An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China

Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China.Methods Literature research,case study and comparative study were used to analyze the quality management system of clinical trials of therapeutic vaccines.Results and Conclusion From the perspective of the sponsor,investigators and the thirdparty technical service company,the problems such as the low efficiency of clinical trial sample preparation and the lax implementation of the protocol by hospital departments in the quality management of clinical trials of therapeutic vaccines in China were found.Then,the optimization plan for the quality management of clinical trials of therapeutic vaccines is proposed,including optimizing the preparation process of therapeutic vaccines and strengthening the training of hospital department personnel.

Evaluation of the Impact of Refined Quality Control Management Model on the Qualified Rate of Disinfection and Sterilization of Surgical Instruments in the Sterilization Supply Center

Objective:To evaluate the application value of a refined quality control management model for a sterilization supply center.Methods:A retrospective analysis was conducted on the work situation of the sterilization supply center from January 2021 to January 2023.The work situation before January 31,2022,was classified as the control group;a routine quality control management model was implemented,and the work situation after January 31,2022,was classified as the observation group.The quality of medical device management and department satisfaction between the two groups were compared.Results:The timely recovery and supply rate,classification and cleaning pass rate,disinfection pass rate,packaging pass rate,sterilization pass rate,and department satisfaction score in the observation group were all higher than those of the control group(P<0.05).Conclusion:Implementing a refined quality control management model in the sterilization supply center can improve the quality management level of medical devices and department satisfaction and is worthy of promotion.

Advances in the Research of Quality Management System of Dairy Enterprises

As the global economy enters a new stage,Chinese dairy enterprises are gradually moving towards the road of internationalization.In this paper,the internationally common quality management system,food safety system and quality traceability system were analyzed and studied to promote the comprehensive transformation and upgrading of dairy industry and broaden the development road with the help of systematic construction.

Introduction of PIC/S Accession Procedure and Suggestions for Establishing a Unified Quality Management System in China

Objective To introduce the accession procedure and evaluation of PIC/S,and help relevant departments in China to understand the requirements of PIC/S in detail,and to promote the process of China’s entry into PIC/S.Methods The procedures and steps of joining PIC/S,the evaluation process of PIC/S,and the experience of several countries in joining PIC/S were introduced and analyzed,which could help the relevant personnel in China understand the specific contents.Results and Conclusion According to the requirements of PIC/S,it is necessary to establish a unified GMP quality management system.

Safety and Quality Control Management Strategy for Urban Railway Engineering Construction

The safety management of urban railway engineering construction involves many different aspects and a wide scope,playing an important role in guaranteeing the safety of construction projects.Management agencies have more stringent requirements on the quality of railway construction.The overall quality of a construction project should meet the construction requirements before the project can be carried out.In this article,the problems in the actual work of the entire life cycle of safety management are explained,and the lessons and experience pertaining to the safety and quality of urban railway construction projects are discussed.The purpose of this paper is to provide references for the management of urban railway construction.

The Problems and Countermeasures of Four Community Pharmacies on Drug Quality Management in Kangping County

Objective To study the drug quality management of four community pharmacies and provide countermeasures and suggestions for improving the drug management level in Kangping County.Methods Literature research and investigation research were adopted in this paper to analyze the current situation and problems of drug management in four community pharmacies in a town of Kangping County.Results and Conclusion The problems of four community pharmacies in a town of Kangping County are low level of drug quality management,insufficient quality and capability of the practitioners and physician’s illegal act such as some licensed pharmacists paid from the linked pharmacies.There are also problems in facilities and equipment,drug display and storage,and document management,which reflects the lack of local drug supervision.Based on the above problems,some countermeasures and suggestions are put forward to strengthen the drug quality management of four community pharmacies in Kangping County.

Crack Prevention and Management Strategies in Bridge Engineering Construction

Cracking during construction is a common occurrence in modern bridge engineering that can directly impact the overall safety of the bridge.Therefore,it is essential to focus on preventing and controlling cracks.As the construction technology for bridge engineering has evolved,the internal quality of construction has significantly improved.However,the appearance quality remains a crucial factor that reflects the technical expertise of a construction company.Therefore,minimizing cracks and improving the appearance quality of concrete are critical issues that require the attention of construction units,supervision departments,and construction companies.This article will analyze the causes of cracking and suggest corresponding prevention and treatment methods.

Biological Evaluation Based Quality Management of Water Resources in Small Xingkai Lake

Taking the water ecosystem of Small Xingkai Lake as research object,through the survey and analysis of aquatic organism indicators,this paper established an ecosystem integrity evaluation system with the biological integrity as the criterion layer. Using the index of biological integrity and comprehensive health index,it evaluated the health status of water ecosystem of Small Xingkai Lake.

The Role of Whole-Process Quality Management Mode in the Self-Protection and Safety of First-Line Medical Staff of COVID-19

At present, the COVID-19 has spread all over the world. In the face of sudden outbreak, it has brought great challenges to the management of nosocomial infection prevention and control. In this battle, how to do well the prevention and control of hospital epidemic situation scientifically and reasonably is the key to hospital management and an important link to ensure the safety of first-line medical staff. Through the clinical practice of our hospital to combat the COVID-19 epidemic situation, we summarize the key points and functions of quality management, and provide management strategies for domestic and foreign countries.

Procedure Design to Fulfill Quality Management System

With the application of the principle of PDCA, and dr awing on the experience of the process methods of the ISO9000 and the system met hods of management, the author analyses the basic requirement to fulfill quality management system in enterprises. Then the author inquires into the procedure t o establish the efficiency quality management system. Finally four stages (plan, do, check, action) and eight steps (decision, plan, analyze, design, do, check, improve, fulfill) are put forward to fulfill quality management system.

Digital Twin-based Quality Management Method for the Assembly Process of Aerospace Products with the Grey-Markov Model and Apriori Algorithm

The assembly process of aerospace products such as satellites and rockets has the characteristics of single-or small-batch production,a long development period,high reliability,and frequent disturbances.How to predict and avoid quality abnormalities,quickly locate their causes,and improve product assembly quality and efficiency are urgent engineering issues.As the core technology to realize the integration of virtual and physical space,digital twin(DT)technology can make full use of the low cost,high efficiency,and predictable advantages of digital space to provide a feasible solution to such problems.Hence,a quality management method for the assembly process of aerospace products based on DT is proposed.Given that traditional quality control methods for the assembly process of aerospace products are mostly post-inspection,the Grey-Markov model and T-K control chart are used with a small sample of assembly quality data to predict the value of quality data and the status of an assembly system.The Apriori algorithm is applied to mine the strong association rules related to quality data anomalies and uncontrolled assembly systems so as to solve the issue that the causes of abnormal quality are complicated and difficult to trace.The implementation of the proposed approach is described,taking the collected centroid data of an aerospace product’s cabin,one of the key quality data in the assembly process of aerospace products,as an example.A DT-based quality management system for the assembly process of aerospace products is developed,which can effectively improve the efficiency of quality management for the assembly process of aerospace products and reduce quality abnormalities.

Analysis and Design of Quality Management Platform for the Entire Process of Characteristic Software Talent Training

At the end of 2021 to create a new model of characteristic software talent training for independent and controllable key software fields,the Ministry of Education and the Ministry of Industry and Information Technology jointly approved the establishment of the first batch of 33 Characteristic Pilot Schools of software.As a member of characteristic software schools,the HIT School of Software has been approved and will focus on the construction of 2 characteristic directions,which are large-scale industrial software and industrial professional application software.In order to achieve the goal,it is urgent to develop a comprehensive management platform to control the entire process of talent training,so that we can standardize,modelling,and digitized the entire process of characteristic software talent training.By relating all aspects of student training with and implementing the ability-index mechanisms,we will continuously collect big-data of the entire process of student growth,and generate multidimensional student ability portraits for evaluating the effect of talent training,and adjust as well as optimizing the growth path for students themselves during their studying.Employers will be able to identify talents accurately and provide effective reference for colleges to adjust training plans.This paper will analyze the needs of the platform,provide demand analysis of the platform,extract the correlation model between training,conclude the relations between ability-index activities and ability indicators,and give a reasonable overall system design scheme.

Construction of Meteorological Observation Quality Management System for Basic Observation Business

A set of closed-loop normative standards of PDCA(planning-implementing-checking-improvement) of the quality management system is applied to promote the standardization, normalization and institutionalization of grass-roots meteorological observations, further improve the service availability and timely rate of data, and improve the quality and efficiency of meteorological observations.

The Important Role of Quality Management in Environmental Monitoring

Environmental protection is an important topic of global concern in recent years,and environmental monitoring is one of the most intuitive and effective means to reflect the environmental situation.With the increasing task of environmental monitoring,the number of environmental monitoring institutions is increasing.It should strengthen quality management to ensure the accuracy and effectiveness of environmental monitoring results.

The Relationship between Visual Satisfaction and Water Clarity and Quality Management in Tourism Fishing Ports

Visual satisfaction of the tourists with a water body is strongly influenced by water clarity, which is in turn influenced by a number of water quality parameters. Visual satisfaction thus stands to benefit from having a water quality management tool that results in better water clarity. A Clarity Suitability Index of Water Quality (CSIWQ), derived from clarity suitability curves of selected water quality parameters, can allow estimation of optimal values for these parameters, while ensuring high visual satisfaction among tourists. The present study used sampling and survey methodologies to investigate water clarity and quality at five tourism fishing ports;simultaneously, tourists’ visual satisfaction with a water body was assessed through a questionnaire based on their perceptions. The relationship between tourists’ visual satisfaction and water clarity was found to be positive and strong, with water clarity having predictive power of 74.2%. The study showed that DO, BOD, TP, and SS were the most critical parameters for water clarity. A continued product approach of CSIWQ was found to be most appropriate for describing the relationship between water clarity and these four parameters. This enabled a CSIWQ Index value to be calculated. With a CSIWQ value of 0.6, water clarity would be more than 2.08 m, and tourists would experience very high satisfaction. CSI curves showed that DO would preferably be 9.0 mg/L, and BOD, TP, and SS less than 0.5 mg/L, 0.12 mg/L, and 45.0 mg/L, respectively. The model thus produced valuable insights for assessing and improving water quality and ensuring high levels of visual satisfaction among tourists in tourism fishing ports. This model identified only four parameters but could be improved by ensuring that other water quality parameters were included, to encourage an increase in the number of tourists and to include monitoring of more pollutant sources.

Identification of the Origins and Risks of Pathologies in Steel Structure Buildings Using Total Quality Management Tools

The steel structure construction is an interesting option to the already established concrete structure at a time when the Brazilian civil construction seeks more efficiency.To promote the use of this material it is necessary to have a better understanding of its characteristics and,especially,of its possible pathologies,to avoid degradation,costs,and even the collapse of the structure.In this study Total Quality Management tools were applied to analyze the pathologies found in five medium and large steel-structured buildings.The most frequent ones were structure corrosion,cracks in the closures,and infiltrations in the interface closure/structure.The Ishikawa Diagram is used to identify the origin of the causes of pathologies and the Gravity Urgency Tendency Matrix(GUT Matrix)is used in the risk analysis of each pathology.The results obtained show that it is possible,through these Quality Management tools,to understand the origin of the pathologies,establishing their dangerousness and the degree of risk each one offers.

A Six Sigma Security Software Quality Management

Today, the demand for security software is Six Sigma quality, i.e. practically zero-defects. A practical and stochastic method is proposed for a Six Sigma security software quality management. Monte Carlo Simulation is used in a Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) approach to security software testing. This elaboration used a published real project’s data from the final product testing lasted for 15 weeks, after which the product was delivered. The experiment utilised the first 12 weeks’ data to allow the results verification on the actual data from the last three weeks. A hypothetical testing project was applied, supposed to be completed in 15 weeks. The product due-date was Week 16 with zero-defects quality assurance aim. The testing project was analysed at the end of the 12th week with three weeks of testing remaining. Running a Monte Carlo Simulation with data from the first 12 weeks produced results which indicated that the product would not be able to meet its due-date with the desired zero-defects quality. To quantify an improvement, another simulation was run to find when zero-defects would be achieved. Simulation predicted that zero-defects would be achieved in week 35 with 56% probability, and there would be 82 defects from Weeks 16 - 35. Therefore, to meet the quality goals, either more resources should be allocated to the project, or the deadline for the project should be moved to Week 36. The paper concluded that utilising Monte Carlo Simulations in a Six Sigma DMAIC structured framework is better than conventional approaches using static analysis methods. When the simulation results were compared to the actual data, it was found to be accurate within ﹣3.5% to +1.3%. This approach helps to improve software quality and achieve the zero-defects quality assurance goal, while assigning quality confidence levels to scheduled product releases.

The Impact of Total Quality Management on Health Services Improvement, Sana’a Hospitals, Yemen (2017-2020)

Background: Total quality management (TQM) plays a major role in quality health services improvement. The aims of the study are to identify the concepts of total quality management in health institutions to know the nature of the relationship between the application of TQM and improving the quality of health services in Sana’a Governorate. Method: This applied research is a descriptive cross-sectional study in which the TQM of 13 affiliated Sana’a Governorate hospitals during “2017-2020”, were evaluated based on self-administered questionnaires. Data were collected by questionnaires including demographical variables, TQM dimensions variables. Data were analyzed by using SPSS version 16. Results: A total of 281 users 98.6% had responded. The employee’s responses for sixth study dimensions were the top manager’s commitment (TMC) 80.46%, customers focusing CF 81.55%, continuous improvement (CI) 82.32%, training (T) 71.51%, and strategic planning of the quality (SPQ) 74.76%, health services quality improvement (HSQI) 74.25%. There is a strong relationship between TQM and HSQI. There is no relationship between demographic factors gender, profession, years of experience, except age with TMC, T, HSQI, qualification with the TMC, CI, T, HSQI and job with all study variables. Conclusion: The application of TQM at hospitals in quality of health services improvement has several challenges, lacking staff experience and lacking leadership support, weakness of the training, customers focusing, continuous improvement, and strategic planning of the quality. Therefore, benefiting from the experiences of leading hospitals in implementing total quality management programs by sending some cadres to these hospitals for training and gaining experience or by hosting experienced cadres to conduct training courses is recommended.

Risk Thinking in ISO Quality Management System

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.