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1.
Biosci. j. (Online) ; 38: e38050, Jan.-Dec. 2022. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1396146

RESUMO

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.


Assuntos
Automação , Glycine max , Produção Agrícola , Estatística
2.
Behav Res Methods ; 54(1): 475-492, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34244984

RESUMO

Illusion of control (IOC) is a bias in the judgment of personal success with implications to learning theories and health policies; some important questions in the investigation of IOC may be related to traditional measures in the field, namely self-assessment using Likert scales about the sense of control. Statistical process control (SPC) and Shewhart charts are methods developed to monitor and control industrial processes, never applied in psychological studies before. The present two studies investigated the use of the technique of Shewhart charts in the analysis of IOC. The purpose was to explore the use of SPC and Shewhart charts in the analysis of data sequences from psychological experiments; the objective was to analyze the results of reaction time (RT) data sequences plotted in SPC charts, in comparison with self-assessment judgments from an IOC task. Participants were 63 undergraduate students (Study 1) and 103 mine workers (Study 2) instructed to try to control a traffic light on a computer by pressing or not the keyboard. Higher probabilities of the successful outcome generated judgments of illusion and shifts (due to cognitive activity) in the charts of RT; lower probabilities resulted in null illusion and RT presented a random and stable profile. Patterns for different groups emerged in Shewhart charts. SPC can contribute to the analysis of the behavior of sequences of data in psychological studies, so that the charts indicate changes and patterns not detected by traditional ANOVA and other linear models.


Assuntos
Ilusões , Humanos
3.
Sensors (Basel) ; 19(14)2019 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-31336711

RESUMO

This paper proposes the use of the Statistical Process Control (SPC), more specifically, the Exponentially Weighted Moving Average method, for the monitoring of drivers using approaches based on the vehicle and the driver's behavior. Based on the SPC, we propose a method for the lane departure detection; a method for detecting sudden driver movements; and a method combined with computer vision to detect driver fatigue. All methods consider information from sensors scattered by the vehicle. The results showed the efficiency of the methods in the identification and detection of unwanted driver actions, such as sudden movements, lane departure, and driver fatigue. Lane departure detection obtained results of up to 76.92% (without constant speed) and 84.16% (speed maintained at ≈60). Furthermore, sudden movements detection obtained results of up to 91.66% (steering wheel) and 94.44% (brake). The driver fatigue has been detected in up to 94.46% situations.

4.
Talanta ; 179: 292-299, 2018 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-29310234

RESUMO

This work proposes the use of near infrared (NIR) spectroscopy in diffuse reflectance mode and multivariate statistical process control (MSPC) based on principal component analysis (PCA) for real-time monitoring of the coffee roasting process. The main objective was the development of a MSPC methodology able to early detect disturbances to the roasting process resourcing to real-time acquisition of NIR spectra. A total of fifteen roasting batches were defined according to an experimental design to develop the MSPC models. This methodology was tested on a set of five batches where disturbances of different nature were imposed to simulate real faulty situations. Some of these batches were used to optimize the model while the remaining was used to test the methodology. A modelling strategy based on a time sliding window provided the best results in terms of distinguishing batches with and without disturbances, resourcing to typical MSPC charts: Hotelling's T2 and squared predicted error statistics. A PCA model encompassing a time window of four minutes with three principal components was able to efficiently detect all disturbances assayed. NIR spectroscopy combined with the MSPC approach proved to be an adequate auxiliary tool for coffee roasters to detect faults in a conventional roasting process in real-time.


Assuntos
Café/química , Culinária , Análise de Alimentos/instrumentação , Modelos Estatísticos , Espectroscopia de Luz Próxima ao Infravermelho/estatística & dados numéricos , Estudos de Viabilidade , Análise de Alimentos/métodos , Humanos , Análise Multivariada , Análise de Componente Principal , Fatores de Tempo
5.
Braz. J. Pharm. Sci. (Online) ; 54(2): e17499, 2018. graf
Artigo em Inglês | LILACS | ID: biblio-1039034

RESUMO

ABSTRACT For the release of pharmaceutical products into the drug market; most of the pharmaceutical companies depend on acceptance criteria - that are set internally, regulatory and/or pharmacopeially. However, statistical process control monitoring is underestimated in most quality control in cases; although it is important not only for process stability and efficiency assessment but also for compliance with all appropriate pharmaceutical practices such as good manufacturing practice and good laboratory practice, known collectively as GXP. The current work aims to investigate two tablet inspection characteristics monitored during in-process control viz. tablet average weight and hardness. Both properties were assessed during the compression phase of the tablet and before the coating stage. Data gathering was performed by the Quality Assurance Team and processed by Commercial Statistical Software packages. Screening of collected results of 31 batches of an antibacterial tablet - based on Fluoroquinolone -showed that all the tested lots met the release specifications, although the process mean has been unstable which could be strongly evident in the variable control chart. Accordingly, the two inspected processes were not in the state of control and require strong actions to correct for the non-compliance to GXP. What is not controlled cannot be predicted in the future and thus the capability analysis would be of no value except to show the process capability retrospectively only. Setting the rules for the application of Statistical Process Control (SPC) should be mandated by Regulatory Agencies.


Assuntos
Comprimidos com Revestimento Entérico/análise , Comprimidos com Revestimento Entérico/normas , Preparações Farmacêuticas/normas , Interpretação Estatística de Dados , Fluoroquinolonas/normas , Composição de Medicamentos/métodos , Indústria Farmacêutica/classificação
6.
Anal Chim Acta ; 985: 41-53, 2017 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-28864193

RESUMO

A distillation device that acquires continuous and synchronized measurements of temperature, percentage of distilled fraction and NIR spectra has been designed for real-time monitoring of distillation processes. As a process model, synthetic commercial gasoline batches produced in Brazil, which contain mixtures of pure gasoline blended with ethanol have been analyzed. The information provided by this device, i.e., distillation curves and NIR spectra, has served as initial information for the proposal of new strategies of process modeling and multivariate statistical process control (MSPC). Process modeling based on PCA batch analysis provided global distillation trajectories, whereas multiset MCR-ALS analysis is proposed to obtain a component-wise characterization of the distillation evolution and distilled fractions. Distillation curves, NIR spectra or compressed NIR information under the form of PCA scores and MCR-ALS concentration profiles were tested as the seed information to build MSPC models. New on-line PCA-based MSPC approaches, some inspired on local rank exploratory methods for process analysis, are proposed and work as follows: a) MSPC based on individual process observation models, where multiple local PCA models are built considering the sole information in each observation point; b) Fixed Size Moving Window - MSPC, in which local PCA models are built considering a moving window of the current and few past observation points; and c) Evolving MSPC, where local PCA models are built with an increasing window of observations covering all points since the beginning of the process until the current observation. Performance of different approaches has been assessed in terms of sensitivity to fault detection and number of false alarms. The outcome of this work will be of general use to define strategies for on-line process monitoring and control and, in a more specific way, to improve quality control of petroleum derived fuels and other substances submitted to automatic distillation processes monitored by NIRS.

7.
Biom J ; 58(6): 1485-1505, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27645002

RESUMO

The use of control charts for monitoring schemes in medical context should consider adjustments to incorporate the specific risk for each individual. Some authors propose the use of a risk-adjusted survival time cumulative sum (RAST CUSUM) control chart to monitor a time-to-event outcome, possibly right censored, using conventional survival models, which do not contemplate the possibility of cure of a patient. We propose to extend this approach considering a risk-adjusted CUSUM chart, based on a cure rate model. We consider a regression model in which the covariates affect the cure fraction. The CUSUM scores are obtained for Weibull and log-logistic promotion time model to monitor a scale parameter for nonimmune individuals. A simulation study was conducted to evaluate and compare the performance of the proposed chart (RACUF CUSUM) with RAST CUSUM, based on optimal control limits and average run length in different situations. As a result, we note that the RAST CUSUM chart is inappropriate when applied to data with a cure rate, while the proposed RACUF CUSUM chart seems to have similar performance if applied to data without a cure rate. The proposed chart is illustrated with simulated data and with a real data set of patients with heart failure treated at the Heart Institute (InCor), at the University of São Paulo, Brazil.


Assuntos
Modelos Estatísticos , Sobreviventes/estatística & dados numéricos , Brasil , Simulação por Computador , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Humanos , Modelos Logísticos , Risco Ajustado , Fatores de Tempo
8.
Postgrad Med J ; 91(1076): 343-54, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26045562

RESUMO

Improvement (defined broadly as purposive efforts to secure positive change) has become an increasingly important activity and field of inquiry within healthcare. This article offers an overview of possible methods for the study of improvement interventions. The choice of available designs is wide, but debates continue about how far improvement efforts can be simultaneously practical (aimed at producing change) and scientific (aimed at producing new knowledge), and whether the distinction between the practical and the scientific is a real and useful one. Quality improvement projects tend to be applied and, in some senses, self-evaluating. They are not necessarily directed at generating new knowledge, but reports of such projects if well conducted and cautious in their inferences may be of considerable value. They can be distinguished heuristically from research studies, which are motivated by and set out explicitly to test a hypothesis, or otherwise generate new knowledge, and from formal evaluations of improvement projects. We discuss variants of trial designs, quasi-experimental designs, systematic reviews, programme evaluations, process evaluations, qualitative studies, and economic evaluations. We note that designs that are better suited to the evaluation of clearly defined and static interventions may be adopted without giving sufficient attention to the challenges associated with the dynamic nature of improvement interventions and their interactions with contextual factors. Reconciling pragmatism and research rigour is highly desirable in the study of improvement. Trade-offs need to be made wisely, taking into account the objectives involved and inferences to be made.

9.
BMJ Qual Saf ; 24(5): 325-36, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25810415

RESUMO

Improvement (defined broadly as purposive efforts to secure positive change) has become an increasingly important activity and field of inquiry within healthcare. This article offers an overview of possible methods for the study of improvement interventions. The choice of available designs is wide, but debates continue about how far improvement efforts can be simultaneously practical (aimed at producing change) and scientific (aimed at producing new knowledge), and whether the distinction between the practical and the scientific is a real and useful one. Quality improvement projects tend to be applied and, in some senses, self-evaluating. They are not necessarily directed at generating new knowledge, but reports of such projects if well conducted and cautious in their inferences may be of considerable value. They can be distinguished heuristically from research studies, which are motivated by and set out explicitly to test a hypothesis, or otherwise generate new knowledge, and from formal evaluations of improvement projects. We discuss variants of trial designs, quasi-experimental designs, systematic reviews, programme evaluations, process evaluations, qualitative studies, and economic evaluations. We note that designs that are better suited to the evaluation of clearly defined and static interventions may be adopted without giving sufficient attention to the challenges associated with the dynamic nature of improvement interventions and their interactions with contextual factors. Reconciling pragmatism and research rigour is highly desirable in the study of improvement. Trade-offs need to be made wisely, taking into account the objectives involved and inferences to be made.


Assuntos
Avaliação de Processos e Resultados em Cuidados de Saúde/métodos , Melhoria de Qualidade/organização & administração , Projetos de Pesquisa , Humanos
10.
Sci. agric. ; 70(6)2013.
Artigo em Inglês | VETINDEX | ID: vti-440741

RESUMO

Quality control is used to evaluate processes and products, and is a powerful tool for reducing variability. The objective of this study was to evaluate the quality of green sugarcane (Saccharum spp.) cutting for mechanized harvest, using statistical quality control tools. Cutting height and damage to ratoon stalks caused by different blade and disc combinations of the basecutter mechanism were used as indicators of quality. Cutting height showed high variability with a controlled process for some treatments. However, these treatments were incapable of producing satisfactory results. The damage index was lower in treatments that used tilted blades, but above the target for all treatments, which caused significant damage to the ratoons. In general, the process of mechanized harvest as assessed by these indicators was found incapable of achieving targeted results and staying below specification limits, and thus requires corrective actions to improve quality.

11.
Sci. agric ; 70(6)2013.
Artigo em Inglês | LILACS-Express | VETINDEX | ID: biblio-1497370

RESUMO

Quality control is used to evaluate processes and products, and is a powerful tool for reducing variability. The objective of this study was to evaluate the quality of green sugarcane (Saccharum spp.) cutting for mechanized harvest, using statistical quality control tools. Cutting height and damage to ratoon stalks caused by different blade and disc combinations of the basecutter mechanism were used as indicators of quality. Cutting height showed high variability with a controlled process for some treatments. However, these treatments were incapable of producing satisfactory results. The damage index was lower in treatments that used tilted blades, but above the target for all treatments, which caused significant damage to the ratoons. In general, the process of mechanized harvest as assessed by these indicators was found incapable of achieving targeted results and staying below specification limits, and thus requires corrective actions to improve quality.

12.
Rev. ciênc. farm. básica apl ; Rev. ciênc. farm. básica apl;33(4)dez. 2012.
Artigo em Português | LILACS | ID: lil-667052

RESUMO

No processo de blistagem, a formação de resíduos é quase inevitável devido à própria dinâmica e o tipo de matéria prima usada no sistema. Neste trabalho, foi realizada uma análise de resíduos de blister no processo de blistagem na Divisão de Sólidos multipropósito, abordando o tipo de equipamento utilizado no processo, as características do produto formado, os principais fatores envolvidos na geração dos resíduos, e sua quantidade gerada nos lotes analisados. Foi empregada a ferramenta CEP para a análise dos resultados. Apesar de todas as variações encontradas, que avaliaram estabilidade e capacidade dos processos, todos os lotes foram aprovados frente às especificações farmacopeicas. No entanto, há provas de que o processo precisa ser melhorado e pode tornar-se mais eficiente, gerando uma economia para empresa.


In the blister packaging process, the formation of waste is almost inevitable, given the dynamics and type of raw material used in the system. In this study, an analysis of blister waste in the blistering process was carried out in the multipurpose solids Division of a pharmaceutical laboratory, with respect to the type of blister-packing machine used in the process, the characteristics of the product manufactured, the main factors involved in the generation of waste and the amount of waste in the batches analyzed. The SPC tool was used to analyze the results. Despite all the variations found in the graphical analysis of stability and process capacity, all batches complied with the pharmacopeial specifications. However, there is evidence that the process should be improved and could be made more efficient, generating savings for the company.


Assuntos
Indústria Farmacêutica/estatística & dados numéricos , Indústria Farmacêutica/métodos , Indústria Farmacêutica/organização & administração , Controle de Qualidade , Comprimidos , Resíduos
13.
Rev. ciênc. farm. básica apl ; Rev. ciênc. farm. básica apl;33(2)ago. 2012.
Artigo em Português | LILACS | ID: lil-655395

RESUMO

O Controle Estatístico de Processo (CEP) é uma ferramenta bastante utilizada para auxiliar no controle da qualidade de parâmetros físicos como peso médio, dureza e friabilidade. Através das cartas de controle é possível detectar desvios dos parâmetros do processo, reduzindo a quantidade de produtos fora da especificação e, consequentemente, os custos da produção. A avaliação de trinta lotes de ibuprofeno em uma indústria farmacêutica, utilizando controle estatístico de processo, permitiu o fornecimento de informações imprescindíveis para a investigação detalhada dos pontos críticos do processo, diagnosticando as possíveis não conformidades na etapa de compressão deste fármaco. Desta maneira, podem-se propor atividades de melhoria, através da identificação e eliminação das causas especiais de variação no processo, com a finalidade de produzir comprimidos com qualidade.


The statistical process control (SPC) is a widely used tool to assist in quality control physical parameters like weight, hardness and friability. Through the control charts it is possible to detect deviations of process parameters, reducing the amount of products out of specification and, consequently, costs of production. The evaluation of thirty lots of ibuprofen in a pharmaceutical company using statistical process control has enabled the provision of essential information for the detailed investigation of the critical points of the process, diagnosing the possible non-conformities in the compression step of the drug. Thus, one can offer improvement activities by identifying and eliminating special causes of variation in the process, in order to produce quality tablets.


Assuntos
Indústria Farmacêutica , Ibuprofeno , Tecnologia Farmacêutica
14.
Rev. ciênc. farm. básica apl ; Rev. ciênc. farm. básica apl;32(1)2011.
Artigo em Português | LILACS | ID: lil-593798

RESUMO

Investigou-se, através de histogramas e cartas de controle X e S, a ferramenta do Controle Estatístico de Processo (CEP) univariado e os parâmetros físicos dureza, peso médio e friabilidade da produção de dez lotes de dipirona sódica comprimidos. Por sua complexidade e influência no processo, a etapa de granulação de cada lote foi concomitantemente caracterizada através de determinações de densidade bruta, densidade compactada, índice de compressibilidade e fator de Hausner, além dos ângulos de repouso, tempos de escoamento e repartições granulométricas. As caracterizações dos granulados serviram como base na investigação da possível influência da etapa de granulação como uma das prováveis causas que poderiam levar o processo a se apresentar fora de controle estatístico. Os resultados da caracterização indicaram certa uniformidade entre os granulados, o que pode significar que não há ligação aparente entre a etapa de granulação e a falta de controle estatístico do processo, demonstrada na avaliação das cartas de controle. Na medida em que permitiu uma maior compreensão do processo, o CEP univariado mostrou sua importância no monitoramento da produção de comprimidos.


In this study, by means of histograms and and s control charts, the production control tool, univariate Statistical Process Control (SPC), was assessed for monitoring the physical variables hardness, weight and friability during the production of ten batches of sodium dipyrone tablets. In view of its complexity and influence on the process, the granulation step was concurrently characterized by determining the gross density, compacted density, compressibility index and Hausner factor, plus the angle of repose, flow time and particle size distributions of each batch. The properties of the granules were used as a basis for testing the hypothesis that the granulation step is probably the cause when the process runs out of statistical control. The results of the characterization indicated a degree of uniformity among the granules, which may mean that the lack of statistical process control demonstrated in the control charts does not arise from the granulation step. To the extent that it enabled a greater understanding of the process, univariate SCP proved its importance in the monitoring of tablet production.


Assuntos
Composição de Medicamentos/métodos , Dipirona , Indústria Farmacêutica/métodos , Fenômenos Químicos/métodos , Controle de Qualidade
15.
Sci. agric. ; 67(6)2010.
Artigo em Inglês | VETINDEX | ID: vti-440517

RESUMO

The mechanized harvest of sugar cane (Saccharum officinarum L.) in Brazil is an irreversible trend and it comes with a great concern about the quality of the cane delivered to the industry. A key component to quality is the billet length which affects the processing of raw material, cane deterioration, invisible losses and load density of transport vehicles. Thus, due to the importance of the billet standard in quality and cost of raw material, this study aimed to evaluate if the mechanized harvesting of sugar cane can supply the quality requirements for the crushing process, regarding the billet length. A plot with burnt sugar cane (3.2 ha) and another one with green sugar cane (8.0 ha) were selected to be harvested by two (2) self-propelled sugar cane harvesters. For each harvested 0.4 ha a sample from each infield wagon was collected. The sample was composed by ten billets. The variability in burnt sugar cane was higher than in green sugar cane, and both harvesters did not present the capacity of keeping the billets with similar lengths when operating either in burnt or green conditions.


A colheita mecanizada de cana-de-açúcar (Saccharum officinarum L.) no Brasil é uma tendência irreversível e junto a ela vem à preocupação com a qualidade da matéria-prima que chega à indústria. O tamanho de rebolos tem influência nessa qualidade por afetar o processo de deterioração da cana, perdas invisíveis e a densidade de carga no transbordo e transporte. Considerando-se a importância do padrão do rebolo na qualidade e custo da matéria-prima, avaliou-se se a colheita mecanizada de cana-de-açúcar pode atender às exigências de qualidade da moagem no que se refere ao indicador tamanho de rebolo. Para tanto, uma área de cana queimada (3,2 ha) e outra de cana crua (8,0 ha) foram selecionadas. As áreas foram colhidas por duas colhedoras automotrizes. Para cada colhedora e área, uma amostra a cada 0,4 ha colhidos foi coletada, junto ao conjunto de transbordo e cada amostra era composta por dez rebolos. Os resultados foram analisados por meio de gráficos de controle, e a capacidade do processo de corte foi determinada. Houve maior variabilidade na condição de cana queimada em relação à cana crua, e que ambas as colhedoras não têm a capacidade de manter os rebolos em tamanhos semelhantes, quando operando nessas duas condições diferentes.

16.
Sci. agric ; 67(6)2010.
Artigo em Inglês | LILACS-Express | VETINDEX | ID: biblio-1497120

RESUMO

The mechanized harvest of sugar cane (Saccharum officinarum L.) in Brazil is an irreversible trend and it comes with a great concern about the quality of the cane delivered to the industry. A key component to quality is the billet length which affects the processing of raw material, cane deterioration, invisible losses and load density of transport vehicles. Thus, due to the importance of the billet standard in quality and cost of raw material, this study aimed to evaluate if the mechanized harvesting of sugar cane can supply the quality requirements for the crushing process, regarding the billet length. A plot with burnt sugar cane (3.2 ha) and another one with green sugar cane (8.0 ha) were selected to be harvested by two (2) self-propelled sugar cane harvesters. For each harvested 0.4 ha a sample from each infield wagon was collected. The sample was composed by ten billets. The variability in burnt sugar cane was higher than in green sugar cane, and both harvesters did not present the capacity of keeping the billets with similar lengths when operating either in burnt or green conditions.


A colheita mecanizada de cana-de-açúcar (Saccharum officinarum L.) no Brasil é uma tendência irreversível e junto a ela vem à preocupação com a qualidade da matéria-prima que chega à indústria. O tamanho de rebolos tem influência nessa qualidade por afetar o processo de deterioração da cana, perdas invisíveis e a densidade de carga no transbordo e transporte. Considerando-se a importância do padrão do rebolo na qualidade e custo da matéria-prima, avaliou-se se a colheita mecanizada de cana-de-açúcar pode atender às exigências de qualidade da moagem no que se refere ao indicador tamanho de rebolo. Para tanto, uma área de cana queimada (3,2 ha) e outra de cana crua (8,0 ha) foram selecionadas. As áreas foram colhidas por duas colhedoras automotrizes. Para cada colhedora e área, uma amostra a cada 0,4 ha colhidos foi coletada, junto ao conjunto de transbordo e cada amostra era composta por dez rebolos. Os resultados foram analisados por meio de gráficos de controle, e a capacidade do processo de corte foi determinada. Houve maior variabilidade na condição de cana queimada em relação à cana crua, e que ambas as colhedoras não têm a capacidade de manter os rebolos em tamanhos semelhantes, quando operando nessas duas condições diferentes.

17.
Rev. ciênc. farm. básica apl ; Rev. ciênc. farm. básica apl;31(1)2010.
Artigo em Português | LILACS | ID: lil-560258

RESUMO

A aplicação do controle estatístico para monitorar o desempenho da etapa de envase de formas farmacêuticas líquidas consiste em obter informações e estabelecer estratégias para a validação do processo, assim como possibilitar o gerenciamento deste a partir da percepção do comportamento das variáveis críticas do produto durante a produção. Esta etapa do processo possui como variável crítica o volume de envase. Variações neste parâmetro fora dos limites de qualidade pré-estabelecidos pela legislação refletem ineficiências durante o processo podendo ocasionar a reprovação do produto. Para demonstrar de forma objetiva o grau de segurança requerida para este tipo de processo foram utilizadas ferramentas do controle estatístico de processo (CEP) para estudar e validar o desempenho da etapa de envase da tintura de iodo fabricada pela indústria farmacêutica Lapon Química e Natural Ltda. (Limoeiro - PE, Brasil), bem como verificar a estabilidade estatística e capacidade do processo. As atividades de melhoria, através da identificação e eliminação das causas especiais de variação do processo, permitiram a redução de sua variabilidade, assegurando uma melhoria contínua da qualidade nos resultados da produção.


Statistical control is used to monitor the performance of the fill phase in the manufacture of liquid pharmaceutical forms, to obtain information and establish criteria for process validation, as well as to enable control of the process, by observing the behavior of the critical variables during production. The critical variable at this stage of the process is the filling volume. Variations in this parameter outside the established legal quality limits reflect inefficiency in the process that may result in product rejection. To demonstrate objectively the degree of security required in this type of process, statistical process control (SPC) tools were used to study and validate the performance of the fill phase in production of iodine tincture by the Pharmaceutical manufacturer Lapon Química e Natural Ltda. (Limoeiro - PE, Brazil), as well as to check the statistical stability and capacity of the process. Optimization of the process, by identifying and removing the specific causes of variation, led to a reduction in its variability, ensuring a continual improvement in the quality of production.


Assuntos
Humanos , Embalagem de Medicamentos , Iodo
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