Sobre a implantação de boas práticas de distribuição de produtos médicos de acordo com a RDC nº 59 de 27 de junho de 2000 - ANVISA e NBR ISO 9001:2000

Pós-graduação em Ciências Farmacêuticas - FCFAR

Levantamento para a implantação de um sistema de gestão da qualidade segundo a norma NBR ISO/IEC 17025:2005 no Laboratório de celulose e papel da UNESP-Itapeva

The aim of this study is to perform a situational analysis of the Laboratory of pulp and paper-UNESP ITAPEVA for conducting proposal the accreditation according to ISO / IEC 17025:2005. The ISO / IEC 17025 establishes the criteria for those laboratories wishing to demonstrate their technical competence, which have an effective quality system and are able to generate technically valid results, establishing a single international standard for certifying the competence of laboratories to carry tests and / or calibrations, including sampling. The case study was conducted on laboratory Pulp and Paper Universidade Estadual Paulista (UNESP), campus Itapeva, where we compared the views of the technician responsible for the laboratory and a regular user. The generated conclusion is that the laboratory is unable to initiate an accreditation process, because it fails the requirements such as quality manual, register of subcontractors, research of customer satisfaction, schedule of internal audits, schedule for completion of critical analysis, profile of the functions required, functions current description, documentation of technical requirements for accommodation and environmental conditions, calibration programs, equipment calibration program, programs calibration standards and reports and / or certificate of test and / or calibration, that are in accordance with ISO / IEC 17025:2005, beyond that there is not the possibility to develop and implement a quality system without the commitment of everyone involved, regardless of the functional hierarchy

Impacto da ABNT NBR 15575 na qualidade da construção civil

The quality in construction is increasingly a concern in this sector, in view of the occurrence of problems in civil works, even when a contractor is certified by ISO 9001. The ISO 9001 certification does not ensure the maintenance of quality because it only establishes the requirements for a quality management system (QMS) to ensure standardization of processes and products. With the development of ISO 15575, standard performance, the builders took on a quality parameter with the requirements established by this Standard, which must be met. Thus, the implementation of a quality management system (QMS) becomes essential, showing users the concern for quality. This study aimed to verify, through a case study, the impact of NBR 15575 quality construction and how that standard of performance may be the key element of ISO 9001 to ensure quality maintenance of civil works

Análise da ABNT NBR ISO 14005:2012 como instrumento de implementação de sistemas de gestão ambiental em pequenas e médias empresas

The use of environmental management systems - EMS has shown to be a key tool for addressing the environmental aspects and impacts of an organization. The vast majority of EMS based on the requirements of ISO 14001:2004, as it is a globally recognized standard and adopt its recommendations is considered to be a guarantee of fulfilling the basic requirements of an EMS. Despite all the benefits that the system provides, we still find many problems in the implementation of EMS, especially in small and medium enterprises or SME. Most of the difficulties of implementation is related to intrinsic factors that companies of this size have, and issues related to the models and methods used to implement an EMS. Thus, this work aimed to assess whether the guidelines of ISO 14005:2012 meet the needs of SMEs for the effective implementation of an environmental management system. For it has been identified in the relation between SMEs and EMS the majof intrinsic problems of SMEs to implement (PII), such as lack of financial and human resources, and lack of commitment from top management to the SGA. Also was also pointed the main implementation issues related to ISO 14001 (ABNT, 2004) or the models or methods (PIM), highlighting the lack of environmental performance criteria, and the need for a path or sequence of steps for implementation. The study of ISO 14005 (ABNT, 2012) showed that the standard guidelines and implementation examples proposed, include solutions for all problems related to EMS implementation SMEs

Aplicação de sistema de gestão da qualidade na execução de obras de pavimentação asfáltica, baseado nas diretrizes da ABNT NBR ISO 9001:2008

This work brings to its content proposed deployment of a system of quality management in paving asphalt based on the elaboration of a basic training to meet those entering this area of civil engineering at a technical manual for the implementation of major services running on paving of roads. The training was designed to serve both those entering the field of asphalt paving, synthesizing the complex processes involved in paving services and providing an overview of the steps in implementation thereof, as well as entrants must meet the enterprise user of this system, providing them an idea of the method used by the company designing the paving of roads. The technical manual presented in turn, has 8 (eight) of the main services components of a work of paving, which are: Mobilization and Maintenance of construction site, Regularization and subfloor preparation, execution or sub-base BGS base (graded gravel plain), Execution of sub-base or base BGTC (graded gravel treated with cement), Implementation of subbase or base Macadam hydraulic Priming bituminous waterproofing, asphalt binder Priming and finally the execution flexible pavement - HMA (hot milled asphalt concrete). These services are presented in the form of IT-Education work, this seven items are presented that guide the performance of services, thus providing overall guidelines to perform the services described in it. The development of IT's was based on experiences in day-to-day paving near the theoretical precepts presented in the literature, so the conditions specified in these documents aim to always guide the implementation of services in general, giving the process a versatility major operation, as this work takes into account the dynamics of such services, as well as the variety of their execution according to local conditions and specified in the project. So in general we can say that this ... (Complete abstract click electronic access below)

Atendimento à norma NBR 12.209/2011 na implantação de uma Estação de Tratamento de Esgotos no município de Guaratinguetá (SP)

The progressive growth of the population and the increase of sewage generated has demanded of society and public policies that, besides the collection network deployment is carried out the treatment and proper disposal of treated sewage in all brazilian municipalities. The aim of this study was to monitor and evaluate the work of implementation of a Sewage Treatment Plant (STP) in Guaratinguetá city of São Paulo state, to identify the compliance with legal requirements and the NBR 12,209/2011. The construction of this ETE met all the requirements of NBR 12209/2011 and benefited a large portion of population with the sewage treatment. Based on the results of this assessment it was concluded that the construction of a STP is relatively simple, differing only on the legal requirements related to the location, area for the construction and materials used in the work. The knowledge generated in this study will assist the public policies in the implementation of STPs in municipalities that do not yet have this basic sanitation

A Review of the Brazilian NBR 15575 Standard: Applying the Simulation and Simplified Methods for Evaluating a Social House Thermal Performance

The new Brazilian ABNT NBR 15575 Standard (the ―Standard‖) recommends two methods for analyzing housing thermal performance: a simplified and a computational simulation method. The aim of this paper is to evaluate both methods and the coherence between each. For this, the thermal performance of a low-cost single-family house was evaluated through the application of the procedures prescribed by the Standard. To accomplish this study, the EnergyPlus software was selected. Comparative analyses of the house with varying envelope U-values and solar absorptance of external walls were performed in order to evaluate the influence of these parameters on the results. The results have shown limitations in the current Standard computational simulation method, due to different aspects: weather files, lack of consideration of passive strategies, and inconsistency with the simplified method. Therefore, this research indicates that there are some aspects to be improved in this Standard, so it could better represent the real thermal performance of social housing in Brazil.

Considerações de interesse sobre a avaliação em laboratório de elementos estruturais em situação de incêndio: contribuições à revisão da NBR 5628:2001

Existe um crescente interesse sobre a pesquisa sobre a segurança das estruturas em situação de incêndio no Brasil, mas ainda existem aspectos que carecem de discussão. A simulação e avaliação em laboratório de elementos estruturais em situação de incêndio é um desses aspectos, principalmente no que diz respeito à metodologia de ensaio. A norma técnica brasileira NBR 5628:2001 necessita de revisão com vistas à adaptação das metodologias internacionais à realidade brasileira ou, até mesmo, à definição de novas metodologias que considerem variáveis relevantes para o contexto local. Este trabalho apresenta um ponto de partida para essas discussões e reúne os parâmetros que norteiam os procedimentos metodológicos para a avaliação de elementos estruturais, em escala natural, com carga, e em situação de incêndio. Parâmetros de interesse como dimensões mínimas dos elementos, taxas de elevação de temperatura com o tempo, infraestrutura para o ensaio, instrumentação dos elementos estruturais, entre outros, são avaliados à luz da normalização nacional e internacional vigente. Espera-se que este trabalho forneça subsídios para a futura revisão da NBR 5628:2001 e estimule pesquisadores brasileiros a ingressar nessa nova e árdua linha de pesquisa.

Shear force and torsion in reinforced concrete beam elements: theoretical analysis based on Brazilian Standard Code ABNT NBR 6118:2007

Reinforced concrete beam elements are submitted to applicable loads along their life cycle that cause shear and torsion. These elements may be subject to only shear, pure torsion or both, torsion and shear combined. The Brazilian Standard Code ABNT NBR 6118:2007 [1] fixes conditions to calculate the transverse reinforcement area in beam reinforced concrete elements, using two design models, based on the strut and tie analogy model, first studied by Mörsch [2]. The strut angle θ (theta) can be considered constant and equal to 45º (Model I), or varying between 30º and 45º (Model II). In the case of transversal ties (stirrups), the variation of angle α (alpha) is between 45º and 90º. When the equilibrium torsion is required, a resistant model based on space truss with hollow section is considered. The space truss admits an inclination angle θ between 30º and 45º, in accordance with beam elements subjected to shear. This paper presents a theoretical study of models I and II for combined shear and torsion, in which ranges the geometry and intensity of action in reinforced concrete beams, aimed to verify the consumption of transverse reinforcement in accordance with the calculation model adopted As the strut angle on model II ranges from 30º to 45º, transverse reinforcement area (Asw) decreases, and total reinforcement area, which includes longitudinal torsion reinforcement (Asℓ), increases. It appears that, when considering model II with strut angle above 40º, under shear only, transverse reinforcement area increases 22% compared to values obtained using model I.

Fundações de construções submetidas a esforços de tração em solo de alta porosidade da região de Campinas - SP

This paper presents the behavior of three bored piles conducted in diabasic soil submitted to uplift forces. The piles were built at the site for Experimental Studies in Soil Mechanics and Foundations of UNICAMP, located in the city of Campinas, Brazil. Field tests have already been conducted at the site (SPT, CPT, DMT and PMT), as well as laboratory tests by using sample soils taken from a well up to 17 m deep. The water table is not checked until a depth of 17 m. In order to check the behavior of the piles when submitted to uplift forces, slow static load tests were carried out as the recommendations of NBR 12131. The carrying capacity of these piles was also provided by means of theoretical methods, appropriate for uplift forces, and through semi-empirical methods appropriate for compression forces, considering only the portion of lateral resistance. The values estimated by using the considered methods were compared to those obtained by means of load tests. One of the tested piles was extracted from the soil to be the subject of a study on its geometry.

EVALUATING VIBRATIONS ON A SMALL-SCALE MODEL OF A TIMBER FOOTBRIDGE

In Brazil, the study of pedestrian-induced vibration on footbridges has been undertaken since the early 1990s, for concrete and steel footbridges. However, there are no recorded studies of this kind for timber footbridges. Brazilian code ABNT NBR 7190 (1997) gives design requirements only for static loads in the case of timber footbridges, without considering the serviceability limit state from pedestrian-induced vibrations. The aim of this work is to perform a theoretical dynamic, numerical and experimental analysis on simply-supported timber footbridges, by using a small-scale model developed from a 24 m span and 2 m width timber footbridge, with two main timber beams. Span and width were scaled down (1:4) to 6 m e 0.5 in, respectively. Among the conclusions reached herein, it is emphasized that the Euler-Bernoulli beam theory is suitable for calculating the vertical and lateral first natural frequencies in simply-supported timber footbridges; however, special attention should be given to the evaluation of lateral bending stiffness, as it leads to conservative values.