Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dos...Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.展开更多
The effects of cast iron pipe corrosion onwater quality risk and microbial ecology in drinking water distribution systems(DWDSs)were investigated.It was found that trihalomethane(THMs)concentration and antibiotic resi...The effects of cast iron pipe corrosion onwater quality risk and microbial ecology in drinking water distribution systems(DWDSs)were investigated.It was found that trihalomethane(THMs)concentration and antibiotic resistance genes(ARGs)increased sharply in the old DWDSs.Under the same residual chlorine concentration conditions,the adenosine triphos-phate concentration in the effluent of old DWDSs(Eff-old)was significantly higher than that in the effluent of newDWDSs.Moreover,stronger bioflocculation ability andweaker hy-drophobicity coexisted in the extracellular polymeric substances of Eff-old,meanwhile,iron particles could be well inserted into the structure of the biofilms to enhance the mechanical strength and stability of the biofilms,hence enhancing the formation of THMs.Old DWDSs significantly influenced the microbial community of bulk water and triggered stronger mi-crobial antioxidant systems response,resulting in higher ARGs abundance.Corroded cast iron pipes induced a unique interaction system of biofilms,chlorine,and corrosion prod-ucts.Therefore,as the age of cast iron pipes increases,the fluctuation of water quality and microbial ecology should be paid more attention to maintain the safety of tap water.展开更多
A knowledge-based network for Section Yidong Bridge,Dongyang River,one tributary of Qiantang River,Zhejiang Province,China,is established in order to model water quality in areas under small data.Then,based on normal ...A knowledge-based network for Section Yidong Bridge,Dongyang River,one tributary of Qiantang River,Zhejiang Province,China,is established in order to model water quality in areas under small data.Then,based on normal transformation of variables with routine monitoring data and normal assumption of variables without routine monitoring data,a conditional linear Gaussian Bayesian network is constructed.A "two-constraint selection" procedure is proposed to estimate potential parameter values under small data.Among all potential parameter values,the ones that are most probable are selected as the "representatives".Finally,the risks of pollutant concentration exceeding national water quality standards are calculated and pollution reduction decisions for decision-making reference are proposed.The final results show that conditional linear Gaussian Bayesian network and "two-constraint selection" procedure are very useful in evaluating risks when there is limited data and can help managers to make sound decisions under small data.展开更多
Software Development Life Cycle (SDLC) is one of the major ingredients for the development of efficient software systems within a time frame and low-cost involvement. From the literature, it is evident that there are ...Software Development Life Cycle (SDLC) is one of the major ingredients for the development of efficient software systems within a time frame and low-cost involvement. From the literature, it is evident that there are various kinds of process models that are used by the software industries for the development of small, medium and long-term software projects, but many of them do not cover risk management. It is quite obvious that the improper selection of the software development process model leads to failure of the software products as it is time bound activity. In the present work, a new software development process model is proposed which covers the risks at any stage of the development of the software product. The model is named a Hemant-Vipin (HV) process model and may be helpful for the software industries for development of the efficient software products and timely delivery at the end of the client. The efficiency of the HV process model is observed by considering various kinds of factors like requirement clarity, user feedback, change agility, predictability, risk identification, practical implementation, customer satisfaction, incremental development, use of ready-made components, quick design, resource organization and many more and found through a case study that the presented approach covers many of parameters in comparison of the existing process models. .展开更多
The SINTEF Building Research Design Guides are a series of Norwegian building technical recommendations.The design guides are highly reputed and widely used in the Norwegian construction sector,serving as a link betwe...The SINTEF Building Research Design Guides are a series of Norwegian building technical recommendations.The design guides are highly reputed and widely used in the Norwegian construction sector,serving as a link between the technical regulations and the design process of the individual construction project.This paper examines the element of risk in the use of multiple design guides to extract information about a topic not explicitly covered by any single guide,using the example of blue-green roofs.The research has been conducted in the form of a document study.While the advice given in the design guides is both valid and coherent,the amount of information presented is likely to be overwhelming for industry professionals.There are great degrees of awareness of quality risk present in the individual design guides,but an overall risk picture is not presented.Input from the fields of project management and psychology can help develop risk awareness strategies.The design guides may benefit from an aggregate level of information,where main technical challenges are grouped into super-level categories.展开更多
Membrane bioreactors（MBR） are highly efficient at intercepting particles and microbes and have become an important technology for wastewater reclamation. However, many pathogens can accumulate in activated sludge du...Membrane bioreactors（MBR） are highly efficient at intercepting particles and microbes and have become an important technology for wastewater reclamation. However, many pathogens can accumulate in activated sludge due to the long residence time usually adopted in MBR, and thus may pose health risks when membrane integrity problems occur.This study presents data from a survey on the occurrence of water-borne Giardia pathogens in reclaimed water from a full-scale wastewater treatment plant with MBR experiencing membrane integrity failure, and assessed the associated risk for green space irrigation. Due to membrane integrity failure, the MBR effluent turbidity varied between 0.23 and 1.90 NTU over a period of eight months. Though this turbidity level still met reclaimed water quality standards（≤ 5 NTU）, Giardia were detected at concentrations of 0.3 to 95 cysts/10 L, with a close correlation between effluent turbidity and Giardia concentration. All β-giardin gene sequences of Giardia in the WWTP influents were genotyped as Assemblages A and B, both of which are known to infect humans. An exponential dose–response model was applied to assess the risk of infection by Giardia. The risk in the MBR effluent with chlorination was9.83 × 10-3, higher than the acceptable annual risk of 1.0 × 10^-4. This study suggested that membrane integrity is very important for keeping a low pathogen level, and multiple barriers are needed to ensure the biological safety of MBR effluent.展开更多
文摘Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.
基金supported by the National Natural Science Foundation of China(Nos.52000043,and 51838005)the intro-duced innovative R&D team project under the“The Pearl River Talent Recruitment Program”of Guangdong Province(No.2019ZT08L387)+2 种基金the Guangdong Natural Science Foundation(No.2023A1515011509)the Science and Technology Research Project of Guangzhou(Nos.202201020177,202102020986 and 202102021044)the special fund from Key Laboratory of Drinking Water Science and Technology,Research Center for Eco-Environmental Sciences,Chinese Academy of Sciences(No.20K01KLDWST).
文摘The effects of cast iron pipe corrosion onwater quality risk and microbial ecology in drinking water distribution systems(DWDSs)were investigated.It was found that trihalomethane(THMs)concentration and antibiotic resistance genes(ARGs)increased sharply in the old DWDSs.Under the same residual chlorine concentration conditions,the adenosine triphos-phate concentration in the effluent of old DWDSs(Eff-old)was significantly higher than that in the effluent of newDWDSs.Moreover,stronger bioflocculation ability andweaker hy-drophobicity coexisted in the extracellular polymeric substances of Eff-old,meanwhile,iron particles could be well inserted into the structure of the biofilms to enhance the mechanical strength and stability of the biofilms,hence enhancing the formation of THMs.Old DWDSs significantly influenced the microbial community of bulk water and triggered stronger mi-crobial antioxidant systems response,resulting in higher ARGs abundance.Corroded cast iron pipes induced a unique interaction system of biofilms,chlorine,and corrosion prod-ucts.Therefore,as the age of cast iron pipes increases,the fluctuation of water quality and microbial ecology should be paid more attention to maintain the safety of tap water.
基金Project(50809058)supported by the National Natural Science Foundation of China
文摘A knowledge-based network for Section Yidong Bridge,Dongyang River,one tributary of Qiantang River,Zhejiang Province,China,is established in order to model water quality in areas under small data.Then,based on normal transformation of variables with routine monitoring data and normal assumption of variables without routine monitoring data,a conditional linear Gaussian Bayesian network is constructed.A "two-constraint selection" procedure is proposed to estimate potential parameter values under small data.Among all potential parameter values,the ones that are most probable are selected as the "representatives".Finally,the risks of pollutant concentration exceeding national water quality standards are calculated and pollution reduction decisions for decision-making reference are proposed.The final results show that conditional linear Gaussian Bayesian network and "two-constraint selection" procedure are very useful in evaluating risks when there is limited data and can help managers to make sound decisions under small data.
文摘Software Development Life Cycle (SDLC) is one of the major ingredients for the development of efficient software systems within a time frame and low-cost involvement. From the literature, it is evident that there are various kinds of process models that are used by the software industries for the development of small, medium and long-term software projects, but many of them do not cover risk management. It is quite obvious that the improper selection of the software development process model leads to failure of the software products as it is time bound activity. In the present work, a new software development process model is proposed which covers the risks at any stage of the development of the software product. The model is named a Hemant-Vipin (HV) process model and may be helpful for the software industries for development of the efficient software products and timely delivery at the end of the client. The efficiency of the HV process model is observed by considering various kinds of factors like requirement clarity, user feedback, change agility, predictability, risk identification, practical implementation, customer satisfaction, incremental development, use of ready-made components, quick design, resource organization and many more and found through a case study that the presented approach covers many of parameters in comparison of the existing process models. .
基金This research was funded by the Research Council of Norway,grant number 237859.The authors gratefully acknowledge the financial support by the Research Council of Norway and several partners through the Centre of Research-based Innovation“Klima 2050”(www.klima2050.no).
文摘The SINTEF Building Research Design Guides are a series of Norwegian building technical recommendations.The design guides are highly reputed and widely used in the Norwegian construction sector,serving as a link between the technical regulations and the design process of the individual construction project.This paper examines the element of risk in the use of multiple design guides to extract information about a topic not explicitly covered by any single guide,using the example of blue-green roofs.The research has been conducted in the form of a document study.While the advice given in the design guides is both valid and coherent,the amount of information presented is likely to be overwhelming for industry professionals.There are great degrees of awareness of quality risk present in the individual design guides,but an overall risk picture is not presented.Input from the fields of project management and psychology can help develop risk awareness strategies.The design guides may benefit from an aggregate level of information,where main technical challenges are grouped into super-level categories.
基金supported by the Creative Research Groups of China (No. 51221892, 21277169)
文摘Membrane bioreactors（MBR） are highly efficient at intercepting particles and microbes and have become an important technology for wastewater reclamation. However, many pathogens can accumulate in activated sludge due to the long residence time usually adopted in MBR, and thus may pose health risks when membrane integrity problems occur.This study presents data from a survey on the occurrence of water-borne Giardia pathogens in reclaimed water from a full-scale wastewater treatment plant with MBR experiencing membrane integrity failure, and assessed the associated risk for green space irrigation. Due to membrane integrity failure, the MBR effluent turbidity varied between 0.23 and 1.90 NTU over a period of eight months. Though this turbidity level still met reclaimed water quality standards（≤ 5 NTU）, Giardia were detected at concentrations of 0.3 to 95 cysts/10 L, with a close correlation between effluent turbidity and Giardia concentration. All β-giardin gene sequences of Giardia in the WWTP influents were genotyped as Assemblages A and B, both of which are known to infect humans. An exponential dose–response model was applied to assess the risk of infection by Giardia. The risk in the MBR effluent with chlorination was9.83 × 10-3, higher than the acceptable annual risk of 1.0 × 10^-4. This study suggested that membrane integrity is very important for keeping a low pathogen level, and multiple barriers are needed to ensure the biological safety of MBR effluent.
