LLMES: an LLMs-based expert system for quality management system audits

Study on Total Quality Management System Construction for Higher Education

Currently, three management system has been in research management applications, but most of the units due market demand and passive pay attention to quality management system where there is no initiative the enterprise system and quality management together, do not take the initiative quality Lane Management System Internal and standardization of good conduct self-examination combined with the results of the final audit found only superficial phenomenon, the problem continues be in a state fire, and the corporate rich resources are in cabinet in sleep . Aiming at these problems, from the EPRI three management system design, audit and research unit focusing on the actual quality management, quality, internal and external audit and research unit project quality management status, internal management and scientific research units how combine the actual quality, the use of effectiveness aspects of the process approach establish quality management system is generally step-depth analysis identify key problems, give solutions, intended be the standard system combined with the actual work improve the quality management system operation .

This article analyses the quality certification, standardization, market and technical barriers to trade relations problems. Certification system and quality management tools development in Lithuania and international context are also analysed. It gives a study of the processes in place designed to normalise international standards, technical regulations and rules in the light of current global economic conditions. The models of Market, standardization and certification relations, Standardization space and typology and National quality certification system are presented in the article. The resultant generalisations and suggestions have been made based on the author‘s research of Lithuanian enterprises. Worldwide economic globalisation processes and the development of international trade have necessitated rapid quality internationalisation processes, as they are crucial in defining the quality of a product or company. These processes mean that more countries are keeping to unified standards and technical regulations, quality and environmental management systems, quality satisfaction evaluation and certification procedures. With their help, it is hoped that not only will the quality of goods and services be assured on an international scale, but that their implementation will lead to the elimination of technical barriers to trade. The main task of this article is to analyze and systemize quality certification, standardization, regulation tools that are used in the Lithuania and international trade, and to present the providence of the more effective usage of them. Technical barriers to international trade are becoming increasingly pervasive because there is a lot of variance in how these technical rules are applied in manufacturing and agriculture, where, in order to guarantee the production of pure and healthy food products, many countries have come up with especially strict and restrictive rules. Given the existing complicated and nonuniform rules, their systematisation is very difficult to achieve. The author suggests technical barriers to trade be divided into five groups. The certification system of Lithuania involves products, organizations and employees conformity assessment. Apart from “traditional” quality (ISO 9001) and environment (ISO 14001) management systems Lithuanian companies use other systems – ISO 22000, ISO/IEC 20000 GMP, ISO/IEC 17021:2006, ISO/TS 16949, ISO/IEC 27001, CMMI, BRC Global Standard, etc. Vehicle technical inspection and jewellery quality hallmarking performed by Lithuanian Assay Office are also a part of product certification activity. It must be highlighted that enterprises in Lithuania do not certify their products to the conformity of EU quality mark (Key Mark) requirements and not develop environmental management system EMAS yet. Nowadays quality management systems (QMS) are implemented no only in business enterprises, but also in hospitals, high education institutions, police departments, city municipalities and other public sector institutions of Lithuania. Although the amount of organizations that use quality management systems ISO 9001 is rising in Lithuania still there are some problems to be solved. However quantitative evaluation of noted indicator is not very informative. That is why the author uses the relative index – the number of ISO 9001 certificates per 1000 citizen for better comparison. According to this index in the number of QMS certificates Lithuania wins behind against the USA, China and India, however signally falls against other new European Union countries. To reach the EU average of this index, Lithuania has to have more than 2000 certificated QMS. Thus, business organizations and state governmental institutions have every reason for the concern. The author provides recommendations for the development of the effective QMS, to improve all certification system of country and introduce the providences of quality management science development.

Purpose: the article is an attempt to present topics related to management system auditing, as well as presenting the history of auditing in the world. The article also emphasizes the importance of conducting risk analysis in the context of a properly functioning quality management system. Design/methodology/approach: the presented considerations indicated the growing position of management systems audit and certification, as well as risk analysis. Findings: the article presents the history of the development of auditing and its industry universality as a way to verify the correct functioning of the organization. The conclusions also highlighted the growing importance of systems implemented into organizations. Practical implications: the number of certificates issued indicate the great importance of international standards in the area of management systems of production and service organizations. Originality/value: the information indicated shows the great importance of quality management, which provides many benefits for the organization. Additionally, the article presents the importance of audit in modern organizations, divides the audit and pays attention to the issue of risk and opportunity management, thus complementing the literature on the subject. Keywords: audit, quality management, management systems, risk analysis. Category of the paper: research and review publication.

EMBO Reports (2018) e47143 Basic and translational biomedical research explores biological and pathophysiological mechanisms with the aim of developing novel therapies, preventive measures, and diagnostics to improve human health. Disappointingly, however, most new therapies fail when they are tested in clinical trials. Although the causes of this “translational attrition” are diverse and often rooted in the complexity of the underlying biology, it has also become clear that methodology is a major issue. The “translational roadblock”, along with what has been dubbed a “reproducibility crisis” [1], has fueled discussions about the reliability and reproducibility of biomedical research in general. There is strong evidence that weaknesses in planning, conducting, analyzing, and (non)reporting of research [2], as well as misidentification or contamination of reagents, biologicals, and cell lines [3], are prevalent factors. Meta‐research has shown that these problems can lead to an inflation of effect size and false positives and consequently decrease the reproducibility and predictiveness of research results. At the same time, the increasing methodological complexity combined with the immense proliferation in research outputs greatly complicates the production and evaluation of reliable evidence. Pressure to publish and hypercompetition for resources further compromise the robustness and rigor of research. Arguably, basic and translational biomedical research has a quality problem. In the 1970s, US cars had major quality problems. By comparison, Japanese cars were much more reliable. The introduction of rigorous quality management in the production process was largely credited for this competitive advantage, which helped the Japanese car industry to dominate the market for decades to come. By now, most industries, including US car manufacturers, the health and pharmaceutical industries as well as clinical medicine, have established sophisticated quality management systems (QMS) on which they spend several percent of their budget. Clearly, these investments pay off as companies …

The paper considers problems of the development and implementation of quality management system (QMS). Introduction of QMS in higher educational establishments presents serious difficulties. The QMS in higher educational establishments requires vast information and data size. There are no dedicated specific programs for QMS. It is the expert system that is able to automate QMS. An expert system is a self-teaching system. Authors offer to organize the knowledgebase of the expert system for QMS from several levels differing by a degree of detailed elaboration of the information. They describe briefly the knowledgebase structure of the expert system.

Purpose Quality management systems are well established in multinationals and SMEs. For establishing and improving such systems, there is a variety of guidelines. Furthermore, there are software tools allowing a self-assessment of the current state of the implemented systems. However, these approaches do not fit for micro-enterprises and start-ups. Their processes are rather informal or not yet specified. Moreover, these companies are often in a phase of strong growth and have only one person in charge. Hence, they face the difficulty to decide if and how a (quality) management system should be implemented. This paper aims to show a first guideline for implementation. Design/methodology/approach The first step comprises a definition of microenterprises and start-ups and an analysis of their specific characteristics. Following, an overview of the DIN EN ISO 9001:2015 and its requirements is given. Next, it is analysed which requirements are relevant for or can be implemented in microenterprises and start-ups. Based on this, a guideline for decision-making is developed to examine if an application of the analysed standard is useful or necessary for the regarded companies. Also, the guideline illustrates how the requirements can be implemented. Findings A literature review, an analysis of the DIN EN ISO 9001:2015, the standards for project management, microenterprises and start-ups have been carried out. Thereby, the need to decide whether to implement implement a quality management system and assistance for the implementation process has been revealed as essential for the companies considered. Literature mostly deals with implementing a quality and/or project management system in multinationals and SMEs but not in very small companies. Furthermore, first practical examples have shown that microenterprises face difficulties when choosing and implementing a quality management system. A practical implementation guideline for these companies is lacking. Originality/value Although there is a lot of research dealing with quality management in SME, research about quality management in microenterprises and start-ups is scarce. This paper offers a first approach for a guideline of implementing an appropriate quality and possibly an additional or alternative project management in microenterprises and start-ups. This should facilitate the process of deciding if and how to implement an adequate management system for the regarded companies.

Purpose – The purpose of this paper is to propose a generic model of Integrated Management System of Quality, Environment and Safety (IMS-QES) that can be adapted and progressively to assimilate various Management Systems, of which highlights: ISO 9001 for Quality; ISO 14001 for Environment; OHSAS 18001 for Occupational Health and Safety. Design/methodology/approach – The model was designed in the real environment of a Portuguese Organization and 160 employees were surveyed. The rate response was equal to 86 percent. The conceived model was implemented in a first phase for the integration of Quality, Environment and Safety Management Systems. Findings – Among the main findings of the survey the paper highlights: the elimination of conflicts between individual systems with resources optimization; creation of added value to the business by eliminating several types of wastes; the integrated management of sustainability components in a global market; the improvement of partnerships with suppliers of goods and services; reducing the number of internal and external audits. Originality/value – This case study is one of the first Portuguese empirical researches about IMS-QES and the paper believes that it can be useful in the creation of a Portuguese guideline for integration, namely the Quality Management Systems; Environmental Management Systems and Occupational Health and Safety Management Systems among others.

Little is known about the complementary performance benefits associated with facilities’ combined use of both quality management systems (QMS) and environmental management systems (EMS), and how these performance benefits might differ from those associated with facilities’ use of only one of these management systems (or neither). We suggest that complementarities arise because each management system fosters the development of internal capabilities that facilitates the adoption and routine operationalization of the other, while maintaining differentiated goals that enhance strategic value. We examine these relationships using a sample of 2,619 manufacturing facilities operating within six OECD countries, while controlling for self-selection issues. Our findings support the idea of complementarity in that facilities, that adopt both QMS and EMS, are associated with positive business performance more than facilities that adopt either QMS or an EMS on its own, or no management system.

Implementation of quality, safety, occupational health and environment management system were done partially in Indonesia. In this research, I would like to present integrated management system. Integrated management system mentioned in this paper is integration between quality management system, environment management system, health and safety management system in organization of construction company. Most of the research done in manufacturing sector not discuss about the implementation of integrated management system in realizing improving organization performance, especially in improving organization performance sustainability in construction company. For improving organization performance, it need to consider knowledge management and information system in integrated management system. Hopefully, it can be one of the key successes to improve organization performance especially in construction company. Information system is recognized to be one of the most important supported to implementation of integration management system. This research will produce integrated management system concept model to increase organization performance using information system: agent based modelling.

The article is devoted to the issues of product requirements management and product quality management in the aerospace industry. The relevance of the topic of requirements management and product quality is shown. The necessity of developing a model containing a formalized requirements management process with implemented quality management procedures is substantiated. The purpose of the research is to highlight the properties of the tasks of managing requirements for products and managing product quality and establishing the relationship between them. The tasks of managing requirements for products are considered on the example of designing a product as a key stage in the formation of requirements for manufactured products. The analysis of the tasks of product quality management is based on the process of quality control of manufactured products, as the process of establishing compliance the actual values of the parameters that describe the product with the requirements for this product. The article presents the structure and properties of the tasks of requirements management systems for products and product quality management based on the tandem model, the rules for the interaction of model elements are also given, and the place of tasks of quality management systems in solving the tasks of the requirements management system is established. The specifics of the key tasks of each of the systems are considered. The relationship between the tasks of quality management and product requirements management using the apparatus of tandem models is shown. The model of representation of the requirements management system and the product quality management system proposed in this article suggests the establishment of boundaries between the processes of these systems. The use of the apparatus of tandem models makes it possible to guarantee compliance with all requirements formed in the process of functioning of quality management and requirements management systems. The results obtained can be used to further formalization of quality management processes in order to form a methodology for designing a digital product quality management system in the aerospace industry.

Internal audit is an effective independent activity within a pharmaceutical industry quality management system. It ensures a thorough analyses and evaluation of the company activities and helps prevent, predict and detect mistakes and weaknesses in order to minimize losses. Internal audits help the organization achieve its goals and ensures all the involved parties that a program complies with regulatory and Good Manufacturing Practice (GMP) requirements. A successful audit, is carried out by quality auditor or audit team members, chosen carefully and properly trained. The auditor should gain as much information in advance before the auditing process begins that should help him to design tools useful in achieving the desired results. There are several sections recommended to be included in the GMP audit checklist: Quality management, Personnel, Facility and Equipment System, Documentation, Production System, Packaging and Labelling System, Storage System, and Laboratory Control System. A quality management system (QMS) is a formalized collection of processes, procedures, and documented policies, therefore the auditor looks to find out if the system complies with GMP requirements. As for the personnel, GMP audit checklist cover all the necessary procedures to ensure that the organization’s hiring and supervising practices are in compliance to GMP requirements, such as competences, trainings, dressing, and hygiene of the employees. Documentation ensures traceability of all development, manufacturing and testing activities, so the auditor needs to verify major types of documents that should be kept and recorded. The checklist includes questions addressing review of the layout, construction, size, location of the facility and main areas such as production area, storage, and laboratory, as well as the installation, operation, instructions, maintenance and cleaning of the equipment used in the manufacture. The production and process audit checklist include organization’s various stages of manufacturing such as weighing or measuring of raw materials, appropriate storage conditions for intermediates, In-Process sampling and controls, contamination control, process validation. Checklist points for internal audit of Packaging and Labelling System include elements ensuring the security and quality of packaging and as well elements that relate to labelling such as documentation, storage of starting materials and finished products, packaging and labelling operations. Internal auditing of storage system should prevent occurrence of mix-ups, damage, physical, chemical or microbial contamination. As for the Laboratory Control System, the GMP checklist questions aim to ensure that pharmaceutical products meet safety, efficacy, purity, and stability standards. The checklist is a good and critical tool to assist in conducting an in-depth and consistent audit and will serve as guideline for evaluation of compliance to standards and documentation, as well as for the effectiveness of the audited process.

The paper summarizes the results of research conducted by domestic and foreign scientists on the existing models of education quality system, the practices of the quality management functioning and approaches to evaluating the indicators of an educational scientific organization activity. The principles of the model of the European Foundation for Quality Management (EFQM) and the model of the balanced scorecard (BSC) are distinguished and analyzed based on the analysis of the practice of the quality management system and its indicators in the course of certifcation and accreditation procedures. The basic criteria and principles of improving the system of university education quality management as an important tool of the university's competitiveness have been determined. The specifc features of the organizational structure of higher education institutions, their functions as a system of socio-economic activity are highlighted; the principles of running the quality management system in higher education institutions are defned. The role and basic elements of the educational activity quality system in the strategic management of higher education institutions are defned. The study proposes a model of sustainable evaluation of the effectiveness of education quality management efciency involving two evaluation components, namely management and evaluation perspectives. Opportunities objects (goals, strategies, partnership, resources, organizational culture, interested parties involvement) and the results indicators (students, customers, employees and other stakeholders satisfaction) were formed. The algorithm for improving the system of ensuring the quality of university educational activities is determined and the need to adapt its practical application to the specifcs of the institution, in particular the management system, education quality and strategic management, is substantiated. It was concluded that the improvement process should be based on the standards and recommendations on higher education quality assurance in the European area, the current national system of education quality assurance and regulatory documents regarding the activities of the system of education quality assurance in a specifc institution. Considering the proposed sustainable system for the management system effectiveness evaluation, the author emphasized that the development of indicators of higher educational institutions activity is to be based on the analysis of the university strategic indicators map. The map is advisable to flexibly adapt the structure of the organization according to the following directions: development, processes, consumers, fnances. For this purpose, it is expedient to choose interconnected strategic prospects for higher education institutions development of and to develop a corresponding system of indicators. It is proved that consistent operation of the university quality management system requires ensuring a connection between the evaluated indicators of all types of higher educational institutions activities and the process of forming university strategic management tasks in the course of working out a development strategy and in achieving the objectives set. Key words: higher education institution, competitiveness, quality culture, educational activity, indicators of the organization's activity, quality assurance system, stakeholders, education quality management.

Over the past 12 years, as directed by federal and provincial regulations, Canadian pipeline companies have been formally developing and implementing Integrity Management Programs (IMPs). Since 1999, IMPs have been a requirement in the Canadian consensus industry standard CSA Z662. Furthermore, since the release of CSA Z662 Annex N in 2005, both the BC OGC and the Alberta Energy Resources Conservation Board (ERCB) (Canadian provincial regulators) have made CSA Z662 Annex N mandatory for their regulated companies. Annex N incorporates key management system (MS) elements such as a company’s policy and commitment, responsibilities, competency, planning, management of change, review and evaluation. This paper presents the findings of IMP audits conducted by the NEB and BC OGC regulators during the period of 2001–2011. This paper also includes the findings of NEB’s analysis of pipeline incidents that occurred between 2005 and 2009 and how these incident findings correlate to the audit findings. This paper is structured as follows: • Integrity management regulatory frameworks • IMP and MS elements and their interconnection • Audit findings from the NEB and the BC OGC • Incident findings from the NEB • Analysis of the audit findings and their correlation to incidents • Trends on IMP and MS audit and incident findings The paper provides a general understanding of the findings and their trends on pipeline integrity management and on incidents in terms of IMP/MS elements as described in Table 1. The results from this study may help stakeholders to determine strategies to increase the adequacy, implementation and effectiveness of pipeline integrity management. This paper does not include any company-specific information nor results and conclusions from any particular audit report or incident.

Enhancing construction quality inspection and management using RFID technology