Assurance Management Research Articles

IV 品質保証と管理 1. 品質保証と管理

IV 品質保証と管理 1. 品質保証と管理

Scientific Opinion on the use of animal-based measures to assess welfare in pigs

Animal-based measures, identified on the basis of scientific evidence, can be used effectively in the evaluation of the welfare of on-farm pigs in relation to laws, codes of practice, quality assurance schemes and management. Some of these measures are also appropriate for ante-mortem inspection and there are additional post-mortem animal-based measures which can be taken at the slaughterhouse. Non-animal-based measures can be used when the association between them and the welfare outcome is strong and when they are more efficient than animalbased measures as a means to safeguard welfare. Both animal-based and non-animal-based measures can be useful predictors of welfare in pigs. In order to assess welfare, a wide range of measures is needed. However, to assess aspects of welfare it is unnecessary to use all animal-based measures on every occasion. The choice of animal-based measures will depend upon the specific objectives of the assessment. The full list is comparable to a ‘toolbox’, from which the appropriate range of measures can be selected. The Welfare Quality® protocol provides information on the majority of the welfare outcomes of the main hazards identified in the EFSA Scientific Opinions but not those where time limitation prevents it. There are currently insufficient animal-based measures to use as welfare outcome indicators on-farm or in the slaughterhouse to assess the issues of pain, frustration and other positive and negative emotional states. The extent to which short-term management can prevent the negative effects of hazards arising from genetic selection, and of most housing-related problems, is extremely limited. Herd monitoring and surveillance programmes should be implemented within the pig industry using a range of appropriate animal-based measures to document welfare changes over time. There should be both initial and ongoing training of assessors to ensure valid and reliable welfare measurement.

Challenges of Deepwater Developments

This keynote paper attempts to catalogue the key business drivers for deepwater developments especially for the Mediterranean, Gulf of Guinea, Gulf of Mexico and other deepwater environments and the challenges arising thereof. The paper goes further to provide some in-depth analysis of the key technical issues such as subsea production systems integrity, multiphase flow assurance management, lessons learned from the shallow water as well as the deepwater areas like the North Sea before addressing some of the technology developments and competency required to take the new regions forward. . The paper ends with a presentation of what the new National Subsea Research Institute [NSRI] in the United Kingdom is doing and can do to support future deepwater developments.

A methodology for qualifying industrial CFD: The Q 3 approach and the role of a protocol

Computational Fluid Dynamics (CFD) analysis has become a useful research and design instrument albeit with errors and uncertainties. Appropriate standards and protocols for increasing confidence and reliability need to be identified and applied. These requirements become more relevant as improvements in hardware, software and user competence increase. Advances in these sectors have led to the increased use of CFD codes in the applied research industry. In the discussion on the opportunities of applying Quality Assurance to Research and Development (R&D) activities, and on investigating methodologies (numerical or experimental), CFD results need to be qualified; rules, and procedures should be instated and followed. This paper proposes a methodological approach to qualify CFD, named Q 3 approach. The approach is based on three interdependent, but related, dimensions: software reliability, user knowledge and process control. Applying the quality of CFD analysis to industrial problems, while following the principles of Quality Assurance, is of particular concerned. The paper aims to focus on the dimensions of user knowledge and process control, which are often overlooked and are of great importance when determining the quality of CFD. The approach discussed here refers to a typical R&D department in a Small or Medium Enterprise (SME) where a CFD code is used as a support tool for process or product development, optimisation and/or innovation. Within the three dimensions, software reliability immediately refers to Verification and Validation (V&V) procedures, a well known issue for those who are involved in code and model development. User knowledge and process control play a vital role in achieving accurate results and cannot be neglected, as per the principles of Quality Assurance. Therefore it is vital to provide continuous CFD analyst training to industrial professionals. Applying a CFD cycled process, which refers to the cyclic logic proposed in Quality Assurance, may face some constrains in specific industrial scenarios. A protocol will serve as an instrument of process control. Within the protocol, the phases of Calculation, Verification and Validation as well as User Defined Model Verification represent critical elements, and are specifically detailed and structured in accordance with the RADAR logic (Results, Approach, Deploy, Assess, Refine) used for Quality Assurance Management. In the case a specific study does not rely on experimental data, an alternative is proposed. The protocol is designed as a single tool that responds to both the need for qualified CFD and the requirement of internal or external audit of Quality Assurance (as far as calculations are concerned), thus increasing cost and personnel efficiency.

Leaving the paediatric emergency department without being seen: Understanding the patient and the risks

The aim of this study is to examine the left-without-being-seen (LWBS) patient population of a tertiary paediatric emergency department (ED) to provide quality assurance and risk management data. This is a prospective observational study of patients who LWBS after presenting to the Royal Children's Hospital Melbourne ED between July and November 2005. Information was collected from electronic databases and follow-up telephone interviews performed by the principal investigator 3-5 days after the presentation. Over the 17-week study period, 7.6% of attendances were recorded as having LWBS. These patients and their presentations resembled the general ED population in many respects. However, there were several significant differences, particularly in relation to age, insurance status, mode of arrival, referral status, arrival time and illness severity. Most families (74%) indicated they would have been equally happy to visit a general practitioner instead had one been available. Prolonged waiting times and recognition that their child's illness was not severe were the most frequent reasons for leaving. Most parents subsequently accessed alternate health care or were planning to do so, and the majority stated their child's illness was improving. Parents maintained a surprisingly positive attitude to their ED presentation. The individual risks associated with leaving the ED before a child has been medically assessed are small. However, when multiplied several thousandfold as a function of the frequency of LWBS patients, the chance of serious adverse events becomes real. Potential risk management strategies include decreasing absolute LWBS numbers by addressing ED overcrowding and providing alternate sources for non-urgent care.

Decision Method of Equipment Reliability Assurance Based on Multi-Level Management

This paper classifies reliability assurance management strategies into four modes, i.e., reactive mode, preventive mode, predictive mode and proactive mode, advanced a decision method of equipment reliability assurance based on multilevel management. The risks of equipment failures are also categorized into four levels according to their degrees of severity and occurring rates. In order to improve pertinence and reduce cost of reliability assurance, it is proposed to adopt a multi-level management strategy in handling the risks. For this purpose, a model for relationship between risk levels and reliability assurance modes, a model for equipment reliability assurance cost and a model for equipment risk increments after reliability assurance have been established. The applied risk management mode for each concrete risk is determined by minimizing the total reliability assurance cost with risk increment serving as a constraint condition. The proposed approach has been demonstrated by using an example.

S2.1 Introduction of rapid syphilis tests in antenatal care services in Tanzania: clients' and service providers' acceptability and uptake of testing

BackgroundSyphilis is still a major cause of morbidity and mortality in women and children. In Tanzania syphilis was shown to cause adverse pregnancy outcomes in 49% and stillbirth in 25%...

Importance of Data Management in a Long-Term Biological Monitoring Program

The long-term Biological Monitoring and Abatement Program (BMAP) has always needed to collect and retain high-quality data on which to base its assessments of ecological status of streams and their recovery after remediation. Its formal quality assurance, data processing, and data management components all contribute to meeting this need. The Quality Assurance Program comprehensively addresses requirements from various institutions, funders, and regulators, and includes a data management component. Centralized data management began a few years into the program when an existing relational database was adapted and extended to handle biological data. The database's main data tables and several key reference tables are described. One of the most important related activities supporting long-term analyses was the establishing of standards for sampling site names, taxonomic identification, flagging, and other components. The implemented relational database supports the transmittal of data to the Oak Ridge Environmental Information System (OREIS) as the permanent repository. We also discuss some limitations to our implementation. Some types of program data were not easily accommodated in the central systems, and many possible data-sharing and integration options are not easily accessible to investigators. From our experience we offer data management advice to other biologically oriented long-term environmental sampling and analysis programs.

Building commissioning: a golden opportunity for reducing energy costs and greenhouse gas emissions in the United States

Commissioning is arguably the single most cost-effective strategy for reducing energy, costs, and greenhouse gas emissions in buildings today. Although commissioning has earned increased recognition in recent years, it remains an enigmatic practice whose visibility severely lags its potential. The application of commissioning to new buildings ensures that they deliver or exceed the performance and energy savings promised by their design and intended operation. When applied to existing buildings, commissioning identifies deficiencies and the almost inevitable “drift” from intended performance over time, and carries out interventions to put the building back on course. More formally, commissioning is a systematic, forensic approach to quality assurance and performance risk management, rather than a technology per se. This article presents the world’s largest compilation and meta-analysis of commissioning experience and the associated literature, comprising 643 non-residential buildings, 99 million ft2 of floorspace, $43 million in commissioning expenditures, and the work of 37 commissioning providers. The median normalized cost to deliver commissioning is $0.30/ft2 ($2009 currencies) for existing buildings and $1.16/ft2 for new construction (or 0.4% of the overall construction cost). The one third of projects for which data are available reveal over 10,000 energy-related deficiencies, the correction of which resulted in 16% median whole-building energy savings in existing buildings and 13% in new construction, with payback times of 1.1 and 4.2 years, respectively. Because energy savings exceed commissioning costs, the associated reductions in greenhouse gas emissions come at a “negative” cost of −$110/tonne CO2 for new buildings and −$25/tonne for new construction. Cases with comprehensive commissioning attained nearly twice the overall median level of savings and five times the savings of the least-thorough projects. Significant non-energy benefits such as improved indoor air quality are also achieved. Applying the median whole-building energy-saving values to the US non-residential buildings stock corresponds to an annual energy-saving potential of $30 billion (and 340 Mt of CO2) by the year 2030.

A fuzzy group analytical hierarchy process approach for software quality assurance management: Fuzzy logarithmic least squares method

This paper proposes a Fuzzy Group Analytical Hierarchy Process approach for assessing the quality of software, with judgments by a group of experts at different levels. The international standard of software quality attributes, ISO/IEC9126-1:2001 which comprises of 6 criteria with 27 subcriteria, is applied as the attributes of software quality. Regarding the prioritization method, the modified fuzzy Logarithmic Least Squares Method (LLSM) is applied to derive the importance weight vectors. The Fuzzy Prioritization Programming for Direct Rating Scales (FPP-DRS) on the basis of the modified fuzzy LLSM and the rescaling functions is proposed to design the direct rating scales in fuzzy number. The Fuzzy Synthesis Programming for Absolute Measurement (FSPAM) including Integrated Fuzzy Scores of Individual Expert (IFSIE) and Group Integrated Fuzzy Score (GIFS) is proposed to aggregate the criteria values from various experts. The proposed approach can help a group of various experts including developers, testers and purchasers, to measure the level of the software quality of the in-house development or the third party development.

Developing competence profiles for educators in environmental education organisations in the Netherlands

This qualitative study explores the meanings and possible merits of introducing competence profiles for enhancing professional development in the environmental education sector in the Netherlands. It presents the three most important environmental education jobs and their underlying competencies alongside their core professional challenges, as identified by environmental educators and experts in the Netherlands. The jobs are: education practitioner, programme leader, and organisational manager. The core professional challenges for the education practitioner entail: developing demand‐driven instructional programmes and spontaneous, ad‐hoc programmes, and addressing task and goal orientations. For the programme leader, they are acquisition of new projects, quality assurance, and project management; and for the organisational manager, they are human resource management, financial management, representing the organisation and showing its performance. The results of the study should inform educational institutions how to develop relevant programmes for future environmental educators, and for the professional development of environmental educators in environmental education organisations.

The Evaluation of Supplier Performance - A Case Study Approach

This study adopted business intelligence tools to implement a platform for supplier evaluation, bases on data from the material management module of its ERP system firstly, and tried to further improve the acceptance of the system. Qualitative research method was applied on this regard. Intensive interviews with members from procurement, quality assurance, and material management departments were conducted with interview framework established from Information System Model. The information garnered from the interviews was analyzed with Formal Concept Analysis (FCA). Major conclusions were used to improve the supplier evaluation system. Based on statistics data about system usage, the improvement gained significant success.

Design and Construction of Sentosa Integrated Resort Developments in Singapore with Mega Steel Trusses using Chinese Structural Steels

This paper describes the construction of the Sentosa Integrated Resort Development in Sinngapore which is one of the major developments to attract visitors all over the world. The first phrase of the Development is completed within 3 years through the use of precast concrete and steel construction. Moreover, heavy mega steel trusses are fabricated with Chinese steel materials, and the entire fabrication, transportation and erection process is found to be highly successful through implementation of quality assurance management systems.

Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study

This article presents experience from the practice of a successful pharmaceutical company related to design and implementation of performance measures (PMs) for deviation management linked to the analysis of impact on the production cost for the selected product. Case study focuses on PMs within good manufacturing practice (GMP) processes related to quality assurance (QA) and quality management, with the aim of complying with its future requirements proposed by the European Commission. Critical areas were identified based on data gathered from the industrial deviation database. Implementation of the suggested corrective actions showed significant improvement in terms of reducing their number for more than 50% per selected deviation category. The results obtained in the course of this practice-oriented study contribute to further improvement of deviation management in the pharmaceutical industry and performance measurement of other GMP processes. The suggested performance measurement concept and problem-solving techniques may serve both practitioners and the decision-makers within QA and quality control (QC) in order to improve their processes by implementing relevant regulatory requirements for quality management and maintain compliance.

Perceptions of registered nurses in four state health insititutions on continuing formal education

This study investigated registered nurses in four selected state health institutions' perceptions with regard to continuing formal education. The relevance of continuing formal education is being emphasised globally by the increasing quest for quality assurance and quality management systems within an ethos of continuous improvement. According to Tlholoe (2006:5), it is important to be committed to continual learning, as people's knowledge become less relevant because skills gained early in a career are insufficient to avoid costly mistakes made through ignorance. Continuing formal education in nursing is a key element to the maintenance of quality in health care delivery. The study described: registered nurses' views on continuing formal education. Registered nurses' perceived barriers to continuing formal education. A quantitative descriptive survey design was chosen using a questionnaire for data collection. The sample consisted of 40 registered nurses working at four state health institutions in the Western Cape Province, South Africa. Convenience sampling was selected to include registered nurses who were on duty on the days during which the researcher visited the health institutions to distribute the questionnaires. The questionnaire contained mainly closed-ended and a few open-ended questions. Content validity of the instrument was ensured by doing a thorough literature review before construction of items and a pretest. Reliability was established by the pretest and providing the same information to all respondents before completion of the questionnaires. The ethical considerations of informed consent, anonymity and confidentiality were adhered to and consent to conduct the study was obtained from relevant authorities. Descriptive statistics, based on calculations using the Microsoft (MS) Excel (for Windows 2000) programme, were used to summarise and describe the research results. The research results indicated that most registered nurses perceive continuing formal education as beneficial to their personal and professional growth and that it could lead towards improving the quality of patient/client care, but barriers exist which prevent or deter them from undertaking continuing formal education programmes. The main structural barriers included lack of funding and lack of coherent staff development planning and physical barriers including job and family responsibilities.

Safety culture in an aircraft maintenance organisation: A view from the inside

This article deals with a case study about the safety culture of an aircraft maintenance organisation. The case study provides ethnographic accounts based on participant observation, interviews and document analysis. Safety culture is specifically related to the development and growth phase of the organisation and explicitly relates safety culture to production interests. The analysis focuses on the various roles and the tensions between the quality assurance and maintenance management departments, and the way aircraft maintenance technicians (AMTs) in practice deal with tensions between safety and production interests. Theoretically this article stresses the value of a process view on organisational development for the analysis of safety culture and the paradoxical relationship between safety and economic interests.

Outpatient Clinics: Efficiency and Cost Implications

Patient waiting time is often the major reason for complaints about the experience of visiting outpatient clinics. Therefore, patient satisfaction with waiting time plays a crucial role in the process of health quality assurance or quality management. This combined with the implementation of the 18-week patient pathway scheme has increased pressure to improve the efficiency of secondary and tertiary healthcare systems. The smooth working of the clinic depends on skilled health and allied professionals with robust referral and imaging display systems.

What’s past is prologue: Organizational learning from a serious patient injury

This exploratory case study examines how one hospital learned from an adverse event (AE), a medication overdose that seriously injured a patient. Using qualitative data analysis, we examined how four professional groups reacted to the AE: physicians, nurses, pharmacists, and representatives from the combined quality assurance and risk management departments. Following the AE, each professional group classified the event differently, assessed a different segment of history, made decisions about different issues, and chose different courses of action. Despite these differences, the physician, nursing and pharmacy management teams all decided on which solutions to implement before the first root cause analysis meeting was convened. Indeed, to understand how the hospital implemented changes in the aftermath of the AE, it was necessary to examine the learning from near misses and other warnings that preceded it. This case highlights the importance of the politics of organizational learning and raises theoretical and practical questions about how hospitals learn from potential and actual adverse events.

Constructing Authorization Systems Using Assurance Management Framework

Model-driven approach has recently received much attention in developing secure software and systems. In addition, software developers have attempted to employ such an emerging approach in the early stage of software development life cycle. However, security concerns are rarely considered and practiced due to the lack of appropriate systematic mechanisms and tools. In this paper, we introduce a multilayered software development life cycle (SDLC), which is based on an assurance management framework (AMF), focusing on the development of authorization systems. AMF facilitates comprehensive realization of formal security model, security policy specification and verification, generation of security enforcement codes, and rigorous conformance testing. We also articulate our experience in analyzing role-based authorization requirements and realizing those requirements in constructing a role-based authorization system.

Biometrics: deployment considerations for successful implementation

Biometric technology is becoming an increasingly important part of next generation identity assurance and risk management systems. Russ Ryan, vice president, National Biometric Security Project explains why careful attention to pre-deployment considerations is vital to ensure the required operational, functional and financial objectives are achieved.