975 resultados para Product safety.
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Shipping list no.: 93-0419-P.
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Shipping list no.: 90-463-P.
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"NIIC-0600-75-H006."
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The authors use social control theory to develop a conceptual model that addresses the effectiveness of regulatory agencies’ (e.g., Food and Drug Administration, Occupational Safety and Health Administration) field-level efforts to obtain conformance with product safety laws. Central to the model are the control processes agencies use when monitoring organizations and enforcing the safety rules. These approaches can be labeled formal control (e.g., rigid enforcement) and informal control (e.g., social instruction). The theoretical framework identifies an important antecedent of control and the relative effectiveness of control’s alternative forms in gaining compliance and reducing opportunism. Furthermore, the model predicts that the regulated firms’ level of agreement with the safety rules moderates the relationships between control and firm responses. A local health department’s administration of state food safety regulations provides the empirical context for testing the hypotheses. The results from a survey of 173 restaurants largely support the proposed model. The study findings inform a discussion of effective methods of administering product safety laws. The authors use social control theory to develop a conceptual model that addresses the effectiveness of regulatory agencies’ (e.g., Food and Drug Administration, Occupational Safety and Health Administration) field-level efforts to obtain conformance with product safety laws. Central to the model are the control processes agencies use when monitoring organizations and enforcing the safety rules. These approaches can be labeled formal control (e.g., rigid enforcement) and informal control (e.g., social instruction). The theoretical framework identifies an important antecedent of control and the relative effectiveness of control’s alternative forms in gaining compliance and reducing opportunism. Furthermore, the model predicts that the regulated firms’ level of agreement with the safety rules moderates the relationships between control and firm responses. A local health department’s administration of state food safety regulations provides the empirical context for testing the hypotheses. The results from a survey of 173 restaurants largely support the proposed model. The study findings inform a discussion of effective methods of administering product safety laws.
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New Approach’ Directives now govern the health and safety of most products whether destined for workplace or domestic use. These Directives have been enacted into UK law by various specific legislation principally relating to work equipment, machinery and consumer products. This research investigates whether the risk assessment approach used to ensure the safety of machinery may be applied to consumer products. Crucially, consumer products are subject to the Consumer Protection Act (CPA) 1987, where there is no direct reference to “assessing risk”. This contrasts with the law governing the safety of products used in the workplace, where risk assessment underpins the approach. New Approach Directives are supported by European harmonised standards, and in the case of machinery, further supported by the risk assessment standard, EN 1050. The system regulating consumer product safety is discussed, its key elements identified and a graphical model produced. This model incorporates such matters as conformity assessment, the system of regulation, near miss and accident reporting. A key finding of the research is that New Approach Directives have a common feature of specifying essential performance requirements that provide a hazard prompt-list that can form the basis for a risk assessment (the hazard identification stage). Drawing upon 272 prosecution cases, and with thirty examples examined in detail, this research provides evidence that despite the high degree of regulation, unsafe consumer products still find their way onto the market. The research presents a number of risk assessment tools to help Trading Standards Officers (TSOs) prioritise their work at the initial inspection stage when dealing with subsequent enforcement action.
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This thesis has been concerned with obtaining evidence to explore the proposition that the provision of occupational health services as arranged at the present time represents a misallocation of resources. The research has been undertaken within the occupational health service of a large Midlands food factory. As the research progressed it became evident that questions were being raised about the nature and scope of occupational health as well as the contribution, in combating danger at work, that occupational health services can make to the health and safety team. These questions have been scrutinized in depth, as they are clearly important, and a resolution of the problem of the definition of occupational health has been proposed. I have taken the approach of attempting to identify specific objectives or benefits of occupational health activities so that it is possible to assess how far these objectives are being achieved. I have looked at three aspects of occupational health; audiometry, physiotherapy and pre-employment medical examinations as these activities embody crucial concepts which are common to all activities in an occupational health programme. A three category classification of occupational health activities is proposed such that the three activities provide examples within each category. These are called personnel therapy, personnel input screening and personnel throughput screening. I conclude that I have not shown audiometry to be cost-effective. My observations of the physiotherapy service lead me to support the suggestion that there is a decline in sickness absence rates due to physiotherapy in industry. With pre-employment medical examinations I have shown that the service is product safety oriented and that benefits are extremely difficult to identify. In regard to the three services studied, in the one factory investigated, and because of the immeasurability of certain activities, I find support for the proposition that the mix of occupational health services as provided at the present time represents a misallocation of resources.
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Considering the plant biodiversity in the Brazilian Northeast, whose components can be inserted into sustainable production systems, the jujube (Ziziphus joazeiro Mart.) emerges as to recovery of its fruit. The present study has as objective to characterize the fruit of the jujube under the physical, physicochemical and chemical approach and assess its conservation by spontaneous lactic fermentation under the influence of chloride, sodium, calcium and potassium. According to the legislation, vegetable acidified by fermentation that is subjected to lactic acid fermentation in order to achieve a final product pH less than or equal to 4.5. The results of the physical, chemical and physico-chemistry of ripe fruit jujube showed the potential of this species for agro-processing. The yield of edible portion (91.83%), soluble solids content (18,98º Brix), titratable acidity (0.14% citric acid), pH (5.30) and its composition, divided in moisture (79.01%), protein (2.01%), lipids (0.52%), carbohydrate (17.59%), fiber, ash (0.76%) and its minerals were consistent with the characteristic profile fruits, thus favoring the development of spontaneous lactic fermentation. The minimum pH and titratable acidity observed maximum in the fermentation process under the influence of mixtures of salts (NaCl and KCl NaCl2) values ranged from 3.4 to 3.7 and from 0.54 to 0.95 (% lactic acid), respectively. The profile of the lactic fermentation of fruit of jujube in brine, fermented microbiological quality and the result of analysis of primary sensory prepared preserved, the application of endorsed by the consumer sensory evaluation, more particularly, derived from fermented fruit preserved in the presence of chloride sodium, in accordance with the traditional techniques of lactic fermentation of vegetables. The results of sensory evaluation conducted with 100 consumers (tasters) revealed an acceptance rate equal to 78% of the preserve. Despite restrictions on the sensory acceptability of fermented under the influence of salts (KCl and CaCl2) substitutes sodium chloride, preserved these perspectives presented to balance the optimization of mixtures, health product safety and consumer awareness towards prefer a more healthy product with reduced sodium content.
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2016
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(PDF has 75 pages)
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Objective. The purpose of this study was to evaluate the effectiveness and safety of misoprostol in two different formulations: vaginal tablets of 25 mu g and one-eighth of a 200-mu g oral tablet, also administered intravaginally, for cervical ripening and labor induction of term pregnancies with an indication for that. Methods. A single-blind, randomized, controlled clinical trial was carried out in 120 pregnant women who randomly received one of the two formulations. The main dependent variables were mode of delivery, need for additional oxytocin, time between beginning of induction and delivery, perinatal results, complications, and maternal side effects. Student's t, Mann-Whitney, chi(2), Fisher's Exact, Wilcoxon and Kolmogorov-Smirnoff tests, as well as survival analysis, were used in the data analysis. Results. There were no significant differences between the groups in terms of general characteristics, uterine contractility, and fetal well-being during labor, cesarean section rates, perinatal outcomes, or maternal adverse events. The mean time between the beginning of cervical ripening and delivery was 31.3 h in the vaginal tablet group and 30.1 h in the oral tablet group, a difference that was not statistically significant. Conclusion. The results showed that the 25-mu g vaginal tablets of misoprostol were as effective and safe for cervical ripening and labor induction as the dose-equivalent fraction of 200-mu g oral tablets.
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"B-278739"--P. 1.
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Objective: Five double-blind, randomized, saline-controlled trials (RCTs) were included in the United States marketing application for an intra-articular hyaluronan (IA-HA) product for the treatment of osteoarthritis (OA) of the knee. We report an integrated analysis of the primary Case Report Form (CRF) data from these trials. Method. Trials were similar in design, patient population and outcome measures - all included the Lequesne Algofunctional Index (LI), a validated composite index of pain and function, evaluating treatment over 3 months. Individual patient data were pooled; a repeated measures analysis of covariance was performed in the intent-to-treat (ITT) population. Analyses utilized both fixed and random effects models. Safety data from the five RCTs were summarized. Results: A total of 1155 patients with radiologically confirmed knee OA were enrolled: 619 received three or five IA-HA injections; 536 received. placebo saline injections. In the active and control groups, mean ages were 61.8 and 61.4 years; 62.4% and 58.8% were women; baseline total Lequesne scores 11.03 and 11.30, respectively. Integrated analysis of the pooled data set found a statistically significant reduction (P < 0.001) in total Lequesne score with hyaluronan (HA) (-2.68) vs placebo (-2.00); estimated difference -0.68 (95% CI: -0.56 to -0.79), effect size 0.20. Additional modeling approaches confirmed robustness of the analyses. Conclusions: This integrated analysis demonstrates that multiple design factors influence the results of RCTs assessing efficacy of intra-articular (IA) therapies, and that integrated analyses based on primary data differ from meta-analyses using transformed data. (C) 2006 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
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Water-filled portable road safety barriers are a common fixture in road works, however their use of water can be problematic, both in terms of the quantity of water used and the transportation of the water to the installation site. This project aims to develop a new design of portable road safety barrier, which will make novel use of composite and foam materials in order to reduce the barrier’s reliance on water in order to control errant vehicles. The project makes use of finite element (FE) techniques in order to simulate and evaluate design concepts. FE methods and models that have previously been tested and validated will be used in combination in order to provide the most accurate numerical simulations available to drive the project forward. LS-DYNA code is as highly dynamic, non-linear numerical solver which is commonly used in the automotive and road safety industries. Several complex materials and physical interactions are to be simulated throughout the course of the project including aluminium foams, composite laminates and water within the barrier during standardised impact tests. Techniques to be used include FE, smoothed particle hydrodynamics (SPH) and weighted multi-parameter optimisation techniques. A detailed optimisation of several design parameters with specific design goals will be performed with LS-DYNA and LS-OPT, which will require a large number of high accuracy simulations and advanced visualisation techniques. Supercomputing will play a central role in the project, enabling the numerous medium element count simulations necessary in order to determine the optimal design parameters of the barrier to be performed. Supercomputing will also allow the development of useful methods of visualisation results and the production of highly detailed simulations for end-product validation purposes. Efforts thus far have been towards integrating various numerical methods (including FEM, SPH and advanced materials models) together in an efficient and accurate manner. Various designs of joining mechanisms have been developed and are currently being developed into FE models and simulations.