Quality Management System Audit Research Articles

Feasibility and prospects for the use of digital technologies in the audit of a testing laboratory

Confirmation of the testing laboratory competence is a necessary condition for ensuring the high quality of its functioning. Currently, the competence check of the testing laboratory is organized through the quality management system (QMS) audit procedure based on the requirements of the legislation. Distinctive features of the present time have determined the necessity to move from traditional formats of QMS audit to remote audit using digital technologies. Thus, the study focuses on the features of remote audit, the main factors determining the effectiveness of its implementation, the analysis of remote audit possibilities when checking the competence of the testing laboratory and development of a program for its implementation. The stages are defined and their characteristics are given for conducting a remote audit when checking the competence of the testing laboratory. On the basis of a risk-oriented approach, key stages and tasks are defined when using digital technologies during remote audit.

Remote Quality Management System Audit. Auditors’ and Auditees’ Perspective and Lessons Learned

Theoretical background: The pandemic situation affected the functioning of each organization, including the assessment of quality management systems. The implementation of remote audits, including remote internal audits, has become an urgent necessity. Purpose of the article: The purpose of this article is to present the results of research on potential difficulties in conducting remote internal audit, from the perspective of auditors and auditees. The auxiliary goal is to collect and organize definitions of remote audit and describe its essence in the light of scientific literature and other sources of a formal nature. Research methods: A review and critical analysis of the literature, the method of a diagnostic survey, and then the method of synthesis and logical reasoning were used. Main findings: Several bottlenecks related to certain difficulties can be identified. Both auditors and audited persons should not waste time searching for relevant documents or records. There is a need to check in advance to what extent the applied information technology is efficient, effective and available to all interested parties during the audit. It is necessary to clarify the roles and tasks before and during audits, and to make sure in advance that all resources, both tangible and intangible, are available during the audit.

A Blockchain-based Approach to Support an ISO 9001:2015 Quality Management System

Quality is an essential element for any company that wants to be recognized successfully; because of this, the companies undergo a certification process under a quality standard such as ISO 9001 that allows them to improve the performance of its operation, differentiate itself from its competitors, achieve a better position in the market and export quickly. In this sense, making and maintaining such certification can be under high pressure over the company, up to become a source of corruption risk, since, in emerging markets, companies may be tempted to perform unethical practices such as falsifying or adulterating documents to maintain their certifications and the benefits derived from it. Besides, considering that the quality management system audit process is based on the verification made by a third party of the documents and records of the company against the quality standard, it becomes necessary to reinforce with technology the audit process to minimize this kind of risk. Given this, a software architecture for a quality management system supported in BPMN and Blockchain technology is proposed to guarantee the integrity and immutability of the system and information, which allows exposing any attempt at fraud and facilitates the audit process's automation.

Research on the Improvement of Spacecraft Manufacturing Enterprise Quality Management System Audit Based on Process Method

This article combines the spacecraft manufacturing enterprises that simultaneously build and operate ISO9001 and AS9100 quality management system. According to the process strengthening requirements of quality management system standards, research and improve the audit work with process method as the core. This article introduces the "turtle chart" process method audit management tool, summarizes the specific model and implementation points of the process method in the quality management system audit. This article analyzes the important role of this method in the internal audit of quality management system, in order to provide reference for spacecraft manufacturing enterprises to improve the audit of quality management system.

DETERMINATION OF AUDIT TIME OF QUALITY MANAGEMENT SYSTEMS

It’s given an approach for determination and calculation by Certification Bodies the audit time of quality management systems for all types of audits (initial management systems certification audits: stage 1 plus stage 2, surveillance audits, re-certification audits) on consideration of size, structure, types of activities, processes, products, services and complexity of quality management systems of client organizations. The methodology for determining audit time of quality management system takes into consideration the type of audit to be conducted and any type of locations of a client organization (e.g. permanent site or temporary site, that both may be physical or virtual site), remote auditing activities (off-site activities) and whether an organization operated a management system over multiple sites, various working shifts or outsourced part of its functions or processes for externally provision (outsourcing). This methodology also is considered by taking into account factors for it’s adjustments that need to be considered to increase or decrease audit time. An algorithm of calculation of labour-intensiveness of activities for quality management system evaluating has been developed. It’s considered an application of the algorithm on the example of an imaginary organization. The adoption of the methodology for determining audit time of quality management system for all types of audits will be useful for application to different interested parties, such as certification bodies or theirs clients or others. Keywords: audit, audit day, audit time of quality management system, certification audit, duration of quality management system audit, effective number of personnel, multi-site management system, permanent site, risk, quality management system, recertification audit, risk category, surveillance audit, temporary site, virtual site.

Innovative method to evaluate quality management system audit results' using single value neutrosophic number

Innovative method to evaluate quality management system audit results' using single value neutrosophic number

Innovative method to evaluate quality management system audit results’ using single value neutrosophic number

Using Quality Management System (QMS) enables the organization to fulfil its purpose and mission to meet customers and regulatory requirements and improve its effectiveness and efficiency on a continuous basis, Quality Audit is very critical tool to ensure that the standards, policies and/or procedures are applied in the organization as planned in QMS, in real world applications, the results of the Quality Audit process depend on the auditors’ human judgments that characterized with doubts sometimes, estimating values another times, and using general impressions in his judgment, which motivate to introduce for the first time the Neutrosophic Quality Audit (NQA) model which can be extended to manage and audit in the future. NQA will be used to enhance the way of evaluating the quality audit results while many uncertainty aspects and indeterminacy do exist, the proposed model using Single Value Neutrosophic Numbers (SVNN) which is an instance of neutrosophic set, to overcome the weakness of using a crisp value to present the result of the audit findings, in addition, using Simplified Neutrosophic Weighted Geometric Average Operator (SNWGAO), and cosine similarity degree, an illustrative example is provided to validate the proposed model.

Introduction of Quality Management System Audit in Medical Device Single Audit Program

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.

ANALISIS KEMAMPUAN BERPIKIR KRITIS AUDITOR INTERNAL PADA TAHAP PERENCANAAN AUDIT SISTEM MANAJEMEN MUTU DI UNIVERSITAS SURABAYA

This study aims to look at how critical thinking skills when planning the audit of quality management system at the University of Surabaya. The background of this research is because there has been no previous study that discusses the critical thinking skills and their relation to the audit planning process. In its practice, this study used a qualitative approach and can be categorized as basic research by conducting interviews and document analysis as the primary method for obtaining the data. It is intended that the results of this study can actually see how the role of critical thinking skills of internal auditors during audit planning. The interviews were conducted at 3 Ubaya internal audit staff. In the other, the analysis is done using several documents were obtained as a result of information that reinforces interviews. From these results, it was found that there is a role of the auditor’s ability to think critically when planning the audit of quality management system in Ubaya. In addition, critical thinking skills possessed by the auditor may develop through experience and the training.Keywords: Internal Internal audit, critical thinking, quality management system.

ANALISIS KEMAMPUAN BERPIKIR KRITIS AUDITOR INTERNAL PADA TAHAP PERENCANAAN AUDIT SISTEM MANAJEMEN MUTU DI UNIVERSITAS SURABAYA

This study aims to look at how critical thinking skills when planning the audit ofquality management system at the University of Surabaya. The background ofthis research is because there has been no previous study that discusses thecritical thinking skills and their relation to the audit planning process. In itspractice, this study used a qualitative approach and can be categorized as basicresearch by conducting interviews and document analysis as the primary methodfor obtaining the data. It is intended that the results of this study can actually see how the role of critical thinking skills of internal auditors during audit planning. The interviews were conducted at 3 Ubaya internal audit staff. In the other, the analysis is done using several documents were obtained as a result of information that reinforces interviews. From these results, it was found that there is a role of the auditor’s ability to think critically when planning the audit of quality management system in Ubaya. In addition, critical thinking skills possessed by the auditor may develop through experience and the training.

MANAGEMENT OF INNOVATION IN HEALTH CARE AT THE REGIONAL LEVEL

The paper reviews topical issues of organization and management of innovative activity in the regional health care system.Objective. Development and scientific substantiation of a conceptual model of managing innovation in the regional health care system, introduction of institutional mechanisms for its implementation, and evaluation of their efficacy in using diagnosis and treatment technologies. Objectives of the study included reviewing the organization status and problems hampering the development, identification of prospects, and justification for appropriate changes in innovation in healthcare system and medical science at the regional level.Material and methods. To conduct a comprehensive assessment of the status and meet challenges of innovation promotion, a methodology for social-hygienic research was worked out including bibliographic and analytical methods, situational analysis, sociological and economic methods, expert assessment, methods for quality management system audit in accordance with ISO 19011:2002, IDEFO function modeling (RD IDEF0-2000), and organizational modeling. The study was based on the analysis of foreign and domestic literature, statistics, methods for managerial modeling, as well as management experience (including innovative methodological approaches) gained by Novosibirsk Research Institute of Traumatology and Orthopedics named after Ya.L. Tsivyan which meets the requirements for a platform for research and innovative product reproduction, including research, clinical, organizational, and managerial aspects. Other facilities were considered in conjunction with the leading innovative platform.Results. The paper presents a scientifically based model of innovative medical environment with its elements as subjects, each with a set of functions. Conceptual model for management includes structuring (resource, processes, and quality management; application of international standards) and strategic management mechanisms, provides a systematic approach to management, and ensures efficient operation of medical institutions and public access to innovative medical diagnostic technologies. The advantage of innovative products and technologies using within the doctrine of innovative management is that they provide a comprehensive approach to the diagnosis and treatment of patients. The introducted managing innovation technologies allow to improve organizational performance of healthcare institutions and to achieve significant medical and social effects: high level of diagnosis and treatment, improved access and quality of care what promotes the public health.Conclusion. Formation of regional innovation medical environment with advanced innovation infrastructure, interaction of its elements through an effective system of coordination and control is a prerequisite and basis for more mature and system-level structure – an industry innovative cluster. Active development of innovation in health care based on cooperation among the different actors of innovation and interagency collaboration provides a professional staff to the sphere of research commercialization, accomplishes innovative technology transfer to a real economy, and enables the integration in the worldwide innovation environment through the implementation of technological and scientific research projects.

QUANTIFYING QUALITY MANAGEMENT SYSTEM PERFORMANCE IN ORDER TO IMPROVE BUSINESS PERFORMANCE

This study investigates current methods of measuring quality management system (QMS) performance. It introduces a methodology to quantify QMS performance in order to provide a reference point for improved QMS performance and, in turn, the business’s performance. By introducing metadata into historical or current QMS internal audit data, the study shows that it is possible, over time, to extract various levels of value-adding data, ranging from high-level, strategic, direction-oriented insight, to process effectiveness and implementation-level guidance. This is accomplished by a repeatable process of infusing cause and effect theming data and process-consequence severity data into the QMS audit- findings data, and subsequently analysing the additional metadata.

ОРГАНИЗАЦИЯ ВНУТРЕННЕГО АУДИТА СИСТЕМЫ МЕНЕДЖМЕНТА КАЧЕСТВА ПРЕДПРИЯТИЯ

Вдосконалено організаційне забезпечення методики проведення внутрішнього аудиту системи менеджменту підприємства. Розроблені: стадії Програми внутрішнього аудиту СМЯ, форма програми внутрішнього аудиту СМЯ, Основні дії при аудиті СМЯ, форма Матриці розподілу відповідальності за окремі етапи процесу внутрішнього аудиту СМЯ. Усовершенствовано организационное обеспечение методики проведения внутреннего аудита системы менеджмента предприятия. Разработаны: стадии Программы внутреннего аудита СМК, форма программы внутреннего аудита СМК, Основные действия при аудите СМК, форма Матрицы распределения ответственности за отдельные этапы процесса внутреннего аудита СМК. Improved organizational support of the methods of conducting internal audit of the management system of the enterprise. Developed: the stage of the Program of internal audit of quality management system, form of the program of internal audit of quality management system, the Basic steps in the audit of the QMS, the form of the Matrix of the distribution of responsibility for individual stages of the process of internal audit of QMS.

Структурна модель процесу внутрішнього аудиту системи управління якістю ДК “Укртрансгаз”

The paper deals with the description of the internal audit management systems. The structural model of the ”internal audit” in accordance with the requirements of the process approach and international standards for quality systems in view of the functioning of the internal audit of quality management system in DC Ukrtransgaz

A combined methodology for supplier selection and performance evaluation

Today, organizations that wish to carry on the sustainable growing need a robust strategic performance measurement and evaluation system because of changing demands of consumers, reduced product life cycle, competitive and globalised markets. In this study, a new methodology is introduced and proposed for increasing the supplier selection and evaluation quality. The new approach considers both qualitative and quantitative variables in evaluating performance for selection of suppliers based on efficiency and effectiveness in one of the biggest car manufacturing factory in Turkey. This new methodology is realized in two steps. In the first stage, qualitative performance evaluation is performed by using fuzzy AHP (Analytical Hierarchical Process) in finding criteria weights and then fuzzy TOPSIS (Technique for Order Preference by Similarity to Ideal Solution) is utilized in finding the ranking of suppliers. So, qualitative variables are transformed into a quantitative variable for using in DEA (Data Envelopment Analysis) methodology as an output called quality management system audit. In the second stage, DEA is performed with one dummy input and four output variables, namely, quality management system audit, warranty cost ratio, defect ratio, quality management. As a result, comparing with the present system applied by the car factory, the new method seems to be some advantages and superiorities for making the decision in buying the quality car luggage side part (panel) by selecting the suitable supplier(s) in an automotive factory of Turkey.

INTERNAL AUDIT AS A PROCESS MANAGEMENT TOOL FOR PROVIDING SPECIALIZED MEDICAL CARE

The paper presents the experience in internal audit at Novosibirsk Research Institute of Traumatology and Orthopaedics including main tasks, criteria, methods, and stages of audit, documentation necessary for its planning and fulfillment, and a procedure for analysis and application of information obtained in the course of audit. The Institute developed and introduced the procedure of conducting of quality management system audit with the account of International Standard requirements for quality management system organization, specificity of structure and production processes in medical setting providing specialized care to patients with spine pathology. Application of the method of internal audit conducting significantly reduced the number of process inconsistencies which in its turn positively influenced the effectiveness of the process and the quality management system as a whole.