Sample records for assurance process involves
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Final Report of the NASA Office of Safety and Mission Assurance Agile Benchmarking Team
NASA Technical Reports Server (NTRS)
Wetherholt, Martha
2016-01-01
To ensure that the NASA Safety and Mission Assurance (SMA) community remains in a position to perform reliable Software Assurance (SA) on NASAs critical software (SW) systems with the software industry rapidly transitioning from waterfall to Agile processes, Terry Wilcutt, Chief, Safety and Mission Assurance, Office of Safety and Mission Assurance (OSMA) established the Agile Benchmarking Team (ABT). The Team's tasks were: 1. Research background literature on current Agile processes, 2. Perform benchmark activities with other organizations that are involved in software Agile processes to determine best practices, 3. Collect information on Agile-developed systems to enable improvements to the current NASA standards and processes to enhance their ability to perform reliable software assurance on NASA Agile-developed systems, 4. Suggest additional guidance and recommendations for updates to those standards and processes, as needed. The ABT's findings and recommendations for software management, engineering and software assurance are addressed herein.
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Student Involvement in the Egyptian Quality Assurance System
ERIC Educational Resources Information Center
Elassy, Noha
2015-01-01
Purpose: The purpose of this paper is to study the extent and the quality of student involvement in the quality assurance process (QAP) in Egyptian higher education institutions (HEIs). Design/methodology/approach: In this study, two qualitative methods were used to explore the extent and the quality of student involvement; these were focus groups…
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Spacelab Data Processing Facility (SLDPF) quality assurance expert systems development
NASA Technical Reports Server (NTRS)
Basile, Lisa R.; Kelly, Angelita C.
1987-01-01
The Spacelab Data Processing Facility (SLDPF) is an integral part of the Space Shuttle data network for missions that involve attached scientific payloads. Expert system prototypes were developed to aid in the performance of the quality assurance function of the Spacelab and/or Attached Shuttle Payloads processed telemetry data. The Spacelab Input Processing System (SIPS) and the Spacelab Output Processing System (SOPS), two expert systems, were developed to determine their feasibility and potential in the quality assurance of processed telemetry data. The capabilities and performance of these systems are discussed.
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NASA Technical Reports Server (NTRS)
1983-01-01
This report summarizes the results of a study conducted by Engineering and Economics Research (EER), Inc. under NASA Contract Number NAS5-27513. The study involved the development of preliminary concepts for automatic and semiautomatic quality assurance (QA) techniques for ground image processing. A distinction is made between quality assessment and the more comprehensive quality assurance which includes decision making and system feedback control in response to quality assessment.
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NASA Technical Reports Server (NTRS)
Lee, Pen-Nan
1991-01-01
Previously, several research tasks have been conducted, some observations were obtained, and several possible suggestions have been contemplated involving software quality assurance engineering at NASA Johnson. These research tasks are briefly described. Also, a brief discussion is given on the role of software quality assurance in software engineering along with some observations and suggestions. A brief discussion on a training program for software quality assurance engineers is provided. A list of assurance factors as well as quality factors are also included. Finally, a process model which can be used for searching and collecting software quality assurance tools is presented.
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Ensuring Quality Assurance in Vocational Education
ERIC Educational Resources Information Center
Idialu, Ethel E.
2013-01-01
Vocational education emphasises skill acquisition. Quality assurance in vocational education is a concept that is concerned with high performance involving activities with vocational education such as teaching, learning, infrastructures, students' behaviour and the entire academic process. Quality vocational education refers to input and output of…
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Assurance Evaluation for OSS Adoption in a Telco Context
NASA Astrophysics Data System (ADS)
Ardagna, Claudio A.; Banzi, Massimo; Damiani, Ernesto; El Ioini, Nabil; Frati, Fulvio
Software Assurance (SwA) is a complex concept that involves different stages of a software development process and may be defined differently depending on its focus, as for instance software quality, security, or dependability. In Computer Science, the term assurance is referred to all activities necessary to provide enough confidence that a software product will satisfy its users’ functional and non-functional requirements.
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Bayesian assurance and sample size determination in the process validation life-cycle.
Faya, Paul; Seaman, John W; Stamey, James D
2017-01-01
Validation of pharmaceutical manufacturing processes is a regulatory requirement and plays a key role in the assurance of drug quality, safety, and efficacy. The FDA guidance on process validation recommends a life-cycle approach which involves process design, qualification, and verification. The European Medicines Agency makes similar recommendations. The main purpose of process validation is to establish scientific evidence that a process is capable of consistently delivering a quality product. A major challenge faced by manufacturers is the determination of the number of batches to be used for the qualification stage. In this article, we present a Bayesian assurance and sample size determination approach where prior process knowledge and data are used to determine the number of batches. An example is presented in which potency uniformity data is evaluated using a process capability metric. By using the posterior predictive distribution, we simulate qualification data and make a decision on the number of batches required for a desired level of assurance.
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Surface-water quality-assurance plan for the U.S. Geological Survey Washington Water Science Center
Mastin, Mark C.
2016-02-19
This Surface-Water Quality-Assurance Plan documents the standards, policies, and procedures used by the U.S. Geological Survey Washington Water Science Center (WAWSC) for activities related to the collection, processing, storage, analysis, and publication of surface-water data. This plan serves as a guide to all WAWSC personnel involved in surface-water data activities, and changes as the needs and requirements of the WAWSC change. Regular updates to this plan represent an integral part of the quality-assurance process. In the WAWSC, direct oversight and responsibility by the hydrographer(s) assigned to a surface-water station, combined with team approaches in all work efforts, assure highquality data, analyses, reviews, and reports for cooperating agencies and the public.
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Building quality into medical product software design.
Mallory, S R
1993-01-01
The software engineering and quality assurance disciplines are a requisite to the design of safe and effective software-based medical devices. It is in the areas of software methodology and process that the most beneficial application of these disciplines to software development can be made. Software is a product of complex operations and methodologies and is not amenable to the traditional electromechanical quality assurance processes. Software quality must be built in by the developers, with the software verification and validation engineers acting as the independent instruments for ensuring compliance with performance objectives and with development and maintenance standards. The implementation of a software quality assurance program is a complex process involving management support, organizational changes, and new skill sets, but the benefits are profound. Its rewards provide safe, reliable, cost-effective, maintainable, and manageable software, which may significantly speed the regulatory review process and therefore potentially shorten the overall time to market. The use of a trial project can greatly facilitate the learning process associated with the first-time application of a software quality assurance program.
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Surface-Water Quality-Assurance Plan for the Tallahassee Office, U.S. Geological Survey
Tomlinson, Stewart A.
2006-01-01
This Tallahassee Office Surface-Water Quality-Assurance Plan documents the standards, policies, and procedures used by the Tallahassee Office for activities related to the collection, processing, storage, analysis, and publication of surface-water data. This plan serves as a guide to all Tallahassee Office personnel involved in surface-water data activities, and changes as the needs and requirements of the Tallahassee Office, Florida Integrated Science Center, and Water Discipline change. Reg-ular updates to this Plan represent an integral part of the quality-assurance process. In the Tallahassee Office, direct oversight and responsibility by the employee(s) assigned to a surface-water station, combined with team approaches in all work efforts, assure high-quality data, analyses, reviews, and reports for cooperating agencies and the public.
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[Service quality in health care: the application of the results of marketing research].
Verheggen, F W; Harteloh, P P
1993-01-01
This paper deals with quality assurance in health care and its relation to quality assurance in trade and industry. We present the service quality model--a model of quality from marketing research--and discuss how it can be applied to health care. Traditional quality assurance appears to have serious flaws. It lacks a general theory of the sources of hazards in the complex process of patient care and tends to stagnate, for no real improvement takes place. Departing from this criticism, modern quality assurance in health care is marked by: defining quality in a preferential sense as "fitness for use"; the use of theories and models of trade and industry (process-control); an emphasis on analyzing the process, instead of merely inspecting it; use of the Deming problem solving technique (plan, do, check, act); improvement of the process of care by altering perceptions of parties involved. We present an experience of application and utilization of this method in the University Hospital Maastricht, The Netherlands. The successful application of this model requires a favorable corporate culture and motivation of the health care workers. This model provides a useful framework to uplift the traditional approach to quality assurance in health care.
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Gems, David; McElwee, Joshua J
2005-03-01
Our recent survey of genes regulated by insulin/IGF-1 signaling (IIS) in Caenorhabditis elegans suggests a role for a number of gene classes in longevity assurance. Based on these findings, we propose a model for the biochemistry of longevity assurance and ageing, which is as follows. Ageing results from molecular damage from highly diverse endobiotic toxins. These are stochastic by-products of diverse metabolic processes, of which reactive oxygen species (ROS) are likely to be only one component. Our microarray analysis suggests a major role in longevity assurance of the phase 1, phase 2 detoxification system involving cytochrome P450 (CYP), short-chain dehydrogenase/reductase (SDR) and UDP-glucuronosyltransferase (UGT) enzymes. Unlike superoxide and hydrogen peroxide detoxification, this system is energetically costly, and requires the excretion from the cell of its products. Given such costs, its activity may be selected against, as predicted by the disposable soma theory. CYP and UGT enzymes target lipophilic molecular species; insufficient activity of this system is consistent with age-pigment (lipofuscin) accumulation during ageing. We suggest that IIS-regulated longevity assurance involves: (a) energetically costly detoxification and excretion of molecular rubbish, and (b) conservation of existing proteins via molecular chaperones. Given the emphasis in this theory on investment in cellular waste disposal, and on protein conservation, we have dubbed it the green theory.
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Integrating Safety and Mission Assurance in Design
NASA Technical Reports Server (NTRS)
Cianciola, Chris; Crane, Kenneth
2008-01-01
This presentation describes how the Ares Projects are learning from the successes and failures of previous launch systems in order to maximize safety and reliability while maintaining fiscal responsibility. The Ares Projects are integrating Safety and Mission Assurance into design activities and embracing independent assessments by Quality experts in thorough reviews of designs and processes. Incorporating Lean thinking into the design process, Ares is also streamlining existing processes and future manufacturing flows which will yield savings during production. Understanding the value of early involvement of Quality experts, the Ares Projects are leading launch vehicle development into the 21st century.
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Software quality: Process or people
NASA Technical Reports Server (NTRS)
Palmer, Regina; Labaugh, Modenna
1993-01-01
This paper will present data related to software development processes and personnel involvement from the perspective of software quality assurance. We examine eight years of data collected from six projects. Data collected varied by project but usually included defect and fault density with limited use of code metrics, schedule adherence, and budget growth information. The data are a blend of AFSCP 800-14 and suggested productivity measures in Software Metrics: A Practioner's Guide to Improved Product Development. A software quality assurance database tool, SQUID, was used to store and tabulate the data.
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The NOνA Module Factory Quality Assurance System
NASA Astrophysics Data System (ADS)
Smith, Alex; the NOνA Collaboration
The NOνA experiment will measure neutrino oscillations using a long-baseline beam, a ∼220-ton near detector and a ∼14-kiloton far detector. Production of ∼12500 modules to build these detectors is an industrial scale operation requiring careful quality assurance to meet the stringent technical specifications. Unlike a typical industrial operation, this project will use primarily a part time labor force of ∼200 University of Minnesota undergraduate students managed by a small team of full time employees. The quality assurance system is involved in nearly every aspect of the production: assembly, scheduling, training, payroll, materials, machine maintenance, test data, and safety compliance. The quality assurance data collected during the assembly process allows us to quickly identify and correct any problems that arise.
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NASA Technical Reports Server (NTRS)
Sleboda, Claire
1997-01-01
Quality assurance programs provide a very effective means to monitor and evaluate medical care. Quality assurance involves: (1) Identify a problem; (2) Determine the source and nature of the problem; (3) Develop policies and methods to effect improvement; (4) Implement those polices; (5) Monitor the methods applied; and (6) Evaluate their effectiveness. Because this definition of quality assurance so closely resembles the Nursing Process, the health unit staff was able to use their knowledge of the nursing process to develop many forms which improve the quality of patient care. These forms include the NASA DFRC Service Report, the occupational injury form (Incident Report), the patient survey (Pre-hospital Evaluation/Care Report), the Laboratory Log Sheet, the 911 Run Sheet, and the Patient Assessment Stamp. Examples and steps which are followed to generate these reports are described.
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Measurement Assurance for End-Item Users
NASA Technical Reports Server (NTRS)
Mimbs, Scott M.
2008-01-01
The goal of a Quality Management System (QMS) as specified in ISO 9001 and AS9100 is to assure the end product meets specifications and customer requirements. Measuring devices, often called measuring and test equipments (MTE), provide the evidence of product conformity to the prescribed requirements. Therefore the processes which employ MTE can become a weak link to the overall QMS if proper attention is not given to development and execution of these processes. Traditionally, calibration of MTE is given more focus in industry standards and process control efforts than the equally important proper usage of the same equipment. It is a common complaint of calibration laboratory personnel that MTE users are only interested in "a sticker." If the QMS requires the MTE "to demonstrate conformity of the product," then the quality of the measurement process must be adequate for the task. This leads to an ad hoc definition; measurement assurance is a discipline that assures that all processes, activities, environments, standards, and procedures involved in making a measurement produce a result that can be rigorously evaluated for validity and accuracy. To evaluate that the existing measurement processes are providing an adequate level of quality to support the decisions based upon this measurement data, an understanding of measurement assurance basics is essential. This topic is complimentary to the calibration standard, ANSI/NCSL Z540.3-2006, which targets the calibration of MTE at the organizational level. This paper will discuss general measurement assurance when MTE is used to provide evidence of product conformity, therefore the target audience of this paper is end item users of MTE. A central focus of the paper will be the verification of tolerances and the associated risks, so calibration professionals may find the paper useful in communication with their customers, MTE users.
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7210.56 air traffic quality assurance
DOT National Transportation Integrated Search
1998-02-01
This order is the culmination of a long and thoughtful process involving the : active participation of nearly all elements of air traffic, including : headquarters, regional offices, facility managers, Air Traffic Supervisors : Committee (SUPCOM), Na...
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Holmes, Robert R.; Singh, Vijay P.
2016-01-01
The importance of streamflow data to the world’s economy, environmental health, and public safety continues to grow as the population increases. The collection of streamflow data is often an involved and complicated process. The quality of streamflow data hinges on such things as site selection, instrumentation selection, streamgage maintenance and quality assurance, proper discharge measurement techniques, and the development and continued verification of the streamflow rating. This chapter serves only as an overview of the streamflow data collection process as proper treatment of considerations, techniques, and quality assurance cannot be addressed adequately in the space limitations of this chapter. Readers with the need for the detailed information on the streamflow data collection process are referred to the many references noted in this chapter.
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[Integrated quality assurance].
Bögel, K; Stöhr, K
1994-07-01
The definition of terms and connotation of "Quality", "Quality Assurance" and "Integration" lead to an analysis and understanding of inhibiting and fostering factors of the "Health Triad" of people, animals and environment. Although "Quality" is largely or ultimately determined by the consumer, there are considerable differences as this term is applied by (a) the individual consumer, (b) the dynamic producer defending or gaining markets, (c) those engaged in traditional product manufacturing, or (d) governments setting (minimum) requirements for the sake of free trade. "Quality Assurance" offers cooperation of partners all along the food chain from "pasture to table". The managerial process turned into a continuum of responsibility and agreement on processes and product characteristics. This overcomes the disadvantages of strategies stressing distinct defense barriers. In practice this philosophy of a predominant role of defence barriers proved largely partnership destructive, in that it permitted to shift responsibilities for failures and to claim administrative competence according to momentary situations and interests. "Integrated Quality Assurance" means mutual agreement of two or more partners along the food chain (e. g. feed producers, farmers, animal health industry, veterinarians and food processors) on product characteristics and production methods. It involves essential system elements including facilities, materials, manpower, information, transport, management etc. Different principles and procedures of quality assurance have been introduced in practice, including agriculture and food processing. These different approaches are not mutually exclusive but largely of complementary nature.(ABSTRACT TRUNCATED AT 250 WORDS)
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Quality Interaction Between Mission Assurance and Project Team Members
NASA Technical Reports Server (NTRS)
Kwong-Fu, Helenann H.; Wilson, Robert K.
2006-01-01
Mission Assurance independent assessments started during the development cycle and continued through post launch operations. In operations, Health and Safety of the Observatory is of utmost importance. Therefore, Mission Assurance must ensure requirements compliance and focus on process improvements required across the operational systems including new/modified products, tools, and procedures. The deployment of the interactive model involves three objectives: Team member Interaction, Good Root Cause Analysis Practices, and Risk Assessment to avoid reoccurrences. In applying this model, we use a metric based measurement process and was found to have the most significant effect, which points to the importance of focuses on a combination of root cause analysis and risk approaches allowing the engineers the ability to prioritize and quantify their corrective actions based on a well-defined set of root cause definitions (i.e. closure criteria for problem reports), success criteria and risk rating definitions.
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As EPA’s environmental research expands into new areas that involve the development of software, quality assurance concepts and procedures that were originally developed for environmental data collection may not be appropriate. Fortunately, software quality assurance is a ...
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Ares Project Overview - Quality in Design
NASA Technical Reports Server (NTRS)
Cianciola, Chris; Crane, Kenneth
2008-01-01
This presentation introduces the audience to the overall goals of the Ares Project, which include providing human access to low-Earth orbit, the Moon, and beyond. The presentation also provides an overview of with the vehicles that will execute those goals and progress made on the vehicles to date. The briefing will provide an introduction to Lean, Six Sigma, and Kaizen practices Ares will use to improve the overall effectiveness and quality of its efforts. Finally, the briefing includes a summary of Safety and Mission Assurance practices being implemented within[Ares to ensure safety and quality early in the design process. Integrating Safety and Mission Assurance in Design: This presentation describes how the Ares Projects are learning from the successes and failures of previous launch systems in order to maximize safety and reliability while maintaining fiscal responsibility. The Ares Projects are integrating Safer T and Mission Assurance into design activities and embracing independent assessments by Quality experts in thorough reviews of designs and processes. Incorporating Lean thinking into the design process, Ares is also streamlining existing processes and future manufacturing flows which will yield savings during production. Understanding the value of early involvement of Quality experts, the Ares Projects are leading launch vehicle development into the 21st century.
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Flight Dynamics Mission Support and Quality Assurance Process
NASA Technical Reports Server (NTRS)
Oh, InHwan
1996-01-01
This paper summarizes the method of the Computer Sciences Corporation Flight Dynamics Operation (FDO) quality assurance approach to support the National Aeronautics and Space Administration Goddard Space Flight Center Flight Dynamics Support Branch. Historically, a strong need has existed for developing systematic quality assurance using methods that account for the unique nature and environment of satellite Flight Dynamics mission support. Over the past few years FDO has developed and implemented proactive quality assurance processes applied to each of the six phases of the Flight Dynamics mission support life cycle: systems and operations concept, system requirements and specifications, software development support, operations planing and training, launch support, and on-orbit mission operations. Rather than performing quality assurance as a final step after work is completed, quality assurance has been built in as work progresses in the form of process assurance. Process assurance activities occur throughout the Flight Dynamics mission support life cycle. The FDO Product Assurance Office developed process checklists for prephase process reviews, mission team orientations, in-progress reviews, and end-of-phase audits. This paper will outline the evolving history of FDO quality assurance approaches, discuss the tailoring of Computer Science Corporations's process assurance cycle procedures, describe some of the quality assurance approaches that have been or are being developed, and present some of the successful results.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
This Quality Assurance Project Plan (QAPjP) establishes the quality assurance procedures and requirements to be implemented for the control of quality-related activities for Phase 3 of the Treatability Study (TS) of In Situ Vitrification (ISV) of Seepage Pit 1, ORNL Waste Area Grouping 7. This QAPjP supplements the Quality Assurance Plan for Oak Ridge National Laboratory Environmental Restoration Program by providing information specific to the ISV-TS. Phase 3 of the TS involves the actual ISV melt operations and posttest monitoring of Pit 1 and vicinity. Previously, Phase 1 activities were completed, which involved determining the boundaries of Pit 1, usingmore » driven rods and pipes and mapping the distribution of radioactivity using logging tools within the pipes. Phase 2 involved sampling the contents, both liquid and solids, in and around seepage Pit 1 to determine their chemical and radionuclide composition and the spatial distribution of these attributes. A separate QAPjP was developed for each phase of the project. A readiness review of the Phase 3 activities presented QAPjP will be conducted prior to initiating field activities, and an Operational Acceptance, Test (OAT) will also be conducted with no contamination involved. After, the OAT is complete, the ISV process will be restarted, and the melt will be allowed to increase with depth and incorporate the radionuclide contamination at the bottom of Pit 1. Upon completion of melt 1, the equipment will be shut down and mobilized to an adjacent location at which melt 2 will commence.« less
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Duke University's Quality Appearance Program
ERIC Educational Resources Information Center
Jackson, Joe
2008-01-01
The Grounds Services Unit at Duke University has implemented a new program that involves a process of self evaluation, which embraces the concept of perpetual and continuous improvement. The Quality Appearance Program (QAP) embellishes and expands upon the Quality Assurance Program concept, but with a twist to grounds management improvement…
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Multinational Quality Assurance
ERIC Educational Resources Information Center
Kinser, Kevin
2011-01-01
Multinational colleges and universities pose numerous challenges to the traditional models of quality assurance that are designed to validate domestic higher education. When institutions cross international borders, at least two quality assurance protocols are involved. To guard against fraud and abuse, quality assurance in the host country is…
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Case study in health information management: strategic planning.
Homan, C V
1992-08-01
The strategic planning process has proven to be invaluable to Riverside Hospital's success. Involvement of all levels of the organization and integration of plans solidifies organizational commitments and provides a framework that assures accomplishment of overall goals. With major developments in computerization of medical records and other systems that support patient care data analysis on the horizon, Riverside's integrated plans are defining crucial information system projects. As the pool of available resources for projects continues to shrink, the planning format described assures funding of information system needs that will secure a position for Riverside in the health care marketplace of the future.
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18 CFR 1302.5 - Assurances required.
Code of Federal Regulations, 2010 CFR
2010-04-01
... assistance is extended or for another purpose involving the provision of similar services or benefits. Where... contain a covenant running with the land assuring nondiscrimination for the period during which the real... purpose involving the provision of similar services or benefits. Where no transfer of property is involved...
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External Strategic Planning Conference.
ERIC Educational Resources Information Center
Los Angeles Community Coll. District, CA. Office of Research and Planning.
In response to a community reputation that has grown increasingly negative, the Los Angeles Community College District (LACCD) devised a strategic plan in 1998 to improve its programs and services and assure the educational success of its students. The planning process involved several steps: (1) revisiting the district mission statement; (2)…
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Code of Federal Regulations, 2011 CFR
2011-01-01
... PROCEDURES FOR IMPLEMENTING NATIONAL ENVIRONMENTAL POLICY ACT § 520.3 Policy. (a) It is ARS policy to comply... are unanticipated and extraordinary may be made in the Office of the Administrator of ARS. (e) ARS... activities involving the ARS to assure that NEPA considerations are addressed early in the planning process...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... PROCEDURES FOR IMPLEMENTING NATIONAL ENVIRONMENTAL POLICY ACT § 520.3 Policy. (a) It is ARS policy to comply... are unanticipated and extraordinary may be made in the Office of the Administrator of ARS. (e) ARS... activities involving the ARS to assure that NEPA considerations are addressed early in the planning process...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... PROCEDURES FOR IMPLEMENTING NATIONAL ENVIRONMENTAL POLICY ACT § 520.3 Policy. (a) It is ARS policy to comply... are unanticipated and extraordinary may be made in the Office of the Administrator of ARS. (e) ARS... activities involving the ARS to assure that NEPA considerations are addressed early in the planning process...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... PROCEDURES FOR IMPLEMENTING NATIONAL ENVIRONMENTAL POLICY ACT § 520.3 Policy. (a) It is ARS policy to comply... are unanticipated and extraordinary may be made in the Office of the Administrator of ARS. (e) ARS... activities involving the ARS to assure that NEPA considerations are addressed early in the planning process...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... PROCEDURES FOR IMPLEMENTING NATIONAL ENVIRONMENTAL POLICY ACT § 520.3 Policy. (a) It is ARS policy to comply... are unanticipated and extraordinary may be made in the Office of the Administrator of ARS. (e) ARS... activities involving the ARS to assure that NEPA considerations are addressed early in the planning process...
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Systems engineering and integration processes involved with manned mission operations
NASA Technical Reports Server (NTRS)
Kranz, Eugene F.; Kraft, Christopher C.
1993-01-01
This paper will discuss three mission operations functions that are illustrative of the key principles of operations SE&I and of the processes and products involved. The flight systems process was selected to illustrate the role of the systems product line in developing the depth and cross disciplinary skills needed for SE&I and providing the foundation for dialogue between participating elements. FDDD was selected to illustrate the need for a structured process to assure that SE&I provides complete and accurate results that consistently support program needs. The flight director's role in mission operations was selected to illustrate the complexity of the risk/gain tradeoffs involved in the development of the flight techniques and flight rules process as well as the absolute importance of the leadership role in developing the technical, operational, and political trades.
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Quality assurance in military medical research and medical radiation accident management.
Hotz, Mark E; Meineke, Viktor
2012-08-01
The provision of quality radiation-related medical diagnostic and therapeutic treatments cannot occur without the presence of robust quality assurance and standardization programs. Medical laboratory services are essential in patient treatment and must be able to meet the needs of all patients and the clinical personnel responsible for the medical care of these patients. Clinical personnel involved in patient care must embody the quality assurance process in daily work to ensure program sustainability. In conformance with the German Federal Government's concept for modern departmental research, the international standard ISO 9001, one of the relevant standards of the International Organization for Standardization (ISO), is applied in quality assurance in military medical research. By its holistic approach, this internationally accepted standard provides an excellent basis for establishing a modern quality management system in line with international standards. Furthermore, this standard can serve as a sound basis for the further development of an already established quality management system when additional standards shall apply, as for instance in reference laboratories or medical laboratories. Besides quality assurance, a military medical facility must manage additional risk events in the context of early recognition/detection of health risks of military personnel on deployment in order to be able to take appropriate preventive and protective measures; for instance, with medical radiation accident management. The international standard ISO 31000:2009 can serve as a guideline for establishing risk management. Clear organizational structures and defined work processes are required when individual laboratory units seek accreditation according to specific laboratory standards. Furthermore, international efforts to develop health laboratory standards must be reinforced that support sustainable quality assurance, as in the exchange and comparison of test results within the scope of external quality assurance, but also in the exchange of special diagnosis data among international research networks. In summary, the acknowledged standard for a quality management system to ensure quality assurance is the very generic standard ISO 9001.Health Phys. 103(2):221-225; 2012.
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[Role of medical information processing for quality assurance in obstetrics].
Selbmann, H K
1983-06-01
The paradigma of problem-orientated assuring of the professional quality of medical case is a kind of "control loop system" consisting of the following 5 steps: routine observation, identification of the problem, analysis of the problem, translation of problem solutions into daily practice and control as to whether the problem has been solved or eliminated. Medical data processing, which involves documentation, electronic data processing and statistics, can make substantial contributions especially to the steps of observation, identification of the problem, and follow-up control. Perinatal data collection, which has already been introduced in 6 Länder of the Federal Republic of Germany, has supplied ample proof of this. These operations were conducted under the heading "internal clinical assuring of quality with external aid". Those clinics who participated in this programme, were given the necessary aid in self-observation (questionnaires, clinical statistics), and they were also given comparative informative data to help them in identifying the problems (clinical profiles, etc.). It is entirely left to the responsibility of the clinics themselves--voluntary cooperation and guarantee of remaining anonymous being a matter of course -- to draw their own consequences from the collected data and to translate these into clinical everyday practice.
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Implementing Financial Assurance for Mitigation Project Success
The Institute for Water Resources (IWR) prepared this white paper on financial assurance for mitigation project success to provide a reference resource for Corps district staff involved with establishing and overseeing financial assurances.
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Sorge, John P; Harmon, C Reid; Sherman, Susan M; Baillie, E Eugene
2005-07-01
We used data management software to compare pathology report data concerning regional lymph node sampling for colorectal carcinoma from 2 institutions using different dissection methods. Data were retrieved from 2 disparate anatomic pathology information systems for all cases of colorectal carcinoma in 2003 involving the ascending and descending colon. Initial sorting of the data included overall lymph node recovery to assess differences between the dissection methods at the 2 institutions. Additional segregation of the data was used to challenge the application's capability of accurately addressing the complexity of the process. This software approach can be used to evaluate data from disparate computer systems, and we demonstrate how an automated function can enable institutions to compare internal pathologic assessment processes and the results of those comparisons. The use of this process has future implications for pathology quality assurance in other areas.
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Ghafoor, Virginia L; Silus, Lauren S
2011-03-15
The development of a policy, evidence-based standard orders, and monitoring for palliative sedation therapy (PST) is described. Concerns regarding PST at the University of Minnesota Medical Center (UMMC) arose and needed to be addressed in a formal process. A multidisciplinary group consisting of palliative care physicians, nurse practitioners, clinical nurse specialists, and clinical pharmacy specialists reached consensus on the practice model and medications to be used for PST. Major elements of the plan included the development and implementation of an institutional policy for palliative sedation; standard orders for patient care, sedation, and monitoring; education for staff, patients, and patients' family members; and quality-assurance monitoring. A literature review was performed to identify research and guidelines defining the practice of PST. Policy content includes the use of a standard order set linking patient care, medication administration, the monitoring of sedation, and symptom management. Approval of the policy involved several UMMC committees. An evaluation matrix was used to determine critical areas for PST monitoring and to guide development of a form to monitor quality. A retrospective chart audit using the quality-assurance monitoring form assessed baseline sedation medication and patient outcomes. Assessment of compliance began in the fall of 2008, after the policy and standard orders were approved by the UMMC medical executive committee. In 2008, two cases of PST were monitored using the standardized form. PST cases will be continually monitored and analyzed. Development of policy, standard orders, and quality-assurance monitoring for PST required a formal multidisciplinary process. A process-improvement process is critical to defining institutional policy, educational goals, and outcome metrics for PST.
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ERIC Educational Resources Information Center
Guinn, Fillmore
2013-01-01
Small non-profit organizations outsource at least one information technology or information assurance process. Outsourcing information technology and information assurance processes has increased every year. The study was to determine the key reasons behind the choice to outsource information technology and information assurance processes. Using…
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The Judgement Processes Involved in the Moderation of Teacher-Assessed Projects
ERIC Educational Resources Information Center
Crisp, Victoria
2017-01-01
Classroom-based assessments have the potential to enhance validity by facilitating the assessment of important skills that are difficult to assess in written examinations. Such assessments tend to be marked by teachers. To ensure consistent marking standards, quality assurance procedures are needed. In the context of continued debate over the…
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USDA-ARS?s Scientific Manuscript database
Iron is an important micronutrient in human and plant nutrition. Adequate iron nutrition during crop production is central for assuring appropriate iron concentrations in the harvestable organs, for human food or animal feed. The whole-plant movement of iron involves several processes, including the...
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Motivations, Costs and Results of AOL: Perceptions of Accounting and Economics Faculty
ERIC Educational Resources Information Center
Eschenfelder, Mark J.; Bryan, Lois D.; Lee, Tanya M.
2014-01-01
The emphasis of the Association to Advance Collegiate Schools of Business (AACSB) on improving student learning through Assurance of Learning (AOL) makes faculty involvement in the process at AACSB accredited schools important. This study examines the attitudes of accounting and economics faculty at AACSB accredited institutions toward the AOL…
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Quality Assurance of Assessment and Moderation Discourses Involving Sessional Staff
ERIC Educational Resources Information Center
Grainger, Peter; Adie, Lenore; Weir, Katie
2016-01-01
Quality assurance is a major agenda in tertiary education. The casualisation of academic work, especially in teaching, is also a quality assurance issue. Casual or sessional staff members teach and assess more than 50% of all university courses in Australia, and yet the research in relation to the role sessional staff play in quality assurance of…
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2012-09-01
the preservation of evidence or due process in mind. In contrast, police operations accept significant tacti- cal restraints military units...generally do not in order to assure due process and preserve evidence. A police action, such as an arrest, that involves maneuver and/or weapons is only...and the unique role they can play in the peace process . Resolution 1325, adopted in 2000, 9 holds a promise to women across the globe that their
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Code of Federal Regulations, 2010 CFR
2010-10-01
... contract due to inadequate assurance or breach of assurance for protection of human subjects. ... the Contracting Officer shall not award a contract involving human subjects until a prospective....103. The Contracting Officer shall require an applicable Federal-wide assurance (FWA), approved by the...
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Runquist, Ryan D Briscoe; Moeller, David A
2013-09-01
Studies of pollen limitation and the reproductive assurance value of selfing are important for examining the process of floral and mating system evolution in flowering plants. Recent meta-analyses have shown that common methods for measuring pollen limitation may often lead to biased estimates. Specifically, experiments involving single- or few-flower manipulations per plant tend to overestimate pollen limitation compared to those involving manipulations on most or all flowers per plant. Little previous work has explicitly tested for reallocation within individual systems using alternative methods and response variables. • We performed single-flower and whole-plant pollen supplementation and emasculation of flowers of Clarkia xantiana subsp. parviflora to estimate pollen limitation (PL) and reproductive assurance (RA). We compared levels of PL and RA using the following response variables: fruit set, seeds/flower, and seeds/plant. We also assessed the germination and viability of seeds to evaluate potential variation in pollen quality among treatments. • Autonomous selfing in Clarkia xantiana subsp. parviflora eliminates pollen limitation and provides reproductive assurance. Estimates from single-flower manipulations were not biased, closely resembling those from whole-plant manipulations. All three response variables followed the same pattern, but treatments were only significantly different for seeds/flower. Pollen quality, as indicated by seed viability, did not differ among treatments. • Partial plant manipulations provided reliable estimates of pollen limitation and reproductive assurance. These estimates were also unaffected by accounting for pollen quality. Although whole plant manipulations are desirable, this experiment demonstrates that in some systems partial plant manipulations can be used in studies where whole-plant manipulations are not feasible.
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45 CFR 611.4 - Assurances required.
Code of Federal Regulations, 2010 CFR
2010-10-01
... purpose involving the provision of similar services and benefits, or for as long as the recipient retains... contain a covenant running with the land assuring nondiscrimination for the period during which the real... purpose involving the provision of similar services or benefits. Where no transfer of property or interest...
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24 CFR 8.50 - Assurances required.
Code of Federal Regulations, 2010 CFR
2010-04-01
... another purpose involving the provision of similar services or benefits. (2) In the case of Federal... contain a covenant running with the land to assure nondiscrimination for the period during which the real... purpose involving the provision of similar services or benefits. (2) Where no transfer of property is...
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Quality assurance in transnational higher education: a case study of the tropEd network
2013-01-01
Introduction Transnational or cross-border higher education has rapidly expanded since the 1980s. Together with that expansion issues on quality assurance came to the forefront. This article aims to identify key issues regarding quality assurance of transnational higher education and discusses the quality assurance of the tropEd Network for International Health in Higher Education in relation to these key issues. Methods Literature review and review of documents. Results From the literature the following key issues regarding transnational quality assurance were identified and explored: comparability of quality assurance frameworks, true collaboration versus erosion of national education sovereignty, accreditation agencies and transparency. The tropEd network developed a transnational quality assurance framework for the network. The network accredits modules through a rigorous process which has been accepted by major stakeholders. This process was a participatory learning process and at the same time the process worked positive for the relations between the institutions. Discussion The development of the quality assurance framework and the process provides a potential example for others. PMID:23537108
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QUEST for Quality for Students: A Student Quality Concept. Volume 3
ERIC Educational Resources Information Center
Galán Palomares, Fernando Miguel; Todorovski, Blazhe; Kažoka, Asnate; Saarela, Henni
2013-01-01
This is the final publication of the QUEST for Quality for Students (QUEST) project, run by the European Students' Union. The QUEST project has managed to analyse students' views on the quality of higher education to identify areas in which students can become increasingly involved in quality assurance and enhancement processes. This publication…
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7 CFR 15b.5 - Assurances required.
Code of Federal Regulations, 2010 CFR
2010-01-01
... assistance is extended or for another purpose involving the provision of similar services or benefits. (2) In... recording this transfer shall contain a covenant running with the land to assure nondiscrimination for the... is extended or for another purpose involving the provision of similar services or benefits. (2) Where...
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Kriz, J; Baues, C; Engenhart-Cabillic, R; Haverkamp, U; Herfarth, K; Lukas, P; Schmidberger, H; Marnitz-Schulze, S; Fuchs, M; Engert, A; Eich, H T
2017-02-01
Field design changed substantially from extended-field RT (EF-RT) to involved-field RT (IF-RT) and now to involved-node RT (IN-RT) and involved-site RT (IS-RT) as well as treatment techniques in radiotherapy (RT) of Hodgkin's lymphoma (HL). The purpose of this article is to demonstrate the establishment of a quality assurance program (QAP) including modern RT techniques and field designs within the German Hodgkin Study Group (GHSG). In the era of modern conformal RT, this QAP had to be fundamentally adapted and a new evaluation process has been intensively discussed by the radiotherapeutic expert panel of the GHSG. The expert panel developed guidelines and criteria to analyse "modern" field designs and treatment techniques. This work is based on a dataset of 11 patients treated within the sixth study generation (HD16-17). To develop a QAP of "modern RT", the expert panel defined criteria for analysing current RT procedures. The consensus of a modified QAP in ongoing and future trials is presented. With this schedule, the QAP of the GHSG could serve as a model for other study groups.
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NASA Technical Reports Server (NTRS)
Tompkins, F. G.
1984-01-01
The Office of Management and Budget (OMB) Circular A-71, transmittal Memorandum No. 1, requires that each agency establish a management control process to assure that appropriate administrative, physical and technical safeguards are incorporated into all new computer applications. In addition to security specifications, the management control process should assure that the safeguards are adequate for the application. The security activities that should be integral to the system development process are examined. The software quality assurance process to assure that adequate and appropriate controls are incorporated into sensitive applications is also examined. Security for software packages is also discussed.
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Involving mental health service users in quality assurance
Weinstein, Jenny
2006-01-01
Abstract Objective This study compares the process and outcomes of two approaches to engaging mental health (MH) service users in the quality assurance (QA) process. Background QA plays a significant role in health and care services, including those delivered in the voluntary sector. The importance of actively, rather than passively, involving service users in evaluation and service development has been increasingly recognized during the last decade. Design This retrospective small‐scale study uses document analysis to compare two QA reviews of a MH Day Centre, one that took place in 1998 as a traditional inspection‐type event and one that took place in 2000 as a collaborative process with a user‐led QA agenda. Setting and participants The project was undertaken with staff, volunteers and service users in a voluntary sector MH Day Centre. Intervention The study compares the management, style, evaluation tools and service user responses for the two reviews; it considers staff perspectives and discusses the implications of a collaborative, user‐led QA process for service development. Results The first traditional top–down inspection‐type QA event had less ownership from service users and staff and served the main purpose of demonstrating that services met organizational standards. The second review, undertaken collaboratively with a user‐led agenda focused on different priorities, evolving a new approach to seeking users’ views and achieving a higher response rate. Conclusions Because both users and staff had participated in most aspects of the second review they were more willing to work together and action plan to improve the service. It is suggested that the process contributed to an evolving ethos of more effective quality improvement and user involvement within the organization. PMID:16677189
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Quality assurance in surgical practice through auditing.
Wong, W T
1980-05-01
An efficient auditing method is presented which involves objective criteria-based numerical screening of medical process and treatment outcome by paramedical staff and detailed analysis of deviated cases by surgeons. If properly performed it requires the study of no more than 50 cases in a diagnostic category to provide sufficient information about the quality of care. Encouraging points as well as problems are communicated to the surgeons to induce the maintenance or improvement of the standard of care. Graphic documentation of case performance is possible, allowing surgeons to compare results with their colleagues. The general performance level of several consecutive studies can be compared at a glance. In addition, logical education programs to improve the medical process can be designed on the basis of the problems identified. As all the cases with an unacceptable outcome are traceable to inadequate medical process, improvement in this area will decrease outcome defects. With the use of auditing and the follow-up technique described, the quality of care in surgery may be assured.
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NASA Technical Reports Server (NTRS)
Chase, V. A.; Harrison, E. S.
1985-01-01
A study was conducted to assess the merits of using graphite/polyimide, NR-150B2 resin, for structural applications on advanced space launch vehicles. The program was divided into two phases: (1) Fabrication Process Development; and (2) Demonstration Components. The first phase of the program involved the selection of a graphite fiber, quality assurance of the NR-150B2 polyimide resin, and the quality assurance of the graphite/polyimide prepreg. In the second phase of the program, a limited number of components were fabricated before the NR-150B2 resin system was removed from the market by the supplier, Du Pont. The advancement of the NR-150B2 polyimide resin binder was found to vary significantly based on previous time and temperature history during the prepregging operation. Strength retention at 316C (600F) was found to be 50% that of room temperature strength. However, the composite would retain its initial strength after 200 hours exposure at 316C (600F). Basic chemistry studies are required for determining NR-150B2 resin binder quality assurance parameters. Graphite fibers are available that can withstand high temperature cure and postcure cycles.
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Monitoring and Assuring the Quality of Digital Aerial Data
NASA Technical Reports Server (NTRS)
Christopherson, Jon
2007-01-01
This viewgraph presentation explains the USGS plan for monitoring and assuring the quality of digital aerial data. The contents include: 1) History of USGS Aerial Imaging Involvement; 2) USGS Research and Results; 3) Outline of USGS Quality Assurance Plan; 4) Other areas of Interest; and 5) Summary
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Simulation of textile manufacturing processes for planning, scheduling, and quality control purposes
NASA Astrophysics Data System (ADS)
Cropper, A. E.; Wang, Z.
1995-08-01
Simulation, as a management information tool, has been applied to engineering manufacture and assembly operations. The application of the principles to textile manufacturing (fiber to fabric) is discussed. The particular problems and solutions in applying the simulation software package to the yarn production processes are discussed with an indication of how the software achieves the production schedule. The system appears to have application in planning, scheduling, and quality assurance. The latter being a result of the traceability possibilities through a process involving mixing and splitting of material.
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Quality assurance, benchmarking, assessment and mutual international recognition of qualifications.
Hobson, R; Rolland, S; Rotgans, J; Schoonheim-Klein, M; Best, H; Chomyszyn-Gajewska, M; Dymock, D; Essop, R; Hupp, J; Kundzina, R; Love, R; Memon, R A; Moola, M; Neumann, L; Ozden, N; Roth, K; Samwel, P; Villavicencio, J; Wright, P; Harzer, W
2008-02-01
The aim of this report is to provide guidance to assist in the international convergence of quality assurance, benchmarking and assessment systems to improve dental education. Proposals are developed for mutual recognition of qualifications, to aid international movement and exchange of staff and students including and supporting developing countries. Quality assurance is the responsibility of all staff involved in dental education and involves three levels: internal, institutional and external. Benchmarking information provides a subject framework. Benchmarks are useful for a variety of purposes including design and validation of programmes, examination and review; they can also strengthen the accreditation process undertaken by professional and statutory bodies. Benchmark information can be used by institutions as part of their programme approval process, to set degree standards. The standards should be developed by the dental academic community through formal groups of experts. Assessment outcomes of student learning are a measure of the quality of the learning programme. The goal of an effective assessment strategy should be that it provides the starting point for students to adopt a positive approach to effective and competent practice, reflective and lifelong learning. All assessment methods should be evidence based or based upon research. Mutual recognition of professional qualifications means that qualifications gained in one country (the home country) are recognized in another country (the host country). It empowers movement of skilled workers, which can help resolve skills shortages within participating countries. These proposals are not intended to be either exhaustive or prescriptive; they are purely for guidance and derived from the identification of what is perceived to be 'best practice'.
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ERIC Educational Resources Information Center
Ashline, Melissa
This review of the professional and programmatic literature in the field of developmental disabilities focuses on ways in which individuals with developmental disabilities and their families are becoming increasingly involved in program evaluation and quality assurance efforts. Three major movements are having an impact on this activity: state and…
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A Systems Engineering Approach to Quality Assurance for Aerospace Testing
NASA Technical Reports Server (NTRS)
Shepherd, Christena C.
2015-01-01
On the surface, it appears that AS91001 has little to say about how to apply a Quality Management System (QMS) to major aerospace test programs (or even smaller ones). It also appears that there is little in the quality engineering Body of Knowledge (BOK)2 that applies to testing, unless it is nondestructive examination (NDE), or some type of lab or bench testing associated with the manufacturing process. However, if one examines: a) how the systems engineering (SE) processes are implemented throughout a test program; and b) how these SE processes can be mapped to the requirements of AS9100, a number of areas for involvement of the quality professional are revealed. What often happens is that quality assurance during a test program is limited to inspections of the test article; what could be considered a manufacturing al fresco approach. This limits the quality professional and is a disservice to the programs and projects, since there are a number of ways that quality can enhance critical processes, and support efforts to improve risk reduction, efficiency and effectiveness.
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Godény, Sándor
2012-02-05
The first two articles in the series were about the definition of quality in healthcare, the quality approach, the importance of quality assurance, the advantages of quality management systems and the basic concepts and necessity of evidence based medicine. In the third article the importance and basic steps of clinical audit are summarised. Clinical audit is an integral part of quality assurance and quality improvement in healthcare, that is the responsibility of any practitioner involved in medical practice. Clinical audit principally measures the clinical practice against clinical guidelines, protocols and other professional standards, and sometimes induces changes to ensure that all patients receive care according to principles of the best practice. The clinical audit can be defined also as a quality improvement process that seeks to identify areas for service improvement, develop and carry out plans and actions to improve medical activity and then by re-audit to ensure that these changes have an effect. Therefore, its aims are both to stimulate quality improvement interventions and to assess their impact in order to develop clinical effectiveness. At the end of the article key points of quality assurance and improvement in medical practice are summarised.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-09
... attacks up to and including the design basis cyber attack threat, thereby achieving high assurance that... provide assurance that safety-related SSCs are protected from cyber attacks. Implementation of 10 CFR 73... of ``high assurance of adequate protection against cyber attacks.'' The proposed revision would not...
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ERIC Educational Resources Information Center
Blanco Ramírez, Gerardo
2014-01-01
Accountability and quality assurance have become central discourses in higher education policy throughout the world. However, accountability and quality assurance involve power and control. Practices and ideas about quality developed in the Global North are spreading rapidly across the Global South, leading to increased uniformity in the…
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The role of microbiological testing in systems for assuring the safety of beef.
Brown, M H; Gill, C O; Hollingsworth, J; Nickelson, R; Seward, S; Sheridan, J J; Stevenson, T; Sumner, J L; Theno, D M; Usborne, W R; Zink, D
2000-12-05
The use of microbiological testing in systems for assuring the safety of beef was considered at a meeting arranged by the International Livestock Educational Foundation as part of the International Livestock Congress, TX, USA, during February, 2000. The 11 invited participants from industry and government research organizations concurred in concluding that microbiological testing is necessary for the implementation and maintenance of effective Hazard Analysis Critical Control Point (HACCP) systems, which are the only means of assuring the microbiological safety of beef; that microbiological testing for HACCP purposes must involve the enumeration of indicator organisms rather than the detection of pathogens; that the efficacy of process control should be assessed against performance criteria and food safety objectives that refer to the numbers of indicator organisms in product; that sampling procedures should allow indicator organisms to be enumerated at very low numbers; and that food safety objectives and microbiological criteria are better related to variables, rather than attributes sampling plans.
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Abdul Rahim, Mohamad R; James, Melissa L; Hickey, Brigid E
2017-10-01
The aim of this study was to maximise the benefits from clinical trials involving technological interventions such as radiation therapy. High compliance to the quality assurance protocols is crucial. We assessed whether the quality of radiation therapy intervention was evaluated in Cochrane systematic reviews. We searched 416 published Cochrane systematic reviews and identified 67 Cochrane systematic reviews that investigated radiation therapy or radiotherapy as an intervention. For each systematic review, either quality assurance or quality control for the intervention was identified by a description of such processes in the published systematic reviews. Of the 67 Cochrane systematic reviews studied, only two mentioned quality assurance or quality control. Our findings revealed that 65 of 67 (97%) Cochrane systematic reviews of radiation therapy interventions failed to consider the quality of the intervention. We suggest that advice about the evaluation of intervention quality be added to author support materials. © 2017 The Royal Australian and New Zealand College of Radiologists.
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Truong, Hoai-An; Taylor, Catherine R; DiPietro, Natalie A
2012-02-10
To develop and validate the Assessment, Development, Assurance Pharmacist's Tool (ADAPT), an instrument for pharmacists and student pharmacists to use in developing and implementing health promotion programs. The 36-item ADAPT instrument was developed using the framework of public health's 3 core functions (assessment, policy development, and assurance) and 10 essential services. The tool's content and usage was assessed and conducted through peer-review and initial validity testing processes. Over 20 faculty members, preceptors, and student pharmacists at 5 institutions involved in planning and implementing health promotion initiatives reviewed the instrument and conducted validity testing. The instrument took approximately 15 minutes to complete and the findings resulted in changes and improvements to elements of the programs evaluated. The ADAPT instrument fills a need to more effectively plan, develop, implement, and evaluate pharmacist-directed public health programs that are evidence-based, high-quality, and compliant with laws and regulations and facilitates documentation of pharmacists' contributions to public health.
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Healthcare software assurance.
Cooper, Jason G; Pauley, Keith A
2006-01-01
Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA's software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted.
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Cooper, Jason G.; Pauley, Keith A.
2006-01-01
Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA’s software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted. PMID:17238324
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[Quality assurance and quality improvement. Personal experiences and intentions].
Roche, B G; Sommer, C
1995-01-01
In may 1994 we were selected by the surgical Swiss association to make a study about quality in USA. During our travel we visited 3 types of institutions: Hospitals, National Institute of standard and Technology, Industry, Johnson & Johnson. We appreciate to compare 2 types of quality programs: Quality Assurance (QA) and Continuous Quality Improvement (CQI). In traditional healthcare circles, QA is the process established to meet external regulatory requirements and to assure that patient care is consistent with established standards. In a modern quality terms, QA outside of healthcare means designing a product or service, as well as controlling its production, so well that quality is inevitable. The ideas of W. Edward Deming is that there is never improvement just by inspection. He developed a theory based on 14 principles. A productive work is accomplished through processes. Understanding the variability of processes is a key to improve quality. Quality management sees each person in an organisation as part of one or more processes. The job of every worker is to receive the work of others, add value to that work, and supply it to the next person in the process. This is called the triple role the workers as customer, processor, and supplier. The main source of quality defects is problems in the process. The old assumption is that quality fails when people do the right thing wrong; the new assumption is that, more often, quality failures arise when people do the wrong think right. Exhortation, incentives and discipline of workers are unlikely to improve quality. If quality is failing when people do their jobs as designed, then exhorting them to do better is managerial nonsense. Modern quality theory is customer focused. Customers are identified internally and externally. The modern approach to quality is thoroughly grounded in scientific and statistical thinking. Like in medicine, the symptom is a defect in quality. The therapist of process must perform diagnostic test, formulate hypotheses of cause, test those hypotheses, apply remedies, and assess the effect of remedies. Total employee involvement is critical. A power comes from enabling all employees to become involved in quality improvement. A great advantage of CQI is the prevention orientation of the concept. The CQI permeated a collegial approach, people learn how to work together to improve. CQI is a time consuming procedure. During our travel we learned the definition of quality as the customer satisfaction. To build a CQI concept in employed time but all employed are involved in quality improvement. Applying CQI we could be able to refuse Quality control programs.
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Mason, M D; Moore, R; Jones, G; Lewis, G; Donovan, J L; Neal, D E; Hamdy, F C; Lane, J A; Staffurth, J N
2016-09-01
The treatment of prostate cancer has evolved markedly over the last 40 years, including radiotherapy, notably with escalated dose and targeting. However, the optimal treatment for localised disease has not been established in comparative randomised trials. The aim of this article is to describe the history of prostate radiotherapy trials, including their quality assurance processes, and to compare these with the ProtecT trial. The UK ProtecT randomised trial compares external beam conformal radiotherapy, surgery and active monitoring for clinically localised prostate cancer and will report on the primary outcome (disease-specific mortality) in 2016 following recruitment between 1999 and 2009. The embedded quality assurance programme consists of on-site machine dosimetry at the nine trial centres, a retrospective review of outlining and adherence to dose constraints based on the trial protocol in 54 participants (randomly selected, around 10% of the total randomised to radiotherapy, n = 545). These quality assurance processes and results were compared with prostate radiotherapy trials of a comparable era. There has been an increasingly sophisticated quality assurance programme in UK prostate radiotherapy trials over the last 15 years, reflecting dose escalation and treatment complexity. In ProtecT, machine dosimetry results were comparable between trial centres and with the UK RT01 trial. The outlining review showed that most deviations were clinically acceptable, although three (1.4%) may have been of clinical significance and were related to outlining of the prostate. Seminal vesicle outlining varied, possibly due to several prostate trials running concurrently with different protocols. Adherence to dose constraints in ProtecT was considered acceptable, with 80% of randomised participants having two or less deviations and planning target volume coverage was excellent. The ProtecT trial quality assurance results were satisfactory and comparable with trials of its era. Future trials should aim to standardise treatment protocols and quality assurance programmes where possible to reduce complexities for centres involved in multiple trials. Copyright © 2016. Published by Elsevier Ltd.
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The NASA Commercial Crew Program (CCP) Mission Assurance Process
NASA Technical Reports Server (NTRS)
Canfield, Amy
2016-01-01
In 2010, NASA established the Commercial Crew Program in order to provide human access to the International Space Station and low earth orbit via the commercial (non-governmental) sector. A particular challenge to NASA has been how to determine the commercial providers transportation system complies with Programmatic safety requirements. The process used in this determination is the Safety Technical Review Board which reviews and approves provider submitted Hazard Reports. One significant product of the review is a set of hazard control verifications. In past NASA programs, 100 percent of these safety critical verifications were typically confirmed by NASA. The traditional Safety and Mission Assurance (SMA) model does not support the nature of the Commercial Crew Program. To that end, NASA SMA is implementing a Risk Based Assurance (RBA) process to determine which hazard control verifications require NASA authentication. Additionally, a Shared Assurance Model is also being developed to efficiently use the available resources to execute the verifications. This paper will describe the evolution of the CCP Mission Assurance process from the beginning of the Program to its current incarnation. Topics to be covered include a short history of the CCP; the development of the Programmatic mission assurance requirements; the current safety review process; a description of the RBA process and its products and ending with a description of the Shared Assurance Model.
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Field spectrometer (S191H) preprocessor tape quality test program design document
NASA Technical Reports Server (NTRS)
Campbell, H. M.
1976-01-01
Program QA191H performs quality assurance tests on field spectrometer data recorded on 9-track magnetic tape. The quality testing involves the comparison of key housekeeping and data parameters with historic and predetermined tolerance limits. Samples of key parameters are processed during the calibration period and wavelength cal period, and the results are printed out and recorded on an historical file tape.
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The Assurance of Learning Process Components and the Effects of Engaging Students in the Learning
ERIC Educational Resources Information Center
Mosca, Joseph B.; Agacer, Gilder; Flaming, Linda; Buzza, John
2011-01-01
Assurance of learning process plays a major role in higher education and has increased the accountability on the part of instructors at all levels. This paper will discuss the role of assurance processes in teaching and the ways to measure these processes of student learning. The research focus will be to determine if student engagement in problem…
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NASA Astrophysics Data System (ADS)
Comyn-Wattiau, Isabelle; Thalheim, Bernhard
Quality assurance is a growing research domain within the Information Systems (IS) and Conceptual Modeling (CM) disciplines. Ongoing research on quality in IS and CM is highly diverse and encompasses theoretical aspects including quality definition and quality models, and practical/empirical aspects such as the development of methods, approaches and tools for quality measurement and improvement. Current research on quality also includes quality characteristics definitions, validation instruments, methodological and development approaches to quality assurance during software and information systems development, quality monitors, quality assurance during information systems development processes and practices, quality assurance both for data and (meta)schemata, quality support for information systems data import and export, quality of query answering, and cost/benefit analysis of quality assurance processes. Quality assurance is also depending on the application area and the specific requirements in applications such as health sector, logistics, public sector, financial sector, manufacturing, services, e-commerce, software, etc. Furthermore, quality assurance must also be supported for data aggregation, ETL processes, web content management and other multi-layered applications. Quality assurance is typically requiring resources and has therefore beside its benefits a computational and economical trade-off. It is therefore also based on compromising between the value of quality data and the cost for quality assurance.
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Guidance for Quality Assurance Project Plans, EPA QA/G-5
provides guidance to EPA employees and other organizations involved in developing Quality Assurance (QA) Project Plans that address the specifications listed in EPA Requirements for QA Project Plans (QA/R-5)
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Quality and security - They work together
NASA Technical Reports Server (NTRS)
Carr, Richard; Tynan, Marie; Davis, Russell
1991-01-01
This paper describes the importance of considering computer security as part of software quality assurance practice. The intended audience is primarily those professionals involved in the design, development, and quality assurance of software. Many issues are raised which point to the need ultimately for integration of quality assurance and computer security disciplines. To address some of the issues raised, the NASA Automated Information Security program is presented as a model which may be used for improving interactions between the quality assurance and computer security community of professionals.
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Strahl, A; Gerlich, C; Wolf, H-D; Gehrke, J; Müller-Garnn, A; Vogel, H
2016-03-01
The sociomedical evaluation by the German Pension Insurance serves the purpose of determining entitlement to disability pensions. A quality assurance concept for the sociomedical evaluation was developed, which is based on a peer Review process. Peer review is an established process of external quality assurance in health care. The review is based on a hierarchically constructed manual that was evaluated in this pilot project. The database consists of 260 medical reports for disability pension of 12 pension insurance agencies. 771 reviews from 19 peers were included in the evaluation of the inter-rater reliability. Kendall's coefficient of concordance W for more than 2 raters is used as primary measure of inter-rater reliability. Reliability appeared to be heterogeneous. Kendalls W varies for the particular criteria from 0.09 to 0.88 and reached for primary criterion reproducibility a value of 0.37. The reliability of the manual seemed acceptable in the context of existing research data and is in line with existing peer review research outcomes. Nevertheless, the concordance is limited and requires optimisation. Starting points for improvement can be seen in a systematic training and regular user meetings of the peers involved. © Georg Thieme Verlag KG Stuttgart · New York.
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Quality Assurance Framework Implementation Guide for Isolated Community Power Systems
DOE Office of Scientific and Technical Information (OSTI.GOV)
Esterly, Sean R.; Baring-Gould, Edward I.; Burman, Kari A.
This implementation guide is a companion document to the 'Quality Assurance Framework for Mini-Grids' technical report. This document is intended to be used by one of the many stakeholder groups that take part in the implementation of isolated power systems. Although the QAF could be applied to a single system, it was designed primarily to be used within the context of a larger national or regional rural electrification program in which many individual systems are being installed. This guide includes a detailed overview of the Quality Assurance Framework and provides guidance focused on the implementation of the Framework from themore » perspective of the different stakeholders that are commonly involved in expanding energy development within specific communities or regions. For the successful long-term implementation of a specific rural electrification program using mini-grid systems, six key stakeholders have been identified that are typically engaged, each with a different set of priorities 1. Regulatory agency 2. Governmental ministry 3. System developers 4. Mini-utility 5. Investors 6. Customers/consumers. This document is broken into two distinct sections. The first focuses on the administrative processes in the development and operation of community-based mini-grid programs, while the second focuses on the process around the installation of the mini-grid project itself.« less
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ERIC Educational Resources Information Center
Hou, Yung-Chi; Ince, Martin; Tsai, Sandy; Wang, Wayne; Hung, Vicky; Lin Jiang, Chung; Chen, Karen Hui-Jung
2016-01-01
Joint degree programs have gained popularity in East Asia, due to the growth of transnational higher education in the region since 2000. However, the external quality assurance (QA) and accreditation of joint degree programs is a challenge for QA agencies, as it normally involves the engagement of several institutions and multiple national…
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Redefining and expanding quality assurance.
Robins, J L
1992-12-01
To meet the current standards of excellence necessary for blood establishments, we have learned from industry that a movement toward organization-wide quality assurance/total quality management must be made. Everyone in the organization must accept responsibility for participating in providing the highest quality products and services. Quality must be built into processes and design systems to support these quality processes. Quality assurance has been redefined to include a quality planning function described as the most effective way of designing quality into processes. A formalized quality planning process must be part of quality assurance. Continuous quality improvement has been identified as the strategy every blood establishment must support while striving for error-free processing as the long-term objective. The auditing process has been realigned to support and facilitate this same objective. Implementing organization-wide quality assurance/total quality management is one proven plan for guaranteeing the quality of the 20 million products that are transfused into 4 million patients each year and for moving toward the new order.
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Quality Assurance Project Plan Development Tool
This tool contains information designed to assist in developing a Quality Assurance (QA) Project Plan that meets EPA requirements for projects that involve surface or groundwater monitoring and/or the collection and analysis of water samples.
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Torres, Leticia; Hu, E.; Tiersch, Terrence R.
2017-01-01
Cryopreservation in aquatic species in general has been constrained to research activities for more than 60 years. Although the need for application and commercialisation pathways has become clear, the lack of comprehensive quality assurance and quality control programs has impeded the progress of the field, delaying the establishment of germplasm repositories and commercial-scale applications. In this review we focus on the opportunities for standardisation in the practices involved in the four main stages of the cryopreservation process: (1) source, housing and conditioning of fish; (2) sample collection and preparation; (3) freezing and cryogenic storage of samples; and (4) egg collection and use of thawed sperm samples. In addition, we introduce some key factors that would assist the transition to commercial-scale, high-throughput application. PMID:26739583
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NASA Astrophysics Data System (ADS)
1989-01-01
A "NASA Tech Briefs" article describing an inspection tool and technique known as Optically Stimulated Electron Emission (OSEE) led to the formation of Photo Acoustic Technology, Inc. (PAT). PAT produces sensors and scanning systems which assure surface cleanliness prior to bonding, coating, painting, etc. The company's OP1000 series realtime pre-processing detection capability assures 100 percent surface quality testing. The technique involves brief exposure of the inspection surface to ultraviolet radiation. The energy interacts with the surface layer, causing free electrons to be emitted from the surface to be picked up by the detector. When contamination is present, it interferes with the electron flow in proportion to the thickness of the contaminant layer enabling measurement by system signal output. OP1000 systems operate in conventional atmospheres on all types of material and detect both organic and inorganic contamination.
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Radiographic Film Processing Quality Assurance: A Self-Teaching Workbook. Quality Assurance Series.
ERIC Educational Resources Information Center
Goldman, Lee W.
This workbook has been designed for use in conjunction with the manual, "Photographic Quality Assurance in Diagnostic Radiology, Nuclear Medicine and Radiation Therapy." Presented are several typical problems arising from the existence of variability and fluctuations in the automatic processing of radiographs, which unless corrected, can…
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Zhang, Yonghong; Sun, Weihong; Gutchell, Emily M; Kvecher, Leonid; Kohr, Joni; Bekhash, Anthony; Shriver, Craig D; Liebman, Michael N; Mural, Richard J; Hu, Hai
2013-01-01
In clinical and translational research as well as clinical trial projects, clinical data collection is prone to errors such as missing data, and misinterpretation or inconsistency of the data. A good quality assurance (QA) program can resolve many such errors though this requires efficient communications between the QA staff and data collectors. Managing such communications is critical to resolving QA problems but imposes a major challenge for a project involving multiple clinical and data processing sites. We have developed a QA issue tracking (QAIT) system to support clinical data QA in the Clinical Breast Care Project (CBCP). This web-based application provides centralized management of QA issues with role-based access privileges. It has greatly facilitated the QA process and enhanced the overall quality of the CBCP clinical data. As a stand-alone system, QAIT can supplement any other clinical data management systems and can be adapted to support other projects. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
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Ishikura, Satoshi
2008-11-01
The process of radiotherapy (RT) is complex and involves understanding of the principles of medical physics, radiobiology, radiation safety, dosimetry, radiation treatment planning, simulation and interaction of radiation with other treatment modalities. Each step in the integrated process of RT needs quality control and quality assurance (QA) to prevent errors and to give high confidence that patients will receive the prescribed treatment correctly. Recent advances in RT, including intensity-modulated and image-guided RT, focus on the need for a systematic RTQA program that balances patient safety and quality with available resources. It is necessary to develop more formal error mitigation and process analysis methods, such as failure mode and effect analysis, to focus available QA resources optimally on process components. External audit programs are also effective. The International Atomic Energy Agency has operated both an on-site and off-site postal dosimetry audit to improve practice and to assure the dose from RT equipment. Several countries have adopted a similar approach for national clinical auditing. In addition, clinical trial QA has a significant role in enhancing the quality of care. The Advanced Technology Consortium has pioneered the development of an infrastructure and QA method for advanced technology clinical trials, including credentialing and individual case review. These activities have an impact not only on the treatment received by patients enrolled in clinical trials, but also on the quality of treatment administered to all patients treated in each institution, and have been adopted globally; by the USA, Europe and Japan also.
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Jäckel, W H
2010-12-01
Particularly in the context of introduction of quality assurance programmes 15 years ago, "quality" became a central issue for rehabilitation, and its importance is bound to grow in the years to come. After giving a general definition of quality, this article deals more closely with 3 aspects of quality: quality development, quality assurance, and data on quality. Quality development in rehabilitation centres demands an atmosphere that supports change, encourages creativity, courage, transparency and involvement, and reduces fear. The creation of such an atmosphere is, in particular, the responsibility of a centre's management. Routine interviews regarding patient as well as employee satisfaction, and the use of strategic planning and management systems have proven successful instruments in the practice of quality development. Compared with other sectors of the health system, quality assurance in rehabilitation is marked by its comprehensive approach, intense patient orientation, scientific underpinning, and nationwide implementation. Regarding the benefits of these programmes for the health system at large, however, no clear scientific proof is available yet. Data gained from quality assurance programmes on the whole show a high amount of patient satisfaction, good quality of structures and processes as well as an improvement of the patients' health status. Between centres, however, there are marked differences of quality in a number of cases, and long-term effectiveness could be improved in some indications. Finally, suggestions are offered concerning further development of quality in rehabilitation as well as of the quality assurance programmes. © Georg Thieme Verlag KG Stuttgart · New York.
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Environment, Safety and Health Self-Assessment Report Fiscal Year 2010
DOE Office of Scientific and Technical Information (OSTI.GOV)
Robinson, Scott
2011-03-23
The Lawrence Berkeley National Laboratory (LBNL) Environment, Safety, and Health (ES&H) Self-Assessment Program was established to ensure that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The ES&H Self-Assessment Program, managed by the Office of Contractor Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The primary objective of the program is to ensure that work is conducted safely and with minimal negative impact to workers, the public, and the environment. Self-assessment follows the five core functions and guiding principles of ISM. Self-assessment is the mechanism used to promote the continuousmore » improvement of the Laboratory's ES&H programs. The process is described in the Environment, Safety, and Health Assurance Plan (PUB-5344) and is composed of three types of self-assessments: Division ES&H Self-Assessment, ES&H Technical Assurance Program Assessment, and Division ES&H Peer Review. The Division ES&H Self-Assessment Manual (PUB-3105) provides the framework by which divisions conduct formal ES&H self-assessments to systematically identify program deficiencies. Issue-specific assessments are designed and implemented by the divisions and focus on areas of interest to division management. They may be conducted by teams and involve advance planning to ensure that appropriate resources are available. The ES&H Technical Assurance Program Manual (PUB-913E) provides the framework for systematic reviews of ES&H programs and processes. The ES&H Technical Assurance Program Assessment is designed to evaluate whether ES&H programs and processes are compliant with guiding regulations, are effective, and are properly implemented by LBNL divisions. The Division ES&H Peer Review Manual provides the framework by which division ISM systems are evaluated and improved. Peer Reviews are conducted by teams under the direction of senior division management and focus on higher-level management issues. Peer Review teams are selected on the basis of members knowledge and experience in the issues of interest to the division director. LBNL periodically requests in-depth independent assessments of selected ES&H programs. Such assessments augment LBNL's established assessment processes and provide an objective view of ES&H program effectiveness. Institutional Findings, Observations, and Noteworthy Practices identified during independent assessments are specifically intended to help LBNL identify opportunities for program improvement. This report includes the results of the Division ES&H Self-Assessment, ES&H Technical Assurance Program Assessment, and Division ES&H Peer Review, respectively.« less
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-09
... the efficiency and effectiveness of FHA's quality assurance process (QAP). The objective of FHA's QAP... control plan (QCP).\\1\\ A copy of the plan must be submitted by the lender when applying for FHA lender... processes: post-endorsement technical reviews, Quality Assurance Division reviews and targeted lender...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Kegel, T.M.
Calibration laboratories are faced with the need to become accredited or registered to one or more quality standards. One requirement common to all of these standards is the need to have in place a measurement assurance program. What is a measurement assurance program? Brian Belanger, in Measurement Assurance Programs: Part 1, describes it as a {open_quotes}quality assurance program for a measurement process that quantifies the total uncertainty of the measurements (both random and systematic components of error) with respect to national or designated standards and demonstrates that the total uncertainty is sufficiently small to meet the user`s requirements.{close_quotes} Rolf Schumachermore » is more specific in Measurement Assurance in Your Own Laboratory. He states, {open_quotes}Measurement assurance is the application of broad quality control principles to measurements of calibrations.{close_quotes} Here, the focus is on one important part of any measurement assurance program: implementation of statistical process control (SPC). Paraphrasing Juran`s Quality Control Handbook, a process is in statistical control if the only observed variations are those that can be attributed to random causes. Conversely, a process that exhibits variations due to assignable causes is not in a state of statistical control. Finally, Carrol Croarkin states, {open_quotes}In the measurement assurance context the measurement algorithm including instrumentation, reference standards and operator interactions is the process that is to be controlled, and its direct product is the measurement per se. The measurements are assumed to be valid if the measurement algorithm is operating in a state of control.{close_quotes} Implicit in this statement is the important fact that an out-of-control process cannot produce valid measurements. 7 figs.« less
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2011-05-27
frameworks 4 CMMI-DEV IEEE / ISO / IEC 15288 / 12207 Quality Assurance ©2011 Walz IEEE Life Cycle Processes & Artifacts • Systems Life Cycle Processes...TAG to ISO TC 176 Quality Management • Quality: ASQ, work experience • Software: three books, consulting, work experience • Systems: Telecom & DoD...and IEEE 730 SQA need to align. The P730 IEEE standards working group has expanded the scope of the SQA process standard to align with IS 12207
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Metrology: Measurement Assurance Program Guidelines
NASA Technical Reports Server (NTRS)
Eicke, W. G.; Riley, J. P.; Riley, K. J.
1995-01-01
The 5300.4 series of NASA Handbooks for Reliability and Quality Assurance Programs have provisions for the establishment and utilization of a documented metrology system to control measurement processes and to provide objective evidence of quality conformance. The intent of these provisions is to assure consistency and conformance to specifications and tolerances of equipment, systems, materials, and processes procured and/or used by NASA, its international partners, contractors, subcontractors, and suppliers. This Measurement Assurance Program (MAP) guideline has the specific objectives to: (1) ensure the quality of measurements made within NASA programs; (2) establish realistic measurement process uncertainties; (3) maintain continuous control over the measurement processes; and (4) ensure measurement compatibility among NASA facilities. The publication addresses MAP methods as applied within and among NASA installations and serves as a guide to: control measurement processes at the local level (one facility); conduct measurement assurance programs in which a number of field installations are joint participants; and conduct measurement integrity (round robin) experiments in which a number of field installations participate to assess the overall quality of particular measurement processes at a point in time.
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Sujan, Mark A; Koornneef, Floor; Chozos, Nick; Pozzi, Simone; Kelly, Tim
2013-09-01
In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.
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[Topic identification for cross-sectoral quality assurance in stroke and TIA treatment].
Meyer, Sven; Willms, Gerald; Broge, Björn; Szecsenyi, Joachim
2016-10-01
The development of cross-sectoral quality assurance programs usually requires extensive topic identification. Illustrated by the complex processes of care for stroke and transient ischemic attacks (TIAs), a method for comprehensive topic identification is presented. The first step involves a thorough literature search in terms of systematic reviews, health technology assessments, guidelines, studies into healthcare delivery and the use of specific instruments. Routine data as well as epidemiologic studies are used to analyze the reality of service provision. In addition, experts are consulted to gain expertise concerning deficits of care, approaches to quality assurance and experience with existing quality assurance programs. Furthermore individual patient experiences are collected to add the patients' perceptions of care. Because of the limitation on the regulatory scope of Book V of the German Social Code, which, in this case, was necessary, another source of information was the legal framework and its impact on rescue chain, acute treatment and rehabilitation. Existent quality management systems, accreditations and quality assurance programs in prevention, acute treatment and rehabilitation have been searched in order to avoid any overlap with existing measures. After identifying a total of 71 quality targets according to deficits of care, recommendations for care and expert opinions in primary and secondary prevention, rescue chain, acute treatment, rehabilitation and supply of assistive equipment and therapies, respectively, the usability of instruments was tested. These instruments included case documentation, patient surveys and routine data. 14 quality targets proved to be reproducible by these instruments and were included in the recommendations for a cross-sectoral quality assurance program for stroke and TIA. Copyright © 2016. Published by Elsevier GmbH.
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Terry, Julia M
2013-05-01
The involvement of service users and carers in nurse education is increasing, with the new standards for pre-registration nurse education in the UK, which require nurse education providers to demonstrate how they are involving users and carers in the planning, delivery, teaching and evaluation of nursing curricula (Nursing and Midwifery Council, 2010). A travel scholarship provided the opportunity to explore best practice in this area, focussing on identifying support systems and processes that enable user involvement. The scholarship was undertaken in the UK and Ireland during a 4 week study tour between June and July 2011, during which I visited 15 universities, and met with nurse education staff, users and carers involved in nurse education programmes. Prerequisite processes, the spectrum and variety of involvement activities, quality assurance and evaluation; and sustainability of user involvement in nurse education are reported in this paper. Service users and carers are an under-utilised resource, and as experts by experience have much to offer students and staff by increased involvement in nurse education programmes. The importance of values, enthusiasm and relationships, the cornerstones that strengthen user involvement; often sustain such partnerships. Copyright © 2012 Elsevier Ltd. All rights reserved.
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Workshop on Assurance for Autonomous Systems for Aviation
NASA Technical Reports Server (NTRS)
Brat, Guillaume; Davies, Misty; Giannakopoulou, Dimitra; Neogi, Natasha
2016-01-01
This report describes the workshop on Assurance for Autonomous Systems for Aviation that was held in January 2016 in conjunction with the SciTech 2016 conference held in San Diego, CA. The workshop explored issues related to assurance for autonomous systems and also the idea of trust in these systems. Specifically, we focused on discussing current practices for assurance of autonomy, identifying barriers specific to autonomy as related to assurance as well as operational scenarios demonstrating the need to address the barriers. Furthermore, attention was given to identifying verification techniques that may be applicable to autonomy, as well as discussing new research directions needed to address barriers, thereby involving potential shifts in current practices.
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Westmoreland, Carl; Carmichael, Paul; Dent, Matt; Fentem, Julia; MacKay, Cameron; Maxwell, Gavin; Pease, Camilla; Reynolds, Fiona
2010-01-01
Assuring consumer safety without the generation of new animal data is currently a considerable challenge. However, through the application of new technologies and the further development of risk-based approaches for safety assessment, we remain confident it is ultimately achievable. For many complex, multi-organ consumer safety endpoints, the development, evaluation and application of new, non-animal approaches is hampered by a lack of biological understanding of the underlying mechanistic processes involved. The enormity of this scientific challenge should not be underestimated. To tackle this challenge a substantial research programme was initiated by Unilever in 2004 to critically evaluate the feasibility of a new conceptual approach based upon the following key components: 1.Developing new, exposure-driven risk assessment approaches. 2.Developing new biological (in vitro) and computer-based (in silico) predictive models. 3.Evaluating the applicability of new technologies for generating data (e.g. "omics", informatics) and for integrating new types of data (e.g. systems approaches) for risk-based safety assessment. Our research efforts are focussed in the priority areas of skin allergy, cancer and general toxicity (including inhaled toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biology and molecular mechanisms that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement in EU-funded projects (e.g. Sens-it-iv, Carcinogenomics), participation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US "Human Toxicology Project" consortium).
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ERIC Educational Resources Information Center
Garrison, Michael J.; Rexeisen, Richard J.
2014-01-01
Although this article provides further evidence of serious impediments to faculty ownership of assurance of learning, including inadequate and misaligned resources, the results indicate that faculty can be energized to become actively engaged in the assurance of learning (AOL) process, particularly when they believe that AOL results are useful and…
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ERIC Educational Resources Information Center
Haapakorpi, Arja
2011-01-01
In Finland, quality assurance related to the Bologna process has been adapted to existing systems of higher education at the national level and a form of implementation is also recognised at the level of the higher education institution. In universities, varied outcomes of quality assurance are based on interaction of organisational structures,…
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Concept of Draft International Standard for a Unified Approach to Space Program Quality Assurance
NASA Astrophysics Data System (ADS)
Stryzhak, Y.; Vasilina, V.; Kurbatov, V.
2002-01-01
For want of the unified approach to guaranteed space project and product quality assurance, implementation of many international space programs has become a challenge. Globalization of aerospace industry and participation of various international ventures with diverse quality assurance requirements in big international space programs requires for urgent generation of unified international standards related to this field. To ensure successful fulfillment of space missions, aerospace companies should design and process reliable and safe products with properties complying or bettering User's (or Customer's) requirements. Quality of the products designed or processed by subcontractors (or other suppliers) should also be in compliance with the main user (customer)'s requirements. Implementation of this involved set of unified requirements will be made possible by creating and approving a system (series) of international standards under a generic title Space Product Quality Assurance based on a system consensus principle. Conceptual features of the baseline standard in this system (series) should comprise: - Procedures for ISO 9000, CEN and ECSS requirements adaptation and introduction into space product creation, design, manufacture, testing and operation; - Procedures for quality assurance at initial (design) phases of space programs, with a decision on the end product made based on the principle of independence; - Procedures to arrange incoming inspection of products delivered by subcontractors (including testing, audit of supplier's procedures, review of supplier's documentation), and space product certification; - Procedures to identify materials and primary products applied; - Procedures for quality system audit at the component part, primary product and materials supplier facilities; - Unified procedures to form a list of basic performances to be under configuration management; - Unified procedures to form a list of critical space product components, and unified procedures to define risks related to the specific component application and evaluate safety for the entire program implementation. In the eyes of the authors, those features together with a number of other conceptual proposals should constitute a unified standard-technical basis for implementing international space programs.
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Chambers, D W
1998-01-01
This is an introduction to the major concepts in total quality management, a loose collection of management approaches that focus on continuous improvement of processes, guided by routine data collection and adjustment of the processes. Customer focus and involvement of all members of an organization are also characteristics commonly found in TQM. The seventy-five-year history of the movement is sketched from its beginning in statistical work on quality assurance through the many improvements and redefinitions added by American and Japanese thinkers. Essential concepts covered include: control cycles, focus on the process rather than the defects, the GEAR model, importance of the customer, upstream quality, just-in-time, kaizen, and service quality.
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Organizing a breast cancer database: data management.
Yi, Min; Hunt, Kelly K
2016-06-01
Developing and organizing a breast cancer database can provide data and serve as valuable research tools for those interested in the etiology, diagnosis, and treatment of cancer. Depending on the research setting, the quality of the data can be a major issue. Assuring that the data collection process does not contribute inaccuracies can help to assure the overall quality of subsequent analyses. Data management is work that involves the planning, development, implementation, and administration of systems for the acquisition, storage, and retrieval of data while protecting it by implementing high security levels. A properly designed database provides you with access to up-to-date, accurate information. Database design is an important component of application design. If you take the time to design your databases properly, you'll be rewarded with a solid application foundation on which you can build the rest of your application.
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Code of Federal Regulations, 2010 CFR
2010-01-01
... for research, training, or educational programs. (1) In the case of application by an institution of... which involves participation by students, fellows or trainees, including but not limited to assistance for research, training, or the provision of facilities, the assurance required by this § 1250.104...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... for research, training, or educational programs. (1) In the case of application by an institution of... which involves participation by students, fellows or trainees, including but not limited to assistance for research, training, or the provision of facilities, the assurance required by this § 1250.104...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... for research, training, or educational programs. (1) In the case of application by an institution of... which involves participation by students, fellows or trainees, including but not limited to assistance for research, training, or the provision of facilities, the assurance required by this § 1250.104...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... for research, training, or educational programs. (1) In the case of application by an institution of... which involves participation by students, fellows or trainees, including but not limited to assistance for research, training, or the provision of facilities, the assurance required by this § 1250.104...
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48 CFR 253.209-1 - Responsible prospective contractors.
Code of Federal Regulations, 2010 CFR
2010-10-01
... required service. (B) Production capability. An evaluation of the prospective contractor's ability to plan.... (C) Quality assurance capability. An assessment of the prospective contractor's capability to meet the quality assurance requirements of the proposed contract. It may involve an evaluation of the...
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22 CFR 124.10 - Nontransfer and use assurances.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 124.10 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS AGREEMENTS, OFF-SHORE PROCUREMENT AND OTHER DEFENSE SERVICES § 124.10 Nontransfer and use assurances. (a) Types of... Controls. With respect to all agreements involving classified articles, including classified technical data...
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Goldberg, Alexander A; Richard, Vincent R; Kyryakov, Pavlo; Bourque, Simon D; Beach, Adam; Burstein, Michelle T; Glebov, Anastasia; Koupaki, Olivia; Boukh-Viner, Tatiana; Gregg, Christopher; Juneau, Mylène; English, Ann M; Thomas, David Y; Titorenko, Vladimir I
2010-07-01
In chronologically aging yeast, longevity can be extended by administering a caloric restriction (CR) diet or some small molecules. These life-extending interventions target the adaptable target of rapamycin (TOR) and cAMP/protein kinase A (cAMP/PKA) signaling pathways that are under the stringent control of calorie availability. We designed a chemical genetic screen for small molecules that increase the chronological life span of yeast under CR by targeting lipid metabolism and modulating housekeeping longevity pathways that regulate longevity irrespective of the number of available calories. Our screen identifies lithocholic acid (LCA) as one of such molecules. We reveal two mechanisms underlying the life-extending effect of LCA in chronologically aging yeast. One mechanism operates in a calorie availability-independent fashion and involves the LCA-governed modulation of housekeeping longevity assurance pathways that do not overlap with the adaptable TOR and cAMP/PKA pathways. The other mechanism extends yeast longevity under non-CR conditions and consists in LCA-driven unmasking of the previously unknown anti-aging potential of PKA. We provide evidence that LCA modulates housekeeping longevity assurance pathways by suppressing lipid-induced necrosis, attenuating mitochondrial fragmentation, altering oxidation-reduction processes in mitochondria, enhancing resistance to oxidative and thermal stresses, suppressing mitochondria-controlled apoptosis, and enhancing stability of nuclear and mitochondrial DNA.
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7 CFR 735.14 - Bonding and other financial assurance requirements.
Code of Federal Regulations, 2013 CFR
2013-01-01
..., the entity issuing the bond or other financial assurance must be subject to service of process in... 7 Agriculture 7 2013-01-01 2013-01-01 false Bonding and other financial assurance requirements... WAREHOUSE ACT General Provisions § 735.14 Bonding and other financial assurance requirements. (a) As a...
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7 CFR 735.14 - Bonding and other financial assurance requirements.
Code of Federal Regulations, 2014 CFR
2014-01-01
..., the entity issuing the bond or other financial assurance must be subject to service of process in... 7 Agriculture 7 2014-01-01 2014-01-01 false Bonding and other financial assurance requirements... WAREHOUSE ACT General Provisions § 735.14 Bonding and other financial assurance requirements. (a) As a...
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7 CFR 735.14 - Bonding and other financial assurance requirements.
Code of Federal Regulations, 2011 CFR
2011-01-01
..., the entity issuing the bond or other financial assurance must be subject to service of process in... 7 Agriculture 7 2011-01-01 2011-01-01 false Bonding and other financial assurance requirements... WAREHOUSE ACT General Provisions § 735.14 Bonding and other financial assurance requirements. (a) As a...
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7 CFR 735.14 - Bonding and other financial assurance requirements.
Code of Federal Regulations, 2012 CFR
2012-01-01
..., the entity issuing the bond or other financial assurance must be subject to service of process in... 7 Agriculture 7 2012-01-01 2012-01-01 false Bonding and other financial assurance requirements... WAREHOUSE ACT General Provisions § 735.14 Bonding and other financial assurance requirements. (a) As a...
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A Quality Assurance Framework for Recruiting, Training (and Retaining) Virtual Adjunct Faculty
ERIC Educational Resources Information Center
Sixl-Daniell, Karin; Williams, Jeremy B.; Wong, Amy
2006-01-01
The paper commences with a brief summary of the literature on the quality assurance process in e-Learning in higher education. This is followed by an overview of the U21Global quality assurance framework. Within this framework there is particular emphasis on the process governing the appointment (and re-appointment) of adjunct faculty; a process…
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van de Vis, J W; Poelman, M; Lambooij, E; Bégout, M-L; Pilarczyk, M
2012-02-01
The objective was to take a first step in the development of a process-oriented quality assurance (QA) system for monitoring and safeguarding of fish welfare at a company level. A process-oriented approach is focused on preventing hazards and involves establishment of critical steps in a process that requires careful control. The seven principles of the Hazard Analysis Critical Control Points (HACCP) concept were used as a framework to establish the QA system. HACCP is an internationally agreed approach for management of food safety, which was adapted for the purpose of safeguarding and monitoring the welfare of farmed fish. As the main focus of this QA system is farmed fish welfare assurance at a company level, it was named Fish Welfare Assurance System (FWAS). In this paper we present the initial steps of setting up FWAS for on growing of sea bass (Dicentrarchus labrax), carp (Cyprinus carpio) and European eel (Anguilla anguilla). Four major hazards were selected, which were fish species dependent. Critical Control Points (CCPs) that need to be controlled to minimize or avoid the four hazards are presented. For FWAS, monitoring of CCPs at a farm level is essential. For monitoring purposes, Operational Welfare Indicators (OWIs) are needed to establish whether critical biotic, abiotic, managerial and environmental factors are controlled. For the OWIs we present critical limits/target values. A critical limit is the maximum or minimum value to which a factor must be controlled at a critical control point to prevent, eliminate or reduce a hazard to an acceptable level. For managerial factors target levels are more appropriate than critical limits. Regarding the international trade of farmed fish products, we propose that FWAS needs to be standardized in aquaculture chains. For this standardization a consensus on the concept of fish welfare, methods to assess welfare objectively and knowledge on the needs of farmed fish are required.
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14 CFR § 1250.104 - Assurances.
Code of Federal Regulations, 2014 CFR
2014-01-01
... for research, training, or educational programs. (1) In the case of application by an institution of... which involves participation by students, fellows or trainees, including but not limited to assistance for research, training, or the provision of facilities, the assurance required by this § 1250.104...
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45 CFR 84.5 - Assurances required.
Code of Federal Regulations, 2010 CFR
2010-10-01
... benefits. (2) In the case of Federal financial assistance extended to provide personal property, the... effecting or recording this transfer shall contain a covenant running with the land to assure... benefits. (2) Where no transfer of property is involved but property is purchased or improved with Federal...
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22 CFR 217.5 - Assurances required.
Code of Federal Regulations, 2010 CFR
2010-04-01
... benefits. (2) In the case of Federal financial assistance extended to provide personal property, the... or recording this transfer shall contain a covenant running with the land to assure nondiscrimination... services or benefits. (2) Where no transfer of property is involved but property is purchased or improved...
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Code of Federal Regulations, 2014 CFR
2014-07-01
... of Healthcare Quality Assurance Review Records § 17.500 General. (a) Section 5705, title 38, United... §§ 17.500 through 17.511, the VA's medical quality assurance program consists of systematic healthcare... utilization of healthcare resources in VA medical facilities. These review activities may involve continuous...
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Code of Federal Regulations, 2013 CFR
2013-07-01
... of Healthcare Quality Assurance Review Records § 17.500 General. (a) Section 5705, title 38, United... §§ 17.500 through 17.511, the VA's medical quality assurance program consists of systematic healthcare... utilization of healthcare resources in VA medical facilities. These review activities may involve continuous...
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Code of Federal Regulations, 2011 CFR
2011-07-01
... of Healthcare Quality Assurance Review Records § 17.500 General. (a) Section 5705, title 38, United... §§ 17.500 through 17.511, the VA's medical quality assurance program consists of systematic healthcare... utilization of healthcare resources in VA medical facilities. These review activities may involve continuous...
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Code of Federal Regulations, 2012 CFR
2012-07-01
... of Healthcare Quality Assurance Review Records § 17.500 General. (a) Section 5705, title 38, United... §§ 17.500 through 17.511, the VA's medical quality assurance program consists of systematic healthcare... utilization of healthcare resources in VA medical facilities. These review activities may involve continuous...
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Code of Federal Regulations, 2010 CFR
2010-07-01
... of Healthcare Quality Assurance Review Records § 17.500 General. (a) Section 5705, title 38, United... §§ 17.500 through 17.511, the VA's medical quality assurance program consists of systematic healthcare... utilization of healthcare resources in VA medical facilities. These review activities may involve continuous...
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29 CFR 32.5 - Assurances required.
Code of Federal Regulations, 2011 CFR
2011-07-01
... Assistant Secretary, that the program or activity will be operated in compliance with this part. An... the purpose involving the provision of similar services or benefits. (2) In the case of Federal financial assistance extended to provide personal property, the assurance will obligate the recipient for...
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29 CFR 32.5 - Assurances required.
Code of Federal Regulations, 2014 CFR
2014-07-01
... Assistant Secretary, that the program or activity will be operated in compliance with this part. An... the purpose involving the provision of similar services or benefits. (2) In the case of Federal financial assistance extended to provide personal property, the assurance will obligate the recipient for...
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29 CFR 32.5 - Assurances required.
Code of Federal Regulations, 2012 CFR
2012-07-01
... Assistant Secretary, that the program or activity will be operated in compliance with this part. An... the purpose involving the provision of similar services or benefits. (2) In the case of Federal financial assistance extended to provide personal property, the assurance will obligate the recipient for...
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29 CFR 32.5 - Assurances required.
Code of Federal Regulations, 2010 CFR
2010-07-01
... Assistant Secretary, that the program or activity will be operated in compliance with this part. An... the purpose involving the provision of similar services or benefits. (2) In the case of Federal financial assistance extended to provide personal property, the assurance will obligate the recipient for...
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29 CFR 32.5 - Assurances required.
Code of Federal Regulations, 2013 CFR
2013-07-01
... Assistant Secretary, that the program or activity will be operated in compliance with this part. An... the purpose involving the provision of similar services or benefits. (2) In the case of Federal financial assistance extended to provide personal property, the assurance will obligate the recipient for...
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Melo, E Correa
2003-08-01
The author describes the reasons why evaluation processes should be applied to the Veterinary Services of Member Countries, either for trade in animals and animal products and by-products between two countries, or for establishing essential measures to improve the Veterinary Service concerned. The author also describes the basic elements involved in conducting an evaluation process, including the instruments for doing so. These basic elements centre on the following:--designing a model, or desirable image, against which a comparison can be made--establishing a list of processes to be analysed and defining the qualitative and quantitative mechanisms for this analysis--establishing a multidisciplinary evaluation team and developing a process for standardising the evaluation criteria.
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Hehmke, Bernd; Berg, Sabine; Salzsieder, Eckhard
2017-05-01
Continuous standardized verification of the accuracy of blood glucose meter systems for self-monitoring after their introduction into the market is an important clinically tool to assure reliable performance of subsequently released lots of strips. Moreover, such published verification studies permit comparison of different blood glucose monitoring systems and, thus, are increasingly involved in the process of evidence-based purchase decision making.
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A European Master's Programme in Public Health Nutrition.
Yngve, A; Warm, D; Landman, J; Sjöström, M
2001-12-01
Effective population-based strategies require people trained and competent in the discipline of Public Health Nutrition. Since 1997, a European Master's Programme in Public Health Nutrition has been undergoing planning and implementation, by establishing initial quality assurance systems with the aid of funding from the European Commission (DG SANCO/F3). Partners from 17 European countries have been involved in the process. A European Network of Public Health Nutrition has been developed and accredited by the European Commission.
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Quality Assurance for Clinical Trials
Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.
2013-01-01
Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352
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Quality Assurance and School Monitoring in Hong Kong
ERIC Educational Resources Information Center
Mok, Magdalena Mo Ching
2007-01-01
This study reports on the Hong Kong education quality assurance and school monitoring system. Three research questions were addressed: (1) Who controls the quality of school education in Hong Kong? (2) What strategies are used in the Hong Kong school education quality assurance process? (3) Agenda for Future Research on quality assurance and…
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E-Learning Quality Assurance: A Process-Oriented Lifecycle Model
ERIC Educational Resources Information Center
Abdous, M'hammed
2009-01-01
Purpose: The purpose of this paper is to propose a process-oriented lifecycle model for ensuring quality in e-learning development and delivery. As a dynamic and iterative process, quality assurance (QA) is intertwined with the e-learning development process. Design/methodology/approach: After reviewing the existing literature, particularly…
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USEPA QUALITY ASSURANCE AUDITOR IS SCHEDULED FOR A VISIT. WHAT CAN I EXPECT?
Environmental studies involving data collection activities conducted by or for the United States Environmental Protection Agency (USEPA) are required to undergo a review of their data collection activities. his review is usually in the form of an independent quality assurance (QA...
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The Rockford School of Medicine Undergraduate Quality Assurance Program
ERIC Educational Resources Information Center
Barr, Daniel; And Others
1976-01-01
An undergraduate program of ambulatory care quality assurance is described which has been operational at the Rockford School of Medicine for three years. Focus is on involving students in peer review and related audit activities. Results of preliminary evaluation are reported and generalizations offered. (JT)
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NASA Technical Reports Server (NTRS)
Maggio, Gaspare; Groen, Frank; Hamlin, Teri; Youngblood, Robert
2010-01-01
Accident Precursor Analysis (APA) serves as the bridge between existing risk modeling activities, which are often based on historical or generic failure statistics, and system anomalies, which provide crucial information about the failure mechanisms that are actually operative in the system. APA docs more than simply track experience: it systematically evaluates experience, looking for under-appreciated risks that may warrant changes to design or operational practice. This paper presents the pilot application of the NASA APA process to Space Shuttle Orbiter systems. In this effort, the working sessions conducted at Johnson Space Center (JSC) piloted the APA process developed by Information Systems Laboratories (ISL) over the last two years under the auspices of NASA's Office of Safety & Mission Assurance, with the assistance of the Safety & Mission Assurance (S&MA) Shuttle & Exploration Analysis Branch. This process is built around facilitated working sessions involving diverse system experts. One important aspect of this particular APA process is its focus on understanding the physical mechanism responsible for an operational anomaly, followed by evaluation of the risk significance of the observed anomaly as well as consideration of generalizations of the underlying mechanism to other contexts. Model completeness will probably always be an issue, but this process tries to leverage operating experience to the extent possible in order to address completeness issues before a catastrophe occurs.
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Challenges of assuring crew safety in space shuttle missions with international cargoes.
Vongsouthy, C; Stenger-Nguyen, P A; Nguyen, H V; Nguyen, P H; Huang, M C; Alexander, R G
2004-02-01
The top priority in America's manned space flight program is the assurance of crew and vehicle safety. This priority gained greater focus during and after the Space Shuttle return-to-flight mission (STS-26). One of the interesting challenges has been to assure crew safety and adequate protection of the Space Shuttle, as a national resource, from increasingly diverse cargoes and operations. The control of hazards associated with the deployment of complex payloads and cargoes has involved many international participants. These challenges are examined in some detail along with examples of how crew safety has evolved in the manned space program and how the international partners have addressed various scenarios involving control and mitigation of potential hazards to crew and vehicle safety. c2003 Published by Elsevier Ltd.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Lewis, Michael G.
This quality assurance project plan describes the technical requirements and quality assurance activities of the environmental data collection/analyses operations to close Central Facilities Area Sewage treatment Plant Lagoon 3 and the land application area. It describes the organization and persons involved, the data quality objectives, the analytical procedures, and the specific quality control measures to be employed. All quality assurance project plan activities are implemented to determine whether the results of the sampling and monitoring performed are of the right type, quantity, and quality to satisfy the requirements for closing Lagoon 3 and the land application area.
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Burstein, Michelle T.; Koupaki, Olivia; Gomez-Perez, Alejandra; Levy, Sean; Pluska, Lukas; Mattie, Sevan; Rafeh, Rami; Iouk, Tatiana; Sheibani, Sara; Greenwood, Michael; Vali, Hojatollah; Titorenko, Vladimir I.
2013-01-01
Macromitophagy controls mitochondrial quality and quantity. It involves the sequestration of dysfunctional or excessive mitochondria within double-membrane autophagosomes, which then fuse with the vacuole/lysosome to deliver these mitochondria for degradation. To investigate a physiological role of macromitophagy in yeast, we examined how the atg32Δ-dependent mutational block of this process influences the chronological lifespan of cells grown in a nutrient-rich medium containing low (0.2%) concentration of glucose. Under these longevity-extending conditions of caloric restriction (CR) yeast cells are not starving. We also assessed a role of macromitophagy in lifespan extension by lithocholic acid (LCA), a bile acid that prolongs yeast longevity under CR conditions. Our findings imply that macromitophagy is a longevity assurance process underlying the synergistic beneficial effects of CR and LCA on yeast lifespan. Our analysis of how the atg32Δ mutation influences mitochondrial morphology, composition and function revealed that macromitophagy is required to maintain a network of healthy mitochondria. Our comparative analysis of the membrane lipidomes of organelles purified from wild-type and atg32Δ cells revealed that macromitophagy is required for maintaining cellular lipid homeostasis. We concluded that macromitophagy defines yeast longevity by modulating vital cellular processes inside and outside of mitochondria. PMID:23553280
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SWiFT Software Quality Assurance Plan.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Berg, Jonathan Charles
This document describes the software development practice areas and processes which contribute to the ability of SWiFT software developers to provide quality software. These processes are designed to satisfy the requirements set forth by the Sandia Software Quality Assurance Program (SSQAP). APPROVALS SWiFT Software Quality Assurance Plan (SAND2016-0765) approved by: Department Manager SWiFT Site Lead Dave Minster (6121) Date Jonathan White (6121) Date SWiFT Controls Engineer Jonathan Berg (6121) Date CHANGE HISTORY Issue Date Originator(s) Description A 2016/01/27 Jon Berg (06121) Initial release of the SWiFT Software Quality Assurance Plan
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NASA Technical Reports Server (NTRS)
1991-01-01
When NASA faced the problem of how and what to feed an astronaut in a sealed capsule under weightless conditions while planning for manned space mission, they enlisted the aid of The Pillsbury Company. There were two principal concerns: barring crumbs of food that might contaminate the spacecraft's atmosphere or float their way into sensitive instruments; and assuring absolute freedom from potentially catastrophic disease-producing bacteria and toxins. Pillsbury quickly solved the first concern, but the other part of the problem was not as easy. They found that with using standard methods, there was no way to be assured there would not be any bacteria. It was concluded that the only way to succeed was to establish control over the entire process, the raw materials, the processing environment and the people involved. Pillsbury developed the Hazard Analysis and Critical Control Point (HACCP) concept. The HACCP is designed to prevent food safety problems rather than to catch them after they have occurred. Three other government agencies are taking preliminary steps toward extending HACCP to meat/poultry and seafood inspection operations. Today, Pillsbury plants are still operating under HACCP.
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Quality Assurance in In-House Continuing Training. Case Studies from Europe.
ERIC Educational Resources Information Center
Severing, Eckart; Stahl, Thomas
Nine European Community Member States (Belgium, Germany, France, Greece, Ireland, Luxembourg, Portugal, Spain, and United Kingdom) conducted national studies that involved case studies of quality assurance in continuing education. Analysis of findings indicated that many firms regarded continuing training as a central instrument for achieving…
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Code of Federal Regulations, 2012 CFR
2012-01-01
... executing. III. Design Control Measures shall be established to assure that applicable regulatory... control of design interfaces and for coordination among participating design organizations. These measures..., approval, release, distribution, and revision of documents involving design interfaces. The design control...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... executing. III. Design Control Measures shall be established to assure that applicable regulatory... control of design interfaces and for coordination among participating design organizations. These measures..., approval, release, distribution, and revision of documents involving design interfaces. The design control...
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NASA Astrophysics Data System (ADS)
Heeager, Lise Tordrup; Tjørnehøj, Gitte
Quality assurance technology is a formal control mechanism aiming at increasing the quality of the product exchanged between vendors and customers. Studies of the adoption of this technology in the field of system development rarely focus on the role of the relationship between the customer and vendor in the process. We have studied how the process of adopting quality assurance technology by a small Danish IT vendor developing pharmacy software for a customer in the public sector was influenced by the relationship with the customer. The case study showed that the adoption process was shaped to a high degree by the relationship and vice versa. The prior high level of trust and mutual knowledge helped the parties negotiate mutually feasible solutions throughout the adoption process. We thus advise enhancing trust-building processes to strengthen the relationships and to balance formal control and social control to increase the likelihood of a successful outcome of the adoption of quality assurance technology in a customer-vendor relationship.
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Operational excellence (six sigma) philosophy: Application to software quality assurance
DOE Office of Scientific and Technical Information (OSTI.GOV)
Lackner, M.
1997-11-01
This report contains viewgraphs on operational excellence philosophy of six sigma applied to software quality assurance. This report outlines the following: goal of six sigma; six sigma tools; manufacturing vs administrative processes; Software quality assurance document inspections; map software quality assurance requirements document; failure mode effects analysis for requirements document; measuring the right response variables; and questions.
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ERIC Educational Resources Information Center
Brady, Norman; Bates, Agnieszka
2016-01-01
The quest continues to standardise quality assurance systems throughout the European Higher Education Area (EHEA) under the auspices of the Bologna Process and led by the European Network for Quality Assurance (ENQA). Mirroring its member organisation in England, the Quality Assurance Agency (QAA), ENQA identifies, as one of its core aims, the…
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A cost-benefit analysis for materials management information systems.
Slapak-Iacobelli, L; Wilde, A H
1993-02-01
The cost-benefit analysis provided the system planners with valuable information that served many purposes. It answered the following questions: Why was the CCF undertaking this project? What were the alternatives? How much was it going to cost? And what was the expected outcome? The process of developing cost-benefit the document kept the project team focused. It also motivated them to involve additional individuals from materials management and accounts payable in its development. A byproduct of this involvement was buy-in and commitment to the project by everyone in these areas. Consequently, the project became a team effort championed by many and not just one. We were also able to introduce two new information system processes: 1) a management review process with goals and anticipated results, and 2) a quality assurance process that ensured the CCF had a better product in the end. The cost-benefit analysis provided a planning tool that assisted in successful implementation of an integrated materials management information system.
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Yamanaka, Ashley; Fialkowski, Marie Kainoa; Wilkens, Lynne; Li, Fenfang; Ettienne, Reynolette; Fleming, Travis; Power, Julianne; Deenik, Jonathan; Coleman, Patricia; Leon Guerrero, Rachael; Novotny, Rachel
2016-09-02
Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region. Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site. Results were summarized to examine and align the implementation of protocol procedures across diverse settings. Data collection protocols focused on food and physical activity were adhered to closely; however, protocols for handling completed forms and ensuring data security showed more variability. Quality assurance protocols are common in the clinical literature but are limited in multi-site community-based studies, especially in underserved populations. The reduction in the number of QA problems found in the second as compared to the first data collection periods for the intervention study attest to the value of this assessment. This paper can serve as a reference for similar studies wishing to implement quality assurance protocols of the data collection process to preserve data integrity and enhance the validity of study findings. NIH clinical trial #NCT01881373.
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Safety Surveillance of Traditional Chinese Medicine: Current and Future
Liu, Shwu-Huey; Chuang, Wu-Chang; Lam, Wing; Jiang, Zaoli
2015-01-01
Herbal medicine, including traditional Chinese medicine, has been used for the prevention, treatment, and cure of disorders or diseases for centuries. In addition to being used directly as therapeutic agents, medicinal plants are also important sources for pharmacological drug research and development. With the increasing consumption of herbal products intended to promote better health, it is extremely important to assure the safety and quality of herbal preparations. However, under current regulation surveillance, herbal preparations may not meet expectations in safety, quality, and efficacy. The challenge is how to assure the safety and quality of herbal products for consumers. It is the responsibility of producers to minimize hazardous contamination and additives during cultivation, harvesting, handling, processing, storage, and distribution. This article reviews the current safety obstacles that have been involved in traditional Chinese herbal medicine preparations with examples of popular herbs. Approaches to improve the safety of traditional Chinese medicine are proposed. PMID:25647717
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Safety policy and requirements for payloads using the Space Transportation System (STS)
NASA Technical Reports Server (NTRS)
1982-01-01
The Space Transportation Operations (STO) safety policy is to minimize STO involvement in the payload and its GSE (ground support equipment) design process while maintaining the assurance of a safe operation. Requirements for assuring payload mission success are the responsibility of the payload organization and are beyond the scope of this document. The intent is to provide the overall safety policies and requirements while allowing for negotiation between the payload organization and the STO operator in the method of implementation of payload safety. This revision provides for a relaxation in the monitoring requirements for inhibits, allows the payload organization to pursue design options and reflects, additionally, some new requirements. As of the issue date of this NHB, payloads which have completed the formal safety assessment reviews of their preliminary design on the basis of the May 1979 issue will be reassessed for compliance with the above changes.
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Staats, Janet S.; Enzor, Jennifer H.; Sanchez, Ana M.; Rountree, Wes; Chan, Cliburn; Jaimes, Maria; Chan, Ray Chun-Fai; Gaur, Amitabh; Denny, Thomas N.; Weinhold, Kent J.
2014-01-01
The External Quality Assurance Program Oversight Laboratory (EQAPOL) Flow Cytometry Program assesses the proficiency of NIH/NIAID/DAIDS-supported and potentially other interested research laboratories in performing Intracellular Cytokine Staining (ICS) assays. The goal of the EQAPOL Flow Cytometry External Quality Assurance Program (EQAP) is to provide proficiency testing and remediation for participating sites. The program is not punitive; rather, EQAPOL aims to help sites identify areas for improvement. EQAPOL utilizes a highly standardized ICS assay to minimize variability and readily identify those sites experiencing technical difficulties with their assays. Here, we report the results of External Proficiency 3 (EP3) where participating sites performed a 7-color ICS assay. On average, sites perform well in the Flow Cytometry EQAP (median score is “Good”). The most common technical issues identified by the program involve protocol adherence and data analysis; these areas have been the focus of site remediation. The EQAPOL Flow Cytometry team is now in the process of expanding the program to 8-color ICS assays. Evaluating polyfunctional ICS responses would align the program with assays currently being performed in support of HIV immune monitoring assays. PMID:24968072
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Hu, E; Liao, T. W.; Tiersch, T. R.
2013-01-01
Cryopreservation of fish sperm has been studied for decades at a laboratory (research) scale. However, high-throughput cryopreservation of fish sperm has recently been developed to enable industrial-scale production. This study treated blue catfish (Ictalurus furcatus) sperm high-throughput cryopreservation as a manufacturing production line and initiated quality assurance plan development. The main objectives were to identify: 1) the main production quality characteristics; 2) the process features for quality assurance; 3) the internal quality characteristics and their specification designs; 4) the quality control and process capability evaluation methods, and 5) the directions for further improvements and applications. The essential product quality characteristics were identified as fertility-related characteristics. Specification design which established the tolerance levels according to demand and process constraints was performed based on these quality characteristics. Meanwhile, to ensure integrity throughout the process, internal quality characteristics (characteristics at each quality control point within process) that could affect fertility-related quality characteristics were defined with specifications. Due to the process feature of 100% inspection (quality inspection of every fish), a specific calculation method, use of cumulative sum (CUSUM) control charts, was applied to monitor each quality characteristic. An index of overall process evaluation, process capacity, was analyzed based on in-control process and the designed specifications, which further integrates the quality assurance plan. With the established quality assurance plan, the process could operate stably and quality of products would be reliable. PMID:23872356
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NASA Technical Reports Server (NTRS)
1992-01-01
This standard specifies the software assurance program for the provider of software. It also delineates the assurance activities for the provider and the assurance data that are to be furnished by the provider to the acquirer. In any software development effort, the provider is the entity or individual that actually designs, develops, and implements the software product, while the acquirer is the entity or individual who specifies the requirements and accepts the resulting products. This standard specifies at a high level an overall software assurance program for software developed for and by NASA. Assurance includes the disciplines of quality assurance, quality engineering, verification and validation, nonconformance reporting and corrective action, safety assurance, and security assurance. The application of these disciplines during a software development life cycle is called software assurance. Subsequent lower-level standards will specify the specific processes within these disciplines.
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NASA Astrophysics Data System (ADS)
Franchetti, Franz; Sandryhaila, Aliaksei; Johnson, Jeremy R.
2014-06-01
In this paper we introduce High Assurance SPIRAL to solve the last mile problem for the synthesis of high assurance implementations of controllers for vehicular systems that are executed in today's and future embedded and high performance embedded system processors. High Assurance SPIRAL is a scalable methodology to translate a high level specification of a high assurance controller into a highly resource-efficient, platform-adapted, verified control software implementation for a given platform in a language like C or C++. High Assurance SPIRAL proves that the implementation is equivalent to the specification written in the control engineer's domain language. Our approach scales to problems involving floating-point calculations and provides highly optimized synthesized code. It is possible to estimate the available headroom to enable assurance/performance trade-offs under real-time constraints, and enables the synthesis of multiple implementation variants to make attacks harder. At the core of High Assurance SPIRAL is the Hybrid Control Operator Language (HCOL) that leverages advanced mathematical constructs expressing the controller specification to provide high quality translation capabilities. Combined with a verified/certified compiler, High Assurance SPIRAL provides a comprehensive complete solution to the efficient synthesis of verifiable high assurance controllers. We demonstrate High Assurance SPIRALs capability by co-synthesizing proofs and implementations for attack detection and sensor spoofing algorithms and deploy the code as ROS nodes on the Landshark unmanned ground vehicle and on a Synthetic Car in a real-time simulator.
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Busch, Jeremiah W.; Delph, Lynda F.
2012-01-01
Background The field of plant mating-system evolution has long been interested in understanding why selfing evolves from outcrossing. Many possible mechanisms drive this evolutionary trend, but most research has focused upon the transmission advantage of selfing and its ability to provide reproductive assurance when cross-pollination is uncertain. We discuss the shared conceptual framework of these ideas and their empirical support that is emerging from tests of their predictions over the last 25 years. Scope These two hypotheses are derived from the same strategic framework. The transmission advantage hypothesis involves purely gene-level selection, with reproductive assurance involving an added component of individual-level selection. Support for both of these ideas has been garnered from population-genetic tests of their predictions. Studies in natural populations often show that selfing increases seed production, but it is not clear if this benefit is sufficient to favour the evolution of selfing, and the ecological agents limiting outcross pollen are often not identified. Pollen discounting appears to be highly variable and important in systems where selfing involves multiple floral adaptations, yet seed discounting has rarely been investigated. Although reproductive assurance appears likely as a leading factor facilitating the evolution of selfing, studies must account for both seed and pollen discounting to adequately test this hypothesis. Conclusions The transmission advantage and reproductive assurance ideas describe components of gene transmission that favour selfing. Future work should move beyond their dichotomous presentation and focus upon understanding whether selection through pollen, seed or both explains the spread of selfing-rate modifiers in plant populations. PMID:21937484
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Busch, Jeremiah W; Delph, Lynda F
2012-02-01
The field of plant mating-system evolution has long been interested in understanding why selfing evolves from outcrossing. Many possible mechanisms drive this evolutionary trend, but most research has focused upon the transmission advantage of selfing and its ability to provide reproductive assurance when cross-pollination is uncertain. We discuss the shared conceptual framework of these ideas and their empirical support that is emerging from tests of their predictions over the last 25 years. These two hypotheses are derived from the same strategic framework. The transmission advantage hypothesis involves purely gene-level selection, with reproductive assurance involving an added component of individual-level selection. Support for both of these ideas has been garnered from population-genetic tests of their predictions. Studies in natural populations often show that selfing increases seed production, but it is not clear if this benefit is sufficient to favour the evolution of selfing, and the ecological agents limiting outcross pollen are often not identified. Pollen discounting appears to be highly variable and important in systems where selfing involves multiple floral adaptations, yet seed discounting has rarely been investigated. Although reproductive assurance appears likely as a leading factor facilitating the evolution of selfing, studies must account for both seed and pollen discounting to adequately test this hypothesis. The transmission advantage and reproductive assurance ideas describe components of gene transmission that favour selfing. Future work should move beyond their dichotomous presentation and focus upon understanding whether selection through pollen, seed or both explains the spread of selfing-rate modifiers in plant populations.
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Background to new entrant safety fitness assurance process
DOT National Transportation Integrated Search
2000-03-01
This report presents the results of background research leading to the development of a New Entrant Safety Fitness Assurance Process, a prequalification and monitoring program for motor carriers entering interstate service. The New Entrant Safety Fit...
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NASA Technical Reports Server (NTRS)
2002-01-01
The NASA/Navy Benchmarking Exchange (NNBE) was undertaken to identify practices and procedures and to share lessons learned in the Navy's submarine and NASA's human space flight programs. The NNBE focus is on safety and mission assurance policies, processes, accountability, and control measures. This report is an interim summary of activity conducted through October 2002, and it coincides with completion of the first phase of a two-phase fact-finding effort.In August 2002, a team was formed, co-chaired by senior representatives from the NASA Office of Safety and Mission Assurance and the NAVSEA 92Q Submarine Safety and Quality Assurance Division. The team closely examined the two elements of submarine safety (SUBSAFE) certification: (1) new design/construction (initial certification) and (2) maintenance and modernization (sustaining certification), with a focus on: (1) Management and Organization, (2) Safety Requirements (technical and administrative), (3) Implementation Processes, (4) Compliance Verification Processes, and (5) Certification Processes.
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Future of Assurance: Ensuring that a System is Trustworthy
NASA Astrophysics Data System (ADS)
Sadeghi, Ahmad-Reza; Verbauwhede, Ingrid; Vishik, Claire
Significant efforts are put in defining and implementing strong security measures for all components of the comput-ing environment. It is equally important to be able to evaluate the strength and robustness of these measures and establish trust among the components of the computing environment based on parameters and attributes of these elements and best practices associated with their production and deployment. Today the inventory of techniques used for security assurance and to establish trust -- audit, security-conscious development process, cryptographic components, external evaluation - is somewhat limited. These methods have their indisputable strengths and have contributed significantly to the advancement in the area of security assurance. However, shorter product and tech-nology development cycles and the sheer complexity of modern digital systems and processes have begun to decrease the efficiency of these techniques. Moreover, these approaches and technologies address only some aspects of security assurance and, for the most part, evaluate assurance in a general design rather than an instance of a product. Additionally, various components of the computing environment participating in the same processes enjoy different levels of security assurance, making it difficult to ensure adequate levels of protection end-to-end. Finally, most evaluation methodologies rely on the knowledge and skill of the evaluators, making reliable assessments of trustworthiness of a system even harder to achieve. The paper outlines some issues in security assurance that apply across the board, with the focus on the trustworthiness and authenticity of hardware components and evaluates current approaches to assurance.
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Quality control and assurance for validation of DOS/I measurements
NASA Astrophysics Data System (ADS)
Cerussi, Albert; Durkin, Amanda; Kwong, Richard; Quang, Timothy; Hill, Brian; Tromberg, Bruce J.; MacKinnon, Nick; Mantulin, William W.
2010-02-01
Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials, quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3. Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor, audit and communicate all research procedures (database, teleconferences, training sessions) between participants ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these strategies.
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NASA Astrophysics Data System (ADS)
Arce, A.; Tarquis, A. M.; Cartagena, M. C.
2012-04-01
The Bologna Process is to improve the quality of education, mobility, diversity and the competitiveness and involves three fundamental changes: transform of the structure of titles, changing in methods of teaching and implementation of the systems of quality assurance. Once that titles structure given by the E.T.S. Agronomic Engineer (ETSIA) have been defined, and introduced new methods of learning, this work has focused in the third point: implementation of quality assurance systems as well as the new three titles planning that begins to impart at ETSIA, Madrid, during 2010-2011 course. The academic year 2010-2011 was the first year of implementation of the Bologna Process, this paper attempts to compare the academic results obtained by students in the three new degrees in the subject of Chemistry I and II compared with the results obtained in the same subject in the degree of Agronomic Engineer in the past four years. The academic results have been lower than expected and worse than in previous courses. The paper tries to account for these results based on the percentage of compliance with the guidance of teachers, and based on student participation and training prior to beginning the course. Finally, propose possible solutions to try to correct these results in future courses, with the aim of improving efficiency rates, success and absenteeism important in the first year since it will condition the dropout rate of these new degrees.
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21 CFR 312.66 - Assurance of IRB review.
Code of Federal Regulations, 2010 CFR
2010-04-01
... proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except...
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All projects planned and implemented under the EPA Dioxin Exposure Initiative (DEI) are required to have completed Quality Assurance Project Plans (QAPPs) EPA Order 5360.1 A2 states, All work funded by the United States Environmental Protection Agency (EPA) that involves the ...
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ERIC Educational Resources Information Center
Garabedian, Todd E.; Galletta, Elizabeth A.
2005-01-01
Building an attractive patent and technology portfolio for potential licensees requires involvement and diligence by the technology transfer office and the inventors. Steps outlined in this article, such as proper treatment of IP to assure rights are not lost, preventing premature disclosures, assuring proper ownership and inventorship of…
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Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice
2014-07-01
This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing. Copyright © 2014 Elsevier B.V. All rights reserved.
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Quality assurance paradigms for artificial intelligence in modelling and simulation
DOE Office of Scientific and Technical Information (OSTI.GOV)
Oren, T.I.
1987-04-01
New classes of quality assurance concepts and techniques are required for the advanced knowledge-processing paradigms (such as artificial intelligence, expert systems, or knowledge-based systems) and the complex problems that only simulative systems can cope with. A systematization of quality assurance problems as well as examples are given to traditional and cognizant quality assurance techniques in traditional and cognizant modelling and simulation.
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Benchmarking Software Assurance Implementation
2011-05-18
product The chicken#. (a.k.a. Process Focused Assessment ) – Management Systems ( ISO 9001, ISO 27001 , ISO 2000) – Capability Maturity Models (CMMI...Assurance PRM, RMM, Assurance for CMMI)) – Lifecycle Processes ( ISO /IEEE 15288, ISO /IEEE 12207) – COBIT, ITIL, MS SDL, OSAMM, BSIMM 5 The egg...a.k.a Product Focused Assessments) – SCAP - NIST-SCAP – ISO /OMG W3C – KDM, BPMN, RIF, XMI, RDF – OWASP Top 10 – SANS TOP 25 – Secure Code Check Lists
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Academic Achievement Standards and Quality Assurance
ERIC Educational Resources Information Center
Sadler, D. Royce
2017-01-01
Quality assurance processes have been applied to many aspects of higher education, including teaching, learning and assessment. At least in the latter domain, quality assurance needs its fundamental tenets critically scrutinised. A common but inadequate approach has been to identify and promote learning environment changes "likely to…
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Software Configuration Management Guidebook
NASA Technical Reports Server (NTRS)
1995-01-01
The growth in cost and importance of software to NASA has caused NASA to address the improvement of software development across the agency. One of the products of this program is a series of guidebooks that define a NASA concept of the assurance processes which are used in software development. The Software Assurance Guidebook, SMAP-GB-A201, issued in September, 1989, provides an overall picture of the concepts and practices of NASA in software assurance. Lower level guidebooks focus on specific activities that fall within the software assurance discipline, and provide more detailed information for the manager and/or practitioner. This is the Software Configuration Management Guidebook which describes software configuration management in a way that is compatible with practices in industry and at NASA Centers. Software configuration management is a key software development process, and is essential for doing software assurance.
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Assured Mission Support Space Architecture (AMSSA) study
NASA Technical Reports Server (NTRS)
Hamon, Rob
1993-01-01
The assured mission support space architecture (AMSSA) study was conducted with the overall goal of developing a long-term requirements-driven integrated space architecture to provide responsive and sustained space support to the combatant commands. Although derivation of an architecture was the focus of the study, there are three significant products from the effort. The first is a philosophy that defines the necessary attributes for the development and operation of space systems to ensure an integrated, interoperable architecture that, by design, provides a high degree of combat utility. The second is the architecture itself; based on an interoperable system-of-systems strategy, it reflects a long-range goal for space that will evolve as user requirements adapt to a changing world environment. The third product is the framework of a process that, when fully developed, will provide essential information to key decision makers for space systems acquisition in order to achieve the AMSSA goal. It is a categorical imperative that military space planners develop space systems that will act as true force multipliers. AMSSA provides the philosophy, process, and architecture that, when integrated with the DOD requirements and acquisition procedures, can yield an assured mission support capability from space to the combatant commanders. An important feature of the AMSSA initiative is the participation by every organization that has a role or interest in space systems development and operation. With continued community involvement, the concept of the AMSSA will become a reality. In summary, AMSSA offers a better way to think about space (philosophy) that can lead to the effective utilization of limited resources (process) with an infrastructure designed to meet the future space needs (architecture) of our combat forces.
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NASA Technical Reports Server (NTRS)
HarrisonFleming, Cody; Spencer, Melissa; Leveson, Nancy; Wilkinson, Chris
2012-01-01
The generation of minimum operational, safety, performance, and interoperability requirements is an important aspect of safely integrating new NextGen components into the Communication Navigation Surveillance and Air Traffic Management (CNS/ATM) system. These requirements are used as part of the implementation and approval processes. In addition, they provide guidance to determine the levels of design assurance and performance that are needed for each element of the new NextGen procedures, including aircraft, operator, and Air Navigation and Service Provider. Using the enhanced Airborne Traffic Situational Awareness for InTrail Procedure (ATSA-ITP) as an example, this report describes some limitations of the current process used for generating safety requirements and levels of required design assurance. An alternative process is described, as well as the argument for why the alternative can generate more comprehensive requirements and greater safety assurance than the current approach.
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Quality assurance after process changes of the production of a therapeutic antibody.
Brass, J M; Krummen, K; Moll-Kaufmann, C
1996-12-01
Process development for the production of a therapeutic humanised antibody is a very complex operation. It involves recombinant genetics, verification of a strong expression system, gene amplification, characterisation of a stable host cell expression system, optimisation and design of the mammalian cell culture fermentation system and development of an efficient recovery process resulting in high yields and product quality. Rapid progress in the field and the wish of some pharmaceutical companies for outsourcing their production are the driving forces for process changes relatively late in the development phase. This literature survey is aimed at identifying the limits of acceptable process changes in up scaling of the fermentation and down stream processing of biopharmaceuticals and defining the demand in production validation to prove product equivalency and identity of the isolated, purified therapeutic antibody.
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Control of the dehydration process in production of intermediate-moisture meat products: a review.
Chang, S F; Huang, T C; Pearson, A M
1996-01-01
IM meat products are produced by lowering the aw to 0.90 to 0.60. Such products are stable at ambient temperature and humidity and are produced in nearly every country in the world, especially in developing areas where refrigeration is limited or unavailable. Traditionally IM meats use low cost sources of energy for drying, such as sun drying, addition of salt, or fermentation. Products produced by different processes are of interest since they do not require refrigeration during distribution and storage. Many different IM meat products can be produced by utilizing modern processing equipment and methods. Production can be achieved in a relatively short period of time and their advantages during marketing and distribution can be utilized. Nevertheless, a better understanding of the principles involved in heat transfer and efficiency of production are still needed to increase efficiency of processing. A basic understanding of the influence of water vapor pressure and sorption phenomena on water activity can materially improve the efficiency of drying of IM meats. Predrying treatments, such as fermentation and humidity control, can also be taken advantage of during the dehydration process. Such information can lead to process optimization and reduction of energy costs during production of IM meats. The development of sound science-based methods to assure the production of high-quality and nutritious IM meats is needed. Finally, such products also must be free of pathogenic microorganisms to assure their success in production and marketing.
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ERIC Educational Resources Information Center
Espy, John; And Others
A project was conducted to field test selected first- and second-year courses in a postsecondary nuclear quality assurance/quality control (QA/QC) technician curriculum and to develop the teaching/learning modules for seven technical specialty courses remaining in the QA/QC technician curriculum. The field testing phase of the project involved the…
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Robust Decision Making for Improved Mission Assurance
2014-06-01
Technology Team (STT) proposed and was approved to receive funding for a set of four research projects advancing foundational decision science and... technology over a three year period of performance. At the time it was approved, the initiative involved 27 collaborating scientists and engineers from five...Appendix E. Sensors Directorate Technologies for Robust Decision Making for Improved Mission Assurance
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Quality Assurance Strategies of Higher Education in Iraq and Kurdistan: A Case Study
ERIC Educational Resources Information Center
Kaghed, Nabeel; Dezaye, Ahmed
2009-01-01
This paper reports on two different strategies that have been implemented in Iraq to improve quality assurance in the higher education sector in Iraq. One strategy has been developed by the Ministry of Higher Education and Scientific Research in Baghdad. It involved conducting a pilot study at the University of Babylon. This pilot included…
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Automatic non-destructive system for quality assurance of welded elements in the aircraft industry
NASA Astrophysics Data System (ADS)
Chady, Tomasz; Waszczuk, Paweł; Szydłowski, Michał; Szwagiel, Mariusz
2018-04-01
Flaws that might be a result of the welding process have to be detected, in order to assure high quality thus reliability of elements exploited in aircraft industry. Currently the inspection stage is conducted manually by a qualified workforce. There are no commercially available systems that could support or replace humans in the flaw detection process. In this paper authors present a novel non-destructive system developed for quality assurance purposes of welded elements utilized in the aircraft industry.
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Sherman, Paul David
2016-04-01
This article presents a framework to identify key mechanisms for developing a logic model blueprint that can be used for an impending comprehensive evaluation of an undergraduate degree program in a Canadian university. The evaluation is a requirement of a comprehensive quality assurance process mandated by the university. A modified RUFDATA (Saunders, 2000) evaluation model is applied as an initiating framework to assist in decision making to provide a guide for conceptualizing a logic model for the quality assurance process. This article will show how an educational evaluation is strengthened by employing a RUFDATA reflective process in exploring key elements of the evaluation process, and then translating this information into a logic model format that could serve to offer a more focussed pathway for the quality assurance activities. Using preliminary program evaluation data from two key stakeholders of the undergraduate program as well as an audit of the curriculum's course syllabi, a case is made for, (1) the importance of inclusivity of key stakeholders participation in the design of the evaluation process to enrich the authenticity and accuracy of program participants' feedback, and (2) the diversification of data collection methods to ensure that stakeholders' narrative feedback is given ample exposure. It is suggested that the modified RUFDATA/logic model framework be applied to all academic programs at the university undergoing the quality assurance process at the same time so that economies of scale may be realized. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Software Quality Assurance Audits Guidebooks
NASA Technical Reports Server (NTRS)
1990-01-01
The growth in cost and importance of software to NASA has caused NASA to address the improvement of software development across the agency. One of the products of this program is a series of guidebooks that define a NASA concept of the assurance processes that are used in software development. The Software Assurance Guidebook, NASA-GB-A201, issued in September, 1989, provides an overall picture of the NASA concepts and practices in software assurance. Second level guidebooks focus on specific activities that fall within the software assurance discipline, and provide more detailed information for the manager and/or practitioner. This is the second level Software Quality Assurance Audits Guidebook that describes software quality assurance audits in a way that is compatible with practices at NASA Centers.
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Emerging and recurrent issues in drug development.
Anello, C
This paper reviews several emerging and recurrent issues relating to the drug development process. These emerging issues include changes to the FDA regulatory environment, internationalization of drug development, advances in computer technology and visualization tools, and efforts to incorporate meta-analysis methodology. Recurrent issues include: renewed interest in statistical methods for handling subgroups in the design and analysis of clinical trials; renewed interest in alternatives to the 'intention-to-treat' analysis in the presence of non-compliance in randomized clinical trials; renewed interest in methodology to address the multiplicities resulting from a variety of sources inherent in the drug development process, and renewed interest in methods to assure data integrity. These emerging and recurrent issues provide a continuing challenge to the international community of statisticians involved in drug development. Moreover, the involvement of statisticians with different perspectives continues to enrich the field and contributes to improvement in the public health.
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The quality assurance-risk management interface.
Little, N
1992-08-01
Involvement with both risk management and quality assurance programs has led many authors to the conclusion that the fundamental differences between these activities are, in fact, very small. "At the point of overlap, it is almost impossible to distinguish the purposes and methods of both functions from one another." "Good risk management includes real improvement in patient care through organized quality assurance activities." The interface between a proactive risk management program and a quality assurance program is dynamic and can serve the legitimate interests of both. There is little to be gained by thinking of them as separate entities and much to be gained by sharing the lessons of both. If one thinks of risk management in terms of "risk" to quality patient care, and that "assuring quality" is the most productive type of risk management, then there is no practical reason to separate one from the other.
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Policy of Quality Assurance in Hong Kong Preschools
ERIC Educational Resources Information Center
Dora, Ho Choi-wa
2007-01-01
This article discusses the sources, processes and impact of the quality assurance policy implemented in Hong Kong preschools. Regarded as a sort of policy alignment between the subsystems of pre-primary, primary and secondary education, the introduction of a quality assurance policy has been directly and indirectly transforming the settlements in…
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Quality Assurance in Sub-Saharan Africa
ERIC Educational Resources Information Center
Materu, Peter; Righetti, Petra
2010-01-01
This article assesses the status and practice of higher education quality assurance in sub-Saharan Africa, focusing on degree-granting tertiary institutions. A main finding is that structured national-level quality assurance processes in African higher education are a very recent phenomenon and that most countries face major capacity constraints.…
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Goal Structuring Notation in a Radiation Hardening Assurance Case for COTS-Based Spacecraft
NASA Technical Reports Server (NTRS)
Witulski, A.; Austin, R.; Evans, J.; Mahadevan, N.; Karsai, G.; Sierawski, B.; LaBel, K.; Reed, R.
2016-01-01
The attached presentation is a summary of how mission assurance is supported by model-based representations of spacecraft systems that can define sub-system functionality and interfacing, reliability parameters, as well as detailing a new paradigm for assurance, a model-centric and not document-centric process.
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Centanni, N; Monroe, M; White, L; Larson, R
1999-01-01
The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.
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Software for Optimizing Quality Assurance of Other Software
NASA Technical Reports Server (NTRS)
Feather, Martin; Cornford, Steven; Menzies, Tim
2004-01-01
Software assurance is the planned and systematic set of activities that ensures that software processes and products conform to requirements, standards, and procedures. Examples of such activities are the following: code inspections, unit tests, design reviews, performance analyses, construction of traceability matrices, etc. In practice, software development projects have only limited resources (e.g., schedule, budget, and availability of personnel) to cover the entire development effort, of which assurance is but a part. Projects must therefore select judiciously from among the possible assurance activities. At its heart, this can be viewed as an optimization problem; namely, to determine the allocation of limited resources (time, money, and personnel) to minimize risk or, alternatively, to minimize the resources needed to reduce risk to an acceptable level. The end result of the work reported here is a means to optimize quality-assurance processes used in developing software.
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Quality audit--a review of the literature concerning delivery of continence care.
Swaffield, J
1995-09-01
This paper outlines the role of quality audit within the framework of quality assurance, presenting the concurrent and retrospective approaches available. The literature survey provides a review of the limited audit tools available and their application to continence services and care delivery, as well as attempts to produce tools from national and local standard setting. Audit is part of a process; it can involve staff, patients and their relatives and the team of professionals providing care, as well as focusing on organizational and management levels. In an era of market delivery of services there is a need to justify why audit is important to continence advisors and managers. Effectiveness, efficiency and economics may drive the National Health Service, but quality assurance, which includes standards and audit tools, offers the means to ensure the quality of continence services and care to patients and auditing is also required in the purchaser/provider contracts for patient services. An overview and progress to date of published and other a projects in auditing continence care and service is presented. By outlining and highlighting the audit of continence service delivery and care as a basis on which to build quality assurance programmes, it is hoped that this knowledge will be shared through the setting up of a central auditing clearing project.
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The Hyper-X Flight Systems Validation Program
NASA Technical Reports Server (NTRS)
Redifer, Matthew; Lin, Yohan; Bessent, Courtney Amos; Barklow, Carole
2007-01-01
For the Hyper-X/X-43A program, the development of a comprehensive validation test plan played an integral part in the success of the mission. The goal was to demonstrate hypersonic propulsion technologies by flight testing an airframe-integrated scramjet engine. Preparation for flight involved both verification and validation testing. By definition, verification is the process of assuring that the product meets design requirements; whereas validation is the process of assuring that the design meets mission requirements for the intended environment. This report presents an overview of the program with emphasis on the validation efforts. It includes topics such as hardware-in-the-loop, failure modes and effects, aircraft-in-the-loop, plugs-out, power characterization, antenna pattern, integration, combined systems, captive carry, and flight testing. Where applicable, test results are also discussed. The report provides a brief description of the flight systems onboard the X-43A research vehicle and an introduction to the ground support equipment required to execute the validation plan. The intent is to provide validation concepts that are applicable to current, follow-on, and next generation vehicles that share the hybrid spacecraft and aircraft characteristics of the Hyper-X vehicle.
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The future of urban water services in Latin America.
Wade, Jeffry S
2012-01-01
In recent decades, problems with the provision of drinking water and sanitation services around the world have increasingly been addressed by attempts at privatisation, recasting clean water as an essentially economic, rather than public, good. This approach gained particular acceptance in Latin America, but with limited success. In order to address the full range of social, economic and environmental values necessary to sustain water resources over time, public and governmental involvement in establishing integrated water management, pursuing ‘soft path’ approaches, assuring stakeholder input and setting policy will be essential to the process.
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Dermatology practice management assures practice development and efficiency.
Wagener, D L
2000-09-01
This article provides an overview of the disciplines involved in managing a dermatology practice today. Several key management processes, including strategic planning, financial analysis, advertising and public relations, information systems management, and compliance program development and monitoring are addressed. This article explores several possible tactics that can be used to help guide your practice in the right direction without overtaxing your resources. Also offered are possible solutions for creating an organization that is poised for success, and a management team capable of steering the practice through the sea of change ahead.
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NASA Astrophysics Data System (ADS)
Gentry, Jeffery D.
2000-05-01
A relational database is a powerful tool for collecting and analyzing the vast amounts of inner-related data associated with the manufacture of composite materials. A relational database contains many individual database tables that store data that are related in some fashion. Manufacturing process variables as well as quality assurance measurements can be collected and stored in database tables indexed according to lot numbers, part type or individual serial numbers. Relationships between manufacturing process and product quality can then be correlated over a wide range of product types and process variations. This paper presents details on how relational databases are used to collect, store, and analyze process variables and quality assurance data associated with the manufacture of advanced composite materials. Important considerations are covered including how the various types of data are organized and how relationships between the data are defined. Employing relational database techniques to establish correlative relationships between process variables and quality assurance measurements is then explored. Finally, the benefits of database techniques such as data warehousing, data mining and web based client/server architectures are discussed in the context of composite material manufacturing.
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ERIC Educational Resources Information Center
Beerkens, Maarja
2015-01-01
Higher education quality assurance systems develop within a complex political environment where national level goals and priorities interact with European and global developments. Furthermore, quality assurance is influenced by broader processes in the public sector that set expectations with respect to accountability, legitimacy and regulatory…
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A Study of Quality Assurance Practices in the Universiti Sains Malaysia (USM), Malaysia
ERIC Educational Resources Information Center
Sim, Helen Khoo Chooi; Idrus, Rozhan M.
2004-01-01
This article looks at the quality assurance practices amongst three (3) groups of staff in the School of Distance Education, Universiti Sains Malaysia, i.e. lecturers, resident tutors and support staff. 9 dimensions of the Quality Assurance Practices i.e. Staff Development, Planning, Work Process, Team Work, Prioritise Customers, Performance…
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ERIC Educational Resources Information Center
Vukasovic, Martina
2014-01-01
The study suggests that institutionalisation of a comprehensive and systematic approach to internal quality assurance of higher education institutions inspired by the Bologna Process has regulative, normative and cultural-cognitive dimensions. It includes development of structures and procedures for quality assurance, as well as boosting of the…
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Internal Quality Assurance Benchmarking. ENQA Workshop Report 20
ERIC Educational Resources Information Center
Blackstock, Douglas; Burquel, Nadine; Comet, Nuria; Kajaste, Matti; dos Santos, Sergio Machado; Marcos, Sandra; Moser, Marion; Ponds, Henri; Scheuthle, Harald; Sixto, Luis Carlos Velon
2012-01-01
The Internal Quality Assurance group of ENQA (IQA Group) has been organising a yearly seminar for its members since 2007. The main objective is to share experiences concerning the internal quality assurance of work processes in the participating agencies. The overarching theme of the 2011 seminar was how to use benchmarking as a tool for…
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Safety considerations in the design and operation of large wind turbines
NASA Technical Reports Server (NTRS)
Reilly, D. H.
1979-01-01
The engineering and safety techniques used to assure the reliable and safe operation of large wind turbine generators utilizing the Mod 2 Wind Turbine System Program as an example is described. The techniques involve a careful definition of the wind turbine's natural and operating environments, use of proven structural design criteria and analysis techniques, an evaluation of potential failure modes and hazards, and use of a fail safe and redundant component engineering philosophy. The role of an effective quality assurance program, tailored to specific hardware criticality, and the checkout and validation program developed to assure system integrity are described.
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COHeRE: Cross-Ontology Hierarchical Relation Examination for Ontology Quality Assurance.
Cui, Licong
Biomedical ontologies play a vital role in healthcare information management, data integration, and decision support. Ontology quality assurance (OQA) is an indispensable part of the ontology engineering cycle. Most existing OQA methods are based on the knowledge provided within the targeted ontology. This paper proposes a novel cross-ontology analysis method, Cross-Ontology Hierarchical Relation Examination (COHeRE), to detect inconsistencies and possible errors in hierarchical relations across multiple ontologies. COHeRE leverages the Unified Medical Language System (UMLS) knowledge source and the MapReduce cloud computing technique for systematic, large-scale ontology quality assurance work. COHeRE consists of three main steps with the UMLS concepts and relations as the input. First, the relations claimed in source vocabularies are filtered and aggregated for each pair of concepts. Second, inconsistent relations are detected if a concept pair is related by different types of relations in different source vocabularies. Finally, the uncovered inconsistent relations are voted according to their number of occurrences across different source vocabularies. The voting result together with the inconsistent relations serve as the output of COHeRE for possible ontological change. The highest votes provide initial suggestion on how such inconsistencies might be fixed. In UMLS, 138,987 concept pairs were found to have inconsistent relationships across multiple source vocabularies. 40 inconsistent concept pairs involving hierarchical relationships were randomly selected and manually reviewed by a human expert. 95.8% of the inconsistent relations involved in these concept pairs indeed exist in their source vocabularies rather than being introduced by mistake in the UMLS integration process. 73.7% of the concept pairs with suggested relationship were agreed by the human expert. The effectiveness of COHeRE indicates that UMLS provides a promising environment to enhance qualities of biomedical ontologies by performing cross-ontology examination.
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An Automatic Image Processing Workflow for Daily Magnetic Resonance Imaging Quality Assurance.
Peltonen, Juha I; Mäkelä, Teemu; Sofiev, Alexey; Salli, Eero
2017-04-01
The performance of magnetic resonance imaging (MRI) equipment is typically monitored with a quality assurance (QA) program. The QA program includes various tests performed at regular intervals. Users may execute specific tests, e.g., daily, weekly, or monthly. The exact interval of these measurements varies according to the department policies, machine setup and usage, manufacturer's recommendations, and available resources. In our experience, a single image acquired before the first patient of the day offers a low effort and effective system check. When this daily QA check is repeated with identical imaging parameters and phantom setup, the data can be used to derive various time series of the scanner performance. However, daily QA with manual processing can quickly become laborious in a multi-scanner environment. Fully automated image analysis and results output can positively impact the QA process by decreasing reaction time, improving repeatability, and by offering novel performance evaluation methods. In this study, we have developed a daily MRI QA workflow that can measure multiple scanner performance parameters with minimal manual labor required. The daily QA system is built around a phantom image taken by the radiographers at the beginning of day. The image is acquired with a consistent phantom setup and standardized imaging parameters. Recorded parameters are processed into graphs available to everyone involved in the MRI QA process via a web-based interface. The presented automatic MRI QA system provides an efficient tool for following the short- and long-term stability of MRI scanners.
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ERIC Educational Resources Information Center
Stalmeijer, Renée; Whittingham, Jill; de Grave, Willem; Dolmans, Diana
2016-01-01
Student evaluation committees play a crucial role in internal quality assurance processes as representatives of the student body. However, the students on these committees sometimes experience difficulty in providing constructive and structured feedback to faculty in an environment characterised by a strong power differential between student and…
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Improving patient safety through quality assurance.
Raab, Stephen S
2006-05-01
Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. To review some of the anatomic pathology laboratory patient safety quality assurance practices. Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Yoo, Jun Soo; Choi, Yong Joon; Smith, Curtis Lee
2016-09-01
This document addresses two subjects involved with the RELAP-7 Software Verification and Validation Plan (SVVP): (i) the principles and plan to assure the independence of RELAP-7 assessment through the code development process, and (ii) the work performed to establish the RELAP-7 assessment plan, i.e., the assessment strategy, literature review, and identification of RELAP-7 requirements. Then, the Requirements Traceability Matrices (RTMs) proposed in previous document (INL-EXT-15-36684) are updated. These RTMs provide an efficient way to evaluate the RELAP-7 development status as well as the maturity of RELAP-7 assessment through the development process.
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Chiropractic quality assurance: standards and guidelines
Gatterman, Meridel I; Dobson, Thomas P; LeFevbre, Ron
2001-01-01
Chiropractic quality assurance involves development of both clinical guidelines and standards. Confusion generated by poor differentiation of guidelines from standards contributes to mistrust of the guideline development process. Guidelines are considered to be recommendations that allow for flexibility and individual patient differences. Standards are more binding and require a high level of supporting evidence. While guidelines serve as educational tools to improve the quality of practice, standards that outline minimum competency are used more as administrative tools on which to base policy. Barriers to development of clinical guidelines and standards include fear that they will create prescriptive “cookbook” practice, and the distrust that guidelines are developed primarily for cost containment. Clinicians also criticize guidelines developed by academics that don't relate to practice, and those based on evidence that lacks clinical relevance. Conflicting guidelines perceived to be based on strong bias or conflict of interest are also suspect. To reduce barriers to acceptance and implementation, guidelines should be inclusive, patient-centered, and based on a variety of evidence and clinical experience.
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McCann, Edward; Higgins, Agnes; Maguire, Gerry; Alexander, Jane; Watts, Mike; Creaner, Mary; Rani, Shobha
2012-09-01
The provision of high-quality education and training that is responsive, relevant, accessible and evidence based is critical if the vision for quality mental health services presented in recent policy initiatives in Ireland is to be fulfilled. This paper reports the findings related to pedagogical approaches and quality assurance mechanisms utilized within mental health education. The study involved canvassing all Higher Education Institutions in Ireland. A total of 227 courses in 31 educational institutes were identified and 149 questionnaires were returned from 129 Course Coordinators. Various quality processes were identified in existing programs; however, formal feedback from service providers, service users and carers was seldom reported. Ongoing evaluation and quality assurance strategies are a key element of governance and there is a need to develop strategies that explore the impact of education programs on mental health education and health outcomes. Recommendations are made in terms of future interprofessional mental health education and practice.
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Krause, Paul; de Lusignan, Simon
2010-01-01
The allure of interoperable systems is that they should improve patient safety and make health services more efficient. The UK's National Programme for IT has made great strides in achieving interoperability; through linkage to a national electronic spine. However, there has been criticism of the usability of the applications in the clinical environment. Analysis of the procurement and assurance process to explore whether they predetermine usability. Processes separate developers from users, and test products against theoretical assurance models of use rather than simulate or pilot in a clinical environment. The current process appears to be effective for back office systems and high risk applications, but too inflexible for developing applications for the clinical setting. For clinical applications agile techniques are more appropriate. Usability testing should become an integrated part of the contractual process and be introduced earlier in the development process.
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[Quality assurance in dentistry--past, present and future].
Vered, Y; Schwartz, N; Babayoff, I
2003-01-01
Quality assurance involves the cycle of quality assessment, formal identification of problems, developing a strategy for resolving problems and implementation of changes. Historically, the term "first do not harm" can be considered as the first step in quality assurance. Patients' high expectations from the outcomes of dental treatment, new technology and cost containment changed the perspectives completely. We are facing a new era of an increasing demand for patients' involvement as well as an increasing demand for accountability of the members of the profession. The article describes the development of the issue of quality assurance during the last thirty years and highlights the difficulties encountered by the profession in adjusting the changes due to lack of education, experience, knowledge and absence of a definition for accepted criteria for action. Developing criteria for appropriateness of dental treatment, developing mechanisms for assessing the art of care, development of large data bases and development of consumers' surveys are some of the leading suggestions for future action. The responsibility for quality and quality assurance lies in the hands of the dental profession. Organized dentistry possesses a social and ethical commitment for the society, as well as professional obligation for the members of the profession. Although cost containment gave rise to the issue of quality, quality assurance should not be measured in financial terms, but in terms of accepting responsibility and working for continuous improvement. Steps in the right direction will, hopefully, lead to a better and more efficient utilization of the available resources and will increase the trust of the public in the profession of dentistry. Therefore, organized dentistry should not leave this important issue to be dealt by non-dental professions or commercial organizations.
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ERIC Educational Resources Information Center
Hou, Angela Yung-Chi; Ince, Martin; Tsai, Sandy; Chiang, Chung Lin
2015-01-01
As quality guardians of higher education, quality assurance agencies are required to guarantee the credibility of the review process and to ensure the objectivity and transparency of their decisions and recommendations. These agencies are therefore expected to use a range of internal and external approaches to prove the quality of their review…
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ERIC Educational Resources Information Center
Lipton, Briony
2015-01-01
Quality assurance policies and practices are critical to the performance of Australian universities both in terms of national funding and international prestige and are redefining the future of the academic enterprise. Quality assurance is not merely the systematic measurement of quality. It is a political and heuristic process, which has…
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Outcomes of Quality Assurance: A Discussion of Knowledge, Methodology and Validity
ERIC Educational Resources Information Center
Stensaker, Bjorn
2008-01-01
A common characteristic in many quality assurance schemes around the world is their implicit and often narrowly formulated understanding of how organisational change is to take place as a result of the process. By identifying some of the underlying assumptions related to organisational change in current quality assurance schemes, the aim of this…
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Evolution of Internal Quality Assurance at One University--A Case Study
ERIC Educational Resources Information Center
O'Sullivan, David
2017-01-01
Purpose: Quality assurance (QA) at one University has evolved over the past 15 years through emerging National and European standards, various leadership initiatives and through the engagement of key stakeholders in co-designing and implementing internal QA processes. In 2000, the QA process was focussed mainly on quality review (QR) that involved…
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Assessing Faculty Bias in Rating Embedded Assurance of Learning Assignments
ERIC Educational Resources Information Center
Kim, Dong-gook; Helms, Marilyn M.
2016-01-01
Assurance of learning (AoL) processes for continuous improvement and accreditation require business schools to assess program goals. Findings from the process can lead to changes in course design or curriculum. Often AoL assignments are embedded into existing courses and assessed at regular intervals. Faculty members may evaluate an assignment in…
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North by Northwest: Quality Assurance and Evaluation Processes in European Education
ERIC Educational Resources Information Center
Grek, Sotiria; Lawn, Martin; Lingard, Bob; Varjo, Janne
2009-01-01
Governing processes in Europe and within Europeanization are often opaque and appearances can deceive. The normative practices of improvement in education, and the connected growth in performance measurement, have been largely understood in their own terms. However, the management of flows of information through quality assurance can be examined…
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Improving Student Retention in Higher Education: Improving Teaching and Learning
ERIC Educational Resources Information Center
Crosling, Glenda; Heagney, Margaret; Thomas, Liz
2009-01-01
As a key performance indicator in university quality assurance processes, the retention of students in their studies is an issue of concern world-wide. Implicit in the process of quality assurance is quality improvement. In this article, we examine student retention from a teaching and learning perspective, in terms of teaching and learning…
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Bennett, Trudy J.; Graham, Jennifer L.; Foster, Guy M.; Stone, Mandy L.; Juracek, Kyle E.; Rasmussen, Teresa J.; Putnam, James E.
2014-01-01
A quality-assurance plan for use in conducting continuous water-quality monitoring activities has been developed for the Kansas Water Science Center in accordance with guidelines set forth by the U.S. Geological Survey. This quality-assurance plan documents the standards, policies, and procedures used by the U.S. Geological Survey in Kansas for activities related to the collection, processing, storage, analysis, and release of continuous water-quality monitoring data. The policies and procedures that are documented in this quality-assurance plan for continuous water-quality monitoring activities complement quality-assurance plans for surface-water and groundwater activities in Kansas.
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Small satellite product assurance
NASA Astrophysics Data System (ADS)
Demontlivault, J.; Cadelec, Jacques
1993-01-01
In order to increase the interest in small satellites, their cost must be reduced; reducing product assurance costs induced by quality requirements is a major objective. For a logical approach, small satellites are classified in three main categories: satellites for experimental operations with a short lifetime, operational satellites manufactured in small mass with long lifetime requirements, operational satellites (long lifetime required), of which only a few models are produced. The various requirements as regards the product assurance are examined for each satellite category: general requirements for space approach, reliability, electronic components, materials and processes, quality assurance, documentation, tests, and management. Ideal product assurance system integrates quality teams and engineering teams.
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Guidelines for preparing a quality assurance plan for district offices of the U.S. Geological Survey
Schroder, L.J.; Shampine, W.J.
1992-01-01
The U.S. Geological Survey has a policy that requires each District office to prepare a Quality Assurance Plan. This plan is a combination of a District's management principles and quality assurance processes. The guidelines presented in this report provide a framework or expanded outline that a District can use to prepare a plan. Parti- cular emphasis is given to a District's: (1) quality assurance policies; (2) organization and staff responsibilities; and (3) program and project planning. The guidelines address the 'how', 'what', and 'who' questions that need to be answered when a District Quality Assurance Plan is prepared.
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Software service history report
DOT National Transportation Integrated Search
2002-01-01
The safe and reliable operation of software within civil aviation systems and equipment has historically been assured through the application of rigorous design assurance applied during the software development process. Increasingly, manufacturers ar...
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Quality assurance: Importance of systems and standard operating procedures
Manghani, Kishu
2011-01-01
It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company. PMID:21584180
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Quality assurance: Importance of systems and standard operating procedures.
Manghani, Kishu
2011-01-01
It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.
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NASA Astrophysics Data System (ADS)
Tamborski, Szymon; Lyu, Hong Chou; Bukowska, Danuta; Dolezyczek, Hubert; Wilczynski, Grzegorz; Szlag, Daniel; Lasser, Theo; Wojtkowski, Maciej; Szkulmowski, Maciej
2016-03-01
We used Optical Coherence Microscopy (OCM) to monitor structural and functional changes due to ischemic stroke in small animals brains in vivo. To obtain lateral resolution of 2.2 μm over the range of 600 μm we used extended focus configuration of OCM instrument involving Bessel beam. It provided access to detailed 3D information about the changes in brain vascular system up to the level of capillaries across I and II/III layers of neocortex. We used photothrombotic stroke model involving photoactive application of rose bengal to assure minimal invasiveness of the procedure and precise localization of the clot distribution center. We present the comparative analysis involving structural and angiographic maps of the stroke-affected brain enabling in-depth insight to the process of development of the disorder.
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Software Process Assurance for Complex Electronics
NASA Technical Reports Server (NTRS)
Plastow, Richard A.
2007-01-01
Complex Electronics (CE) now perform tasks that were previously handled in software, such as communication protocols. Many methods used to develop software bare a close resemblance to CE development. Field Programmable Gate Arrays (FPGAs) can have over a million logic gates while system-on-chip (SOC) devices can combine a microprocessor, input and output channels, and sometimes an FPGA for programmability. With this increased intricacy, the possibility of software-like bugs such as incorrect design, logic, and unexpected interactions within the logic is great. With CE devices obscuring the hardware/software boundary, we propose that mature software methodologies may be utilized with slight modifications in the development of these devices. Software Process Assurance for Complex Electronics (SPACE) is a research project that used standardized S/W Assurance/Engineering practices to provide an assurance framework for development activities. Tools such as checklists, best practices and techniques were used to detect missing requirements and bugs earlier in the development cycle creating a development process for CE that was more easily maintained, consistent and configurable based on the device used.
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The Evolution of the NASA Commercial Crew Program Mission Assurance Process
NASA Technical Reports Server (NTRS)
Canfield, Amy C.
2016-01-01
In 2010, the National Aeronautics and Space Administration (NASA) established the Commercial Crew Program (CCP) in order to provide human access to the International Space Station and low Earth orbit via the commercial (non-governmental) sector. A particular challenge to NASA has been how to determine that the Commercial Provider's transportation system complies with programmatic safety requirements. The process used in this determination is the Safety Technical Review Board which reviews and approves provider submitted hazard reports. One significant product of the review is a set of hazard control verifications. In past NASA programs, 100% of these safety critical verifications were typically confirmed by NASA. The traditional Safety and Mission Assurance (S&MA) model does not support the nature of the CCP. To that end, NASA S&MA is implementing a Risk Based Assurance process to determine which hazard control verifications require NASA authentication. Additionally, a Shared Assurance Model is also being developed to efficiently use the available resources to execute the verifications.
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NASA Processes and Requirements for Conducting Human-in-the-Loop Closed Chamber Tests
NASA Technical Reports Server (NTRS)
Barta, Daniel J.; Montz, Michael E.
2004-01-01
NASA has specific processes and requirements that must be followed for tests involving human subjects to be conducted in a safe and effective manner. There are five distinct phases of test operations. Phase one, the test request phase, consists of those activities related to initiating, processing, reviewing, and evaluating the test request. Phase two, the test preparation phase consists of those activities related to planning, coordinating, documenting, and building up the test. Phase three, the test readiness phase consists of those activities related to verifying and reviewing the planned test operations. Phase four, the test activity phase, consists of all pretest operations, functional checkouts, emergency drills, and test operations. Phase five, the post test activity phase, consists of those activities performed once the test is completed, including briefings, documentation of anomalies, data reduction and archiving, and reporting. Project management processes must be followed for facility modifications and major test buildup, which include six phases: initiation and assessment, requirements evaluation, preliminary design, detailed design, use readiness review (URR) and acceptance. Compliance with requirements for safety and quality assurance are documented throughout the test buildup and test operation processes. Tests involving human subjects must be reviewed by the applicable Institutional Review Board (IRB).
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Franklin, Marvin A.
2000-01-01
The U.S. Geological Survey, Water Resources Division, has a policy that requires each District office to prepare a Surface Water Quality-Assurance Plan. The plan for each District describes the policies and procedures that ensure high quality in the collection, processing, analysis, computer storage, and publication of surface-water data. The North Florida Program Office Surface Water Quality-Assurance Plan documents the standards, policies, and procedures used by the North Florida Program office for activities related to the collection, processing, storage, analysis, and publication of surface-water data.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Vile, D; Zhang, L; Cuttino, L
2016-06-15
Purpose: To create a quality assurance program based upon a risk-based assessment of a newly implemented SirSpheres Y-90 procedure. Methods: A process map was created for a newly implemented SirSpheres procedure at a community hospital. The process map documented each step of this collaborative procedure, as well as the roles and responsibilities of each member. From the process map, different potential failure modes were determined as well as any current controls in place. From this list, a full failure mode and effects analysis (FMEA) was performed by grading each failure mode’s likelihood of occurrence, likelihood of detection, and potential severity.more » These numbers were then multiplied to compute the risk priority number (RPN) for each potential failure mode. Failure modes were then ranked based on their RPN. Additional controls were then added, with failure modes corresponding to the highest RPNs taking priority. Results: A process map was created that succinctly outlined each step in the SirSpheres procedure in its current implementation. From this, 72 potential failure modes were identified and ranked according to their associated RPN. Quality assurance controls and safety barriers were then added for failure modes associated with the highest risk being addressed first. Conclusion: A quality assurance program was created from a risk-based assessment of the SirSpheres process. Process mapping and FMEA were effective in identifying potential high-risk failure modes for this new procedure, which were prioritized for new quality assurance controls. TG 100 recommends the fault tree analysis methodology to design a comprehensive and effective QC/QM program, yet we found that by simply introducing additional safety barriers to address high RPN failure modes makes the whole process simpler and safer.« less
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MEMS Reliability Assurance Activities at JPL
NASA Technical Reports Server (NTRS)
Kayali, S.; Lawton, R.; Stark, B.
2000-01-01
An overview of Microelectromechanical Systems (MEMS) reliability assurance and qualification activities at JPL is presented along with the a discussion of characterization of MEMS structures implemented on single crystal silicon, polycrystalline silicon, CMOS, and LIGA processes. Additionally, common failure modes and mechanisms affecting MEMS structures, including radiation effects, are discussed. Common reliability and qualification practices contained in the MEMS Reliability Assurance Guideline are also presented.
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ERIC Educational Resources Information Center
Ashour, Sanaa
2017-01-01
The United Arab Emirates (UAE) is a federation of seven autonomous emirates that follow different economic models. There is a process for quality assurance at the federal level, however, each emirate takes its own approach to assure the quality of its institutions. This has resulted in different procedures and varying levels of oversight and…
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Quality assurance in Australian hospitals: who does it and how?
Renwick, M; Harvey, R
1990-01-01
To seek information on the type, method and extent of quality assurance being undertaken in all public and private hospitals within Australia. Mailed questionnaire. There was a predominance of two types of review being undertaken. Some important deficiencies in the quality assurance process were identified. Far more private than public hospitals reviewed medical records and surveyed patient satisfaction.
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NASA's Approach to Software Assurance
NASA Technical Reports Server (NTRS)
Wetherholt, Martha
2015-01-01
NASA defines software assurance as: the planned and systematic set of activities that ensure conformance of software life cycle processes and products to requirements, standards, and procedures via quality, safety, reliability, and independent verification and validation. NASA's implementation of this approach to the quality, safety, reliability, security and verification and validation of software is brought together in one discipline, software assurance. Organizationally, NASA has software assurance at each NASA center, a Software Assurance Manager at NASA Headquarters, a Software Assurance Technical Fellow (currently the same person as the SA Manager), and an Independent Verification and Validation Organization with its own facility. An umbrella risk mitigation strategy for safety and mission success assurance of NASA's software, software assurance covers a wide area and is better structured to address the dynamic changes in how software is developed, used, and managed, as well as it's increasingly complex functionality. Being flexible, risk based, and prepared for challenges in software at NASA is essential, especially as much of our software is unique for each mission.
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ERIC Educational Resources Information Center
Lim, Fion Choon Boey
2010-01-01
Assuring the quality of transnational education has been an endeavour of increasing importance in the internationalisation of higher education but is also increasingly challenging given the involvement of many stakeholders. This paper focuses on the experiences of and challenges faced by private tertiary education providers in Malaysia and…
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Assuring NASA's Safety and Mission Critical Software
NASA Technical Reports Server (NTRS)
Deadrick, Wesley
2015-01-01
What is IV&V? Independent Verification and Validation (IV&V) is an objective examination of safety and mission critical software processes and products. Independence: 3 Key parameters: Technical Independence; Managerial Independence; Financial Independence. NASA IV&V perspectives: Will the system's software: Do what it is supposed to do?; Not do what it is not supposed to do?; Respond as expected under adverse conditions?. Systems Engineering: Determines if the right system has been built and that it has been built correctly. IV&V Technical Approaches: Aligned with IEEE 1012; Captured in a Catalog of Methods; Spans the full project lifecycle. IV&V Assurance Strategy: The IV&V Project's strategy for providing mission assurance; Assurance Strategy is driven by the specific needs of an individual project; Implemented via an Assurance Design; Communicated via Assurance Statements.
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ERIC Educational Resources Information Center
LaFleur, Elizabeth K.; Babin, Laurie A.; Lopez, Tara Burnthorne
2009-01-01
This article describes the process one marketing faculty followed to demonstrate assurance of learning for marketing students and presents longitudinal results associated with a course-embedded direct assessment device in the Principles of Marketing course. The process follows closely the Association to Advance Collegiate Schools of Business…
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ERIC Educational Resources Information Center
Ala-Va¨ha¨la¨, Timo
2016-01-01
This article analyses Finnish higher education institutions' reception of the implementation of the new quality assurance systems that governments participating in the Bologna Process have committed to establishing in the Berlin Communique´ of 2003. The data were collected using a web survey and the respondents were classified with a cluster…
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Students' Roles in Maintaining Quality and in Enhancing Learning: Is There a Tension?
ERIC Educational Resources Information Center
Little, Brenda; Williams, Ruth
2010-01-01
This article is about student engagement and in particular the engagement of students in internal institutional quality assurance processes in the UK. It discusses the extent to which the introduction of more explicit internal and external quality assurance processes militate against the notion of the student as a part of a "cohesive learning…
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Shreve, Elizabeth A.; Downs, Aimee C.
2005-01-01
This report describes laboratory procedures used by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory for the processing and analysis of fluvial-sediment samples for concentration of sand and finer material. The report details the processing of a sediment sample through the laboratory from receiving the sediment sample, through the analytical process, to compiling results of the requested analysis. Procedures for preserving sample integrity, calibrating and maintaining of laboratory and field instruments and equipment, analyzing samples, internal quality assurance and quality control, and validity of the sediment-analysis results also are described. The report includes a list of references cited and a glossary of sediment and quality-assurance terms.
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Implementation of Programmatic Quality and the Impact on Safety
NASA Technical Reports Server (NTRS)
Huls, Dale Thomas; Meehan, Kevin
2005-01-01
The purpose of this paper is to discuss the implementation of a programmatic quality assurance discipline within the International Space Station Program and the resulting impact on safety. NASA culture has continued to stress safety at the expense of quality when both are extremely important and both can equally influence the success or failure of a Program or Mission. Although safety was heavily criticized in the media after Colimbiaa, strong case can be made that it was the failure of quality processes and quality assurance in all processes that eventually led to the Columbia accident. Consequently, it is possible to have good quality processes without safety, but it is impossible to have good safety processes without quality. The ISS Program quality assurance function was analyzed as representative of the long-term manned missions that are consistent with the President s Vision for Space Exploration. Background topics are as follows: The quality assurance organizational structure within the ISS Program and the interrelationships between various internal and external organizations. ISS Program quality roles and responsibilities with respect to internal Program Offices and other external organizations such as the Shuttle Program, JSC Directorates, NASA Headquarters, NASA Contractors, other NASA Centers, and International Partner/participants will be addressed. A detailed analysis of implemented quality assurance responsibilities and functions with respect to NASA Headquarters, the JSC S&MA Directorate, and the ISS Program will be presented. Discussions topics are as follows: A comparison of quality and safety resources in terms of staffing, training, experience, and certifications. A benchmark assessment of the lessons learned from the Columbia Accident Investigation (CAB) Report (and follow-up reports and assessments), NASA Benchmarking, and traditional quality assurance activities against ISS quality procedures and practices. The lack of a coherent operational and sustaining quality assurance strategy for long-term manned space flight. An analysis of the ISS waiver processes and the Problem Reporting and Corrective Action (PRACA) process implemented as quality functions. Impact of current ISS Program procedures and practices with regards to operational safety and risk A discussion regarding a "defense-in-depth" approach to quality functions will be provided to address the issue of "integration vs independence" with respect to the roles of Programs, NASA Centers, and NASA Headquarters. Generic recommendations are offered to address the inadequacies identified in the implementation of ISS quality assurance. A reassessment by the NASA community regarding the importance of a "quality culture" as a component within a larger "safety culture" will generate a more effective and value-added functionality that will ultimately enhance safety.
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18 CFR 1309.9 - How does TVA provide financial assistance in conformity with the Act?
Code of Federal Regulations, 2010 CFR
2010-04-01
... involving the provision of similar services or benefits. Where the financial assistance involves the... contain a covenant running with the land assuring compliance with this part and the guidelines contained... assistance is extended or for another purpose involving the provision of similar services or benefits. Where...
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Quality Assurance Project Plan for Citizen Science Projects
The Quality Assurance Project Plan is necessary for every project that collects or uses environmental data. It documents the project planning process and serves as a blueprint for how your project will run.
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Making the Business Case for Software Assurance
2009-04-01
and Capability dEtermination-SPICE, ISO /IEC 15504, 1998. [ ISO 2007] International Organization for Standardization. " ISO /IEC 27001 & 27002 ...Implementing the Process Areas 6.2.7 Differences Between the CMMI and Software CMM Process Areas 6.3 The CMMI Appraisal Process 6.4 Adapting ISO 15504 to...Secure Software Assurance 6.4.1 Assessment and the Secure Life Cycle 6.4.2 ISO 15504 Capability Levels 6.5 Adapting the ISOIIEC 21287 Standard Approach to
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What is the Final Verification of Engineering Requirements?
NASA Technical Reports Server (NTRS)
Poole, Eric
2010-01-01
This slide presentation reviews the process of development through the final verification of engineering requirements. The definition of the requirements is driven by basic needs, and should be reviewed by both the supplier and the customer. All involved need to agree upon a formal requirements including changes to the original requirements document. After the requirements have ben developed, the engineering team begins to design the system. The final design is reviewed by other organizations. The final operational system must satisfy the original requirements, though many verifications should be performed during the process. The verification methods that are used are test, inspection, analysis and demonstration. The plan for verification should be created once the system requirements are documented. The plan should include assurances that every requirement is formally verified, that the methods and the responsible organizations are specified, and that the plan is reviewed by all parties. The options of having the engineering team involved in all phases of the development as opposed to having some other organization continue the process once the design has been complete is discussed.
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Assessment of the NASA Flight Assurance Review Program
NASA Technical Reports Server (NTRS)
Holmes, J.; Pruitt, G.
1983-01-01
The NASA flight assurance review program to develop minimum standard guidelines for flight assurance reviews was assessed. Documents from NASA centers and NASA headquarters to determine current design review practices and procedures were evaluated. Six reviews were identified for the recommended minimum. The practices and procedures used at the different centers to incorporate the most effective ones into the minimum standard review guidelines were analyzed and guidelines for procedures, personnel and responsibilies, review items/data checklist, and feedback and closeout were defined. The six recommended reviews and the minimum standards guidelines developed for flight assurance reviews are presented. Observations and conclusions for further improving the NASA review and quality assurance process are outlined.
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Lambing, John H.
2006-01-01
In accordance with guidelines set forth by the Office of Water Quality in the Water Resources Discipline of the U.S. Geological Survey (USGS), a quality-assurance plan has been created for use by the USGS Montana Water Science Center in conducting water-quality activities. This quality-assurance plan documents the standards, policies, and procedures used by the USGS Montana Water Science Center for activities related to the collection, processing, storage, analysis, and publication of water-quality data. The policies and procedures presented in this quality-assurance plan for water-quality activities complement the quality-assurance plans for surface-water and ground-water activities and suspended-sediment analysis.
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ERIC Educational Resources Information Center
Iskandar
2017-01-01
Implementation of quality assurance systems in IAIN STS Jambi implemented in early 2012, through the build system of internal quality assurance based on ISO 9001: 2008, in the process of implementation required strong reasons behind not growing atmosphere of academic standards of accreditation of study programs and institutions that are reflected…
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The patient's perspective in the Dutch National Technical Agreement on Telemedicine.
Meijer, Wouter J
2008-01-01
In 2007, the Dutch National Technical Agreement (NTA) for Telemedicine was established. Telemedicine deals with care processes. The goals of Telemedicine were defined broadly, including quality of life in non-medical terms as seen from the patient's perspective: 1) independence, 2) self-reliance; 3) participation in society and social life and 4) self-determination (autonomy through freedom of choice) for the care consumer and his environment. Quality aspects were defined at three levels:1) patient level Telemedicine must be in line with his needs. 2) level of information provision, such as: patient's rights in information control were also defined in the NTA: the care consumer has ultimate control over his own data. The care consumer decides who, in which functional capacity within the care process, is entitled to access which data at which level (reading) and is entitled to process it in some way: making additions, changes or possibly deleting (writing). On request, the healthcare provider must allow the care consumer access to his own data as quickly as possible and/or provide a copy of (part of) the record.3) level of business processes, e.g.it is important that the care process is designed on the basis of statutory requirements for the allocation and registration of the roles, rights and obligations of all actors concerned. For quality assurance, the processes must be defined on the basis of the function that they perform in the achievement of the goals (intended outcome), from the starting situation (input). The intended outcome means that the needs or requirements of the involved parties are fulfilled. The quality of the Telemedicine service must be assured in a cyclical and ongoing process. This can best be done by developing a quality management system based on indicators and criteria for quality.
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The management of ultrasound equipment at Sheffield Teaching Hospitals NHS Foundation Trust
Peacock, M
2013-01-01
Management of ultrasound equipment at Sheffield Teaching Hospitals NHS Foundation Trust is described. The organisation and input of various stakeholders and their involvement with ultrasound equipment management and scientific ultrasound is discussed. Two important stakeholders are the Medical Equipment Management Group and the Radiation Safety Steering Committee. The Medical Equipment Management Group has a specific sub-group, the Ultrasound sub-group, and its role is to coordinate the purchase, replacement and quality assurance of ultrasound equipment in the Trust. The Radiation Safety Steering Committee has a non-ionising radiation representative and the role of this committee is to provide corporate assurance that any health and safety issues arising from the use of radiation to either patients, members of the public or staff within the Trust are being effectively managed. The Ultrasound sub-group of the Medical Equipment Management Group has successfully brought together management of all ultrasound equipment within the Trust and is in the process of fulfilling the quality assurance and training milestones set out by the Medical Equipment Management Group. Advice from the Radiation Safety Steering Committee has helped to increase awareness of ultrasound safety and good scanning practice, especially in the case of neonatal ultrasound imaging, within the Trust. In addition, the RSSC has given advice on clinical pathways for patients undergoing ionising radiation imaging while being treated by extra-corporeal shockwave lithotripsy. PMID:27433195
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Super Safety and Health Day at KSC
NASA Technical Reports Server (NTRS)
2000-01-01
Employees take a look at this NASCAR auto being displayed during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''
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Super Safety and Health Day at KSC
NASA Technical Reports Server (NTRS)
2000-01-01
Center Director Roy Bridges talks to workers outside the Hazardous Maintenance Facility during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''
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2000-10-18
Center Director Roy Bridges talks to workers outside the Hazardous Maintenance Facility during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Center Director Roy Bridges talks to workers outside the Hazardous Maintenance Facility during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Employees at KSC look over a display of work-related shoes in an exhibit tent during Super Safety and Health Day. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Employees take a look at this NASCAR auto being displayed during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
In an exhibit tent during Super Safety and Health Day at KSC, employees sample iced tea from a vendor. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of healthand safety-related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Employees at KSC look over a display of work-related shoes in an exhibit tent during Super Safety and Health Day. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
In an exhibit tent during Super Safety and Health Day at KSC, employees sample iced tea from a vendor. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of healthand safety-related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Employees take a look at this NASCAR auto being displayed during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Employees gather around a demonstration by Florida Power and Light during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of healthand safety-related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Employees gather around a demonstration by Florida Power and Light during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of healthand safety-related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
In the Training Auditorium at KSC, Center Director Roy Bridges addresses attendees at a presentation for Super Safety and Health Day. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
In the Training Auditorium at KSC, Center Director Roy Bridges addresses attendees at a presentation for Super Safety and Health Day. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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Super Safety and Health Day at KSC
NASA Technical Reports Server (NTRS)
2000-01-01
Employees gather around a demonstration by Florida Power and Light during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health- and safety-related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''
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Super Safety and Health Day at KSC
NASA Technical Reports Server (NTRS)
2000-01-01
In an exhibit tent during Super Safety and Health Day at KSC, employees sample iced tea from a vendor. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health- and safety-related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''
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Super Safety and Health Day at KSC
NASA Technical Reports Server (NTRS)
2000-01-01
Vendor tents and displays filled the grounds in the Industrial Area as well as LC 39 Area during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''
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[Challenges of Digital Medicine].
Blaser, Jürg
2018-06-01
Challenges of Digital Medicine Abstract. Digitization is increasingly covering more and more sectors, including medicine. To ensure medical operation 365 × 24 hours, progressively more human and financial resources are necessary. The transformation of patient histories from paper into electronic patient records focused initially on documentation. Today, hospital information systems are increasingly used as a platform for the communication of all professionals involved in the patient process - in Switzerland, however, so far without providing patients direct access to their data. Digititizing processes intend to increase efficiency, but also to enhance clinical and administrative decision support and quality assurance. The introduction of the electronic patient record in Switzerland in 2020 is expected to provide cross-company, more complete documentation of patient care. Multimorbid patients, often treated in different institutions and by different specialists, should benefit from this in particular. Advances in artificial intelligence offer new opportunities in medicine. Challenges include ensuring reliable data protection, and better interoperability of the systems involved. Semantically structured, machine-readable data exchange is a necessity for both networked services and internationally competitive research.
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ERIC Educational Resources Information Center
Costes, Nathalie; Crozier, Fiona; Cullen, Peter; Grifoll, Josep; Harris, Nick; Helle, Emmi; Hopbach, Achim; Kekalainen, Helka; Knezevic, Bozana; Sits, Tanel; Sohm, Kurt
2008-01-01
Quality assurance for higher education in Europe has developed significantly since 2002, and has increasingly influenced, and been influenced by, the Bologna Process. A major step in the Bologna Process was taken at the ministerial meeting in Bergen in May 2005, with the adoption of the Standards and Guidelines for Quality Assurance in the…
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The Award of the PhD Degree in Kenyan Universities: A Quality Assurance Perspective
ERIC Educational Resources Information Center
Ayiro, Laban P.; Sang, James K.
2011-01-01
This article attempts to bring to the fore the need for enhanced quality assurance processes in the award of PhDs by Kenyan universities. The findings reveal that quality challenges exist in the institutional processes established for the award of this advanced degree across the universities in the country. It is hoped that the findings will stir…
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Garcí A-de-León-Chocano, Ricardo; Sáez, Carlos; Muñoz-Soler, Verónica; Garcí A-de-León-González, Ricardo; García-Gómez, Juan M
2015-12-01
This is the first paper of a series of two regarding the construction of data quality (DQ) assured repositories for the reuse of information on infant feeding from birth until two years old. This first paper justifies the need for such repositories and describes the design of a process to construct them from Electronic Health Records (EHR). As a result, Part 1 proposes a computational process to obtain quality-assured datasets represented by a canonical structure extracted from raw data from multiple EHR. For this, 13 steps were defined to ensure the harmonization, standardization, completion, de-duplication, and consistency of the dataset content. Moreover, the quality of the input and output data for each of these steps is controlled according to eight DQ dimensions: predictive value, correctness, duplication, consistency, completeness, contextualization, temporal-stability and spatial-stability. The second paper of the series will describe the application of this computational process to construct the first quality-assured repository for the reuse of information on infant feeding in the perinatal period aimed at the monitoring of clinical activities and research. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Sowunmi, Olaperi Yeside; Misra, Sanjay; Fernandez-Sanz, Luis; Crawford, Broderick; Soto, Ricardo
2016-01-01
The importance of quality assurance in the software development process cannot be overemphasized because its adoption results in high reliability and easy maintenance of the software system and other software products. Software quality assurance includes different activities such as quality control, quality management, quality standards, quality planning, process standardization and improvement amongst others. The aim of this work is to further investigate the software quality assurance practices of practitioners in Nigeria. While our previous work covered areas on quality planning, adherence to standardized processes and the inherent challenges, this work has been extended to include quality control, software process improvement and international quality standard organization membership. It also makes comparison based on a similar study carried out in Turkey. The goal is to generate more robust findings that can properly support decision making by the software community. The qualitative research approach, specifically, the use of questionnaire research instruments was applied to acquire data from software practitioners. In addition to the previous results, it was observed that quality assurance practices are quite neglected and this can be the cause of low patronage. Moreover, software practitioners are neither aware of international standards organizations or the required process improvement techniques; as such their claimed standards are not aligned to those of accredited bodies, and are only limited to their local experience and knowledge, which makes it questionable. The comparison with Turkey also yielded similar findings, making the results typical of developing countries. The research instrument used was tested for internal consistency using the Cronbach's alpha, and it was proved reliable. For the software industry in developing countries to grow strong and be a viable source of external revenue, software assurance practices have to be taken seriously because its effect is evident in the final product. Moreover, quality frameworks and tools which require minimum time and cost are highly needed in these countries.
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NASA Astrophysics Data System (ADS)
Perdani, C. G.; Chasanah, N. U.; Sucipto
2018-03-01
Small and Medium Enterprises (SMEs) have an important role to catch opportunities in the global halal market. To achieve halal standards, bakery SMEs need to implement Halal Assurance System (HAS). The objective of this research was to evaluate HAS applied by SMEs in bakery product processing. Evaluation was conducted by audit method in accordance to Indonesian Halal Assurance System (a guideline regarding the Fulfillment of Criteria of Halal Assurance System in Processing Industry – namely HAS 23101). The result of the evaluation shows that 44% of HAS criteria have been met. Halal team is the key of HAS management, therefore the team needs to be institutionally established. Halal policy need to be documented and announced to the public. Regular training will improve understanding and awareness of the importance of HAS responsibilities among stakeholders. With regard to bread ingredients, 85% products hold halal certificate from MUI (Indonesian Ulema Council). Halal Control Point (HCP) of production process can be derived from contamination of haram (not permitted by Islamic Law) and najis (dirty according to Islamic Law) in term of material, equipment, and packaging process. It requires top management commitment and cooperation of a good halal team to implement a sustainable halal system.
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Quality Assurance of UMLS Semantic Type Assignments Using SNOMED CT Hierarchies.
Gu, H; Chen, Y; He, Z; Halper, M; Chen, L
2016-01-01
The Unified Medical Language System (UMLS) is one of the largest biomedical terminological systems, with over 2.5 million concepts in its Metathesaurus repository. The UMLS's Semantic Network (SN) with its collection of 133 high-level semantic types serves as an abstraction layer on top of the Metathesaurus. In particular, the SN elaborates an aspect of the Metathesaurus's concepts via the assignment of one or more types to each concept. Due to the scope and complexity of the Metathesaurus, errors are all but inevitable in this semantic-type assignment process. To develop a semi-automated methodology to help assure the quality of semantic-type assignments within the UMLS. The methodology uses a cross-validation strategy involving SNOMED CT's hierarchies in combination with UMLS semantic types. Semantically uniform, disjoint concept groups are generated programmatically by partitioning the collection of all concepts in the same SNOMED CT hierarchy according to their respective semantic-type assignments in the UMLS. Domain experts are then called upon to review the concepts in any group having a small number of concepts. It is our hypothesis that a semantic-type assignment combination applicable only to a very small number of concepts in a SNOMED CT hierarchy is an indicator of potential problems. The methodology was applied to the UMLS 2013AA release along with the SNOMED CT from January 2013. An overall error rate of 33% was found for concepts proposed by the quality-assurance methodology. Supporting our hypothesis, that number was four times higher than the error rate found in control samples. The results show that the quality-assurance methodology can aid in effective and efficient identification of UMLS semantic-type assignment errors.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Yung, J; Stefan, W; Reeve, D
2015-06-15
Purpose: Phantom measurements allow for the performance of magnetic resonance (MR) systems to be evaluated. Association of Physicists in Medicine (AAPM) Report No. 100 Acceptance Testing and Quality Assurance Procedures for MR Imaging Facilities, American College of Radiology (ACR) MR Accreditation Program MR phantom testing, and ACR MRI quality control (QC) program documents help to outline specific tests for establishing system performance baselines as well as system stability over time. Analyzing and processing tests from multiple systems can be time-consuming for medical physicists. Besides determining whether tests are within predetermined limits or criteria, monitoring longitudinal trends can also help preventmore » costly downtime of systems during clinical operation. In this work, a semi-automated QC program was developed to analyze and record measurements in a database that allowed for easy access to historical data. Methods: Image analysis was performed on 27 different MR systems of 1.5T and 3.0T field strengths from GE and Siemens manufacturers. Recommended measurements involved the ACR MRI Accreditation Phantom, spherical homogenous phantoms, and a phantom with an uniform hole pattern. Measurements assessed geometric accuracy and linearity, position accuracy, image uniformity, signal, noise, ghosting, transmit gain, center frequency, and magnetic field drift. The program was designed with open source tools, employing Linux, Apache, MySQL database and Python programming language for the front and backend. Results: Processing time for each image is <2 seconds. Figures are produced to show regions of interests (ROIs) for analysis. Historical data can be reviewed to compare previous year data and to inspect for trends. Conclusion: A MRI quality assurance and QC program is necessary for maintaining high quality, ACR MRI Accredited MR programs. A reviewable database of phantom measurements assists medical physicists with processing and monitoring of large datasets. Longitudinal data can reveal trends that although are within passing criteria indicate underlying system issues.« less
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Spacelab Data Processing Facility (SLDPF) quality assurance expert systems development
NASA Technical Reports Server (NTRS)
Kelly, Angelita C.; Basile, Lisa; Ames, Troy; Watson, Janice; Dallam, William
1987-01-01
Spacelab Data Processing Facility (SLDPF) expert system prototypes were developed to assist in the quality assurance of Spacelab and/or Attached Shuttle Payload (ASP) processed telemetry data. The SLDPF functions include the capturing, quality monitoring, processing, accounting, and forwarding of mission data to various user facilities. Prototypes for the two SLDPF functional elements, the Spacelab Output Processing System and the Spacelab Input Processing Element, are described. The prototypes have produced beneficial results including an increase in analyst productivity, a decrease in the burden of tedious analyses, the consistent evaluation of data, and the providing of concise historical records.
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Spacelab Data Processing Facility (SLDPF) quality assurance expert systems development
NASA Technical Reports Server (NTRS)
Kelly, Angelita C.; Basile, Lisa; Ames, Troy; Watson, Janice; Dallam, William
1987-01-01
Spacelab Data Processing Facility (SLDPF) expert system prototypes have been developed to assist in the quality assurance of Spacelab and/or Attached Shuttle Payload (ASP) processed telemetry data. SLDPF functions include the capturing, quality monitoring, processing, accounting, and forwarding of mission data to various user facilities. Prototypes for the two SLDPF functional elements, the Spacelab Output Processing System and the Spacelab Input Processing Element, are described. The prototypes have produced beneficial results including an increase in analyst productivity, a decrease in the burden of tedious analyses, the consistent evaluation of data, and the providing of concise historical records.
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Quality assurance and accreditation.
1997-01-01
In 1996, the Joint Commission International (JCI), which is a partnership between the Joint Commission on Accreditation of Healthcare Organizations and Quality Healthcare Resources, Inc., became one of the contractors of the Quality Assurance Project (QAP). JCI recognizes the link between accreditation and quality, and uses a collaborative approach to help a country develop national quality standards that will improve patient care, satisfy patient-centered objectives, and serve the interest of all affected parties. The implementation of good standards provides support for the good performance of professionals, introduces new ideas for improvement, enhances the quality of patient care, reduces costs, increases efficiency, strengthens public confidence, improves management, and enhances the involvement of the medical staff. Such good standards are objective and measurable; achievable with current resources; adaptable to different institutions and cultures; and demonstrate autonomy, flexibility, and creativity. The QAP offers the opportunity to approach accreditation through research efforts, training programs, and regulatory processes. QAP work in the area of accreditation has been targeted for Zambia, where the goal is to provide equal access to cost-effective, quality health care; Jordan, where a consensus process for the development of standards, guidelines, and policies has been initiated; and Ecuador, where JCI has been asked to help plan an approach to the evaluation and monitoring of the health care delivery system.
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NASA Technical Reports Server (NTRS)
1972-01-01
Guidelines for the design, development, and fabrication of electronic components and circuits for use in spacecraft construction are presented. The subjects discussed involve quality control procedures and test methodology for the following subjects: (1) monolithic integrated circuits, (2) hybrid integrated circuits, (3) transistors, (4) diodes, (5) tantalum capacitors, (6) electromechanical relays, (7) switches and circuit breakers, and (8) electronic packaging.
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ERIC Educational Resources Information Center
Berkhout, Sarie
2006-01-01
In this response I argue that the notion of quality is embedded in the tension between powerful patterns of inherited epistemic and symbolic understanding and the dynamic of the creative, imaginative moments of understanding and design. This would take the idea of co-producer/creator of knowledge beyond the boundaries of (re)packaging commodities…
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p53 on the crossroad between regeneration and cancer.
Charni, Meital; Aloni-Grinstein, Ronit; Molchadsky, Alina; Rotter, Varda
2017-01-01
Regeneration and tumorigenesis share common molecular pathways, nevertheless the outcome of regeneration is life, whereas tumorigenesis leads to death. Although the process of regeneration is strictly controlled, malignant transformation is unrestrained. In this review, we discuss the involvement of TP53, the major tumor-suppressor gene, in the regeneration process. We point to the role of p53 as coordinator assuring that regeneration will not shift to carcinogenesis. The fluctuation in p53 activity during the regeneration process permits a tight control. On one hand, its inhibition at the initial stages allows massive proliferation, on the other its induction at advanced steps of regeneration is essential for preservation of robustness and fidelity of the regeneration process. A better understanding of the role of p53 in regulation of regeneration may open new opportunities for implementation of TP53-based therapies, currently available for cancer patients, in regenerative medicine.
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Schulz, Erich; Barrett, James W.; Price, Colin
1998-01-01
As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with “business rules” declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short. PMID:9670131
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Read Code quality assurance: from simple syntax to semantic stability.
Schulz, E B; Barrett, J W; Price, C
1998-01-01
As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with "business rules" declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short.
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NASA Technical Reports Server (NTRS)
1975-01-01
The primary objectives during this portion of the extended mission were to assure survival of the spacecraft for a third Mercury encounter through conservation of attitude control gas and to conduct trajectory correction maneuvers (TCMs) as necessary to target the spacecraft for a solar occultation zone pass. Special support activities included TCMs 6 and 7 conducted on October 30, 1974 and on February 12-13, 1975, respectively. This period also saw the DSN interface organization involved in (1) the allocation of sufficient coverage to assure accurate orbit determination solutions, (2) monitoring of DSN implementation for Viking to assure maintenance of compatible interfaces and capabilities required for Mariner 10, and (3) the development of encounter coverage, sequences, and readiness test plans.
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Requirement Assurance: A Verification Process
NASA Technical Reports Server (NTRS)
Alexander, Michael G.
2011-01-01
Requirement Assurance is an act of requirement verification which assures the stakeholder or customer that a product requirement has produced its "as realized product" and has been verified with conclusive evidence. Product requirement verification answers the question, "did the product meet the stated specification, performance, or design documentation?". In order to ensure the system was built correctly, the practicing system engineer must verify each product requirement using verification methods of inspection, analysis, demonstration, or test. The products of these methods are the "verification artifacts" or "closure artifacts" which are the objective evidence needed to prove the product requirements meet the verification success criteria. Institutional direction is given to the System Engineer in NPR 7123.1A NASA Systems Engineering Processes and Requirements with regards to the requirement verification process. In response, the verification methodology offered in this report meets both the institutional process and requirement verification best practices.
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Integrated Risk Information System (IRIS)
Assure ; CASRN 76578 - 14 - 8 Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data , as outlined in the IRIS assessment development process . Sections I ( Health Hazard Assessments for Noncarcinogenic Effects
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Annual Quality Assurance Conference Abstracts by Barbara Marshik
25th Annual Quality Assurance Conference. Abstracts: Material and Process Conditions for Successful Use of Extractive Sampling Techniques and Certification Methods Errors in the Analysis of NMHC and VOCs in CNG-Based Engine Emissions by Barbara Marshik
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NASA Post-Columbia Safety & Mission Assurance, Review and Assessment Initiatives
NASA Astrophysics Data System (ADS)
Newman, J. Steven; Wander, Stephen M.; Vecellio, Don; Miller, Andrew J.
2005-12-01
On February 1, 2003, NASA again experienced a tragic accident as the Space Shuttle Columbia broke apart upon reentry, resulting in the loss of seven astronauts. Several of the findings and observations of the Columbia Accident Investigation Board addressed the need to strengthen the safety and mission assurance function at NASA. This paper highlights key steps undertaken by the NASA Office of Safety and Mission Assurance (OSMA) to establish a stronger and more- robust safety and mission assurance function for NASA programs, projects, facilities and operations. This paper provides an overview of the interlocking OSMA Review and Assessment Division (RAD) institutional and programmatic processes designed to 1) educate, inform, and prepare for audits, 2) verify requirements flow-down, 3) verify process capability, 4) verify compliance with requirements, 5) support risk management decision making, 6) facilitate secure web- based collaboration, and 7) foster continual improvement and the use of lessons learned.
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Software for Analyzing Laminar-to-Turbulent Flow Transitions
NASA Technical Reports Server (NTRS)
Chang, Chau-Lyan
2004-01-01
Software assurance is the planned and systematic set of activities that ensures that software processes and products conform to requirements, standards, and procedures. Examples of such activities are the following: code inspections, unit tests, design reviews, performance analyses, construction of traceability matrices, etc. In practice, software development projects have only limited resources (e.g., schedule, budget, and availability of personnel) to cover the entire development effort, of which assurance is but a part. Projects must therefore select judiciously from among the possible assurance activities. At its heart, this can be viewed as an optimization problem; namely, to determine the allocation of limited resources (time, money, and personnel) to minimize risk or, alternatively, to minimize the resources needed to reduce risk to an acceptable level. The end result of the work reported here is a means to optimize quality-assurance processes used in developing software. This is achieved by combining two prior programs in an innovative manner
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NASA Technical Reports Server (NTRS)
Callender, E. David; Steinbacher, Jody
1989-01-01
This is the fourth of five volumes on Information System Life-Cycle and Documentation Standards. This volume provides a well organized, easily used standard for assurance documentation for information systems and software, hardware, and operational procedures components, and related processes. The specifications are developed in conjunction with the corresponding management plans specifying the assurance activities to be performed.
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Phyllis C. Adams; Glenn A. Christensen
2012-01-01
A rigorous quality assurance (QA) process assures that the data and information provided by the Forest Inventory and Analysis (FIA) program meet the highest possible standards of precision, completeness, representativeness, comparability, and accuracy. FIA relies on its analysts to check the final data quality prior to release of a Stateâs data to the national FIA...
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Risk management and lessons learned solutions for satellite product assurance
NASA Astrophysics Data System (ADS)
Larrère, Jean-Luc
2004-08-01
The historic trend of the space industry towards lower cost programmes and more generally a better economic efficiency raises a difficult question to the quality assurance community: how to achieve the same—or better—mission success rate while drastically reducing the cost of programmes, hence the cost and level of quality assurance activities. EADS Astrium Earth Observation and Science (France) Business Unit have experimented Risk Management and Lessons Learned on their satellite programmes to achieve this goal. Risk analysis and management are deployed from the programme proposal phase through the development and operations phases. Results of the analysis and the corresponding risk mitigation actions are used to tailor the product assurance programme and activities. Lessons learned have been deployed as a systematic process to collect positive and negative experience from past and on-going programmes and feed them into new programmes. Monitoring and justification of their implementation in programmes is done under supervision from the BU quality assurance function. Control of the system is ensured by the company internal review system. Deployment of these methods has shown that the quality assurance function becomes more integrated in the programme team and development process and that its tasks gain focus and efficiency while minimising the risks associated with new space programmes.
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Purtell, D L
1990-11-01
The Health Care Quality Improvement Act of 1986 can help protect medical professionals and healthcare facilities from antitrust and defamation claims and other forms of litigation arising from the peer review process. Some hospitals may need to make major changes in their peer review activity as a result of the act. The healthcare entity, not the physicians involved in peer review, has the burden of complying with the provisions of the act. Failure to comply with the act can lead to loss of immunity from damages, fines, and potential exclusion from the Medicare program. The potential for liability has sparked a need for hospitals to reexamine and possibly reorganize medical staff and update procedures and related governing documents. Healthcare entities may consider changes such as implementing a director of medical affairs function, choosing medical staff for multiple-year terms, and centralizing physician review files. In the 1980s many hospitals created quality assurance and risk management programs. Risk managers need to share data with quality assurance personnel, who must in turn share the information with medical staff involved with credentialing, peer review, and medical affairs management. Legal counsel will need to be familiar with the legalities of the act, as well as the hospital's peer review procedures and operations. General legal counsel should oversee coordination of hospital proceedings and assist in educating staff on the legalities of peer review.
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Sustainable development: concept, value and practice.
Barrow, C J
1995-11-01
The author discusses the concept of sustainable development (SD) and explores the effectiveness of implementation strategies. Approaches to implementing sustainable development include 1) "a stocktaking approach" that involves regional and national environmental audits, resource accounting, and national environmental action plans; and 2) "changes in people's attitudes." Each approach reinforces the other. Eden examined the International Chamber of Commerce reactions to the 1987 Brundtland Report and found that business generally favored SD over no-growth environmentalism. SD occurs as a process with a variety of routes that most often involve technology that improves upon traditional methods or protects from the destructive effects of modernization. SD assures that environmental quality is maintained, and economic and social development enhances resources and the environment. SD allows for the best quality of life for people. SD assures that future generations do not have reduced options. SD prevents or avoids major natural catastrophes. The requirements are corrective treatment of root causes of nonsustainability and a shift away from consumption-oriented life styles. Trade-offs must be made. Politicians and planners must use a longer planning perspective. There must be transition to smaller population numbers. Resource conflicts must be resolved. Pollution must be reduced and resources must not be wasted. Local resources should be used for agriculture, industry, and power generation. There should be a transition to a more equitable sharing of resources. The author identifies 12 other requirements. Progress thus far is disappointing and not demonstrably evident.
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Tool Use Within NASA Software Quality Assurance
NASA Technical Reports Server (NTRS)
Shigeta, Denise; Port, Dan; Nikora, Allen P.; Wilf, Joel
2013-01-01
As space mission software systems become larger and more complex, it is increasingly important for the software assurance effort to have the ability to effectively assess both the artifacts produced during software system development and the development process itself. Conceptually, assurance is a straightforward idea - it is the result of activities carried out by an organization independent of the software developers to better inform project management of potential technical and programmatic risks, and thus increase management's confidence in the decisions they ultimately make. In practice, effective assurance for large, complex systems often entails assessing large, complex software artifacts (e.g., requirements specifications, architectural descriptions) as well as substantial amounts of unstructured information (e.g., anomaly reports resulting from testing activities during development). In such an environment, assurance engineers can benefit greatly from appropriate tool support. In order to do so, an assurance organization will need accurate and timely information on the tool support available for various types of assurance activities. In this paper, we investigate the current use of tool support for assurance organizations within NASA, and describe on-going work at JPL for providing assurance organizations with the information about tools they need to use them effectively.
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10 CFR 4.21 - General requirements.
Code of Federal Regulations, 2010 CFR
2010-01-01
... purpose involving the provision of similar services or benefits. In the case of personal property the... instrument effecting or recording the transfer shall contain a covenant running with the land assuring... benefits. Where no transfer of property is involved, but property is improved with Federal financial...
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Software Process Assurance for Complex Electronics (SPACE)
NASA Technical Reports Server (NTRS)
Plastow, Richard A.
2007-01-01
Complex Electronics (CE) are now programmed to perform tasks that were previously handled in software, such as communication protocols. Many of the methods used to develop software bare a close resemblance to CE development. For instance, Field Programmable Gate Arrays (FPGAs) can have over a million logic gates while system-on-chip (SOC) devices can combine a microprocessor, input and output channels, and sometimes an FPGA for programmability. With this increased intricacy, the possibility of software-like bugs such as incorrect design, logic, and unexpected interactions within the logic is great. Since CE devices are obscuring the hardware/software boundary, we propose that mature software methodologies may be utilized with slight modifications in the development of these devices. Software Process Assurance for Complex Electronics (SPACE) is a research project that looks at using standardized S/W Assurance/Engineering practices to provide an assurance framework for development activities. Tools such as checklists, best practices and techniques can be used to detect missing requirements and bugs earlier in the development cycle creating a development process for CE that will be more easily maintained, consistent and configurable based on the device used.
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An institutional review board-based clinical research quality assurance program.
Lad, Pramod M; Dahl, Rebecca
2013-01-01
Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.
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Quality-Assurance Plan for Water-Quality Activities in the USGS Ohio Water Science Center
Francy, Donna S.; Shaffer, Kimberly H.
2008-01-01
In accordance with guidelines set forth by the Office of Water Quality in the Water Resources Discipline of the U.S. Geological Survey, a quality-assurance plan has been written for use by the Ohio Water Science Center in conducting water-quality activities. This quality-assurance plan documents the standards, policies, and procedures used by the Ohio Water Science Center for activities related to the collection, processing, storage, analysis, and publication of water-quality data. The policies and procedures documented in this quality-assurance plan for water-quality activities are meant to complement the Ohio Water Science Center quality-assurance plans for water-quality monitors, the microbiology laboratory, and surface-water and ground-water activities.
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3D MEMS in Standard Processes: Fabrication, Quality Assurance, and Novel Measurement Microstructures
NASA Technical Reports Server (NTRS)
Lin, Gisela; Lawton, Russell A.
2000-01-01
Three-dimensional MEMS microsystems that are commercially fabricated require minimal post-processing and are easily integrated with CMOS signal processing electronics. Measurements to evaluate the fabrication process (such as cross-sectional imaging and device performance characterization) provide much needed feedback in terms of reliability and quality assurance. MEMS technology is bringing a new class of microscale measurements to fruition. The relatively small size of MEMS microsystems offers the potential for higher fidelity recordings compared to macrosize counterparts, as illustrated in the measurement of muscle cell forces.
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Decision Science Challenges for C2 Agility
2014-06-01
decision -making effectiveness , but also the adaptive capacities needed to assure the resilience of the decision -making process itself. New methods are... effectiveness , but also the adaptive capacities needed to assure the resilience of the decision -making process itself. New methods are needed to help...of the literature on human biases and limitations, and hence it has been formative of entire programs of resarch and development on
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National Radiation Hardness Assurance (RHA) Planning For NASA Missions: Updated Guidance
NASA Technical Reports Server (NTRS)
LaBel, Kenneth A.; Pellish, Jonathan Allen
2014-01-01
Radiation Hardness Assurance (RHA) is the process of ensuring space system performance in the presence of a space radiation environment. Herein, we present an updated NASA methodology for RHA focusing on content, deliverables and timeframes.
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Notional Radiation Hardness Assurance (RHA) Planning For NASA Missions: Updated Guidance
NASA Technical Reports Server (NTRS)
LaBel, Kenneth A.; Pellish, Jonathan A.
2014-01-01
Radiation Hardness Assurance (RHA) is the process of ensuring space system performance in the presence of a space radiation environment. Herein, we present an updated NASA methodology for RHA focusing on content, deliverables and timeframes.
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DKIST visible broadband imager data processing pipeline
NASA Astrophysics Data System (ADS)
Beard, Andrew; Cowan, Bruce; Ferayorni, Andrew
2014-07-01
The Daniel K. Inouye Solar Telescope (DKIST) Data Handling System (DHS) provides the technical framework and building blocks for developing on-summit instrument quality assurance and data reduction pipelines. The DKIST Visible Broadband Imager (VBI) is a first light instrument that alone will create two data streams with a bandwidth of 960 MB/s each. The high data rate and data volume of the VBI require near-real time processing capability for quality assurance and data reduction, and will be performed on-summit using Graphics Processing Unit (GPU) technology. The VBI data processing pipeline (DPP) is the first designed and developed using the DKIST DHS components, and therefore provides insight into the strengths and weaknesses of the framework. In this paper we lay out the design of the VBI DPP, examine how the underlying DKIST DHS components are utilized, and discuss how integration of the DHS framework with GPUs was accomplished. We present our results of the VBI DPP alpha release implementation of the calibration, frame selection reduction, and quality assurance display processing nodes.
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Risk-based requirements management framework with applications to assurance cases
NASA Astrophysics Data System (ADS)
Feng, D.; Eyster, C.
The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.
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García-Peñalvo, Francisco J.; Pérez-Blanco, Jonás Samuel; Martín-Suárez, Ana
2014-01-01
This paper discusses how cloud-based architectures can extend and enhance the functionality of the training environments based on virtual worlds and how, from this cloud perspective, we can provide support to analysis of training processes in the area of health, specifically in the field of training processes in quality assurance for pharmaceutical laboratories, presenting a tool for data retrieval and analysis that allows facing the knowledge discovery in the happenings inside the virtual worlds. PMID:24778593
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Rydlund, Jr., Paul H.; Densmore, Brenda K.
2012-01-01
Geodetic surveys have evolved through the years to the use of survey-grade (centimeter level) global positioning to perpetuate and post-process vertical datum. The U.S. Geological Survey (USGS) uses Global Navigation Satellite Systems (GNSS) technology to monitor natural hazards, ensure geospatial control for climate and land use change, and gather data necessary for investigative studies related to water, the environment, energy, and ecosystems. Vertical datum is fundamental to a variety of these integrated earth sciences. Essentially GNSS surveys provide a three-dimensional position x, y, and z as a function of the North American Datum of 1983 ellipsoid and the most current hybrid geoid model. A GNSS survey may be approached with post-processed positioning for static observations related to a single point or network, or involve real-time corrections to provide positioning "on-the-fly." Field equipment required to facilitate GNSS surveys range from a single receiver, with a power source for static positioning, to an additional receiver or network communicated by radio or cellular for real-time positioning. A real-time approach in its most common form may be described as a roving receiver augmented by a single-base station receiver, known as a single-base real-time (RT) survey. More efficient real-time methods involving a Real-Time Network (RTN) permit the use of only one roving receiver that is augmented to a network of fixed receivers commonly known as Continually Operating Reference Stations (CORS). A post-processed approach in its most common form involves static data collection at a single point. Data are most commonly post-processed through a universally accepted utility maintained by the National Geodetic Survey (NGS), known as the Online Position User Service (OPUS). More complex post-processed methods involve static observations among a network of additional receivers collecting static data at known benchmarks. Both classifications provide users flexibility regarding efficiency and quality of data collection. Quality assurance of survey-grade global positioning is often overlooked or not understood and perceived uncertainties can be misleading. GNSS users can benefit from a blueprint of data collection standards used to ensure consistency among USGS mission areas. A classification of GNSS survey qualities provide the user with the ability to choose from the highest quality survey used to establish objective points with low uncertainties, identified as a Level I, to a GNSS survey for general topographic control without quality assurance, identified as a Level IV. A Level I survey is strictly limited to post-processed methods, whereas Level II, Level III, and Level IV surveys integrate variations of a RT approach. Among these classifications, techniques involving blunder checks and redundancy are important, and planning that involves the assessment of the overall satellite configuration, as well as terrestrial and space weather, are necessary to ensure an efficient and quality campaign. Although quality indicators and uncertainties are identified in post-processed methods using CORS, the accuracy of a GNSS survey is most effectively expressed as a comparison to a local benchmark that has a high degree of confidence. Real-time and post-processed methods should incorporate these "trusted" benchmarks as a check during any campaign. Global positioning surveys are expected to change rapidly in the future. The expansion of continuously operating reference stations, combined with newly available satellite signals, and enhancements to the conterminous geoid, are all sufficient indicators for substantial growth in real-time positioning and quality thereof.
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Quality Assurance in School Health
ERIC Educational Resources Information Center
Newell, Susan; Schoenike, Sumner L.; Lisko, Elaine A.
2003-01-01
School nurses need to become more influential administrators, managers, and entrepreneurs. They must learn to lead and collaborate effectively in designing, implementing, and evaluating coordinated school health programs. Quality assurance is an essential ingredient in this process that requires accurate, timely, and confidential incident…
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Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M
2009-07-01
The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.
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[Quality assurance in oncology: experiences of an ISO certification].
Szentirmay, Zoltán; Cseh, Lujza; Ottó, Szabolcs; Kásler, Miklós
2002-01-01
The ISO 9001 quality assurance of the National Institute of Oncology has been achieved successfully. We give an account of the brief history and the structure of the assurance system of the Institute, the process of setting our goals, and also the experience gained from drafting ISO 9001 handbook and flowcharts. Apart from the bureaucratic nature of quality assurance, it is a good opportunity for us to investigate our everyday work, put it into orderly manner and work more reliably. Experience has shown that the introduction of a quality assurance system increases the level of patient care, the documentation helps the Institute or some of its departments, or even individuals prevent law suits, and serves as a sound basis for proposing promotion, salary increases and bonuses, or even honors.
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Quality-assurance plan for water-resources activities of the U.S. Geological Survey in Idaho
Packard, F.A.
1996-01-01
To ensure continued confidence in its products, the Water Resources Division of the U.S. Geological Survey implemented a policy that all its scientific work be performed in accordance with a centrally managed quality-assurance program. This report establishes and documents a formal policy for current (1995) quality assurance within the Idaho District of the U.S. Geological Survey. Quality assurance is formalized by describing district organization and operational responsibilities, documenting the district quality-assurance policies, and describing district functions. The districts conducts its work through offices in Boise, Idaho Falls, Twin Falls, Sandpoint, and at the Idaho National Engineering Laboratory. Data-collection programs and interpretive studies are conducted by two operating units, and operational and technical assistance is provided by three support units: (1) Administrative Services advisors provide guidance on various personnel issues and budget functions, (2) computer and reports advisors provide guidance in their fields, and (3) discipline specialists provide technical advice and assistance to the district and to chiefs of various projects. The district's quality-assurance plan is based on an overall policy that provides a framework for defining the precision and accuracy of collected data. The plan is supported by a series of quality-assurance policy statements that describe responsibilities for specific operations in the district's program. The operations are program planning; project planning; project implementation; review and remediation; data collection; equipment calibration and maintenance; data processing and storage; data analysis, synthesis, and interpretation; report preparation and processing; and training. Activities of the district are systematically conducted under a hierarchy of supervision an management that is designed to ensure conformance with Water Resources Division goals quality assurance. The district quality-assurance plan does not describe detailed technical activities that are commonly termed "quality-control procedures." Instead, it focuses on current policies, operations, and responsibilities that are implemented at the management level. Contents of the plan will be reviewed annually and updated as programs and operations change.
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Bradshaw, Kelsey M.; Donohue, Brad; Wilks, Chelsey
2014-01-01
Errors have been found to frequently occur in the management of case records within mental health service systems. In cases involving interpersonal violence, such errors have been found to negatively impact service implementation and lead to significant trauma and fatalities. In an effort to ensure adherence to specified standards of care, quality assurance programs (QA) have been developed to monitor and enhance service implementation. These programs have generally been successful in facilitating record management. However, these systems are rarely disseminated, and not well integrated. Therefore, within the context of interpersonal violence, we provide an extensive review of evidence supported record keeping practices, and methods to assist in assuring these practices are implemented with adherence. PMID:24976786
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Conn, Kathleen E.; Huffman, Raegan L.; Barton, Cynthia
2017-05-08
In accordance with guidelines set forth by the Office of Water Quality in the Water Mission Area of the U.S. Geological Survey, a quality-assurance plan has been created for use by the Washington Water Science Center (WAWSC) in conducting water-quality activities. This qualityassurance plan documents the standards, policies, and procedures used by the WAWSC for activities related to the collection, processing, storage, analysis, and publication of water-quality data. The policies and procedures documented in this quality-assurance plan for water-quality activities complement the quality-assurance plans for surface-water and groundwater activities at the WAWSC.
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The development of a contract quality assurance program within the Virginia Department of Highways.
DOT National Transportation Integrated Search
1989-01-01
In order to assure the quality of construction products and processes, the Virginia Department of Transportation has established three levels of construction control. First, contractors themselves provide oversight and quality control as set out in t...
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10 CFR 71.121 - Internal inspection.
Code of Federal Regulations, 2013 CFR
2013-01-01
... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...
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10 CFR 71.121 - Internal inspection.
Code of Federal Regulations, 2012 CFR
2012-01-01
... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...
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10 CFR 71.121 - Internal inspection.
Code of Federal Regulations, 2011 CFR
2011-01-01
... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...
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10 CFR 71.121 - Internal inspection.
Code of Federal Regulations, 2014 CFR
2014-01-01
... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...
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10 CFR 71.121 - Internal inspection.
Code of Federal Regulations, 2010 CFR
2010-01-01
... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...
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2000-10-18
In the Training Auditorium at KSC, Brig. General Donald P. Pettit, commander of the 45th Space Wing, speaks to attendees at a presentation for Super Safety and Health Day. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Vendor tents and displays filled the grounds in the Industrial Area as well as LC 39 Area during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
Vendor tents and displays filled the grounds in the Industrial Area as well as LC 39 Area during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
During Super Safety and Health Day at KSC, workers from Florida Power and Light (at left) demonstrate to an interested group of KSC employees how they safely handle high power lines. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
In the Training Auditorium at KSC, Brig. General Donald P. Pettit, commander of the 45th Space Wing, speaks to attendees at a presentation for Super Safety and Health Day. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
During Super Safety and Health Day at KSC, workers from Florida Power and Light (at left) demonstrate to an interested group of KSC employees how they safely handle high power lines. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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Class Model Development Using Business Rules
NASA Astrophysics Data System (ADS)
Skersys, Tomas; Gudas, Saulius
New developments in the area of computer-aided system engineering (CASE) greatly improve processes of the information systems development life cycle (ISDLC). Much effort is put into the quality improvement issues, but IS development projects still suffer from the poor quality of models during the system analysis and design cycles. At some degree, quality of models that are developed using CASE tools can be assured using various. automated. model comparison, syntax. checking procedures. It. is also reasonable to check these models against the business domain knowledge, but the domain knowledge stored in the repository of CASE tool (enterprise model) is insufficient (Gudas et al. 2004). Involvement of business domain experts into these processes is complicated because non- IT people often find it difficult to understand models that were developed by IT professionals using some specific modeling language.
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High-level waste tank farm set point document
DOE Office of Scientific and Technical Information (OSTI.GOV)
Anthony, J.A. III
1995-01-15
Setpoints for nuclear safety-related instrumentation are required for actions determined by the design authorization basis. Minimum requirements need to be established for assuring that setpoints are established and held within specified limits. This document establishes the controlling methodology for changing setpoints of all classifications. The instrumentation under consideration involve the transfer, storage, and volume reduction of radioactive liquid waste in the F- and H-Area High-Level Radioactive Waste Tank Farms. The setpoint document will encompass the PROCESS AREA listed in the Safety Analysis Report (SAR) (DPSTSA-200-10 Sup 18) which includes the diversion box HDB-8 facility. In addition to the PROCESS AREASmore » listed in the SAR, Building 299-H and the Effluent Transfer Facility (ETF) are also included in the scope.« less
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The Columbia River Protection Supplemental Technologies Quality Assurance Project Plan
DOE Office of Scientific and Technical Information (OSTI.GOV)
Fix, N. J.
Pacific Northwest National Laboratory researchers are working on the Columbia River Protection Supplemental Technologies Project. This project is a U. S. Department of Energy, Office of Environmental Management-funded initiative designed to develop new methods, strategies, and technologies for characterizing, modeling, remediating, and monitoring soils and groundwater contaminated with metals, radionuclides, and chlorinated organics. This Quality Assurance Project Plan provides the quality assurance requirements and processes that will be followed by the Technologies Project staff.
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The Soils and Groundwater – EM-20 S&T Roadmap Quality Assurance Project Plan
DOE Office of Scientific and Technical Information (OSTI.GOV)
Fix, N. J.
The Soils and Groundwater – EM-20 Science and Technology Roadmap Project is a U.S. Department of Energy, Office of Environmental Management-funded initiative designed to develop new methods, strategies and technology for characterizing, modeling, remediating, and monitoring soils and groundwater contaminated with metals, radionuclides, and chlorinated organics. This Quality Assurance Project Plan provides the quality assurance requirements and processes that will be followed by EM-20 Roadmap Project staff.
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[The evolution of nursing record-keeping].
Didry, Pascale
2017-05-01
Nursing record-keeping forms an integral part of the provision of care. It helps to assure its traceability and monitoring. It also contributes to the circulation of information among the different players involved in the patient's treatment, thereby helping to assure the quality and safety of care. For nurses, whose professional history has its roots in a culture of oral communication, record-keeping represents the affirmation of a real nursing way of thinking. Copyright © 2017 Elsevier Masson SAS. All rights reserved.
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Quality assurance of qualitative research: a review of the discourse
2011-01-01
Background Increasing demand for qualitative research within global health has emerged alongside increasing demand for demonstration of quality of research, in line with the evidence-based model of medicine. In quantitative health sciences research, in particular clinical trials, there exist clear and widely-recognised guidelines for conducting quality assurance of research. However, no comparable guidelines exist for qualitative research and although there are long-standing debates on what constitutes 'quality' in qualitative research, the concept of 'quality assurance' has not been explored widely. In acknowledgement of this gap, we sought to review discourses around quality assurance of qualitative research, as a first step towards developing guidance. Methods A range of databases, journals and grey literature sources were searched, and papers were included if they explicitly addressed quality assurance within a qualitative paradigm. A meta-narrative approach was used to review and synthesise the literature. Results Among the 37 papers included in the review, two dominant narratives were interpreted from the literature, reflecting contrasting approaches to quality assurance. The first focuses on demonstrating quality within research outputs; the second focuses on principles for quality practice throughout the research process. The second narrative appears to offer an approach to quality assurance that befits the values of qualitative research, emphasising the need to consider quality throughout the research process. Conclusions The paper identifies the strengths of the approaches represented in each narrative and recommend these are brought together in the development of a flexible framework to help qualitative researchers to define, apply and demonstrate principles of quality in their research. PMID:22182674
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MRT fuel element inspection at Dounreay
DOE Office of Scientific and Technical Information (OSTI.GOV)
Gibson, J.
1997-08-01
To ensure that their production and inspection processes are performed in an acceptable manner, ie. auditable and traceable, the MTR Fuel Element Fabrication Plant at Dounreay operates to a documented quality system. This quality system, together with the fuel element manufacturing and inspection operations, has been independently certified to ISO9002-1987, EN29002-1987 and BS5750:Pt2:1987 by Lloyd`s Register Quality Assurance Limited (LRQA). This certification also provides dual accreditation to the relevant German, Dutch and Australian certification bodies. This paper briefly describes the quality system, together with the various inspection stages involved in the manufacture of MTR fuel elements at Dounreay.
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AMPK at the Nexus of Energetics and Aging
Burkewitz, Kristopher; Zhang, Yue; Mair, William B.
2014-01-01
When energy supply is low, organisms respond by slowing aging and increasing resistance to diverse age-related pathologies. Targeting the mechanisms underpinning this response may therefore treat multiple disorders through a single intervention. Here we discuss AMP-activated protein kinase (AMPK) as an integrator and mediator of several pathways and processes linking energetics to longevity. Activated by low energy, AMPK is both pro-longevity and druggable, but its role in some pathologies may not be beneficial. As such, activating AMPK may modulate multiple longevity pathways to promote healthy aging, but unlocking its full potential may require selective targeting towards substrates involved in longevity-assurance. PMID:24726383
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Ashar, B S; Dang, J M; Krause, D; Luke, M C
2011-12-01
The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.
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[Drug information for patients (Package Leaflets), and user testing in EU].
Yamamoto, Michiko; Doi, Hirohisa; Furukawa, Aya
2015-01-01
Patients and consumers have desired high quality drug information in their pharmacotherapy, and are entitled to receive it. It is desirable that the information should be aimed at shared decision-making between patients and healthcare professionals about medications. The quality of drug information available to patients should also be assured. With an aim to improve the quality of "Drug Guide for Patients", we investigated Patient Information Leaflets (PILs) which are approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) with regard to the criteria of development and user testing for assuring the quality of the PILs. In the European Union (EU), these are called Package Leaflets (PLs). PILs have been a legal requirement in the UK since 1999 for all medications. The user testing of PILs has been implemented as evidence since 2005 so that people can rely on the information provided in the leaflet. Execution of PILs which follow the guidance of the user testing, according to the guidance of this user testing, would reflect the views of patients. Here, we introduce the development process and implementation of user testing of PILs. In terms of readability, accessibility and understandability of drug information for patients, we need to discuss involving the public in decisions on how its quality should be assured and how it can be made easily be comprehensible for patients, in order to make effective use of "Drug Guide for Patients" in the future in Japan.
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Client-side Medical Image Colorization in a Collaborative Environment.
Virag, Ioan; Stoicu-Tivadar, Lăcrămioara; Crişan-Vida, Mihaela
2015-01-01
The paper presents an application related to collaborative medicine using a browser based medical visualization system with focus on the medical image colorization process and the underlying open source web development technologies involved. Browser based systems allow physicians to share medical data with their remotely located counterparts or medical students, assisting them during patient diagnosis, treatment monitoring, surgery planning or for educational purposes. This approach brings forth the advantage of ubiquity. The system can be accessed from a any device, in order to process the images, assuring the independence towards having a specific proprietary operating system. The current work starts with processing of DICOM (Digital Imaging and Communications in Medicine) files and ends with the rendering of the resulting bitmap images on a HTML5 (fifth revision of the HyperText Markup Language) canvas element. The application improves the image visualization emphasizing different tissue densities.
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Nuclear Technology Series. Course 31: Quality-Assurance Practices.
ERIC Educational Resources Information Center
Center for Occupational Research and Development, Inc., Waco, TX.
This technical specialty course is one of thirty-five courses designed for use by two-year postsecondary institutions in five nuclear technician curriculum areas: (1) radiation protection technician, (2) nuclear instrumentation and control technician, (3) nuclear materials processing technician, (4) nuclear quality-assurance/quality-control…
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The 300 Area Integrated Field Research Challenge Quality Assurance Project Plan
DOE Office of Scientific and Technical Information (OSTI.GOV)
Fix, N. J.
Pacific Northwest National Laboratory and a group of expert collaborators are using the U.S. Department of Energy Hanford Site 300 Area uranium plume within the footprint of the 300-FF-5 groundwater operable unit as a site for an Integrated Field-Scale Subsurface Research Challenge (IFRC). The IFRC is entitled Multi-Scale Mass Transfer Processes Controlling Natural Attenuation and Engineered Remediation: An IFRC Focused on the Hanford Site 300 Area Uranium Plume Project. The theme is investigation of multi-scale mass transfer processes. A series of forefront science questions on mass transfer are posed for research that relate to the effect of spatial heterogeneities; themore » importance of scale; coupled interactions between biogeochemical, hydrologic, and mass transfer processes; and measurements/approaches needed to characterize and model a mass transfer-dominated system. This Quality Assurance Project Plan provides the quality assurance requirements and processes that will be followed by the 300 Area IFRC Project. This plan is designed to be used exclusively by project staff.« less
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Badrick, Tony; Graham, Peter
2018-03-28
Internal Quality Control and External Quality Assurance are separate but related processes that have developed independently in laboratory medicine over many years. They have different sample frequencies, statistical interpretations and immediacy. Both processes have evolved absorbing new understandings of the concept of laboratory error, sample material matrix and assay capability. However, we do not believe at the coalface that either process has led to much improvement in patient outcomes recently. It is the increasing reliability and automation of analytical platforms along with improved stability of reagents that has reduced systematic and random error, which in turn has minimised the risk of running less frequent IQC. We suggest that it is time to rethink the role of both these processes and unite them into a single approach using an Average of Normals model supported by more frequent External Quality Assurance samples. This new paradigm may lead to less confusion for laboratory staff and quicker responses to and identification of out of control situations.
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Improving quality: bridging the health sector divide.
Pringle, Mike
2003-12-01
All too often, quality assurance looks at just one small part of the complex system that is health care. However, evidently each individual patient has one set of experiences and outcomes, often involving a range of health professionals in a number of settings across multiple sectors. In order to solve the problems of this complexity, we need to establish high-quality electronic recording in each of the settings. In the UK, primary care has been leading the way in adopting information technology and can now use databases for individual clinical care, for quality assurance using significant event and conventional auditing, and for research. Before we can understand and quality-assure the whole health care system, we need electronic patient records in all settings and good communication to build a summary electronic health record for each patient. Such an electronic health record will be under the control of the patient concerned, will be shared with the explicit consent of the patient, and will form the vehicle for quality assurance across all sectors of the health service.
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Proposed reliability cost model
NASA Technical Reports Server (NTRS)
Delionback, L. M.
1973-01-01
The research investigations which were involved in the study include: cost analysis/allocation, reliability and product assurance, forecasting methodology, systems analysis, and model-building. This is a classic example of an interdisciplinary problem, since the model-building requirements include the need for understanding and communication between technical disciplines on one hand, and the financial/accounting skill categories on the other. The systems approach is utilized within this context to establish a clearer and more objective relationship between reliability assurance and the subcategories (or subelements) that provide, or reenforce, the reliability assurance for a system. Subcategories are further subdivided as illustrated by a tree diagram. The reliability assurance elements can be seen to be potential alternative strategies, or approaches, depending on the specific goals/objectives of the trade studies. The scope was limited to the establishment of a proposed reliability cost-model format. The model format/approach is dependent upon the use of a series of subsystem-oriented CER's and sometimes possible CTR's, in devising a suitable cost-effective policy.
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NASA Technical Reports Server (NTRS)
Plante, Jeannete
2010-01-01
GEIA-STD-0005-1 defines the objectives of, and requirements for, documenting processes that assure customers and regulatory agencies that AHP electronic systems containing lead-free solder, piece parts, and boards will satisfy the applicable requirements for performance, reliability, airworthiness, safety, and certify-ability throughout the specified life of performance. It communicates requirements for a Lead-Free Control Plan (LFCP) to assist suppliers in the development of their own Plans. The Plan documents the Plan Owner's (supplier's) processes, that assure their customer, and all other stakeholders that the Plan owner's products will continue to meet their requirements. The presentation reviews quality assurance requirements traceability and LFCP template instructions.
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Management of government quality assurance functions for NASA contracts
NASA Technical Reports Server (NTRS)
1993-01-01
This handbook sets forth requirements for NASA direction and management of government quality assurance functions performed for NASA contracts and is applicable to all NASA installations. These requirements will standardize management to provide the minimum oversight and effective use of resources. This handbook implements Federal Acquisition Regulation (FAR) Part 46, NASA FAR Supplement 18-46, Quality Assurance, and NMI 7410.1. Achievement of established quality and reliability goals at all levels is essential to the success of NASA programs. Active participation by NASA and other agency quality assurance personnel in all phases of contract operations, including precontract activity, will assist in the economic and timely achievement of program results. This involves broad participation in design, development, procurement, inspection, testing, and preventive and corrective actions. Consequently, government, as well as industry, must place strong emphasis on the accomplishment of all functions having a significant bearing on quality and reliability from program initiation through end-use of supplies and services produced. For purposes of implementing NASA and other agency agreements, and to provide for uniformity and consistency, the terminology and definitions prescribed herein and in a future handbook shall be utilized for all NASA quality assurance delegations and subsequent redelegations.
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Management of government quality assurance functions for NASA contracts
NASA Astrophysics Data System (ADS)
1993-04-01
This handbook sets forth requirements for NASA direction and management of government quality assurance functions performed for NASA contracts and is applicable to all NASA installations. These requirements will standardize management to provide the minimum oversight and effective use of resources. This handbook implements Federal Acquisition Regulation (FAR) Part 46, NASA FAR Supplement 18-46, Quality Assurance, and NMI 7410.1. Achievement of established quality and reliability goals at all levels is essential to the success of NASA programs. Active participation by NASA and other agency quality assurance personnel in all phases of contract operations, including precontract activity, will assist in the economic and timely achievement of program results. This involves broad participation in design, development, procurement, inspection, testing, and preventive and corrective actions. Consequently, government, as well as industry, must place strong emphasis on the accomplishment of all functions having a significant bearing on quality and reliability from program initiation through end-use of supplies and services produced. For purposes of implementing NASA and other agency agreements, and to provide for uniformity and consistency, the terminology and definitions prescribed herein and in a future handbook shall be utilized for all NASA quality assurance delegations and subsequent redelegations.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Fix, N. J.
The scope of the Fluor Hanford, Inc. Groundwater and Technical Integration Support (Master Project) is to provide technical and integration support to Fluor Hanford, Inc., including operable unit investigations at 300-FF-5 and other groundwater operable units, strategic integration, technical integration and assessments, remediation decision support, and science and technology. This Quality Assurance Management Plan provides the quality assurance requirements and processes that will be followed by the Fluor Hanford, Inc. Groundwater and Technical Integration Support (Master Project).
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CERT Resilience Management Model - Mail-Specific Process Areas: Mail Revenue Assurance (Version 1.0)
2014-08-01
Revenue Assurance ( MRA ), Mail Transportation (MT), and Mail Delivery (MD)—were accepted by the USPIS, as well as an initial draft of the MRA PA...versions of two complete PAs, MI [Allen 2014b] and MRA , were accepted by the USPIS. Following this initial effort, the USPIS asked CERT to extend the...Revenue Assurance ( MRA ) is to ensure that the USPS is compensated for all mail that is accepted, transported, and delivered. Outline MRA:SG1
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Quality assurance program requirements, Amendment 5 (9-26-79) to August 1973 issue
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
This standard sets forth general requirements for planning, managing, conducting, and evaluating quality assurance programs for reactor development and test facility projects and associated processes, structures, components, and systems. These quality assurance requirements are based on proven practices and provide the means of control and verification whereby those responsible fo poject management can assure that the quality required for safe, reliable, and economical operation will be achieved. The objective of the program of the programs covered by this standard is to assure that structures, components, systems, and facilities are designed, developed, manufactured, constructed, operated, and maintained in compliance with establishedmore » engineering criteria. To achieve this objective, controls are to be established and implemented at predetermined points, and necessary action taken to prevent, detect, and correct any deficiencies.« less
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Perera, D P; Andrades, Marie; Wass, Val
2017-12-08
The International Membership Examination (MRCGP[INT]) of the Royal College of General Practitioners UK is a unique collaboration between four South Asian countries with diverse cultures, epidemiology, clinical facilities and resources. In this setting good quality assurance is imperative to achieve acceptable standards of inter rater reliability. This study aims to explore the process of peer feedback for examiner quality assurance with regard to factors affecting the implementation and acceptance of the method. A sequential mixed methods approach was used based on focus group discussions with examiners (n = 12) and clinical examination convenors who acted as peer reviewers (n = 4). A questionnaire based on emerging themes and literature review was then completed by 20 examiners at the subsequent OSCE exam. Qualitative data were analysed using an iterative reflexive process. Quantitative data were integrated by interpretive analysis looking for convergence, complementarity or dissonance. The qualitative data helped understand the issues and informed the process of developing the questionnaire. The quantitative data allowed for further refining of issues, wider sampling of examiners and giving voice to different perspectives. Examiners stated specifically that peer feedback gave an opportunity for discussion, standardisation of judgments and improved discriminatory abilities. Interpersonal dynamics, hierarchy and perception of validity of feedback were major factors influencing acceptance of feedback. Examiners desired increased transparency, accountability and the opportunity for equal partnership within the process. The process was stressful for examiners and reviewers; however acceptance increased with increasing exposure to receiving feedback. The process could be refined to improve acceptability through scrupulous attention to training and selection of those giving feedback to improve the perceived validity of feedback and improved reviewer feedback skills to enable better interpersonal dynamics and a more equitable feedback process. It is important to highlight the role of quality assurance and peer feedback as a tool for continuous improvement and maintenance of standards to examiners during training. Examiner quality assurance using peer feedback was generally a successful and accepted process. The findings highlight areas for improvement and guide the path towards a model of feedback that is responsive to examiner views and cultural sensibilities.
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WE-E-BRD-01: HDR Brachytherapy I: Overview of Clinical Application and QA
DOE Office of Scientific and Technical Information (OSTI.GOV)
Libby, B; Showalter, T
2014-06-15
With the increased usage of high dose rate (HDR) brachytherapy and the introduction of dedicated image guided brachytherapy suites, it is necessary to review the processes and procedures associated with safely delivering these treatments in the expedited time scales that dedicated treatment suites afford. The speakers will present the clinical aspects of switching from LDR to HDR treatments, including guidelines for patient selection, and the clinical outcomes comparing LDR to HDR. The speakers will also discuss the HDR treatment process itself, because the shortened clinical timeline involved with a streamlined scan/plan/treat workflow can introduce other issues. Safety and QA aspectsmore » involved with the streamlined process, including increased personnel required for parallel tasks, and possible interfering tasks causing delays in patient treatments will also be discussed. Learning Objectives: To understand the clinical aspects of HDR Brachytherapy, including common clinical indications, patient selection, and the evolving evidence in support of this therapeutic modality To review the current prominent clinical trials for HDR brachytherapy To interpret the established guidelines for HDR brachytherapy quality assurance for implementation into practical clinical settings. To introduce the basic requirements for image guided brachytherapy.« less
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[Quality assurance of rehabilitation by the German pension insurance: an overview].
Klosterhuis, H; Baumgarten, E; Beckmann, U; Erbstösser, S; Lindow, B; Naumann, B; Widera, T; Zander, J
2010-12-01
The German pension insurance has in recent years developed a comprehensive programme for quality assurance in rehabilitation, and has implemented the programme into routine practice. Different aspects of rehabilitation are evaluated with differentiated instruments. Issues dealt with inter alia include the quality of rehabilitative care in a narrower sense, the structure and organisation of the rehabilitation centres, as well as quality from the patients' perspective. On the whole, positive results predominate. Big differences in quality however have been found between the rehabilitation centres. The data collections and data evaluations carried out make a continuous process of quality assurance reporting possible for use by rehabilitation centres and pension insurance agencies. This will enable targeted initiatives for quality improvement. The methods and procedures of quality assurance are enhanced at regular intervals, and the scope of quality assurance is extended. Thus, rehab quality assurance is also expanded to cover ambulant rehabilitation or rehabilitation of children and young people. © Georg Thieme Verlag KG Stuttgart · New York.
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Quality Assurance in American and British Higher Education: A Comparison.
ERIC Educational Resources Information Center
Stanley, Elizabeth C.; Patrick, William J.
1998-01-01
Compares quality improvement and accountability processes in the United States and United Kingdom. For the United Kingdom, looks at quality audits, institutional assessment, standards-based quality assurance, and research assessment; in the United States, looks at regional and specialized accreditation, performance indicator systems, academic…
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THE LAKE MICHIGAN MASS BALANCE PROJECT: QUALITY ASSURANCE PLAN FOR MATHEMATICAL MODELLING
This report documents the quality assurance process for the development and application of the Lake Michigan Mass Balance Models. The scope includes the overall modeling framework as well as the specific submodels that are linked to form a comprehensive synthesis of physical, che...
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32 CFR 322.4 - Responsibilities.
Code of Federal Regulations, 2010 CFR
2010-07-01
... determination to the NSA/CSS Appeal Authority. (iv) Assure the timeliness of responses. (5) Receive, process and...) Advise the requester of the Agency's decision. (iv) Notify the requester of any adverse determination... decision is made in favor of a requester. (vi) Assure the timeliness of responses. (6) Ensure that Agency...
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ERIC Educational Resources Information Center
Gulikers, Judith T. M.; Baartman, Liesbeth K. J.; Biemans, Harm J. A.
2010-01-01
Schools are held more responsible for evaluating, quality assuring and improving their student assessments. Teachers' lack of understanding of new, competence-based assessments as well as the lack of key stakeholders' involvement, hamper effective and efficient self-evaluations by teachers of innovative, competence-based assessments (CBAs). While…
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Malkoske, Kyle; Nielsen, Michelle; Brown, Erika
The Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) have worked together in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment and technologies, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. Early community engagement and uptake survey data showed 70% of Canadian centers are part of this process and that the data in the guideline documents reflect, and are influencing the way Canadian radiation treatmentmore » centres run their technical quality control programs. As the TQC development framework matured as a cross-country initiative, guidance documents have been developed in many clinical technologies. Recently, there have been new TQC documents initiated for Gamma Knife and Cyberknife technologies where the entire communities within Canada are involved in the review process. At the same time, QARSAC reviewed the suite as a whole for the first time and it was found that some tests and tolerances overlapped across multiple documents as single tests could pertain to multiple quality control areas. The work to streamline the entire suite has allowed for improved usability of the suite while keeping the integrity of single quality control areas. The suite will be published by the JACMP, in the coming year.« less
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Software Quality Assurance Metrics
NASA Technical Reports Server (NTRS)
McRae, Kalindra A.
2004-01-01
Software Quality Assurance (SQA) is a planned and systematic set of activities that ensures conformance of software life cycle processes and products conform to requirements, standards and procedures. In software development, software quality means meeting requirements and a degree of excellence and refinement of a project or product. Software Quality is a set of attributes of a software product by which its quality is described and evaluated. The set of attributes includes functionality, reliability, usability, efficiency, maintainability, and portability. Software Metrics help us understand the technical process that is used to develop a product. The process is measured to improve it and the product is measured to increase quality throughout the life cycle of software. Software Metrics are measurements of the quality of software. Software is measured to indicate the quality of the product, to assess the productivity of the people who produce the product, to assess the benefits derived from new software engineering methods and tools, to form a baseline for estimation, and to help justify requests for new tools or additional training. Any part of the software development can be measured. If Software Metrics are implemented in software development, it can save time, money, and allow the organization to identify the caused of defects which have the greatest effect on software development. The summer of 2004, I worked with Cynthia Calhoun and Frank Robinson in the Software Assurance/Risk Management department. My task was to research and collect, compile, and analyze SQA Metrics that have been used in other projects that are not currently being used by the SA team and report them to the Software Assurance team to see if any metrics can be implemented in their software assurance life cycle process.
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Neuderth, S; Lukasczik, M; Musekamp, G; Gerlich, C; Saupe-Heide, M; Löbmann, R; Vogel, H
2013-02-01
There so far is no standardized program for external quality assurance in inpatient parent-child prevention and rehabilitation in Germany. Therefore, instruments and methods of external quality assurance were developed and evaluated on behalf of the federal-level health insurance institutions. On the level of structure quality, a modular questionnaire for assessing structural features of rehabilitation/prevention centers, basic and allocation criteria as well as a checklist for visitations were developed. Structural data were collected in a nationwide survey of parent-child prevention and rehabilitation centers. Process and outcome quality data were collected in n=38 centers. Process quality was assessed using multiple methods (process-related structural features, case-related routine documentation, and incident-related patient questionnaires). Outcome quality was measured via patient questionnaires (n=1 799 patients). We used a multi-level modelling approach by adjusting relevant confounders on institutional and patient levels. The methods, instruments and analyzing procedures developed for measuring quality on the level of structure, processes and outcomes were adjusted in cooperation with all relevant stakeholders. Results are exemplarily presented for all quality assurance tools. For most of the risk-adjusted outcome parameters, we found no significant differences between institutions. For the first time, a comprehensive, standardized and generally applicable set of methods and instruments for routine use in comparative quality measurement of inpatient parent-child prevention and rehabilitation is available. However, it should be considered that the very heterogeneous field of family-oriented measures can not be covered entirely by an external quality assurance program. Therefore, methods and instruments have to be adapted continuously to the specifics of this area of health care and to new developments. © Georg Thieme Verlag KG Stuttgart · New York.
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NASA Astrophysics Data System (ADS)
Miner, E. D.
2004-11-01
The great emphasis on assuring that the nation's students become competent in reading and writing has led in many US states to the elimination of science teaching in the lower elementary grades. This in turn has led to an ever-decreasing understanding of science by students, as well as a corresponding drop in those who choose scientific careers. One method of attacking this problem is to include scientific content in the reading and writing curriculum. The Cassini Mission has funded an initiative which has included the Bay Area Writing Project, Project FIRST (Foundations In Reading trough Science and Technology), and CAPSI (Caltech Pre-college Science Initiative) in writing such a science-based reading and writing curriculum, entitled "Reading, Writing and Rings." The author worked closely with one of the primary writers to assure that the content was scientifically accurate, serving in the process as an educator-mentor for the curriculum writer. This paper discusses that interaction, shows the finished product, and documents some of the results from beta testing in elementary schools in Victorville and Oakland, California, as well as in other classrooms in the San Francisco Bay Area. This type of involvement in education and public outreach utilizes the respective strengths of both the scientific and educational communities and can serve as a model for effective interaction between the two. More information on the product is available at the website listed below.
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Assuring Quality in Large-Scale Online Course Development
ERIC Educational Resources Information Center
Parscal, Tina; Riemer, Deborah
2010-01-01
Student demand for online education requires colleges and universities to rapidly expand the number of courses and programs offered online while maintaining high quality. This paper outlines two universities respective processes to assure quality in large-scale online programs that integrate instructional design, eBook custom publishing, Quality…
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Quality Assurance, Open and Distance Learning, and Australian Universities
ERIC Educational Resources Information Center
Reid, Ian C.
2005-01-01
Open and distance education has integrated quality assurance processes since its inception. Recently, the increased use of distance teaching systems, technologies, and pedagogies by universities without a distance education heritage has enabled them to provide flexible learning opportunities. They have done this in addition to, or instead of,…
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42 CFR 423.128 - Dissemination of Part D plan information.
Code of Federal Regulations, 2010 CFR
2010-10-01
... tiered formulary structure and utilization management procedures used) functions; (iii) The process for... under § 423.564 et. seq. (8) Quality assurance policies and procedures. A description of the quality assurance policies and procedures required under § 423.153(c), as well as the medication therapy management...
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Nuclear Technology Series. Course 14: Introduction to Quality Assurance/Quality Control.
ERIC Educational Resources Information Center
Technical Education Research Center, Waco, TX.
This technical specialty course is one of thirty-five courses designed for use by two-year postsecondary institutions in five nuclear technician curriculum areas: (1) radiation protection technician, (2) nuclear instrumentation and control technician, (3) nuclear materials processing technician, (4) nuclear quality-assurance/quality-control…
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U.S. Geological Survey quality-assurance plan for surface-water activities in Kansas, 2015
Painter, Colin C.; Loving, Brian L.
2015-01-01
This Surface Water Quality-Assurance Plan documents the standards, policies, and procedures used by the Kansas Water Science Center (KSWSC) of the U.S. Geological Survey (USGS) for activities related to the collection, processing, storage, analysis, and publication of surface-water data.
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Quality Assurance in Distance and Open Learning
ERIC Educational Resources Information Center
Mahafzah, Mohammed Hasan
2012-01-01
E-learning has become an increasingly important teaching and learning mode in educational institutions and corporate training. The evaluation of E-learning, however, is essential for the quality assurance of E-learning courses. This paper constructs a three-phase evaluation model for E-learning courses, which includes development, process, and…
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Case for Quality Assurance in ESP [English For Specific Purposes] Programmes.
ERIC Educational Resources Information Center
Tan San Yee, Christine
There is now a need, just like in industry, for quality assurance in education, for injecting systematically planned and formal processes, precise definitions, objectivity, and measurability in education. The demand for educational excellence in industry is "out there," and companies in more advanced countries are partnering educational…
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16 CFR 1107.21 - Periodic testing.
Code of Federal Regulations, 2012 CFR
2012-01-01
... samples selected for testing pass the test, there is a high degree of assurance that the other untested... determining the testing interval include, but are not limited to, the following: (i) High variability in test... process management techniques and tests provide a high degree of assurance of compliance if they are not...
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16 CFR § 1107.21 - Periodic testing.
Code of Federal Regulations, 2013 CFR
2013-01-01
... samples selected for testing pass the test, there is a high degree of assurance that the other untested... determining the testing interval include, but are not limited to, the following: (i) High variability in test... process management techniques and tests provide a high degree of assurance of compliance if they are not...
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16 CFR 1107.21 - Periodic testing.
Code of Federal Regulations, 2014 CFR
2014-01-01
... samples selected for testing pass the test, there is a high degree of assurance that the other untested... determining the testing interval include, but are not limited to, the following: (i) High variability in test... process management techniques and tests provide a high degree of assurance of compliance if they are not...
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Collaborative Provision Quality Assurance Isn't Just Red Tape …
ERIC Educational Resources Information Center
Hughes, Claire; Thomas, Helen
2017-01-01
This paper discusses some research which was undertaken to explore perceptions around quality assurance within collaborative partnership (CP) working, from a range of internal and external stakeholders. The responses we received are being used to enhance policy and processes and inform the development of guidance materials to support all…
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ERIC Educational Resources Information Center
Walsh, Patrick L.
1982-01-01
The Educational Quality Assessment and Assurance System for continuing education in health sciences includes three components to measure inputs, processes, and outcomes. They are (1) Program Coordinator Competency List, (2) Quality Assessment and Assurance Program, and (3) evaluation of educational programs. (SK)
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NASA Astrophysics Data System (ADS)
Compton, Senja V.; Compton, David A.
1989-12-01
Recently, the area of food analysis and product safety has become of major concern to consumers. Therefore, companies involved in the quality assurance of theirproducts have been encouraged to perform extensive analyses to guarantee safety and satisfaction. One of the largest consumer products in the beverage marketplace is coffee. Much emphasis has been placed upon the safety of the decaffeination processes used by various manufacturers; these involve extraction of the caffeine by a solvent system that may be aqueous or organic, and is sometimes,super-critical. Additionally, aroma (fragrance) of brewing coffee has been found to be of major concern to the individual by the marketing departments of the coffee companies. The heads ace analysis of coffees can be used to discover the species retained after the decaffeination of coffee, as well as to distinguish the volatile species released upon treatment of the coffee at boiling water temperatures.
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Transdisciplinary Research and Evaluation for Community Health Initiatives
Harper, Gary W.; Neubauer, Leah C.; Bangi, Audrey K.; Francisco, Vincent T.
2010-01-01
Transdisciplinary research and evaluation projects provide valuable opportunities to collaborate on interventions to improve the health and well-being of individuals and communities. Given team members’ diverse backgrounds and roles or responsibilities in such projects, members’ perspectives are significant in strengthening a project’s infrastructure and improving its organizational functioning. This article presents an evaluation mechanism that allows team members to express the successes and challenges incurred throughout their involvement in a multisite transdisciplinary research project. Furthermore, their feedback is used to promote future sustainability and growth. Guided by a framework known as organizational development, the evaluative process was conducted by a neutral entity, the Quality Assurance Team. A mixed-methods approach was utilized to garner feedback and clarify how the research project goals could be achieved more effectively and efficiently. The multiple benefits gained by those involved in this evaluation and implications for utilizing transdisciplinary research and evaluation teams for health initiatives are detailed. PMID:18936267
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Statistical auditing of toxicology reports.
Deaton, R R; Obenchain, R L
1994-06-01
Statistical auditing is a new report review process used by the quality assurance unit at Eli Lilly and Co. Statistical auditing allows the auditor to review the process by which the report was generated, as opposed to the process by which the data was generated. We have the flexibility to use different sampling techniques and still obtain thorough coverage of the report data. By properly implementing our auditing process, we can work smarter rather than harder and continue to help our customers increase the quality of their products (reports). Statistical auditing is helping our quality assurance unit meet our customers' need, while maintaining or increasing the quality of our regulatory obligations.
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Latysh, Natalie E.; Wetherbee, Gregory A.
2007-01-01
The U.S. Geological Survey (USGS) Branch of Quality Systems operates external quality assurance programs for the National Atmospheric Deposition Program/Mercury Deposition Network (NADP/MDN). Beginning in 2004, three programs have been implemented: the system blank program, the interlaboratory comparison program, and the blind audit program. Each program was designed to measure error contributed by specific components in the data-collection process. The system blank program assesses contamination that may result from sampling equipment, field exposure, and routine handling and processing of the wet-deposition samples. The interlaboratory comparison program evaluates bias and precision of analytical results produced by the Mercury Analytical Laboratory (HAL) for the NADP/MDN, operated by Frontier GeoSciences, Inc. The HAL's performance is compared with the performance of five other laboratories. The blind audit program assesses bias and variability of MDN data produced by the HAL using solutions disguised as environmental samples to ascertain true laboratory performance. This report documents the implementation of quality assurance procedures for the NADP/MDN and the operating procedures for each of the external quality assurance programs conducted by the USGS. The USGS quality assurance information provides a measure of confidence to NADP/MDN data users that measurement variability is distinguished from environmental signals.
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Food fortification: issues on quality assurance and impact evaluation in developing countries.
Florentino, R
2003-01-01
Quality assurance and impact evaluation are essential components of a food fortification program and should be integrated in the fortification process. Quality assurance will ensure that the micronutrient meant to be delivered is indeed reaching the target population at the correct level. Impact evaluation will determine the effectiveness of food fortification as a strategy in controlling micronutrient deficiency and enable program planners to make decisions on the future of the program. In developing countries, both quality assurance and impact evaluation are often constrained not only by inadequacy of facilities as well as financial and manpower resources, but by unclear definition of objectives and inappropriate design. It is therefore necessary to consider the target audience for the quality assurance monitoring and impact evaluation in order to clearly define their objectives and in turn suit the design to these objectives, at the same time as the limitations in financial and manpower resources are considered.
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Mission Assurance Modeling and Simulation: A Cyber Security Roadmap
NASA Technical Reports Server (NTRS)
Gendron, Gerald; Roberts, David; Poole, Donold; Aquino, Anna
2012-01-01
This paper proposes a cyber security modeling and simulation roadmap to enhance mission assurance governance and establish risk reduction processes within constrained budgets. The term mission assurance stems from risk management work by Carnegie Mellon's Software Engineering Institute in the late 19905. By 2010, the Defense Information Systems Agency revised its cyber strategy and established the Program Executive Officer-Mission Assurance. This highlights a shift from simply protecting data to balancing risk and begins a necessary dialogue to establish a cyber security roadmap. The Military Operations Research Society has recommended a cyber community of practice, recognizing there are too few professionals having both cyber and analytic experience. The authors characterize the limited body of knowledge in this symbiotic relationship. This paper identifies operational and research requirements for mission assurance M&S supporting defense and homeland security. M&S techniques are needed for enterprise oversight of cyber investments, test and evaluation, policy, training, and analysis.
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[Quality assurance systems and occupational medicine system: an history twenty years along].
Apostoli, Pietro
2014-01-01
Along the last tventy years, in our country the quality assurance systems and the occupational medicine deeply interacted both in theoretical and practical fields of interest at three levels: (i) the need of preventive and therefore of occupational medicine in quality assurance systems; (ii) the need on reverse of quality in prevention and occupational mnedicine mainly in qualification and updating process; (iii) the evidence, proofs of efficacy or appropriateness of different preventive procedures and occupational physician activities; (iv) the connection with European and national legal directives and with technical or good practice norms. Finally we discuss about the role of occupational physician as the global consultant for enterprise, as a mandatory strategic technical figure in a typical multidisciplinary processes as the implementation of the quality systems.
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Pdsg1 and Pdsg2, Novel Proteins Involved in Developmental Genome Remodelling in Paramecium
Hoehener, Cristina; Singh, Aditi; Swart, Estienne C.; Nowacki, Mariusz
2014-01-01
The epigenetic influence of maternal cells on the development of their progeny has long been studied in various eukaryotes. Multicellular organisms usually provide their zygotes not only with nutrients but also with functional elements required for proper development, such as coding and non-coding RNAs. These maternally deposited RNAs exhibit a variety of functions, from regulating gene expression to assuring genome integrity. In ciliates, such as Paramecium these RNAs participate in the programming of large-scale genome reorganization during development, distinguishing germline-limited DNA, which is excised, from somatic-destined DNA. Only a handful of proteins playing roles in this process have been identified so far, including typical RNAi-derived factors such as Dicer-like and Piwi proteins. Here we report and characterize two novel proteins, Pdsg1 and Pdsg2 (Paramecium protein involved in Development of the Somatic Genome 1 and 2), involved in Paramecium genome reorganization. We show that these proteins are necessary for the excision of germline-limited DNA during development and the survival of sexual progeny. Knockdown of PDSG1 and PDSG2 genes affects the populations of small RNAs known to be involved in the programming of DNA elimination (scanRNAs and iesRNAs) and chromatin modification patterns during development. Our results suggest an association between RNA-mediated trans-generational epigenetic signal and chromatin modifications in the process of Paramecium genome reorganization. PMID:25397898
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Pdsg1 and Pdsg2, novel proteins involved in developmental genome remodelling in Paramecium.
Arambasic, Miroslav; Sandoval, Pamela Y; Hoehener, Cristina; Singh, Aditi; Swart, Estienne C; Nowacki, Mariusz
2014-01-01
The epigenetic influence of maternal cells on the development of their progeny has long been studied in various eukaryotes. Multicellular organisms usually provide their zygotes not only with nutrients but also with functional elements required for proper development, such as coding and non-coding RNAs. These maternally deposited RNAs exhibit a variety of functions, from regulating gene expression to assuring genome integrity. In ciliates, such as Paramecium these RNAs participate in the programming of large-scale genome reorganization during development, distinguishing germline-limited DNA, which is excised, from somatic-destined DNA. Only a handful of proteins playing roles in this process have been identified so far, including typical RNAi-derived factors such as Dicer-like and Piwi proteins. Here we report and characterize two novel proteins, Pdsg1 and Pdsg2 (Paramecium protein involved in Development of the Somatic Genome 1 and 2), involved in Paramecium genome reorganization. We show that these proteins are necessary for the excision of germline-limited DNA during development and the survival of sexual progeny. Knockdown of PDSG1 and PDSG2 genes affects the populations of small RNAs known to be involved in the programming of DNA elimination (scanRNAs and iesRNAs) and chromatin modification patterns during development. Our results suggest an association between RNA-mediated trans-generational epigenetic signal and chromatin modifications in the process of Paramecium genome reorganization.
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Complex and differential glial responses in Alzheimer's disease and ageing.
Rodríguez, José J; Butt, Arthur M; Gardenal, Emanuela; Parpura, Vladimir; Verkhratsky, Alexei
2016-01-01
Glial cells and their association with neurones are fundamental for brain function. The emergence of complex neurone-glial networks assures rapid information transfer, creating a sophisticated circuitry where both types of neural cells work in concert, serving different activities. All glial cells, represented by astrocytes, oligodendrocytes, microglia and NG2-glia, are essential for brain homeostasis and defence. Thus, glia are key not only for normal central nervous system (CNS) function, but also to its dysfunction, being directly associated with all forms of neuropathological processes. Therefore, the progression and outcome of neurological and neurodegenerative diseases depend on glial reactions. In this review, we provide a concise account of recent data obtained from both human material and animal models demonstrating the pathological involvement of glia in neurodegenerative processes, including Alzheimer's disease (AD), as well as physiological ageing.
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Technology and Tool Development to Support Safety and Mission Assurance
NASA Technical Reports Server (NTRS)
Denney, Ewen; Pai, Ganesh
2017-01-01
The Assurance Case approach is being adopted in a number of safety-mission-critical application domains in the U.S., e.g., medical devices, defense aviation, automotive systems, and, lately, civil aviation. This paradigm refocuses traditional, process-based approaches to assurance on demonstrating explicitly stated assurance goals, emphasizing the use of structured rationale, and concrete product-based evidence as the means for providing justified confidence that systems and software are fit for purpose in safely achieving mission objectives. NASA has also been embracing assurance cases through the concepts of Risk Informed Safety Cases (RISCs), as documented in the NASA System Safety Handbook, and Objective Hierarchies (OHs) as put forth by the Agency's Office of Safety and Mission Assurance (OSMA). This talk will give an overview of the work being performed by the SGT team located at NASA Ames Research Center, in developing technologies and tools to engineer and apply assurance cases in customer projects pertaining to aviation safety. We elaborate how our Assurance Case Automation Toolset (AdvoCATE) has not only extended the state-of-the-art in assurance case research, but also demonstrated its practical utility. We have successfully developed safety assurance cases for a number of Unmanned Aircraft Systems (UAS) operations, which underwent, and passed, scrutiny both by the aviation regulator, i.e., the FAA, as well as the applicable NASA boards for airworthiness and flight safety, flight readiness, and mission readiness. We discuss our efforts in expanding AdvoCATE capabilities to support RISCs and OHs under a project recently funded by OSMA under its Software Assurance Research Program. Finally, we speculate on the applicability of our innovations beyond aviation safety to such endeavors as robotic, and human spaceflight.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Kodaira, S., E-mail: koda@nirs.go.jp; Kurano, M.; Hosogane, T.
A CR-39 plastic nuclear track detector was used for quality assurance of mixed oxide fuel pellets for next-generation nuclear power plants. Plutonium (Pu) spot sizes and concentrations in the pellets are significant parameters for safe use in the plants. We developed an automatic Pu detection system based on dense α-radiation tracks in the CR-39 detectors. This system would greatly improve image processing time and measurement accuracy, and will be a powerful tool for rapid pellet quality assurance screening.
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Matthes, Wilbur J.; Sholar, Clyde J.; George, John R.
1992-01-01
This report describes procedures used by the Iowa District sediment laboratory of the U.S. Geological Survey to assure the quality of sediment-laboratory data. These procedures can be used by other U.S. Geological Survey laboratories regardless of size and type of operation for quality assurance and quality control of specific sediment-laboratory processes. Also described are the equipment, specifications, calibration and maintenance, and the protocol for methods used in the analyses of fluvial sediment for concentration or particle size.
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Software Quality Assurance and Controls Standard
2010-04-27
Software Quality Assurance d C t l St d dan on ro s an ar Sue Carroll Principal Software Quality Analyst, SAS John Wal z VP Technology and...for Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that...Cycle (SLC) process? • What is in a SQA Process? • Where are SQA Controls? • What is the SQA standards history? Wh t i h i i SQA?• a s c ang ng n
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Abercrombie, Robert K; Sheldon, Frederick T; Grimaila, Michael R
2010-01-01
In earlier works, we presented a computational infrastructure that allows an analyst to estimate the security of a system in terms of the loss that each stakeholder stands to sustain as a result of security breakdowns. In this paper, we discuss how this infrastructure can be used in the subject domain of mission assurance as defined as the full life-cycle engineering process to identify and mitigate design, production, test, and field support deficiencies of mission success. We address the opportunity to apply the Cyberspace Security Econometrics System (CSES) to Carnegie Mellon University and Software Engineering Institute s Mission Assurance Analysismore » Protocol (MAAP) in this context.« less
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21 CFR 1270.33 - Records, general requirements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... assure freedom from risk factors for and clinical evidence of HIV infection, hepatitis B, and hepatitis C... performed and to relate the records to the particular tissue involved. (b) All human tissue shall be...
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Measuring Assurance of Learning Goals: Effectiveness of Computer Training and Assessment Tools
ERIC Educational Resources Information Center
Murphy, Marianne C.; Sharma, Aditya; Rosso, Mark
2012-01-01
Teaching office applications such as word processing, spreadsheet and presentation skills has been widely debated regarding its necessity, extent and delivery method. Training and Assessment applications such as MyITLab, SAM, etc. are popular tools for training students and are particularly useful in measuring Assurance of Learning (AOL)…
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20 CFR 655.1305 - Assurances and obligations of H-2A employers.
Code of Federal Regulations, 2010 CFR
2010-04-01
..., including employment-related health and safety laws; (2) Provide for or secure housing for those workers who... LABOR TEMPORARY EMPLOYMENT OF FOREIGN WORKERS IN THE UNITED STATES Labor Certification Process for Temporary Agricultural Employment in the United States (H-2A Workers) § 655.1305 Assurances and obligations...
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A Network Approach to Curriculum Quality Assessment
ERIC Educational Resources Information Center
Jordens, J. Zoe; Zepke, Nick
2009-01-01
This paper argues for an alternative approach to quality assurance in New Zealand universities that locates evaluation not with external auditors but with members of the teaching team. In the process, aspects of network theories are introduced as the basis for an approach to quality assurance. From this, the concept of networks is extended to…
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The Assessment of Business Knowledge and Integration for Assurance of Learning: An Application
ERIC Educational Resources Information Center
Hawkins, Alfred G., Jr.
2010-01-01
AACSB has mandated that the documentation of student learning will become increasingly important in decisions regarding initial accreditation and reaffirmation. Assurance of learning is a major part of the accreditation and reaffirmation process. All universities will need to develop a set of learning goals for all their programs. These learning…
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Quality assurance, training, and certification in ozone air pollution studies
Susan Schilling; Paul Miller; Brent Takemoto
1996-01-01
Uniform, or standard, measurement methods of data are critical to projects monitoring change to forest systems. Standardized methods, with known or estimable errors, contribute greatly to the confidence associated with decisions on the basis of field data collections (Zedaker and Nicholas 1990). Quality assurance (QA) for the measurement process includes operations and...
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Quality Assurance for Digital Learning Object Repositories: Issues for the Metadata Creation Process
ERIC Educational Resources Information Center
Currier, Sarah; Barton, Jane; O'Beirne, Ronan; Ryan, Ben
2004-01-01
Metadata enables users to find the resources they require, therefore it is an important component of any digital learning object repository. Much work has already been done within the learning technology community to assure metadata quality, focused on the development of metadata standards, specifications and vocabularies and their implementation…
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Self-Regulation with Rules: Lessons Learned from a New Quality Assurance Process for Ontario
ERIC Educational Resources Information Center
Lang, Daniel W.
2015-01-01
Purpose: The purpose of this paper is to discuss how the province over time has addressed problems that are generic to many jurisdictions in assuring quality -- level of aggregation, pooling, definition of new and continuing programs, scope of jurisdiction, role of governors, performance indicators, relationship to accreditation, programs versus…
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Lean Six Sigma and Assurance of Learning: Challenges and Opportunities
ERIC Educational Resources Information Center
Rexeisen, Richard J.; Owens, Ernest L., Jr.; Garrison, Michael J.
2018-01-01
The importance, and associated challenges, of faculty ownership and engagement in the assurance of learning (AoL) process are well documented in the literature. The authors demonstrate how schools can further their AoL objectives by encouraging and subsequently supporting organic, faculty-led initiatives. Specifically, we present a case study of a…
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Explore The NASA Safety Center
2015-07-01
The NASA Safety Center (NSC) reports to NASA’s Office of Safety and Mission Assurance and supports the Safety and Mission Assurance (SMA) requirements of NASA’s portfolio of programs and projects. The NSC focuses on development of the personnel, processes and tools needed for the safe and successful achievement of NASA’s strategic goals.
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ERIC Educational Resources Information Center
Frank, Andrea; Kurth, Detlef; Mironowicz, Izabela
2012-01-01
Over the last two decades, considerable progress has been made in establishing and implementing robust, comparable quality assurance processes throughout much of the European higher education sector. However, concerns persist over degree portability and recognition as current systems are rooted in national contexts. In particular, specialised…
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Quality Assurance in Online Education: The Universitas 21 Global Approach
ERIC Educational Resources Information Center
Chua, Alton; Lam, Wing
2007-01-01
Despite the proliferation of online education, concerns remain about the quality of online programmes. Quality assurance (QA) has become a prominent issue, not only for educational institutions and accreditors, but also for students and employers alike. This paper describes some of the rather unique QA processes used at Universitas 21 Global…
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Assuring Quality in Online Course Delivery
ERIC Educational Resources Information Center
Matuga, Julia M.; Wooldridge, Deborah G.; Poirier, Sandra
2011-01-01
This paper examines the critical issue of assuring quality online course delivery by examining four key components of online teaching and learning. The topic of course delivery is viewed as a cultural issue that permeates processes from the design of an online course to its evaluation. First, the authors examine and review key components of and…
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78 FR 72071 - Notice of Availability: Application Requirements for the American Assured Fuel Supply
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-02
... the material in the AFS beyond ensuring that Westinghouse, the private company storing the AFS LEU for.... Policy and Process for Accessing AFS Material The DOE requests that persons or companies that seek to... or make any warranty, express or implied beyond assuring that Westinghouse, the company storing AFS...
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Supporting Quality Timely PhD Completions: Delivering Research Outcomes
ERIC Educational Resources Information Center
Gasson, Susan
2015-01-01
The case study used a three-phase organising process to explain how design and implementation of an accessible and interactive electronic thesis submission form streamlined quality assurance of theses and their timely dissemination via an online thesis repository. The quality of the theses submitted is assured by key academics in their final sign…
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49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes
Code of Federal Regulations, 2010 CFR
2010-10-01
... system (all its elements including hardware and software) must be designed to assure safe operation with... unsafe errors in the software due to human error in the software specification, design, or coding phases... (hardware or software, or both) are used in combination to ensure safety. If a common mode failure exists...
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Luk, Hsiang-Ning; Ennever, John F; Day, Yuan-Ji; Wong, Chih-Shung; Sun, Wei-Zen
2015-03-01
For this guidance article, the Ethics Review Task Force (ERTF) of the Journal reviewed and discussed the ethics issues related to publication of human research in the field of anesthesia. ERTF first introduced international ethics principles and minimal requirements of reporting of ethics practices, followed by discussing the universal problems of publication ethics. ERTF then compared the accountability and methodology of several medical journals in assuring authors' ethics compliance. Using the Taiwan Institutional Review Board system as an example, ERTF expressed the importance of institutional review board registration and accreditation to assure human participant protection. ERTF presented four major human research misconducts in the field of anesthesia in recent years. ERTF finally proposed a flow-chart to guide journal peer reviewers and editors in ethics review during the editorial process in publishing. Examples of template languages applied in the Ethics statement section in the manuscript are expected to strengthen the ethics compliance of the authors and to set an ethical culture for all the stakeholders involved in human research. Copyright © 2015. Published by Elsevier B.V.
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The evolving story of information assurance at the DoD.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Campbell, Philip LaRoche
2007-01-01
This document is a review of five documents on information assurance from the Department of Defense (DoD), namely 5200.40, 8510.1-M, 8500.1, 8500.2, and an ''interim'' document on DIACAP [9]. The five documents divide into three sets: (1) 5200.40 & 8510.1-M, (2) 8500.1 & 8500.2, and (3) the interim DIACAP document. The first two sets describe the certification and accreditation process known as ''DITSCAP''; the last two sets describe the certification and accreditation process known as ''DIACAP'' (the second set applies to both processes). Each set of documents describes (1) a process, (2) a systems classification, and (3) a measurement standard.more » Appendices in this report (a) list the Phases, Activities, and Tasks of DITSCAP, (b) note the discrepancies between 5200.40 and 8510.1-M concerning DITSCAP Tasks and the System Security Authorization Agreement (SSAA), (c) analyze the DIACAP constraints on role fusion and on reporting, (d) map terms shared across the documents, and (e) review three additional documents on information assurance, namely DCID 6/3, NIST 800-37, and COBIT{reg_sign}.« less
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Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.
Flandrin-Gresta, Pascale; Cornillet, Pascale; Hayette, Sandrine; Gachard, Nathalie; Tondeur, Sylvie; Mauté, Carole; Cayuela, Jean-Michel
2015-01-01
Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.
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Philosophy on astronaut protection: A physician`s perspective
DOE Office of Scientific and Technical Information (OSTI.GOV)
Holloway, H
The National Aeronautics and Space Administration has a responsibility to assure that proper ethical standards are applied in establishing and applying limits for the control of radiation doses to the astronauts. Such a responsibility obviously includes assuring that the astronauts are properly informed of the hazards associated with individuals missions and that they agree to accept the associated risks. The responsibility, however, does not end there. It includes a need to discuss how to initiate a discourse for developing the related ethical standards and how to determine who should be involved in their establishment. To assure that such proper communicationsmore » on matters that encompass the realms of policy, science, politics, and ethics. There is also a need to mesh public perceptions with those of the scientific and technical community. This will be a monumental undertaking.« less
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National Ignition Facility quality assurance program plan revision 2
DOE Office of Scientific and Technical Information (OSTI.GOV)
Wolfe, C R
1998-06-01
NIF Project activities will be conducted in a manner consistent with the guidance and direction of the DOE Order on Quality Assurance (414.1), the LLNL QA Program, and the Laser Directorate QA Plan. Quality assurance criteria will be applied in a graded manner to achieve a balance between the rigor of application of QA measures and the scale, cost, and complexity of the work involved. Accountability for quality is everyone's, extending from the Project Manager through established lines of authority to all Project personnel, who are responsible for the requisite quality of their own work. The NLF QA Program willmore » be implemented by personnel conducting their activities to meet requirements and expectations, according to established plans and procedures that reflect the way business is to be conducted on the Project.« less
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Quality Assurance Program Plan for SFR Metallic Fuel Data Qualification
DOE Office of Scientific and Technical Information (OSTI.GOV)
Benoit, Timothy; Hlotke, John Daniel; Yacout, Abdellatif
2017-07-05
This document contains an evaluation of the applicability of the current Quality Assurance Standards from the American Society of Mechanical Engineers Standard NQA-1 (NQA-1) criteria and identifies and describes the quality assurance process(es) by which attributes of historical, analytical, and other data associated with sodium-cooled fast reactor [SFR] metallic fuel and/or related reactor fuel designs and constituency will be evaluated. This process is being instituted to facilitate validation of data to the extent that such data may be used to support future licensing efforts associated with advanced reactor designs. The initial data to be evaluated under this program were generatedmore » during the US Integral Fast Reactor program between 1984-1994, where the data includes, but is not limited to, research and development data and associated documents, test plans and associated protocols, operations and test data, technical reports, and information associated with past United States Nuclear Regulatory Commission reviews of SFR designs.« less
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21 CFR 1000.55 - Recommendation for quality assurance programs in diagnostic radiology facilities.
Code of Federal Regulations, 2011 CFR
2011-04-01
... procedure that involves irradiation of any part of the human body for the purpose of diagnosis or..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) RADIOLOGICAL HEALTH GENERAL Radiation Protection...
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Anatomic modeling using 3D printing: quality assurance and optimization.
Leng, Shuai; McGee, Kiaran; Morris, Jonathan; Alexander, Amy; Kuhlmann, Joel; Vrieze, Thomas; McCollough, Cynthia H; Matsumoto, Jane
2017-01-01
The purpose of this study is to provide a framework for the development of a quality assurance (QA) program for use in medical 3D printing applications. An interdisciplinary QA team was built with expertise from all aspects of 3D printing. A systematic QA approach was established to assess the accuracy and precision of each step during the 3D printing process, including: image data acquisition, segmentation and processing, and 3D printing and cleaning. Validation of printed models was performed by qualitative inspection and quantitative measurement. The latter was achieved by scanning the printed model with a high resolution CT scanner to obtain images of the printed model, which were registered to the original patient images and the distance between them was calculated on a point-by-point basis. A phantom-based QA process, with two QA phantoms, was also developed. The phantoms went through the same 3D printing process as that of the patient models to generate printed QA models. Physical measurement, fit tests, and image based measurements were performed to compare the printed 3D model to the original QA phantom, with its known size and shape, providing an end-to-end assessment of errors involved in the complete 3D printing process. Measured differences between the printed model and the original QA phantom ranged from -0.32 mm to 0.13 mm for the line pair pattern. For a radial-ulna patient model, the mean distance between the original data set and the scanned printed model was -0.12 mm (ranging from -0.57 to 0.34 mm), with a standard deviation of 0.17 mm. A comprehensive QA process from image acquisition to completed model has been developed. Such a program is essential to ensure the required accuracy of 3D printed models for medical applications.
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ISO 9000 and/or Systems Engineering Capability Maturity Model?
NASA Technical Reports Server (NTRS)
Gholston, Sampson E.
2002-01-01
For businesses and organizations to remain competitive today they must have processes and systems in place that will allow them to first identify customer needs and then develop products/processes that will meet or exceed the customers needs and expectations. Customer needs, once identified, are normally stated as requirements. Designers can then develop products/processes that will meet these requirements. Several functions, such as quality management and systems engineering management are used to assist product development teams in the development process. Both functions exist in all organizations and both have a similar objective, which is to ensure that developed processes will meet customer requirements. Are efforts in these organizations being duplicated? Are both functions needed by organizations? What are the similarities and differences between the functions listed above? ISO 9000 is an international standard of goods and services. It sets broad requirements for the assurance of quality and for management's involvement. It requires organizations to document the processes and to follow these documented processes. ISO 9000 gives customers assurance that the suppliers have control of the process for product development. Systems engineering can broadly be defined as a discipline that seeks to ensure that all requirements for a system are satisfied throughout the life of the system by preserving their interrelationship. The key activities of systems engineering include requirements analysis, functional analysis/allocation, design synthesis and verification, and system analysis and control. The systems engineering process, when followed properly, will lead to higher quality products, lower cost products, and shorter development cycles. The System Engineering Capability Maturity Model (SE-CMM) will allow companies to measure their system engineering capability and continuously improve those capabilities. ISO 9000 and SE-CMM seem to have a similar objective, which is to document the organization's processes and certify to potential customers the capability of a supplier to control the processes that determine the quality of the product or services being produced. The remaining sections of this report examine the differences and similarities between ISO 9000 and SE-CMM and make recommendations for implementation.
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Frank Gilbreth and health care delivery method study driven learning.
Towill, Denis R
2009-01-01
The purpose of this article is to look at method study, as devised by the Gilbreths at the beginning of the twentieth century, which found early application in hospital quality assurance and surgical "best practice". It has since become a core activity in all modern methods, as applied to healthcare delivery improvement programmes. The article traces the origin of what is now currently and variously called "business process re-engineering", "business process improvement" and "lean healthcare" etc., by different management gurus back to the century-old pioneering work of Frank Gilbreth. The outcome is a consistent framework involving "width", "length" and "depth" dimensions within which healthcare delivery systems can be analysed, designed and successfully implemented to achieve better and more consistent performance. Healthcare method (saving time plus saving motion) study is best practised as co-joint action learning activity "owned" by all "players" involved in the re-engineering process. However, although process mapping is a key step forward, in itself it is no guarantee of effective re-engineering. It is not even the beginning of the end of the change challenge, although it should be the end of the beginning. What is needed is innovative exploitation of method study within a healthcare organisational learning culture accelerated via the Gilbreth Knowledge Flywheel. It is shown that effective healthcare delivery pipeline improvement is anchored into a team approach involving all "players" in the system especially physicians. A comprehensive process study, constructive dialogue, proper and highly professional re-engineering plus managed implementation are essential components. Experience suggests "learning" is thereby achieved via "natural groups" actively involved in healthcare processes. The article provides a proven method for exploiting Gilbreths' outputs and their many successors in enabling more productive evidence-based healthcare delivery as summarised in the "learn-do-learn-do" feedback loop in the Gilbreth Knowledge Flywheel.
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46 CFR 160.132-13 - Approval inspections and tests for prototype davits.
Code of Federal Regulations, 2012 CFR
2012-10-01
... reviewed under § 160.132-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.132-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...
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46 CFR 160.115-13 - Approval inspections and tests for prototype winches.
Code of Federal Regulations, 2012 CFR
2012-10-01
... reviewed under § 160.115-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.115-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...
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46 CFR 160.115-13 - Approval inspections and tests for prototype winches.
Code of Federal Regulations, 2014 CFR
2014-10-01
... reviewed under § 160.115-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.115-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...
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46 CFR 160.115-13 - Approval inspections and tests for prototype winches.
Code of Federal Regulations, 2013 CFR
2013-10-01
... reviewed under § 160.115-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.115-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...
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46 CFR 160.132-13 - Approval inspections and tests for prototype davits.
Code of Federal Regulations, 2013 CFR
2013-10-01
... reviewed under § 160.132-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.132-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...
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46 CFR 160.132-13 - Approval inspections and tests for prototype davits.
Code of Federal Regulations, 2014 CFR
2014-10-01
... reviewed under § 160.132-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.132-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...
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A Validity-Based Approach to Quality Control and Assurance of Automated Scoring
ERIC Educational Resources Information Center
Bejar, Isaac I.
2011-01-01
Automated scoring of constructed responses is already operational in several testing programmes. However, as the methodology matures and the demand for the utilisation of constructed responses increases, the volume of automated scoring is likely to increase at a fast pace. Quality assurance and control of the scoring process will likely be more…
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ERIC Educational Resources Information Center
Patchner, Michael A.; Balgopal, Pallassana R.
Three studies were undertaken to examine topics of care planning, personnel management, and quality assurance in long-term care facilities. The first study examined the formulation and implementation processes of care planning for nursing home residents. The exemplary homes' care planning included the existence of strong care planning leadership,…
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ERIC Educational Resources Information Center
Shah, Mahsood; Nair, Chenicheri Sid; Stanford, Sue-Ann
2011-01-01
Governments in many countries have funded independent agencies to undertake quality audits of higher education institutions. Such agencies ensure that universities and other higher education providers have effective systems and processes to assure quality assurance in core and support areas. While external quality audits have been in place for a…
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Quality of Care Assessment: The Role of Faculty at Academic Medical Centers.
ERIC Educational Resources Information Center
Brook, Robert H.
Currently, there is not a single university medical center in which an acceptable routine system to assure quality of care has been established. This may result from reliance on the structure of the medical education process as a proxy measure to assure that physicians perform appropriately in their role. Several studies have been conducted to…
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Accountability in the Greek Higher Education System as a High-Stakes Policymaking Instrument
ERIC Educational Resources Information Center
Gouvias, Dionysios
2012-01-01
One of the main aims of the so-called common "European Higher Education Area" is the creation of a European framework for higher education (HE) qualifications and a network of "quality assurance agencies." In the light of the above processes, recent legislation in Greece on quality assurance in HE and the operation and…
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Developing a Customized Program Assessment Methodology for Assurance of Learning: A Case Study
ERIC Educational Resources Information Center
Baker, Hope; Brawley, Dorothy; Campbell, Jane; Capozzoli, Ernest; Malgeri, Linda; Roberts, Gary
2007-01-01
For most academic institutions, selecting and/or designing a Program Assessment methodology for Assurance of Learning is a challenging task. This paper describes the steps taken to establish goals, values and criteria driving this process for a College of Business. In this case analysis, we document the options we explored in finding the right…
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Greece before the Bologna Process: Confronting or Embracing Quality Assurance in Higher Education?
ERIC Educational Resources Information Center
Stamoulas, Aristotelis
2006-01-01
The globalization of education, with its multiple associations with the growth of the knowledge society, the increasing penetration of market forces in higher education and the treatment of education as an exportable good, supplied in different forms and by various providers, exerts the need for systematic quality assurance in higher education. In…
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ERIC Educational Resources Information Center
Alexander, Rodney T.
2017-01-01
Organizational computing devices are increasingly becoming targets of cyber-attacks, and organizations have become dependent on the safety and security of their computer networks and their organizational computing devices. Business and government often use defense in-depth information assurance measures such as firewalls, intrusion detection…
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Walking the Line: Quality Assurance Policy Development and Implementation in Vi?t Nam
ERIC Educational Resources Information Center
Madden, Meggan
2014-01-01
Although Vi?t Nam's experiences with quality assurance (QA) policy development have been influenced by its relationships with, and funding from, the World Bank and regional organizations, the state-centric values of the Socialist Republic of Vi?t Nam still navigate the implementation process. The development of QA in Vietnamese higher education…
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University Administrators' Conceptions of Quality and Approaches to Quality Assurance
ERIC Educational Resources Information Center
Goff, Lori
2017-01-01
As the quality of university education garners increasingly more interest in both the public and in the literature, and as quality assurance (QA) processes are developed and implemented within universities around the world, it is important to carefully consider what is meant by the term quality. This study attempts to add to the literature…
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Elusive Search for Quality Education: The Case of Quality Assurance and Teacher Accountability
ERIC Educational Resources Information Center
Odhiambo, George
2008-01-01
Purpose: The purpose of this paper is to examine issues of quality and quality assurance in Kenyan schools, identify reasons why Kenya government has difficulties in achieving its well documented search for quality education and to trace the process for ensuring the accountability of teachers in Kenya. This focus is done under conditions of…
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NASA Astrophysics Data System (ADS)
Iwaki, Y.
2010-07-01
The Quality Assurance (QA) of measurand has been discussed over many years by Quality Engineering (QE). It is need to more discuss about ISO standard. It is mining to find out root fault element for improvement of measured accuracy, and it remove. The accuracy assurance needs to investigate the Reference Material (RM) for calibration and an improvement accuracy of data processing. This research follows the accuracy improvement in field of data processing by how to improve of accuracy. As for the fault element relevant to measurement accuracy, in many cases, two or more element is buried exist. The QE is to assume the generating frequency of fault state, and it is solving from higher ranks for fault factor first by "Failure Mode and Effects Analysis (FMEA)". Then QE investigate the root cause over the fault element by "Root Cause Analysis (RCA)" and "Fault Tree Analysis (FTA)" and calculate order to the generating element of assume specific fault. These days comes, the accuracy assurance of measurement result became duty in the Professional Test (PT). ISO standard was legislated by ISO-GUM (Guide of express Uncertainty in Measurement) as guidance of an accuracy assurance in 1993 [1] for QA. Analysis method of ISO-GUM is changed into Exploratory Data Analysis (EDA) from Analysis of Valiance (ANOVA). EDA calculate one by one until an assurance performance is obtained according to "Law of the propagation of uncertainty". If the truth value was unknown, ISO-GUM is changed into reference value. A reference value set up by the EDA and it does check with a Key Comparison (KC) method. KC is comparing between null hypothesis and frequency hypothesis. It performs operation of assurance by ISO-GUM in order of standard uncertainty, the combined uncertainty of many fault elements and an expansion uncertain for assurance. An assurance value is authorized by multiplying the final expansion uncertainty [2] by K of coverage factor. K-value is calculated from the Effective Free Degree (EFD) which thought the number of samples is important. Free degree is based on maximum likelihood method of an improved information criterion (AIC) for a Quality Control (QC). The assurance performance of ISO-GUM is come out by set up of the confidence interval [3] and is decided. The result of research of "Decided level/Minimum Detectable Concentration (DL/MDC)" was able to profit by the operation. QE has developed for the QC of industry. However, these have been processed by regression analysis by making frequency probability of a statistic value into normalized distribution. The occurrence probability of the statistics value of a fault element which is accompanied element by a natural phenomenon becomes an abnormal distribution in many cases. The abnormal distribution needs to obtain an assurance value by other method than statistical work of type B in ISO-GUM. It is tried fusion the improvement of worker by QE became important for reservation of the reliability of measurement accuracy and safety. This research was to make the result of Blood Chemical Analysis (BCA) in the field of clinical test.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Fix, N. J.
This Quality Assurance Project Plan provides the quality assurance requirements and processes that will be followed by staff working on the 100-NR-2 Apatite Project. The U.S. Department of Energy, Fluor Hanford, Inc., Pacific Northwest National Laboratory, and the Washington Department of Ecology agreed that the long-term strategy for groundwater remediation at 100-N would include apatite sequestration as the primary treatment, followed by a secondary treatment. The scope of this project covers the technical support needed before, during, and after treatment of the targeted subsurface environment using a new high-concentration formulation.
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Quality assurance, an administrative means to a managerial end: Part IV.
Clark, G B
1992-01-01
This is the fourth and final part of a series of articles on laboratory quality surveillance. Part I addressed the historical background of medical quality assurance. Part II covered surveillance guidelines of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the College of American Pathologists with emphasis on quality assurance (QA) and the ten-step process. Part III focused on the JCAHO transition from QA to quality assessment and improvement. Part IV concludes the series by discussing the systematic identification of quality indicators in the total quality management and continuous quality improvement environment.
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NASA Technical Reports Server (NTRS)
1972-01-01
A long life assurance program for the development of design, process, test, and application guidelines for achieving reliable spacecraft hardware was conducted. The study approach consisted of a review of technical data performed concurrently with a survey of the aerospace industry. The data reviewed included design and operating characteristics, failure histories and solutions, and similar documents. The topics covered by the guidelines are reported. It is concluded that long life hardware is achieved through meticulous attention to many details and no simple set of rules can suffice.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Bekelman, Justin E.; Yahalom, Joachim
2009-02-01
Purpose: Standards for the reporting of radiotherapy details in randomized controlled trials (RCTs) are lacking. Although radiotherapy (RT) is an important component of curative therapy for Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL), we postulated that RT reporting may be inadequate in Phase III HL and NHL trials. Methods and Materials: We searched PubMed and the Cochrane registry for reports of RCTs involving RT and either HL or NHL published between 1998 and 2007. We screened 133 titles and abstracts to identify relevant studies. We included a total of 61 reports. We assessed these reports for the presence of sixmore » quality measures: target volume, radiation dose, fractionation, radiation prescription, quality assurance (QA) process use, and adherence to QA (i.e., reporting of major or minor deviations). Results: Of 61 reports, 23 (38%) described the target volume. Of the 42 reports involving involved-field RT alone, only 8 (19%) adequately described the target volume. The radiation dose and fractionation was described in most reports (54 reports [89%] and 39 reports [64%], respectively). Thirteen reports specified the RT prescription point (21%). Only 12 reports (20%) described using a RT QA process, and 7 reports (11%) described adherence to the QA process. Conclusion: Reporting of RT in HL and NHL RCTs is deficient. Because the interpretation, replication, and application of RCT results depend on adequate description and QA of therapeutic interventions, consensus standards for RT reporting should be developed and integrated into the peer-review process.« less
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A Systems Engineering Approach to Quality Assurance for Aerospace Testing
NASA Technical Reports Server (NTRS)
Shepherd, Christena C.
2014-01-01
On the surface, it appears that AS9100 has little to say about how to apply a Quality Management System (QMS) to major aerospace test programs (or even smaller ones). It also appears that there is little in the quality engineering Body of Knowledge (BOK) that applies to testing, unless it is nondestructive examination (NDE), or some type of lab or bench testing associated with the manufacturing process. However, if one examines: a) how the systems engineering (SE) processes are implemented throughout a test program; and b) how these SE processes can be mapped to the requirements of AS9100, a number of areas for involvement of the quality professional are revealed. What often happens is that quality assurance during a test program is limited to inspections of the test article; what could be considered a manufacturing al fresco approach. This limits the quality professional and is a disservice to the programs and projects, since there are a number of ways that quality can enhance critical processes, and support efforts to improve risk reduction, efficiency and effectiveness. The Systems Engineering (SE) discipline is widely used in aerospace to ensure the progress from Stakeholder Expectations (the President, Congress, the taxpayers) to a successful, delivered product or service. Although this is well known, what is not well known is that these same SE processes are implemented in varying complexity, to prepare for and implement test projects that support research, development, verification and validation, qualification, and acceptance test projects. Although the test organization's terminology may vary from the SE terminology, and from one test service provider to another, the basic process is followed by successful, reliable testing organizations. For this analysis, NASA Procedural Requirements (NPR) 7123.1, NASA Systems Engineering Processes and Requirements is used to illustrate the SE processes that are used for major aerospace testing. Many of these processes are also implemented for smaller test projects, and this set of processes will also look familiar to those who have participated in launch site activation and flight demonstrations.
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Quality assurance and quality improvement in U.S. clinical molecular genetic laboratories.
Chen, Bin; Richards, C Sue; Wilson, Jean Amos; Lyon, Elaine
2011-04-01
A robust quality-assurance program is essential for laboratories that perform molecular genetic testing to maintain high-quality testing and be able to address challenges associated with performance or delivery of testing services as the use of molecular genetic tests continues to expand in clinical and public health practice. This unit discusses quality-assurance and quality-improvement considerations that are critical for molecular genetic testing performed for heritable diseases and conditions. Specific discussion is provided on applying regulatory standards and best practices in establishing/verifying test performance, ensuring quality of the total testing process, monitoring and maintaining personnel competency, and continuing quality improvement. The unit provides a practical reference for laboratory professionals to use in recognizing and addressing essential quality-assurance issues in human molecular genetic testing. It should also provide useful information for genetics researchers, trainees, and fellows in human genetics training programs, as well as others who are interested in quality assurance and quality improvement for molecular genetic testing. 2011 by John Wiley & Sons, Inc.
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[The hospital perspective: disease management and integrated health care].
Schrappe, Matthias
2003-06-01
Disease Management is a transsectoral, population-based form of health care, which addresses groups of patients with particular clinical entities and risk factors. It refers both to an evidence-based knowledge base and corresponding guidelines, evaluates outcome as a continuous quality improvement process and usually includes active participation of patients. In Germany, the implementation of disease management is associated with financial transactions for risk adjustment between health care assurances [para. 137 f, Book V of Social Code (SGB V)] and represents the second kind of transsectoral care, besides a program designed as integrated health care according to para. 140 a ff f of Book V of Social Code. While in the USA and other countries disease management programs are made available by several institutions involved in health care, in Germany these programs are offered by health care insurers. Assessment of disease management from the hospital perspective will have to consider three questions: How large is the risk to compensate inadequate quality in outpatient care? Are there synergies in internal organisational development? Can the risk of inadequate funding of the global "integrated" budget be tolerated? Transsectoral quality assurance by valid performance indicators and implementation of a quality improvement process are essential. Internal organisational changes can be supported, particularly in the case of DRG introduction. The economic risk and financial output depends on the kind of disease being focussed by the disease management program. In assessing the underlying scientific evidence of their cost effectiveness, societal costs will have to be precisely differentiated from hospital-associated costs.
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Achieving Maximum Integration Utilizing Requirements Flow Down
NASA Technical Reports Server (NTRS)
Archiable, Wes; Askins, Bruce
2011-01-01
A robust and experienced systems engineering team is essential for a successful program. It is often a challenge to build a core systems engineering team early enough in a program to maximize integration and assure a common path for all supporting teams in a project. Ares I was no exception. During the planning of IVGVT, the team had many challenges including lack of: early identification of stakeholders, team training in NASA s system engineering practices, solid requirements flow down and a top down documentation strategy. The IVGVT team started test planning early in the program before the systems engineering framework had been matured due to an aggressive schedule. Therefore the IVGVT team increased their involvement in the Constellation systems engineering effort. Program level requirements were established that flowed down to IVGVT aligning all stakeholders to a common set of goals. The IVGVT team utilized the APPEL REQ Development Management course providing the team a NASA focused model to follow. The IVGVT team engaged directly with the model verification and validation process to assure that a solid set of requirements drove the need for the test event. The IVGVT team looked at the initial planning state, analyzed the current state and then produced recommendations for the ideal future state of a wide range of systems engineering functions and processes. Based on this analysis, the IVGVT team was able to produce a set of lessons learned and to provide suggestions for future programs or tests to use in their initial planning phase.
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[Quality assurance in intensive care: the situation in Switzerland].
Frutiger, A
1999-10-30
The movement for quality in medicine is starting to take on the dimensions of a crusade. Quite logically it has also reached the intensive care community. Due to their complex multidisciplinary functioning and because of the high costs involved, ICUs are model services reflecting the overall situation in our hospitals. The situation of Swiss intensive care is particularly interesting, because for over 25 years standards for design and staffing of Swiss ICUs have been in effect and were enforced via onsite visits by the Swiss Society of Intensive Care without government involvement. Swiss intensive care thus defined its structures long before the word "accreditation" had even been used in this context. While intensive care in Switzerland is practised in clearly defined, well equipped and adequately staffed units, much less is known about process quality and outcomes of these services. Statistics on admissions, length of stay and length of mechanical ventilation, as well as severity data based on a simple classification system, are collected nationwide and allow some limited insight into the overall process of care. Results of intensive care are not systematically assessed. In response to the constant threat of cost containment, Swiss ICUs should increasingly focus on process quality and results, while maintaining their existing good structures.
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NASA Technical Reports Server (NTRS)
Vosteen, Louis F.; Hadcock, Richard N.
1994-01-01
A study of past composite aircraft structures programs was conducted to determine the lessons learned during the programs. The study focused on finding major underlying principles and practices that experience showed have significant effects on the development process and should be recognized and understood by those responsible for using of composites. Published information on programs was reviewed and interviews were conducted with personnel associated with current and past major development programs. In all, interviews were conducted with about 56 people representing 32 organizations. Most of the people interviewed have been involved in the engineering and manufacturing development of composites for the past 20 to 25 years. Although composites technology has made great advances over the past 30 years, the effective application of composites to aircraft is still a complex problem that requires experienced personnel with special knowledge. All disciplines involved in the development process must work together in real time to minimize risk and assure total product quality and performance at acceptable costs. The most successful programs have made effective use of integrated, collocated, concurrent engineering teams, and most often used well-planned, systematic development efforts wherein the design and manufacturing processes are validated in a step-by-step or 'building block' approach. Such approaches reduce program risk and are cost effective.
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Kozar, Mark D.; Kahle, Sue C.
2013-01-01
This report documents the standard procedures, policies, and field methods used by the U.S. Geological Survey’s (USGS) Washington Water Science Center staff for activities related to the collection, processing, analysis, storage, and publication of groundwater data. This groundwater quality-assurance plan changes through time to accommodate new methods and requirements developed by the Washington Water Science Center and the USGS Office of Groundwater. The plan is based largely on requirements and guidelines provided by the USGS Office of Groundwater, or the USGS Water Mission Area. Regular updates to this plan represent an integral part of the quality-assurance process. Because numerous policy memoranda have been issued by the Office of Groundwater since the previous groundwater quality assurance plan was written, this report is a substantial revision of the previous report, supplants it, and contains significant additional policies not covered in the previous report. This updated plan includes information related to the organization and responsibilities of USGS Washington Water Science Center staff, training, safety, project proposal development, project review procedures, data collection activities, data processing activities, report review procedures, and archiving of field data and interpretative information pertaining to groundwater flow models, borehole aquifer tests, and aquifer tests. Important updates from the previous groundwater quality assurance plan include: (1) procedures for documenting and archiving of groundwater flow models; (2) revisions to procedures and policies for the creation of sites in the Groundwater Site Inventory database; (3) adoption of new water-level forms to be used within the USGS Washington Water Science Center; (4) procedures for future creation of borehole geophysics, surface geophysics, and aquifer-test archives; and (5) use of the USGS Multi Optional Network Key Entry System software for entry of routine water-level data collected as part of long-term water-level monitoring networks.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
None
2010-04-01
The American Recovery and Reinvestment Act of 2009 (Recovery Act) was established to jumpstart the U.S. economy, create or save millions of jobs, and invest in the Nation's energy future. The Department of Energy received approximately $37 billion through the Recovery Act to support a variety of science, energy and environmental initiatives. The Office of Management and Budget (OMB) issued guidance for carrying out stimulus-related activities which requires, among other things, that recipients ensure funds provided by the Recovery Act are clearly distinguishable from non-Recovery Act funds in all reporting systems and that recipients' actions are transparent to the public.more » To meet these requirements, the Department's recipients must clearly and accurately track and report on 18 separate data elements. In addition, the Department was to develop and implement a process to ensure that recipient information reported to the public was free from material omissions and significant reporting errors. Our recent report (OAS-RA-10-01, October 2009) noted that the Department had developed a quality assurance process to facilitate the quarterly reviews of recipient data and planned to test it during the first quarterly reporting cycle. To determine whether the Department's quality assurance process was effective, we examined information reported by recipients of Departmental funding as of September 30, 2009. We also sought to determine whether the Department's prime contractors were prepared to track and report on Recovery Act activities. The Department had taken a number of actions designed to ensure the accuracy and transparency of reported Recovery Act results. This process identified potential anomalies with information reported by 1,113 of 2,038, or 55 percent of recipients. We view the Department's data quality assurance efforts as both timely and significant. As noted by our audit testing, however, opportunities exist to strengthen the process. In particular: (1) Site officials did not always ensure that anomalies, once identified during the quality assurance process, were actually resolved. For example, the Department's process identified that about 740 of the approximately 10,000 jobs reported in the first quarter of Fiscal Year 2010 as created/retained were for projects reported as having no funds spent. Although these problems were referred to site officials for follow-up and/or correction, the information was never actually changed; (2) The Department did not always utilize the correct basis when evaluating the accuracy of 'funds provided' data submitted by grant recipients. For example, in its analysis process, the Department used data reflecting 'funds obligated' rather than the correct amount of 'total grant awards'. This generated a number of potential false positives; and, (3) Duplicate reports by certain recipients, resulting in overstatements of as much as $137 million of the more than $18 billion obligated, were not corrected. We observed that the Department had taken prompt action to ensure that its prime facility management contractors could properly report Recovery Act information. Notably, the seven contractors in this category included in our review had modified their accounting systems, as necessary, to ensure that they could accurately track and report on Recovery Act activities. The systems at each of these entities had been restructured so that they: (i) could separate Recovery Act and non-Recovery Act funds; and, (ii) had adequate processing capacity to handle the projected increase in transactions. We found the Department's decision to limit its reviews to the four elements that it considered to be critical (award amount, invoiced amount, jobs created/retained, and project status) to be reasonable. We concluded, however, other elements or dependent relationships should not be completely excluded from review. Beyond its initial development and implementation of its quality assurance process, the Department had taken steps to improve its ability to ensure that Recovery Act information was both accurate and transparent to the public. Specifically, officials changed the quality assurance plan based on initial data reviews. Department officials also informed us that they are in the process of updating their quality assurance process to meet new OMB requirements. For example, recent guidance directed agencies to focus on certain data elements, such as award number and recipient name, during their quality assurance reviews. In addition, subsequent to our review, the Department added two more data elements and comparisons to its quarterly assurance process, including an analysis of costs/expenditures and a comparison of the recipient reported project status to the Department's data contained in its financial system.« less
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ERIC Educational Resources Information Center
Bachman, Lyle F.
1989-01-01
Applied linguistics and psychometrics have influenced language testing, providing additional tools for investigating factors affecting language test performance and assuring measurement reliability. An examination is presented of language testing, including the theoretical issues involved, the methodological advances, language test development,…
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15 CFR 923.57 - Continuing consultation.
Code of Federal Regulations, 2011 CFR
2011-01-01
...) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE OCEAN AND COASTAL RESOURCE MANAGEMENT COASTAL ZONE MANAGEMENT PROGRAM REGULATIONS Coordination, Public Involvement and National Interest... agencies, regional agencies, and areawide agencies within the coastal zone to assure the full participation...
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15 CFR 923.57 - Continuing consultation.
Code of Federal Regulations, 2010 CFR
2010-01-01
...) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE OCEAN AND COASTAL RESOURCE MANAGEMENT COASTAL ZONE MANAGEMENT PROGRAM REGULATIONS Coordination, Public Involvement and National Interest... agencies, regional agencies, and areawide agencies within the coastal zone to assure the full participation...
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Biosimilars in rheumatology: A review of the evidence and their place in the treatment algorithm
Skapenko, Alla
2017-01-01
Abstract Determining biosimilarity involves a comprehensive exercise with a focus on determining the comparability of the molecular characteristics and preclinical profile of the biosimilar and reference product, such that there is less need for extensive clinical testing to assure comparability of clinical outcomes. Three anti-TNF biosimilar agents are approved for patients with rheumatic diseases in the European Union. The infliximab (Remicade®) biosimilars CT-P13 (Remsima® and Inflectra®) and SB2 (Flixabi®) and the etanercept (Enbrel®) biosimilar SB4 (Benepali®) have shown close comparability to their reference medicinal products, having undergone extensive evaluations. Guidelines on the treatment of rheumatic diseases have acknowledged that biosimilars and biologic DMARDs (bDMARDs) are interchangeable in clinical practice, except when patients experience lack of efficacy or tolerability with the reference agent. Given that cost is a barrier to effective bDMARD use, the introduction of less costly biosimilars is likely to widen access and dissipate treatment inequalities. Physicians faced with prescribing decisions should be reassured by the robust and exhaustive process that is involved in assuring comparability of biosimilars with their reference agents. De novo usage of a biosimilar and switching to a biosimilar following lack of efficacy or tolerability with a different reference biologic agent are likely to be strategies most easily adopted, although switching during successful treatment should also be considered given the potential cost implications. The introduction of biosimilar bDMARDs has the potential to improve patient access to effective biologic therapy, to better accommodate restraints within healthcare budgets and to improve overall patient outcomes. PMID:28903543
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Quality assurance aspects of GSR analysis by SEM/EDX: a report of first-hand experiences
NASA Astrophysics Data System (ADS)
Charles, Sebastien; Dehan, Didier; Geusens, Nadia; Nys, Bart
2009-05-01
Like many forensic science labs, the Belgian National Institute of Forensic Science (NICC) is involved in a Quality Assurance program aiming towards an ISO17025 Accreditation. Since last year, a project is underway in the GSR lab to validate the method used in the analysis of GSR samples acquired from the hands of suspects by SEM/EDX. The project is well underway, and is planned to lead to accreditation for this technique by the start of 2010. The presentation will discuss several aspects of the functioning of the lab that have to be addressed when preparing for this accreditation. Some of these issues and problems are so involved that separate sub-projects were defined in order to provide a manageable solution. The following topics will be treated in detail: definition of the scope of the accreditation, the validation of the SEM/EDX method with respect to : accuracy, precision, reproducibility and robustness, and the documentation of the Chain of Custody (CoC) of the samples and their storage. One specific sub-project that will be discussed is the study of contamination monitoring in different relevant locations of the lab. Finally, as we have recently acquired a new microscope, the technical criteria we used in the acquisition study will be presented with a focus on their relevance in a QA context. We feel this discussion is informative, both for labs that are pursuing a formal accreditation in the future, and those that work already in such a context and are in the process of acquiring new equipment.
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Mittermayer, Renato; Huić, Mirjana; Mestrović, Josipa
2010-12-01
Avedis Donabedian defined the quality of care as the kind of care, which is expected to maximize an inclusive measure of patient welfare, after taking into account the balance of expected gains and losses associated with the process of care in all its segments. According to the World Medical Assembly, physicians and health care institutions have an ethical and professional obligation to strive for continuous quality improvement of services and patient safety with the ultimate goal to improve both individual patient outcomes as well as population health. Health technology assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner, with the aim to formulate safe and effective health policies that are patient focused and seek to achieve the highest value. The Agency for Quality and Accreditation in Health was established in 2007 as a legal, public, independent, nonprofit institution under the Act on Quality of Health Care. The Agency has three departments: Department of Quality and Education, Department of Accreditation, and Department of Development, Research, and Health Technology Assessment. According to the Act, the Agency should provide the procedure of granting, renewal and cancellation of accreditation of healthcare providers; proposing to the Minister, in cooperation with professional associations, the plan and program for healthcare quality assurance, improvement, promotion and monitoring; proposing the healthcare quality standards as well as the accreditation standards to the Minister; keeping a register of accreditations and providing a database related to accreditation, healthcare quality improvement, and education; providing education in the field of healthcare quality assurance, improvement and promotion; providing the HTA procedure and HTA database, supervising the healthcare insurance standards, and providing other services in the field of healthcare quality assurance, improvement, promotion and monitoring, according to the Act. Formal activities of the Agency in the field of HTA actually began in summer 2009. In the field of quality and accreditation, the plan and program of healthcare quality assurance, improvement, promotion and monitoring was finished and published in October 2010; preparation of the healthcare quality standards as well as the accreditation standards is still in process, with the aim to start accreditation process at 10 hospitals in 2011. Education in the field of healthcare quality assurance, improvement and promotion has been established as a continuous process from the beginning. The Agency is member of the International Society for Quality in Health Care (ISQua) and participates in the work of the European Accreditation Network (EAN). In the field of HTA, the Agency has established international collaboration and support, which resulted in its appointment and participation in the European network for Health Technology Assessment (EUnetHTA) Joint Action Project as a EUnetHTA Partner, as well as its membership in the international society, HTAi. TAIEX project has been approved as a two-day workshop in December 2010. The Croatian HTA Guidelines have been issued with the aim to start the HTA process and reports that should serve as recommendations, as a support to policy-makers at the national level, in particular the Croatian Ministry of Health and Social Welfare, and Croatian Institute of Health Insurance, in making evidence-informed decisions on the strategic planning, investment, management and implementation of technologies in health care, on funding (reimbursement) and coverage of health technologies, and at hospital level on the request from hospital directors and policy teams. In conclusion, establishment of all these measures in Croatia is by no means an easy and quick process, however, we do believe that it is feasible through continuous and close collaboration of all those involved.
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Security Hardened Cyber Components for Nuclear Power Plants: Phase I SBIR Final Technical Report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Franusich, Michael D.
SpiralGen, Inc. built a proof-of-concept toolkit for enhancing the cyber security of nuclear power plants and other critical infrastructure with high-assurance instrumentation and control code. The toolkit is based on technology from the DARPA High-Assurance Cyber Military Systems (HACMS) program, which has focused on applying the science of formal methods to the formidable set of problems involved in securing cyber physical systems. The primary challenges beyond HACMS in developing this toolkit were to make the new technology usable by control system engineers and compatible with the regulatory and commercial constraints of the nuclear power industry. The toolkit, packaged as amore » Simulink add-on, allows a system designer to assemble a high-assurance component from formally specified and proven blocks and generate provably correct control and monitor code for that subsystem.« less
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2000-10-18
During Super Safety and Health Day at KSC, keynote speaker Dr. Beck Weathers is given a memento of his visit by Center Director Roy Bridges. Weathers spoke about his ordeal of surviving the 1996 Mt. Everest disaster and the lessons learned from the experience. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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Dependent seniors garment design
NASA Astrophysics Data System (ADS)
Caldas, A. L.; Carvalho, M. A.; Lopes, H. P.
2017-10-01
This paper is part of a PhD research in Textile Engineering at University of Minho and aims to establish an ergonomic pattern design methodology to be used in the construction of garments for elderly women, aged 65 and over, dependent of care. The research was developed with a close contact with four institutions involved in supporting this aged population, located in the cities of Guimarães (Portugal) and Teresina (Brazil). These clothes should be adequate to their anthropometrics and their special needs, in accordance with important functional factors for the dependency of their caregiver, such as: care for the caregiver and comfort for the user. Questions regarding the functional properties of the materials, the pattern design process, trimmings and the assembling process of the garments are specially considered in the desired comfort levels, in order to provide an adequate handling by facilitating the dressing and undressing tasks, but also to assure the user the needed comfort in all its variables.
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2000-10-18
During Super Safety and Health Day at KSC, keynote speaker Dr. Beck Weathers grimaces over the satellite photo of Mt. Everest being presented by Center Director Roy Bridges. Weathers spoke about his ordeal of surviving the 1996 Mt. Everest disaster and the lessons learned from the experience. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
During Super Safety and Health Day at KSC, keynote speaker Dr. Beck Weathers is given a memento of his visit by Center Director Roy Bridges. Weathers spoke about his ordeal of surviving the 1996 Mt. Everest disaster and the lessons learned from the experience. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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2000-10-18
During Super Safety and Health Day at KSC, keynote speaker Dr. Beck Weathers grimaces over the satellite photo of Mt. Everest being presented by Center Director Roy Bridges. Weathers spoke about his ordeal of surviving the 1996 Mt. Everest disaster and the lessons learned from the experience. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is “Safety and Health First.” KSC’s number one goal is to “Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.
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Allegrante, John P; Barry, Margaret M; Auld, M Elaine; Lamarre, Marie-Claude; Taub, Alyson
2009-06-01
The interest in competencies, standards, and quality assurance in the professional preparation of public health professionals whose work involves health promotion and health education dates back several decades. In Australia, Europe, and North America, where the interest in credentialing has gained momentum, there have been rapidly evolving efforts to codify competencies and standards of practice as well as the processes by which quality and accountability can be ensured in academic professional preparation programs. The Galway Consensus Conference was conceived as a first step in an effort to explore the development of an international consensus regarding the core competencies of health education specialists and professionals in health promotion and the commonalities and differences in establishing uniform standards for the accreditation of academic professional preparation programs around the world. This article describes the purposes, objectives, and process of the Galway Consensus Conference and the background to the meeting that was convened.
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Reference dosimeter system of the iaea
NASA Astrophysics Data System (ADS)
Mehta, Kishor; Girzikowsky, Reinhard
1995-09-01
Quality assurance programmes must be in operation at radiation processing facilities to satisfy national and international Standards. Since dosimetry has a vital function in these QA programmes, it is imperative that the dosimetry systems in use at these facilities are well calibrated with a traceability to a Primary Standard Dosimetry Laboratory. As a service to the Member States, the International Atomic Energy Agency operates the International Dose Assurance Service (IDAS) to assist in this process. The transfer standard dosimetry system that is used for this service is based on ESR spectrometry. The paper describes the activities undertaken at the IAEA Dosimetry Laboratory to establish the QA programme for its reference dosimetry system. There are four key elements of such a programme: quality assurance manual; calibration that is traceable to a Primary Standard Dosimetry Laboratory; a clear and detailed statement of uncertainty in the dose measurement; and, periodic quality audit.
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7 Processes that Enable NASA Software Engineering Technologies: Value-Added Process Engineering
NASA Technical Reports Server (NTRS)
Housch, Helen; Godfrey, Sally
2011-01-01
The presentation reviews Agency process requirements and the purpose, benefits, and experiences or seven software engineering processes. The processes include: product integration, configuration management, verification, software assurance, measurement and analysis, requirements management, and planning and monitoring.
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Integration of laboratory and process testing data
Tyszkiewicz, Michael
1995-01-01
The author describes ACS Inc.'s Pro-LIMS system which integrates laboratory and process procedures. The system has been shown to be an important toolfor quality assurance in the process manufacturing industry. PMID:18924782
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Quality Assurance and Continuous Improvement: A Case Study of the University of Bahrain
ERIC Educational Resources Information Center
Al-Alawi, Yaser; Al-Kaabi, Dheya; Rashdan, Suad; Al-Khaleefa, Lobna
2009-01-01
In recent years, Bahrain has taken serious actions to diversify its sources of income and solve major national problems such as unemployment. Through this process it discovered that one of the main factors for its economic problems was the quality of higher education on offer. This led to the creation of a national Quality Assurance Authority that…
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Statistical Modeling for Radiation Hardness Assurance: Toward Bigger Data
NASA Technical Reports Server (NTRS)
Ladbury, R.; Campola, M. J.
2015-01-01
New approaches to statistical modeling in radiation hardness assurance are discussed. These approaches yield quantitative bounds on flight-part radiation performance even in the absence of conventional data sources. This allows the analyst to bound radiation risk at all stages and for all decisions in the RHA process. It also allows optimization of RHA procedures for the project's risk tolerance.
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ERIC Educational Resources Information Center
Hsieh, Chuo-Chun
2016-01-01
This paper focuses on the process and mechanism of higher education policy change related to quality assurance in a globalized world. In particular, the purpose of the study was to identify the impact of globalization on domestic policy change in Taiwan, characterized as a peripheral country. Taiwan's experience in terms of developing a national…
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The Use of the ETS Major Field Test for Assurance of Business Content Learning: Assurance of Waste?
ERIC Educational Resources Information Center
Mason, Paul M.; Coleman, B. Jay; Steagall, Jeffrey W.; Gallo, Andres A.; Fabritius, Michael M.
2011-01-01
Exit exams have become the currency of choice for both institutions and accrediting bodies seeking to demonstrate student learning. Most researchers have ignored the opportunity costs of these tests and the fundamental question of whether the exams add value to the assessment process already in place on college campuses (course testing and GPA). A…
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Software Assurance Curriculum Project Volume 2: Undergraduate Course Outlines
2010-08-01
Contents Acknowledgments iii Abstract v 1 An Undergraduate Curriculum Focus on Software Assurance 1 2 Computer Science I 7 3 Computer Science II...confidence that can be integrated into traditional software development and acquisition process models . Thus, in addition to a technology focus...testing throughout the software development life cycle ( SDLC ) AP Security and complexity—system development challenges: security failures
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Maintaining High Assurance in Asynchronous Messaging
2015-10-24
Assurance in Asynchronous Messaging Kevin E. Foltz and William R. Simpson Abstract—Asynchronous messaging is the delivery of a message without... integrity , and confidentiality guarantees. End-to-end security for asynchronous messaging must be provided by the asynchronous messaging layer itself... continuing its processing. At the completion of message transmission, the sender does not know when or whether the receiver received it. The message
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ERIC Educational Resources Information Center
Montecinos, Carmen; Madrid, Romina; Fernández, María Beatriz; Ahumada, Luis
2014-01-01
The current study examined the goal orientations that could be inferred from how teachers from six municipal schools in Chile described their understandings, emotions, and behaviors during their participation in the assessment phase of the School Management Quality Assurance System. Content analysis of focus group interview transcripts evidenced…
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Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities.
Lynch, Rob; Barabani, David; Bellorado, Kathy; Canisius, Peter; Heathcote, Doug; Johnson, Alan; Wyman, Ned; Parry, Derek Willison
2018-01-01
In multi-product biopharma facilities, the protection from product contamination due to the manufacture of multiple products simultaneously is paramount to assure product quality. To that end, the use of traditional changeover methods (elastomer change-out, full sampling, etc.) have been widely used within the industry and have been accepted by regulatory agencies. However, with the endorsement of Quality Risk Management (1), the use of risk-based approaches may be applied to assess and continuously improve established changeover processes. All processes, including changeover, can be improved with investment (money/resources), parallel activities, equipment design improvements, and standardization. However, processes can also be improved by eliminating waste. For product changeover, waste is any activity not needed for the new process or that does not provide added assurance of the quality of the subsequent product. The application of a risk-based approach to changeover aligns with the principles of Quality Risk Management. Through the use of risk assessments, the appropriate changeover controls can be identified and controlled to assure product quality is maintained. Likewise, the use of risk assessments and risk-based approaches may be used to improve operational efficiency, reduce waste, and permit concurrent manufacturing of products. © PDA, Inc. 2018.
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ERIC Educational Resources Information Center
Burton, Lindy
Three retrospective studies related children's socially inappropriate behavior to needs for approval and self assurance. Four girls and 16 boys (a sex difference of p=.006) involved in road accidents, aged 5 to 15, who were consecutively admitted to a hospital for arm and leg fractures were matched with controls. The accident children shared a…
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A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation.
Faya, Paul; Stamey, James D; Seaman, John W
2017-01-01
For manufacturers of sterile drug products, steam sterilization is a common method used to provide assurance of the sterility of manufacturing equipment and products. The validation of sterilization processes is a regulatory requirement and relies upon the estimation of key resistance parameters of microorganisms. Traditional methods have relied upon point estimates for the resistance parameters. In this paper, we propose a Bayesian method for estimation of the well-known D T , z , and F o values that are used in the development and validation of sterilization processes. A Bayesian approach allows the uncertainty about these values to be modeled using probability distributions, thereby providing a fully risk-based approach to measures of sterility assurance. An example is given using the survivor curve and fraction negative methods for estimation of resistance parameters, and we present a means by which a probabilistic conclusion can be made regarding the ability of a process to achieve a specified sterility criterion. LAY ABSTRACT: For manufacturers of sterile drug products, steam sterilization is a common method used to provide assurance of the sterility of manufacturing equipment and products. The validation of sterilization processes is a regulatory requirement and relies upon the estimation of key resistance parameters of microorganisms. Traditional methods have relied upon point estimates for the resistance parameters. In this paper, we propose a Bayesian method for estimation of the critical process parameters that are evaluated in the development and validation of sterilization processes. A Bayesian approach allows the uncertainty about these parameters to be modeled using probability distributions, thereby providing a fully risk-based approach to measures of sterility assurance. An example is given using the survivor curve and fraction negative methods for estimation of resistance parameters, and we present a means by which a probabilistic conclusion can be made regarding the ability of a process to achieve a specified sterility criterion. © PDA, Inc. 2017.
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MERCURY CEMS: TECHNOLOGY UPDATE
The paper reviews the technologies involved with continuous emission monitors (CEMs) for mercury (Hg) which are receiving incresed attention and focus. Their potential use as a compliance assurance tool is of particular interest. While Hg CEMs are currently used in Europe for com...
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48 CFR 370.302 - Types of assurances.
Code of Federal Regulations, 2011 CFR
2011-10-01
....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...
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48 CFR 370.302 - Types of assurances.
Code of Federal Regulations, 2012 CFR
2012-10-01
....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...
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48 CFR 370.302 - Types of assurances.
Code of Federal Regulations, 2010 CFR
2010-10-01
....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...
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48 CFR 370.302 - Types of assurances.
Code of Federal Regulations, 2013 CFR
2013-10-01
....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...
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48 CFR 370.302 - Types of assurances.
Code of Federal Regulations, 2014 CFR
2014-10-01
....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...
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ERIC Educational Resources Information Center
Wagner, Stacey
2001-01-01
Describes the training at the Idaho National Engineering and Environmental Laboratory, the foremost nuclear energy and environmental laboratory in the United States. Suggests that the key to assurance is getting workers, most of whom are unionized, involved in their own safety training. (JOW)
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Cheung, Carol C; D'Arrigo, Corrado; Dietel, Manfred; Francis, Glenn D; Fulton, Regan; Gilks, C Blake; Hall, Jacqueline A; Hornick, Jason L; Ibrahim, Merdol; Marchetti, Antonio; Miller, Keith; van Krieken, J Han; Nielsen, Soren; Swanson, Paul E; Taylor, Clive R; Vyberg, Mogens; Zhou, Xiaoge; Torlakovic, Emina E
2017-04-01
The numbers of diagnostic, prognostic, and predictive immunohistochemistry (IHC) tests are increasing; the implementation and validation of new IHC tests, revalidation of existing tests, as well as the on-going need for daily quality assurance monitoring present significant challenges to clinical laboratories. There is a need for proper quality tools, specifically tissue tools that will enable laboratories to successfully carry out these processes. This paper clarifies, through the lens of laboratory tissue tools, how validation, verification, and revalidation of IHC tests can be performed in order to develop and maintain high quality "fit-for-purpose" IHC testing in the era of precision medicine. This is the final part of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."
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A process to help assure successful commercial space ventures
NASA Astrophysics Data System (ADS)
Mihara, Sam K.
1999-01-01
The purpose of this paper is to describe a process for successful space business ventures-a methodology used by highly successful commercial ventures, but relatively new to space business enterprises. What do highly successful commercial business ventures have in common? How do these companies differ from most commercial space ventures? The answer is the implementation of a state-of-the-art customer satisfaction process. Take the case of the latest winners of the Malcolm Baldrige National Quality Award. What did they do that helped to achieve this performance? The answer is they implemented an effective process that measures and achieves the highest possible level of customer satisfaction. The same process can be implemented by space enterprises to achieve comparable commercial results. This paper describes the six-step process, including examples of each step. It concludes with the strong recommendation that this process be implemented to assure success in the commercial space world.
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Moore, Craig S.; Liney, Gary P.; Beavis, Andrew W.
2004-01-01
We are implementing the use of magnetic resonance (MR) images for head and neck radiotherapy planning, which involves their registration with computed tomography (CT). The quality assurance (QA) of the registration process was an initial step of this program. A phantom was built, and appropriate materials were identified to produce clinically relevant MR T1 and T2 contrast for its constituent “anatomy.” We performed a characterization of the distortion detectable within our phantom. Finally, we assessed the accuracy of image registration by contouring structures in the registered/fused data sets using the treatment planning system. Each structure was contoured using each modality, in turn, blind of the other. The position, area, and perimeter of each structure were assessed as a measure of accuracy of the entire image registration process. Distortion effects in the MR image were shown to be minimized by choosing a suitable (≥±30 kHz) receiver bandwidth. Remaining distortion was deemed clinically acceptable within ±15 cm of the magnetic field isocenter. A coefficient of agreement (A) analysis gave values to be within 9% of unity, where A=RaRp and Ra/p is the ratio of the area/perimeter of a particular structure on CT to that on MR. The center of each structure of interest agreed to within 1.8 mm. A QA process has been developed to assess the accuracy of using multimodality image registration in the planning of radiotherapy for the head and neck; we believe its introduction is feasible and safe. PACS numbers: 87.53.Xd, 87.57.Gg, 87.59.Fm; 87.61.‐c, 87.66.Xa PMID:15753931
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Davis, Gregory C; Beals, John M; Johnson, Craig; Mayer, Mark H; Meiklejohn, Bruce I; Mitlak, Bruce H; Roth, Jody L; Towns, John K; Veenhuizen, Melissa
2009-07-01
Policy makers around the world are currently considering the creation of a regulatory pathway for follow-on biologics (FOB), which will have to account for the substantial technical challenges associated with FOB development. These challenges will likely involve more complexity than comparability assessments of process changes made by the same manufacturer. The history of industry-regulator comparability discussions helps explain why the same degree of testing and flexibility now applied to change-control within a manufacturer's own process, at this time, cannot be extrapolated to the observed and possibly unknown differences between two manufacturing processes that are independently developed by different (non-collaborating) parties. This commentary provides recommendations on the technical aspects that should be considered in the creation of an approval pathway for FOB products. In the authors' view, analytical methodology in its current state cannot alone provide full assurance that the FOB is sufficiently similar to the innovator product. Moreover, the FOB manufacturer will not have access to the extensive knowledge accumulated by the innovator manufacturer from early development through marketing. Thus, extensive clinical evaluation will likely be necessary to provide assurance that the FOB is safe and efficacious. If such testing demonstrates the FOB is safe and efficacious per existing regulatory standards, the product should receive marketing approval as a 'similar' product. Since 'similarity' is a fundamentally different determination than establishing interchangeability between the two products, an interchangeability determination must be based on additional testing and market experience to ensure patient safety. Post-marketing surveillance of the FOB should be conducted to ensure that the approved molecule has similar clinical safety and efficacy as the innovator product, prior to any consideration of interchangeability.
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10 CFR 71.119 - Control of special processes.
Code of Federal Regulations, 2010 CFR
2010-01-01
... shall establish measures to assure that special processes, including welding, heat treating, and nondestructive testing are controlled and accomplished by qualified personnel using qualified procedures in...
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2009-02-25
CAPE CANAVERAL, Fla. – NASA's Chief Safety and Mission Assurance Officer, Bryan D. O'Connor (left), presents a Quality and Safety Achievement Recognition, or QASAR, award for 2008 to Steven M. Davis (center). Davis, an employee of the Defense Contract Management Agency at NASA's Kennedy Space Center, received the award for his attention to detail in an incident involving a space shuttle solid rocket booster. At right is Dr. Michael Ryschkewitsch, NASA's chief engineer. Davis received the award at NASA's sixth annual Project Management Challenge in Daytona Beach, Fla. The QASAR award recognizes individual government and contractor employees who have demonstrated exemplary performance in contributing to the quality and/or safety of products, services, processes or management programs and activities. Photo credit: NASA/Ben Smegelsky
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Norman, Kay
2015-12-01
This article explores the concept and processes involved in professional socialisation and how mentors and nurse managers can help to foster positive aspects of this in their practice. Positive professional socialisation needs champions to instil fundamental professional values and behaviours in nursing staff, and managers need to support mentors to influence and lead the way in promoting standards of excellence in the nursing profession to assure public trust and confidence, and ultimately patient safety. The time out activities will ask you to consider and develop possible strategies to help support mentors and staff, and aim to encourage you to explore the potential benefits of positive professional socialisation for your team in delivering high quality patient care.
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Gietelink, Lieke; Wouters, Michel W J M; Tanis, Pieter J; Deken, Marion M; Ten Berge, Martijn G; Tollenaar, Rob A E M; van Krieken, J Han; de Noo, Mirre E
2015-09-01
The circumferential resection margin (CRM) is a significant prognostic factor for local recurrence, distant metastasis, and survival after rectal cancer surgery. Therefore, availability of this parameter is essential. Although the Dutch total mesorectal excision trial raised awareness about CRM in the late 1990s, quality assurance on pathologic reporting was not available until the Dutch Surgical Colorectal Audit (DSCA) started in 2009. The present study describes the rates of CRM reporting and involvement since the start of the DSCA and analyzes whether improvement of these parameters can be attributed to the audit. Data from the DSCA (2009-2013) were analyzed. Reporting of CRM and CRM involvement was plotted for successive years, and variations of these parameters were analyzed in a funnelplot. Predictors of CRM involvement were determined in univariable analysis and the independent influence of year of registration on CRM involvement was analyzed in multivariable analysis. A total of 12,669 patients were included for analysis. The mean percentage of patients with a reported CRM increased from 52.7% to 94.2% (2009-2013) and interhospital variation decreased. The percentage of patients with CRM involvement decreased from 14.2% to 5.6%. In multivariable analysis, the year of DSCA registration remained a significant predictor of CRM involvement. After the introduction of the DSCA, a dramatic improvement in CRM reporting and a major decrease of CRM involvement after rectal cancer surgery have occurred. This study suggests that a national quality assurance program has been the driving force behind these achievements. Copyright © 2015 by the National Comprehensive Cancer Network.
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Monitoring radiation use in cardiac fluoroscopy imaging procedures
DOE Office of Scientific and Technical Information (OSTI.GOV)
Stevens, Nathaniel T.; Steiner, Stefan H.; Smith, Ian R.
2011-01-15
Purpose: Timely identification of systematic changes in radiation delivery of an imaging system can lead to a reduction in risk for the patients involved. However, existing quality assurance programs involving the routine testing of equipment performance using phantoms are limited in their ability to effectively carry out this task. To address this issue, the authors propose the implementation of an ongoing monitoring process that utilizes procedural data to identify unexpected large or small radiation exposures for individual patients, as well as to detect persistent changes in the radiation output of imaging platforms. Methods: Data used in this study were obtainedmore » from records routinely collected during procedures performed in the cardiac catheterization imaging facility at St. Andrew's War Memorial Hospital, Brisbane, Australia, over the period January 2008-March 2010. A two stage monitoring process employing individual and exponentially weighted moving average (EWMA) control charts was developed and used to identify unexpectedly high or low radiation exposure levels for individual patients, as well as detect persistent changes in the radiation output delivered by the imaging systems. To increase sensitivity of the charts, we account for variation in dose area product (DAP) values due to other measured factors (patient weight, fluoroscopy time, and digital acquisition frame count) using multiple linear regression. Control charts are then constructed using the residual values from this linear regression. The proposed monitoring process was evaluated using simulation to model the performance of the process under known conditions. Results: Retrospective application of this technique to actual clinical data identified a number of cases in which the DAP result could be considered unexpected. Most of these, upon review, were attributed to data entry errors. The charts monitoring the overall system radiation output trends demonstrated changes in equipment performance associated with relocation of the equipment to a new department. When tested under simulated conditions, the EWMA chart was capable of detecting a sustained 15% increase in average radiation output within 60 cases (<1 month of operation), while a 33% increase would be signaled within 20 cases. Conclusions: This technique offers a valuable enhancement to existing quality assurance programs in radiology that rely upon the testing of equipment radiation output at discrete time frames to ensure performance security.« less
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Testing of optical components to assure performance in a high-average-power environment
NASA Astrophysics Data System (ADS)
Chow, Robert; Taylor, John R.; Eickelberg, William K.; Primdahl, Keith A.
1997-11-01
Evaluation and testing of the optical components used in the atomic vapor laser isotope separation plant is critical for qualification of suppliers, developments of new optical multilayer designs and manufacturing processes, and assurance of performance in the production cycle. The range of specifications requires development of specialized test equipment and methods which are not routine or readily available in industry. Specifications are given on material characteristics such as index homogeneity, subsurface damage left after polishing, microscopic surface defects and contamination, coating absorption, and high average power laser damage. The approach to testing these performance characteristics and assuring the quality throughout the production cycle is described.
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Quality Assurance Systems in Education and Training in Europe
NASA Astrophysics Data System (ADS)
Voinia, Claudiu Sorin; Tuşa, Ana; Simion, Carmen
2014-11-01
Member States have a duty to compare and learn more about the national education and professional training. The objectives of this paper were to identify specific characteristics, developments and highlighting key priorities in coordinating the development of specific quality assurance processes in the European Union. The aim of this work was to present the quality assurance systems in vocational education and training systems in the Member States of the European Union. The results were to identify the extent to which national initiatives of EU member States show interest in the quality of education. Data from research can be useful in developing strategic sector development programs, and local schools
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Scarinci, Isabel C; Moore, Artisha; Benjamin, Regina; Vickers, Selwyn; Shikany, James; Fouad, Mona
2017-02-01
We describe the formulation and implementation of a participatory evaluation plan for three Transdisciplinary Collaborative Centers for Health Disparities Research funded by the National Institute of Minority Health and Health Disparities. Although different in scope of work, all three centers share a common goal of establishing sustainable centers in health disparities science in three priority areas - social determinants of health, men's health research, and health policy research. The logic model guides the process, impact, and outcome evaluation. Emphasis is placed on process evaluation in order to establish a "blue print" that can guide other efforts as well as assure that activities are being implemented as planned. We have learned three major lessons in this process: (1) Significant engagement, participation, and commitment of all involved is critical for the evaluation process; (2) Having a "roadmap" (logic model) and "directions" (evaluation worksheets) are instrumental in getting members from different backgrounds to follow the same path; and (3) Participation of the evaluator in the leadership and core meetings facilitates continuous feedback. Copyright © 2016 Elsevier Ltd. All rights reserved.
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Fast algorithm for spectral processing with application to on-line welding quality assurance
NASA Astrophysics Data System (ADS)
Mirapeix, J.; Cobo, A.; Jaúregui, C.; López-Higuera, J. M.
2006-10-01
A new technique is presented in this paper for the analysis of welding process emission spectra to accurately estimate in real-time the plasma electronic temperature. The estimation of the electronic temperature of the plasma, through the analysis of the emission lines from multiple atomic species, may be used to monitor possible perturbations during the welding process. Unlike traditional techniques, which usually involve peak fitting to Voigt functions using the Levenberg-Marquardt recursive method, sub-pixel algorithms are used to more accurately estimate the central wavelength of the peaks. Three different sub-pixel algorithms will be analysed and compared, and it will be shown that the LPO (linear phase operator) sub-pixel algorithm is a better solution within the proposed system. Experimental tests during TIG-welding using a fibre optic to capture the arc light, together with a low cost CCD-based spectrometer, show that some typical defects associated with perturbations in the electron temperature can be easily detected and identified with this technique. A typical processing time for multiple peak analysis is less than 20 ms running on a conventional PC.
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Shiver, Stacy A; Schmitt, Karla; Cooksey, Adrian
2009-01-01
The business of sexually transmitted disease (STD) prevention and control demands technology that is capable of supporting a wide array of program activities-from the processing of laboratory test results to the complex and confidential process involved in contact investigation. The need for a tool that enables public health officials to successfully manage the complex operations encountered in an STD prevention and control program, and the need to operate in an increasingly poor resource environment, led the Florida Bureau of STD to develop the Patient Reporting Investigation Surveillance Manager. Its unique approach, technical architecture, and sociotechnical philosophy have made this business application successful in real-time monitoring of disease burden for local communities, identification of emerging outbreaks, monitoring and assurance of appropriate treatments, improving access to laboratory data, and improving the quality of data for epidemiologic analysis. Additionally, the effort attempted to create and release a product that promoted the Centers for Disease Control and Prevention's ideas for integration of programs and processes.
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Gabardi, Steven; Tichy, Eric M
2013-03-01
To review the components of the Congressional mandate for risk evaluation and mitigation strategies (REMS) managed by the Food and Drug Administration and assess their impact on health care providers practicing within the organ transplant arena. A non-date-limited search of MEDLINE and EMBASE (January 2007-June 2012) was conducted by using the following search terms: risk evaluation and mitigation strategies, REMS, and organ transplant, including a query of the individual organs. Information from the Federal Register and the Food and Drug Administration was also evaluated. REMS are strategies implemented to manage known or potential risks associated with medications and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product. Elements of REMS programs may consist of 3 levels: a medication guide, communication plan, and elements to assure safe use. A medication guide is used to help prevent serious adverse events, aid in patients' decision making, and enhance medication adherence. Communication plans help educate health care providers and encourage adherence with REMS. The elements to assure safe use is a restrictive process implemented when it is deemed necessary to ensure safe access for patients to products with known serious risks. In transplant medicine, REMS currently exist for belatacept (medication guide and communication plan) and the mycophenolic acid derivatives (medication guide and elements to assure safe use). REMS are another step in the evolution of the development and marketing of pharmaceutical agents. Use of REMS in solid-organ transplant is becoming common. Transplant clinicians must provide required patient education and become involved with other aspects of REMS implementation to reduce the serious risks of pharmaceuticals and to improve patients' outcomes.
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Software Assurance Curriculum Project Volume 1: Master of Software Assurance Reference Curriculum
2010-08-01
activity by providing a check on the relevance and currency of the process used to develop the MSwA2010 curriculum content. Figure 2 is an expansion of...random oracle model, symmetric crypto primitives, modes of operations, asymmetric crypto primitives (Chapter 5) [16] Detailed design...encryption, public key encryption, digital signatures, message authentication codes, crypto protocols, cryptanalysis, and further detailed crypto
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NASA Technical Reports Server (NTRS)
1976-01-01
The quality assurance program demonstrates recognition of the quality aspects and an organized approach to achieve them. It ensures that quality requirements are determined and satisfied throughout all phases of contract performance, including preliminary and engineering design, development, fabrication, processing, assembly, inspection, test, checkout, packaging, shipping, storage, maintenance field use, flight preparations, flight operations and post-flight analysis, as applicable.
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ERIC Educational Resources Information Center
Maxime, Francoise; Maze, Armelle
2006-01-01
This article aims to study the design and the organization of auditing systems to develop environmental or quality assurance schemes at the farm level and the role that extension services could play in these processes. It starts by discussing the issue of combining auditing and advisory activities and developing auditing competences. Empirical…
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International role of US geoscience
NASA Technical Reports Server (NTRS)
1987-01-01
Geologic processes are global in scope and no country or continent has areas that encompass all the phonomena. Joint participation between U.S. and foreign scientists is indispensable for advancing basic scientific concepts and their application to economic and policy issues in the U.S. Up-to-date knowledge is critical to assure an adequate flow of industrial minerals and to assure an adequate supply of strategic minerals.
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1998-01-01
such as central processing unit (CPU) usage, disk input/output (I/O), memory usage, user activity, and number of logins attempted. The statistics... EMERALD Commercial anomaly detection, system monitoring SRI porras@csl.sri.com www.csl.sri.com/ emerald /index. html Gabriel Commercial system...sensors, it starts to protect the network with minimal configuration and maximum intelligence. T 11 EMERALD TITLE EMERALD (Event Monitoring
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Quality Assurance Assessment of the F-35 Lightning II Program
2013-09-30
assurance personnel had not verified epoxy primer, urethane topcoat, and abrasion - resistant coating processes. In another case, there was no indication...other for electrical resistance . A review of drawing requirements and discussions Contractor Assessments DODIG-2013-140 │ 11 with personnel noted that...the operators were not required to perform the electrical resistance verification, even though it was later determined to be required. Finally, the
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ERIC Educational Resources Information Center
Campos, Bartolo
2004-01-01
The accreditation systems of higher education institutions and/or programs are becoming a policy measure used to find a balance between their autonomy and public assurance concerning the quality of the qualifications they award. This article analyses, from the point of view of this balance of power, the process of development of the Portuguese…
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Quality Assurance for Postgraduate Programs: Design of a Model Applied on a University in Chile
ERIC Educational Resources Information Center
Careaga Butter, Marcelo; Meyer Aguilera, Eduardo; Badilla Quintana, María Graciela; Jiménez Pérez, Laura; Sepúlveda Valenzuela, Eileen
2017-01-01
The quality of Education in Chile is a controversial topic that has been in the public debate in the last several years. To ensure quality in graduate programs, accreditation is compulsory. The current article presents a model to improve the process of self-regulation. The main objective was to design a Model of Quality Assurance for Postgraduate…
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ERIC Educational Resources Information Center
Khan, Wasi Uz Zaman; AlAjmi, Abdullah Ahmed Ali; Al Zubaidy, Sarim
2018-01-01
This case study was undertaken to assess the effectiveness of the modifications into the engineering programmes adopted by the Military Technological College (MTC) to satisfy the needs of Omani armed forces. It discusses the role of Quality Assurance (QA) in engineering education and accreditation process in the context of four engineering…
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Clinical audit: shining a light on good practice.
Grainger, Angela
2010-07-01
Healthcare organisations undertake quality assurance to produce safe and effective patient care systems. Statutory quality assurance requirements are met through external reviews, monitoring and inspection processes, and each NHS trust must produce a corporate annual quality account. However, this can result in approaching audits as if they are 'tick-box activities'. This article discusses how organisations can avoid this trap by applying audit results to practice.