Management System Audit Research Articles

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.

Making internal audits business-relevant

Internal management system audits are sometimes seen as policing activities focusing on compliance and documentation rather than something that contributes to improvements. Previous research has focused on what to change in order to make auditing more business-relevant; fewer studies provide focus on how these changes can be operationalised. The purpose of this paper is to understand how internal audits can be carried out in a way that is perceived to add value beyond verifying compliance towards a standard. This study is based on action research in a global company in the consumer electronics sector. The study confirms that internal audits can add value beyond verifying compliance, acting as a generative mechanism for business-relevant improvements. However, this requires both short- and long-term changes in the auditing process; examples of changes are decreased time from audit to report, closer dialogue with management by the establishment of a sponsor role linking management and auditors, and giving up the cyclic audit programme in favour of a programme aligned with business objectives, strategies, and risks.

Auditing management systems for safety controls, alarms, and interlocks: How effective are your instrumented protective systems?

Auditing management systems for safety controls, alarms, and interlocks: How effective are your instrumented protective systems?

A Method for Optimizing the Integrated Management System Audit Program

The application of Integrated Management Systems (IMS) is now attracting the attention of senior management of a variety of organizations: refineries, instrument-making enterprises, aviation enterprises, defense organizations, etc. However, performing ISM audits as a verification of conformance to different ISO standards with a substantial reduction or limitation of available resources remains a major problem. At the same time, continuous improvement of management principles and, in particular, transition to risk-based thinking provide a greater interest in the rational use of ISO standards. In this article we suggest a technique of optimization of IMS audit program based on principles of continuous adaptation when collecting data during a single audit micro-cycle. An additional advantage of the proposed technique is the use of numerical metrics of IT-security audit, contributing to continuous improvement of the level of IT security in organizations.

Sistema de Gestión de Auditorías para el Centro de Soporte UCI-Audit Management System for the UCI Support Center

El presente artículo pertenece a una investigación para la realización de un sistema que audite los procedimientos que se realizan en el centro de soporte de la universidad de ciencias informáticas (UCI). El objetivo de la implementación de este sistema es incrementar la prestación de servicios de Tecnologías de la Información (TI) en el centro. Para llevar a cabo la implementación de dicho sistema fueron analizados los sistemas de gestión de auditoría de servicios de TI existentes en la actualidad como resultado de un profundo estudio del arte en el ámbito nacional e internacional, se describieron las herramientas y tecnologías utilizadas en la solución desarrollada (metodología, patrones, softwares, lenguajes de programación, etc.) que permitieron una implementación eficiente en corto tiempo del sistema propuesto. Lo antes escrito se refleja de manera positiva en una mejor satisfacción de los clientes y por consiguiente en una mayor aceptación de los servicios brindados por la entidad.

EVALUASI PENGGUNAAN SISTEM INFORMASI “TEAMMATE” DALAM PELAKSANAAN TUGAS AUDIT PADA INSPEKTORAT JENDERAL KEMENTERIAN KEUANGAN

This research is motivated by the use of technology is considered important because it can help the activity or activities of the o.rganization, including the audit field through the use of the Audit Management System (AMS) where the organization is required to prepare a mechanism/infrastructure of modern information technology-based. The subjects of this study is the Inspectorate General as one unit in the Ministry of Finance that the task of implementing internal control and promote public confidence in the Ministry of Finance. Inspectorate General of the Ministry of Finance in 2011 has been working with the company Wolters Kluwer Audit, Risk & Compliance through the use of Teammate Application in order to implement the Audit Management System (AMS). Results from this study showed that the controls applied to the Inspector General of the Ministry of Finance to the security and confidentiality of information on the Teammate Application is very adequate. However, the Inspectorate General of the Ministry of Finance still have to pay attention to the weaknesses arising from the use of commercial systems to support the operations. Keywords: Audit Management System (AMS), Teammate Application, information system.

Assessing hygiene practices during fish selling in retail stores

Purpose – The purpose of this paper is to assess hygiene practices during fish selling in retail stores. Design/methodology/approach – The data were collected by observations during inspections carried out in 100 randomly selected food retail stores, both independent and chain, selling fresh fish, fish products and other seafood. Stores were located in and around the area of Warsaw, Poland. The inspection check list consisted of 43 questions based on rigorist requirements of Commission Regulation (EC) 852, 853 and Codex Alimentarius. The question form was divided into three hygiene sectors: hygiene conditions of seafood departments; hygiene of fish selling process; personal hygiene of employees. Inspections were unannounced, and were conducted by discreet visual observations of employees work routine and selling procedures. Findings – The level of hygiene compliances with inspection criteria was unexpectedly low. The highest percentage of compliance appeared in the hygiene of fish selling processes (in 44 percent of the stores compliance with evaluated criteria was found), less one compliance levels appeared in personal hygiene (18 percent) and hygiene of seafood department’s hygiene conditions (23 percent). Neither the size of the store, nor its location and type (independent and local or global chain) affected the compliance rate. Research limitations/implications – The main research limitation is that assessment was done only by observation method. This is one of audit/inspection methods according to ISO 19011/2011, guidelines for auditing management systems. However, this kind of inspection cannot assess microbiological cleanliness or other like ATP or symptoms of diseases expect of only visible signs. The used inspection check list needs more testing and more analyses should be done for its reliability and validity. Practical implications – Adequate hygiene practices are critical in preventing cross-contamination. However, none of the inspected stores ensured full implementation of all hygiene requirements during the sale of fish. The results indicated that a greater effort should be made to increase hygiene level both in small and large size retail stores. The designed inspection questionnaire proved to be a successful format for detailed evaluation of hygiene practices during the sale of fish. However, more work and analyses should be done for its reliability and validity. Social implications – The findings bring some information for the consumers that in many retail stores the hygiene level during the fish sales might be insufficient. Originality/value – The paper presents additional and detailed data on hygiene practices during fish selling, which are rarely pointed out by other authors. The applied evaluation method showed a low level of compliance with the rigorous hygienic criteria, adopted in this study, that may raise some food safety concerns.

The auditing of process safety

There is growing concern with respect to the effectiveness of auditing of process safety management systems as undertaken by major hazard operators. Although criticisms of process safety auditing are periodically expressed by accident investigators, competent authorities and respected commentators it is rare to hear from those who are involved in the process of audit. This paper attempts to redress the balance and its subject is the auditing of process safety from the viewpoint of those process safety practitioners who play a role in that process. An online survey was distributed to a cross section of process safety professionals which explored the themes of audit organisation, audit criteria and audit team composition and training provision. The majority of respondents declared that their business conducts dedicated process safety audits. Those that did not were split on the question of whether general safety audits diluted the auditing of process safety. No correlation was observed between process safety content in general safety audits and opinion on dilution. The majority of respondents declared that their business uses internal standards against which safety audits are performed and against which the audit is conducted. The role of part time auditor was the most commonly found member amongst audit teams with the majority of organisations choosing to deploy internal resources to train their own auditors.

Modeling the Process of Business Management Systems Control

Innovative trends in production management increasingly involve implementation and auditing of standardized management systems according to ISO standards. Within the paper are presented the results of research focused on optimization of auditing system processes in the area of quality, environment and safety. There was constructed an algorithm and quantified mathematical model of integrated auditing and using Gantt chart, the visualization of annual auditing plan was realized. Verified and validated proposed model offers possibilities of its extending for the capacity management and indicators of integrated auditing processes of business management systems.

A Study on Safety Audit Management System in Kuwait

A Study on Safety Audit Management System in Kuwait

Compliance with the Health Information and Quality Authority of Ireland National Standard for Patient Discharge Summary Information: a retrospective study in secondary care.

Unexplained changes to medication are common at hospital discharge and underscore the need to standardise patient discharge clinical documentation. In 2013, the Health Information and Quality Authority in Ireland published a Standard on the structure and content of discharge summaries. The intention was to ensure that all necessary information was complete and communicated to the next care provider. This study investigated one Hospital's compliance with the Standard, and appraised two methods of electronic discharge communication (Symphony or Tallaght Education and Audit Management System (TEAMS)). A retrospective survey of 198 randomly selected discharge summaries was conducted at the study hospital, a 600 bed academic teaching hospital located in Dublin, Ireland. Of the 198 evaluated summaries, mean total compliance was 77%±4.2 (95% CI 76.3 to 77.5). Most (84.7%, n=173) summaries were completed using one of the systems (TEAMS). Absence of communication about alteration of preadmission medication was frequent (107 out of 130 patients (82.3%, CI 76.2 to 89.2)). Higher compliance rates were observed however, when information was interfaced or where there were dedicated fields to be completed. Efforts to improve compliance with the National Standard for Patient Discharge Summary Information should focus on reporting changes made to medication during hospitalisation.

O Impacto Financeiro das Auditorias da Qualidade nas empresas Portuguesas

This paper discusses the main theme the financial implications that Portuguese companies with the implementation and subsequent certification of the Quality System and respective Quality Audits. The literature review shows that companies do not publish financial results on the subject in question, making it necessary to acquire information through a questionnaire. About 126 questionnaires were sent. Our sample is however 32 validados.Pode to complete questionnaires that the top 5 overall benefits or indirect financial benefits for Portuguese companies were, respectively: improving internal organization; improving the company's image; increasing customer satisfaction; continuous improvement in customer service; improving competitive position. In terms of direct financial benefits the 3 main benefits obtained by the companies were: turnover increase; Performance (cost reduction); Increased business productivity. So it is expected to contribute to the knowledge of the impact, notably financial of Quality Management Systems and respective audits in Portuguese companies.

Performance Management System in Action, Survey and Questionnaire Finding in Higher Education in Bahrain

This paper focus on performance management system in practice based on survey and questionnaires and supported by literature work. Ever since the establishments of these higher education institutions, little has been done regarding administrative rules and policies on the use of performance management system and practices. Thus, it became compulsory to assess the current system and consider performance management system as one of the important parts. This entails enhancement of the existing performance management system in the above-mentioned selected higher education institutions. The performance management system is expected to standardize the correct method in the system of promotion, and give incentives and rewards to administrative officers and employees in the higher education institutions on a yearly basis. Thus, this research study was conducted to determine the level of adequacy of the present performance management system as a basis of promotion and rewards in the five selected higher education institutions in Bahrain. This study aims to conduct a performance management system audit of selected higher education institutions in Bahrain towards a strategic performance management system. Specifically, the study addresses the following: What is the profile of these selected five higher education institutions operating in Bahrain’s performance management system in the areas of: Demographic profile; Vision, mission, value and strategy; Organization and structure; Employees, talent management, leadership development; Employee relations; Staffing; Continues education program; and Performance management? To what extent do respondents correlate significantly in their perceptions? What are the strengths and weaknesses resulting from the respondents perceptions on the PMS profiles? Based on the findings, what strategic PMS is applicable to the selected higher education institutions? The study aimed to audit the Performance Management System of Higher Education Institutions in the Kingdom of Bahrain towards a strategic performance management system. The descriptive method of research was used in this study with prepared structured questionnaires as basis for the data needed in auditing the present appraisal tool used by higher education institutions. Two groups of respondents namely the administrative managers and administrative employees with the corresponding numbers of 150 each or a total of 300 were the respondents in this study. The study was conducted in the selected five public and private higher education institutions in the Kingdom of Bahrain. These selected higher education institutions are established, one of them a government and a prime institution of higher learning. This primer university was established in the late sixties during the integration of the Higher Education Institutes for male and female teachers into the system. These institutes later integrated with other colleges and formed into the primer government university. The other four higher education institutions were established in the late 1990s and 2000s and maintain their higher learning standards within the requirements of the Ministry of Education in Bahrain. This research environment was based on the current locations of these selected five higher education institutions within Manama and the neighboring towns in the state nation of Bahrain where most of the employees are diversified from the academic staff to administrative employees like Bahrainis, Indians, Pakistanis, Egyptians, western people, other Asian and Arab nationalities among others. Such diversities of people working in these selected higher education institutions made it unique to this study since all of these people are affected for whatever result the performance management system will provide to them. The demographic profile comprised age groups between 31 to 35; the respondents’ educational attainments; work experiences from 6 to 10 years, and number of years in their present jobs. The major areas studied were: Vision, Mission, Value and Strategy; Organization and structure; Employees’ talent management, and leadership development; Employee relations; Staffing, Continuous education program; and Performance management. The respondents received copies of the survey questionnaire through e-mail, postal system, or personal approach. The output of the research work served as a basis to derive a strategic performance management system model for higher education institutions in the Kingdom of Bahrain. Responses to the questions were tested at α = .05 or α = .01 where appropriate. Correlation analysis was used to test significance of associations of respondents’ responses. The weighted means were tested for significance using a t-test. To conform with international standards, only means that were at least 3.5 were accepted as strengths and means below 3.5 were considered weaknesses. The Statistical Package for Social Sciences (SPSS) software is used throughout the study to process the data.

Understanding firms׳ selection of their ISO 9000 third-party certifiers

Non-financial auditing and third-party certification of management systems (such as the ISO 9000 quality management system) is becoming a pervasive activity amongst an increasing number of firms and their supply chains. Though the literature has paid substantial attention to adopting firms, there has been little focus on the interrelationship between third-party certifiers and adopting firms. Building on voluntary standards literature and the attitude theory, we investigate how do firms choose from a competing set of certification bodies and how does such a decision impact their satisfaction with certification. We use a sample of 539 firms in Australia and New Zealand certified against ISO 9000 standard. We demonstrate that the selection of third-party certifiers is influenced by firms׳ auditing orientation and that firms oriented to continuous improvement auditing (as opposed to mere compliance with the standard) focus on choosing reputable auditing firms. We have also determined that reputable certifiers deliver more insightful audits, which contribute to overall satisfaction with the certification. The findings have implications for managers and for certification bodies. Managers should understand that cost savings from certification services have negative impact on the satisfaction from certification. For certification bodies, the paper provides an insight how firms select their certifiers.

Corporate social responsibility audit: Theoretical aspects

This paper puts a conceptual framework to outline research for corporate social responsibility (CSR) audit based on the analysis of current CRS literature and audit models as implementation of CSR. It is intended to make clear the phenomena about the relationship between audit, implementation of business ethics principles and corporate governance. However, most studies do not take into account modify CSR audit. This paper reports part of a research we carried out on the theoretical interpretation of the corporate social responsibility audit. This paper examines the corporate social responsibility audit as a composition of four categories - management system audits, on-site audits, verbal probability expressions (VPE) audits and technology audits. The paper concludes suggests to systematize multiple audits so that they can be conduct in three types of audits - environmental management audits covering in-house companies, environmental technology audits of products, and environmental audits of sites, including non-manufacturing sites and non-consolidated subsidiaries.

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.

Auditing technology management processes

This paper introduces a new approach to the auditing of technology management systems. The approach is based on a process model of technology management covering identification, selection, acquisition, exploitation and protection of both product and process technologies. An application of the audit to three business units within a high–technology company is used to demonstrate the feasibility and utility of the approach.

Effective general practice: audit and feedback for the primary series of immunisations

General practice immunisation audits do not always match the national rates recorded on the New Zealand (NZ) National Immunisation Register (NIR). To complete audits at one general practice for infants requiring the primary series of immunisations (6-week, 3-month and 5-month vaccines) over a 12-month period and compare findings with the NIR audit. A manual and electronic practice management system (PMS) audit were compared with identical NIR audit parameters for completion of the 5-month vaccination from 1 February 2011 to 1 February 2012. All three results were then combined with further sub-audits of the total practice newborn population to produce a multifaceted audit, identifying further eligible patients. The NIR database query tool was used to corroborate data on partially immunised and unimmunised patients identified. All three initial audits produced different results for vaccinated and eligible patients: NIR 31/36; PMS audit 39/43; manual audit 41/48. The multifaceted audit identified 48 eligible infants. All 48 (100%) started their primary series-95.8% (46 of 48) fully immunised; 4.2% (2 of 48) partially immunised, missing only one injection. None were unimmunised, contrary to initial audits. Lower levels of timeliness of delivery were confirmed for this practice, with 52.1% (25 of 48) immunised on time. Results show 9.7% higher levels of immunisation than reported by NIR statistics for this practice (95.8% vs 86.1%), above current NZ government and World Health Organization targets. The multifaceted audit produced the best estimate of eligible patients and identified deficiencies in vaccine delivery.

An empirical analysis of the integration of internal and external management system audits

This paper presents the results of a research study whose main objectives were to analyze and compare internal and external management system audits regarding their implementation and integration in Spanish companies. Nine variables were investigated, namely the audit team, schedule, strategy, plan, report, methodology, guidelines, frequency and outputs. The results show that there are some significant differences regarding the audit team formation, the auditing guidelines used and the frequency of conducting the audits. The rest of the variables did not exhibit significant differences between internal and external audits. In addition, the integration level of both these categories of audits is very high for all the audit elements analyzed.

Neural network analysis of construction safety management systems: a case study in Singapore

A neural network analysis was conducted on a quantitative occupational safety and health management system (OSHMS) audit with accident data obtained from the Singapore construction industry. The analysis is meant to investigate, through a case study, how neural network methodology can be used to understand the relationship between OSHMS elements and safety performance, and identify the critical OSHMS elements that have significant influence on the occurrence and severity of accidents in Singapore. Based on the analysis, the model may be used to predict the severity of accidents with adequate accuracy. More importantly, it was identified that the three most significant OSHMS elements in the case study are: incident investigation and analysis, emergency preparedness, and group meetings. The findings imply that learning from incidents, having well-prepared consequence mitigation strategies and open communication can reduce the severity and likelihood of accidents on construction worksites in Singapore. It was also demonstrated that a neural network approach is feasible for analysing empirical OSHMS data to derive meaningful insights on how to improve safety performance.