Approach to the development of a Unified Framework for Safety Critical Software Development

This work is based on a case study of a manufacturing company in Johannesburg, South Africa. The paper presents a set of findings based on an investigation into Quality Management System (QMS) implementation at a company located in the Northern part of Johannesburg. The paper discusses challenges experienced in QMS implementation, successes achieved, failures, and propose recommendations on how to improve QMS implementation and maintain a sustainable management system. Observations, unstructured interviews and structured questionnaires were used. Triangulation was concluded on 20% of respondents using unstructured interviews. Questionnaires were distributed to 114 respondents divided into three segments, namely; customers, Top Management and employees. 62% responses were received back properly completed. The results revealed that the customers involved in the study preferred to do business with companies where QMS has been implemented. The responses from Management showed that QMS implementation is of importance to them and is an empowerment tool to their employees.

Since 2007, the pipeline industry has experienced a large increase in pipeline construction. Construction inspections performed by the Department of Transportation (DOT) Pipeline Hazardous Materials Safety Administration (PHMSA) have revealed numerous quality issues. These inspections, coupled with several pre-commissioning pressure test failures, first year in-service failures, and other material and construction problems, brought construction quality to the attention of the oil and gas pipeline industry. A proven method for improving quality in other industries is through the implementation of a quality management system (QMS). One widely accepted QMS used across industries is ISO 9001. Additionally, several QMS standards specific to the oil and gas industry have been developed. Due to the uniqueness of pipeline construction projects, PHMSA solicited proposals in 2013 for a research and development project titled, “Improving Quality Management Systems for Pipeline Construction Activities” which was awarded to and co-funded by DNV GL. This paper describes the QMS framework for pipeline construction activities and an accompanying guidance document developed by DNV GL. The framework and guidance document are intended to assist pipeline operating companies and contractors in the development and implementation of a company-specific QMS, with a goal of elevating the focus on quality to the level of safety. The framework adopts a risk-based, process approach, as defined in other QMS and management system documents, and follows the plan-do-act-check methodology. The QMS framework is designed to be scalable for a wide range of pipeline construction projects, including liquid and gas transmission pipelines and gas distribution lines. The framework includes the general management system components, as well as specific sections on implementation of a QMS for a pipeline construction project. The QMS framework and guidance document developed are intended to be used either as a stand-alone management system or as the quality component in a company’s corporate management system.

Abstract. Standards for quality management systems require support for the system resources: human, infrastructure, process environment, knowledge, competence, awareness, communication, documented information. Objective. To conduct a systematic analysis of resource management in certified quality management systems of dental institutions; suggest ways to improve it. Materials and Methods. Forms №№ 17, 20 of the state statistical reporting, internal documents of municipal non-profit enterprises: "Zhytomyr Regional Dental Medical Association"; Kharkiv Regional Council "Regional Dental Clinic"; "Chernihiv Regional Dental Clinic of the Chernihiv Regional Council" were used (a total of 37 units). Methods: medical and statistical; system approach; content and comparative analysis; graphic. Results. It has been established that the institutions are provided with highly qualified competent medical staff, but there are no dental hygienists among the positions and individuals of specialists, which overloads dentists with simpler preventive procedures. At the same time, preventive measures are important to prevent the development of caries, periodontitis and diseases of the oral mucosa. There is no widespread involvement of employees in freelance organizational structures, monitoring and internal audit of processes and quality management systems. Heads of institutions did not organize the development and implementation of local clinical protocols based on evidence data. Dental care technologies are regulated by industry standards developed in 2004 on the basis of professional consensus. Clinical pathway of the patient, as organizational regulations of dental care, are descriptive textual in nature, the direction of the patient's movement is not traced, as well as the sequence of interaction of structural units - participants in the treatment and diagnostic process. Clinical quality indicators are not implemented in institutions and are not subject to calculations and monitoring. This creates risks for the effectiveness of patient-centered dental care. External and internal interactions of institutions and their structural units are unclear; there is a shortage of medical equipment; modern digital technologies are used to a limited extent for internal and external communications. Conclusion. Opportunities for the implementation of quality management, laid down in the standard, in each dental institution in the real conditions of its operation are not fully used, which requires the attention of heads of institutions in problematic areas.

The general goal of education is to develop Indonesian people completely in the sense that carried out education still maintain unity, diversity and develop individual’s ideals. Every citizen has the right to obtain education equally with excellence and a balance (equity) between the utilization (access) with achievement. The higher education system must be able to create a quality higher education that is also affordable by the people of Indonesia. A university leader must be in-line and lead a "quality revolution". All energy and attention are focused on the "quality revolution". For this reason, this paper will examine the Implementation of Higher Education Quality Management Systems. As a case study is that has implemented a Quality Management System. According to Law No. 12 of 2012 concerning Higher Education. Quality Higher Education is Higher Education that produces graduates who are able to actively develop their potential and produce Science and / or Technology that is useful for the Community, nation, and country. The government operates a higher education quality assurance system to get quality education. The Higher Education quality assurance system referred to consists of: a. internal quality assurance system developed by Higher Education; and b. external quality assurance system carried out through accreditation. Implementation of Quality Management Systems in Higher Education can produce Quality and Affordable Education.

An overview of the issue of software quality is presented, including models of software quality and different approaches to its measurement: this includes well known models such as those of Gilb [1] and Kitchenham [2]. Issues specific to instructional software are then considered with respect to its development, evaluation and characterisation. The framework proposed by Chen [3] is briefly presented and an approach to improving the design of instructional is outlined. INTRODUCTION: THE ISSUE OF SOFTWARE QUALITY. Current approaches to assuring and measuring software quality are predominantly process based rather than product based. There are two major assumptions here: 1) if we look after the process the product will look after itself 2) quality must be built in to a software product, as this can only be assessed when it is complete and it is too late to alter it. These approaches carry the obvious danger that we can develop a seemingly wonderful quality management system which still allows us to deliver poor software: the process functions smoothly, delivering a product on time, within budget and with all appropriate documents approved and signed, whereas the product may function far from smoothly. Probably the main reason for this emphasis on procedure is that the software product is notoriously difficult to assess for quality whereas the process is much more amenable. In spite of this official standards for quality management systems, such as BS 5750, require procedures aimed at continually improving both process and product quality. In order to do this in any meaningful way it is necessary to be able to assess product quality. Transactions on Information and Communications Technologies vol 8, © 1994 WIT Press, www.witpress.com, ISSN 1743-3517

Introduction-Objective: Assessing the quality of health service provision at a Department level is difficult and needs to be documented. Documentation is achieved by certification. In spite of the increasing trend for more specialized quality standards, ISO 9001:2015 is the most widespread one. The Directorate of the Department of Urology of the University General Hospital of Heraklion, in cooperation with the Hospital Administration proceeded to study/ install the quality management system (QMS) according to ISO 9001:2015 for the provision by the Department of Urology and its Special Units (Non-Invasive Urology-Lithotripsy & Cystoscopy-Urodynamics) of diagnostic, therapeutic and nursing services as well as for the production of scientific work, research activity and provision of educational services. The procedure was implemented in July 2017 through the Special Account for Research of the University of Crete; using funds from a specific program set up for the development of the Department of Urology. To the best of our knowledge, this is the first case of certification of a Urological Department in a Public Hospital in Greece. The purpose of this study is to present the initial experience/results from the implementation of a QMS according to ISO 9001:2015 at our Department. Material and Methods: The procedure was initiated by providing medical-nursing and administrative staff with self-assessment questionnaires and special forms for problem-filling and improvement suggestions. All forms were filled in anonymously. All data gathered were processed by our quality management consultant. The results were presented to the parties involved in an open meeting at the Department and formed the basis for the QMS design. Through a 12-month strenuous workout with meetings about every 15 days, a QMS consisting of 14 procedures, two working instructions, 17 forms, and 13 administrative nursing protocols was set up. The system included 24 forms provided by the Ministry of Health and 29 clinical nursing protocols issued by the local Health Region. The staff was systematically trained in keeping them up and, with suggestions/ corrective actions the QMS was improved. Results: Through patient satisfaction questionnaires, the Department was rated with 9.1/10 (reception/stay), 9.8/10 (medical follow up), 9.3/10 (nursing care) and 9.2/10 (general service). With the implementation of the QMS, quality indicators related to medical-nursing care (drop-fall rates, fever rates, admission severity-related mortality, etc.) are monitored. Through staff meetings the progress of indicators is presented and actions are being taken aiming at improvements. The operation of the Department has been parameterized and co-perception has been conquered. By implementing a QMS, future goals have also been set: a) Higher staff participation rate problems/suggestions for improvement recording, b) Monitoring achievement of research objectives through standardized procedures, c) Higher satisfaction score achievement, d) Certification according to EN 15224, in order to introduce the of clinical risk concept by adopting scientifically registered protocols in daily diagnostic/ therapeutic practice. Conclusions: Certification of the QMS of a Urological Department in a Public Hospital is difficult but feasible. It can be successful despite organizational-technical difficulties/lack of resources. The benefits are many, such as enhancing organizational structure efficiency and improving communication within/outside the hospital.

The aim of the study was to explore the challenges that principals experience in the implementation of quality management system (QMS) in Schools within Mpumalanga Province, South Africa. The main problem which the study investigated was concerned with the factors that lead to principal’s leadership challenges in implementing QMS in the Mashishila and Badplaas circuits’ schools. The study utilized pragmatism as a research paradigm, this allowed for many different ways of interpreting data in this case from both quantitative and qualitative sources. The population of the study was 443 school principals of Gert Sibande District of Mpumalanga province of South Africa. The sample size was 214 and this included 8 participants who took part in a focus group discussion while the rest participated in a survey. In terms of data analysis quantitative analysis was applied for close ended questions that were drawn from responses from the survey. Quantitative data was processed using the Statistical Package for Social Science (SPSS) computer software version 2.0 and results of such analysis were presented in tables and figures. Qualitative data analysis was completed by first categorizing and discussing responses for each item according to themes (thematic analysis), before editing and coding. From the findings of the FGD study it was clear participants felt strongly regarding the Department of Education’s failure to give school adequate technical support to ensure that the QMS implementation is efficient. Furthermore, evidence drew from some of the participants through the FGD voiced and severe shortages of specialists in QMS who can best advise the schools on the technical aspects of the implementation. The study also revealed that there is existence of sabotage and politics at the workplace. This scenario was regarded as one of the factors significantly influencing the lack of effectiveness of QMS implementation by the principals. It was revealed that the inadequacy of leadership skills amongst principals was a challenge they faced in the implementation of the QMS. It is recommended that the DoE reviews the financial resource being channeled to schools for the implementation of QMS with the view of liaising with schools in order to increase the resources. An increase in the available resource will ease some of challenges especially on resources required to engage the technical support through frequent workshops for school managers to effectively implement the programmes. It was recommended that the DoE considers the engagement of the independent body or bodies to oversee and evaluate the implementation of quality management system in schools. This will bring integrity and transparency to the implementation process of QMS.

Both the lean manufacturing (LM) and the quality management system (QMS) are clear initiatives with a goal of improving effectiveness and efficiencies. This review paper aims at exploring the impact of LM tools on QMS. Many organisations tackle lean philosophy, ISO 9001 standard individually. But this kind of attempt lacks focus on the synergy and the advantage from the potential collaboration. Few studies were conducted to explore the linkage between LM and QMS and whether they can coexist in the Manufacturing Industries or not. Though LM is generally proposed as a driver for QMS, a conceptual model is necessary to be developed in order to investigate the integration between LM and QMS. The model is proposed in this paper with a future direction of empirical investigation using AMOS 22 structural equation modelling to test the developed proposition. The originality of this paper lies in observing and measuring the impact of 11 LM tools on the QMS implementation with eventual contribution to operations management by focusing on hard LM aspects and their interrelationships with QMS in one integrated model.

The aim was to produce quality results that clinical laboratories need to implement and maintain continuous quality improvement systems. In recent years, health organizations have increasingly prioritized the quality of laboratory services by implementing quality management systems (QMSs) and building quality improvement activities. Efforts to strengthen laboratory systems in the African region have received increased attention in recent years. Assessing the implementation levels of laboratory quality management system components is important to identify the gaps that need further improvements. A cross-sectional study design was used between March and May 2017 in selected government hospitals of Ethiopia, and sample size was determined using a finite population formula, and a proportional sampling technique was employed; a sample size of 184 (62%) was calculated from 295 laboratory professionals. All respondents were informed about the laboratory's experience in the quality management system implementation; of those, only 138 (79%) engaged in the implementation process. From the 18 selected laboratory quality management components, 5 were observed to have the list implementation status, which are: (1) Performance of internal quality control for all tests, (2) Development and communication of a quality manual for all tests, (3) Adequacy of storage space for the supplies, (4) Development of an action plan based on internal audit, and (5) monitoring of environmental conditions. Running quality controls for all types of tests became a headache in almost all laboratories. From 12 selected quality indicators studied in this research, the 5 indicators with either poor or very poor performance outcome were: control of documents 136 (77.7%), control of records 123 (70.3%), development of manuals and policies 122 (69.7%), development of process and procedures 120 (68.6%), and internal communication 114 (65.1%). This research indicated the top 3 LQMS components with either poor or very poor implementation status: (1) Performance of internal quality controls for all tests, (2) Development and communication of quality manuals for all tests, (3) Adequacy of storage space for the supplies. Of the quality indicators studied, control of documents was perceived to have poor performance outcome by 136 (77.7%) of study participants.

The principal objective of the research was to determine the influence exerted by the implementation of standard quality management systems on the improvement of selected logistics processes in small and medium-sized enterprises, which operate in the textile industry. Empirical research was carried out by the authors in the year 2017 on a group of small and medium-sized enterprises that operate in the textile industry in Poland and Slovakia. The research involved 33 organizations (20 Polish, and 13 Slovak ones). The research process and the analysis of the acquired results made it possible to address the research questions posed and to state, among others, that standardized quality management systems exert a relatively large influence on perfecting selected subsystems and logistic processes in the researched organizations.

Result of the implementation of a quality management system based on the ISO 9001:2015 standard in a surgical intensive care unit.

How Hospitals Choose a Quality Management System: Relevant Criteria in Large Spanish Hospitals

PurposeThe purpose of this paper is to examine the contribution from the use of quality tools and the implementation of quality management systems (QMSs) to the management of an organization. The question is if these aspects have an impact on the important elements of a QMS, like critical success factors (CSFs), but more on the performance derived from its functioning.Design/methodology/approachA questionnaire was created and addressed to Greek companies which were certified with at least one QMS standard, in this case ISO 9001:2008.FindingsIt was concluded that companies implementing more than one QMS and more than nine quality tools gave more importance to specific CSFs of the QMS and also displayed better performance from the rest of the companies. The final conclusion is that the utilization of tools, techniques, and the implementation of more than one QMS – integration of management systems (MSs) – can contribute to many aspects of organization functioning.Research limitations/implicationsThis study was based on the perception (subjective data) of only one quality manager/representative of each company. The companies were not asked about specific actions they have established to integrate their MSs.Practical implicationsThis paper provides a closest look to the utilization of more than one QMS and the use of quality tools. These actions, as concluded, can play an important role in the management of organizations, and managers could use them in an appropriate way.Originality/valueThis paper aims to evaluate the value of QMS integration and the utilization of quality tools to specific issues of QMS as CSFs and performance in Greek companies.

Impact of implementation of quality management systems on internal communications and external relations at schools

Quality management system at the domestic fish processing plants and methods to improve the quality management system are researched in the article. The purpose of the research is to examine the quality management system in the domestic fish processing companies, assessing the quality of fish production by the affinity diagram tool, as well as by determining the organoleptic characteristics and chemical composition of the chilled saltwater fish. As a result of theoretical and experimental studies it is determined the prospects of implementation of quality management system in the enterprise, as well as monitoring the development of new appropriate and effective methods to improve the performance of the current system. It was found that all samples comply with the requirements of the standard, i. e. this product is a high-quality fish processing plants for consumption. Thus, the introduction and improvement of the quality management system to fish processing companies is necessary for the production of quality products.