The importance of risk thinking is emphasized in the ISO quality management system.In order to do a good job in quality management,we should use risk thinking to do a good job in risk management,improve the level of q...The importance of risk thinking is emphasized in the ISO quality management system.In order to do a good job in quality management,we should use risk thinking to do a good job in risk management,improve the level of quality management,and enhance customer satisfaction,so that enterprises can meet the international quality certification standards in the process of development,and have greater development space in the market.Therefore,this paper studies the risk thinking in the ISO quality management system,summarizes the concept of risk thinking in the ISO quality management system,analyzes the problems existing in the application of risk thinking in the ISO quality management system of Chinese enterprises,and puts forward some suggestions for improvement one by one.It is hoped that the analysis can promote Chinese enterprises to fully integrate risk-based thinking into quality management,calmly cope with risks and opportunities,and make customers more satisfied with their services and products.展开更多
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
In recent years, the method of TQM (Total Quality Management) is widely recognized. However, contents of target entities for assessment are various, and it is very difficult to define the whole scope of TQM. On the ot...In recent years, the method of TQM (Total Quality Management) is widely recognized. However, contents of target entities for assessment are various, and it is very difficult to define the whole scope of TQM. On the other hand, it is very important to define the whole target entities of quality management about the TQM because lack of important target entities may cause significant risk of loss in future. Furthermore, target entities of TQM should correspond to needs and priority of an objective requirement and that should be based on the consideration of basic principle of quality management. In the previous study, we have proposed the “framework of new TQM” of assessment for a total quality management of organizations based on the original concept of “TQM matrix”. On the other hand, we have proposed the view point of “Three-Dimensional Unification Value Models” for an evaluation of system product. Therefore, in this paper, we propose the target entities of whole assessment of quality management of organization totally based on the consideration of “New TQM framework” and the view point of “Three-Dimensional Unification Value Models”. Also, this paper proposes the result of verification based on the result of comparison between proposed target entities of assessment and American Malcolm Baldrige Prize for Performance Excellence.展开更多
In this study, interval-parameter programming, two-stage stochastic progranaming （TSP）, and conditional value-at-risk （CVaR） were incorporated into a general optimization framework, leading to an interval-paramete...In this study, interval-parameter programming, two-stage stochastic progranaming （TSP）, and conditional value-at-risk （CVaR） were incorporated into a general optimization framework, leading to an interval-parameter CVaR-based two-stage programming （ICTP） method. The ICTP method had several advantages： （i） its objective function simultaneously took expected cost and risk cost into consideration, and also used discrete random variables and discrete intervals to reflect uncertain properties; （ii） it quantitatively evaluated the right tail of distributions of random variables which could better calculate the risk of violated environmental standards; （iii） it was useful for helping decision makers to analyze the trade-offs between cost and risk; and （iv） it was effective to penalize the second-stage costs, as well as to capture the notion of risk in stochastic programming. The developed model was applied to sulfur dioxide abatement in an air quality management system. The results indicated that the ICTP method could be used for generating a series of air quality management schemes under different risk-aversion levels, for identifying desired air quality management strategies for decision makers, and for considering a proper balance between system economy and environmental quality.展开更多
The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to it...The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.展开更多
In the previous study, we suggested the concept of new TQM based on the consideration of basic concept of Quality Control. Also, in the previous study, we suggested the target domains and entities of product and proce...In the previous study, we suggested the concept of new TQM based on the consideration of basic concept of Quality Control. Also, in the previous study, we suggested the target domains and entities of product and process based on the TQM Matrix and view point of Three Dimensional Unification Value Models for managing quality of organization systems. Furthermore, in the previous study, we suggest the Common Management Process of organizations. Based on the above suggestion, in this paper, we would like to propose the Common Management Process Model of Total Quality Management based on the consideration of situation analysis and more precise definition of TQM Matrix and Three Dimensional Unification Value Model of “Product and Process”. Improvement of quality and efficiency of organization management can be expected by the integration of conventional different management such as quality assurance, quality improvement, risk management, investment individually from the view point of common management process.展开更多
`The application of sewage sludge(SS)to forested lands may lead to the downward migration of potentially toxic elements(PTEs)through rainfall and thus pose risk to the subsoil and groundwater.Batch column experiments ...`The application of sewage sludge(SS)to forested lands may lead to the downward migration of potentially toxic elements(PTEs)through rainfall and thus pose risk to the subsoil and groundwater.Batch column experiments were conducted using leaching water equivalent to the rainfall amount in the study area over 3 years to investigate changes in concentrations of PTEs,including copper(Cu),zinc(Zn),lead(Pb),cadmium(Cd),and nickel(Ni)in the leachate from the acidic forest soil.Water quality index of leachate,potential ecological risk and human health risk in soil at different leaching stages were compared.Sewage sludge was applied at SS/soil mass ratios of 0:100(controls),15:85(T1),30:70(T2),45:55(T3),60:40(T4),and 75:25(T5).All treatments resulted in increased PTEs concentration in the upper 20 cm soil,T3-T5 increased potential ecological risk from"low"(control)to"moderate"or"considerable".During first year leaching,PTEs concentration increased with increasing SS/soil ratios,but the water quality index of T1-T3 was"excellent"or"good".Pb,Cu,Cd,and Ni in the 20-40 cm soil depth,and Zn in the 60-80 cm soil depth were also enriched,but potential ecological risk was"low".In subsequent leaching,PTEs concentration of leachate gradually returned to the background value and water quality index was"excellent".There were no significant changes in PTEs and ecological risk observed.During the monitoring process,the health risk caused by the migration of PTEs to the human body was always within the acceptable range.Overall,this study provides a reference for the management of risks from the application of SS on forestlands,i.e.,SS/soil ratios<45:55 is recommended on forestlands,and special attention should be given to early leaching risk.In addition,it also provides an important assessment method for the risk of PTEs leaching and migration in forested land application.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
目的探讨重症监护室(intensive care unit,ICU)住院患者中应用循环质控理念联合风险管理模式的效果。方法选取2023年1—5月寿光市人民医院ICU住院患者335例作为对照组,实施常规医院感染管理;选取2023年6—12月ICU住院患者340例作为干预...目的探讨重症监护室(intensive care unit,ICU)住院患者中应用循环质控理念联合风险管理模式的效果。方法选取2023年1—5月寿光市人民医院ICU住院患者335例作为对照组,实施常规医院感染管理;选取2023年6—12月ICU住院患者340例作为干预组,实施循环质控理念联合风险管理模式。比较2组管理质量、风险事件、医院感染发生率及患者满意度。结果干预组管理质量(感染监测、组织管理、风险评估、制度建设)评分高于对照组(P<0.05);干预组风险事件发生率(1.47%)低于对照组(4.48%)(P<0.05);干预组医院感染发生率(3.82%)低于对照组(7.46%)(P<0.05);干预组患者满意度(98.24%)低于对照组(95.52%)(P<0.05)。结论循环质控理念联合风险管理模式应用于ICU住院患者中,可提高管理质量,减少风险事件与医院感染发生,促进患者满意度提升,体现了《ICU十大安全目标》的执行标准。展开更多
文摘The importance of risk thinking is emphasized in the ISO quality management system.In order to do a good job in quality management,we should use risk thinking to do a good job in risk management,improve the level of quality management,and enhance customer satisfaction,so that enterprises can meet the international quality certification standards in the process of development,and have greater development space in the market.Therefore,this paper studies the risk thinking in the ISO quality management system,summarizes the concept of risk thinking in the ISO quality management system,analyzes the problems existing in the application of risk thinking in the ISO quality management system of Chinese enterprises,and puts forward some suggestions for improvement one by one.It is hoped that the analysis can promote Chinese enterprises to fully integrate risk-based thinking into quality management,calmly cope with risks and opportunities,and make customers more satisfied with their services and products.
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.
文摘In recent years, the method of TQM (Total Quality Management) is widely recognized. However, contents of target entities for assessment are various, and it is very difficult to define the whole scope of TQM. On the other hand, it is very important to define the whole target entities of quality management about the TQM because lack of important target entities may cause significant risk of loss in future. Furthermore, target entities of TQM should correspond to needs and priority of an objective requirement and that should be based on the consideration of basic principle of quality management. In the previous study, we have proposed the “framework of new TQM” of assessment for a total quality management of organizations based on the original concept of “TQM matrix”. On the other hand, we have proposed the view point of “Three-Dimensional Unification Value Models” for an evaluation of system product. Therefore, in this paper, we propose the target entities of whole assessment of quality management of organization totally based on the consideration of “New TQM framework” and the view point of “Three-Dimensional Unification Value Models”. Also, this paper proposes the result of verification based on the result of comparison between proposed target entities of assessment and American Malcolm Baldrige Prize for Performance Excellence.
文摘In this study, interval-parameter programming, two-stage stochastic progranaming （TSP）, and conditional value-at-risk （CVaR） were incorporated into a general optimization framework, leading to an interval-parameter CVaR-based two-stage programming （ICTP） method. The ICTP method had several advantages： （i） its objective function simultaneously took expected cost and risk cost into consideration, and also used discrete random variables and discrete intervals to reflect uncertain properties; （ii） it quantitatively evaluated the right tail of distributions of random variables which could better calculate the risk of violated environmental standards; （iii） it was useful for helping decision makers to analyze the trade-offs between cost and risk; and （iv） it was effective to penalize the second-stage costs, as well as to capture the notion of risk in stochastic programming. The developed model was applied to sulfur dioxide abatement in an air quality management system. The results indicated that the ICTP method could be used for generating a series of air quality management schemes under different risk-aversion levels, for identifying desired air quality management strategies for decision makers, and for considering a proper balance between system economy and environmental quality.
文摘The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.
文摘In the previous study, we suggested the concept of new TQM based on the consideration of basic concept of Quality Control. Also, in the previous study, we suggested the target domains and entities of product and process based on the TQM Matrix and view point of Three Dimensional Unification Value Models for managing quality of organization systems. Furthermore, in the previous study, we suggest the Common Management Process of organizations. Based on the above suggestion, in this paper, we would like to propose the Common Management Process Model of Total Quality Management based on the consideration of situation analysis and more precise definition of TQM Matrix and Three Dimensional Unification Value Model of “Product and Process”. Improvement of quality and efficiency of organization management can be expected by the integration of conventional different management such as quality assurance, quality improvement, risk management, investment individually from the view point of common management process.
基金supported by National Natural Science Foundation of China(grant nos.31971629,42007335)Natural Science Foundation of Guangdong Province(2021A1515012157)。
文摘`The application of sewage sludge(SS)to forested lands may lead to the downward migration of potentially toxic elements(PTEs)through rainfall and thus pose risk to the subsoil and groundwater.Batch column experiments were conducted using leaching water equivalent to the rainfall amount in the study area over 3 years to investigate changes in concentrations of PTEs,including copper(Cu),zinc(Zn),lead(Pb),cadmium(Cd),and nickel(Ni)in the leachate from the acidic forest soil.Water quality index of leachate,potential ecological risk and human health risk in soil at different leaching stages were compared.Sewage sludge was applied at SS/soil mass ratios of 0:100(controls),15:85(T1),30:70(T2),45:55(T3),60:40(T4),and 75:25(T5).All treatments resulted in increased PTEs concentration in the upper 20 cm soil,T3-T5 increased potential ecological risk from"low"(control)to"moderate"or"considerable".During first year leaching,PTEs concentration increased with increasing SS/soil ratios,but the water quality index of T1-T3 was"excellent"or"good".Pb,Cu,Cd,and Ni in the 20-40 cm soil depth,and Zn in the 60-80 cm soil depth were also enriched,but potential ecological risk was"low".In subsequent leaching,PTEs concentration of leachate gradually returned to the background value and water quality index was"excellent".There were no significant changes in PTEs and ecological risk observed.During the monitoring process,the health risk caused by the migration of PTEs to the human body was always within the acceptable range.Overall,this study provides a reference for the management of risks from the application of SS on forestlands,i.e.,SS/soil ratios<45:55 is recommended on forestlands,and special attention should be given to early leaching risk.In addition,it also provides an important assessment method for the risk of PTEs leaching and migration in forested land application.
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. .
文摘目的探讨重症监护室(intensive care unit,ICU)住院患者中应用循环质控理念联合风险管理模式的效果。方法选取2023年1—5月寿光市人民医院ICU住院患者335例作为对照组,实施常规医院感染管理;选取2023年6—12月ICU住院患者340例作为干预组,实施循环质控理念联合风险管理模式。比较2组管理质量、风险事件、医院感染发生率及患者满意度。结果干预组管理质量(感染监测、组织管理、风险评估、制度建设)评分高于对照组(P<0.05);干预组风险事件发生率(1.47%)低于对照组(4.48%)(P<0.05);干预组医院感染发生率(3.82%)低于对照组(7.46%)(P<0.05);干预组患者满意度(98.24%)低于对照组(95.52%)(P<0.05)。结论循环质控理念联合风险管理模式应用于ICU住院患者中,可提高管理质量,减少风险事件与医院感染发生,促进患者满意度提升,体现了《ICU十大安全目标》的执行标准。
