Integrating Safety and Mission Assurance into Systems Engineering Modeling Practices

NASA Technical Reports Server (NTRS)

Beckman, Sean; Darpel, Scott

2015-01-01

During the early development of products, flight, or experimental hardware, emphasis is often given to the identification of technical requirements, utilizing such tools as use case and activity diagrams. Designers and project teams focus on understanding physical and performance demands and challenges. It is typically only later, during the evaluation of preliminary designs that a first pass, if performed, is made to determine the process, safety, and mission quality assurance requirements. Evaluation early in the life cycle, though, can yield requirements that force a fundamental change in design. This paper discusses an alternate paradigm for using the concepts of use case or activity diagrams to identify safety hazard and mission quality assurance risks and concerns using the same systems engineering modeling tools being used to identify technical requirements. It contains two examples of how this process might be used in the development of a space flight experiment, and the design of a Human Powered Pizza Delivery Vehicle, along with the potential benefits to decrease development time, and provide stronger budget estimates.

Organizing safety: conditions for successful information assurance programs.

PubMed

Collmann, Jeff; Coleman, Johnathan; Sostrom, Kristen; Wright, Willie

2004-01-01

Organizations must continuously seek safety. When considering computerized health information systems, "safety" includes protecting the integrity, confidentiality, and availability of information assets such as patient information, key components of the technical information system, and critical personnel. "High Reliability Theory" (HRT) argues that organizations with strong leadership support, continuous training, redundant safety mechanisms, and "cultures of high reliability" can deploy and safely manage complex, risky technologies such as nuclear weapons systems or computerized health information systems. In preparation for the Health Insurance Portability and Accountability Act (HIPAA) of 1996, the Office of the Assistant Secretary of Defense (Health Affairs), the Offices of the Surgeons General of the United States Army, Navy and Air Force, and the Telemedicine and Advanced Technology Research Center (TATRC), US Army Medical Research and Materiel Command sponsored organizational, doctrinal, and technical projects that individually and collectively promote conditions for a "culture of information assurance." These efforts include sponsoring the "P3 Working Group" (P3WG), an interdisciplinary, tri-service taskforce that reviewed all relevant Department of Defense (DoD), Miliary Health System (MHS), Army, Navy and Air Force policies for compliance with the HIPAA medical privacy and data security regulations; supporting development, training, and deployment of OCTAVE(sm), a self-directed information security risk assessment process; and sponsoring development of the Risk Information Management Resource (RIMR), a Web-enabled enterprise portal about health information assurance.

Assuring bridge safety and serviceability in Europe

DOT National Transportation Integrated Search

2010-08-01

U.S. engineers need advanced tools and protocols to better assess and assure safety and serviceability of bridges. The Federal Highway Administration, American Association of State Highway and Transportation Officials, and National Cooperative Highwa...

The role of microbiological testing in systems for assuring the safety of beef.

PubMed

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.

23 CFR Appendix C to Part 1200 - ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM

Code of Federal Regulations, 2013 CFR

2013-04-01

... 23 Highways 1 2013-04-01 2013-04-01 false ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM C APPENDIX C... STATE HIGHWAY SAFETY GRANT PROGRAMS Pt. 1200, App. C APPENDIX C TO PART 1200—ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM State: Fiscal Year: The State has elected to implement a Teen Traffic Safety Program—a...

23 CFR Appendix C to Part 1200 - Assurances for Teen Traffic Safety Program

Code of Federal Regulations, 2014 CFR

2014-04-01

... 23 Highways 1 2014-04-01 2014-04-01 false Assurances for Teen Traffic Safety Program C Appendix C... STATE HIGHWAY SAFETY GRANT PROGRAMS Pt. 1200, App. C Appendix C to Part 1200—Assurances for Teen Traffic Safety Program State: Fiscal Year: The State has elected to implement a Teen Traffic Safety Program—a...

Bayesian assurance and sample size determination in the process validation life-cycle.

PubMed

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.

Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

NASA Technical Reports Server (NTRS)

Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline

2010-01-01

We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.

Office of Safety and Mission Assurance Review Report

NASA Technical Reports Server (NTRS)

2000-01-01

This document summarizes questions and concerns raised during the 1999 IV&V Facility's Annual Review Presentation to the Office of Safety and Mission Assurance (OSMA). Recommendations are provided for issues and action items identified.

Safety assurance and compliance program (SACP) : accomplishments for CY 2001

DOT National Transportation Integrated Search

2002-08-01

This recent research report by the Federal Railroad Administration (FRA), posted online, provides ease of access to information on the Safety Assurance and Compliance Program. The FRA promotes and helps ensure the safety of the nation's railroad indu...

Changing the Safety and Mission Assurance (S and MA) Paradigm

NASA Technical Reports Server (NTRS)

Malone, Roy W.; Safie, Fayssal M.

2010-01-01

This slide presentation reviews the change in the work and impact of the Safety and Mission Assurance directorate at Marshall Space Flight Center. It reviews the background and the reasons given for a strong Safety & Mission Assurance presence in all planning for space flight. This was pointed out by the Rogers Commission Report after the Space Challenger accident, by the Columbia Accident Investigation Board (CAIB) and by a 2006 NASA Exploration Safety Study (NESS) Team. The overall objective of the work in this area was to improve and maintain S&MA expertise and skills. Training for this work was improved and the S&MA organization was reorganized. This has resulted in a paradigm shift for NASA's safety efforts, which is described. The presentation then reviews the impact of the new S&MA work in the Ares I design and development.

Safety and Mission Assurance Knowledge Management Retention: Managing Knowledge for Successful Mission Operations

NASA Technical Reports Server (NTRS)

Johnson, Teresa A.

2006-01-01

Knowledge Management is a proactive pursuit for the future success of any large organization faced with the imminent possibility that their senior managers/engineers with gained experiences and lessons learned plan to retire in the near term. Safety and Mission Assurance (S&MA) is proactively pursuing unique mechanism to ensure knowledge learned is retained and lessons learned captured and documented. Knowledge Capture Event/Activities/Management helps to provide a gateway between future retirees and our next generation of managers/engineers. S&MA hosted two Knowledge Capture Events during 2005 featuring three of its retiring fellows (Axel Larsen, Dave Whittle and Gary Johnson). The first Knowledge Capture Event February 24, 2005 focused on two Safety and Mission Assurance Safety Panels (Space Shuttle System Safety Review Panel (SSRP); Payload Safety Review Panel (PSRP) and the latter event December 15, 2005 featured lessons learned during Apollo, Skylab, and Space Shuttle which could be applicable in the newly created Crew Exploration Vehicle (CEV)/Constellation development program. Gemini, Apollo, Skylab and the Space Shuttle promised and delivered exciting human advances in space and benefits of space in people s everyday lives on earth. Johnson Space Center's Safety & Mission Assurance team work over the last 20 years has been mostly focused on operations we are now beginning the Exploration development program. S&MA will promote an atmosphere of knowledge sharing in its formal and informal cultures and work processes, and reward the open dissemination and sharing of information; we are asking "Why embrace relearning the "lessons learned" in the past?" On the Exploration program the focus will be on Design, Development, Test, & Evaluation (DDT&E); therefore, it is critical to understand the lessons from these past programs during the DDT&E phase.

Technical Excellence and Communication: The Cornerstones for Successful Safety and Mission Assurance Programs

NASA Technical Reports Server (NTRS)

Malone, Roy W.; Livingston, John M.

2010-01-01

The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center (MSFC) Safety and Mission Assurance (S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.

Technical Excellence and Communication, the Cornerstones for Successful Safety and Mission Assurance Programs

NASA Astrophysics Data System (ADS)

Malone, Roy W.; Livingston, John M.

2010-09-01

The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center(MSFC) Safety and Mission Assurance(S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization’s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.

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.

30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Safety and pollution prevention equipment... Gas Production Safety Systems § 250.806 Safety and pollution prevention equipment quality assurance... install only certified safety and pollution prevention equipment (SPPE) in wells located on the OCS. SPPE...

Healthcare software assurance.

PubMed

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.

Healthcare Software Assurance

PubMed Central

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

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.

Assuring safety without animal testing: Unilever's ongoing research programme to deliver novel ways to assure consumer safety.

PubMed

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).

Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the System-Wide Safety and Assurance Technologies Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2015-01-01

The Aviation Safety Program (AvSP) System-Wide Safety and Assurance Technologies (SSAT) Project asked the AvSP Systems and Portfolio Analysis Team to identify SSAT-related trends. SSAT had four technical challenges: advance safety assurance to enable deployment of NextGen systems; automated discovery of precursors to aviation safety incidents; increasing safety of human-automation interaction by incorporating human performance, and prognostic algorithm design for safety assurance. This report reviews incident data from the NASA Aviation Safety Reporting System (ASRS) for system-component-failure- or-malfunction- (SCFM-) related and human-factor-related incidents for commercial or cargo air carriers (Part 121), commuter airlines (Part 135), and general aviation (Part 91). The data was analyzed by Federal Aviation Regulations (FAR) part, phase of flight, SCFM category, human factor category, and a variety of anomalies and results. There were 38 894 SCFM-related incidents and 83 478 human-factorrelated incidents analyzed between January 1993 and April 2011.

Challenges of assuring crew safety in space shuttle missions with international cargoes.

PubMed

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.

Safety and Mission Assurance Knowledge Management Retention

NASA Technical Reports Server (NTRS)

Johnson, Teresa A.

2006-01-01

This viewgraph presentation reviews the issues surrounding the management of knowledge in regards to safety and mission assurance. The JSC workers who were hired in the 1960's are slated to retire in the next two to three years. The experiences and knowledge of these NASA workers must be identified, and disseminated. This paper reviews some of the strategies that the S&MA is developing to capture that valuable institutional knowledge.

Software assurance standard

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.

Assessment of the State-of-the-Art of System-Wide Safety and Assurance Technologies

NASA Technical Reports Server (NTRS)

Roychoudhury, Indranil; Reveley, Mary S.; Phojanamongkolkij, Nipa; Leone, Karen M.

2017-01-01

Since its initiation, the System-wide Safety Assurance Technologies (SSAT) Project has been focused on developing multidisciplinary tools and techniques that are verified and validated to ensure prevention of loss of property and life in NextGen and enable proactive risk management through predictive methods. To this end, four technical challenges have been listed to help realize the goals of SSAT, namely (i) assurance of flight critical systems, (ii) discovery of precursors to safety incidents, (iii) assuring safe human-systems integration, and (iv) prognostic algorithm design for safety assurance. The objective of this report is to provide an extensive survey of SSAT-related research accomplishments by researchers within and outside NASA to get an understanding of what the state-of-the-art is for technologies enabling each of the four technical challenges. We hope that this report will serve as a good resource for anyone interested in gaining an understanding of the SSAT technical challenges, and also be useful in the future for project planning and resource allocation for related research.

Assuring fish safety and quality in international fish trade.

PubMed

Ababouch, Lahsen

2006-01-01

International trade in fishery commodities reached US 58.2 billion dollars in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US 17.4 billion dollars in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building.

30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 2 2011-07-01 2011-07-01 false Safety and pollution prevention equipment... pollution prevention equipment quality assurance requirements. (a) General requirements. (1) Except as provided in paragraph (b)(1) of this section, you may install only certified safety and pollution...

The FAA's Approach to Quality Assurance in the Flight Safety Analysis of Launch and Reentry Vehicles

NASA Astrophysics Data System (ADS)

Murray, Daniel P.; Weil, Andre

2010-09-01

The U.S. Federal Aviation Administration(FAA) Office of Commercial Space Transportation’s safety mission is to ensure protection of the public, property, and the national security and foreign policy interests of the United States during commercial launch and reentry activities. As part of this mission, the FAA issues licenses to the operators of launch and reentry vehicles who successfully demonstrate compliance with FAA regulations. To meet these regulations, vehicle operators submit an application that contains, among other things, flight safety analyses of their proposed missions. In the process of evaluating these submitted analyses, the FAA often conducts its own independent analyses, using input data from the submitted license application. These analyses are conducted according to approved procedures using industry developed tools. To assist in achieving the highest levels of quality in these independent analyses, the FAA has developed a quality assurance program that consists of multiple levels of review. These reviews rely on the work of multiple teams, as well as additional, independently performed work of support contractors. This paper describes the FAA’s quality assurance process for flight safety analyses. Members of the commercial space industry may find that elements of this process can be easily applied to their own analyses, improving the quality of the material they submit to the FAA in their license applications.

Adapting viral safety assurance strategies to continuous processing of biological products.

PubMed

Johnson, Sarah A; Brown, Matthew R; Lute, Scott C; Brorson, Kurt A

2017-01-01

There has been a recent drive in commercial large-scale production of biotechnology products to convert current batch mode processing to continuous processing manufacturing. There have been reports of model systems capable of adapting and linking upstream and downstream technologies into a continuous manufacturing pipeline. However, in many of these proposed continuous processing model systems, viral safety has not been comprehensively addressed. Viral safety and detection is a highly important and often expensive regulatory requirement for any new biological product. To ensure success in the adaption of continuous processing to large-scale production, there is a need to consider the development of approaches that allow for seamless incorporation of viral testing and clearance/inactivation methods. In this review, we outline potential strategies to apply current viral testing and clearance/inactivation technologies to continuous processing, as well as modifications of existing unit operations to ensure the successful integration of viral clearance into the continuous processing of biological products. Biotechnol. Bioeng. 2017;114: 21-32. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Work Done For the Safety and Assurance Directorate

NASA Technical Reports Server (NTRS)

Struhar, Paul T., Jr.

2004-01-01

The Safety and Assurance Directorate (SAAD) has a vision. The vision is to be an essential part of NASA Glenn's journey to excellence. SAAD is in charge of leading safety, security, and quality and is important to our customers. When it comes to programmatic and technical decision making and implementation, SAAD provides clear safety, reliability, maintainable, quality assurance and security. I worked on a couple different things during my internship with Sandra Hardy. I did a lot of logistics for meeting and trips. I helped run the budget for the SAAD directorate. I also worked with Rich Miller for one week and we took water samples and ran tests. We also calibrated the different equipment. There is a lot more to meetings than people see. I did one for a retirement party. I had to get work orders and set up the facilities where the event is going to take place. I also set up a trip to Plum Brook Station. I had to order vans and talk with the people up there to see when a good time was. I also had to make invitations and coordinate everything. I also help Sandy run the numbers in the budget. We use excel to do this, which makes it a lot easier. things. He is in the environmental safety office. I learned how to collaborate the equipment using alpha and beta sources. I went out with him and we took water samples and tested them for conductivity and chlorine. I have learned a lot in the short time I've been here. It has been a great experience and I have has the pleasure of meeting and working with great people.

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.

Process-Based Mission Assurance- Knowledge Management System

NASA Astrophysics Data System (ADS)

Kantzes, Zachary S.; Wander, Stephen; Otero, Suzanne; Vantine, William; Stuart, Richard

2005-12-01

The Process-Based Mission Assurance - Knowledge Management System (PBMA-KMS) implemented at the National Aeronautics and Space Administration (NASA) focuses on the practical application of the knowledge management (KM) theory and is based on a systems engineering management approach coupled to a continual improvement and risk management philosophy. Not to be confused with an Agency mandate, an intense focus has been placed on grassroots input to the future of the product. By providing emphasis to both Agency safety and mission success objectives and individual users' needs, the PBMA-KMS team has been able to be both reactive to Agency requirements and proactive to the needs of the community.PBMA-KMS is an excellent case study on how to use new approaches to facilitate and integrate safety into the culture of an organization. Principle discussion topics include: • Overarching themes,• Tactical approaches,• Highlights of key functionalities, and• Agency KM approach of managed Darwinism.PBMA-KMS can show how, by providing top-level guidance along with the necessary tools and support, the organization not only receives immediate value, but the long-ranging benefits of a more experienced, effective, and engaged workforce.

John F. Kennedy Space Center, Safety, Reliability, Maintainability and Quality Assurance, Survey and Audit Program

NASA Technical Reports Server (NTRS)

1994-01-01

This document is the product of the KSC Survey and Audit Working Group composed of civil service and contractor Safety, Reliability, and Quality Assurance (SR&QA) personnel. The program described herein provides standardized terminology, uniformity of survey and audit operations, and emphasizes process assessments rather than a program based solely on compliance. The program establishes minimum training requirements, adopts an auditor certification methodology, and includes survey and audit metrics for the audited organizations as well as the auditing organization.

Cascade Distillation System Design for Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Sargusingh, Miriam J.; Callahan, Michael R.

2015-01-01

Per the NASA Human Health, Life Support and Habitation System Technology Area 06 report "crewed missions venturing beyond Low-Earth Orbit (LEO) will require technologies with improved reliability, reduced mass, self-sufficiency, and minimal logistical needs as an emergency or quick-return option will not be feasible." To meet this need, the development team of the second generation Cascade Distillation System (CDS 2.0) opted a development approach that explicitely incorporate consideration of safety, mission assurance, and autonomy. The CDS 2.0 prelimnary design focused on establishing a functional baseline that meets the CDS core capabilities and performance. The critical design phase is now focused on incorporating features through a deliberative process of establishing the systems failure modes and effects, identifying mitigative strategies, and evaluating the merit of the proposed actions through analysis and test. This paper details results of this effort on the CDS 2.0 design.

Cascade Distillation System Design for Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Sarguisingh, Miriam; Callahan, Michael R.; Okon, Shira

2015-01-01

Per the NASA Human Health, Life Support and Habitation System Technology Area 06 report "crewed missions venturing beyond Low-Earth Orbit (LEO) will require technologies with improved reliability, reduced mass, self-sufficiency, and minimal logistical needs as an emergency or quick-return option will not be feasible".1 To meet this need, the development team of the second generation Cascade Distillation System (CDS 2.0) chose a development approach that explicitly incorporate consideration of safety, mission assurance, and autonomy. The CDS 2.0 preliminary design focused on establishing a functional baseline that meets the CDS core capabilities and performance. The critical design phase is now focused on incorporating features through a deliberative process of establishing the systems failure modes and effects, identifying mitigation strategies, and evaluating the merit of the proposed actions through analysis and test. This paper details results of this effort on the CDS 2.0 design.

Practicing chemical process safety: a look at the layers of protection.

PubMed

Sanders, Roy E

2004-11-11

This presentation will review a few public perceptions of safety in chemical plants and refineries, and will compare these plant workplace risks to some of the more traditional occupations. The central theme of this paper is to provide a "within-the-fence" view of many of the process safety practices that world class plants perform to pro-actively protect people, property, profits as well as the environment. It behooves each chemical plant and refinery to have their story on an image-rich presentation to stress stewardship and process safety. Such a program can assure the company's employees and help convince the community that many layers of safety protection within our plants are effective, and protect all from harm.

Drug safety assurance through clinical genotyping: near-term considerations for a system-wide implementation of personalized medicine.

PubMed

Kane, Michael D; Springer, John A; Sprague, Jon E

2008-07-01

The rationale and overall system-wide behavior of a clinical genotyping information system (both DNA analysis and data management) requires a near-term, scalable approach, which is emerging in the focused implementation of pharmacogenomics and drug safety assurance. The challenges to implementing a successful clinical genotyping system are described, as are how the benefits of a focused, near-term system for drug safety assessment and assurance overcome the logistical and operational challenges that perpetually hinder the development of a societal-scale clinical genotyping system. This rationale is based on the premise that a focused application domain for clinical genotyping, specifically drug safety assurance, provides a transition paradigm for both professionals and consumers of healthcare, thereby facilitating the movement of genotyping from bench to bedside and paving the way for the adoption of prognostic and diagnostic applications in clinical genomics.

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.

Assurance of reliability and safety in liquid hydrocarbons marine transportation and storing

NASA Astrophysics Data System (ADS)

Korshunov, G. I.; Polyakov, S. L.; Shunmin, Li

2017-10-01

The problems of assurance of safety and reliability in the liquid hydrocarbons marine transportation and storing are described. The requirements of standard IEC61511 have to be fulfilled for the load/unload in tanker’s system under dynamic loads on the pipeline system. The safety zones for fires of the type “fireball” and the spillage have to be determined when storing the liquid hydrocarbons. An example of the achieved necessary safety level of the duplicated load system, the conditions of the pipelines reliable operation under dynamic loads, the principles of the method of the liquid hydrocarbons storage safety zones under possible accident conditions are represented.

Quality assurance of radiotherapy in cancer treatment: toward improvement of patient safety and quality of care.

PubMed

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.

Procuring interoperability at the expense of usability: a case study of UK National Programme for IT assurance process.

PubMed

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.

Feminist Heuristics: Transforming the Foundation of Food Quality and Safety Assurance Systems

ERIC Educational Resources Information Center

Kimura, Aya Hirata

2012-01-01

Food safety and quality assurance systems have emerged as a key mechanism of food governance in recent years and are also popular among alternative agrofood movements, such as the organic and fair trade movements. Rural sociologists have identified many problems with existing systems, including corporate cooptation, the marginalization of small…

One in a Million Given the Accident: Assuring Nuclear Weapon Safety

DOE Office of Scientific and Technical Information (OSTI.GOV)

Weaver, Jason

2015-08-25

Since the introduction of nuclear weapons, there has not been a single instance of accidental or unauthorized nuclear detonation, but there have been numerous accidents and “close calls.” As the understanding of these environments has increased, the need for a robust nuclear weapon safety philosophy has grown. This paper describes some of the methods used by the Nuclear Weapon Complex today to assure nuclear weapon safety, including testing, modeling, analysis, and design features. Lastly, it also reviews safety’s continued role in the future and examines how nuclear safety’s present maturity can play a role in strengthening security and other areasmore » and how increased coordination can improve safety and reduce long-term cost.« less

Argument-Based Airworthiness Assurance of Small UAS

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2015-01-01

Presently, there are three avenues by which Unmanned Aircraft System (UAS) operations are authorized in the U.S. National Airspace System (NAS): obtaining either (i) a certificate of authorization (COA), or (ii) a special airworthiness certificate (SAC) in either the experimental, or the restricted category, or (iii) an exemption from an airworthiness certificate together with a civil COA. The first is meant primarily for public entities, such as NASA; the remaining two are the only available means for civil UAS operations. Recently, the Federal Aviation Administration (FAA) has also proposed a regulatory framework targeted for certain small UAS, specifically those weighing 55 pounds or less, although final rulemaking remains pending. We have previously shown how an assurance case can aggregate heterogeneous reasoning and safety evidence, with application to UAS safety. In this paper, we describe how assurance cases can serve as a common framework to justify overall system safety, unifying both operational aspects and airworthiness, in particular system design assurance. We also show how this approach can coexist with, and augment, existing safety analysis processes and best-practices, by transforming the artifacts they produce into structured assurance arguments. To illustrate the applicability and utility of our approach, we have been applying it for the design assurance of an unmanned rotorcraft system, intended for precision agriculture operations, as part of the NASA Unmanned Aircraft System (UAS) Integration in the National Airspace System (NAS) project.

Explore The NASA Safety Center

NASA Image and Video Library

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.

[Practice report: the process-based indicator dashboard. Visualising quality assurance results in standardised processes].

PubMed

Petzold, Thomas; Hertzschuch, Diana; Elchlep, Frank; Eberlein-Gonska, Maria

2014-01-01

Process management (PM) is a valuable method for the systematic analysis and structural optimisation of the quality and safety of clinical treatment. PM requires a high motivation and willingness to implement changes of both employees and management. Definition of quality indicators is required to systematically measure the quality of the specified processes. One way to represent comparable quality results is the use of quality indicators of the external quality assurance in accordance with Sect. 137 SGB V—a method which the Federal Joint Committee (GBA) and the institutions commissioned by the GBA have employed and consistently enhanced for more than ten years. Information on the quality of inpatient treatment is available for 30 defined subjects throughout Germany. The combination of specified processes with quality indicators is beneficial for the information of employees. A process-based indicator dashboard provides essential information about the treatment process. These can be used for process analysis. In a continuous consideration of these indicator results values can be determined and errors will be remedied quickly. If due consideration is given to these indicators, they can be used for benchmarking to identify potential process improvements. Copyright © 2014. Published by Elsevier GmbH.

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.

Evaluation of Design Assurance Regulations for Safety of Space Navigation Services

NASA Astrophysics Data System (ADS)

Ratti, B.; Sarno, M.; De Andreis, C.

2005-12-01

The European Space Agency (ESA), the European Community (EC), and the European Organisation for the Safety of Air Navigation (Eurocontrol) are contributing to the development of a Global positioning and Navigation Satellite System, known as GNSS. The development programme is carried out in two main steps:• GNSS-1: the first-generation system, based on signals received from the GPS (USA) and GLONASS (Russia) constellations, and augmentation systems like EGNOS (European Geostationary Navigation Overlay Service)• GNSS-2: the second-generation system, that will achieve the ultimate objective of European sovereignty for position determination, navigation and time dissemination. This system, named Galileo, comprises a global space and ground control infrastructure.The Galileo navigation signal will be used in the frame of safety-critical transport applications, thus it is necessary to assess the space safety assurance activity against the civil safety regulations and safety management system.. RTCA DO-254 and IEC 61508 standards, considered as part of best practice engineering references, for the development of safety- related systems in most applications, were selected during phases B2 and C0 of the Galileo project for this purpose.

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.

Microbial Performance of Food Safety Control and Assurance Activities in a Fresh Produce Processing Sector Measured Using a Microbial Assessment Scheme and Statistical Modeling.

PubMed

Njage, Patrick Murigu Kamau; Sawe, Chemutai Tonui; Onyango, Cecilia Moraa; Habib, I; Njagi, Edmund Njeru; Aerts, Marc; Molenberghs, Geert

2017-01-01

Current approaches such as inspections, audits, and end product testing cannot detect the distribution and dynamics of microbial contamination. Despite the implementation of current food safety management systems, foodborne outbreaks linked to fresh produce continue to be reported. A microbial assessment scheme and statistical modeling were used to systematically assess the microbial performance of core control and assurance activities in five Kenyan fresh produce processing and export companies. Generalized linear mixed models and correlated random-effects joint models for multivariate clustered data followed by empirical Bayes estimates enabled the analysis of the probability of contamination across critical sampling locations (CSLs) and factories as a random effect. Salmonella spp. and Listeria monocytogenes were not detected in the final products. However, none of the processors attained the maximum safety level for environmental samples. Escherichia coli was detected in five of the six CSLs, including the final product. Among the processing-environment samples, the hand or glove swabs of personnel revealed a higher level of predicted contamination with E. coli , and 80% of the factories were E. coli positive at this CSL. End products showed higher predicted probabilities of having the lowest level of food safety compared with raw materials. The final products were E. coli positive despite the raw materials being E. coli negative for 60% of the processors. There was a higher probability of contamination with coliforms in water at the inlet than in the final rinse water. Four (80%) of the five assessed processors had poor to unacceptable counts of Enterobacteriaceae on processing surfaces. Personnel-, equipment-, and product-related hygiene measures to improve the performance of preventive and intervention measures are recommended.

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…

Changing the S and MA [Safety and Mission Assurance] Paradigm

NASA Technical Reports Server (NTRS)

Malone, Roy W., Jr.

2010-01-01

Objectives: 1) Optimize S&MA organization to best facilitate Shuttle transition in 2010, successfully support Ares developmental responsibilities, and minimize the impacts of the gap between last Shuttle flight and start of Ares V Project. 2) Improve leveraging of critical skills and experience between Shuttle and Ares. 3) Split technical and supervisory functions to facilitate technical penetration. 4) Create Chief Safety and Mission Assurance Officer (CSO) stand-alone position for successfully implementation of S&MA Technical Authority. 5) Minimize disruption to customers. 6) Provide early involvement of S&MA leadership team and frequent/open communications with S&MA team members and steak-holders.

SAFEGUARD: An Assured Safety Net Technology for UAS

NASA Technical Reports Server (NTRS)

Dill, Evan T.; Young, Steven D.; Hayhurst, Kelly J.

2016-01-01

As demands increase to use unmanned aircraft systems (UAS) for a broad spectrum of commercial applications, regulatory authorities are examining how to safely integrate them without loss of safety or major disruption to existing airspace operations. This work addresses the development of the Safeguard system as an assured safety net technology for UAS. The Safeguard system monitors and enforces conformance to a set of rules defined prior to flight (e.g., geospatial stay-out or stay-in regions, speed limits, altitude limits). Safeguard operates independently of the UAS autopilot and is strategically designed in a way that can be realized by a small set of verifiable functions to simplify compliance with regulatory standards for commercial aircraft. A framework is described that decouples the system from any other devices on the UAS as well as introduces complementary positioning source(s) for applications that require integrity and availability beyond what the Global Positioning System (GPS) can provide. Additionally, the high level logic embedded within the software is presented, as well as the steps being taken toward verification and validation (V&V) of proper functionality. Next, an initial prototype implementation of the described system is disclosed. Lastly, future work including development, testing, and system V&V is summarized.

The NASA Commercial Crew Program (CCP) Shared Assurance Model for Safety

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul D.

2014-01-01

NASA established the Commercial Crew Program in order to provide human access to the International Space Station and low earth orbit via the commercial (nongovernmental) sector. A particular challenge to NASA is how to determine the commercial provider's transportation system complies with Programmatic safety requirements while at the same time allowing the provider the flexibility to demonstrate compliance. This will be accomplished through the use of Shared Assurance and Risk Based Assessment by NASA thus shifting more responsibility to the Provider. This model will be the focus of this presentation.

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…

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

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

Software safety - A user's practical perspective

NASA Technical Reports Server (NTRS)

Dunn, William R.; Corliss, Lloyd D.

1990-01-01

Software safety assurance philosophy and practices at the NASA Ames are discussed. It is shown that, to be safe, software must be error-free. Software developments on two digital flight control systems and two ground facility systems are examined, including the overall system and software organization and function, the software-safety issues, and their resolution. The effectiveness of safety assurance methods is discussed, including conventional life-cycle practices, verification and validation testing, software safety analysis, and formal design methods. It is concluded (1) that a practical software safety technology does not yet exist, (2) that it is unlikely that a set of general-purpose analytical techniques can be developed for proving that software is safe, and (3) that successful software safety-assurance practices will have to take into account the detailed design processes employed and show that the software will execute correctly under all possible conditions.

Feasibility study of using statistical process control to customized quality assurance in proton therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rah, Jeong-Eun; Oh, Do Hoon; Shin, Dongho

Purpose: To evaluate and improve the reliability of proton quality assurance (QA) processes and, to provide an optimal customized tolerance level using the statistical process control (SPC) methodology. Methods: The authors investigated the consistency check of dose per monitor unit (D/MU) and range in proton beams to see whether it was within the tolerance level of the daily QA process. This study analyzed the difference between the measured and calculated ranges along the central axis to improve the patient-specific QA process in proton beams by using process capability indices. Results: The authors established a customized tolerance level of ±2% formore » D/MU and ±0.5 mm for beam range in the daily proton QA process. In the authors’ analysis of the process capability indices, the patient-specific range measurements were capable of a specification limit of ±2% in clinical plans. Conclusions: SPC methodology is a useful tool for customizing the optimal QA tolerance levels and improving the quality of proton machine maintenance, treatment delivery, and ultimately patient safety.« less

Feasibility study of using statistical process control to customized quality assurance in proton therapy.

PubMed

Rah, Jeong-Eun; Shin, Dongho; Oh, Do Hoon; Kim, Tae Hyun; Kim, Gwe-Ya

2014-09-01

To evaluate and improve the reliability of proton quality assurance (QA) processes and, to provide an optimal customized tolerance level using the statistical process control (SPC) methodology. The authors investigated the consistency check of dose per monitor unit (D/MU) and range in proton beams to see whether it was within the tolerance level of the daily QA process. This study analyzed the difference between the measured and calculated ranges along the central axis to improve the patient-specific QA process in proton beams by using process capability indices. The authors established a customized tolerance level of ±2% for D/MU and ±0.5 mm for beam range in the daily proton QA process. In the authors' analysis of the process capability indices, the patient-specific range measurements were capable of a specification limit of ±2% in clinical plans. SPC methodology is a useful tool for customizing the optimal QA tolerance levels and improving the quality of proton machine maintenance, treatment delivery, and ultimately patient safety.

Nursing Student Experiences Regarding Safe Use of Electronic Health Records: A Pilot Study of the Safety and Assurance Factors for EHR Resilience Guides.

PubMed

Whitt, Karen J; Eden, Lacey; Merrill, Katreena Collette; Hughes, Mckenna

2017-01-01

Previous research has linked improper electronic health record configuration and use with adverse patient events. In response to this problem, the US Office of the National Coordinator for Health Information Technology developed the Safety and Assurance Factors for EHR Resilience guides to evaluate electronic health records for optimal use and safety features. During the course of their education, nursing students are exposed to a variety of clinical practice settings and electronic health records. This descriptive study evaluated 108 undergraduate and 51 graduate nursing students' ratings of electronic health record features and safe practices, as well as what they learned from utilizing the computerized provider order entry and clinician communication Safety and Assurance Factors for EHR Resilience guide checklists. More than 80% of the undergraduate and 70% of the graduate students reported that they experienced user problems with electronic health records in the past. More than 50% of the students felt that electronic health records contribute to adverse patient outcomes. Students reported that many of the features assessed were not fully implemented in their electronic health record. These findings highlight areas where electronic health records can be improved to optimize patient safety. The majority of students reported that utilizing the Safety and Assurance Factors for EHR Resilience guides increased their understanding of electronic health record features.

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.

10 CFR 71.103 - Quality assurance organization.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and... that are important to safety have been correctly performed. (c) The persons and organizations...

10 CFR 71.103 - Quality assurance organization.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and... that are important to safety have been correctly performed. (c) The persons and organizations...

Semiquantitative analysis of gaps in microbiological performance of fish processing sector implementing current food safety management systems: a case study.

PubMed

Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

2014-08-01

Fish processing plants still face microbial food safety-related product rejections and the associated economic losses, although they implement legislation, with well-established quality assurance guidelines and standards. We assessed the microbial performance of core control and assurance activities of fish exporting processors to offer suggestions for improvement using a case study. A microbiological assessment scheme was used to systematically analyze microbial counts in six selected critical sampling locations (CSLs). Nine small-, medium- and large-sized companies implementing current food safety management systems (FSMS) were studied. Samples were collected three times on each occasion (n = 324). Microbial indicators representing food safety, plant and personnel hygiene, and overall microbiological performance were analyzed. Microbiological distribution and safety profile levels for the CSLs were calculated. Performance of core control and assurance activities of the FSMS was also diagnosed using an FSMS diagnostic instrument. Final fish products from 67% of the companies were within the legally accepted microbiological limits. Salmonella was absent in all CSLs. Hands or gloves of workers from the majority of companies were highly contaminated with Staphylococcus aureus at levels above the recommended limits. Large-sized companies performed better in Enterobacteriaceae, Escherichia coli, and S. aureus than medium- and small-sized ones in a majority of the CSLs, including receipt of raw fish material, heading and gutting, and the condition of the fish processing tables and facilities before cleaning and sanitation. Fish products of 33% (3 of 9) of the companies and handling surfaces of 22% (2 of 9) of the companies showed high variability in Enterobacteriaceae counts. High variability in total viable counts and Enterobacteriaceae was noted on fish products and handling surfaces. Specific recommendations were made in core control and assurance activities

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.

Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

NASA Technical Reports Server (NTRS)

Guarro, Sergio B.

2010-01-01

This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

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…

The Role of ESA TEC-QTE in the ISS Safety Process

NASA Astrophysics Data System (ADS)

Orlandi, M.; Rohr, T.; Stienstra, M. H.; Semprimoschnig, C.

2013-09-01

On the 17th of July 2000, the Materials and Processes Reciprocal Agreement was signed between NASA and ESA to define the process for selection and certification of materials used in the Space Shuttle and the International Space Station. Consecutively, on the 20th of June 2003 this agreement was extended to the Automated Transport Vehicle (ATV). It is therefore the responsibility of ESA TEC-QTE, the Materials Space Evaluation and Radiation Effects section, part of the Product Assurance and Safety Department, to ensure that all materials, parts and processes of each of the ISS payloads not only function as required but also do not pose a risk to the safety of the crew members. In this context, TEC-QTE provides qualified expertise to support the ESA Flight Safety Review and assesses safety aspects related to manned projects (materials properties, fluid system compatibility, fungus resistance). This is supported by the Materials Space Evaluation and Radiation Effects section's Materials and Electrical Components laboratory having at its disposition a range of facilities designed to perform environmental effects testing of which off-gassing tests according to ECSS-Q-ST-70-29C (equivalent to NASA STD 6001 test 7) and outgassing tests according to ECSS-Q-ST-70-02C (equivalent to ASTM-E-595). The ESA facility to perform flammability tests according to ECSS-Q-ST-70-21A (equivalent to NASA STD 6001 test1) was moved to Astrium Bremen.TEC-QTE is in charge of reviewing and approving, via RFA or MUA , all materials that do not meet safety requirements as well as COTS or CAM (black boxes) equipment.The safety process ends with the issue of the Materials Certification of the reviewed payload hardware that shows compliance with the relevant materials and processes requirements and standards.In addition to the safety related activities for the ISS, specialised TEC-QTE personnel provide measurements of the air quality inside the ATV and assess whether the toxicity index is within

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2013 CFR

2013-01-01

... changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the... 10 Energy 4 2013-01-01 2013-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2012 CFR

2012-01-01

... changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the... 10 Energy 4 2012-01-01 2012-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2011 CFR

2011-01-01

... changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the... 10 Energy 4 2011-01-01 2011-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2014 CFR

2014-01-01

... changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the... 10 Energy 4 2014-01-01 2014-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality...

IEEE Std 730 Software Quality Assurance: Supporting CMMI-DEV v1.3, Product and Process Quality Assurance

DTIC Science & Technology

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

An outline of a risk assessment-based system of meat safety assurance and its future prospects.

PubMed

Berends, B R; van Knapen, F

1999-10-01

Discussed are the outlines of a risk assessment-based system of meat safety assurance to replace the current meat inspection. An example of a system that uses the Hazard Analysis of Critical Control Points (HACCP)-principles in the entire production chain from stable to table is also given. Continuous evaluation of risks is the main driving force of the new system. Only then the system has the means to remain flexible and provide for the data necessary to convince trade partners that the products they buy are safe. A monitoring system that keeps track of the important health hazards in the entire chain from stable to table is therefore necessary. This includes monitoring of cases of disease in the human population caused by the hazardous agents of concern. Coordination of the monitoring and control and processing of the information is done by an independent body. Furthermore, the system demands a production from stable to table that is based on the ideas of Integrated Quality Control (IQC), HACCP, and certification of production processes and quality control procedures. Clear legislation provides for criteria about acceptable or unacceptable health risks for the consumer and determines at what moments which risks should be controlled by the producers. Simultaneously, the legislation has to be flexible enough to be able to adapt quickly to any changes in risks, or in the way risks should be controlled. In the new system current meat inspection can easily be carried out by employees of the slaughter houses and is no longer a direct responsibility of the authorities. The authorities only demand certain safety levels and verify whether producers stick to these. Producers remain fully responsible for the safety and quality of their products, and fully liable in case of any damage to the consumers' health. However, it is to be expected that some EU Member-States miss the organizational and agricultural basis for a successful application of the new system. Consequences

Quality Assurance Processes in Finnish Universities: Direct and Indirect Outcomes and Organisational Conditions

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,…

30 CFR 7.7 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 7.7 Section 7.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.7 Quality assurance. Applicants granted...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality... the Quality Assurance criteria in § 830.122. (b) The contractor responsible for a DOE nuclear facility...

30 CFR 14.8 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Quality assurance. Applicants granted an approval or an extension of approval under this Part must: (a) In...

30 CFR 15.8 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 15.8 Section 15.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... § 15.8 Quality assurance. (a) Applicants granted an approval or an extension of approval under this...

Application of Gap Analysis to Education: A Case Study of the Food Safety and Quality Assurance Program at the University of Guelph

ERIC Educational Resources Information Center

Fuchs, C.; Wilcock, A.; Aung, M.

2004-01-01

This study was designed to identify the skills and knowledge deemed important for food safety professionals and the degree to which the Food Safety and Quality Assurance (FSQA) program at the Univ. of Guelph helps students to develop these skills. The research included 2 phases: interviews were conducted to identify these skill and knowledge…

Early Engagement of Safety and Mission Assurance Expertise Using Systems Engineering Tools: A Risk-Based Approach to Early Identification of Safety and Assurance Requirements

NASA Technical Reports Server (NTRS)

Darpel, Scott; Beckman, Sean

2016-01-01

Decades of systems engineering practice have demonstrated that the earlier the identification of requirements occurs, the lower the chance that costly redesigns will needed later in the project life cycle. A better understanding of all requirements can also improve the likelihood of a design's success. Significant effort has been put into developing tools and practices that facilitate requirements determination, including those that are part of the model-based systems engineering (MBSE) paradigm. These efforts have yielded improvements in requirements definition, but have thus far focused on a design's performance needs. The identification of safety & mission assurance (S&MA) related requirements, in comparison, can occur after preliminary designs are already established, yielding forced redesigns. Engaging S&MA expertise at an earlier stage, facilitated by the use of MBSE tools, and focused on actual project risk, can yield the same type of design life cycle improvements that have been realized in technical and performance requirements.

The role of food quality assurance and product certification systems on marketing aspects

NASA Astrophysics Data System (ADS)

Petrović, Z.; Milićević, D.; Nastasijević, I.; Đorđević, V.; Trbović, D.; Velebit, B.

2017-09-01

The level of quality that a product offers to consumers is a fundamental aspect of competition in many markets. Consumers’ confidence in the safety and quality of foods they buy and consume is a significant support to the economic development of production organizations of this type, and therefore the overall economic development. Consumer concerns about food safety as well as the globalization of food production have also led to the existence of a global internationally linked food production and distribution system. The necessity demanded by the consumer population to provide safe food with consistent quality at an attractive price imposes a choice of an appropriate quality assurance model in accordance with the specific properties of the product and the production processes. Modern trends, especially for the last ten years in quality assurance within specific production, such as the food industry, have marked the trend of hyperproduction and a number of production and safety standards, as well as a change of approach in the certification process of organizations according to one or more standards. This can be an additional source of costs for organizations, and can burden the food business operator`s budget in order to ensure their consistent application and maintenance. Quality assurance (QA) standards are considered to be a proven mechanism for delivering quality of product.

10 CFR 71.101 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... quality assurance actions related to control of the physical characteristics and quality of the material... through 71.137 and satisfying any specific provisions that are applicable to the licensee's activities... assurance requirement's importance to safety. (c) Approval of program. (1) Before the use of any package for...

Challenges in High-Assurance Runtime Verification

NASA Technical Reports Server (NTRS)

Goodloe, Alwyn E.

2016-01-01

Safety-critical systems are growing more complex and becoming increasingly autonomous. Runtime Verification (RV) has the potential to provide protections when a system cannot be assured by conventional means, but only if the RV itself can be trusted. In this paper, we proffer a number of challenges to realizing high-assurance RV and illustrate how we have addressed them in our research. We argue that high-assurance RV provides a rich target for automated verification tools in hope of fostering closer collaboration among the communities.

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.

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.

Assuring the quality, safety, and efficacy of DNA vaccines.

PubMed

Robertson, J S; Griffiths, E

2001-02-01

Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. It is useful for such scientists to be aware of these processes as the development of a novel vaccine could be problematic owing to the starting material often being developed in a research laboratory under ill-defined conditions. This paper examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations that must be addressed during preclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinees chromosomes, and the potential for the formation of anti-DNA antibodies.

Assuring the quality, safety, and efficacy of DNA vaccines.

PubMed

Robertson, James S; Griffiths, Elwyn

2006-01-01

Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. It is useful for such scientists to be aware of these processes, as the development of a novel vaccine could be problematic as a result of the starting material often being developed in a research laboratory under ill-defined conditions. This chapter examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations which must be addressed during nonclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinee's chromosomes and the potential for the formation of anti-DNA antibodies.

DICOM index tracker enterprise: advanced system for enterprise-wide quality assurance and patient safety monitoring

NASA Astrophysics Data System (ADS)

Zhang, Min; Pavlicek, William; Panda, Anshuman; Langer, Steve G.; Morin, Richard; Fetterly, Kenneth A.; Paden, Robert; Hanson, James; Wu, Lin-Wei; Wu, Teresa

2015-03-01

DICOM Index Tracker (DIT) is an integrated platform to harvest rich information available from Digital Imaging and Communications in Medicine (DICOM) to improve quality assurance in radiology practices. It is designed to capture and maintain longitudinal patient-specific exam indices of interests for all diagnostic and procedural uses of imaging modalities. Thus, it effectively serves as a quality assurance and patient safety monitoring tool. The foundation of DIT is an intelligent database system which stores the information accepted and parsed via a DICOM receiver and parser. The database system enables the basic dosimetry analysis. The success of DIT implementation at Mayo Clinic Arizona calls for the DIT deployment at the enterprise level which requires significant improvements. First, for geographically distributed multi-site implementation, the first bottleneck is the communication (network) delay; the second is the scalability of the DICOM parser to handle the large volume of exams from different sites. To address this issue, DICOM receiver and parser are separated and decentralized by site. To facilitate the enterprise wide Quality Assurance (QA), a notable challenge is the great diversities of manufacturers, modalities and software versions, as the solution DIT Enterprise provides the standardization tool for device naming, protocol naming, physician naming across sites. Thirdly, advanced analytic engines are implemented online which support the proactive QA in DIT Enterprise.

Quality Interaction Between Mission Assurance and Project Team Members

NASA Technical Reports Server (NTRS)

Kwong-Fu, Helenann H.; Wilson, Robert K.

2006-01-01

This viewgraph presentation demonstrates the importance of value added Mission Assurance to flight operations in order to assure mission success and the Health and Safety of the mission, (i.e., the Spitzer space Telescope.)

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...

Assuring Ground-Based Detect and Avoid for UAS Operations

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganeshmadhav Jagadeesh; Berthold, Randall; Fladeland, Matthew; Storms, Bruce; Sumich, Mark

2014-01-01

One of the goals of the Marginal Ice Zones Observations and Processes Experiment (MIZOPEX) NASA Earth science mission was to show the operational capabilities of Unmanned Aircraft Systems (UAS) when deployed on challenging missions, in difficult environments. Given the extreme conditions of the Arctic environment where MIZOPEX measurements were required, the mission opted to use a radar to provide a ground-based detect-and-avoid (GBDAA) capability as an alternate means of compliance (AMOC) with the see-and-avoid federal aviation regulation. This paper describes how GBDAA safety assurance was provided by interpreting and applying the guidelines in the national policy for UAS operational approval. In particular, we describe how we formulated the appropriate safety goals, defined the processes and procedures for system safety, identified and assembled the relevant safety verification evidence, and created an operational safety case in compliance with Federal Aviation Administration (FAA) requirements. To the best of our knowledge, the safety case, which was ultimately approved by the FAA, is the first successful example of non-military UAS operations using GBDAA in the U.S. National Airspace System (NAS), and, therefore, the first nonmilitary application of the safety case concept in this context.

Faculty Ownership of the Assurance of Learning Process: Determinants of Faculty Engagement and Continuing Challenges

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…

Performance of food safety management systems in poultry meat preparation processing plants in relation to Campylobacter spp. contamination.

PubMed

Sampers, Imca; Jacxsens, Liesbeth; Luning, Pieternel A; Marcelis, Willem J; Dumoulin, Ann; Uyttendaele, Mieke

2010-08-01

A diagnostic instrument comprising a combined assessment of core control and assurance activities and a microbial assessment instrument were used to measure the performance of current food safety management systems (FSMSs) of two poultry meat preparation companies. The high risk status of the company's contextual factors, i.e., starting from raw materials (poultry carcasses) with possible high numbers and prevalence of pathogens such as Campylobacter spp., requires advanced core control and assurance activities in the FSMS to guarantee food safety. The level of the core FSMS activities differed between the companies, and this difference was reflected in overall microbial quality (mesophilic aerobic count), presence of hygiene indicators (Enterobacteriaceae, Staphylococcus aureus, and Escherichia coli), and contamination with pathogens such as Salmonella, Listeria monocytogenes, and Campylobacter spp. The food safety output expressed as a microbial safety profile was related to the variability in the prevalence and contamination levels of Campylobacter spp. in poultry meat preparations found in a Belgian nationwide study. Although a poultry meat processing company could have an advanced FSMS in place and a good microbial profile (i.e., lower prevalence of pathogens, lower microbial numbers, and less variability in microbial contamination), these positive factors might not guarantee pathogen-free products. Contamination could be attributed to the inability to apply effective interventions to reduce or eliminate pathogens in the production chain of (raw) poultry meat preparations.

Evolution of International Space Station Program Safety Review Processes and Tools

NASA Technical Reports Server (NTRS)

Ratterman, Christian D.; Green, Collin; Guibert, Matt R.; McCracken, Kristle I.; Sang, Anthony C.; Sharpe, Matthew D.; Tollinger, Irene V.

2013-01-01

the new ISS hazard system utilized focused user research and iterative design methods employed by the Human Computer Interaction Group at NASA Ames Research Center. Particularly, the approach emphasized the reduction of workload associated with document and data management activities so more resources can be allocated to the operational use of data in problem solving, safety analysis, and recurrence control. The methods and techniques used to understand existing processes and systems, to recognize opportunities for improvement, and to design and review improvements are described with the intent that similar techniques can be employed elsewhere in safety operations. A second goal of this paper is to provide and overview of the web-based data system implemented by ISS. The software selected for the ISS hazard systemMission Assurance System (MAS)is a NASA-customized vairant of the open source software project Bugzilla. The origin and history of MAS as a NASA software project and the rationale for (and advantages of) using open-source software are documented elsewhere (Green, et al., 2009).

Strengthening Internal Quality Assurance Processes: Facilitating Student Evaluation Committees to Contribute

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…

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.

Technical Reference Suite Addressing Challenges of Providing Assurance for Fault Management Architectural Design

NASA Technical Reports Server (NTRS)

Fitz, Rhonda; Whitman, Gerek

2016-01-01

Research into complexities of software systems Fault Management (FM) and how architectural design decisions affect safety, preservation of assets, and maintenance of desired system functionality has coalesced into a technical reference (TR) suite that advances the provision of safety and mission assurance. The NASA Independent Verification and Validation (IVV) Program, with Software Assurance Research Program support, extracted FM architectures across the IVV portfolio to evaluate robustness, assess visibility for validation and test, and define software assurance methods applied to the architectures and designs. This investigation spanned IVV projects with seven different primary developers, a wide range of sizes and complexities, and encompassed Deep Space Robotic, Human Spaceflight, and Earth Orbiter mission FM architectures. The initiative continues with an expansion of the TR suite to include Launch Vehicles, adding the benefit of investigating differences intrinsic to model-based FM architectures and insight into complexities of FM within an Agile software development environment, in order to improve awareness of how nontraditional processes affect FM architectural design and system health management.

Relational-database model for improving quality assurance and process control in a composite manufacturing environment

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.

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…

24 CFR 232.630 - Assurance of completion.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon which the fire safety equipment is to be installed is subject to a mortgage insured or held by the... the contract for installation as he may from time to time prescribe. ...

24 CFR 232.630 - Assurance of completion.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon which the fire safety equipment is to be installed is subject to a mortgage insured or held by the... the contract for installation as he may from time to time prescribe. ...

24 CFR 232.630 - Assurance of completion.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon which the fire safety equipment is to be installed is subject to a mortgage insured or held by the... the contract for installation as he may from time to time prescribe. ...

Model Based Mission Assurance: Emerging Opportunities for Robotic Systems

NASA Technical Reports Server (NTRS)

Evans, John W.; DiVenti, Tony

2016-01-01

The emergence of Model Based Systems Engineering (MBSE) in a Model Based Engineering framework has created new opportunities to improve effectiveness and efficiencies across the assurance functions. The MBSE environment supports not only system architecture development, but provides for support of Systems Safety, Reliability and Risk Analysis concurrently in the same framework. Linking to detailed design will further improve assurance capabilities to support failures avoidance and mitigation in flight systems. This also is leading new assurance functions including model assurance and management of uncertainty in the modeling environment. Further, the assurance cases, a structured hierarchal argument or model, are emerging as a basis for supporting a comprehensive viewpoint in which to support Model Based Mission Assurance (MBMA).

[Role of medical information processing for quality assurance in obstetrics].

PubMed

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.

49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

Code of Federal Regulations, 2011 CFR

2011-10-01

.../Programmable/Electronic Safety (E/E/P/ES) Related Systems, Parts 1-7 as follows: (A) IEC 61508-1 (1998-12) Part.... (B) IEC 61508-2 (2000-05) Part 2: Requirements for electrical/electronic/programmable electronic...

49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

Code of Federal Regulations, 2012 CFR

2012-10-01

.../Programmable/Electronic Safety (E/E/P/ES) Related Systems, Parts 1-7 as follows: (A) IEC 61508-1 (1998-12) Part.... (B) IEC 61508-2 (2000-05) Part 2: Requirements for electrical/electronic/programmable electronic...

49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

Code of Federal Regulations, 2014 CFR

2014-10-01

.../Programmable/Electronic Safety (E/E/P/ES) Related Systems, Parts 1-7 as follows: (A) IEC 61508-1 (1998-12) Part.... (B) IEC 61508-2 (2000-05) Part 2: Requirements for electrical/electronic/programmable electronic...

49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

Code of Federal Regulations, 2013 CFR

2013-10-01

.../Programmable/Electronic Safety (E/E/P/ES) Related Systems, Parts 1-7 as follows: (A) IEC 61508-1 (1998-12) Part.... (B) IEC 61508-2 (2000-05) Part 2: Requirements for electrical/electronic/programmable electronic...

Defense Contract Management Agency Santa Ana Quality Assurance Oversight Needs lmprovement

DTIC Science & Technology

2013-04-19

Management Agency Santa Ana Quality Assurance Oversight Needs Improvement What We Did We determined whether the Defense Contract Management Agency (DCMA...for critical safety items (CSIs). For this audit, we reviewed QA oversight of four contracts valued at about $278 million. What We Found The DCMA...limited assurance that 18,507 critical safety items, consisting of T-11 parachutes, oxygen masks, drone parachutes, and breathing apparatuses met

24 CFR 232.630 - Assurance of completion.

Code of Federal Regulations, 2011 CFR

2011-04-01

... MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND ASSISTED... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon which the fire safety equipment is to be installed is subject to a mortgage insured or held by the...

DoD Nuclear Weapons Personnel Reliability Assurance

DTIC Science & Technology

2016-04-27

destructive power, and the potential consequences of an accident or unauthorized act. Assured nuclear weapons safety, security, and control remain of...DOD INSTRUCTION 5210.42 DOD NUCLEAR WEAPONS PERSONNEL RELIABILITY ASSURANCE Originating Component: Office of the Under Secretary of...from the DoD Issuances Website at http://www.dtic.mil/whs/directives. Reissues and renames: DoD Instruction 5210.42, “ Nuclear Weapons Personnel

Safety and Mission Assurance: A NASA Perspective

NASA Technical Reports Server (NTRS)

Higginbotham, Scott A.

2016-01-01

Manned spaceflight is an incredibly complex and inherently risky human endeavor. As the result of the lessons learned through years of triumph and tragedy, the National Aeronautics and Space Administration (NASA) has embraced a comprehensive and integrated approach to the challenge of ensuring safety and mission success. This presentation will provide an overview of some of the techniques employed in this effort, with a focus on the processing operations performed at the Kennedy Space Center (KSC).

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.

Towards Run-time Assurance of Advanced Propulsion Algorithms

NASA Technical Reports Server (NTRS)

Wong, Edmond; Schierman, John D.; Schlapkohl, Thomas; Chicatelli, Amy

2014-01-01

This paper covers the motivation and rationale for investigating the application of run-time assurance methods as a potential means of providing safety assurance for advanced propulsion control systems. Certification is becoming increasingly infeasible for such systems using current verification practices. Run-time assurance systems hold the promise of certifying these advanced systems by continuously monitoring the state of the feedback system during operation and reverting to a simpler, certified system if anomalous behavior is detected. The discussion will also cover initial efforts underway to apply a run-time assurance framework to NASA's model-based engine control approach. Preliminary experimental results are presented and discussed.

Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.

PubMed

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.

Pre-analytical phase: The automated ProTube device supports quality assurance in the phlebotomy process.

PubMed

Piva, Elisa; Tosato, Francesca; Plebani, Mario

2015-12-07

Most errors in laboratory medicine occur in the pre-analytical phase of the total testing process. Phlebotomy, a crucial step in the pre-analytical phase influencing laboratory results and patient outcome, calls for quality assurance procedures and automation in order to prevent errors and ensure patient safety. We compared the performance of a new small, automated device, the ProTube Inpeco, designed for use in phlebotomy with a complete traceability of the process, with a centralized automated system, BC ROBO. ProTube was used for 15,010 patients undergoing phlebotomy with 48,776 tubes being labeled. The mean time and standard deviation (SD) for blood sampling was 3:03 (min:sec; SD ± 1:24) when using ProTube, against 5:40 (min:sec; SD ± 1:57) when using BC ROBO. The mean number of patients per hour managed at each phlebotomy point was 16 ± 3 with ProTube, and 10 ± 2 with BC ROBO. No tubes were labeled erroneously or incorrectly, even if process failure occurred in 2.8% of cases when ProTube was used. Thanks to its cutting edge technology, the ProTube has many advantages over BC ROBO, above all in verifying patient identity, and in allowing a reduction in both identification error and tube mislabeling.

Process safety improvement--quality and target zero.

PubMed

Van Scyoc, Karl

2008-11-15

Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.

A conceptual study of automatic and semi-automatic quality assurance techniques for round image processing

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.

Using RUFDATA to guide a logic model for a quality assurance process in an undergraduate university program.

PubMed

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.

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.'''

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.'''

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.'''

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.'''

Review of the Constellation Level II Safety, Reliability, and Quality Assurance (SR&QA) Requirements Documents during Participation in the Constellation Level II SR&QA Forum

NASA Technical Reports Server (NTRS)

Cameron, Kenneth D.; Gentz, Steven J.; Beil, Robert J.; Minute, Stephen A.; Currie, Nancy J.; Scott, Steven S.; Thomas, Walter B., III; Smiles, Michael D.; Schafer, Charles F.; Null, Cynthia H.;

Redefining and expanding quality assurance.

PubMed

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.

Assurance of Fault Management: Risk-Significant Adverse Condition Awareness

NASA Technical Reports Server (NTRS)

Fitz, Rhonda

2016-01-01

Fault Management (FM) systems are ranked high in risk-based assessment of criticality within flight software, emphasizing the importance of establishing highly competent domain expertise to provide assurance for NASA projects, especially as spaceflight systems continue to increase in complexity. Insight into specific characteristics of FM architectures seen embedded within safety- and mission-critical software systems analyzed by the NASA Independent Verification Validation (IVV) Program has been enhanced with an FM Technical Reference (TR) suite. Benefits are aimed beyond the IVV community to those that seek ways to efficiently and effectively provide software assurance to reduce the FM risk posture of NASA and other space missions. The identification of particular FM architectures, visibility, and associated IVV techniques provides a TR suite that enables greater assurance that critical software systems will adequately protect against faults and respond to adverse conditions. The role FM has with regard to overall asset protection of flight software systems is being addressed with the development of an adverse condition (AC) database encompassing flight software vulnerabilities.Identification of potential off-nominal conditions and analysis to determine how a system responds to these conditions are important aspects of hazard analysis and fault management. Understanding what ACs the mission may face, and ensuring they are prevented or addressed is the responsibility of the assurance team, which necessarily should have insight into ACs beyond those defined by the project itself. Research efforts sponsored by NASAs Office of Safety and Mission Assurance defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs, and allowing queries based on project, mission

Adopting Quality Assurance Technology in Customer-Vendor Relationships: A Case Study of How Interorganizational Relationships Influence the Process

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.

Risk-Significant Adverse Condition Awareness Strengthens Assurance of Fault Management Systems

NASA Technical Reports Server (NTRS)

Fitz, Rhonda

2017-01-01

As spaceflight systems increase in complexity, Fault Management (FM) systems are ranked high in risk-based assessment of software criticality, emphasizing the importance of establishing highly competent domain expertise to provide assurance. Adverse conditions (ACs) and specific vulnerabilities encountered by safety- and mission-critical software systems have been identified through efforts to reduce the risk posture of software-intensive NASA missions. Acknowledgement of potential off-nominal conditions and analysis to determine software system resiliency are important aspects of hazard analysis and FM. A key component of assuring FM is an assessment of how well software addresses susceptibility to failure through consideration of ACs. Focus on significant risk predicted through experienced analysis conducted at the NASA Independent Verification & Validation (IV&V) Program enables the scoping of effective assurance strategies with regard to overall asset protection of complex spaceflight as well as ground systems. Research efforts sponsored by NASAs Office of Safety and Mission Assurance (OSMA) defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs and allowing queries based on project, mission type, domain/component, causal fault, and other key characteristics. Vulnerability in off-nominal situations, architectural design weaknesses, and unexpected or undesirable system behaviors in reaction to faults are curtailed with the awareness of ACs and risk-significant scenarios modeled for analysts through this database. Integration within the Enterprise Architecture at NASA IV&V enables interfacing with other tools and datasets, technical support, and accessibility across the Agency. This paper discusses the development of an improved workflow process utilizing

Risk-Significant Adverse Condition Awareness Strengthens Assurance of Fault Management Systems

NASA Technical Reports Server (NTRS)

Fitz, Rhonda

2017-01-01

As spaceflight systems increase in complexity, Fault Management (FM) systems are ranked high in risk-based assessment of software criticality, emphasizing the importance of establishing highly competent domain expertise to provide assurance. Adverse conditions (ACs) and specific vulnerabilities encountered by safety- and mission-critical software systems have been identified through efforts to reduce the risk posture of software-intensive NASA missions. Acknowledgement of potential off-nominal conditions and analysis to determine software system resiliency are important aspects of hazard analysis and FM. A key component of assuring FM is an assessment of how well software addresses susceptibility to failure through consideration of ACs. Focus on significant risk predicted through experienced analysis conducted at the NASA Independent Verification Validation (IVV) Program enables the scoping of effective assurance strategies with regard to overall asset protection of complex spaceflight as well as ground systems. Research efforts sponsored by NASA's Office of Safety and Mission Assurance defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs and allowing queries based on project, mission type, domaincomponent, causal fault, and other key characteristics. Vulnerability in off-nominal situations, architectural design weaknesses, and unexpected or undesirable system behaviors in reaction to faults are curtailed with the awareness of ACs and risk-significant scenarios modeled for analysts through this database. Integration within the Enterprise Architecture at NASA IVV enables interfacing with other tools and datasets, technical support, and accessibility across the Agency. This paper discusses the development of an improved workflow process utilizing this

Food safety management systems performance in African food processing companies: a review of deficiencies and possible improvement strategies.

PubMed

Kussaga, Jamal B; Jacxsens, Liesbeth; Tiisekwa, Bendantunguka Pm; Luning, Pieternel A

2014-08-01

This study seeks to provide insight into current deficiencies in food safety management systems (FSMS) in African food-processing companies and to identify possible strategies for improvement so as to contribute to African countries' efforts to provide safe food to both local and international markets. This study found that most African food products had high microbiological and chemical contamination levels exceeding the set (legal) limits. Relative to industrialized countries, the study identified various deficiencies at government, sector/branch, retail and company levels which affect performance of FSMS in Africa. For instance, very few companies (except exporting and large companies) have implemented HACCP and ISO 22000:2005. Various measures were proposed to be taken at government (e.g. construction of risk-based legislative frameworks, strengthening of food safety authorities, recommend use of ISO 22000:2005, and consumers' food safety training), branch/sector (e.g. sector-specific guidelines and third-party certification), retail (develop stringent certification standards and impose product specifications) and company levels (improving hygiene, strict raw material control, production process efficacy, and enhancing monitoring systems, assurance activities and supportive administrative structures). By working on those four levels, FSMS of African food-processing companies could be better designed and tailored towards their production processes and specific needs to ensure food safety. © 2014 Society of Chemical Industry.

Defining Baconian Probability for Use in Assurance Argumentation

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.

2016-01-01

The use of assurance cases (e.g., safety cases) in certification raises questions about confidence in assurance argument claims. Some researchers propose to assess confidence in assurance cases using Baconian induction. That is, a writer or analyst (1) identifies defeaters that might rebut or undermine each proposition in the assurance argument and (2) determines whether each defeater can be dismissed or ignored and why. Some researchers also propose denoting confidence using the counts of defeaters identified and eliminated-which they call Baconian probability-and performing arithmetic on these measures. But Baconian probabilities were first defined as ordinal rankings which cannot be manipulated arithmetically. In this paper, we recount noteworthy definitions of Baconian induction, review proposals to assess confidence in assurance claims using Baconian probability, analyze how these comport with or diverge from the original definition, and make recommendations for future practice.

Safety and Mission Assurance for In-House Design Lessons Learned from Ares I Upper Stage

NASA Technical Reports Server (NTRS)

Anderson, Joel M.

2011-01-01

This viewgraph presentation identifies lessons learned in the course of the Ares I Upper Stage design and in-house development effort. The contents include: 1) Constellation Organization; 2) Upper Stage Organization; 3) Presentation Structure; 4) Lesson-Importance of Systems Engineering/Integration; 5) Lesson-Importance of Early S&MA Involvement; 6) Lesson-Importance of Appropriate Staffing Levels; 7) Lesson-Importance S&MA Team Deployment; 8) Lesson-Understanding of S&MA In-Line Engineering versus Assurance; 9) Lesson-Importance of Close Coordination between Supportability and Reliability/Maintainability; 10) Lesson-Importance of Engineering Data Systems; 11) Lesson-Importance of Early Development of Supporting Databases; 12) Lesson-Importance of Coordination with Safety Assessment/Review Panels; 13) Lesson-Implementation of Software Reliability; 14) Lesson-Implementation of S&MA Technical Authority/Chief S&MA Officer; 15) Lesson-Importance of S&MA Evaluation of Project Risks; 16) Lesson-Implementation of Critical Items List and Government Mandatory Inspections; 17) Lesson-Implementation of Critical Items List Mandatory Inspections; 18) Lesson-Implementation of Test Article Safety Analysis; and 19) Lesson-Importance of Procurement Quality.

Technical Reference Suite Addressing Challenges of Providing Assurance for Fault Management Architectural Design

NASA Technical Reports Server (NTRS)

Fitz, Rhonda; Whitman, Gerek

2016-01-01

Research into complexities of software systems Fault Management (FM) and how architectural design decisions affect safety, preservation of assets, and maintenance of desired system functionality has coalesced into a technical reference (TR) suite that advances the provision of safety and mission assurance. The NASA Independent Verification and Validation (IV&V) Program, with Software Assurance Research Program support, extracted FM architectures across the IV&V portfolio to evaluate robustness, assess visibility for validation and test, and define software assurance methods applied to the architectures and designs. This investigation spanned IV&V projects with seven different primary developers, a wide range of sizes and complexities, and encompassed Deep Space Robotic, Human Spaceflight, and Earth Orbiter mission FM architectures. The initiative continues with an expansion of the TR suite to include Launch Vehicles, adding the benefit of investigating differences intrinsic to model-based FM architectures and insight into complexities of FM within an Agile software development environment, in order to improve awareness of how nontraditional processes affect FM architectural design and system health management. The identification of particular FM architectures, visibility, and associated IV&V techniques provides a TR suite that enables greater assurance that critical software systems will adequately protect against faults and respond to adverse conditions. Additionally, the role FM has with regard to strengthened security requirements, with potential to advance overall asset protection of flight software systems, is being addressed with the development of an adverse conditions database encompassing flight software vulnerabilities. Capitalizing on the established framework, this TR suite provides assurance capability for a variety of FM architectures and varied development approaches. Research results are being disseminated across NASA, other agencies, and the

Soyuz-TM-based interim Assured Crew Return Vehicle (ACRV) for the Space Station Freedom

NASA Technical Reports Server (NTRS)

Semenov, Yu. P.; Babkov, Oleg I.; Timchenko, Vladimir A.; Craig, Jerry W.

1993-01-01

The concept of using the available Soyuz-TM Assured Crew Return Vehicle (ACRV) spacecraft for the assurance of the safety of the Space Station Freedom (SSF) crew after the departure of the Space Shuttle from SSF was proposed by the NPO Energia and was accepted by NASA in 1992. The ACRV will provide the crew with the capability to evacuate a seriously injured/ill crewmember from the SSF to a ground-based care facility under medically tolerable conditions and with the capability for a safe evacuation from SSF in the events SSF becomes uninhabitable or the Space Shuttle flights are interrupted for a time that exceeds SSF ability for crew support and/or safe operations. This paper presents the main results of studies on Phase A (including studies on the service life of ACRV; spacecraft design and operations; prelaunch processing; mission support; safety, reliability, maintenance and quality and assurance; landing, and search/rescue operations; interfaces with the SSF and with Space Shuttle; crew accommodation; motion of orbital an service modules; and ACRV injection by the Expendable Launch Vehicles), along with the objectives of further work on the Phase B.

Spaceflight Safety on the North Coast of America

NASA Technical Reports Server (NTRS)

Ciancone, Michael L.; Havenhill, Maria T.; Terlep, Judith A.

1996-01-01

Spaceflight Safety (SFS) engineers at NASA Lewis Research Center (LeRC) are responsible for evaluating the microgravity fluids and combustion experiments, payloads and facilities developed at NASA LeRC which are manifested for spaceflight on the Space Shuttle, the Russian space station Mir, and/or the International Space Station (ISS). An ongoing activity at NASA LeRC is the comprehensive training of its SFS engineers through the creation and use of safety tools and processes. Teams of SFS engineers worked on the development of an Internet website (containing a spaceflight safety knowledge database and electronic templates of safety products) and the establishment of a technical peer review process (known as the Safety Assurance for Lewis Spaceflight Activities (SALSA) review).

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.

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.'''

Safety Surveillance of Traditional Chinese Medicine: Current and Future

PubMed Central

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

TU-FG-201-12: Designing a Risk-Based Quality Assurance Program for a Newly Implemented Y-90 Microspheres Procedure

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

A Concept of Operations for an Integrated Vehicle Health Assurance System

NASA Technical Reports Server (NTRS)

Hunter, Gary W.; Ross, Richard W.; Berger, David E.; Lekki, John D.; Mah, Robert W.; Perey, Danie F.; Schuet, Stefan R.; Simon, Donald L.; Smith, Stephen W.

2013-01-01

This document describes a Concept of Operations (ConOps) for an Integrated Vehicle Health Assurance System (IVHAS). This ConOps is associated with the Maintain Vehicle Safety (MVS) between Major Inspections Technical Challenge in the Vehicle Systems Safety Technologies (VSST) Project within NASA s Aviation Safety Program. In particular, this document seeks to describe an integrated system concept for vehicle health assurance that integrates ground-based inspection and repair information with in-flight measurement data for airframe, propulsion, and avionics subsystems. The MVS Technical Challenge intends to maintain vehicle safety between major inspections by developing and demonstrating new integrated health management and failure prevention technologies to assure the integrity of vehicle systems between major inspection intervals and maintain vehicle state awareness during flight. The approach provided by this ConOps is intended to help optimize technology selection and development, as well as allow the initial integration and demonstration of these subsystem technologies over the 5 year span of the VSST program, and serve as a guideline for developing IVHAS technologies under the Aviation Safety Program within the next 5 to 15 years. A long-term vision of IVHAS is provided to describe a basic roadmap for more intelligent and autonomous vehicle systems.

Surface-Water Quality-Assurance Plan for the USGS Wisconsin Water Science Center

USGS Publications Warehouse

Garn, H.S.

2007-01-01

This surface-water quality-assurance plan documents the standards, policies, and procedures used by the Wisconsin Water Science Center of the U.S. Geological Survey, Water Resources Discipline, for activities related to the collection, processing, storage, analysis, management, and publication of surface-water data. The roles and responsibilities of Water Science Center personnel in following these policies and procedures including those related to safety and training are presented.

Manned space flight nuclear system safety. Volume 6: Space base nuclear system safety plan

NASA Technical Reports Server (NTRS)

1972-01-01

A qualitative identification of the steps required to assure the incorporation of radiological system safety principles and objectives into all phases of a manned space base program are presented. Specific areas of emphasis include: (1) radiological program management, (2) nuclear system safety plan implementation, (3) impact on program, and (4) summary of the key operation and design guidelines and requirements. The plan clearly indicates the necessity of considering and implementing radiological system safety recommendations as early as possible in the development cycle to assure maximum safety and minimize the impact on design and mission plans.

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.

Construction of quality-assured infant feeding process of care data repositories: definition and design (Part 1).

PubMed

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.

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.

Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa.

PubMed

Dzingirayi, Garikayi; Korsten, Lise

2016-07-01

Growing global consumer concern over food safety in the fresh produce industry requires producers to implement necessary quality assurance systems. Varying effectiveness has been noted in how countries and food companies interpret and implement food safety standards. A diagnostic instrument (DI) for global fresh produce industries was developed to measure the compliancy of companies with implemented food safety standards. The DI is made up of indicators and descriptive grids for context factors and control and assurance activities to measure food safety output. The instrument can be used in primary production to assess food safety performance. This study applied the DI to measure food safety standard compliancy of mushroom farming in South Africa. Ten farms representing almost half of the industry farms and more than 80% of production were independently assessed for their horticultural safety management system (HSMS) compliance via in-depth interviews with each farm's quality assurance personnel. The data were processed using Microsoft Office Excel 2010 and are represented in frequency tables. The diagnosis revealed that the mushroom farming industry had an average food safety output. The farms were implementing an average-toadvanced HSMS and operating in a medium-risk context. Insufficient performance areas in HSMSs included inadequate hazard analysis and analysis of control points, low specificity of pesticide assessment, and inadequate control of suppliers and incoming materials. Recommendations to the industry and current shortcomings are suggested for realization of an improved industry-wide food safety assurance system.

Assure

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

Improving food safety within the dairy chain: an application of conjoint analysis.

PubMed

Valeeva, N I; Meuwissen, M P M; Lansink, A G J M Oude; Huirne, R B M

2005-04-01

This study determined the relative importance of attributes of food safety improvement in the production chain of fluid pasteurized milk. The chain was divided into 4 blocks: "feed" (compound feed production and its transport), "farm" (dairy farm), "dairy processing" (transport and processing of raw milk, delivery of pasteurized milk), and "consumer" (retailer/catering establishment and pasteurized milk consumption). The concept of food safety improvement focused on 2 main groups of hazards: chemical (antibiotics and dioxin) and microbiological (Salmonella, Escherichia coli, Mycobacterium paratuberculosis, and Staphylococcus aureus). Adaptive conjoint analysis was used to investigate food safety experts' perceptions of the attributes' importance. Preference data from individual experts (n = 24) on 101 attributes along the chain were collected in a computer-interactive mode. Experts perceived the attributes from the "feed" and "farm" blocks as being more vital for controlling the chemical hazards; whereas the attributes from the "farm" and "dairy processing" were considered more vital for controlling the microbiological hazards. For the chemical hazards, "identification of treated cows" and "quality assurance system of compound feed manufacturers" were considered the most important attributes. For the microbiological hazards, these were "manure supply source" and "action in salmonellosis and M. paratuberculosis cases". The rather high importance of attributes relating to quality assurance and traceability systems of the chain participants indicates that participants look for food safety assurance from the preceding participants. This information has substantial decision-making implications for private businesses along the chain and for the government regarding the food safety improvement of fluid pasteurized milk.

Quality assurance for gamma knives

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jones, E.D.; Banks, W.W.; Fischer, L.E.

1995-09-01

This report describes and summarizes the results of a quality assurance (QA) study of the Gamma Knife, a nuclear medical device used for the gamma irradiation of intracranial lesions. Focus was on the physical aspects of QA and did not address issues that are essentially medical, such as patient selection or prescription of dose. A risk-based QA assessment approach was used. Sample programs for quality control and assurance are included. The use of the Gamma Knife was found to conform to existing standards and guidelines concerning radiation safety and quality control of external beam therapies (shielding, safety reviews, radiation surveys,more » interlock systems, exposure monitoring, good medical physics practices, etc.) and to be compliant with NRC teletherapy regulations. There are, however, current practices for the Gamma Knife not covered by existing, formalized regulations, standards, or guidelines. These practices have been adopted by Gamma Knife users and continue to be developed with further experience. Some of these have appeared in publications or presentations and are slowly finding their way into recommendations of professional organizations.« less

Model Based Mission Assurance in a Model Based Systems Engineering (MBSE) Framework: State-of-the-Art Assessment

NASA Technical Reports Server (NTRS)

Cornford, Steven L.; Feather, Martin S.

2016-01-01

This report explores the current state of the art of Safety and Mission Assurance (S&MA) in projects that have shifted towards Model Based Systems Engineering (MBSE). Its goal is to provide insight into how NASA's Office of Safety and Mission Assurance (OSMA) should respond to this shift. In MBSE, systems engineering information is organized and represented in models: rigorous computer-based representations, which collectively make many activities easier to perform, less error prone, and scalable. S&MA practices must shift accordingly. The "Objective Structure Hierarchies" recently developed by OSMA provide the framework for understanding this shift. Although the objectives themselves will remain constant, S&MA practices (activities, processes, tools) to achieve them are subject to change. This report presents insights derived from literature studies and interviews. The literature studies gleaned assurance implications from reports of space-related applications of MBSE. The interviews with knowledgeable S&MA and MBSE personnel discovered concerns and ideas for how assurance may adapt. Preliminary findings and observations are presented on the state of practice of S&MA with respect to MBSE, how it is already changing, and how it is likely to change further. Finally, recommendations are provided on how to foster the evolution of S&MA to best fit with MBSE.

30 CFR 14.8 - Quality assurance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Standards and Technology, U.S. Department of Commerce or other nationally or internationally recognized...

30 CFR 14.8 - Quality assurance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Standards and Technology, U.S. Department of Commerce or other nationally or internationally recognized...

30 CFR 14.8 - Quality assurance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Standards and Technology, U.S. Department of Commerce or other nationally or internationally recognized...

Can the Analytical Hierarchy Process Model Be Effectively Applied in the Prioritization of Information Assurance Defense In-Depth Measures? --A Quantitative Study

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…

Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative.

PubMed

McLean, Brian

2015-09-10

 To perform a quality assurance and performance improvement project through review of our single center data on the safety and patient acceptability of the stellate ganglion blockade (SGB) procedure for the relief of symptoms related to chronic post-traumatic stress disorder.  Our interventional pain management service has been offering trials of SGB therapy to assist with the management of the sympathetically mediated anxiety and hyperarousal symptoms of severe and treatment-refractory combat-related PTSD. There have been multiple case series in the literature describing the potential impact of this procedure for PTSD symptom management as well as the safety of image-guided procedures. We wished to ensure that we were performing this procedure safely and that patients were tolerating and accepting of this adjunctive treatment option.  We conducted a review of our quality assurance and performance improvement data over the past 18 months during which we performed 250 stellate ganglion blocks for the management of PTSD symptoms to detect any potential complications or unanticipated side effects.  We also analyzed responses from an anonymous patient de-identified survey collected regarding the comfort and satisfaction associated with the procedure.  We did not identify any immediate post-procedural complications or delayed complications from any of the 250 procedures performed from November 2013 to April 2015. Of the 110 surveys that were returned and tabulated, 100% of the patients surveyed were overall satisfied with our process and with the procedure, 100% said they would recommend the procedure to a friend, and 95% stated that they would be willing to undergo as many repeat procedures as necessary based on little discomfort and tolerable side effects.  Our quality assurance assessment suggests that in our center the SGB procedure for PTSD is a safe, well-tolerated, and acceptable treatment adjunct in the management of

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.

Training, Quality Assurance Factors, and Tools Investigation: a Work Report and Suggestions on Software Quality Assurance

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.

[Integrated quality assurance].

PubMed

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)

Benchmarking Software Assurance Implementation

DTIC Science & Technology

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

16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Reasonable steps to assure information... PRODUCT SAFETY ACT Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate... of the Acts It Administers § 1101.33 Reasonable steps to assure information release is fair in the...

Formal Assurance Arguments: A Solution In Search of a Problem?

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.

2015-01-01

An assurance case comprises evidence and argument showing how that evidence supports assurance claims (e.g., about safety or security). It is unsurprising that some computer scientists have proposed formalizing assurance arguments: most associate formality with rigor. But while engineers can sometimes prove that source code refines a formal specification, it is not clear that formalization will improve assurance arguments or that this benefit is worth its cost. For example, formalization might reduce the benefits of argumentation by limiting the audience to people who can read formal logic. In this paper, we present (1) a systematic survey of the literature surrounding formal assurance arguments, (2) an analysis of errors that formalism can help to eliminate, (3) a discussion of existing evidence, and (4) suggestions for experimental work to definitively answer the question.

Read Code Quality Assurance

PubMed Central

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

Radiological safety status and quality assurance audit of medical X-ray diagnostic installations in India.

PubMed

Sonawane, A U; Singh, Meghraj; Sunil Kumar, J V K; Kulkarni, Arti; Shirva, V K; Pradhan, A S

2010-10-01

We conducted a radiological safety and quality assurance (QA) audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp), linearity of tube current (mA station) and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM) (Model RAD/FLU-9001), dose Test-O-Meter (ToM) (Model 6001), ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%), lack of congruence of radiation and optical field (23%), nonlinearity of mA station (16%) and timer (9%), improper collimator/diaphragm (19.6%), faulty adjustor knob for alignment of field size (4%), nonavailability of warning light (red light) at the entrance of the X-ray room (29%), and use of mobile protective barriers without lead glass viewing window (14%). The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body.

Database management systems for process safety.

PubMed

Early, William F

2006-03-17

Several elements of the process safety management regulation (PSM) require tracking and documentation of actions; process hazard analyses, management of change, process safety information, operating procedures, training, contractor safety programs, pre-startup safety reviews, incident investigations, emergency planning, and compliance audits. These elements can result in hundreds of actions annually that require actions. This tracking and documentation commonly is a failing identified in compliance audits, and is difficult to manage through action lists, spreadsheets, or other tools that are comfortably manipulated by plant personnel. This paper discusses the recent implementation of a database management system at a chemical plant and chronicles the improvements accomplished through the introduction of a customized system. The system as implemented modeled the normal plant workflows, and provided simple, recognizable user interfaces for ease of use.

Establishment and implementation of common product assurance and safety requirements for the contractors of the Columbus programme

NASA Astrophysics Data System (ADS)

Wessels, H.; Stephan, H. J.

1991-08-01

When establishing the Columbus Product Assurance (PA)/safety requirements, the international environment of the Space Station Freedom program has to be taken into account. Considerations given to multiple ways of requirement definition and stages within the European Space Agency (ESA) Procedures, Specifications, and Standards (PSS-01) series of documents and the NASA Space Station requirements are discussed. A series of adaptations introduced by way of tailoring the basic ESA and NASA requirement sets to the Columbus program's needs are described. For the implementation of these tailored requirements, a scheme is developed, which recognizes the PA/safety approach within the European industries by way of various company handbooks and manuals. The changes introduced in the PSS-01 series and the applicable NASA Space Station requirements in recent years, has coincided with the establishment of Columbus PA/safety requirements. To achieve the necessary level of cooperation between ESA and the Columbus industries, a PA Working Group (PAWG) is established. The PAWG supervises the establishement of the Common PA/Safety Plan and the Standards to be used. Due to the high number of European industries participating in the Columbus program, a positive influence on the evolution of the industrial approaches in PA/safety can be expected. Cooperation in the PAWG has brought issues to light which are related to the ESA PSS-01 series and its requirements. Due to the rapid changes of recent years, basic company documentation has not followed the development, specifically as various recent ESA projects use different project specifc issues of the evolving PSS-01 documents.

Querying Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

2014-01-01

Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

System Safety in an IT Service Organization

NASA Astrophysics Data System (ADS)

Parsons, Mike; Scutt, Simon

Within Logica UK, over 30 IT service projects are considered safetyrelated. These include operational IT services for airports, railway infrastructure asset management, nationwide radiation monitoring and hospital medical records services. A recent internal audit examined the processes and documents used to manage system safety on these services and made a series of recommendations for improvement. This paper looks at the changes and the challenges to introducing them, especially where the service is provided by multiple units supporting both safety and non-safety related services from multiple locations around the world. The recommendations include improvements to service agreements, improved process definitions, routine safety assessment of changes, enhanced call logging, improved staff competency and training, and increased safety awareness. Progress is reported as of today, together with a road map for implementation of the improvements to the service safety management system. A proposal for service assurance levels (SALs) is discussed as a way forward to cover the wide variety of services and associated safety risks.

Broad spectrum detoxification: the major longevity assurance process regulated by insulin/IGF-1 signaling?

PubMed

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.

NASA Software Assurance's Roles in Research and Technology

NASA Technical Reports Server (NTRS)

Wetherholt, Martha

2010-01-01

This slide presentation reviews the interactions between the scientist and engineers doing research and technology and the software developers and others who are doing software assurance. There is a discussion of the role of the Safety and Mission Assurance (SMA) in developing software to be used for research and technology, and the importance of this role as the technology moves to the higher levels of the technology readiness levels (TRLs). There is also a call to change the way the development of software is developed.

76 FR 33188 - Quality Assurance Requirements for Respirators; Notice of Withdrawal

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-08

... Quality Assurance Requirements for Respirators; Notice of Withdrawal AGENCY: Centers for Disease Control... approved under 42 CFR Part 84 by the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention and the Mine Safety and Health Administration (MSHA). NIOSH has...

Reliability and quality assurance on the MOD 2 wind system

NASA Technical Reports Server (NTRS)

Mason, W. E. B.; Jones, B. G.

1981-01-01

The Safety, Reliability, and Quality Assurance (R&QA) approach developed for the largest wind turbine generator, the Mod 2, is described. The R&QA approach assures that the machine is not hazardous to the public or to the operating personnel, is operated unattended on a utility grid, demonstrates reliable operation, and helps establish the quality assurance and maintainability requirements for future wind turbine projects. The significant guideline consisted of a failure modes and effects analysis (FMEA) during the design phase, hardware inspections during parts fabrication, and three simple documents to control activities during machine construction and operation.

Probability of loss of assured safety in temperature dependent systems with multiple weak and strong links.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Johnson, Jay Dean; Oberkampf, William Louis; Helton, Jon Craig

2004-12-01

Relationships to determine the probability that a weak link (WL)/strong link (SL) safety system will fail to function as intended in a fire environment are investigated. In the systems under study, failure of the WL system before failure of the SL system is intended to render the overall system inoperational and thus prevent the possible occurrence of accidents with potentially serious consequences. Formal developments of the probability that the WL system fails to deactivate the overall system before failure of the SL system (i.e., the probability of loss of assured safety, PLOAS) are presented for several WWSL configurations: (i) onemore » WL, one SL, (ii) multiple WLs, multiple SLs with failure of any SL before any WL constituting failure of the safety system, (iii) multiple WLs, multiple SLs with failure of all SLs before any WL constituting failure of the safety system, and (iv) multiple WLs, multiple SLs and multiple sublinks in each SL with failure of any sublink constituting failure of the associated SL and failure of all SLs before failure of any WL constituting failure of the safety system. The indicated probabilities derive from time-dependent temperatures in the WL/SL system and variability (i.e., aleatory uncertainty) in the temperatures at which the individual components of this system fail and are formally defined as multidimensional integrals. Numerical procedures based on quadrature (i.e., trapezoidal rule, Simpson's rule) and also on Monte Carlo techniques (i.e., simple random sampling, importance sampling) are described and illustrated for the evaluation of these integrals. Example uncertainty and sensitivity analyses for PLOAS involving the representation of uncertainty (i.e., epistemic uncertainty) with probability theory and also with evidence theory are presented.« less

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

Aviation Safety: Efforts to Implement Flight Operational Quality Assurance Programs

DOT National Transportation Integrated Search

1997-12-01

Flight Operational Quality Assurance (FOQA) programs seek to use flight data to : detect technical flaws, unsafe practices, or conditions outside of desired : operating procedures early enough to allow timely intervention to avert : accidents or inci...

10 CFR 830.203 - Unreviewed safety question process.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Unreviewed safety question process. 830.203 Section 830.203 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.203 Unreviewed safety question process. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE...

Formal Foundations for Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2015-01-01

Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

Savannah River Laboratory quality assurance manual. Revision 2

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1985-02-01

The SRL quality assurance program is a management activity that verifies that the results of our research and development are adequate for their intended use and that our facilities function properly. The program is based on Savannah River Quality Assurance Plan (DPW-82-111-2, Rev 0) as applied through Quality Assurance Procedures and Divisional Plans (following section). The AED policy states that ''all activities shall be conducted to achieve a high quality of product and performance...'' The policy contains 18 considerations to be applied ''proportional to needs, based on the technical and professional judgment of responsible Du Pont employees.'' Quality is themore » responsibility of each individual and his line organization, as is safety. To ensure that quality is being considered for all SRL activities, all research programs are reviewed, and all facilities are assessed. These assessments and reviews are the nucleus of the Quality Assurance program.« less

Safety systems in gamma irradiation facilities.

PubMed

Drndarevic, V

1997-08-01

A new electronic device has been developed to guard against individuals gaining entry through the product entry and exit ports into our irradiation facility for industrial sterilization. This device uses the output from electronic sensors and pressure mats to assure that only the transport cabins may pass through these ports. Any intention of personnel trespassing is detected, the process is stopped by the safety system, and the source is placed in safe position. Owing to a simple construction, the new device enables reliable operation, is inexpensive, easy to implement, and improves the existing safety systems.

DOE-OES-EML quality assurance program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sanderson, C.G.

1980-01-01

Contractor laboratories handling radioactive materials for the US Department of Energy (DOE) are required to monitor the environmental exposure and publish annual reports for the Division of Operational and Environmental Safety (OES). In order to determine the validity of the data contained in these reports the Environmental Measurements Laboratory (EML) was requested to develop, coordinate, and conduct an Environmental Quality Assurance Program (QAP). There are four major phases to the DOE-OES-EML Quality Assurance Program: sample collection and preparation, sample analyses at EML, quarterly sample distribution, and reporting the data returned by the participants. The various phases of the QAP andmore » the data reported during the first year of the program are discussed.« less

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.

Survey of Software Assurance Techniques for Highly Reliable Systems

NASA Technical Reports Server (NTRS)

Nelson, Stacy

2004-01-01

This document provides a survey of software assurance techniques for highly reliable systems including a discussion of relevant safety standards for various industries in the United States and Europe, as well as examples of methods used during software development projects. It contains one section for each industry surveyed: Aerospace, Defense, Nuclear Power, Medical Devices and Transportation. Each section provides an overview of applicable standards and examples of a mission or software development project, software assurance techniques used and reliability achieved.

Nuclear Powerplant Safety: Operations.

ERIC Educational Resources Information Center

Department of Energy, Washington, DC. Nuclear Energy Office.

Powerplant systems and procedures that ensure the day-to-day health and safety of people in and around the plant is referred to as operational safety. This safety is the result of careful planning, good engineering and design, strict licensing and regulation, and environmental monitoring. Procedures that assure operational safety at nuclear…

Implementing Software Safety in the NASA Environment

NASA Technical Reports Server (NTRS)

Wetherholt, Martha S.; Radley, Charles F.

1994-01-01

Until recently, NASA did not consider allowing computers total control of flight systems. Human operators, via hardware, have constituted the ultimate safety control. In an attempt to reduce costs, NASA has come to rely more and more heavily on computers and software to control space missions. (For example. software is now planned to control most of the operational functions of the International Space Station.) Thus the need for systematic software safety programs has become crucial for mission success. Concurrent engineering principles dictate that safety should be designed into software up front, not tested into the software after the fact. 'Cost of Quality' studies have statistics and metrics to prove the value of building quality and safety into the development cycle. Unfortunately, most software engineers are not familiar with designing for safety, and most safety engineers are not software experts. Software written to specifications which have not been safety analyzed is a major source of computer related accidents. Safer software is achieved step by step throughout the system and software life cycle. It is a process that includes requirements definition, hazard analyses, formal software inspections, safety analyses, testing, and maintenance. The greatest emphasis is placed on clearly and completely defining system and software requirements, including safety and reliability requirements. Unfortunately, development and review of requirements are the weakest link in the process. While some of the more academic methods, e.g. mathematical models, may help bring about safer software, this paper proposes the use of currently approved software methodologies, and sound software and assurance practices to show how, to a large degree, safety can be designed into software from the start. NASA's approach today is to first conduct a preliminary system hazard analysis (PHA) during the concept and planning phase of a project. This determines the overall hazard potential of

Perceptions and efficacy of flight operational quality assurance (FOQA) programs among small-scale operators.

DOT National Transportation Integrated Search

2012-01-01

Despite safety and economic advantages, as well as endorsements by the International Civil Aviation Organization, the : FAA, the National Transportation Safety Board, and Congress, voluntary Flight Operational Quality Assurance (FOQA) : participation...

Automating Nuclear-Safety-Related SQA Procedures with Custom Applications

DOE PAGES

Freels, James D.

2016-01-01

Nuclear safety-related procedures are rigorous for good reason. Small design mistakes can quickly turn into unwanted failures. Researchers at Oak Ridge National Laboratory worked with COMSOL to define a simulation app that automates the software quality assurance (SQA) verification process and provides results in less than 24 hours.

DoD Veterinary Service Activity Role in DoD Food Safety.

DTIC Science & Technology

1998-01-01

medical research and development; zoonotic disease prevention and control; and food safety and quality assurance. The latter mission is not all encompassing...within DoD. This paper reviews the division of responsibilities, within DoD, for food safety and quality assurance. The complexity of the division...and the problem it causes joint operations planners are explored. A proposal for integrating overall strategic responsibility for food safety and quality assurance into the DoD Veterinary Service Activity is developed.

Safety, Health, and Fire Prevention Guide for Hospital Safety Managers

DTIC Science & Technology

1993-03-01

Safety committee S 2-5 Oxygen quality assurance program 0 2-6 Safety and fire prevention library 0 2-7 Safety services to Dental Activities • 2-8...Chapter 2 Safety Management 2-1. Safety policy statement Health Services Command (HSC) Supplement (Suppl) 1 to Army Regulation (AR) 385-10 and the...Management. (b) The medical staff. (c) The nursing service . (d) Logistics. (e) Nutritional care. (f) Preventive medicine. * 2-3 USAEHA TG No. 152 March 1993 (g

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2005-01-01

NASA (National Aeronautics and Space Administration) relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft (manned or unmanned) launched that did not have a computer on board that provided vital command and control services. Despite this growing dependence on software control and monitoring, there has been no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Led by the NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard (STD-18l9.13B) has recently undergone a significant update in an attempt to provide that consistency. This paper will discuss the key features of the new NASA Software Safety Standard. It will start with a brief history of the use and development of software in safety critical applications at NASA. It will then give a brief overview of the NASA Software Working Group and the approach it took to revise the software engineering process across the Agency.

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 5 2013-10-01 2013-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 5 2012-10-01 2012-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 5 2014-10-01 2014-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

Super Safety and Health Day at KSC

NASA Technical Reports Server (NTRS)

2000-01-01

During Super Safety and Health Day at KSC, two employees were recognized for submitting winning entries in the theme and logo/poster contests. At left, Center Director Roy Bridges congratulates Dave Earhart with United Space Alliance (USA) for his winning logo; at right, Brig. Gen. Ronald D. Pettit congratulates David Koval with Space Gateway Support (SGS) for his winning theme, '''Safety and Health: A Working Relationship.''' 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.'''

International Harmonization of Food Safety Assessment of Pesticide Residues.

PubMed

Ambrus, Árpád

2016-01-13

This paper summarizes the development of principles and methods applied within the program of the FAO/WHO Codex Alimentarius during the past 50 years for the safety assessment of pesticide residues in food and feed and establishing maximum residue limits (MRLs) to promote free international trade and assure the safety of consumers. The role of major international organizations in this process, the FAO capacity building activities, and some problematic areas that require special attention are briefly described.

Development of a Safety Monitoring and Assurance System for chilled food products.

PubMed

Koutsoumanis, K; Taoukis, P S; Nychas, G J E

2005-04-15

The principles of a novel chill chain management policy, coded Safety Monitoring and Assurance System (SMAS) for the optimisation of the distribution of chilled food products within the chill chain are developed. In this system, a new approach based on actual risk evaluation at important points of the chill chain is used in order to promote products to the next stage of distribution. This evaluation based on product's time-temperature history, variation in product's characteristics (e.g. a(w), pH, etc.), and the use of predictive models for the growth of food pathogens, allows to give priority to products in such a way that risk at consumption time is minimized. The effectiveness of SMAS was evaluated against the First In First Out (FIFO) approach, the current method for food distribution, in a case study on the risk of listeriosis of cooked ham using the Monte Carlo simulation technique. Furthermore, the two approaches were compared for their effect on the quality of the products in terms of remaining shelf life at the time of consumption. The results showed that following the SMAS approach the risk of listerisosis is significantly lower while the spoiled products at the time of consumption are significantly reduced compared to FIFO approach.

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.

Leadership, safety climate, and continuous quality improvement: impact on process quality and patient safety.

PubMed

McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R

2014-10-01

Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

Leadership, safety climate, and continuous quality improvement: impact on process quality and patient safety.

PubMed

McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R

2015-01-01

Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

Nonthermal processing technologies as food safety intervention processes

USDA-ARS?s Scientific Manuscript database

Foods should provide sensorial satisfaction and nutrition to people. Yet, foodborne pathogens cause significant illness and lose of life to human kind every year. A processing intervention step may be necessary prior to the consumption to ensure the safety of foods. Nonthermal processing technologi...

Experiments To Demonstrate Chemical Process Safety Principles.

ERIC Educational Resources Information Center

Dorathy, Brian D.; Mooers, Jamisue A.; Warren, Matthew M.; Mich, Jennifer L.; Murhammer, David W.

2001-01-01

Points out the need to educate undergraduate chemical engineering students on chemical process safety and introduces the content of a chemical process safety course offered at the University of Iowa. Presents laboratory experiments demonstrating flammability limits, flash points, electrostatic, runaway reactions, explosions, and relief design.…

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…

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

Reception of the Quality Assurance Commitments of the Bologna Process in Finnish Higher Education Institutions

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…

Safety, Reliability, and Quality Assurance Provisions for the Office of Aeronautics, Exploration and Technology Centers

NASA Technical Reports Server (NTRS)

1991-01-01

This Handbook establishes general safety, reliability, and quality assurance (SR&QA) guidelines for use on flight and ground-based projects conducted at the Ames, Langley, and Lewis Research Centers, hereafter identified as the Office of Aeronautics, Exploration and Technology (OAET) Centers. This document is applicable to all projects and operations conducted at these Centers except for those projects covered by more restrictive provisions such as the Space Shuttle, Space Station, and unmanned spacecraft programs. This Handbook is divided into two parts. The first (Chapters 1 and 2) establishes the SR&QA guidelines applicable to the OAET Centers, and the second (Appendices A, B, C, and D) provides examples and definitions for the total SR&QA program. Each center should implement SR&QA programs using these guidelines with tailoring appropriate to the special projects conducted by each Center. This Handbook is issued in loose-leaf form and will be revised by page changes.

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.

Evaluating Outsourcing Information Technology and Assurance Expertise by Small Non-Profit Organizations

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…

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…

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.…

[Food safety of GMOs].

PubMed

Joudrier, P

2009-01-01

In this presentation, we review the complexity of the different biological events which occur during life cell cycles. Indeed transgenesis is not an unknown event for cells. In the second part of this article, the complex and complete evaluation process destined to assure the food safety of GMOs, before they are released on the market, is describd. Some ansers to questions frequently asked about the GMOs are given. It is concludedthat GMOs are probably more safe than their conventional non-GM counterpart.

Assuring Safety in Bus Transportation--Update on Federal Legislation.

ERIC Educational Resources Information Center

Craft, Nick

2003-01-01

Discusses the growing use of vans for transportation by child care centers and increasing concerns about van safety. Presents information on relevant federal legislation related to motor vehicle safety and the safety standards of the National Highway Traffic Safety Administration. Recommends that child care programs replace retiring vans with…

Lonizing radiation regulations and the dental practitioner: 3. Quality assurance in dental radiography.

PubMed

Rout, John; Brown, Jackie

2012-06-01

This is the last in a series of three articles on X-ray dose reduction and covers aspects of quality assurance. The first outlined radiation physics and protection and the second the legislation relating to radiation safety. Quality assurance is an essential part of dental radiography and is required to produce images of a consistently high standard, necessary for accurate diagnosis.

College Quality Assurance Assurances. Mendip Papers 020.

ERIC Educational Resources Information Center

Sallis, E.; Hingley, P.

This paper discusses the increasing interest in quality assurance in British education including its measurement and management through the introduction of a quality assurance system. The reasons and benefits of beginning a quality assurance system are discussed, and questions of what constitutes quality, whether it is quality in fact…

Surface-water quality-assurance plan for the Wisconsin district of the U. S. Geological Survey, Water Resources Division

USGS Publications Warehouse

Garn, H.S.

2002-01-01

This surface-water quality-assurance plan documents the standards, policies, and procedures used by the Wisconsin District of the U.S. Geological Survey, Water Resources Division, for activities related to the collection, processing, storage, analysis, management, and publication of surface-water data. The roles and responsibilities of District personnel in following these policies and procedures including those related to safety and training are presented.

Safety Assurances at Space Test Centres: Lessons Learned

NASA Astrophysics Data System (ADS)

Alarcon Ruiz, Raul; O'Neil, Sean; Valls, Rafel Prades

2010-09-01

The European Space Agency’s(ESA) experts in quality, cleanliness and contamination control, safety, test facilities and test methods have accumulated valuable experience during the performance of dedicated audits of space test centres in Europe over a period of 10 years. This paper is limited to a summary of the safety findings and provides a valuable reference to the lessons learned, identifying opportunities for improvement in the areas of risk prevention measures associated to the safety of all test centre personnel, the test specimen, the test facilities and associated infrastructure. Through the analysis of the audit results the authors present what are the main lessons learned, and conclude how an effective safety management system will contribute to successful test campaigns and have a positive impact on the cost and schedule of space projects.

Statistical process control analysis for patient quality assurance of intensity modulated radiation therapy

NASA Astrophysics Data System (ADS)

Lee, Rena; Kim, Kyubo; Cho, Samju; Lim, Sangwook; Lee, Suk; Shim, Jang Bo; Huh, Hyun Do; Lee, Sang Hoon; Ahn, Sohyun

2017-11-01

This study applied statistical process control to set and verify the quality assurances (QA) tolerance standard for our hospital's characteristics with the criteria standards that are applied to all the treatment sites with this analysis. Gamma test factor of delivery quality assurances (DQA) was based on 3%/3 mm. Head and neck, breast, prostate cases of intensity modulated radiation therapy (IMRT) or volumetric arc radiation therapy (VMAT) were selected for the analysis of the QA treatment sites. The numbers of data used in the analysis were 73 and 68 for head and neck patients. Prostate and breast were 49 and 152 by MapCHECK and ArcCHECK respectively. C p value of head and neck and prostate QA were above 1.0, C pml is 1.53 and 1.71 respectively, which is close to the target value of 100%. C pml value of breast (IMRT) was 1.67, data values are close to the target value of 95%. But value of was 0.90, which means that the data values are widely distributed. C p and C pml of breast VMAT QA were respectively 1.07 and 2.10. This suggests that the VMAT QA has better process capability than the IMRT QA. Consequently, we should pay more attention to planning and QA before treatment for breast Radiotherapy.

49 CFR 385.321 - What failures of safety management practices disclosed by the safety audit will result in a...

Code of Federal Regulations, 2010 CFR

2010-10-01

... disclosed by the safety audit will result in a notice to a new entrant that its USDOT new entrant... MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.321 What failures of safety management practices disclosed by the safety audit will result in a notice...

Safety of High Speed Ground Transportation Systems : Analytical Methodology for Safety Validation of Computer Controlled Subsystems : Volume 2. Development of a Safety Validation Methodology

DOT National Transportation Integrated Search

1995-01-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety cortical functions in high-speed rail or magnetic levitation ...

Software Assurance Challenges for the Commercial Crew Program

NASA Technical Reports Server (NTRS)

Cuyno, Patrick; Malnick, Kathy D.; Schaeffer, Chad E.

2015-01-01

This paper will provide a description of some of the challenges NASA is facing in providing software assurance within the new commercial space services paradigm, namely with the Commercial Crew Program (CCP). The CCP will establish safe, reliable, and affordable access to the International Space Station (ISS) by purchasing a ride from commercial companies. The CCP providers have varying experience with software development in safety-critical space systems. NASA's role in providing effective software assurance support to the CCP providers is critical to the success of CCP. These challenges include funding multiple vehicles that execute in parallel and have different rules of engagement, multiple providers with unique proprietary concerns, providing equivalent guidance to all providers, permitting alternates to NASA standards, and a large number of diverse stakeholders. It is expected that these challenges will exist in future programs, especially if the CCP paradigm proves successful. The proposed CCP approach to address these challenges includes a risk-based assessment with varying degrees of engagement and a distributed assurance model. This presentation will describe NASA IV&V Program's software assurance support and responses to these challenges.

The quality assurance liaison: Combined technical and quality assurance support

NASA Astrophysics Data System (ADS)

Bolivar, S. L.; Day, J. L.

1993-03-01

The role of the quality assurance liaison, the responsibilities of this position, and the evolutionary changes in duties over the last six years are described. The role of the quality assurance liaison has had a very positive impact on the Los Alamos Yucca Mountain Site Characterization (YW) quality assurance program. Having both technical and quality assurance expertise, the quality assurance liaisons are able to facilitate communications with scientists on quality assurance issues and requirements, thereby generating greater productivity in scientific investigations. The quality assurance liaisons help ensure that the scientific community knows and implements existing requirements, is aware of new or changing regulations, and is able to conduct scientific work within Project requirements. The influence of the role of the quality assurance liaison can be measured by an overall improvement in attitude of the staff regarding quality assurance requirements and improved job performance, as well as a decrease in deficiencies identified during both internal and external audits and surveillances. This has resulted in a more effective implementation of quality assurance requirements.

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 8 2011-10-01 2011-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 8 2013-10-01 2013-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 8 2014-10-01 2014-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 8 2012-10-01 2012-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

Challenges in performance of food safety management systems: a case of fish processing companies in Tanzania.

PubMed

Kussaga, Jamal B; Luning, Pieternel A; Tiisekwa, Bendantunguka P M; Jacxsens, Liesbeth

2014-04-01

This study provides insight for food safety (FS) performance in light of the current performance of core FS management system (FSMS) activities and context riskiness of these systems to identify the opportunities for improvement of the FSMS. A FSMS diagnostic instrument was applied to assess the performance levels of FSMS activities regarding context riskiness and FS performance in 14 fish processing companies in Tanzania. Two clusters (cluster I and II) with average FSMS (level 2) operating under moderate-risk context (score 2) were identified. Overall, cluster I had better (score 3) FS performance than cluster II (score 2 to 3). However, a majority of the fish companies need further improvement of their FSMS and reduction of context riskiness to assure good FS performance. The FSMS activity levels could be improved through hygienic design of equipment and facilities, strict raw material control, proper follow-up of critical control point analysis, developing specific sanitation procedures and company-specific sampling design and measuring plans, independent validation of preventive measures, and establishing comprehensive documentation and record-keeping systems. The risk level of the context could be reduced through automation of production processes (such as filleting, packaging, and sanitation) to restrict people's interference, recruitment of permanent high-skilled technological staff, and setting requirements on product use (storage and distribution conditions) on customers. However, such intervention measures for improvement could be taken in phases, starting with less expensive ones (such as sanitation procedures) that can be implemented in the short term to more expensive interventions (setting up assurance activities) to be adopted in the long term. These measures are essential for fish processing companies to move toward FSMS that are more effective.

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.

Quality-assurance plan for groundwater activities, U.S. Geological Survey, Washington Water Science Center

USGS Publications Warehouse

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

Sampling the food processing environment: taking up the cudgel for preventive quality management in food processing environments.

PubMed

Wagner, Martin; Stessl, Beatrix

2014-01-01

The Listeria monitoring program for Austrian cheese factories was established in 1988. The basic idea is to control the introduction of L. monocytogenes into the food processing environment, preventing the pathogen from contaminating the food under processing. The Austrian Listeria monitoring program comprises four levels of investigation, dealing with routine monitoring of samples and consequences of finding a positive sample. Preventive quality control concepts attempt to detect a foodborne hazard along the food processing chain, prior to food delivery, retailing, and consumption. The implementation of a preventive food safety concept provokes a deepened insight by the manufacturers into problems concerning food safety. The development of preventive quality assurance strategies contributes to the national food safety status and protects public health.

Overview of Risk Mitigation for Safety-Critical Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This report presents a high-level overview of a general strategy to mitigate the risks from threats to safety-critical computer-based systems. In this context, a safety threat is a process or phenomenon that can cause operational safety hazards in the form of computational system failures. This report is intended to provide insight into the safety-risk mitigation problem and the characteristics of potential solutions. The limitations of the general risk mitigation strategy are discussed and some options to overcome these limitations are provided. This work is part of an ongoing effort to enable well-founded assurance of safety-related properties of complex safety-critical computer-based aircraft systems by developing an effective capability to model and reason about the safety implications of system requirements and design.

Developing and Implementing a Quality Assurance Strategy for Electroconvulsive Therapy.

PubMed

Hollingsworth, Jessa; Baliko, Beverly; McKinney, Selina; Rosenquist, Peter

2018-04-17

The literature provides scant guidance in effective quality assurance strategies concerning the use of electroconvulsive therapy (ECT) for the treatment of psychiatric conditions. Numerous guidelines are published that provide guidance in the delivery of care; however, little has been done to determine how a program or facility might ensure compliance to best practice for safety, tolerability, and efficacy in performing ECT. The objective of this project was to create a quality assurance strategy specific to ECT. Determining standards for quality care and clarifying facility policy were key outcomes in establishing an effective quality assurance strategy. An audit tool was developed utilizing quality criteria derived from a systematic review of ECT practice guidelines, peer review, and facility policy. All ECT procedures occurring over a 2-month period of May to June 2017 were retrospectively audited and compared against target compliance rates set for the facility's ECT program. Facility policy was adapted to reflect quality standards, and audit findings were used to inform possible practice change initiatives, were used to create benchmarks for continuous quality monitoring, and were integrated into regular hospital quality meetings. Clarification on standards of care and the use of clinical auditing in ECT was an effective starting point in the development of a quality assurance strategy. Audit findings were successfully integrated into the hospital's overall quality program, and recognition of practice compliance informed areas for future quality development and policy revision in this small community-based hospital in the southeastern United States. This project sets the foundation for a quality assurance strategy that can be used to help monitor procedural safety and guide future improvement efforts in delivering ECT. Although it is just the first step in creating meaningful quality improvement, setting clear standards and identifying areas of greatest

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.

Implementation of Programmatic Quality and the Impact on Safety

NASA Astrophysics Data System (ADS)

Huls, Dale T.; Meehan, Kevin M.

2005-12-01

The implementation of an inadequate programmatic quality assurance discipline has the potential to adversely affect safety and mission success. This is best demonstrated in the lessons provided by the Apollo 1 Apollo 13 Challenger, and Columbia accidents; NASA Safety and Mission Assurance (S&MA) benchmarking exchanges; and conclusions reached by the Shuttle Return-to-Flight Task Group established following the Columbia Shuttle accident. Examples from the ISS Program demonstrate continuing issues with programmatic quality. Failure to adequately address programmatic quality assurance issues has a real potential to lead to continued inefficiency, increases in program costs, and additional catastrophic accidents.

Environment, Safety, and Health Self-Assessment Report, Fiscal Year 2008

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chernowski, John

2009-02-27

Self-Assessment annually. The primary focus of the review is workplace safety. The MESH review is an evaluation of division management of ES&H in its research and operations, focusing on implementation and effectiveness of the division's ISM plan. It is a peer review performed by members of the LBNL Safety Review Committee (SRC), with staff support from OCA. Each division receives a MESH review every two to four years, depending on the results of the previous review. The ES&H Technical Assurance Program (TAP) provides the framework for systematic reviews of ES&H programs and processes. The intent of ES&H Technical Assurance assessments is to provide assurance that ES&H programs and processes comply with their guiding regulations, are effective, and are properly implemented by LBNL divisions. The Appendix B Performance Evaluation and Measurement Plan (PEMP) requires that LBNL sustain and enhance the effectiveness of integrated safety, health, and environmental protection through a strong and well-deployed system. Information required for Appendix B is provided by EH&S Division functional managers. The annual Appendix B report is submitted at the close of the fiscal year. This assessment is the Department of Energy's (DOE) primary mechanism for evaluating LBNL's contract performance in ISM.« less

Safety Considerations in the Chemical Process Industries

NASA Astrophysics Data System (ADS)

Englund, Stanley M.

There is an increased emphasis on chemical process safety as a result of highly publicized accidents. Public awareness of these accidents has provided a driving force for industry to improve its safety record. There has been an increasing amount of government regulation.

Quality-assurance plan for the analysis of suspended sediment by the U.S. Geological Survey in Montana

USGS Publications Warehouse

Dodge, Kent A.; Lambing, John H.

2006-01-01

A quality-assurance plan has been developed for use by the sediment laboratory of the U.S. Geological Survey Montana Water Science Center in conducting activities related to the analysis of suspended sediment. The plan documents quality-assurance policies for sediment-laboratory certification, personnel responsibilities and training, documentation requirements, and laboratory safety. The plan also documents quality-assurance procedures related to laboratory equipment and supplies, sample management, sample analysis, analytical quality control, and data management.

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.

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...

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...

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...

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...

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.

Competence assurance in a complex company

DOE Office of Scientific and Technical Information (OSTI.GOV)

Clarke, C.C.; Sykes, R.M.

1996-11-01

Competence is the fundamental control that is used in industry to function in a safe and effective manner. Even after all mechanical interventions are applied within a system, the competence of human beings is relied upon to make the final decisions and to implement the ultimate actions. To be effective, an Organization must assure itself that all the controls and barriers that are necessary to keep the operations of the business within the designed envelope, are effectively working at or above the minimum required levels. This assurance applies equally to workforce competence as it does to alarms and other automaticmore » control systems. The HSE Management System,/HSE Case methodology that evolved into regulation from the Cullen enquiry into the Piper Alpha disaster demands that specific competence must be in place, and that management must sign off that this is so. Assurance of competence involves identifying critical abilities and defining the standards to which they must be consistently performed, and then implementing a consistent and rigorous means of testing and validating the people who occupy roles that include critical abilities. This paper addresses with the methods that Shell Exploration and Production B.V. has developed to ensure that the competence are in place for critical occupational health, safety and environmental roles.« less

NASA Expendable Launch Vehicle (ELV) Payload Safety Review Process

NASA Technical Reports Server (NTRS)

Starbus, Calvert S.; Donovan, Shawn; Dook, Mike; Palo, Tom

2007-01-01

Issues addressed by this program: (1) Complicated roles and responsibilities associated with multi-partner projects (2) Working relationships and communications between all organizations involved in the payload safety process (3) Consistent interpretation and implementation of safety requirements from one project to the rest (4) Consistent implementation of the Tailoring Process (5) Clearly defined NASA decision-making-authority (6) Bring Agency-wide perspective to each ElV payload project. Current process requires a Payload Safety Working Group (PSWG) for eac payload with representatives from all involved organizations.

The Evolution of Process Safety: Current Status and Future Direction.

PubMed

Mannan, M Sam; Reyes-Valdes, Olga; Jain, Prerna; Tamim, Nafiz; Ahammad, Monir

2016-06-07

The advent of the industrial revolution in the nineteenth century increased the volume and variety of manufactured goods and enriched the quality of life for society as a whole. However, industrialization was also accompanied by new manufacturing and complex processes that brought about the use of hazardous chemicals and difficult-to-control operating conditions. Moreover, human-process-equipment interaction plus on-the-job learning resulted in further undesirable outcomes and associated consequences. These problems gave rise to many catastrophic process safety incidents that resulted in thousands of fatalities and injuries, losses of property, and environmental damages. These events led eventually to the necessity for a gradual development of a new multidisciplinary field, referred to as process safety. From its inception in the early 1970s to the current state of the art, process safety has come to represent a wide array of issues, including safety culture, process safety management systems, process safety engineering, loss prevention, risk assessment, risk management, and inherently safer technology. Governments and academic/research organizations have kept pace with regulatory programs and research initiatives, respectively. Understanding how major incidents impact regulations and contribute to industrial and academic technology development provides a firm foundation to address new challenges, and to continue applying science and engineering to develop and implement programs to keep hazardous materials within containment. Here the most significant incidents in terms of their impact on regulations and the overall development of the field of process safety are described.

Quality assurance in transnational higher education: a case study of the tropEd network

PubMed Central

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

NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

2011-01-01

System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual

Software Quality Assurance and Verification for the MPACT Library Generation Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liu, Yuxuan; Williams, Mark L.; Wiarda, Dorothea

This report fulfills the requirements for the Consortium for the Advanced Simulation of Light-Water Reactors (CASL) milestone L2:RTM.P14.02, “SQA and Verification for MPACT Library Generation,” by documenting the current status of the software quality, verification, and acceptance testing of nuclear data libraries for MPACT. It provides a brief overview of the library generation process, from general-purpose evaluated nuclear data files (ENDF/B) to a problem-dependent cross section library for modeling of light-water reactors (LWRs). The software quality assurance (SQA) programs associated with each of the software used to generate the nuclear data libraries are discussed; specific tests within the SCALE/AMPX andmore » VERA/XSTools repositories are described. The methods and associated tests to verify the quality of the library during the generation process are described in detail. The library generation process has been automated to a degree to (1) ensure that it can be run without user intervention and (2) to ensure that the library can be reproduced. Finally, the acceptance testing process that will be performed by representatives from the Radiation Transport Methods (RTM) Focus Area prior to the production library’s release is described in detail.« less

Assuring safety without animal testing: the case for the human testis in vitro.

PubMed

Chapin, Robert E; Boekelheide, Kim; Cortvrindt, Rita; van Duursen, Majorie B M; Gant, Tim; Jegou, Bernard; Marczylo, Emma; van Pelt, Ans M M; Post, Janine N; Roelofs, Maarke J E; Schlatt, Stefan; Teerds, Katja J; Toppari, Jorma; Piersma, Aldert H

2013-08-01

From 15 to 17 June 2011, a dedicated workshop was held on the subject of in vitro models for mammalian spermatogenesis and their applications in toxicological hazard and risk assessment. The workshop was sponsored by the Dutch ASAT initiative (Assuring Safety without Animal Testing), which aims at promoting innovative approaches toward toxicological hazard and risk assessment on the basis of human and in vitro data, and replacement of animal studies. Participants addressed the state of the art regarding human and animal evidence for compound mediated testicular toxicity, reviewed existing alternative assay models, and brainstormed about future approaches, specifically considering tissue engineering. The workshop recognized the specific complexity of testicular function exemplified by dedicated cell types with distinct functionalities, as well as different cell compartments in terms of microenvironment and extracellular matrix components. This complexity hampers quick results in the realm of alternative models. Nevertheless, progress has been achieved in recent years, and innovative approaches in tissue engineering may open new avenues for mimicking testicular function in vitro. Although feasible, significant investment is deemed essential to be able to bring new ideas into practice in the laboratory. For the advancement of in vitro testicular toxicity testing, one of the most sensitive end points in regulatory reproductive toxicity testing, such an investment is highly desirable. Copyright © 2013. Published by Elsevier Inc. All rights reserved.

A risk-based, product-level approach for assuring aquatic environmental safety of cleaning products in the context of sustainability: The Environmental Safety Check (ESC) scheme of the A.I.S.E. Charter for Sustainable Cleaning.

PubMed

Pickup, John Alexander; Dewaele, Joost; Furmanski, Nicola L; Kowalczyk, Agnieszka; Luijkx, Gerard Ca; Mathieu, Sophie; Stelter, Norbert

2017-01-01

Cleaning products have long been a focus of efforts to improve sustainability and assure safety for the aquatic environment when disposed of after use. The latter is addressed at ingredient level through environmental risk assessment, including in formal frameworks such as REACH. Nevertheless, in the context of programs to improve overall sustainability, stakeholders demand both environmental safety assurance and progress at product level. Current product-level approaches for aquatic toxicity (e.g., USEtox™, Critical Dilution Volume) can be seen as predominantly hazard-based. The more logical approach would be risk-based, because ecotoxicity is generally threshold-dependent and hazard-based assessment produces conflicts with risk-based learnings. The development of a risk-based approach to assess formulated products is described: the International Association for Soaps, Detergents and Maintenance Products (A.I.S.E.) Charter Environmental Safety Check (ESC), which is consistent with the scientific principles underlying REACH. This is implemented through a simple spreadsheet tool and internal database of ingredient parameters including predicted no-effect concentration (PNEC) and removal rate. A novel feature is applying market volume information for both product types and ingredients to permit a risk-based calculation. To pass the ESC check, the projected environmental safety ratio (PESR) for each ingredient as formulated and dosed (unless cleared by a published risk assessment or exempted as inherently low risk) must be less than 1. The advantages of a risk-based approach are discussed. The strengths and limitations of various possible approaches to standard-setting, product-ranking and driving continuous improvement in respect of potential ecotoxic impacts on the aquatic environment are considered. It is proposed that as ecotoxicity is generally accepted to be threshold-dependent, with no effect below the threshold, the most constructive approach to continuous

Certification Processes for Safety-Critical and Mission-Critical Aerospace Software

NASA Technical Reports Server (NTRS)

Nelson, Stacy

2003-01-01

This document is a quick reference guide with an overview of the processes required to certify safety-critical and mission-critical flight software at selected NASA centers and the FAA. Researchers and software developers can use this guide to jumpstart their understanding of how to get new or enhanced software onboard an aircraft or spacecraft. The introduction contains aerospace industry definitions of safety and safety-critical software, as well as, the current rationale for certification of safety-critical software. The Standards for Safety-Critical Aerospace Software section lists and describes current standards including NASA standards and RTCA DO-178B. The Mission-Critical versus Safety-Critical software section explains the difference between two important classes of software: safety-critical software involving the potential for loss of life due to software failure and mission-critical software involving the potential for aborting a mission due to software failure. The DO-178B Safety-critical Certification Requirements section describes special processes and methods required to obtain a safety-critical certification for aerospace software flying on vehicles under auspices of the FAA. The final two sections give an overview of the certification process used at Dryden Flight Research Center and the approval process at the Jet Propulsion Lab (JPL).

Integrating Microscopic Analysis into Existing Quality Assurance Processes

NASA Astrophysics Data System (ADS)

Frühberger, Peter; Stephan, Thomas; Beyerer, Jürgen

When technical goods, like mainboards and other electronic components, are produced, quality assurance (QA) is very important. To achieve this goal, different optical microscopes can be used to analyze a variety of specimen to gain comprehensive information by combining the acquired sensor data. In many industrial processes, cameras are used to examine these technical goods. Those cameras can analyze complete boards at once and offer a high level of accuracy when used for completeness checks. When small defects, e.g. soldered points, need to be examined in detail, those wide area cameras are limited. Microscopes with large magnification need to be used to analyze those critical areas. But microscopes alone cannot fulfill this task within a limited time schedule, because microscopic analysis of complete motherboards of a certain size is time demanding. Microscopes are limited concerning their depth of field and depth of focus, which is why additional components like XY moving tables need to be used to examine the complete surface. Yet today's industrial production quality standards require a 100 % control of the soldered components within a given time schedule. This level of quality, while keeping inspection time low, can only be achieved when combining multiple inspection devices in an optimized manner. This paper presents results and methods of combining industrial cameras with microscopy instrumenting a classificatory based approach intending to keep already deployed QA processes in place but extending them with the purpose of increasing the quality level of the produced technical goods while maintaining high throughput.

An Investigation of Proposed Techniques for Quantifying Confidence in Assurance Arguments

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. Michael

2016-01-01

The use of safety cases in certification raises the question of assurance argument sufficiency and the issue of confidence (or uncertainty) in the argument's claims. Some researchers propose to model confidence quantitatively and to calculate confidence in argument conclusions. We know of little evidence to suggest that any proposed technique would deliver trustworthy results when implemented by system safety practitioners. Proponents do not usually assess the efficacy of their techniques through controlled experiment or historical study. Instead, they present an illustrative example where the calculation delivers a plausible result. In this paper, we review current proposals, claims made about them, and evidence advanced in favor of them. We then show that proposed techniques can deliver implausible results in some cases. We conclude that quantitative confidence techniques require further validation before they should be recommended as part of the basis for deciding whether an assurance argument justifies fielding a critical system.

Integrating system safety into the basic systems engineering process

NASA Technical Reports Server (NTRS)

Griswold, J. W.

1971-01-01

The basic elements of a systems engineering process are given along with a detailed description of what the safety system requires from the systems engineering process. Also discussed is the safety that the system provides to other subfunctions of systems engineering.

Construction of quality-assured infant feeding process of care data repositories: Construction of the perinatal repository (Part 2).

PubMed

García-de-León-Chocano, Ricardo; Muñoz-Soler, Verónica; Sáez, Carlos; García-de-León-González, Ricardo; García-Gómez, Juan M

2016-04-01

This is the second in a series of two papers regarding the construction of data quality (DQ) assured repositories, based on population data from Electronic Health Records (EHR), for the reuse of information on infant feeding from birth until the age of two. This second paper describes the application of the computational process of constructing the first quality-assured repository for the reuse of information on infant feeding in the perinatal period, with the aim of studying relevant questions from the Baby Friendly Hospital Initiative (BFHI) and monitoring its deployment in our hospital. The construction of the repository was carried out using 13 semi-automated procedures to assess, recover or discard clinical data. The initial information consisted of perinatal forms from EHR related to 2048 births (Facts of Study, FoS) between 2009 and 2011, with a total of 433,308 observations of 223 variables. DQ was measured before and after the procedures using metrics related to eight quality dimensions: predictive value, correctness, duplication, consistency, completeness, contextualization, temporal-stability, and spatial-stability. Once the predictive variables were selected and DQ was assured, the final repository consisted of 1925 births, 107,529 observations and 73 quality-assured variables. The amount of discarded observations mainly corresponds to observations of non-predictive variables (52.90%) and the impact of the de-duplication process (20.58%) with respect to the total input data. Seven out of thirteen procedures achieved 100% of valid births, observations and variables. Moreover, 89% of births and ~98% of observations were consistent according to the experts׳ criteria. A multidisciplinary approach along with the quantification of DQ has allowed us to construct the first repository about infant feeding in the perinatal period based on EHR population data. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol

PubMed Central

2013-01-01

Background Implementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to ensure that EHR-enabled clinical work systems are safe and effective. Methods/Design This work is conceptually grounded in an 8-dimension model of safe and effective health information technology use. Our first aim is to develop self-assessment guides that can be used by health care institutions to evaluate certain high-risk components of their EHR-enabled clinical work systems. We will solicit input from subject matter experts and relevant stakeholders to develop guides focused on 9 specific risk areas and will subsequently pilot test the guides with individuals representative of likely users. The second aim will be to examine the utility of the self-assessment guides by beta testing the guides at selected facilities and conducting on-site evaluations. Our multidisciplinary team will use a variety of methods to assess the content validity and perceived usefulness of the guides, including interviews, naturalistic observations, and document analysis. The anticipated output of this work will be a series of self-administered EHR safety assessment guides with clear, actionable, checklist-type items. Discussion Proactive assessment of patient safety risks increases the resiliency of health care organizations to unanticipated hazards of EHR use. The resulting products and lessons learned from the development of the assessment guides are expected to be helpful to organizations that are beginning the EHR selection and implementation process as well as those that have already

Regulatory and Safety Requirements for Food Cultures

PubMed Central

Laulund, Svend; Wind, Anette; Derkx, Patrick M. F.; Zuliani, Véronique

2017-01-01

The increased use of food cultures to ferment perishable raw materials has potentiated the need for regulations to assess and assure the safety of food cultures and their uses. These regulations differ from country to country, all aimed at assuring the safe use of food cultures which has to be guaranteed by the food culture supplier. Here we highlight national differences in regulations and review a list of methods and methodologies to assess the safety of food cultures at strain level, at production, and in the final product. PMID:28545249

Margins Associated with Loss of Assured Safety for Systems with Multiple Time-Dependent Failure Modes.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Helton, Jon C.; Brooks, Dusty Marie; Sallaberry, Cedric Jean-Marie.

Representations for margins associated with loss of assured safety (LOAS) for weak link (WL)/strong link (SL) systems involving multiple time-dependent failure modes are developed. The following topics are described: (i) defining properties for WLs and SLs, (ii) background on cumulative distribution functions (CDFs) for link failure time, link property value at link failure, and time at which LOAS occurs, (iii) CDFs for failure time margins defined by (time at which SL system fails) – (time at which WL system fails), (iv) CDFs for SL system property values at LOAS, (v) CDFs for WL/SL property value margins defined by (property valuemore » at which SL system fails) – (property value at which WL system fails), and (vi) CDFs for SL property value margins defined by (property value of failing SL at time of SL system failure) – (property value of this SL at time of WL system failure). Included in this presentation is a demonstration of a verification strategy based on defining and approximating the indicated margin results with (i) procedures based on formal integral representations and associated quadrature approximations and (ii) procedures based on algorithms for sampling-based approximations.« less

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.

Usalpharma: A Cloud-Based Architecture to Support Quality Assurance Training Processes in Health Area Using Virtual Worlds

PubMed Central

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

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…

Lessons learned from process incident databases and the process safety incident database (PSID) approach sponsored by the Center for Chemical Process Safety.

PubMed

Sepeda, Adrian L

2006-03-17

Learning from the experiences of others has long been recognized as a valued and relatively painless process. In the world of process safety, this learning method is an essential tool since industry has neither the time and resources nor the willingness to experience an incident before taking corrective or preventative steps. This paper examines the need for and value of process safety incident databases that collect incidents of high learning value and structure them so that needed information can be easily and quickly extracted. It also explores how they might be used to prevent incidents by increasing awareness and by being a tool for conducting PHAs and incident investigations. The paper then discusses how the CCPS PSID meets those requirements, how PSID is structured and managed, and its attributes and features.

High assurance SPIRAL

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.

NASA guidelines for assuring the adequacy and appropriateness of security safeguards in sensitive applications

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.

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.

Pilot education and safety awareness programs

NASA Technical Reports Server (NTRS)

Shearer, M.; Reynard, W. D.

1984-01-01

Guidelines necessary for the implementation of safety awareness programs for commuter airlines are discussed. A safety office can be viewed as fulfilling either an education and training function or a quality assurance function. Issues such as management structure, motivation, and cost limitations are discussed.

LANL Safeguards and Security Assurance Program. Revision 6

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1995-04-03

The Safeguards and Security (S and S) Assurance Program provides a continuous quality improvement approach to ensure effective, compliant S and S program implementation throughout the Los Alamos National Laboratory. Any issues identified through the various internal and external assessments are documented, tracked and closed using the Safeguards and Security Issue Management Program. The Laboratory utilizes an integrated S and S systems approach to protect US Department of Energy (DOE) interests from theft or diversion of special nuclear material (SNM), sabotage, espionage, loss or theft of classified/controlled matter or government property, and other hostile acts that may cause unacceptable impactsmore » on national security, health and safety of employees and the public, and the environment. This document explains the basis, scope, and conduct of the S and S process to include: self-assessments, issue management, risk assessment, and root cause analysis. It also provides a discussion of S and S topical areas, roles and responsibilities, process flow charts, minimum requirements, methodology, terms, and forms.« less

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.

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…

Assuring Rural Hospital Patient Safety: What Should Be the Priorities?

ERIC Educational Resources Information Center

Coburn, Andrew F.; Wakefield, Mary; Casey, Michelle; Moscovice, Ira; Payne, Susan; Loux, Stephenie

2004-01-01

Context: Since reports on patient safety were issued by the Institute of Medicine, a number of interventions have been recommended and standards designed to improve hospital patient safety, including the Leapfrog, evidence-based safety standards. These standards are based on research conducted largely in urban hospitals, and it may not be possible…

Current food safety management systems in fish-exporting companies require further improvements to adequately cope with contextual pressure: case study.

PubMed

Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

2014-10-01

Fish-processing plants still face food safety (FS) challenges worldwide despite the existence of several quality assurance standards and food safety management systems/s (FSMSs). This study assessed performance of FSMS in fish exporting sector considering pressure from the context in which they operate. A FSMS diagnostic tool with checklist was used to assess the context, FSMS, and FS output in 9 Kenyan fish exporting companies. Majority (67%) companies operated at moderate- to high-risk context but with an average performance in control and assurance activities. This situation could be insufficient to deal with ambiguity, uncertainty, and vulnerability issues in the context characteristics. Contextual risk posed by product characteristics (nature of raw materials) and chain environment characteristics was high. Risk posed by the chain environment characteristics, low power in supplier relationships, and low degree of authority in customer relationships was high. Lack of authority in relationship with suppliers would lead to high raw material risk situation. Even though cooling facilities, a key control activity, was at an advanced level, there was inadequate packaging intervention equipment which coupled with inadequate physical intervention equipment could lead to further weakened FSMS performance. For the fish companies to improve their FSMS to higher level and enhance predictability, they should base their FSMS on scientific information sources, historical results, and own experimental trials in their preventive, intervention, and monitoring systems. Specific suggestions are derived for improvements toward higher FSMS activity levels or lower risk levels in context characteristics. Weak areas in performance of control and assurance activities in export fish-processing sector already implementing current quality assurance guidelines and standards were studied taking into consideration contextual pressure wherein the companies operate. Important mitigation

Plan delivery quality assurance for CyberKnife: Statistical process control analysis of 350 film-based patient-specific QAs.

PubMed

Bellec, J; Delaby, N; Jouyaux, F; Perdrieux, M; Bouvier, J; Sorel, S; Henry, O; Lafond, C

2017-07-01

Robotic radiosurgery requires plan delivery quality assurance (DQA) but there has never been a published comprehensive analysis of a patient-specific DQA process in a clinic. We proposed to evaluate 350 consecutive film-based patient-specific DQAs using statistical process control. We evaluated the performance of the process to propose achievable tolerance criteria for DQA validation and we sought to identify suboptimal DQA using control charts. DQAs were performed on a CyberKnife-M6 using Gafchromic-EBT3 films. The signal-to-dose conversion was performed using a multichannel-correction and a scanning protocol that combined measurement and calibration in a single scan. The DQA analysis comprised a gamma-index analysis at 3%/1.5mm and a separate evaluation of spatial and dosimetric accuracy of the plan delivery. Each parameter was plotted on a control chart and control limits were calculated. A capability index (Cpm) was calculated to evaluate the ability of the process to produce results within specifications. The analysis of capability showed that a gamma pass rate of 85% at 3%/1.5mm was highly achievable as acceptance criteria for DQA validation using a film-based protocol (Cpm>1.33). 3.4% of DQA were outside a control limit of 88% for gamma pass-rate. The analysis of the out-of-control DQA helped identify a dosimetric error in our institute for a specific treatment type. We have defined initial tolerance criteria for DQA validations. We have shown that the implementation of a film-based patient-specific DQA protocol with the use of control charts is an effective method to improve patient treatment safety on CyberKnife. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

48 CFR 246.371 - Notification of potential safety issues.

Code of Federal Regulations, 2010 CFR

2010-10-01

... safety issues. 246.371 Section 246.371 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Clauses 246.371 Notification of potential safety issues. (a) Use the clause at 252.246-7003, Notification of Potential Safety...

A Dividend in Food Safety

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.

49 CFR 385.313 - Who will conduct the safety audit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.313 Who will conduct the safety audit? An individual certified under the FMCSA regulations to perform safety audits will conduct the safety audit. ... 49 Transportation 5 2010-10-01 2010-10-01 false Who will conduct the safety audit? 385.313 Section...

Quality Assurance: Patient Chart Reviews

NASA Astrophysics Data System (ADS)

Oginni, B. M.; Odero, D. O.

2009-07-01

Recent developments in radiation therapy have immensely impacted the way the radiation dose is delivered to patients undergoing radiation treatments. However, the fundamental quality assurance (QA) issues underlying the radiation therapy still remain the accuracy of the radiation dose and the radiation safety. One of the major duties of clinical medical physicists in the radiation therapy departments still revolves around ensuring the accuracy of dose delivery to the planning target volume (PTV), the reduction of unintended radiation to normal organs and minimization of the radiation exposure to the medical personnel based on ALARA (as low as reasonably achievable) principle. Many of the errors in radiation therapy can be minimized through a comprehensive program of periodic checks. One of the QA procedures on the patient comes in the form of chart reviews which could be in either electronic or paper-based format. We present the quality assurance procedures that have to be performed on the patient records from the beginning and periodically to the end of the treatment, based on the guidelines from the American Association of Physicists in Medicine (AAPM) and American College of Physicians (ACP).

Probability of loss of assured safety in systems with multiple time-dependent failure modes.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Helton, Jon Craig; Pilch, Martin.; Sallaberry, Cedric Jean-Marie.

2012-09-01

Weak link (WL)/strong link (SL) systems are important parts of the overall operational design of high-consequence systems. In such designs, the SL system is very robust and is intended to permit operation of the entire system under, and only under, intended conditions. In contrast, the WL system is intended to fail in a predictable and irreversible manner under accident conditions and render the entire system inoperable before an accidental operation of the SL system. The likelihood that the WL system will fail to deactivate the entire system before the SL system fails (i.e., degrades into a configuration that could allowmore » an accidental operation of the entire system) is referred to as probability of loss of assured safety (PLOAS). Representations for PLOAS for situations in which both link physical properties and link failure properties are time-dependent are derived and numerically evaluated for a variety of WL/SL configurations, including PLOAS defined by (i) failure of all SLs before failure of any WL, (ii) failure of any SL before failure of any WL, (iii) failure of all SLs before failure of all WLs, and (iv) failure of any SL before failure of all WLs. The effects of aleatory uncertainty and epistemic uncertainty in the definition and numerical evaluation of PLOAS are considered.« less

Modernization of software quality assurance

NASA Technical Reports Server (NTRS)

Bhaumik, Gokul

1988-01-01

The customers satisfaction depends not only on functional performance, it also depends on the quality characteristics of the software products. An examination of this quality aspect of software products will provide a clear, well defined framework for quality assurance functions, which improve the life-cycle activities of software development. Software developers must be aware of the following aspects which have been expressed by many quality experts: quality cannot be added on; the level of quality built into a program is a function of the quality attributes employed during the development process; and finally, quality must be managed. These concepts have guided our development of the following definition for a Software Quality Assurance function: Software Quality Assurance is a formal, planned approach of actions designed to evaluate the degree of an identifiable set of quality attributes present in all software systems and their products. This paper is an explanation of how this definition was developed and how it is used.

Guidelines for the processing and quality assurance of benthic invertebrate samples collected as part of the National Water-Quality Assessment Program

USGS Publications Warehouse

Cuffney, T.F.; Gurtz, M.E.; Meador, M.R.

1993-01-01

Benthic invertebrate samples are collected as part of the U.S. Geological Survey's National Water-Quality Assessment Program. This is a perennial, multidisciplinary program that integrates biological, physical, and chemical indicators of water quality to evaluate status and trends and to develop an understanding of the factors controlling observed water quality. The Program examines water quality in 60 study units (coupled ground- and surface-water systems) that encompass most of the conterminous United States and parts of Alaska and Hawaii. Study-unit teams collect and process qualitative and semi-quantitative invertebrate samples according to standardized procedures. These samples are processed (elutriated and subsampled) in the field to produce as many as four sample components: large-rare, main-body, elutriate, and split. Each sample component is preserved in 10-percent formalin, and two components, large-rare and main-body, are sent to contract laboratories for further processing. The large-rare component is composed of large invertebrates that are removed from the sample matrix during field processing and placed in one or more containers. The main-body sample component consists of the remaining sample materials (sediment, detritus, and invertebrates) and is subsampled in the field to achieve a volume of 750 milliliters or less. The remaining two sample components, elutriate and split, are used for quality-assurance and quality-control purposes. Contract laboratories are used to identify and quantify invertebrates from the large-rare and main-body sample components according to the procedures and guidelines specified within this document. These guidelines allow the use of subsampling techniques to reduce the volume of sample material processed and to facilitate identifications. These processing procedures and techniques may be modified if the modifications provide equal or greater levels of accuracy and precision. The intent of sample processing is to

40 CFR 68.65 - Process safety information.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.65 Process safety... data; (4) Reactivity data: (5) Corrosivity data; (6) Thermal and chemical stability data; and (7...; (ii) Process chemistry; (iii) Maximum intended inventory; (iv) Safe upper and lower limits for such...

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…

Seafood Safety and Quality: The Consumer’s Role

PubMed Central

Hicks, Doris T.

2016-01-01

All the good news about seafood—the health and nutritional benefits, the wide varieties and flavors—has had a positive effect on consumption: people are eating more seafood (http://www.seagrant.sunysb.edu/seafood/pdfs/SeafoodSavvy.pdf). Yet consumers want to be assured that seafood is as safe as, or safer to eat than, other foods. When you hear “seafood safety”, think of a safety net designed to protect you, the consumer, from food-borne illness. Every facet of the seafood industry, from harvester to consumer, plays a role in holding up the safety net. The role of state and federal agencies, fishermen, aquaculturists, retailers, processors, restaurants, and scientists is to provide, update, and carry out the necessary handling, processing, and inspection procedures to give consumers the safest seafood possible. The consumer’s responsibility is to follow through with proper handling techniques, from purchase to preparation. It doesn’t matter how many regulations and inspection procedures are set up; the final edge of the safety net is held by the consumer. This article will give you the information you need to educate yourself and be assured that the fish and shellfish you consume are safe. The most common food-borne illnesses are caused by a combination of bacteria naturally present in our environment and food handling errors made in commercial settings, food service institutions, or at home. PMID:28231165

Virginia Tech: The Challenge of Assuring Safety

ERIC Educational Resources Information Center

Rikleen, Lauren Stiller

2007-01-01

The recent events at Virginia Tech reinforce the idea that nothing is more fundamental for college leaders to address than campus security and safety. After the tears, the makeshift memorials, and the intensely painful series of funerals, higher education must come to grips with the fact that it has just had its own September 11. Assessing and…

STS safety approval process for small self-contained payloads

NASA Technical Reports Server (NTRS)

Gum, Mary A.

1988-01-01

The safety approval process established by the National Aeronautics and Space Administration for Get Away Special (GAS) payloads is described. Although the designing organization is ultimately responsible for the safe operation of its payload, the Get Away Special team at the Goddard Space Flight Center will act as advisors while iterative safety analyses are performed and the Safety Data Package inputs are submitted. This four phase communications process will ultimately give NASA confidence that the GAS payload is safe, and successful completion of the Phase 3 package and review will clear the way for flight aboard the Space Transportation System orbiter.

A tiered quality assurance review process for clinical data management standard operating procedures in an academic health center.

PubMed

Ittenbach, Richard F; Baker, Cynthia L; Corsmo, Jeremy J

2014-05-01

Standard operating procedures (SOPs) were once considered the province of the pharmaceutical industry but are now viewed as a key component of quality assurance programs. To address variability and increase the rigor of clinical data management (CDM) operations, the Cincinnati Children's Hospital Medical Center (CCHMC) decided to create CDM SOPs. In response to this challenge, and as part of a broader institutional initiative, the CCHMC leadership established an executive steering committee to oversee the development and implementation of CDM SOPs. This resulted in the creation of a quality assurance review process with three review panels: an SOP development team (16 clinical data managers and technical staff members), a faculty review panel (8 senior faculty and administrators), and an expert advisory panel (3 national CDM experts). This innovative, tiered review process helped ensure that the new SOPs would be created and implemented in accord with good CDM practices and standards. Twelve fully vetted, institutionally endorsed SOPs and one CDM template resulted from the intensive, iterative 10-month process (December 2011 to early October 2012). Phased implementation, which incoporated the CDM SOPs into the existing audit process for certain types of clinical research studies, was on schedule at the time of this writing. Once CCHMC researchers have had the opportunity to use the SOPs over time and across a broad range of research settings and conditions, the SOPs will be revisited and revalidated.

Dialysis Facility Safety: Processes and Opportunities.

PubMed

Garrick, Renee; Morey, Rishikesh

2015-01-01

Unintentional human errors are the source of most safety breaches in complex, high-risk environments. The environment of dialysis care is extremely complex. Dialysis patients have unique and changing physiology, and the processes required for their routine care involve numerous open-ended interfaces between providers and an assortment of technologically advanced equipment. Communication errors, both within the dialysis facility and during care transitions, and lapses in compliance with policies and procedures are frequent areas of safety risk. Some events, such as air emboli and needle dislodgments occur infrequently, but are serious risks. Other adverse events include medication errors, patient falls, catheter and access-related infections, access infiltrations and prolonged bleeding. A robust safety system should evaluate how multiple, sequential errors might align to cause harm. Systems of care can be improved by sharing the results of root cause analyses, and "good catches." Failure mode effects and analyses can be used to proactively identify and mitigate areas of highest risk, and methods drawn from cognitive psychology, simulation training, and human factor engineering can be used to advance facility safety. © 2015 Wiley Periodicals, Inc.

New challenges in assuring vaccine quality.

PubMed Central

Dellepiane, N.; Griffiths, E.; Milstien, J. B.

2000-01-01

In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. PMID:10743279

Integrated deterministic and probabilistic safety analysis for safety assessment of nuclear power plants

DOE PAGES

Di Maio, Francesco; Zio, Enrico; Smith, Curtis; ...

2015-07-06

The present special issue contains an overview of the research in the field of Integrated Deterministic and Probabilistic Safety Assessment (IDPSA) of Nuclear Power Plants (NPPs). Traditionally, safety regulation for NPPs design and operation has been based on Deterministic Safety Assessment (DSA) methods to verify criteria that assure plant safety in a number of postulated Design Basis Accident (DBA) scenarios. Referring to such criteria, it is also possible to identify those plant Structures, Systems, and Components (SSCs) and activities that are most important for safety within those postulated scenarios. Then, the design, operation, and maintenance of these “safety-related” SSCs andmore » activities are controlled through regulatory requirements and supported by Probabilistic Safety Assessment (PSA).« less

Risk-based process safety assessment and control measures design for offshore process facilities.

PubMed

Khan, Faisal I; Sadiq, Rehan; Husain, Tahir

2002-09-02

Process operation is the most hazardous activity next to the transportation and drilling operation on an offshore oil and gas (OOG) platform. Past experiences of onshore and offshore oil and gas activities have revealed that a small mis-happening in the process operation might escalate to a catastrophe. This is of especial concern in the OOG platform due to the limited space and compact geometry of the process area, less ventilation, and difficult escape routes. On an OOG platform, each extra control measure, which is implemented, not only occupies space on the platform and increases congestion but also adds extra load to the platform. Eventualities in the OOG platform process operation can be avoided through incorporating the appropriate control measures at the early design stage. In this paper, the authors describe a methodology for risk-based process safety decision making for OOG activities. The methodology is applied to various offshore process units, that is, the compressor, separators, flash drum and driers of an OOG platform. Based on the risk potential, appropriate safety measures are designed for each unit. This paper also illustrates that implementation of the designed safety measures reduces the high Fatal accident rate (FAR) values to an acceptable level.

49 CFR 385.319 - What happens after completion of the safety audit?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false What happens after completion of the safety audit...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.319 What happens after...

Verification and Implementation of Operations Safety Controls for Flight Missions

NASA Technical Reports Server (NTRS)

Smalls, James R.; Jones, Cheryl L.; Carrier, Alicia S.

2010-01-01

There are several engineering disciplines, such as reliability, supportability, quality assurance, human factors, risk management, safety, etc. Safety is an extremely important engineering specialty within NASA, and the consequence involving a loss of crew is considered a catastrophic event. Safety is not difficult to achieve when properly integrated at the beginning of each space systems project/start of mission planning. The key is to ensure proper handling of safety verification throughout each flight/mission phase. Today, Safety and Mission Assurance (S&MA) operations engineers continue to conduct these flight product reviews across all open flight products. As such, these reviews help ensure that each mission is accomplished with safety requirements along with controls heavily embedded in applicable flight products. Most importantly, the S&MA operations engineers are required to look for important design and operations controls so that safety is strictly adhered to as well as reflected in the final flight product.

The Implementation and Maintenance of a Behavioral Safety Process in a Petroleum Refinery

ERIC Educational Resources Information Center

Myers, Wanda V.; McSween, Terry E.; Medina, Rixio E.; Rost, Kristen; Alvero, Alicia M.

2010-01-01

A values-centered and team-based behavioral safety process was implemented in a petroleum oil refinery. Employee teams defined the refinery's safety values and related practices, which were used to guide the process design and implementation. The process included (a) a safety assessment; (b) the clarification of safety-related values and related…

Evaluation of halal assurance system (HAS) implementation on bakery products processing in small and medium enterprises (case study in X Bakery Batu, East Java)

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.

49 CFR 385.311 - What will the safety audit consist of?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.311 What will the safety audit consist of? The safety audit will consist of a review of the new entrant's safety management systems and a... 49 Transportation 5 2010-10-01 2010-10-01 false What will the safety audit consist of? 385.311...

49 CFR 385.315 - Where will the safety audit be conducted?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.315 Where will the safety audit be conducted? The safety audit will generally be conducted at the new entrant's business premises. ... 49 Transportation 5 2010-10-01 2010-10-01 false Where will the safety audit be conducted? 385.315...

Aviation Safety Reporting System: Process and Procedures

NASA Technical Reports Server (NTRS)

Connell, Linda J.

1997-01-01

The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

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…

Analytical methodology for safety validation of computer controlled subsystems. Volume 1 : state-of-the-art and assessment of safety verification/validation methodologies

DOT National Transportation Integrated Search

1995-09-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety critical functions in high-speed rail or magnetic levitation ...

Nuclear Powerplant Safety: Design and Planning.

ERIC Educational Resources Information Center

Department of Energy, Washington, DC. Nuclear Energy Office.

The most important concern in the design, construction and operation of nuclear powerplants is safety. Nuclear power is one of the major contributors to the nation's supply of electricity; therefore, it is important to assure its safe use. Each different type of powerplant has special design features and systems to protect health and safety. One…

Safety Analysis of Soybean Processing for Advanced Life Support

NASA Technical Reports Server (NTRS)

Hentges, Dawn L.

1999-01-01

Soybeans (cv. Hoyt) is one of the crops planned for food production within the Advanced Life Support System Integration Testbed (ALSSIT), a proposed habitat simulation for long duration lunar/Mars missions. Soybeans may be processed into a variety of food products, including soymilk, tofu, and tempeh. Due to the closed environmental system and importance of crew health maintenance, food safety is a primary concern on long duration space missions. Identification of the food safety hazards and critical control points associated with the closed ALSSIT system is essential for the development of safe food processing techniques and equipment. A Hazard Analysis Critical Control Point (HACCP) model was developed to reflect proposed production and processing protocols for ALSSIT soybeans. Soybean processing was placed in the type III risk category. During the processing of ALSSIT-grown soybeans, critical control points were identified to control microbiological hazards, particularly mycotoxins, and chemical hazards from antinutrients. Critical limits were suggested at each CCP. Food safety recommendations regarding the hazards and risks associated with growing, harvesting, and processing soybeans; biomass management; and use of multifunctional equipment were made in consideration of the limitations and restraints of the closed ALSSIT.

[Quality assurance in interventional cardiology].

PubMed

Gülker, H

2009-10-01

Quality assurance in clinical studies aiming at approval of pharmaceutical products is submitted to strict rules, controls and auditing regulations. Comparative instruments to ensure quality in diagnostic and therapeutic procedures are not available in interventional cardiology, likewise in other fields of cardiovascular medicine. Quality assurance simply consists of "quality registers" with basic data not externally controlled. Based on the experiences of clinical studies and their long history of standardization it is assumed that these data may be severely flawed thus being inappropriate to set standards for diagnostic and therapeutic strategies. The precondition for quality assurance are quality data. In invasive coronary angiography and intervention medical indications, the decision making process interventional versus surgical revascularization, technical performance and after - care are essential aspects affecting quality of diagnostics and therapy. Quality data are externally controlled data. To collect quality data an appropriate infrastructure is a necessary precondition which is not existent. For an appropriate infrastructure investments have to be done both to build up as well as to sustain the necessary preconditions. As long as there are no infrastructure and no investments there will be no "quality data". There exist simply registers of data which are not proved to be a basis for significant assurance and enhancement in quality in interventional coronary cardiology. Georg Thieme Verlag KG Stuttgart, New York.

Quality assurance in forensic odontology

PubMed

Solheim, T

2018-05-30

Quality assurance or quality control is a term and concept coming from the industry. Here it is most important. All products must have a minimum quality and variation in size, for example, must be kept within certain strict limits. There must be a system to control this. May be not every single product is controlled, but spot tests must be taken. Measures must be taken to improve the quality if it is not good enough. This concept has been transferred to medicine, odontology, and consequently also to forensic odontology. These areas have in common with industry the production of that certain products. However, they are usually handmade and not produced in an industrial process. In addition, dentistry is a great deal of art and judgement and quality control of these factors may be difficult. In this paper, I will focus on forensic odontology. What are the problems? What can we do and cannot do? In addition, how can we assure the quality of the work, the assessment and conclusion, and the report? I have some personal opinions on that and I will give some suggestions. Quality assurance on an international level is difficult. Conditions and juridical systems are different in different countries. Especially forensic odontologists are different and have different opinions. This presentation will be relevant to the ongoing discussion and attempts at revising the IOFOS' guidelines for quality assurance.

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2007-01-01

NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those

Assuring Software Reliability

DTIC Science & Technology

2014-08-01

technologies and processes to achieve a required level of confidence that software systems and services function in the intended manner. 1.3 Security Example...that took three high-voltage lines out of service and a software fail- ure (a race condition3) that disabled the computing service that notified the... service had failed. Instead of analyzing the details of the alarm server failure, the reviewers asked why the following software assurance claim had

[Quality assurance in ENT tumor surgery].

PubMed

Eckel, H E; Streppel, M; Schmalenbach, K; Volling, P; Schrappe, M; Dietz, A; Bootz, F

2000-12-01

Quality control is of special importance in head and neck oncology since the quality of medical care constitutes a vital parameter for the diseased patient. In contrast to other medical specialties, no quality assurance program for head and neck cancer patients has yet been established in Germany. Therefore, a survey was conducted to assess the quality assurance instruments that are in use today in otorhinolaryngology-head and neck (ORL-HNS) centers. In a nationwide survey, questionnaires were sent out to 146 German ORL-HNS departments (the return rate was 75%). 56% of all departments apply dedicated quality assurance processes, and 38% have appointed a formal quality assurance officer. Interdisciplinary oncological conferences are held in the vast majority of all departments with the participation of radiation oncologists in 86 (78%), medical oncologists in 84 (76%), diagnostic radiologists in 82 (74%), and pathologists in 73 (66%). Morbidity-mortality conferences are held in seven departments (6%). A standardized follow-up of oncological patients is carried out in 95 units (86%), and 53 departments use computer-assisted data bases to organize their follow-up data (48%). A wide variety of documentation systems is in use throughout the country: 78 units (71%) offer formal follow-up to their oncological patients. This survey documents a wide-spread interest in quality assurance procedures. Many individual efforts are being undertaken. However, no uniform quality assurance or auditing system is currently in use in Germany nor is a commonly accepted data base available. The ability to offer oncological follow-up within the national social security system is generally considered indispensable for the maintenance of high-quality oncological care in ORL-HNS departments.

Just in Time Assurance

DTIC Science & Technology

2010-04-01

constrained to the objects it manages A local reference monitor can be maintained, updated, and replaced with minimal effect on the rest of the system...Compositional assurance is the path towards the goal of JIT Assurance Construct individual assurance case for each trusted tcomponen Provide argument that...local policies combine to enforce the overall system policy Composability enables JIT Assurance A component can be patched, upgraded, refreshed

An institutional review board-based clinical research quality assurance program.

PubMed

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.

Maintaining a Quality Environmental Health & Safety Program.

ERIC Educational Resources Information Center

Otto, Ann K.; And Others

1994-01-01

The college or university human resources department's responsibilities in assuring a healthy and safe environment are enumerated. First, issues to be considered in school safety are outlined, and then the role of the health and safety officer is discussed. A sample job description and list of duties are included. (MSE)

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

Enhancing the NASA Expendable Launch Vehicle Payload Safety Review Process Through Program Activities

NASA Technical Reports Server (NTRS)

Palo, Thomas E.

2007-01-01

The safety review process for NASA spacecraft flown on Expendable Launch Vehicles (ELVs) has been guided by NASA-STD 8719.8, Expendable Launch Vehicle Payload Safety Review Process Standard. The standard focused primarily on the safety approval required to begin pre-launch processing at the launch site. Subsequent changes in the contractual, technical, and operational aspects of payload processing, combined with lessons-learned supported a need for the reassessment of the standard. This has resulted in the formation of a NASA ELV Payload Safety Program. This program has been working to address the programmatic issues that will enhance and supplement the existing process, while continuing to ensure the safety of ELV payload activities.

Quality Assurance of Quality Assurance Agencies from an Asian Perspective: Regulation, Autonomy and Accountability

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…

Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Whiteside, Iain J.

2012-01-01

We introduce hierarchical safety cases (or hicases) as a technique to overcome some of the difficulties that arise creating and maintaining industrial-size safety cases. Our approach extends the existing Goal Structuring Notation with abstraction structures, which allow the safety case to be viewed at different levels of detail. We motivate hicases and give a mathematical account of them as well as an intuition, relating them to other related concepts. We give a second definition which corresponds closely to our implementation of hicases in the AdvoCATE Assurance Case Editor and prove the correspondence between the two. Finally, we suggest areas of future enhancement, both theoretically and practically.

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.

Assured Crew Return Vehicle

NASA Technical Reports Server (NTRS)

Stone, D. A.; Craig, J. W.; Drone, B.; Gerlach, R. H.; Williams, R. J.

1991-01-01

The developmental status is discussed regarding the 'lifeboat' vehicle to enhance the safety of the crew on the Space Station Freedom (SSF). NASA's Assured Crew Return Vehicle (ACRV) is intended to provide a means for returning the SSF crew to earth at all times. The 'lifeboat' philosophy is the key to managing the development of the ACRV which further depends on matrixed support and total quality management for implementation. The risk of SSF mission scenarios are related to selected ACRV mission requirements, and the system and vehicle designs are related to these precepts. Four possible ACRV configurations are mentioned including the lifting-body, Apollo shape, Discoverer shape, and a new lift-to-drag concept. The SCRAM design concept is discussed in detail with attention to the 'lifeboat' philosophy and requirements for implementation.

10 CFR Appendix B to Part 50 - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants

Code of Federal Regulations, 2010 CFR

2010-01-01

... undue risk to the health and safety of the public. This appendix establishes quality assurance...: reactor physics, stress, thermal, hydraulic, and accident analyses; compatibility of materials...

49 CFR 385.319 - What happens after completion of the safety audit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false What happens after completion of the safety audit... REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.319 What happens after completion of the safety audit? (a) Upon completion of the safety audit, the auditor will review the findings...

75 FR 68224 - Safety Management Systems for Part 121 Certificate Holders

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

... the general framework for an organization-wide safety management approach to air carrier operations... System? An SMS is an organization-wide approach to managing safety risk and assuring the effectiveness of... under 14 CFR part 121 to develop and implement a safety management system (SMS) to improve the safety of...

[Quality assurance in oncology: experiences of an ISO certification].

PubMed

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.

Quality Assurance.

ERIC Educational Resources Information Center

Massachusetts Career Development Inst., Springfield.

This booklet is one of six texts from a workplace literacy curriculum designed to assist learners in facing the increased demands of the workplace. The booklet contains five sections that cover the following topics: (1) importance of reliability; (2) meaning of quality assurance; (3) historical development of quality assurance; (4) statistical…

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…

48 CFR 252.209-7010 - Critical Safety Items.

Code of Federal Regulations, 2014 CFR

2014-10-01

... personal injury or loss of life; or (iii) An uncommanded engine shutdown that jeopardizes safety. Design... personal injury or loss of life. (b) Identification of critical safety items. One or more of the items... control activity: (Insert additional lines as necessary) (c) Heightened quality assurance surveillance...

48 CFR 252.209-7010 - Critical Safety Items.

Code of Federal Regulations, 2013 CFR

2013-10-01

... personal injury or loss of life; or (iii) An uncommanded engine shutdown that jeopardizes safety. Design... personal injury or loss of life. (b) Identification of critical safety items. One or more of the items... control activity: (Insert additional lines as necessary) (c) Heightened quality assurance surveillance...

48 CFR 252.209-7010 - Critical Safety Items.

Code of Federal Regulations, 2012 CFR

2012-10-01

... personal injury or loss of life; or (iii) An uncommanded engine shutdown that jeopardizes safety. Design... personal injury or loss of life. (b) Identification of critical safety items. One or more of the items... control activity: (Insert additional lines as necessary) (c) Heightened quality assurance surveillance...

48 CFR 252.209-7010 - Critical Safety Items.

Code of Federal Regulations, 2011 CFR

2011-10-01

... personal injury or loss of life; or (iii) An uncommanded engine shutdown that jeopardizes safety. Design... personal injury or loss of life. (b) Identification of critical safety items. One or more of the items... control activity: (Insert additional lines as necessary) (c) Heightened quality assurance surveillance...

Risk Classification and Risk-based Safety and Mission Assurance

NASA Technical Reports Server (NTRS)

Leitner, Jesse A.

2014-01-01

Recent activities to revamp and emphasize the need to streamline processes and activities for Class D missions across the agency have led to various interpretations of Class D, including the lumping of a variety of low-cost projects into Class D. Sometimes terms such as Class D minus are used. In this presentation, mission risk classifications will be traced to official requirements and definitions as a measure to ensure that projects and programs align with the guidance and requirements that are commensurate for their defined risk posture. As part of this, the full suite of risk classifications, formal and informal will be defined, followed by an introduction to the new GPR 8705.4 that is currently under review.GPR 8705.4 lays out guidance for the mission success activities performed at the Classes A-D for NPR 7120.5 projects as well as for projects not under NPR 7120.5. Furthermore, the trends in stepping from Class A into higher risk posture classifications will be discussed. The talk will conclude with a discussion about risk-based safety and mission assuranceat GSFC.

Safety assessment for EPS electron-proton spectrometer

NASA Technical Reports Server (NTRS)

Gleeson, P.

1971-01-01

A safety analysis was conducted to identify the efforts required to assure relatively hazard free operation of the EPS and to meet the safety requirements of the program. Safety engineering criteria, principles, and techniques in applicable disciplines are stressed in the performance of the system and subsystem studies; in test planning; in the design, development, test, evaluation, and checkout of the equipment; and the operating procedures for the EPS program.

Economic-Oriented Stochastic Optimization in Advanced Process Control of Chemical Processes

PubMed Central

Dobos, László; Király, András; Abonyi, János

2012-01-01

Finding the optimal operating region of chemical processes is an inevitable step toward improving economic performance. Usually the optimal operating region is situated close to process constraints related to product quality or process safety requirements. Higher profit can be realized only by assuring a relatively low frequency of violation of these constraints. A multilevel stochastic optimization framework is proposed to determine the optimal setpoint values of control loops with respect to predetermined risk levels, uncertainties, and costs of violation of process constraints. The proposed framework is realized as direct search-type optimization of Monte-Carlo simulation of the controlled process. The concept is illustrated throughout by a well-known benchmark problem related to the control of a linear dynamical system and the model predictive control of a more complex nonlinear polymerization process. PMID:23213298

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.

Integrated Response Time Evaluation Methodology for the Nuclear Safety Instrumentation System

NASA Astrophysics Data System (ADS)

Lee, Chang Jae; Yun, Jae Hee

2017-06-01

Safety analysis for a nuclear power plant establishes not only an analytical limit (AL) in terms of a measured or calculated variable but also an analytical response time (ART) required to complete protective action after the AL is reached. If the two constraints are met, the safety limit selected to maintain the integrity of physical barriers used for preventing uncontrolled radioactivity release will not be exceeded during anticipated operational occurrences and postulated accidents. Setpoint determination methodologies have actively been developed to ensure that the protective action is initiated before the process conditions reach the AL. However, regarding the ART for a nuclear safety instrumentation system, an integrated evaluation methodology considering the whole design process has not been systematically studied. In order to assure the safety of nuclear power plants, this paper proposes a systematic and integrated response time evaluation methodology that covers safety analyses, system designs, response time analyses, and response time tests. This methodology is applied to safety instrumentation systems for the advanced power reactor 1400 and the optimized power reactor 1000 nuclear power plants in South Korea. The quantitative evaluation results are provided herein. The evaluation results using the proposed methodology demonstrate that the nuclear safety instrumentation systems fully satisfy corresponding requirements of the ART.

CERT Resilience Management Model - Mail-Specific Process Areas: Mail Revenue Assurance (Version 1.0)

DTIC Science & Technology

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

How important is vehicle safety in the new vehicle purchase process?

PubMed

Koppel, Sjaanie; Charlton, Judith; Fildes, Brian; Fitzharris, Michael

2008-05-01

Whilst there has been a significant increase in the amount of consumer interest in the safety performance of privately owned vehicles, the role that it plays in consumers' purchase decisions is poorly understood. The aims of the current study were to determine: how important vehicle safety is in the new vehicle purchase process; what importance consumers place on safety options/features relative to other convenience and comfort features, and how consumers conceptualise vehicle safety. In addition, the study aimed to investigate the key parameters associated with ranking 'vehicle safety' as the most important consideration in the new vehicle purchase. Participants recruited in Sweden and Spain completed a questionnaire about their new vehicle purchase. The findings from the questionnaire indicated that participants ranked safety-related factors (e.g., EuroNCAP (or other) safety ratings) as more important in the new vehicle purchase process than other vehicle factors (e.g., price, reliability etc.). Similarly, participants ranked safety-related features (e.g., advanced braking systems, front passenger airbags etc.) as more important than non-safety-related features (e.g., route navigation systems, air-conditioning etc.). Consistent with previous research, most participants equated vehicle safety with the presence of specific vehicle safety features or technologies rather than vehicle crash safety/test results or crashworthiness. The key parameters associated with ranking 'vehicle safety' as the most important consideration in the new vehicle purchase were: use of EuroNCAP, gender and education level, age, drivers' concern about crash involvement, first vehicle purchase, annual driving distance, person for whom the vehicle was purchased, and traffic infringement history. The findings from this study are important for policy makers, manufacturers and other stakeholders to assist in setting priorities with regard to the promotion and publicity of vehicle safety features

On-farm quality assurance programs: a survey of producer and industry leader opinions.

PubMed

Payne, M; Bruhn, C M; Reed, B; Scearce, A; O'Donnell, J

1999-10-01

To assess interest in implementing a California dairy quality assurance program, practices and opinions of dairy producers and industry leaders were surveyed by a mailed questionnaire and by focus groups. The majority of the 55 participants in the focus group were dairy producers; processor marketing executives, extension dairy advisors, packinghouse executives, and dairy veterinarians were represented. The consensus among the focus groups was that a quality assurance program should be voluntary, be managed by creameries, and confer an economic advantage to participants. Focus group members listed chemical and microbial food safety (in both meat and milk), environmental health, and animal welfare as issues that should be addressed. Of the 1440 questionnaires mailed with producers' milk checks, 413 were returned. Information was collected regarding opinions and practices pertaining to administration of drugs to animals, medical records and animal identification, culling practices, manure management, cow welfare, and feeding of animal protein. An overwhelming 99% of producers believed they were responsible for the safety of meat and milk leaving the farm. Sixty percent of producers said that they would consider joining a California-specific quality assurance program, whereas 9% indicated that they would not. Producers would be more likely to join if their processor believed it would impart a market advantage and if the program standards were controlled by producers.

An Automatic Image Processing Workflow for Daily Magnetic Resonance Imaging Quality Assurance.

PubMed

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.

Safety: Special Effects of Thermal Runaway Chapter Heading for Encyclopedia of Electrochemical Power Sources (PREPRINT)

DTIC Science & Technology

2007-11-09

been following developments related to the recent lithium ion battery recalls and is preparing itself for revising its battery safety standard...manufacturer (OEM) Critical Components Committee. In October 2006, the IPC Lithium Ion Battery Subcommittee, that represents both the major...cover process requirements, quality control and assurance for lithium ion battery cells. Electric and Hybrid Electric Vehicle Power Source Testing In

Read Code quality assurance: from simple syntax to semantic stability.

PubMed

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.

49 CFR 385.309 - What is the purpose of the safety audit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false What is the purpose of the safety audit? 385.309... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.309 What is the purpose of the safety audit? The purpose of a safety audit is to: (a) Provide educational and technical assistance to...

A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems.

PubMed

Jacxsens, L; Kussaga, J; Luning, P A; Van der Spiegel, M; Devlieghere, F; Uyttendaele, M

2009-08-31

A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the most emerging challenges is to assess the performance of a present FSMS. The objective of this work is to explain the development of a Microbial Assessment Scheme (MAS) as a tool for a systematic analysis of microbial counts in order to assess the current microbial performance of an implemented FSMS. It is assumed that low numbers of microorganisms and small variations in microbial counts indicate an effective FSMS. The MAS is a procedure that defines the identification of critical sampling locations, the selection of microbiological parameters, the assessment of sampling frequency, the selection of sampling method and method of analysis, and finally data processing and interpretation. Based on the MAS assessment, microbial safety level profiles can be derived, indicating which microorganisms and to what extent they contribute to food safety for a specific food processing company. The MAS concept is illustrated with a case study in the pork processing industry, where ready-to-eat meat products are produced (cured, cooked ham and cured, dried bacon).

Quality-assurance and data management plan for groundwater activities by the U.S. Geological Survey in Kansas, 2014

USGS Publications Warehouse

Putnam, James E.; Hansen, Cristi V.

2014-01-01

As the Nation’s principle earth-science information agency, the U.S. Geological Survey (USGS) is depended on to collect data of the highest quality. This document is a quality-assurance plan for groundwater activities (GWQAP) of the Kansas Water Science Center. The purpose of this GWQAP is to establish a minimum set of guidelines and practices to be used by the Kansas Water Science Center to ensure quality in groundwater activities. Included within these practices are the assignment of responsibilities for implementing quality-assurance activities in the Kansas Water Science Center and establishment of review procedures needed to ensure the technical quality and reliability of the groundwater products. In addition, this GWQAP is intended to complement quality-assurance plans for surface-water and water-quality activities and similar plans for the Kansas Water Science Center and general project activities throughout the USGS. This document provides the framework for collecting, analyzing, and reporting groundwater data that are quality assured and quality controlled. This GWQAP presents policies directing the collection, processing, analysis, storage, review, and publication of groundwater data. In addition, policies related to organizational responsibilities, training, project planning, and safety are presented. These policies and practices pertain to all groundwater activities conducted by the Kansas Water Science Center, including data-collection programs, interpretive and research projects. This report also includes the data management plan that describes the progression of data management from data collection to archiving and publication.

Quality assurance in Australian hospitals: who does it and how?

PubMed

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.

Margin of Safety Definition and Examples Used in Safety Basis Documents and the USQ Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beaulieu, R. A.

The Nuclear Safety Management final rule, 10 CFR 830, provides an undefined term, margin of safety (MOS). Safe harbors listed in 10 CFR 830, Table 2, such as DOE-STD-3009 use but do not define the term. This lack of definition has created the need for the definition. This paper provides a definition of MOS and documents examples of MOS as applied in a U.S. Department of Energy (DOE) approved safety basis for an existing nuclear facility. If we understand what MOS looks like regarding Technical Safety Requirements (TSR) parameters, then it helps us compare against other parameters that do notmore » involve a MOS. This paper also documents parameters that are not MOS. These criteria could be used to determine if an MOS exists in safety basis documents. This paper helps DOE, including the National Nuclear Security Administration (NNSA) and its contractors responsible for the safety basis improve safety basis documents and the unreviewed safety question (USQ) process with respect to MOS.« less

14 CFR 414.19 - Technical criteria for reviewing a safety approval application.

Code of Federal Regulations, 2011 CFR

2011-01-01

...-developed criteria must define— (i) Design and minimum performance; (ii) Quality assurance system... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Technical criteria for reviewing a safety... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety Approval Review and...

System safety management lessons learned from the US Army acquisition process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Piatt, J.A.

1989-05-01

The Assistant Secretary of the Army for Research, Development and Acquisition directed the Army Safety Center to provide an audit of the causes of accidents and safety of use restrictions on recently fielded systems by tracking residual hazards back through the acquisition process. The objective was to develop lessons learned'' that could be applied to the acquisition process to minimize mishaps in fielded systems. System safety management lessons learned are defined as Army practices or policies, derived from past successes and failures, that are expected to be effective in eliminating or reducing specific systemic causes of residual hazards. They aremore » broadly applicable and supportive of the Army structure and acquisition objectives. Pacific Northwest Laboratory (PNL) was given the task of conducting an independent, objective appraisal of the Army's system safety program in the context of the Army materiel acquisition process by focusing on four fielded systems which are products of that process. These systems included the Apache helicopter, the Bradley Fighting Vehicle (BFV), the Tube Launched, Optically Tracked, Wire Guided (TOW) Missile and the High Mobility Multipurpose Wheeled Vehicle (HMMWV). The objective of this study was to develop system safety management lessons learned associated with the acquisition process. The first step was to identify residual hazards associated with the selected systems. Since it was impossible to track all residual hazards through the acquisition process, certain well-known, high visibility hazards were selected for detailed tracking. These residual hazards illustrate a variety of systemic problems. Systemic or process causes were identified for each residual hazard and analyzed to determine why they exist. System safety management lessons learned were developed to address related systemic causal factors. 29 refs., 5 figs.« less

Understanding and Evaluating Assurance Cases

NASA Technical Reports Server (NTRS)

Rushby, John; Xu, Xidong; Rangarajan, Murali; Weaver, Thomas L.

2015-01-01

Assurance cases are a method for providing assurance for a system by giving an argument to justify a claim about the system, based on evidence about its design, development, and tested behavior. In comparison with assurance based on guidelines or standards (which essentially specify only the evidence to be produced), the chief novelty in assurance cases is provision of an explicit argument. In principle, this can allow assurance cases to be more finely tuned to the specific circumstances of the system, and more agile than guidelines in adapting to new techniques and applications. The first part of this report (Sections 1-4) provides an introduction to assurance cases. Although this material should be accessible to all those with an interest in these topics, the examples focus on software for airborne systems, traditionally assured using the DO-178C guidelines and its predecessors. A brief survey of some existing assurance cases is provided in Section 5. The second part (Section 6) considers the criteria, methods, and tools that may be used to evaluate whether an assurance case provides sufficient confidence that a particular system or service is fit for its intended use. An assurance case cannot provide unequivocal "proof" for its claim, so much of the discussion focuses on the interpretation of such less-than-definitive arguments, and on methods to counteract confirmation bias and other fallibilities in human reasoning.

Controlled versus automatic processes: which is dominant to safety? The moderating effect of inhibitory control.

PubMed

Xu, Yaoshan; Li, Yongjuan; Ding, Weidong; Lu, Fan

2014-01-01

This study explores the precursors of employees' safety behaviors based on a dual-process model, which suggests that human behaviors are determined by both controlled and automatic cognitive processes. Employees' responses to a self-reported survey on safety attitudes capture their controlled cognitive process, while the automatic association concerning safety measured by an Implicit Association Test (IAT) reflects employees' automatic cognitive processes about safety. In addition, this study investigates the moderating effects of inhibition on the relationship between self-reported safety attitude and safety behavior, and that between automatic associations towards safety and safety behavior. The results suggest significant main effects of self-reported safety attitude and automatic association on safety behaviors. Further, the interaction between self-reported safety attitude and inhibition and that between automatic association and inhibition each predict unique variances in safety behavior. Specifically, the safety behaviors of employees with lower level of inhibitory control are influenced more by automatic association, whereas those of employees with higher level of inhibitory control are guided more by self-reported safety attitudes. These results suggest that safety behavior is the joint outcome of both controlled and automatic cognitive processes, and the relative importance of these cognitive processes depends on employees' individual differences in inhibitory control. The implications of these findings for theoretical and practical issues are discussed at the end.

Controlled versus Automatic Processes: Which Is Dominant to Safety? The Moderating Effect of Inhibitory Control

PubMed Central

Xu, Yaoshan; Li, Yongjuan; Ding, Weidong; Lu, Fan

2014-01-01

This study explores the precursors of employees' safety behaviors based on a dual-process model, which suggests that human behaviors are determined by both controlled and automatic cognitive processes. Employees' responses to a self-reported survey on safety attitudes capture their controlled cognitive process, while the automatic association concerning safety measured by an Implicit Association Test (IAT) reflects employees' automatic cognitive processes about safety. In addition, this study investigates the moderating effects of inhibition on the relationship between self-reported safety attitude and safety behavior, and that between automatic associations towards safety and safety behavior. The results suggest significant main effects of self-reported safety attitude and automatic association on safety behaviors. Further, the interaction between self-reported safety attitude and inhibition and that between automatic association and inhibition each predict unique variances in safety behavior. Specifically, the safety behaviors of employees with lower level of inhibitory control are influenced more by automatic association, whereas those of employees with higher level of inhibitory control are guided more by self-reported safety attitudes. These results suggest that safety behavior is the joint outcome of both controlled and automatic cognitive processes, and the relative importance of these cognitive processes depends on employees' individual differences in inhibitory control. The implications of these findings for theoretical and practical issues are discussed at the end. PMID:24520338

78 FR 41075 - Federal Housing Administration (FHA): Single Family Quality Assurance-Solicitation of Information...

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...

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…

Audit of the informed consent process as a part of a clinical research quality assurance program.

PubMed

Lad, Pramod M; Dahl, Rebecca

2014-06-01

Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

The Role of Patient Safety in the Device Purchasing Process

DTIC Science & Technology

2005-05-01

Juliana J. Brixey, Danielle Paige, James P. Turley Abstract To examine how patient safety considerations are incorporated into medical device...Despite the general awareness of patient safety, its importance, and its role in medical device comparisons and purchasing decisions, this study...into the medical device purchasing process. We presently have a set of guidelines in development to help hospitals better emphasize patient safety

Managing safety and quality through the red meat chain.

PubMed

Desmarchelier, P; Fegan, N; Smale, N; Small, A

2007-09-01

To successfully manage food safety and quality risks in meat production, a holistic approach is required. The ideal would be a fully integrated assurance system, with effective controls applied at all stages. However, the red meat industry is by nature somewhat fragmented, and a truly integrated system is not at present achievable in all but a few operations. This paper describes a variety of assurance initiatives, and explores how targeted research and development can be used to augment assurance programmes by providing underpinning knowledge, using the Australian beef and lamb industry as an example.

European perspectives of food safety.

PubMed

Bánáti, Diána

2014-08-01

Food safety has been a growing concern among European Union (EU) citizens over the last decades. Despite the fact that food has never been safer, consumers are considerably uncertain and increasingly critical about the safety of their food. The introduction of new principles, such as the primary responsibility of producers, traceability, risk analysis, the separation of risk assessment and risk management provided a more transparent, science-based system in Europe, which can help to restore consumers' lost confidence. The present EU integrated approach to food safety 'from farm to fork' aims to assure a high level of food safety within the EU. © 2014 Society of Chemical Industry.

Assuring quality in narrative analysis.

PubMed

Bailey, P H

1996-04-01

Many nurse-researchers using qualitative strategies have been concerned with assuring quality in their work. The early literature reveals that the concepts of validity and reliability, as understood from the positivist perspective, are somehow inappropriate and inadequate when applied to interpretive research. More recent literature suggests that because of the positivist and interpretive paradigms are epistemologically divergent, the transfer of quality criteria from one perspective to the other is not automatic or even reasonable. The purpose of this article, therefore, is to clarify what the terms quality, trustworthiness, credibility, authenticity, and goodness mean in qualitative research findings. The process of assuring quality, validation, in qualitative research will be discussed within the context of the interpretive method, narrative analysis. A brief review of quality in narrative analysis nursing research will also be presented.

Quality assurance of qualitative research: a review of the discourse

PubMed Central

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

NASA Space Shuttle Program: Shuttle Environmental Assurance (SEA) Initiative

NASA Technical Reports Server (NTRS)

Glover, Steve E.; McCool, Alex (Technical Monitor)

2002-01-01

The first Space Shuttle flight was in 1981 and the fleet was originally expected to be replaced with a new generation vehicle in the early 21st century. Space Shuttle Program (SSP) elements proactively address environmental and obsolescence concerns and continue to improve safety and supportability. The SSP manager created the Shuttle Environmental Assurance (SEA) Initiative in 2000. SEA is to provide an integrated approach for the SSP to promote environmental excellence, proactively manage materials obsolescence, and optimize associated resources.

40 CFR 68.65 - Process safety information.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.65 Process safety... data; (4) Reactivity data: (5) Corrosivity data; (6) Thermal and chemical stability data; and (7... operator shall document that equipment complies with recognized and generally accepted good engineering...

Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers.

PubMed

Tembuyser, Lien; Dequeker, Elisabeth M C

2016-01-01

Quality assurance is an indispensable element in a molecular diagnostic laboratory. The ultimate goal is to warrant patient safety. Several risks that can compromise high quality procedures are at stake, from sample collection to the test performed by the laboratory, the reporting of test results to clinicians, and the organization of effective external quality assessment schemes. Quality assurance should therefore be safeguarded at each level and should imply a holistic multidisciplinary approach. This review aims to provide an overview of good quality assurance practices and discusses certain risks and recommendations to promote and improve quality assurance for both diagnostic laboratories and for external quality assessment providers. The number of molecular targets is continuously rising, and new technologies are evolving. As this poses challenges for clinical implementation and increases the demand for external quality assessment, the formation of an international association for improving quality assurance in molecular pathology is called for.

AACE: an innovative partnership to enhance aircraft safety

NASA Astrophysics Data System (ADS)

Shurtleff, William W.

1999-01-01

The Federal Aviation Administration established the Airworthiness Assurance Center of Excellence (AACE) in September 1997, through a cooperative agreement grant with Iowa State University (ISU) and The Ohio State University (OSU). A technical support contract with the Center is now in place as well. Initially the Center has five areas of concentration supporting advances in airworthiness assurance. These are 1. Maintenance, inspection, and repair, 2. Propulsion and fuel systems safety, 3. Crashworthiness, 4. Advanced materials, and 5. Landing gear systems performance and safety. AACE has nine core members who provide guidance to the Program Management Office at ISU/OSU through a Board of Directors. The core members are: Arizona State University, Iowa State University, Northwestern University, The Ohio State University, University of Dayton, University of Maryland, University of California - Los Angeles, Wichita State University, and Sandia National Laboratories. The organization also includes numerous academic affiliates, industry partners, government laboratories and other organizations. The Center now has over thirty technical projects supporting technical advances in airworthiness assurance. All these projects have industry guidance and support. This paper discusses the current technical program of the center and the highlights of the five-year plan for technical work. Also included is a description of the factors that make the Center an innovative partnership to promote aircraft safety.

Laser safety programs in general surgery.

PubMed

Lanzafame, R J

1994-06-01

General surgery represents a speciality where, while any procedure can be performed with lasers, there are no procedures for which the laser is the sine quo non. The general surgeon may perform a variety of procedures with a multitude of laser wavelengths and technologies. Laser safety in general surgery requires a multidisciplinary approach. Effective laser safety requires the oversight of the hospital's "laser usage committee" and "laser safety officer" while providing a workable framework for daily laser use in a variety of clinical scenarios simultaneously. This framework must be user-friendly rather than oppressive. This presentation will describe laser safety at the Rochester General Hospital, a tertiary care, community-based teaching hospital. The safety program incorporates the following components: input to physician credentialing and training, education and in-servicing of nursing and technical personnel, equipment purchase and maintenance, quality assurance, and safety monitoring. The University of Rochester general surgery residency training program mandates laser training during the PGY-2 year. This program stresses the safe use of lasers and provides the basis for graded hands-on experience during the surgical residency. The greatest challenge for laser safety in general surgery centers on the burgeoning field of minimally invasive surgery. Safety assurance must be balanced so as to maintain a safe operating-room environment while ensuring patient safety and the ability to permit the surgery to proceed efficiently. Safety measures for laparoscopic procedures must be sensitive to the needs of the surgical team while not providing confusing signals for the "gallery" observers. This task is critical for the safe operation of lasers in general surgery. Effective laser safety in general surgery requires constant vigilance tempered with sensitivity to the needs of the surgeon and the patient as laser technology and its applications continue to evolve.

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…

Autonomous system for launch vehicle range safety

NASA Astrophysics Data System (ADS)

Ferrell, Bob; Haley, Sam

2001-02-01

The Autonomous Flight Safety System (AFSS) is a launch vehicle subsystem whose ultimate goal is an autonomous capability to assure range safety (people and valuable resources), flight personnel safety, flight assets safety (recovery of valuable vehicles and cargo), and global coverage with a dramatic simplification of range infrastructure. The AFSS is capable of determining current vehicle position and predicting the impact point with respect to flight restriction zones. Additionally, it is able to discern whether or not the launch vehicle is an immediate threat to public safety, and initiate the appropriate range safety response. These features provide for a dramatic cost reduction in range operations and improved reliability of mission success. .

Cultural safety as an ethic of care: a praxiological process.

PubMed

McEldowney, Rose; Connor, Margaret J

2011-10-01

New writings broadening the construct of cultural safety, a construct initiated in Aotearoa New Zealand, are beginning to appear in the literature. Therefore, it is considered timely to integrate these writings and advance the construct into a new theoretical model. The new model reconfigures the constructs of cultural safety and cultural competence as an ethic of care informed by a postmodern perspective. Central to the new model are three interwoven, co-occurring components: an ethic of care, which unfolds within a praxiological process shaped by the context. Context is expanded through identifying the three concepts of relationality, generic competence, and collectivity, which are integral to each client-nurse encounter. The competence associated with cultural safety as an ethic of care is always in the process of development. Clients and nurses engage in a dialogue to establish the level of cultural safety achieved at given points in a care trajectory.

A Study on Run Time Assurance for Complex Cyber Physical Systems

DTIC Science & Technology

2013-04-18

safety verification approach was applied to synchronization of distributed local clocks of the nodes on a CAN bus by Jiang et al. [36]. The class of...mode of interaction between the instrumented system and the checker, we distin- guish between synchronous and asynchronous monitoring. In synchronous ...occurred. Synchronous monitoring may deliver a higher degree of assurance than the asynchronous one, because it can block a dangerous action. However

A qualitative study of Southern U.S. consumers' top of the mind beliefs about the safety of local beef.

PubMed

Telligman, Amy L; Worosz, Michelle R; Bratcher, Christy L

2017-02-01

Following the Reasoned Action Approach, the aim of this study was to explore consumers' top-of-mind food safety beliefs about local beef. Beef consumers recruited from farmers' markets (N = 101) and grocery stores (N = 174) across the state of Alabama participated in face-to-face intercept surveys. The survey included closed- and open-ended questions designed to elicit consumers' food safety beliefs about local beef. Results indicate that beef safety was not a top-of-mind concern for a majority of participants, however of the total number of participants familiar with the term "local beef" (n = 168, 61%), a majority (n = 105, 63%) associated local beef with improved food safety. Content analysis of verbatim text revealed that consumers believed local beef was safer because they possess greater knowledge about the product and less shipping was involved. Respondents also believe that locally processed meat is derived from small-scale operations which provided the assurance that local beef is more likely to meet U.S. regulatory standards and therefore be safer. Consumers believe they have more oversight of local beef due to both their relationships with supply chain actors and proximity which also provided food safety assurances. Copyright © 2016 Elsevier Ltd. All rights reserved.

Medical Physics Challenges for the Implementation of Quality Assurance Programmes in Radiation Oncology.

PubMed

Meghzifene, A

2017-02-01

The importance of quality assurance in radiation therapy, as well as its positive consequences on patient treatment outcome, is well known to radiation therapy professionals. In low- and middle-income countries, the implementation of quality assurance in radiation therapy is especially challenging, due to a lack of staff training, a lack of national guidelines, a lack of quality assurance equipment and high patient daily throughput. According to the International Atomic Energy Agency (IAEA) Directory of Radiotherapy Centres, the proportion of linear accelerators compared with Co-60 machines has increased significantly in recent years in low- and middle-income countries. However, this increase in the proportion of relatively more demanding technology is not always accompanied with the necessary investment in staff training and quality assurance. The IAEA provides supports to low- and middle-income countries to develop and strengthen quality assurance programmes at institutional and national level. It also provides guidance, through its publications, on quality assurance and supports implementation of comprehensive clinical audits to identify gaps and makes recommendations for quality improvement in radiation therapy. The new AAPM TG100 report suggests a new approach to quality management in radiation therapy. If implemented, it will lead to improved cost-effectiveness of radiation therapy in all income settings. Low- and middle-income countries could greatly benefit from this new approach as it will help direct their scarce resources to areas where they can produce the optimum impact on patient care, without compromising patient safety. Copyright © 2016. Published by Elsevier Ltd.

Assuring the safety of genetically modified (GM) foods: the importance of an holistic, integrative approach.

PubMed

Cockburn, Andrew

2002-09-11

Genes change continuously by natural mutation and recombination enabling man to select and breed crops having the most desirable traits such as yield or flavour. Genetic modification (GM) is a recent development which allows specific genes to be identified, isolated, copied and inserted into other plants with a high level of specificity. The food safety considerations for GM crops are basically the same as those arising from conventionally bred crops, very few of which have been subject to any testing yet are generally regarded as being safe to eat. In contrast a rigorous safety testing paradigm has been developed for GM crops, which utilises a systematic, stepwise and holistic approach. The resultant science based process, focuses on a classical evaluation of the toxic potential of the introduced novel trait and the wholesomeness of the transformed crop. In addition, detailed consideration is given to the history and safe use of the parent crop as well as that of the gene donor. The overall safety evaluation is conducted under the concept known as substantial equivalence which is enshrined in all international crop biotechnology guidelines. This provides the framework for a comparative approach to identify the similarities and differences between the GM product and its comparator which has a known history of safe use. By building a detailed profile on each step in the transformation process, from parent to new crop, and by thoroughly evaluating the significance from a safety perspective, of any differences that may be detected, a very comprehensive matrix of information is constructed which enables the conclusion as to whether the GM crop, derived food or feed is as safe as its traditional counterpart. Using this approach in the evaluation of more than 50 GM crops which have been approved worldwide, the conclusion has been that foods and feeds derived from genetically modified crops are as safe and nutritious as those derived from traditional crops. The lack of

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.

Model-Based Assurance Case+ (MBAC+): Tutorial on Modeling Radiation Hardness Assurance Activities

NASA Technical Reports Server (NTRS)

Austin, Rebekah; Label, Ken A.; Sampson, Mike J.; Evans, John; Witulski, Art; Sierawski, Brian; Karsai, Gabor; Mahadevan, Nag; Schrimpf, Ron; Reed, Robert A.

2017-01-01

This presentation will cover why modeling is useful for radiation hardness assurance cases, and also provide information on Model-Based Assurance Case+ (MBAC+), NASAs Reliability Maintainability Template, and Fault Propagation Modeling.

78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

[Update on microbiological quality assurance meat and meat products in Morocco].

PubMed

Rachidi, H; Latrache, H

2018-03-01

Food safety has become an absolute necessity in all countries. As a result, Morocco has taken several measures and actions to develop food safety and food-borne disease control. This study aimed to highlight the level of improvement in the quality assurance of meat and meat products in Morocco. It is based on a non-exhaustive review of the regulatory texts governing food safety in the country, as well as a statistical study on establishments of meat and meat products adopting a self-checking system and approved by the National Office of Sanitary Safety of Food. Morocco has introduced several laws and regulations requiring sanitary control of food products. Also, the number of establishments of meat and meat products adopting a system of self-control and approved by the National Office of Sanitary Safety of Food has improved significantly. It has increased from 58 in 2007 to 273 in 2016. The adoption of self-monitoring systems allows better access to international markets, improved quality of food products and a considerable reduction in microbial contamination. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Laser Welding Process Monitoring Systems: Advanced Signal Analysis for Quality Assurance

NASA Astrophysics Data System (ADS)

D'Angelo, Giuseppe

Laser material processing today is widely used in industry. Especially laser welding became one of the key-technologies, e. g., for the automotive sector. This is due to the improvement and development of new laser sources and the increasing knowledge gained at countless scientific research projects. Nevertheless, it is still not possible to use the full potential of this technology. Therefore, the introduction and application of quality-assuring systems is required. For a long time, the statement "the best sensor is no sensor" was often heard. Today, a change of paradigm can be observed. On the one hand, ISO 9000 and other by law enforced regulations have led to the understanding that quality monitoring is an essential tool in modern manufacturing and necessary in order to keep production results in deterministic boundaries. On the other hand, rising quality requirements not only set higher and higher requirements for the process technology but also demand qualityassurance measures which ensure the reliable recognition of process faults. As a result, there is a need for reliable online detection and correction of welding faults by means of an in-process monitoring. The chapter describes an advanced signals analysis technique to extract information from signals detected, during the laser welding process, by optical sensors. The technique is based on the method of reassignment which was first applied to the spectrogram by Kodera, Gendrin and de Villedary22,23 and later generalized to any bilinear time-frequency representation by Auger and Flandrin.24 Key to the method is a nonlinear convolution where the value of the convolution is not placed at the center of the convolution kernel but rather reassigned to the center of mass of the function within the kernel. The resulting reassigned representation yields significantly improved components localization. We compare the proposed time-frequency distributions by analyzing signals detected during the laser welding of

Implementation of a "No Fly" safety culture in a multicenter radiation medicine department.

PubMed

Potters, Louis; Kapur, Ajay

2012-01-01

The safe delivery of radiation therapy requires multiple disciplines and interactions to perform flawlessly for each patient. Because treatment is individualized and every aspect of the patient's care is unique, it is difficult to regiment a delivery process that works flawlessly. The purpose of this study is to describe one safety-directed component of our quality program called the "No Fly Policy" (NFP). Our quality assurance program for radiation therapy reviewed the entire process of care prior, during, and after a patient's treatment course. Each component of care was broken down and rebuilt within a matrix of multidisciplinary safety quality checklists (QCL). The QCL process map was subsequently streamlined with revised task due dates and stopping rules. The NFP was introduced to place a holding pattern on treatment initiation pending reconciliation of associated stopping events. The NFP was introduced in a pilot phase using a Six-Sigma process improvement approach. Quantitative analysis on the performance of the new QCLs was performed using crystal reports in the Oncology Information Systems. Root cause analysis was conducted. Notable improvements in QCL performance were observed. The variances among staff in completing tasks reduced by a factor of at least 3, suggesting better process control. Steady improvements over time indicated an increasingly compliant and controlled adoption of the new safety-oriented process map. Stopping events led to rescheduling treatments with average and maximum delays of 2 and 4 days, respectively, with no reported adverse effects. The majority of stopping events were due to incomplete plan approvals stemming from treatment planning delays. Whereas these may have previously solicited last-minute interventions, including intensity modulated radiation therapy quality assurance, the NFP enabled nonpunitive, reasonable schedule adjustments to mitigate compromises in safe delivery. Implementation of the NFP has helped to mitigate

SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

EPA Science Inventory

This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

Enhancing the traditional hospital design process: a focus on patient safety.

PubMed

Reiling, John G; Knutzen, Barbara L; Wallen, Thomas K; McCullough, Susan; Miller, Ric; Chernos, Sonja

2004-03-01

In 2002 St. Joseph's Community Hospital (West Bend, WI), a member of SynergyHealth, brought together leaders in health care and systems engineering to develop a set of safety-driven facility design principles that would guide the hospital design process. DESIGNING FOR SAFETY: Hospital leadership recognized that a cross-departmental team approach would be needed and formed the 11-member Facility Design Advisory Council, which, with departmental teams and the aid of architects, was responsible for overseeing the design process and for ensuring that the safety considerations were met. The design process was a team approach, with input from national experts, patients and families, hospital staff and physicians, architects, contractors, and the community. The new facility, designed using safety-driven design principles, reflects many innovative design elements, including truly standardized patient rooms, new technology to minimize falls, and patient care alcoves for every patient room. The new hospital has been designed with maximum adaptability and flexibility in mind, to accommodate changes and provide for future growth. The architects labeled the innovative design. The Synergy Model, to describe the process of shaping the entire building and its spaces to work efficiently as a whole for the care and safety of patients. Construction began on the new facility in August 2003 and is expected to be completed in 2005.

The Development of Project Orion Ground Safety Requirements

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul; Condzella, Bill; Williams, Jeff

2011-01-01

In spite of a very compressed schedule, Project Orion's AFT safety team was able to pull together a comprehensive set of ground safety requirements using existing requirements and subject matter experts. These requirements will serve as the basis for the design of GSE and ground operations. Using the above lessons as a roadmap, new Projects can produce the same results. A rigorous set of ground safety requirements is required to assure ground support equipment (GSE) and associated flight hardware ground operations are conducted safety

Advanced Test Reactor Safety Basis Upgrade Lessons Learned Relative to Design Basis Verification and Safety Basis Management

DOE Office of Scientific and Technical Information (OSTI.GOV)

G. L. Sharp; R. T. McCracken

The Advanced Test Reactor (ATR) is a pressurized light-water reactor with a design thermal power of 250 MW. The principal function of the ATR is to provide a high neutron flux for testing reactor fuels and other materials. The reactor also provides other irradiation services such as radioisotope production. The ATR and its support facilities are located at the Test Reactor Area of the Idaho National Engineering and Environmental Laboratory (INEEL). An audit conducted by the Department of Energy's Office of Independent Oversight and Performance Assurance (DOE OA) raised concerns that design conditions at the ATR were not adequately analyzedmore » in the safety analysis and that legacy design basis management practices had the potential to further impact safe operation of the facility.1 The concerns identified by the audit team, and issues raised during additional reviews performed by ATR safety analysts, were evaluated through the unreviewed safety question process resulting in shutdown of the ATR for more than three months while these concerns were resolved. Past management of the ATR safety basis, relative to facility design basis management and change control, led to concerns that discrepancies in the safety basis may have developed. Although not required by DOE orders or regulations, not performing design basis verification in conjunction with development of the 10 CFR 830 Subpart B upgraded safety basis allowed these potential weaknesses to be carried forward. Configuration management and a clear definition of the existing facility design basis have a direct relation to developing and maintaining a high quality safety basis which properly identifies and mitigates all hazards and postulated accident conditions. These relations and the impact of past safety basis management practices have been reviewed in order to identify lessons learned from the safety basis upgrade process and appropriate actions to resolve possible concerns with respect to the current ATR

Quality Assurance Project Plan for Citizen Science Projects

EPA Pesticide Factsheets

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.

The Standards Paradox: How Quality Assurance Regimes Can Subvert Teaching and Learning in Higher Education

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…

76 FR 11339 - Update to NFPA 101, Life Safety Code, for State Home Facilities

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 51 RIN 2900-AN59 Update to NFPA 101, Life Safety Code..., Life Safety Code. The change is designed to assure that State Home facilities meet current industry- wide standards regarding life safety and fire safety. DATES: Effective Date: This final rule is...

[Quality assurance of rehabilitation by the German pension insurance: an overview].

PubMed

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.

System Guidelines for EMC Safety-Critical Circuits: Design, Selection, and Margin Demonstration

NASA Technical Reports Server (NTRS)

Lawton, R. M.

1996-01-01

Demonstration of required safety margins on critical electrical/electronic circuits in large complex systems has become an implementation and cost problem. These margins are the difference between the activation level of the circuit and the electrical noise on the circuit in the actual operating environment. This document discusses the origin of the requirement and gives a detailed process flow for the identification of the system electromagnetic compatibility (EMC) critical circuit list. The process flow discusses the roles of engineering disciplines such as systems engineering, safety, and EMC. Design and analysis guidelines are provided to assist the designer in assuring the system design has a high probability of meeting the margin requirements. Examples of approaches used on actual programs (Skylab and Space Shuttle Solid Rocket Booster) are provided to show how variations of the approach can be used successfully.

Organizational Culture and Safety

NASA Technical Reports Server (NTRS)

Adams, Catherine A.

2003-01-01

'..only a fool perseveres in error.' Cicero. Humans will break the most advanced technological devices and override safety and security systems if they are given the latitude. Within the workplace, the operator may be just one of several factors in causing accidents or making risky decisions. Other variables considered for their involvement in the negative and often catastrophic outcomes include the organizational context and culture. Many organizations have constructed and implemented safety programs to be assimilated into their culture to assure employee commitment and understanding of the importance of everyday safety. The purpose of this paper is to examine literature on organizational safety cultures and programs that attempt to combat vulnerability, risk taking behavior and decisions and identify the role of training in attempting to mitigate unsafe acts.

Motor Carrier Safety Fitness Determination: An Improved Process

DOT National Transportation Integrated Search

1996-12-01

PREFACE This report was undertaken to define an improved process for motor carrier safety fitness determination. It was produced by the Research and Special Program Administration's (RSPA} John A. Volpe National Transportation Systems Center (the Vol...

Evolutionary conservation of regulated longevity assurance mechanisms

PubMed Central

McElwee, Joshua J; Schuster, Eugene; Blanc, Eric; Piper, Matthew D; Thomas, James H; Patel, Dhaval S; Selman, Colin; Withers, Dominic J; Thornton, Janet M; Partridge, Linda; Gems, David

2007-01-01

Background To what extent are the determinants of aging in animal species universal? Insulin/insulin-like growth factor (IGF)-1 signaling (IIS) is an evolutionarily conserved (public) regulator of longevity; yet it remains unclear whether the genes and biochemical processes through which IIS acts on aging are public or private (that is, lineage specific). To address this, we have applied a novel, multi-level cross-species comparative analysis to compare gene expression changes accompanying increased longevity in mutant nematodes, fruitflies and mice with reduced IIS. Results Surprisingly, there is little evolutionary conservation at the level of individual, orthologous genes or paralogous genes under IIS regulation. However, a number of gene categories are significantly enriched for genes whose expression changes in long-lived animals of all three species. Down-regulated categories include protein biosynthesis-associated genes. Up-regulated categories include sugar catabolism, energy generation, glutathione-S-transferases (GSTs) and several other categories linked to cellular detoxification (that is, phase 1 and phase 2 metabolism of xenobiotic and endobiotic toxins). Protein biosynthesis and GST activity have recently been linked to aging and longevity assurance, respectively. Conclusion These processes represent candidate, regulated mechanisms of longevity-control that are conserved across animal species. The longevity assurance mechanisms via which IIS acts appear to be lineage-specific at the gene level (private), but conserved at the process level (or semi-public). In the case of GSTs, and cellular detoxification generally, this suggests that the mechanisms of aging against which longevity assurance mechanisms act are, to some extent, lineage specific. PMID:17612391

10 CFR 71.37 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under consideration...

Mars mission safety

DOE Office of Scientific and Technical Information (OSTI.GOV)

Buden, D.

1989-06-01

Precautions that need to be taken to assure safety on a manned Mars mission with nuclear thermal propulsion are briefly considered. What has been learned from the 1955 SNAP-10A operation of a nuclear reactor in space and from the Rover/NERVA project is reviewed. The ways that radiation hazards can be dealt with at various stages of a Mars mission are examined.

Quality Assurance for University Teaching.

ERIC Educational Resources Information Center

Ellis, Roger, Ed.

This book, written from a British perspective, presents 17 papers on quality assurance in teaching at the university level. The first eight papers address issues of assuring quality and include: (1) "Quality Assurance for University Teaching; Issues and Approaches" (Roger Ellis); (2) "A British Standard for University…

Assured Human-Autonomy Interaction through Machine Self-Confidence

NASA Astrophysics Data System (ADS)

Aitken, Matthew

Autonomous systems employ many layers of approximations in order to operate in increasingly uncertain and unstructured environments. The complexity of these systems makes it hard for a user to understand the systems capabilities, especially if the user is not an expert. However, if autonomous systems are to be used efficiently, their users must trust them appropriately. This purpose of this work is to implement and assess an 'assurance' that an autonomous system can provide to the user to elicit appropriate trust. Specifically, the autonomous system's perception of its own capabilities is reported to the user as the self-confidence assurance. The self-confidence assurance should allow the user to more quickly and accurately assess the autonomous system's capabilities, generating appropriate trust in the autonomous system. First, this research defines self-confidence and discusses what the self-confidence assurance is attempting to communicate to the user. Then it provides a framework for computing the autonomous system's self-confidence as a function of self-confidence factors which correspond to individual elements in the autonomous system's process. In order to explore this idea, self-confidence is implemented on an autonomous system that uses a mixed observability Markov decision process model to solve a pursuit-evasion problem on a road network. The implementation of a factor assessing the goodness of the autonomy's expected performance is focused on in particular. This work highlights some of the issues and considerations in the design of appropriate metrics for the self-confidence factors, and provides the basis for future research for computing self-confidence in autonomous systems.

49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been performed...

Orthodontic soldering techniques: aspects of quality assurance in the dental laboratory.

PubMed

Heidemann, Jutta; Witt, Emil; Feeg, Martin; Werz, Rainer; Pieger, Klaus

2002-07-01

In Germany, the dental technician is required by the Medical Products Act (MPG) to produce workpieces of high safety and quality and to document these properties. Soldering continues to be the prevailing joining technique in the dental laboratory, although problems arise from the susceptibility to corrosion and the low strength of soldered joints. This study aimed to reveal sources of defects in dental laboratory workpieces in order to achieve optimization in terms of quality assurance. The joints were produced by various dental technicians using three different soldering techniques. These joining techniques were investigated for their quality and their corrosion properties during immersion in ferric chloride, orthodontic appliance cleanser, and artificial saliva. Observance of the soldering instructions by the dental technicians was checked. Corrosion attack was confirmed by scanning electron microscopy and by measuring the ion concentrations of copper, silver and zinc in the corrosive agents, using atomic emission spectroscopy with stimulation by inductively coupled plasma (ICP-AES analysis). Incomplete filling of the soldering gap, porosities resulting from the production process, poor corrosion properties, and in particular a high variability of the measured values point to insufficient reliability of two soldering techniques. Variations in quality were also detected among the technicians' modes of operation. The analyses confirm the need for quality assurance of soldering techniques and for increased support for alternative joining techniques such as laser welding in the future. The results of the studies on laser welding are presented in a separate publication.

Improving Individual Acceptance of Health Clouds through Confidentiality Assurance.

PubMed

Ermakova, Tatiana; Fabian, Benjamin; Zarnekow, Rüdiger

2016-10-26

Cloud computing promises to essentially improve healthcare delivery performance. However, shifting sensitive medical records to third-party cloud providers could create an adoption hurdle because of security and privacy concerns. This study examines the effect of confidentiality assurance in a cloud-computing environment on individuals' willingness to accept the infrastructure for inter-organizational sharing of medical data. We empirically investigate our research question by a survey with over 260 full responses. For the setting with a high confidentiality assurance, we base on a recent multi-cloud architecture which provides very high confidentiality assurance through a secret-sharing mechanism: Health information is cryptographically encoded and distributed in a way that no single and no small group of cloud providers is able to decode it. Our results indicate the importance of confidentiality assurance in individuals' acceptance of health clouds for sensitive medical data. Specifically, this finding holds for a variety of practically relevant circumstances, i.e., in the absence and despite the presence of conventional offline alternatives and along with pseudonymization. On the other hand, we do not find support for the effect of confidentiality assurance in individuals' acceptance of health clouds for non-sensitive medical data. These results could support the process of privacy engineering for health-cloud solutions.

Improving Individual Acceptance of Health Clouds through Confidentiality Assurance

PubMed Central

Fabian, Benjamin; Zarnekow, Rüdiger

2016-01-01

Summary Background Cloud computing promises to essentially improve healthcare delivery performance. However, shifting sensitive medical records to third-party cloud providers could create an adoption hurdle because of security and privacy concerns. Objectives This study examines the effect of confidentiality assurance in a cloud-computing environment on individuals’ willingness to accept the infrastructure for inter-organizational sharing of medical data. Methods We empirically investigate our research question by a survey with over 260 full responses. For the setting with a high confidentiality assurance, we base on a recent multi-cloud architecture which provides very high confidentiality assurance through a secret-sharing mechanism: Health information is cryptographically encoded and distributed in a way that no single and no small group of cloud providers is able to decode it. Results Our results indicate the importance of confidentiality assurance in individuals’ acceptance of health clouds for sensitive medical data. Specifically, this finding holds for a variety of practically relevant circumstances, i.e., in the absence and despite the presence of conventional offline alternatives and along with pseudonymization. On the other hand, we do not find support for the effect of confidentiality assurance in individuals’ acceptance of health clouds for non-sensitive medical data. These results could support the process of privacy engineering for health-cloud solutions. PMID:27781238

The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734. PMID:22463698

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.

Making the Business Case for Software Assurance

DTIC Science & Technology

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

Safety assurance of non-deterministic flight controllers in aircraft applications

NASA Astrophysics Data System (ADS)

Noriega, Alfonso

Loss of control is a serious problem in aviation that primarily affects General Aviation. Technological advancements can help mitigate the problem, but the FAA certification process makes certain solutions economically unfeasible. This investigation presents the design of a generic adaptive autopilot that could potentially lead to a single certification for use in several makes and models of aircraft. The autopilot consists of a conventional controller connected in series with a robust direct adaptive model reference controller. In this architecture, the conventional controller is tuned once to provide outer-loop guidance and navigation to a reference model. The adaptive controller makes unknown aircraft behave like the reference model, allowing the conventional controller to successfully provide navigation without the need for retuning. A strong theoretical foundation is presented as an argument for the safety and stability of the controller. The stability proof of direct adaptive controllers require that the plant being controlled has no unstable transmission zeros and has a nonzero high frequency gain. Because most conventional aircraft do not readily meet these requirements, a process known as sensor blending was used. Sensor blending consists of using a linear combination of the plant's outputs that has no unstable transmission zeros and has a nonzero high frequency gain to drive the adaptive controller. Although this method does not present a problem for regulators, it can lead to a steady state error in tracking applications. The sensor blending theory was expanded to take advantage of the system's dynamics to allow for zero steady state error tracking. This method does not need knowledge of the specific system's dynamics, but instead uses the structure of the A and B matrices to perform the blending for the general case. The generic adaptive autopilot was tested in two high-fidelity nonlinear simulators of two typical General Aviation aircraft. The results

SU-F-T-251: The Quality Assurance for the Heavy Patient Load Department in the Developing Country: The Primary Experience of An Entire Workflow QA Process Management in Radiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xie, J; Wang, J; Peng, J

Purpose: To implement an entire workflow quality assurance (QA) process in the radiotherapy department and to reduce the error rates of radiotherapy based on the entire workflow management in the developing country. Methods: The entire workflow QA process management starts from patient registration to the end of last treatment including all steps through the entire radiotherapy process. Error rate of chartcheck is used to evaluate the the entire workflow QA process. Two to three qualified senior medical physicists checked the documents before the first treatment fraction of every patient. Random check of the treatment history during treatment was also performed.more » A total of around 6000 patients treatment data before and after implementing the entire workflow QA process were compared from May, 2014 to December, 2015. Results: A systemic checklist was established. It mainly includes patient’s registration, treatment plan QA, information exporting to OIS(Oncology Information System), documents of treatment QAand QA of the treatment history. The error rate derived from the chart check decreases from 1.7% to 0.9% after our the entire workflow QA process. All checked errors before the first treatment fraction were corrected as soon as oncologist re-confirmed them and reinforce staff training was accordingly followed to prevent those errors. Conclusion: The entire workflow QA process improved the safety, quality of radiotherapy in our department and we consider that our QA experience can be applicable for the heavily-loaded radiotherapy departments in developing country.« less

Annual Quality Assurance Conference Abstracts by Barbara Marshik

EPA Pesticide Factsheets

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

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.

Quality Assurance for Clinical Trials

PubMed Central

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

Software Design Improvements. Part 2; Software Quality and the Design and Inspection Process

NASA Technical Reports Server (NTRS)

Lalli, Vincent R.; Packard, Michael H.; Ziemianski, Tom

1997-01-01

The application of assurance engineering techniques improves the duration of failure-free performance of software. The totality of features and characteristics of a software product are what determine its ability to satisfy customer needs. Software in safety-critical systems is very important to NASA. We follow the System Safety Working Groups definition for system safety software as: 'The optimization of system safety in the design, development, use and maintenance of software and its integration with safety-critical systems in an operational environment. 'If it is not safe, say so' has become our motto. This paper goes over methods that have been used by NASA to make software design improvements by focusing on software quality and the design and inspection process.

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…

Quality assurance in transition.

PubMed

Blumenfeld, S N

1993-06-01

This paper outlines the early approaches to quality assurance, and its transition from business to health care. It then describes the development of the more recent trends in quality assurance of Total Quality Management and Continuous Quality Improvement and discusses the strengths and weaknesses of these approaches. The paper then goes on to show how these approaches have been modified for application to peripheral health services in developing countries through the work of the Primary Health Care Operations Research Project and the Quality Assurance Project.

Safety Sufficiency for NextGen: Assessment of Selected Existing Safety Methods, Tools, Processes, and Regulations

NASA Technical Reports Server (NTRS)

Xu, Xidong; Ulrey, Mike L.; Brown, John A.; Mast, James; Lapis, Mary B.

2013-01-01

NextGen is a complex socio-technical system and, in many ways, it is expected to be more complex than the current system. It is vital to assess the safety impact of the NextGen elements (technologies, systems, and procedures) in a rigorous and systematic way and to ensure that they do not compromise safety. In this study, the NextGen elements in the form of Operational Improvements (OIs), Enablers, Research Activities, Development Activities, and Policy Issues were identified. The overall hazard situation in NextGen was outlined; a high-level hazard analysis was conducted with respect to multiple elements in a representative NextGen OI known as OI-0349 (Automation Support for Separation Management); and the hazards resulting from the highly dynamic complexity involved in an OI-0349 scenario were illustrated. A selected but representative set of the existing safety methods, tools, processes, and regulations was then reviewed and analyzed regarding whether they are sufficient to assess safety in the elements of that OI and ensure that safety will not be compromised and whether they might incur intolerably high costs.

[Russian and foreign legal-standards bases for guaranteeing the parasitic safety of raw produce and food products].

PubMed

Lovgalev, A S

1998-01-01

The paper analyzes the standard legal and methodological assurance of the quality and safety of animal food raw materials and foodstuffs (meat, meat products, fish, shellfish, crayfish and their processing products) by the parasitic purity rates according the requirements under the Russian Federation's laws "On Sanitary and Epidemiological Well-Being of the Population", "On Protection of Consumer's Rights", "On Certification of Products and Services", those of SanPiN, such as 2.3.2.560-96 "Sanitary Requirements for the Quality and Safety of Food Raw Materials and Foodstuffs" and 3.2.569-96 "Prevention of Parasitic Diseases in the Russian Federation".

IEC 61511 and the capital project process--a protective management system approach.

PubMed

Summers, Angela E

2006-03-17

This year, the process industry has reached an important milestone in process safety-the acceptance of an internationally recognized standard for safety instrumented systems (SIS). This standard, IEC 61511, documents good engineering practice for the assessment, design, operation, maintenance, and management of SISs. The foundation of the standard is established by several requirements in Part 1, Clauses 5-7, which cover the development of a management system aimed at ensuring that functional safety is achieved. The management system includes a quality assurance process for the entire SIS lifecycle, requiring the development of procedures, identification of resources and acquisition of tools. For maximum benefit, the deliverables and quality control checks required by the standard should be integrated into the capital project process, addressing safety, environmental, plant productivity, and asset protection. Industry has become inundated with a multitude of programs focusing on safety, quality, and cost performance. This paper introduces a protective management system, which builds upon the work process identified in IEC 61511. Typical capital project phases are integrated with the management system to yield one comprehensive program to efficiently manage process risk. Finally, the paper highlights areas where internal practices or guidelines should be developed to improve program performance and cost effectiveness.

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1993-01-01

The Aerospace Safety Advisory Panel (ASAP) provided oversight on the safety aspects of many NASA programs. In addition, ASAP undertook three special studies. At the request of the Administrator, the panel assessed the requirements for an assured crew return vehicle (ACRV) for the space station and reviewed the organization of the safety and mission quality function within NASA. At the behest of Congress, the panel formed an independent, ad hoc working group to examine the safety and reliability of the space shuttle main engine. Section 2 presents findings and recommendations. Section 3 consists of information in support of these findings and recommendations. Appendices A, B, C, and D, respectively, cover the panel membership, the NASA response to the findings and recommendations in the March 1992 report, a chronology of the panel's activities during the reporting period, and the entire ACRV study report.

Safety assurance of cosmetics in Japan: current situation and future prospects.

PubMed

Inomata, Shinji

2014-01-01

The Japanese Pharmaceutical Affairs Law distinguishes cosmetics from quasi-drugs, and specifies that they must have a mild effect on the human body and must be safe to use over the long term. Therefore, the safety of cosmetics needs to be thoroughly evaluated and confirmed, taking into account the type of cosmetic, application method, conditions of use and so on. Post-marketing surveys of customers' complaints and case reports of adverse effects are important to monitor and confirm the safety of products. Although manufacturing and marketing of cosmetics are becoming more globalized, the regulations relevant to cosmetics safety still vary from country to country. Thus, compliance with different regulations in various markets is a major issue for producers. In particular, further development of alternatives to animal testing remains an urgent global issue.

Surface-Water Quality-Assurance Plan for the Tallahassee Office, U.S. Geological Survey

USGS Publications Warehouse

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.

The implementation of a quality assurance procedure for the Veterinary Services of France.

PubMed

Gerster, F; Guerson, N; Moreau, V; Mulnet, O; Provot, S; Salabert, C

2003-08-01

Due to the increasing complexity of food production systems and the concerns that these systems raise, there has been increasing demand from the general public for more State control of these processes. In France, it is the official Veterinary Services who are responsible for food safety and who must respond to these demands. The Veterinary Service is formulating a quality assurance procedure in accordance with standard EN 45004-ISO 17020, which determines the requirements that inspection bodies must follow to be recognised, at national, European and international level, as competent and reliable. As part of this procedure, the Veterinary Service will review requirements in terms of organisation, functions, qualifications and resources. The progress of inspection service orders, from their conception by the Central Administration, to their implementation by decentralised services, must be carefully managed. It is essential that service orders be implemented effectively and systematically by using recognised methods and issuing adequate inspection reports. The training and qualifications of inspectors are very important: their skills must remain up-to-date so that there is always a network of qualified staff, that is, staff who have an understanding of production processes and who have recognised competences in terms of initial training, continuous professional development and adequate experience. The quality systems implemented will only meet expectations if they are continuously monitored by means of regular evaluations. For this reason, both internal and external audits are performed. These new practices contribute to establishing a basis for the improvement of internal evaluation. In order to facilitate the implementation of a quality assurance procedure for inspection services, several tools, that are linked with the information system of the government department responsible for food, are, or will be, at the disposal of the decentralised Veterinary Services, i

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…

10 CFR Appendix B to Part 50 - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants

Code of Federal Regulations, 2014 CFR

2014-01-01

... related to the design, fabrication, construction, and testing of the structures, systems, and components... components. The pertinent requirements of this appendix apply to all activities affecting the safety-related..., which comprises those quality assurance actions related to the physical characteristics of a material...