An evaluation of occupational health risk assessment methodologies from South African enterprises: noise risk assessment field study

Background: The South African occupational health and safety regulations, prescribing risk assessments be conducted by employers, are non-prescriptive with regard to the tools and techniques to be used. Consequently, companies freely adopt the numerous available tools and techniques from which risk management decisions are derived. Thus, risk management, ensuing from the results derived from these tools and techniques, is likely to vary from company to company. Objective: The objective of the study was to evaluate risk assessment processes and methodologies that are used and recorded in noise risk assessment reports, in four manufacturing companies. Methods: This was a case study, whereby risk assessment records were obtained from four South African companies with different operational units, from the manufacturing and utilities sectors. Results: There were inter- and intra-company variations in the processes related to the legal context in which the risk assessments were conducted, the risk assessment tools and techniques used, the risk criteria definitions, the statements about the effectiveness of controls in use, and the risk evaluation outcomes. Inter- and intra-company variations in risk rankings and risk prioritisation outcomes were also observed ­ a consequence of the risk perceptions of the assessors assigning a risk level to the noise hazard. In some instances, the adopted risk assessment tools and techniques categorised the risk from noise that was at or above regulated health and safety standards as 'insignificant', which those companies used as justification for taking no further measures to eliminate or reduce the risk. Conclusion: The use of different risk assessment processes, tools and techniques resulted in some facilities categorising noise as an insignificant hazard, which may contribute to high noise emissions and uncontrolled exposures.

Research on Influencing Factors of Drug Clinical Trial Risks in China Based on Literature Analysis / 中国医学伦理学

【Objective:】 To sort out the influencing factors of drug clinical trial risks and improve the risk management level of drug clinical trials in China. 【Methods:】 The literature analysis method was used to sort out the literature related to the risk management of drug clinical trials in China, and the text analysis method was used to summarize and refine the influencing factors of drug clinical trial risks. 【Results:】 The risk categories of drug clinical trials were divided into 5 parts, namely drug clinical trial institution management, ethics committee management, clinical trial designs, researchers, and subjects, involving 13 main risk influencing factors and 21 specific risk points. 【Conclusion:】 By strengthening the construction of drug clinical trial institutions and ethical management capabilities, optimizing research protocol design, enhancing researchers’ awareness and ability, and establishing a subject management system to improve the quality of drug clinical trials.

Risks and suggestions of Investigator-Initiated Clinical Trial approvals based on drug supply and security / 中华医学科研管理杂志

Objective:To improve the standard and quality of clinical trials, the possible risks of Investigator-Initiated Clinical Trial(IIT) approvals based on drug supply and security were discussed and suggestions were put forward.Methods:According to the laws and regulations and literature review, concerning experimental drug supply and security during project negotiation, the risk points of IIT approvals were comprehensively analyzed and suggestions were put forward.Results:There are four main types of risks in assessing IIT approvals in terms of drug supply and security: drug entry and sales, drug promotion, discounts of observation fees, and concept confusion. Healthcare institutions should pay attention to and coordinate the IIT approvals.Conclusions:IIT is a supplement and extension of Industry Sponsored Trial(IST), which should be actively carried out by healthcare institutions while also paying attention to the security and risk prevention of drug supply, ensuring a standardized and orderly manner.

Noise exposure abatement: a perspective from industry occupational health risk assessment reports

Background: Occupational health risk assessments are building blocks for occupational health programmes, allowing for the rating of identified risks and the continuous re-evaluation of the effectiveness of abatement measures. In South African industry, occupational health risk assessments are formally documented in reports, which can be presented as demonstration of legal compliance with legislation. Objective: To identify noise abatement measures recorded in noise risk assessment reports of four manufacturing companies and to rate their effectiveness. Methods: We analysed the occupational health risk assessment reports from 21 operational facilities in four South African companies from the manufacturing and utilities sectors to evaluate, through document analysis, the recorded noise abatement measures. Noise abatement measure effectiveness was rated using a preassigned effectiveness percentage scale. Results: Administrative controls and hearing protection devices were the most commonly used noise exposure abatement measures, but hearing conservation programmes were generally poorly formulated. There were inter- and intra-company differences in the qualitative risk assessment approaches used for rating or ranking the noise risk, which led to different risk conclusions and prioritisation outcomes. The calculated control effectiveness of the abatement measures showed that noise exposure remained largely unacceptable: 16 of the 21 operational units had unacceptable noise exposures, four had tolerable exposures, and one had broadly acceptable exposures. Conclusion: The four companies' common noise abatement measures, as elements of formalised hearing conservation programmes, which included administrative controls and hearing protection devices, were not effective in reducing noise exposure to the broadly acceptable level, reflective of limited use of engineering controls.

Risk Identification and Evaluation of Clinical Trials of I nnovative Drugs under New Policy Environment / 中国药房

OBJECTIVE：To identify and evaluate the risk factors of innovative drug clinical trials ，and to provide references for the development of risk management and control strategies. METHODS ：Using the method of literature research ，the risk factors of innovative drug clinical trials were obtained ，classified and sorted out ，and the risk evaluation indicators were initially formed. On this basis ，the questionnaire was designed. By means of interview and questionnaire survey ，54 experts were invited from 4 tertiary hospitals and 1 contract research organization to score. SPSS 24.0 software was used to perform principal component analysis on risk event status data. RESULTS & CONCLUSIONS ：The risk evaluation system included 9 first-class indicators such as policy and legal risk ，clinical trial institution risk and trial scheme design risk ，and 31 second-class indicators such as industrial policy，law and regulation changes ，intellectual property risk . According to the analysis ，the risk factors of innovative drug clinical trials mainly included drug and biological sample management risk ，trial scheme design risk ，clinical trial institution risk ，safety report management risk ，ethical review risk ，policy and legal risk ，and subject management risk. Relevant parties in clinical trials need to focus on monitoring various risk factors ，establish dynamic monitoring and control mechanism and implementation guarantee mechanism ，and effectively prevent and control risk ，to promote the smooth implementation of clinical trials.

Detección de problemas alimentarios y su relación con hábitos alimentarios en adolescentes / Detection of eating problems and their relationship with eating habits in adolescents

Resumen El propósito de este trabajo fue hacer la detección de probables casos de trastornos de la conducta alimentaria (TCA) en adolescentes, así como analizar su relación con los hábitos alimentarios (HA) dentro del contexto escolar. Participaron 3,144 alumnos/as (49.7% chicas y 50.3% chicos), con edades entre 13 y 17 años (M = 14.41, DE = 0.79). Fueron registradas distintas variables: sociodemográficas, índice de masa corporal (IMC) e ingesta alimentaria, además de aplicar el Cuestionario de Actitudes Alimentarias (EAT-40) y el Cuestionario de Imagen Corporal (BSQ). Se identificaron diferencias significativas en EAT-40 y BSQ, con una mayor proporción de chicas vs. chicos que superaron el punto de corte. Respecto al IMC, aunque la mayoría estaba en normopeso, el 17.6% tuvo infrapeso, 20.4% sobrepeso y 7.1% obesidad. El 5.6% de todos los participantes fueron identificados como probables casos de TCA, con una mayor proporción de mujeres (9.6%) que de hombres (1.8%). No hubo correlación con los HA, pero sí mayor proporción de chicas que consumían menos alimentos y bebidas durante el desayuno y el recreo. Un dato alarmante es que 5.6% de las chicas y 2.5% de los chicos no consumían nada durante toda la mañana escolar.

Abstract A study of detection of probable cases of eating disorders (ED) in teenagers, studying their possible relationship with their dietary habits (DH) in the school context has been carried out. The participants were 3,144 students (49.7 % girls and 50.3 % boys) aged between 13 and 17 years old (M = 14.41, SD = 0.79). Different variables were recorded: sociodemographic, body mass index (BMI) and dietary intake, in addition to applying the Eating Attitudes Questionnaire (EAT-40) and the Body Shape Questionnaire (BSQ). Significant differences were identified in EAT-40 and BSQ, with a greater proportion of girls vs. boys exceeding the cut-off point. Regarding the BMI, although most were in normal weight, the 17.6% were underweight, 20.4% overweight and 7.1% obese. Based on all the data, 5.6% of all participants were identified as probable cases of ED, with a higher proportion of women (9.6%) that men (1.8%). There was no correlation with DH, but there were a higher proportion of girls who consumed less food and beverages during breakfast and recess. An alarming fact is that 5.6% of girls and 2.5% of boys did not consume anything during the whole school time.

Research on Fault Risk Identification and Control of CT Simulator Based on FMEA / 中国医疗器械杂志

OBJECTIVE@#To explore the high-risk fault risk of CT simulator and the main causes of the risk, and to put forward effective risk management strategies.@*METHODS@#The failure mode and effect analysis method was used to identify and control the operational fault risk of CT simulator.@*RESULTS@#5 major fault components, 8 fault failure models and 17 failure causes were analyzed. The top 5 failure causes are:anode target surface burn caused by direct scanning without warming up the tube (590.4), tube failure (518.2), burnout of joints caused by aging of high voltage cables (424.2), motor carbon brush wear (304.8) and belt break (296.4).@*CONCLUSIONS@#The failure mode and effect analysis method can effectively identify the risk of equipment failure, and thus specifically formulate risk management and control measures to ensure the normal operation of equipment and the safety of doctors and patients.

Scientific research project management of common risks and countermeasures / 中华医学科研管理杂志

The project's scientific research project to improve the smooth knot problem for the credibility of Research management sector is very important,but in fact some of the project is not only the project node title,or because of subjective and objective factors that lead to project failure,brought credibility to the project undertaking unit loss.This common scientific research project on risk analysis and identification,reporting that the project's adverse reporting motivation,the strength of the research team,project costs capability,scientific research project of the natural properties of the risk,as well as technical and scientific research platform so may result in risk project delay or failure.Articles from Research management policies,systems,methods,attitude problem-a response.