Study on the Application of Quality Risk Management on Drug Collinear Production

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.

Risk-based water quality decision-making under small data using Bayesian network

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.

HV Process Model of Software Development

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. .

Surpassing the Limits to Human Cognition?On the Level of Detail in the Norwegian Building Design Guides

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.

Risk assessment of Giardia from a full scale MBR sewage treatment plant caused by membrane integrity failure

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.