A failure mode and effect analysis (FMEA)-based approach for risk assessment of scientific processes in non-regulated research laboratories

AbstractNowadays, Quality Management tools such as failure mode and effect analysis (FMEA) are widely used throughout the aeronautical, automotive, software, food services, health care and many other industries to sustain and improve quality and safety. The increasing complexity of scientific research makes it more difficult to maintain all activities under control, in order to guarantee validity and reproducibility of results. Even in non-regulated research, scientists need to be supported with management tools that maximize study performance and outcomes, while facilitating the research process. Frequently, steps that involve human intervention are the weak links in the process. Risk analysis therefore gives considerable benefit to analytical validation, assessing and avoiding failures due to human error, potential imprecision in applying protocols, uncertainty in equipment function and imperfect control of materials. This paper describes in detail how FMEA methodology can be applied as a performance improvement tool in the field of non-regulated research, specifically on a basic Life Sciences research process. We chose as "pilot process" the selection of oligonucleotide aptamers for therapeutic purposes, as an example of a complex and multi-step process, suitable for technology transfer. We applied FMEA methodology, seeking every opportunity for error and its impact on process output, and then, a set of improvement actions was generated covering most aspects of laboratory practice, such as equipment management and staff training. We also propose a useful tool supporting the risk assessment of research processes and its outputs and that we named "FMEA strip worksheet." These tools can help scientists working in non-regulated research to approach Quality Management and to perform risk evaluation of key scientific procedures and processes with the final aim to increase and better control efficiency and efficacy of their research

An Exploration of Enterprise Architecture Research

Management of the enterprise architecture has become increasingly recognized as a crucial part of both business and IT management. Still, a common understanding and methodological consistency seems far from being developed. Acknowledging the significant role of research in moving the development process along, this article employs different bibliometric methods, complemented by an extensive qualitative interpretation of the research field, to provide a unique overview of the enterprise architecture literature. After answering our research questions about the collaboration via co-authorships, the intellectual structure of the research field and its most influential works, and the principal themes of research, we propose an agenda for future research based on the findings from the above analyses and their comparison to empirical insights from the literature. In particular, our study finds a considerable degree of co-authorship clustering and a positive impact of the extent of co-authorship on the diffusion of works on enterprise architecture. In addition, this article identifies three major research streams and shows that research to date has revolved around specific themes, while some of high practical relevance receive minor attention. Hence, the contribution of our study is manifold and offers support for researchers and practitioners alike

A phantom based evaluation on the effects of patient breathing motion on Stereotactic Body Radiotherapy treatment volumes

Aim: The aim of the study was to design an upper body phantom to mimic the movement of the lesion inside the lungs during a breathing cycle. Phantom design included an assessment of the motion observed for lung lesions, identification of suitable phantom materials as well as design of a motorized arm to mimic the movements observed inside the lung area of the phantom. Introduction: Expansion margins are added to clinical target volumes contoured by Oncologists in order to safeguard against under- or over-treatment of the target volume. They are designed to account for errors during setup, inaccuracies on the linear accelerator, and movement of targets inside the patient. If the margins are too small, there is a risk that the lesion/target may not receive the necessary dose, due to being partially missed. On the other hand, if the margins are too wide, the lesion will be covered, but normal tissue may receive unnecessary dose, resulting in additional side effects to the patient. Assessment of the impact of these margins is not possible in a static phantom and the availability of a low-cost motorized phantom would assist in the validation of these margins. Method: Previously treated patients' 4D CT scanning data were used to quantify the amount of movement seen for lesions within the lung. A phantom was then designed and built in an attempt to mimic both patient anatomy and movement. Materials were identified to replicate anatomical shape and densities of various organs in the thorax, as seen on CT scan data. Two treatment planning systems (Monaco, (Elekta) and Eclipse (Varian)) were used to determine the dosimetric characteristics of the materials. This was compared to actual dose as delivered by a linear accelerator (Elekta Synergy). Results: Paths were calculated from the breathing cycles during the 4D-CT scan sets and templates designed to mimic these movements. A thorax phantom was built with the appropriate materials suitable and matched densities to replicate a human thorax. Comparing transmission for these materials on a linear accelerator for 6MV and 10MV energy, the deviation from planned versus measured dose varied between 1.67% to 3.32% and 0.45% to 2.30%, respectively for the silicon material and between 0.77% to 3.22% and 0.17% to 2.57% for the 3D printed bone for 6MV and 10MV. iv Conclusion: The measurements done on the linear accelerator matched closely with the calculated values on the treatment planning system for transmission through the materials in the customised phantom. Various proposals were put forward to mimic the movement of the targets within the lung regions. However, it was not possible to manufacture a mechanically based working model due to the small movements observed (<5mm). It is recommended that a robotic solution be investigated as alternative to mimic these small movements

Quality management in a private speech-language therapy practice

This study investigated the principles of quality management and their application to a private speech-language therapy practice. The history of quality management and the development of quality management in industry and health care services were reviewed. Quality was defined in terms of the context of the author's private speech-language therapy practice and a working definition of quality was developed. The principles in the development of a quality management programme were described. These principles were used to develop and implement a quality management programme in the author's private speech-language therapy practice. Financial management and client satisfaction were selected as strategic quality factors in the initial stages of the quality management programme. Practice policies were revised to establish success criteria and to measure the practice's conformance to these criteria. The quality management programme enabled the author to improve the quality and effectiveness of her practice's financial management system and to demonstrate the client-centered orientation of the practice by implementing client satisfaction as a quality indicator

High definition systems in Japan

The successful implementation of a strategy to produce high-definition systems within the Japanese economy will favorably affect the fundamental competitiveness of Japan relative to the rest of the world. The development of an infrastructure necessary to support high-definition products and systems in that country involves major commitments of engineering resources, plants and equipment, educational programs and funding. The results of these efforts appear to affect virtually every aspect of the Japanese industrial complex. The results of assessments of the current progress of Japan toward the development of high-definition products and systems are presented. The assessments are based on the findings of a panel of U.S. experts made up of individuals from U.S. academia and industry, and derived from a study of the Japanese literature combined with visits to the primary relevant industrial laboratories and development agencies in Japan. Specific coverage includes an evaluation of progress in R&D for high-definition television (HDTV) displays that are evolving in Japan; high-definition standards and equipment development; Japanese intentions for the use of HDTV; economic evaluation of Japan's public policy initiatives in support of high-definition systems; management analysis of Japan's strategy of leverage with respect to high-definition products and systems

Scientific and Technical Publishing at Goddard Space Flight Center in Fiscal Year 1994

This publication is a compilation of scientific and technical material that was researched, written, prepared, and disseminated by the Center's scientists and engineers during FY94. It is presented in numerical order of the GSFC author's sponsoring technical directorate; i.e., Code 300 is the Office of Flight Assurance, Code 400 is the Flight Projects Directorate, Code 500 is the Mission Operations and Data Systems Directorate, Code 600 is the Space Sciences Directorate, Code 700 is the Engineering Directorate, Code 800 is the Suborbital Projects and Operations Directorate, and Code 900 is the Earth Sciences Directorate. The publication database contains publication or presentation title, author(s), document type, sponsor, and organizational code. This is the second annual compilation for the Center