Quality assurance and quality control in the laboratory andrology

Quality assurance （QA） and quality control （QC） are fundamental aspects of any laboratory measurement. However, in comparison with other medical disciplines, the need for QA and QC in laboratory andrology has been recognized only recently. Furthermore, there is evidence that the effort required to undertake QA and QC has not been wholly welcomed by some clinicians. Nevertheless, accrediting bodies and regulatory authorities increasingly require evidence that laboratories have effective QA and QC measures in place because both are central to the quality management processes. Following the publication of the 5th edition of the World Health Organization Laboratory Manual, existing QA and QC systems will need to be updated to take into account some of the methodological changes recommended by the manual. Three of these are discussed in this commentary; they relate to： （i） the move to infer semen volume from its weight; （ii） the re-classification of sperm motility grades from four to three; and （iii） the publication of a lower reference limit for morphology of 4% （with a corresponding 95% confidence interval of 3%-4%）. The importance of QA and QC in all laboratory tests, including up and coming new tests to assess sperm DNA integrity, is discussed. The need for adequate initial training and continuing professional development programmes to support laboratory scientists performing andrology is also described.

Dynamic estimation and reliability control of quality assurance for bored piles

A systematic method was proposed to estimate the occurrence probability of defective piles(OPDP) from a site according to quality assurance inspection. The OPDP was firstly suggested as the criterion to weight the performance of a pile foundation. Its prior distribution and updating distribution were deduced to follow Beta distributions. To calibrate the OPDP, a dynamic estimation model was established according to the relationships between prior mean and variance and updating mean and variance. Finally, a reliability-control method dealing with uncertainties arising from quality assurance inspection was formalized to judge whether all the bored piles from a site can be accepted. It is exemplified that the OPDP can be substantially improved when more definite prior information and sampling formation become available. For the example studied herein, the Bayesian estimator of updating variance for OPDP is reduced from 0.0037 to 0.0014 for the first inspection, from 0.0014 to 0.0009 for the second inspection, and with less uncertainty by incorporating experience information.

Software Industry-oriented Education with Embedded Quality Assurance Mechanisms

This paper presents a broad range of suggestions on the concept of quality-assured industry-oriented higher education in software engineering,a central theme of the annual CEISIE(CEISEE this year) workshops since the first one held in Harbin,China,in 2005.It draws on the lessons of collaborative experiences involving academics and industrialists from Europe and China.These experiences make the case for a strong role for software industryoriented higher education in the production of the software architects,developers and engineers required for the future.

Application of Statistical Process Control for Setting Action Thresholds as Quality Assurance of Dose Verifications in External Beam Radiotherapy

Purpose: To test the concept of Statistical Process Control (SPC) as a Quality Assurance (QA) procedure for dose verifications in external beam radiation therapy in conventional and 3D Conformal Radiotherapy (3D-CRT) treatment of cervical cancer. Materials and Methods: A study of QA verification of target doses of 198 cervical cancer patients undergoing External Beam Radiotherapy (EBRT) treatments at two different cancer treatment centers in Kenya was conducted. The target doses were determined from measured entrance doses by the diode in vivo dosimetry. Process Behavior Charts (PBC) developed by SPC were applied for setting Action Thresholds (AT) on the target doses. The AT set was then proposed as QA limits for acceptance or rejection of verified target doses overtime of the EBRT process. Result and Discussion: Target doses for the 198 patients were calculated and SPC applied to test whether the action limits set by the Process Behavior Charts could be applied as QA for verified doses in EBRT. Results for the two sub-groups of n = 3 and n = 4 that were tested produced action thresholds which are within clinical dose specifications for both conventional AP/PA and 3D-CRT EBRT treatment techniques for cervical cancer. Conclusion: Action thresholds set by SPC were within the clinical dose specification of ±5% uncertainty for both conventional AP/PA and 3D-CRT EBRT treatment techniques for cervical cancer. So the concept of SPC could be applied in setting QA action limits for dose verifications in EBRT.

QUALITY ASSURANCE INFORMATION SYSTEM FOR AGILE MANUFACTURING

The customer driven dynamic global market and geographical distribution of collaborating partners bring new challenges to the development of quality assurance information system (QAIS) for agile manufacturing. With recent dramatic advances in information technology, firstly the requirements of QAIS are examined in agile manufacturing environment, then a new implementation framework of a distributed QAIS is presented, where a deve loping environment of QAIS is established and some critical techniques are studied. Finally a prototype system based on world wide web (WWW) is accomplished.

A Quality Assurance Model for Airborne Safety-Critical Software

The tragic nature of safety-critical software failure’s consequences makes high quality and extreme reliability requirements in such types of software of paramount importance. Far too many accidents have been caused by software failure error or where such failure/error was part of the problem. Safety-critical software is widely applied in diverse areas, ranging from medical equipment to airborne systems. Currently, the trend in the use of safety-critical software in the aerospace industry is mostly concentrated on avionic systems. While standards for certification and development of safety-critical software have been developed by authorities and the industry, very little research has been done to address safety-critical software quality. In this paper, we study safety-critical software embedded in airborne systems. We propose a lifecycle specially modeled for the development of safety-critical software in compliance with the DO-178B standard and a software quality assurance (SQA) model based on a set of four acceptance criteria that builds quality into safety-critical software throughout its development.

Development and Challenge of HIV/AIDS Testing Laboratory Network and Quality Assurance System in China

This paper describes the development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China. At present,the HIV/AIDS testing laboratories includes three classes,the National AIDS Reference Laboratory,HIV/AIDS confirmatory laboratories and HIV/AIDS screening laboratories. All of them are accredited by the health authorities,and each class of laboratories take charge of their function strictly according to the "National Management of HIV/AIDS Detection (2006)". A complete quality assurance and quality control system for HIV/AIDS testing has been developed,which includes technical training,strict laboratory monitoring and approval,examination or proficiency testing on HIV/AIDS detection,and quality evaluation and supervision of HIV/AIDS diagnostic kits. Besides conduct the routine anti-HIV antibody test,more and more laboratories began to conduct other tests,such as CD4+ T lymphocyte cell counting,HIV viral load,HIV DNA PCR,genotyping,drug resistance,and HIV-1 recent infection test. The primary challenges faced by the HIV/AIDS testing laboratory network are in the areas of laboratory management and quality control. For example,the provincial PT program is inefficient,the internal quality control is conducted perfunctorily,personnel training can not met the needs of the workplace,which need to be improved.

Influence of quality assurance on patients dose reduction in some hospitals

The radiation dose received by patients undergoing chest radiography was included. 200 patients who attended these investigations in 10 hospitals in Iran were randomly selected from all ages groups and both female and male. Critically ill patients were excluded. This paper presents the work, which was implemented on 200 patients and evaluated using the entrance skin dose （ESD） in the posterior anterior （PA） chest projection measured directly at the center of the X-ray field. In addition, the machine room, and dark room .parameters, as well as work practices and repeat rates were studied. The quality control （QC） parameters and the ESD before and after QC were evaluated utilizing an anthropomorphic phantom to define the optimal exposure condition at all hospitals. This research shows that after using the QC parameters and after optimization of the exposure conditions, the ESD was decreased by 42% on average. Also the qua/ity of the radiographs generally increased. The reported method is easily implemented in any clinical situation where optimization of chest radiography is needed.

A strategy for population pharmaceutical quality assessment based on quality by design

From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide databased information for approval.Not only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.

Partial Quality Assessment of ⁶⁰Co-Teletherapy Machine Performance

The aim of this study was to assess the performance of 60Co-teletherapy unit at Radiation and Isotopes Center in Khartoum, using the common tools used for quality control (Front pointer, Graphic paper, Pin, Non-screen film, meter and Check plate). The collected and analyzed data revealed that: there was a difference between the calculated theoretical field size (FS) and the measured one relative to the change of SSD;and the average FS shift was 0.9 cm relative to the standard one, while the machine isocenter was almost fixed at 0° with a shift of 0.003 cm, which was within the standard limit (0.2 cm). The diaphragm isocenter showed a shift of ±0.36 cm (i.e. in clock and anti clock wise) in average relative to standard limit (±0.3 cm) and the couch vertical isocenter (CVI) relative to the SSD changes was exceeded the standard limit (0.2 cm) by a factor of 0.9 cm. Also the SSD determined by the optical distance indicator was greater than the actual SSD (determined by Front pointer and measured by scale meter) by an average of 0.8 cm;which exceeded the limit (0.3 cm) by an average factor of 0.5 cm. The study also showed that the penumbra profile (1.5 cm) was less than the actual specified for 60Co-teletherapy machine, while the radiation beam was so homogeneous across the field size.

Picture Quality Assessment-Based on Rate Control for Variable Bandwidth Networks

The growing popularity of Internet applications and services has rendered high subjective video quality crucial to the user experience. Increasing needs for better video resolution and faster transmission bandwidths present challenges to the goal of achieving balance between video quality and coding cost. In this paper, we propose a Perceptive Variable Bit-Rate Control （PVBRC） framework for the state-of-the-art video coding standard High-Efficiency Video Coding （HEVC）/H.265. PVBRC allocates a bit-rate to a picture while taking a Comprehensive Picture Quality Assessment （CPQA） model and perceptive target bit-rate allocation into consideration. The CPQA model calculates the objective and perceptive quality of both source and reconstructed pictures by referring to the human vision system. The coding bit-rate is then dynamically allocated by the result of the CPQA model according to differences in picture content. In PVBRC, the quantization parameter for current picture encoding is updated by an effective fuzzy logical controller to satisfy the transmission requirements of the Internet of Things. Experimental results show that the proposed PVBRC can achieve average bit savings by 11.49% when compared with constant bit-rate control under the same objective and subjective video quality.

The use of mathematics in software quality assurance

The use of mathematics for documenting, in- specting, and testing software is explained and illus- trated. Three measures of software quality are described and discussed. Then three distinct complementary approaches to software quality assurance are presented. A case study, the testing and inspection of a safety-critical system, is discussed in detail.

Study on Factors Influencing the Quality of Automatic Monitoring Data of Pollution Sources and Technical Assurance Measures

Automatic monitoring data of pollution sources is an important basis for environmental supervision and management.At present,it is difficult to guarantee the quality of automatic monitoring data of pollution sources,and it is difficult to play the role of the monitoring data.In response to this problem,the factors influencing the quality of automatic monitoring data of pollution sources were analyzed in detail,and technical assurance measures for the quality of automatic monitoring data of pollution sources in Shandong Province were studied.Besides,the dynamic management and control idea of automatic monitoring of pollution sources was proposed,and specific technical measures were analyzed from five aspects of standardizing automatic monitoring equipment of pollution sources,improving the data collection and transmission system,establishing a mechanism for reporting operating status information of monitoring equipment,setting alarm rules and alarm processing procedures,and statistically analyzing the operating status of the equipment.Practice has proved that the dynamic management and control system can effectively ensure the quality of automatic monitoring data of pollution sources.

QualiTeam: A Support Tool When Learning Software Quality and Testing Concepts

QualiTeam is a web application to support the teaching-learning process on Software Quality Assurance, Quality Control and Testing introductory concepts. It has two main objectives: to facilitate the understanding of concepts learned in theory and to facilitate the monitoring of SW projects that students develop. The system gives the teacher control and the students a guide on the activities that must be carried out throughout a software project development. QualiTeam is a tool conceived to help in the challenge of providing students with concrete examples with which they can practice and clarify the topics taught in the classroom. With it, students can apply concepts that, in the initial training of a software engineer, are generally taught only at a theoretical level such as: review process, change requests, trouble reports, document version control and testing documentation management. QualiTeam is free and available online. It has been in operation for 5 years, through which improvements have been made until achieving a quite stable version.

A Hybrid Evaluation Framework of CMM and COBIT for Improving the Software Development Quality

It is essential to study quality of software production like others. Software productions have special properties. They are intangible. So, qualitative evaluation encountered with complexity. Hence, proposing a model in order to evaluate the quality of Software productions is considerable to most software managers and experts. In this paper, regarding to improve software productions quality, the process of software production has been determined, using CMM standard framework of maturity level. In CMM it does not present a method for measurement and evaluation maturity level, the presented process in CMM standard mapped by COBIT control objectives has been combined in the process of software productions development in developed hybrid framework. In this research, the processes have been mapped utilizing focus and established group, in parallel of software production in different maturity level of CMM mapped by COBIT framework. In order to show the capabilities of proposed framework, the hybrid evaluation model was employed in a software developing organization as a case study. According to the results of evaluation, improvements proceedings and action plans have been proposed and discussed to enhance the software production processes.

Replacing liquid fyrite with digital to improve <i>in vitro</i>fertilization laboratory quality control procedures

In clinical in vitro fertilization (IVF), optimal culture conditions are required for production of high quality embryos and for achieving high pregnancy rates. Cell culture systems require vigilant attention to quality control and quality assurance, and upgrades to equipment and procedures require strenuous deliberation. During a 2-week maintenance period, we undertook an extensive analysis of incubator carbon dioxide (CO2) monitoring and the effect on culture media pH by comparing our traditional liquid Fyrite instruments to a certified and calibrated digital CO2 analyzer. The digital analyzer produced consistently lower CO2 readings and significantly greater precision than the liquid Fyrite. Media pH measurements showed significant variation depending on CO2 calibration device;however pH remained within manufacturers’ specifications. After superior performance by the digital analyzer, we incorporated this device into the incubator calibration and daily quality control procedures. A retrospective comparison of overall lab performance before and after this equipment switch demonstrated improved clinical pregnancy and implantation rates. This report illustrates the necessary caution when altering established laboratory procedures and equipment while highlighting the benefits of judiciously updating techniques and equipment in a laboratory setting that is often stubborn to change pre-existing, ingrained methodology.

Assessment of the quality of randomized controlled trials on pharmaceutical care for asthmatic patients in journals of China's Mainland

The objective of this study was to assess the quality of randomized controlled trials（RCTs） on pharmaceutical care for asthma tic patients conducted by pharmacists in China's Mainland, to identify the problems in current studies, and to provide some references for further studies. The China National Knowledge Infrastructure（CNKI）, Wanfang Database, and VIP Database were searched for randomized controlled trials on pharmaceutical care for asthma tic patients, and only those studies undertaken by pharmacists were included. Information about the study design and reporting of selected studies was extracted and collected to systematically analyze these studies. Meanwhile, the Cochrane Collaboration＇s tool for assessing risk of bias was used to assess potential biases related to these studies. Ultimately, 14 articles were included in this study. No study determined the sample size in a scientific way. No article reported a scientific and detailed method of random sequence generation or allocation concealment. Two（14.3%） studies claimed to have implemented a double-blinding and a single-blinding respectively, but neither of them reported any details about how they performed the blinding. No study employed a blinding of outcome assessment. Five（35.7%） studies either stated statistical methods incompletely or used them incorrectly. One（7.1%） study reported an attrition without employing an intention-to-treat analysis. All studies reported eligibility criteria for participants to some extent, and all these criteria involved diagnosis of asthma, but only four（28.6%） of them reported patients＇ ages and three（21.4%） described the severity and the stage of asthma. Nine（64.3%） reported baseline data in the text rather than in a table, and 13（92.9%） involved comparisons between groups with significance tests either explicitly or implicitly. No report made a distinction between primary and secondary outcomes. Two（14.3%） mentioned informed consent of subjects, while no article reported ethical approval. ＂Unclear risk＂ made up the highest percentage of the studies analyzed according to the risk of bias assessment by the Cochrane Collaboration＇s tool. Our study demonstrates that the quality of RCTs on pharmaceutical care for asthma tic patients conducted by Chinese pharmacists is suboptimal, especially with regards to study design and reporti ng.

Development of an integrated policy making tool for assessing air quality and human health benefits of air pollution control

Efficient air quality management is critical to protect public health from the adverse impacts of air pollution. To evaluate the effectiveness of air pollution control strategies, the US Environmental Protection Agency （US EPA） has developed the Software for Model Attainment Test-Community Edition （SMAT-CE） to assess the air quality attainment of emission reductions, and the Environmental Benefits Mapping and Analysis Program- Community Edition （BenMAP-CE） to evaluate the health and economic benefits of air quality improvement respectively. Since scientific decision-making requires timely and coherent information, developing the linkage between SMAT-CE and BenMAP-CE into an integrated assessment platform is desirable. To address this need, a new module linking SMAT-CE to BenMAP-CE has been developed and tested. The new module streamlines the assessment of air quality and human health benefits for a proposed air pollution control strategy. It also implements an optimized data gridding algorithm which significantly enhances the computational efficiency without compro- mising accuracy. The performance of the integrated software package is demonstrated through a case study that evaluates the air quality and associated economic benefits of a national-level control strategy of PM2.5. The results of the case study show that the proposed emission reduction reduces the number of nonattainment sites from 379 to 25 based on the US National Ambient Air Quality Standards, leading to more than USS334billion ofeconomic benefits annually from improved public health. The integration of the science-based software tools in this study enhances the efficiency of developing effective and optimized emission control strategies for policy makers.

The Report of Virtual Exhibition Software Development

The main structure and key techniques of our Virtual Exhibition Software are summarized. It demonstrates the practice of Software Engineering during the development of our project and discusses the use of UML in it.