975 resultados para Product safety.


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Transportation Systems Center, Cambridge, Mass.

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Includes papers describing research sponsored by the Office of Nuclear Regulatory Research, NRC.

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Warranty is an important element of marketing new products. The servicing of warranty results in additional costs to the manufacturer. Warranty logistics deals with various issues relating to the servicing of warranty. Proper management of warranty logistics is needed not only to reduce the warranty servicing cost but also to ensure customer satisfaction as customer dissatisfaction has a negative impact on sales and revenue. Unfortunately, warranty logistics has received very little attention. The paper links the literature on warranty and on logistics and then discusses the different issues in warranty logistics. It highlights the challenges and identifies some research topics of potential interest to operational researchers. (C) 2003 Elsevier B.V. All rights reserved.

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Most consumers consider complementary and alternative medicine (CAM) products inherently safe. The growing simultaneous use of CAM products and pharmaceutical drugs by Australian consumers increases the risk of CAM-drug interactions. The Therapeutic Goods Administration (TGA) has a two-tier, risk-based regulatory system for therapeutic goods - CAM products are regulated as low risk products and are assessed for quality and safety; and sponsors of products must hold the evidence for any claim of efficacy made about them. Adverse reactions to CAM products can be classified as intrinsic (innate to the product), or extrinsic (where the risk is not related to the product itself, but results from the failure of good manufacturing practice). Adverse reactions to CAM practices can be classified as risks of commission (which includes removal of medical therapy) and risks of omission (which includes failure to refer when appropriate). While few systematic studies of adverse events with CAM exist, and under-reporting is likely, most CAM products and practices do not appear to present a high risk; their safety needs to be put into the perspective of wider safety issues. A priority for research is to rigorously define the risks associated with both CAM products and practices so that their potential impact on public health can be assessed.

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In the case of surgical scalpels, blade retraction and disposability have been incorporated into a number of commercial designs to address sharps injury and infection transmission issues. Despite these new designs, the traditional metal reusable scalpel is still extensively used and this paper attempts to determine whether the introduction of safety features has compromised the ergonomics and so potentially the take-up of the newer designs. Examples of scalpels have been analysed to determine the ergonomic impact of these design changes. Trials and questionnaires were carried out using both clinical and non-clinical user groups, with the trials making use of assessment of incision quality, cutting force, electromyography and video monitoring. The results showed that ergonomic performance was altered by the design changes and that while these could be for the worse, the introduction of safety features could act as a catalyst to encourage re-evaluation of the ergonomic demands of a highly traditional product.

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Objective - To evaluate long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration (nAMD). Design - Twenty-four–month, open-label, multicenter, phase IV extension study. Participants - Two hundred thirty-four patients previously treated with ranibizumab for 12 months in the EXCITE/SUSTAIN study. Methods - Ranibizumab 0.5 mg administered at the investigator's discretion as per the European summary of product characteristics 2007 (SmPC, i.e., ranibizumab was administered if a patient experienced a best-corrected visual acuity [BCVA] loss of >5 Early Treatment Diabetic Retinopathy Study letters measured against the highest visual acuity [VA] value obtained in SECURE or previous studies [EXCITE and SUSTAIN], attributable to the presence or progression of active nAMD in the investigator's opinion). Main Outcome Measures - Incidence of ocular or nonocular adverse events (AEs) and serious AEs, mean change in BCVA from baseline over time, and the number of injections. Results - Of 234 enrolled patients, 210 (89.7%) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months. Approximately 42% of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8%; 1 event related to study drug), cataract (11.5%; 1 event related to treatment procedure), and increased intraocular pressure (6.4%; 1 event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6% of patients; none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0% each). Arterial thromboembolic events were reported in 5.6% of the patients. Five (2.1%) deaths occurred during the study, none related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline. Conclusions - The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the European ranibizumab SmPC at the investigator's discretion was well tolerated over 2 years. No new safety signals were identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study baseline, which may be the result of disease progression or possible undertreatment.

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Software product line modeling aims at capturing a set of software products in an economic yet meaningful way. We introduce a class of variability models that capture the sharing between the software artifacts forming the products of a software product line (SPL) in a hierarchical fashion, in terms of commonalities and orthogonalities. Such models are useful when analyzing and verifying all products of an SPL, since they provide a scheme for divide-and-conquer-style decomposition of the analysis or verification problem at hand. We define an abstract class of SPLs for which variability models can be constructed that are optimal w.r.t. the chosen representation of sharing. We show how the constructed models can be fed into a previously developed algorithmic technique for compositional verification of control-flow temporal safety properties, so that the properties to be verified are iteratively decomposed into simpler ones over orthogonal parts of the SPL, and are not re-verified over the shared parts. We provide tool support for our technique, and evaluate our tool on a small but realistic SPL of cash desks.

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A relatively high proportion of harvested seafood is still wasted due to spoilage, particularly in developing countries, or because they are by-catches or have little economic value, seemingly related to inherent problems linked to unattractive color, flavor, texture, small size, and high-fat content. Thus, many fish and seafood species are still underutilized.

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Quality management provides to companies a framework to improve quality in overall systems, reduction of costs, reallocation of resources efficiently, correct planning of strategies, prevent or correct errors in the right time and increase the performance of companies. In this text, we discuss the different theories in this field, their obligatory or non-obligatory compliance, the importance of quality management for exporting companies and a case study of a Colombian firm that its main objective is to manage quality. In conclusion, we find out that there is different types of quality management systems such as Juran’s trilogy, Deming 14 points, Six sigma, HACCP, and so on; also that companies have to manage suppliers and that quality has a positive influence on exports volume; in the case of Colombian small and medium enterprises, it can be mentioned that the majority has implemented tools regarding quality management but is not enough.

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The behavior of the hydroxyl units of synthetic goethite and its dehydroxylated product hematite was characterized using a combination of Fourier transform infrared (FTIR) spectroscopy and X-ray diffraction (XRD) during the thermal transformation over a temperature range of 180-270 degrees C. Hematite was detected at temperatures above 200 degrees C by XRD while goethite was not observed above 230 degrees C. Five intense OH vibrations at 3212-3194, 1687-1674, 1643-1640, 888-884 and 800-798 cm(-1), and a H2O vibration at 3450-3445 cm(-1) were observed for goethite. The intensity of hydroxyl stretching and bending vibrations decreased with the extent of dehydroxylation of goethite. Infrared absorption bands clearly show the phase transformation between goethite and hematite: in particular. the migration of excess hydroxyl units from goethite to hematite. Two bands at 536-533 and 454-452 cm(-1) are the low wavenumber vibrations of Fe-O in the hematite structure. Band component analysis data of FTIR spectra support the fact that the hydroxyl units mainly affect the a plane in goethite and the equivalent c plane in hematite.

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This paper presents a preliminary study on the dielectric properties and curing of three different types of epoxy resins mixed at various stichiometric mixture of hardener, flydust and aluminium powder under microwave energy. In this work, the curing process of thin layers of epoxy resins using microwave radiation was investigated as an alternative technique that can be implemented to develop a new rapid product development technique. In this study it was observed that the curing time and temperature were a function of the percentage of hardener and fillers presence in the epoxy resins. Initially dielectric properties of epoxy resins with hardener were measured which was directly correlated to the curing process in order to understand the properties of cured specimen. Tensile tests were conducted on the three different types of epoxy resins with hardener and fillers. Modifying dielectric properties of the mixtures a significant decrease in curing time was observed. In order to study the microstructural changes of cured specimen the morphology of the fracture surface was carried out by using scanning electron microscopy.

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This paper investigates the effectiveness of virtual product placement as a marketing tool by examining the relationship between brand recall and recognition and virtual product placement. It also aims to address a gap in the existing academic literature by focusing on the impact of product placement on recall and recognition of new brands. The growing importance of product placement is discussed and a review of previous research on product placement and virtual product placement is provided. The research methodology used to study the recall and recognition effects of virtual product placement are described and key findings presented. Finally, implications are discussed and recommendations for future research provided.