiro was the worst performer, especially the decrease of the elective surgeries. The results illustrate the potential of indicators to monitor crisis effects on hospital care.
Subject(s)
Humans , Adult , Aged , State Health Plans , Economic Recession , Health Services Accessibility , Inpatients , National Health Programs/economics , Quality of Health Care , Surgical Procedures, Operative/mortality , Surgical Procedures, Operative/trends , Brazil/epidemiology , Health Care Rationing , Hospital Information Systems , Hospital Mortality/trends , Angioplasty/statistics & numerical data , Elective Surgical Procedures/statistics & numerical data , Arthroplasty, Replacement, Hip/statistics & numerical data , Resource Allocation , Healthcare Disparities , Middle AgedABSTRACT
Objective:Through the establishment of shewhart control chart,to grasp the variation of products and avoid the occur-rence of failures.Methods:According to the characteristics and control requirements of quality parameters,several types of typical pa-rameters were introduced to illustrate the detection results and create the control charts in order to confirm whether the production was under the control. Results:The analysis of control charts could expedite the operator discovering the process variation caused by spe-cial factors,and taking corrective/preventive actions so that the products consistently complied with the regulatory specifications and production instructions. Conclusion:Control charts can be used as a monitoring tool in pharmaceutical manufacturing process,which can reduce the reject ratio and promote the continuous improvement of products.
ABSTRACT
ABSTRACT: The objective of this study was to evaluate the use of statistical quality control tools in the analysis of the uniformity of a microsprinkler irrigation system. For the analysis of irrigation Christiansen uniformity coefficient (CUC) and the distribution uniformity coefficient (DU) were statistically analyzed by means of the Shewhart control charts and process capability index (Cp). For the experiment 25 tests were carried out with a single micro sprinkler and subsequently seven different spacing between micro sprinklers were simulated. Control charts contributed to the diagnosis of the treatments to be under control and with satisfactory uniformity outcomes. Increase in process capability index was directly proportional to the average of CUC and DU.
RESUMO: O estudo objetivou avaliar o uso das ferramentas do controle estatístico de qualidade na análise da uniformidade de um sistema de irrigação por microaspersão. Para a análise da irrigação foram utilizados os coeficientes de uniformidade de Christiansen (CUC) e o coeficiente de uniformidade de distribuição (CUD), e estes foram analisados estatisticamente através dos gráficos de controle de Shewhart e do índice de capacidade do processo (Cp). Para o experimento foram realizados 25 ensaios com um único microaspersor, sendo posteriormente simulados sete diferentes espaçamentos entre microaspersores. Os gráficos de controle contribuíram para o diagnóstico dos tratamentos sob controle e com resultados satisfatórios de uniformidade. O aumento do índice de capacidade do processo mostrou-se diretamente proporcional as médias dos valores de CUC e CUD.
ABSTRACT
Durante o processo de colheita mecanizada de cana-de-açúcar, o desgaste das facas do mecanismo de corte basal é fator diretamente relacionado com a qualidade do corte realizado pelas máquinas, sendo o emprego de ferramentas de controle de qualidade importantes no monitoramento deste processo. Assim, o presente trabalho, desenvolvido na região de Ribeirão Preto, teve por objetivo avaliar o desgaste das facas do corte basal e os danos causados às soqueiras na colheita mecanizada de cana-de-açúcar, sob a ótica do controle estatístico de qualidade (CEQ). O desgaste das facas foi quantificado por meio da perda de massa e de suas dimensões, enquanto a qualidade do corte foi avaliada pela altura e pelos danos às soqueiras, classificados visualmente em função do nível de dano causado. Os resultados obtidos mostraram que o desgaste das facas ocorreu de maneira mais acentuada em determinados períodos de utilização, porém mantendo-se dentro de padrões de controle. A altura de corte não foi afetada pelo desgaste das facas, mantendo-se dentro dos limites de qualidade desejáveis para a operação. Finalmente, os danos causados às soqueiras variaram entre si em função de cada face de corte das facas avaliadas, havendo predominância de determinadas classes de danos em cada face de corte, porém sempre se mantendo dentro dos padrões aceitáveis pelo controle estatístico.
During the sugarcane mechanized harvester process, the wear of base cutting knives is directly correlated to the quality of the cut made by the machines, and the use of quality control tools important in monitoring this process. Thus, the present study in Ribeirão Preto region aimed to assess the knives cut baseline and damage caused to wear brass knuckles in mechanized harvesting of cane raw sugar, from the viewpoint of statistical quality control (SQC). The wear of the knives was quantified by mass loss and its dimensions, while cutting quality was assessed by cutting height and damage to stumps visually classified according to the level of damage caused. The results showed that the wear of the knives was more pronounced in certain periods of use, but still within control standards. The cutting height was not affected by the wear of the knives, keeping within the limits of desirable quality for operation. Eventually damage the stumps ranged among themselves depending on each face of the cutting knives evaluated, and the predominance of certain classes of damage in each cutting face, but always remained in statistical control.
ABSTRACT
The detection of unusual patterns in the occurrence of diseases is an important challenge to health workers interested in early identification of epidemics. The objective of this study was to provide an early signal of infectious disease epidemics by analyzing the disease dynamics. A two-stage monitoring system was applied, which consists of univariate Box-Jenkins model or autoregressive integrated moving average model and subsequent tracking signals from several statistical process-control charts. The analyses were illustrated on January 2000–August 2009 national measles data reported monthly to the Expanded Programme on Immunization (EPI) in Bangladesh. The results of this empirical study revealed that the most adequate model for the occurrences of measles in Bangladesh was the seasonal autoregressive integrated moving average (3, 1, 0) (0, 1, 1)12 model, and the statistical process-control charts detected no measles epidemics during September 2007–August 2009. The two-stage monitoring system performed well to capture the measles dynamics in Bangladesh without detection of an epidemic because of high measles-vaccination coverage.
ABSTRACT
A semeadura mecanizada da mamona (Ricinus communis L.) pode reduzir o tempo de operação e os custos associados à mão-de-obra, porém a escassez de informações nesta área tem prejudicado a adoção correta desta tecnologia. Assim, objetivou-se com esse trabalho verificar a regularidade da distribuição longitudinal de sementes do híbrido Lyra de mamona, em área de plantio direto e sua relação com rendimento de grãos; bem como a viabilidade da aplicação de cartas de controle para a avaliação do processo de semeadura, nesta cultura. O ensaio foi conduzido em área comercial de produção de grãos de mamona sob plantio direto, sendo avaliadas: distribuição longitudinal, porcentagens de espaçamentos normais, falhos e duplos na linha, número de planta por metro linear, altura de plantas, altura e comprimento do racemo primário e rendimento de grãos. Utilizou-se a estatística descritiva, a análise de correlações e as cartas de controle para a avaliação dos parâmetros propostos. Há necessidade de refinamento nas regulagens de semeadoras-adubadoras de precisão para a semeadura do híbrido Lyra de mamona, em áreas de plantio direto; a distribuição longitudinal de sementes de mamona influencia vários parâmetros fitotécnicos, incluindo o rendimento de grãos; a aplicação da carta de controle é uma ferramenta eficiente para a avaliação do processo de semeadura da mamona.
The mechanized sowing of castor bean (Ricinus communis L.) can reduce the operation time and the costs associated to labor, however the privation of information in this area have damaged the correct adoption of this technology. Thus, the research had as an aim to verify the regularity of longitudinal distribution of hybrid Lyra castor bean seeds, in a no-tillage system area, and its relationship with yield; and the viability of control charts for evaluation of sowing in this crop. The essay was carded out in a commercial area of grain production in no-tillage system. one evaluated: longitudinal distribution, percentage of normal, defective and double spaces in line, number of plants per linear meter, height of plants, height and length of primer raceme and yield. For the evaluation of the proposed parameters, one used the describable statistic, the correlation analysis and control charts. The results allowed to conclude that it is necessary to enhance the regulation of seeder-fertilizer for mechanized sowing of castor bean hybrid Lyra, in no-tillage system areas. The longitudinal distribution of castor bean affect seeds grain yield and other phytotechnic parameters and the control charts are efficient to evaluate the mechanized castor bean sowing.
ABSTRACT
Epidemias devem ser consideradas não como um tipo especial de doença, mas sim como parte de um complexo processo de distribuição de patologias no tempo e no espaço. Diversas classificações de doenças existem, sendo oficial a CID atualmente em sua décima versão. As cartas de controle, empregadas pelo serviço de saúde, permitem uma aproximação à fase, endêmica ou epidêmica, em que se encontram especialmente doenças sujeitas a vigilância em todo o mundo, as quarentenáveis. O conceito de surto deve ser encarado como um indício de concentração de episódios que merece estudo mais profundo. As mais importantes doenças transmissíveis no mundo em desenvolvimento são chamadas negligenciadas e merecem atenção especial das agências de fomento de pesquisa por não serem tidas como prioritárias pela indústria farmacêutica. No Brasil, a Agenda de Prioridades de Pesquisa em Saúde inclui diversas doenças dessa natureza e tem sido contempladas em editais do CNPq e do Ministério da Saúde.