How does IATF 16949 add value to ISO 9001? An empirical study

This article analyses the added value of IATF 16949–a standard for qualitymanagement in the automotive sector–with respect to ISO 9001, the most popularstandard for quality management worldwide. An exploratory qualitative study wascarried out based on a multiple case study. Eight companies operating at differentlevels of the Spanish automotive sector supply chain were analysed and 27 interviewswere conducted–17 with managers of these companies and 10 with auditors andconsultants. Multiple internal and external sources of documentation were alsoanalysed. Thefindings show that IATF 16949 adds value to a moreflexible ISO9001 infive main areas: market, customer service in the supply chain, operationalperformance, staff, and technology. Overall, IATF 16949 is seen as a‘license tooperate’for automotive sector suppliers, for whom ISO 9001 seems to have lost itssignalling value. This study sheds light on the raison d’être of sectoral standards forQMSs such as IATF 16949 and contributes to the literature on the neo-institutionalapproach to QMSs and explains some of the main weaknesses of ISO 9001.This article is a result of the Research Group funded by the Basque Autonomous Government (Gruposde Investigación del Sistema Universitario Vasco; GIC 15/176

A Change Management Approach to Enhance Facility Maintenance Programs

A recent study assigned a grade of D+ on the nation\u27s public infrastructure. Because of this poor asset condition, many organizations tend to respond to maintenance in a reactive mode; however, relying on corrective maintenance leads to increased maintenance costs due to unplanned downtime, increased labor costs, and inefficient use of personnel. To address this situation, asset management (AM) principles should be employed to transition organizations towards a proactive maintenance program. Unfortunately, it has been shown that two-thirds of the organizations failed to implement general change efforts. Therefore, an organizational change management framework should be followed to implement a change that will successfully transition organizations from reactive to proactive maintenance. This research effort focuses on building the framework for a change message to help Air Force decision-makers implement new Information Technology (IT) that addresses key AM principles such as asset condition and remaining service life. A Delphi study was utilized to elicit expert field knowledge on facility maintenance and respective IT. Results from the study, combined with literature guidance, helped formulate a change message to implement BUILDER™ to enable a proactive maintenance paradigm

Enhancing the Performance of Electricity Distribution Companies in Nigeria via Internal Control System

The study evaluates internal control system and performance of Electricity Distribution Companies in Nigeria. To achieve the objectives of the study, primary and secondary data were used. The secondary data include journals, textbooks and the publications of the Nigerian Electricity Regulatory Commission and the primary data was collected using a well structured and tested questionnaire from one-hundred and twenty (120) respondents in three (3) Electricity Distribution Companies in Nigeria. The respondents were selected through random sampling technique. The data collected was analysed using descriptive statistics and Chi-square with the aid of Statistical Package for Social Sciences (SPSS). The findings of the study suggest that weak internal control system can reduce the overall performance of Electricity Distribution Companies in Nigeria. The analysis also showed that effective internal control systems have significant impact on the companies’ service delivery and that effective internal control systems have significant impact on the companies’ revenue generation. The study concludes that lack of effective internal control system in Nigerian Electricity Distribution Companies is one of the major causes of poor service delivery to the members of the public and as a result of this; the revenue they obtain from the services cannot sustain them. Key words: Internal Control System, Performance, Internal Audit, Corporate governance,  Enterprise Risk Management

Framework for Security Transparency in Cloud Computing

The migration of sensitive data and applications from the on-premise data centre to a cloud environment increases cyber risks to users, mainly because the cloud environment is managed and maintained by a third-party. In particular, the partial surrender of sensitive data and application to a cloud environment creates numerous concerns that are related to a lack of security transparency. Security transparency involves the disclosure of information by cloud service providers about the security measures being put in place to protect assets and meet the expectations of customers. It establishes trust in service relationship between cloud service providers and customers, and without evidence of continuous transparency, trust and confidence are affected and are likely to hinder extensive usage of cloud services. Also, insufficient security transparency is considered as an added level of risk and increases the difficulty of demonstrating conformance to customer requirements and ensuring that the cloud service providers adequately implement security obligations. The research community have acknowledged the pressing need to address security transparency concerns, and although technical aspects for ensuring security and privacy have been researched widely, the focus on security transparency is still scarce. The relatively few literature mostly approach the issue of security transparency from cloud providers’ perspective, while other works have contributed feasible techniques for comparison and selection of cloud service providers using metrics such as transparency and trustworthiness. However, there is still a shortage of research that focuses on improving security transparency from cloud users’ point of view. In particular, there is still a gap in the literature that (i) dissects security transparency from the lens of conceptual knowledge up to implementation from organizational and technical perspectives and; (ii) support continuous transparency by enabling the vetting and probing of cloud service providers’ conformity to specific customer requirements. The significant growth in moving business to the cloud – due to its scalability and perceived effectiveness – underlines the dire need for research in this area. This thesis presents a framework that comprises the core conceptual elements that constitute security transparency in cloud computing. It contributes to the knowledge domain of security transparency in cloud computing by proposing the following. Firstly, the research analyses the basics of cloud security transparency by exploring the notion and foundational concepts that constitute security transparency. Secondly, it proposes a framework which integrates various concepts from requirement engineering domain and an accompanying process that could be followed to implement the framework. The framework and its process provide an essential set of conceptual ideas, activities and steps that can be followed at an organizational level to attain security transparency, which are based on the principles of industry standards and best practices. Thirdly, for ensuring continuous transparency, the thesis proposes an essential tool that supports the collection and assessment of evidence from cloud providers, including the establishment of remedial actions for redressing deficiencies in cloud provider practices. The tool serves as a supplementary component of the proposed framework that enables continuous inspection of how predefined customer requirements are being satisfied. The thesis also validates the proposed security transparency framework and tool in terms of validity, applicability, adaptability, and acceptability using two different case studies. Feedbacks are collected from stakeholders and analysed using essential criteria such as ease of use, relevance, usability, etc. The result of the analysis illustrates the validity and acceptability of both the framework and tool in enhancing security transparency in a real-world environment

Coordination of impedance controllers and flexible power for curative congestion management in real-time applications

As the share of feed-in from renewable energy sources rises in German electricity grids, established preventive congestion management processes are called into question. Curative congestion management may increase the utilization of already existing grid capacity without the large investments necessary for conventional grid expansion. The curative paradigm shift requires fast reacting remedial measures, such as innovative power flow controlling devices, as well as reliable algorithms to determine and activate them in due time. This work shows how an automated system can coordinate distributed FACTS devices, that influence a power line's series reactance, and active power from flexible units to solve line overloads in high voltage grids. First, linear sensitivities for gradual reactance changes are derived. Based on this, an optimization and a heuristic approach for automated curative coordination of both types of remedial measures is conceptualized as well as implemented and tested in simulations. Then, the heuristic approach is implemented within a distributed agent-based control algorithm, along with fallback strategies to be executed if agent communication fails. This system is then tested in a laboratory setup to evaluate its real-time applicability. The laboratory setup consists of multiple (Power) Hardware-in-the-Loop modules to create an experimental environment considering many real-world factors that are usually neglected in software simulations. This way, not just the agent algorithm itself, but also the influence of communication delays, reaction times of real power flow controlling devices as well as the integration into a control center environment are evaluated

An Agile Quality Management System For Laboratory Developed Tests

ABSTRACT AN AGILE QUALITY MANAGEMENT SYSTEM FOR LABORATORY DEVELOPED TESTS By RITA D’ANGELO MAY 2017 Advisor: Dr. Ratna Babu Chinnan Major: Industrial & Systems Engineering Degree: Doctor of Philosophy Statement of the Problem: We explore the 2014 draft guidance by the FDA entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDT) extended from the medical device industry and discuss how these requirements may be applicable to laboratory medicine. We introduce terms, definitions and provide a call for action for leaders to prepare for the potential adherence to regulatory requirements and explore if compliance was achievable in a laboratory environment to design, develop and validate Laboratory Developed Tests. If not, why not, and what would be the limiting steps. Method: We perform interviews with laboratory professionals to explore their concerns and challenges regarding the FDA draft guidance then translate the results into strategic factors. Based on the feedback, we surveyed laboratory experts in the field of LDT to develop and test strategic factors that would comprise an effective quality management system framework (QMS) to comply with the FDA proposal. We describe the methodology to translate the strategic factors into a design that would transform the existing laboratory structure into a regulatory quality management system. Conclusion: Nine interviewees and 35 survey respondents shared the importance of risk classification, process validation, patient safety and general ambiguity for the development of LDT. We utilize the top supporting statements and associated factors chosen by experts as extremely important for LDT development as the building blocks for implementation of a regulatory QMS framework. The framework includes six phases of implementation: 1) establishment of a leadership support structure, 2) training, 3) pre-assessment of current laboratory processes, 4) adoption of design control, 5) process controls, 6) process validation and the application of an agile Stage Gate technique for test development. Respondents agree that a regulatory agile quality management system is needed in laboratories that develop LDT. Utilizing the strategic factors, we develop a novel approach to LDT design, development and testing that extends the existing laboratory structure with a proven product development methodology technique called agile stage gate hybrid with the assignment of dedicated, accountable cross-functional teams for go/no-go approvals at every step and institute a coordinator position to review, document and expedite LDT development throughout the testing process

Establishment of a novel predictive reliability assessment strategy for ship machinery

There is no doubt that recent years, maritime industry is moving forward to novel and sophisticated inspection and maintenance practices. Nowadays maintenance is encountered as an operational method, which can be employed both as a profit generating process and a cost reduction budget centre through an enhanced Operation and Maintenance (O&M) strategy. In the first place, a flexible framework to be applicable on complex system level of machinery can be introduced towards ship maintenance scheduling of systems, subsystems and components.;This holistic inspection and maintenance notion should be implemented by integrating different strategies, methodologies, technologies and tools, suitably selected by fulfilling the requirements of the selected ship systems. In this thesis, an innovative maintenance strategy for ship machinery is proposed, namely the Probabilistic Machinery Reliability Assessment (PMRA) strategy focusing towards the reliability and safety enhancement of main systems, subsystems and maintainable units and components.;In this respect, the combination of a data mining method (k-means), the manufacturer safety aspects, the dynamic state modelling (Markov Chains), the probabilistic predictive reliability assessment (Bayesian Belief Networks) and the qualitative decision making (Failure Modes and Effects Analysis) is employed encompassing the benefits of qualitative and quantitative reliability assessment. PMRA has been clearly demonstrated in two case studies applied on offshore platform oil and gas and selected ship machinery.;The results are used to identify the most unreliability systems, subsystems and components, while advising suitable practical inspection and maintenance activities. The proposed PMRA strategy is also tested in a flexible sensitivity analysis scheme.There is no doubt that recent years, maritime industry is moving forward to novel and sophisticated inspection and maintenance practices. Nowadays maintenance is encountered as an operational method, which can be employed both as a profit generating process and a cost reduction budget centre through an enhanced Operation and Maintenance (O&M) strategy. In the first place, a flexible framework to be applicable on complex system level of machinery can be introduced towards ship maintenance scheduling of systems, subsystems and components.;This holistic inspection and maintenance notion should be implemented by integrating different strategies, methodologies, technologies and tools, suitably selected by fulfilling the requirements of the selected ship systems. In this thesis, an innovative maintenance strategy for ship machinery is proposed, namely the Probabilistic Machinery Reliability Assessment (PMRA) strategy focusing towards the reliability and safety enhancement of main systems, subsystems and maintainable units and components.;In this respect, the combination of a data mining method (k-means), the manufacturer safety aspects, the dynamic state modelling (Markov Chains), the probabilistic predictive reliability assessment (Bayesian Belief Networks) and the qualitative decision making (Failure Modes and Effects Analysis) is employed encompassing the benefits of qualitative and quantitative reliability assessment. PMRA has been clearly demonstrated in two case studies applied on offshore platform oil and gas and selected ship machinery.;The results are used to identify the most unreliability systems, subsystems and components, while advising suitable practical inspection and maintenance activities. The proposed PMRA strategy is also tested in a flexible sensitivity analysis scheme

Beyond certification: The maintenance of ISO 9000 in Malaysian service organisations

This research is an in-depth study of the quality management systems of two Malaysian "government-linked companies" (GLCs) classified as being in the service industry. Both are mature holders of ISO 9000 certification and the research focuses on how they have gone about maintaining and improving their quality management system (QMS), the extent to which they have succeeded, and what management and employees of the companies feel have been critical success factors and problems to be overcome. A case study approach is used for this study. The study has been comprehensive in its data collection with 30 individual face-to-face interviews with top management, middle management, lower management in charge of operations and quality, the management representative responsible for the implementation of ISO 9000 in the case companies being conducted, 300 questionnaires being distributed to employees of both companies, and a thorough review of ISO 9000 and other quality documents carried out. The results of the study showed that the two companies maintain their ISO 9000 based on the requirements of the standard. However, to support the technical requirements and in order to maintain the quality system more effectively and strive for excellence, the study highlights the need for integrating the human resource aspects of quality management into the quality system. Critical success factors of ISO 9000 maintenance identified are top management commitment, employee involvement, recognition and reward, teamwork, continuous improvement, and quality culture. The main problems associated with maintaining ISO 9000 faced by the companies are lack of cooperation and commitment from people, lack of knowledge and training, lack of communication, and lack of awareness and understanding on ISO 9000. Measures outlined to overcome the problems include closer interaction between people, training of management and employee on ISO 9000 and related subjects, skill and competency, and better communication. The study has identified lessons to be drawn by similar companies facing similar challenges and those striving for excellence. It has provided insights into the improvements and changes brought by the continued maintenance of the ISO 9000 after certification. It has also added to the knowledge on aspects of organisational development for service companies and casting new light on various theories put forward in the quality management literature. Further, the development of a framework for effective ISO 9000 maintenance in service organisations will enable it to be tested and compared with other industry frameworks in future studies