Sample records for procedures quality assurance

  1. 40 CFR Appendix C to Part 61 - Quality Assurance Procedures

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 8 2010-07-01 2010-07-01 false Quality Assurance Procedures C Appendix C to Part 61 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...—Quality Assurance Procedures Procedure 1—Determination of Adequate Chromatographic Peak Resolution In this...

  2. HANDBOOK: QUALITY ASSURANCE/QUALITY CONTROL (QA/QC) PROCEDURES FOR HAZARDOUS WASTE INCINERATION

    EPA Science Inventory

    Resource Conservation and Recovery Act regulations for hazardous waste incineration require trial burns by permit applicants. uality Assurance Project Plan (QAPjP) must accompany a trial burn plan with appropriate quality assurance/quality control procedures. uidance on the prepa...

  3. Standard procedures and quality-control practices for the U.S. Geological Survey National Field Quality Assurance Program from 1982 through 1993

    USGS Publications Warehouse

    Stanley, D.L.

    1995-01-01

    The U.S. Geological Survey operates the National Field Quality Assurance Program to provide quality- assurance reference samples to field personnel who make water-quality field measurements. The program monitors the accuracy and precision of pH, specific conductance, and alkalinity field measurements. This report documents the operational procedures and quality-control techniques used in operating the quality-assurance program.

  4. U.S. Geological Survey quality-assurance plan for continuous water-quality monitoring in Kansas, 2014

    USGS Publications Warehouse

    Bennett, Trudy J.; Graham, Jennifer L.; Foster, Guy M.; Stone, Mandy L.; Juracek, Kyle E.; Rasmussen, Teresa J.; Putnam, James E.

    2014-01-01

    A quality-assurance plan for use in conducting continuous water-quality monitoring activities has been developed for the Kansas Water Science Center in accordance with guidelines set forth by the U.S. Geological Survey. This quality-assurance plan documents the standards, policies, and procedures used by the U.S. Geological Survey in Kansas for activities related to the collection, processing, storage, analysis, and release of continuous water-quality monitoring data. The policies and procedures that are documented in this quality-assurance plan for continuous water-quality monitoring activities complement quality-assurance plans for surface-water and groundwater activities in Kansas.

  5. APPLICATION OF SOFTWARE QUALITY ASSURANCE CONCEPTS AND PROCEDURES TO ENVIORNMENTAL RESEARCH INVOLVING SOFTWARE DEVELOPMENT

    EPA Science Inventory

    As EPA’s environmental research expands into new areas that involve the development of software, quality assurance concepts and procedures that were originally developed for environmental data collection may not be appropriate. Fortunately, software quality assurance is a ...

  6. Procedure 5 Quality Assurance Requirements For Vapor Phase Mercury Continuous Emissions Monitoring Systems And Sorbent Trap Monitoring Systems Used For Compliance Determination At Stationary Sources

    EPA Pesticide Factsheets

    Promulgated quality assurance Procedure 5 Quality Assurance Requirements For Vapor Phase Mercury Continuous Emissions Monitoring Systems And Sorbent Trap Monitoring Systems Used For Compliance Determination At Stationary Sources

  7. 23 CFR 637.207 - Quality assurance program.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Quality assurance program. 637.207 Section 637.207... CONSTRUCTION INSPECTION AND APPROVAL Quality Assurance Procedures for Construction § 637.207 Quality assurance program. (a) Each STD's quality assurance program shall provide for an acceptance program and an...

  8. Quality-Assurance Plan for Water-Quality Activities of the U.S. Geological Survey Montana Water Science Center

    USGS Publications Warehouse

    Lambing, John H.

    2006-01-01

    In accordance with guidelines set forth by the Office of Water Quality in the Water Resources Discipline of the U.S. Geological Survey (USGS), a quality-assurance plan has been created for use by the USGS Montana Water Science Center in conducting water-quality activities. This quality-assurance plan documents the standards, policies, and procedures used by the USGS Montana Water Science Center for activities related to the collection, processing, storage, analysis, and publication of water-quality data. The policies and procedures presented in this quality-assurance plan for water-quality activities complement the quality-assurance plans for surface-water and ground-water activities and suspended-sediment analysis.

  9. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  10. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  11. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  12. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  13. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  14. Quality-Assurance Plan for Water-Quality Activities in the USGS Ohio Water Science Center

    USGS Publications Warehouse

    Francy, Donna S.; Shaffer, Kimberly H.

    2008-01-01

    In accordance with guidelines set forth by the Office of Water Quality in the Water Resources Discipline of the U.S. Geological Survey, a quality-assurance plan has been written for use by the Ohio Water Science Center in conducting water-quality activities. This quality-assurance plan documents the standards, policies, and procedures used by the Ohio Water Science Center for activities related to the collection, processing, storage, analysis, and publication of water-quality data. The policies and procedures documented in this quality-assurance plan for water-quality activities are meant to complement the Ohio Water Science Center quality-assurance plans for water-quality monitors, the microbiology laboratory, and surface-water and ground-water activities.

  15. 40 CFR 31.45 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 31.45 Section 31.45... Requirements Reports, Records, Retention, and Enforcement § 31.45 Quality assurance. If the grantee's project... quality assurance practices consisting of policies, procedures, specifications, standards, and...

  16. Quality-assurance plan for water-quality activities in the U.S. Geological Survey Washington Water Science Center

    USGS Publications Warehouse

    Conn, Kathleen E.; Huffman, Raegan L.; Barton, Cynthia

    2017-05-08

    In accordance with guidelines set forth by the Office of Water Quality in the Water Mission Area of the U.S. Geological Survey, a quality-assurance plan has been created for use by the Washington Water Science Center (WAWSC) in conducting water-quality activities. This qualityassurance plan documents the standards, policies, and procedures used by the WAWSC for activities related to the collection, processing, storage, analysis, and publication of water-quality data. The policies and procedures documented in this quality-assurance plan for water-quality activities complement the quality-assurance plans for surface-water and groundwater activities at the WAWSC.

  17. 24 CFR 200.954 - Supplementary specific requirements under the HUD building product standard and certification...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... shall also include the manufacturer's name, plant location, and shelf life. (c) Periodic tests and quality assurance. Under the procedures set forth in § 200.935(d)(8) concerning periodic tests and quality... administrator. (2) The administrator shall also review the quality assurance procedures twice a year to assure...

  18. 24 CFR 200.954 - Supplementary specific requirements under the HUD building product standard and certification...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... shall also include the manufacturer's name, plant location, and shelf life. (c) Periodic tests and quality assurance. Under the procedures set forth in § 200.935(d)(8) concerning periodic tests and quality... administrator. (2) The administrator shall also review the quality assurance procedures twice a year to assure...

  19. Revision 2 of the Enbridge Quality Assurance Project Plan

    EPA Pesticide Factsheets

    This Quality Assurance Project Plan (QAPP) presents Revision 2 of the organization, objectives, planned activities, and specific quality assurance/quality control (QA/QC) procedures associated with the Enbridge Marshall Pipeline Release Project.

  20. 42 CFR 457.495 - State assurance of access to care and procedures to assure quality and appropriateness of care.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false State assurance of access to care and procedures to assure quality and appropriateness of care. 457.495 Section 457.495 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE...

  1. 42 CFR 457.495 - State assurance of access to care and procedures to assure quality and appropriateness of care.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 4 2014-10-01 2014-10-01 false State assurance of access to care and procedures to assure quality and appropriateness of care. 457.495 Section 457.495 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE...

  2. 42 CFR 457.495 - State assurance of access to care and procedures to assure quality and appropriateness of care.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 4 2012-10-01 2012-10-01 false State assurance of access to care and procedures to assure quality and appropriateness of care. 457.495 Section 457.495 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE...

  3. 42 CFR 457.495 - State assurance of access to care and procedures to assure quality and appropriateness of care.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false State assurance of access to care and procedures to assure quality and appropriateness of care. 457.495 Section 457.495 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE...

  4. 42 CFR 457.495 - State assurance of access to care and procedures to assure quality and appropriateness of care.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 4 2011-10-01 2011-10-01 false State assurance of access to care and procedures to assure quality and appropriateness of care. 457.495 Section 457.495 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE...

  5. 23 CFR 650.313 - Inspection procedures.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Quality control and quality assurance. Assure systematic quality control (QC) and quality assurance (QA... periodic field review of inspection teams, periodic bridge inspection refresher training for program managers and team leaders, and independent review of inspection reports and computations. (h) Follow-up on...

  6. Quality assurance: Importance of systems and standard operating procedures

    PubMed Central

    Manghani, Kishu

    2011-01-01

    It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company. PMID:21584180

  7. Quality assurance: Importance of systems and standard operating procedures.

    PubMed

    Manghani, Kishu

    2011-01-01

    It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

  8. Evaluation of procedures for quality assurance specifications

    DOT National Transportation Integrated Search

    2004-10-01

    The objective of this project was to develop a comprehensive quality assurance (QA) manual, supported by scientific evidence and statistical theory, which provides step-by-step procedures and instructions for developing effective and efficient QA spe...

  9. 42 CFR 423.128 - Dissemination of Part D plan information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... tiered formulary structure and utilization management procedures used) functions; (iii) The process for... under § 423.564 et. seq. (8) Quality assurance policies and procedures. A description of the quality assurance policies and procedures required under § 423.153(c), as well as the medication therapy management...

  10. 24 CFR 200.935 - Administrator qualifications and procedures for HUD building products certification programs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... guidelines in any quality assurance review: (1) ASQC Q9000-1-1994 Quality Management and Quality Assurance... Systems—Model for Quality Assurance in Final Inspection and Test; (5) ASQC Q9004-1-1994 Quality Management... in interpreting testing standards, test methods, evaluating test reports and quality control programs...

  11. ENVIRONMENTAL TECHNOLOGY VERIFICATION REPORT, MIRATECH CORPORATIONM GECO 3001 AIR/FUEL RATIO CONTROLLER

    EPA Science Inventory

    Details on the verification test design, measurement test procedures, and Quality assurance/Quality Control (QA/QC) procedures can be found in the test plan titled Testing and Quality Assurance Plan, MIRATECH Corporation GECO 3100 Air/Fuel Ratio Controller (SRI 2001). It can be d...

  12. Quality-assurance and data-management plan for water-quality activities in the Kansas Water Science Center, 2014

    USGS Publications Warehouse

    Rasmussen, Teresa J.; Bennett, Trudy J.; Foster, Guy M.; Graham, Jennifer L.; Putnam, James E.

    2014-01-01

    As the Nation’s largest water, earth, and biological science and civilian mapping information agency, the U.S. Geological Survey is relied on to collect high-quality data, and produce factual and impartial interpretive reports. This quality-assurance and data-management plan provides guidance for water-quality activities conducted by the Kansas Water Science Center. Policies and procedures are documented for activities related to planning, collecting, storing, documenting, tracking, verifying, approving, archiving, and disseminating water-quality data. The policies and procedures described in this plan complement quality-assurance plans for continuous water-quality monitoring, surface-water, and groundwater activities in Kansas.

  13. ENQA: 10 Years (2000-2010): A Decade of European Co-Operation in Quality Assurance in Higher Education

    ERIC Educational Resources Information Center

    Crozier, Fiona, Ed.; Costes, Nathalie, Ed.; Ranne, Paula, Ed.; Stalter, Maria, Ed.

    2010-01-01

    The history of ENQA (European Association for Quality Assurance in Higher Education) arises in the late 1990s when the first formal procedures for quality assurance begun to stabilize on a national level. As a result of the European Pilot Projects in the field of external quality assurance during the nineties, participants felt the need for…

  14. EPA Region 3 Quality Management Plans

    EPA Pesticide Factsheets

    Has links to resources that describe the Region's Quality Assurance Program, which is a collection of the Region's ongoing quality assurance (QA) policies, procedures, responsibilities and management systems.

  15. Quality-assurance plan for the analysis of fluvial sediment by laboratories of the U.S. Geological Survey

    USGS Publications Warehouse

    Matthes, Wilbur J.; Sholar, Clyde J.; George, John R.

    1992-01-01

    This report describes procedures used by the Iowa District sediment laboratory of the U.S. Geological Survey to assure the quality of sediment-laboratory data. These procedures can be used by other U.S. Geological Survey laboratories regardless of size and type of operation for quality assurance and quality control of specific sediment-laboratory processes. Also described are the equipment, specifications, calibration and maintenance, and the protocol for methods used in the analyses of fluvial sediment for concentration or particle size.

  16. Quality Procedures in the European Higher Education Area and Beyond--Visions for the Future: Third ENQA Survey. ENQA Occasional Papers 18

    ERIC Educational Resources Information Center

    Grifoll, Josep; Hopbach, Achim; Kekalainen, Helka; Lugano, Nathalie; Rozsnyai, Christina; Shopov, Todor

    2012-01-01

    Higher education reforms over the last decade, resulting in the establishment of the European Higher Education Area, with new social demands and expectations, have greatly impacted quality assurance in higher education. As a follow-up activity to two previous surveys on external quality procedures, the European Association for Quality Assurance in…

  17. Principles and Practices for Quality Assurance and Quality Control

    USGS Publications Warehouse

    Jones, Berwyn E.

    1999-01-01

    Quality assurance and quality control are vital parts of highway runoff water-quality monitoring projects. To be effective, project quality assurance must address all aspects of the project, including project management responsibilities and resources, data quality objectives, sampling and analysis plans, data-collection protocols, data quality-control plans, data-assessment procedures and requirements, and project outputs. Quality control ensures that the data quality objectives are achieved as planned. The historical development and current state of the art of quality assurance and quality control concepts described in this report can be applied to evaluation of data from prior projects.

  18. Data Validation & Laboratory Quality Assurance for Region 9

    EPA Pesticide Factsheets

    In all hazardous site investigations it is essential to know the quality of the data used for decision-making purposes. Validation of data requires that appropriate quality assurance and quality control (QA/QC) procedures be followed.

  19. Concept of Draft International Standard for a Unified Approach to Space Program Quality Assurance

    NASA Astrophysics Data System (ADS)

    Stryzhak, Y.; Vasilina, V.; Kurbatov, V.

    2002-01-01

    For want of the unified approach to guaranteed space project and product quality assurance, implementation of many international space programs has become a challenge. Globalization of aerospace industry and participation of various international ventures with diverse quality assurance requirements in big international space programs requires for urgent generation of unified international standards related to this field. To ensure successful fulfillment of space missions, aerospace companies should design and process reliable and safe products with properties complying or bettering User's (or Customer's) requirements. Quality of the products designed or processed by subcontractors (or other suppliers) should also be in compliance with the main user (customer)'s requirements. Implementation of this involved set of unified requirements will be made possible by creating and approving a system (series) of international standards under a generic title Space Product Quality Assurance based on a system consensus principle. Conceptual features of the baseline standard in this system (series) should comprise: - Procedures for ISO 9000, CEN and ECSS requirements adaptation and introduction into space product creation, design, manufacture, testing and operation; - Procedures for quality assurance at initial (design) phases of space programs, with a decision on the end product made based on the principle of independence; - Procedures to arrange incoming inspection of products delivered by subcontractors (including testing, audit of supplier's procedures, review of supplier's documentation), and space product certification; - Procedures to identify materials and primary products applied; - Procedures for quality system audit at the component part, primary product and materials supplier facilities; - Unified procedures to form a list of basic performances to be under configuration management; - Unified procedures to form a list of critical space product components, and unified procedures to define risks related to the specific component application and evaluate safety for the entire program implementation. In the eyes of the authors, those features together with a number of other conceptual proposals should constitute a unified standard-technical basis for implementing international space programs.

  20. Surface Water Quality-Assurance Plan for the North Florida Program Office of the U.S. Geological Survey

    USGS Publications Warehouse

    Franklin, Marvin A.

    2000-01-01

    The U.S. Geological Survey, Water Resources Division, has a policy that requires each District office to prepare a Surface Water Quality-Assurance Plan. The plan for each District describes the policies and procedures that ensure high quality in the collection, processing, analysis, computer storage, and publication of surface-water data. The North Florida Program Office Surface Water Quality-Assurance Plan documents the standards, policies, and procedures used by the North Florida Program office for activities related to the collection, processing, storage, analysis, and publication of surface-water data.

  1. 40 CFR Appendix C to Part 61 - Quality Assurance Procedures

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 9 2014-07-01 2014-07-01 false Quality Assurance Procedures C Appendix C to Part 61 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS Pt. 61, App. C Appendix C to Part 61...

  2. 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.

  3. Institutionalisation of Internal Quality Assurance: Focusing on Institutional Work and the Significance of Disciplinary Differences

    ERIC Educational Resources Information Center

    Vukasovic, Martina

    2014-01-01

    The study suggests that institutionalisation of a comprehensive and systematic approach to internal quality assurance of higher education institutions inspired by the Bologna Process has regulative, normative and cultural-cognitive dimensions. It includes development of structures and procedures for quality assurance, as well as boosting of the…

  4. Quality Assurance and Accreditation in Higher Education: India vis-à-vis European Countries

    ERIC Educational Resources Information Center

    Dey, Niradhar

    2011-01-01

    Quality assurance (QA) and accreditation in higher education include the systematic management and assessment of procedures to monitor performance and to address areas of improvement. In the context of globalization, without assuring the quality of higher education programmes it is not possible to ensure credit transfer and student mobility, to…

  5. Quality Assurance and Quality Control, Part 2.

    PubMed

    Akers, Michael J

    2015-01-01

    The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.

  6. 40 CFR 160.35 - Quality assurance unit.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

  7. 40 CFR 160.35 - Quality assurance unit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

  8. 40 CFR 160.35 - Quality assurance unit.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

  9. 40 CFR 160.35 - Quality assurance unit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

  10. 40 CFR 160.35 - Quality assurance unit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

  11. 42 CFR 493.643 - Fee for determination of program compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... laboratory's scope and volume of testing (excluding tests performed for quality control, quality assurance... procedure or examination for a single analyte. (Tests performed for quality control, quality assurance, and... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration...

  12. TECHNICAL GUIDANCE DOCUMENT: QUALITY ASSURANCE AND QUALITY CONTROL FOR WASTE CONTAINMENT FACILITIES

    EPA Science Inventory

    This Technical Guidance Document provides comprehensive guidance on procedures for quality assurance and quality control for waste containment facilities. he document includes a discussion of principles and concepts, compacted soil liners, soil drainage systems, geosynthetic drai...

  13. TECHNICAL GUIDANCE DOCUMENT: QUALITY ASSURANCE AND QUALITY CONTROL FOR WASTE CONTAINMENT FACILITIES

    EPA Science Inventory

    This Technical Guidance Document provides comprehensive guidance on procedures for quality assurance and quality control for waste containment facilities. The document includes a discussion of principles and concepts, compacted soil liners, soil drainage systems, geosynthetic dr...

  14. 48 CFR 246.472 - Inspection stamping.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.472 Inspection stamping. (a) DoD quality inspection approval marking designs (stamps) may be used for both prime...) Policies and procedures regarding the use of National Aeronautics and Space Administration (NASA) quality...

  15. Software quality assurance plan for GCS

    NASA Technical Reports Server (NTRS)

    Duncan, Stephen E.; Bailey, Elizabeth K.

    1990-01-01

    The software quality assurance (SQA) function for the Guidance and Control Software (GCS) project which is part of a software error studies research program is described. The SQA plan outlines all of the procedures, controls, and audits to be carried out by the SQA organization to ensure adherence to the policies, procedures, and standards for the GCS project.

  16. Product assurance policies and procedures for flight dynamics software development

    NASA Technical Reports Server (NTRS)

    Perry, Sandra; Jordan, Leon; Decker, William; Page, Gerald; Mcgarry, Frank E.; Valett, Jon

    1987-01-01

    The product assurance policies and procedures necessary to support flight dynamics software development projects for Goddard Space Flight Center are presented. The quality assurance and configuration management methods and tools for each phase of the software development life cycles are described, from requirements analysis through acceptance testing; maintenance and operation are not addressed.

  17. One or Multiple Paths to Quality Assurance of Higher Education Institutions in the United Arab Emirates

    ERIC Educational Resources Information Center

    Ashour, Sanaa

    2017-01-01

    The United Arab Emirates (UAE) is a federation of seven autonomous emirates that follow different economic models. There is a process for quality assurance at the federal level, however, each emirate takes its own approach to assure the quality of its institutions. This has resulted in different procedures and varying levels of oversight and…

  18. Quality-assurance procedures: Method 5G determination of particulate emissions from wood heaters from a dilution tunnel sampling location

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

    Ward, T.E.; Hartman, M.W.; Olin, R.C.

    1989-06-01

    Quality-assurance procedures are contained in this comprehensive document intended to be used as an aid for wood-heater manufacturers and testing laboratories in performing particulate matter sampling of wood heaters according to EPA protocol, Method 5G. These procedures may be used in research and development, and as an aid in auditing and certification testing. A detailed, step-by-step quality assurance guide is provided to aid in the procurement and assembly of testing apparatus, to clearly describe the procedures, and to facilitate data collection and reporting. Suggested data sheets are supplied that can be used as an aid for both recordkeeping and certificationmore » applications. Throughout the document, activity matrices are provided to serve as a summary reference. Checklists are also supplied that can be used by testing personnel. Finally, for the purposes of ensuring data quality, procedures are outlined for apparatus operation, maintenance, and traceability. These procedures combined with the detailed description of the sampling and analysis protocol will help ensure the accuracy and reliability of Method 5G emission-testing results.« less

  19. COMMUNITY MULTISCALE AIR QUALITY ( CMAQ ) MODEL - QUALITY ASSURANCE AND VERSION CONTROL

    EPA Science Inventory

    This presentation will be given to the EPA Exposure Modeling Workgroup on January 24, 2006. The quality assurance and version control procedures for the Community Multiscale Air Quality (CMAQ) Model are presented. A brief background of CMAQ is given, then issues related to qual...

  20. 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

  1. 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 collected as part of long-term water-level monitoring networks.

  2. Quality Assurance Project Plan for Closure of the Central Facilities Area Sewage Treatment Plant Lagoon 3 and Land Application Area

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

    Lewis, Michael G.

    This quality assurance project plan describes the technical requirements and quality assurance activities of the environmental data collection/analyses operations to close Central Facilities Area Sewage treatment Plant Lagoon 3 and the land application area. It describes the organization and persons involved, the data quality objectives, the analytical procedures, and the specific quality control measures to be employed. All quality assurance project plan activities are implemented to determine whether the results of the sampling and monitoring performed are of the right type, quantity, and quality to satisfy the requirements for closing Lagoon 3 and the land application area.

  3. Quality assurance of weather data for agricultural system model input

    USDA-ARS?s Scientific Manuscript database

    It is well known that crop production and hydrologic variation on watersheds is weather related. Rarely, however, is meteorological data quality checks reported for agricultural systems model research. We present quality assurance procedures for agricultural system model weather data input. Problems...

  4. Multi-Site Quality Assurance Project Plan for Wisconsin Public Service Corporation, Peoples Gas Light and Coke Company, and North Shore Gas

    EPA Pesticide Factsheets

    This Multi-Site QAPP presents the organization, data quality objectives (DQOs), a set of anticipated activities, sample analysis, data handling and specific Quality Assurance/Quality Control (QA/QC) procedures associated with Studies done in EPA Region 5

  5. Optimal procedures for quality assurance specifications

    DOT National Transportation Integrated Search

    2003-04-01

    This manual is a comprehensive guide that a highway agency can use when developing new, or modifying existing, acceptance plans and quality assurance specifications. It provides necessary instruction and illustrative examples to lead the agency throu...

  6. 222-S Laboratory Quality Assurance Plan. Revision 1

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

    Meznarich, H.K.

    1995-07-31

    This Quality Assurance Plan provides,quality assurance (QA) guidance, regulatory QA requirements (e.g., 10 CFR 830.120), and quality control (QC) specifications for analytical service. This document follows the U.S Department of Energy (DOE) issued Hanford Analytical Services Quality Assurance Plan (HASQAP). In addition, this document meets the objectives of the Quality Assurance Program provided in the WHC-CM-4-2, Section 2.1. Quality assurance elements required in the Guidelines and Specifications for Preparing Quality Assurance Program Plans (QAMS-004) and Interim Guidelines and Specifications for Preparing Quality Assurance Project Plans (QAMS-005) from the US Environmental Protection Agency (EPA) are covered throughout this document. A qualitymore » assurance index is provided in the Appendix A. This document also provides and/or identifies the procedural information that governs laboratory operations. The personnel of the 222-S Laboratory and the Standards Laboratory including managers, analysts, QA/QC staff, auditors, and support staff shall use this document as guidance and instructions for their operational and quality assurance activities. Other organizations that conduct activities described in this document for the 222-S Laboratory shall follow this QA/QC document.« less

  7. Quality control of EUVE databases

    NASA Technical Reports Server (NTRS)

    John, L. M.; Drake, J.

    1992-01-01

    The publicly accessible databases for the Extreme Ultraviolet Explorer include: the EUVE Archive mailserver; the CEA ftp site; the EUVE Guest Observer Mailserver; and the Astronomical Data System node. The EUVE Performance Assurance team is responsible for verifying that these public EUVE databases are working properly, and that the public availability of EUVE data contained therein does not infringe any data rights which may have been assigned. In this poster, we describe the Quality Assurance (QA) procedures we have developed from the approach of QA as a service organization, thus reflecting the overall EUVE philosophy of Quality Assurance integrated into normal operating procedures, rather than imposed as an external, post facto, control mechanism.

  8. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  9. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  10. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  11. 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...

  12. Quality-assurance plan for the analysis of fluvial sediment by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory

    USGS Publications Warehouse

    Shreve, Elizabeth A.; Downs, Aimee C.

    2005-01-01

    This report describes laboratory procedures used by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory for the processing and analysis of fluvial-sediment samples for concentration of sand and finer material. The report details the processing of a sediment sample through the laboratory from receiving the sediment sample, through the analytical process, to compiling results of the requested analysis. Procedures for preserving sample integrity, calibrating and maintaining of laboratory and field instruments and equipment, analyzing samples, internal quality assurance and quality control, and validity of the sediment-analysis results also are described. The report includes a list of references cited and a glossary of sediment and quality-assurance terms.

  13. 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.

  14. 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.

  15. 48 CFR 1346.401 - General.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false General. 1346.401 Section 1346.401 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 1346.401 General. Agency procedures for documenting...

  16. Quality Assurance of Software Used In Aircraft Or Related Products

    DOT National Transportation Integrated Search

    1993-02-01

    This advisory circular (AC) provides an acceptable means, but not the only means, to show compliance with the quality assurance requirements of Federal Aviation Regulations (FAR) Part 21, Certification Procedures for Products and Parts, as applicable...

  17. 21 CFR 58.35 - Quality assurance unit.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

  18. 21 CFR 58.35 - Quality assurance unit.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

  19. 21 CFR 58.35 - Quality assurance unit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

  20. 21 CFR 58.35 - Quality assurance unit.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

  1. 21 CFR 58.35 - Quality assurance unit.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

  2. [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.

  3. [Positional accuracy and quality assurance of Backup JAWs required for volumetric modulated arc therapy].

    PubMed

    Tatsumi, Daisaku; Nakada, Ryosei; Ienaga, Akinori; Yomoda, Akane; Inoue, Makoto; Ichida, Takao; Hosono, Masako

    2012-01-01

    The tolerance of the Backup diaphragm (Backup JAW) setting in Elekta linac was specified as 2 mm according to the AAPM TG-142 report. However, the tolerance and the quality assurance procedure for volumetric modulated arc therapy (VMAT) was not provided. This paper describes positional accuracy and quality assurance procedure of the Backup JAWs required for VMAT. It was found that a gap-width error of the Backup JAW by a sliding window test needed to be less than 1.5 mm for prostate VMAT delivery. It was also confirmed that the gap-widths had been maintained with an error of 0.2 mm during the past one year.

  4. Opinion of gastroenterologists towards quality assurance in endoscopy.

    PubMed

    de Jonge, Vincent; Kuipers, Ernst J; van Leerdam, Monique E

    2011-03-01

    Quality assurance has become an important issue. Many societies are adopting quality assurance programs in order to monitor and improve quality of care. To assess the opinion of gastroenterologists towards quality assurance on the endoscopy department. A survey was sent to all gastroenterologists (n=319) in the Netherlands. It assessed their opinion on a quality assurance program for endoscopy units, including its design, logistics, and content. 200 gastroenterologists (63%) completed the questionnaire. 95% had a positive opinion towards quality assurance and 67% supposed an increase in quality. 28% assumed a negative impact on the time available for patient contact by introducing a quality assurance program and 35% that the capacity would decrease. A negative attitude towards disclosure of results to insurance companies (23%) and media (53%) was reported. Female gastroenterologists were less positive to share the results with other stakeholders (p<0.05). Most important quality measurements were assessment of complications (97%), standardised reporting (96%), and adequate patient information (95%). Gastroenterologists have a positive attitude towards quality assurance. However, concerns do exist about time investment and disclosure of results to others. Information provision and procedure characteristics were considered the most important aspects of quality assurance. Copyright © 2010 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  5. 21 CFR 106.90 - Coding.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.90 Coding. The manufacturer shall code all infant formulas in conformity...

  6. Diagnostic equipment outside the laboratory.

    PubMed Central

    Burrin, J M; Fyffe, J A

    1988-01-01

    A questionnaire was circulated to clinical biochemistry laboratories in the North West Thames region of the United Kingdom requesting information on extralaboratory equipment. Data on the types and numbers of instruments in use, their relationship with the laboratory, and quality assurance procedures were obtained. Laboratories were prepared to maintain equipment over which they had no responsibility for purchase, training of users, or use. The quality assurance of these instruments gave even greater cause for concern. Although internal quality control procedures were performed on many of the instruments, laboratories were involved in only a minority of these procedures. Quality control procedures and training of users were undertaken on site in less than 50% of blood gas analysers and bilirubin meters and in less than 25% of glucose meters. External quality assessment procedures were non-existent for all of the instruments in use with the exception of glucose stick meters in two laboratories. PMID:3192750

  7. Quality Assurance Specifications for Planetary Protection Assays

    NASA Astrophysics Data System (ADS)

    Baker, Amy

    As the European Space Agency planetary protection (PP) activities move forward to support the ExoMars and other planetary missions, it will become necessary to increase staffing of labo-ratories that provide analyses for these programs. Standardization of procedures, a comprehen-sive quality assurance program, and unilateral training of personnel will be necessary to ensure that the planetary protection goals and schedules are met. The PP Quality Assurance/Quality Control (QAQC) program is designed to regulate and monitor procedures performed by labora-tory personnel to ensure that all work meets data quality objectives through the assembly and launch process. Because personnel time is at a premium and sampling schedules are often de-pendent on engineering schedules, it is necessary to have flexible staffing to support all sampling requirements. The most productive approach to having a competent and flexible work force is to establish well defined laboratory procedures and training programs that clearly address the needs of the program and the work force. The quality assurance specification for planetary protection assays has to ensure that labora-tories and associated personnel can demonstrate the competence to perform assays according to the applicable standard AD4. Detailed subjects included in the presentation are as follows: • field and laboratory control criteria • data reporting • personnel training requirements and certification • laboratory audit criteria. Based upon RD2 for primary and secondary validation and RD3 for data quality objectives, the QAQC will provide traceable quality assurance safeguards by providing structured laboratory requirements for guidelines and oversight including training and technical updates, standardized documentation, standardized QA/QC checks, data review and data archiving.

  8. Assuring Quality in Collaborative Provision.

    ERIC Educational Resources Information Center

    Bocock, Jean; Edwards, Judith

    1998-01-01

    This bulletin is intended to help British further education colleges clarify their rationale for entering into collaborative programs, assess prospective partners, define and implement good practice at all stages of provision, and establish rigorous quality assurance procedures. Following an introduction, Further Education Funding Council…

  9. 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.

  10. 15 CFR 996.32 - Appeals.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Other Quality Assurance Program Matters § 996.32 Appeals. (a... Coastal Zone Management, NOAA, using procedures to be established at the time of the appeal, and which...

  11. 15 CFR 996.32 - Appeals.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Other Quality Assurance Program Matters § 996.32 Appeals. (a... Coastal Zone Management, NOAA, using procedures to be established at the time of the appeal, and which...

  12. 15 CFR 996.32 - Appeals.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Other Quality Assurance Program Matters § 996.32 Appeals. (a... Coastal Zone Management, NOAA, using procedures to be established at the time of the appeal, and which...

  13. 15 CFR 996.32 - Appeals.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Other Quality Assurance Program Matters § 996.32 Appeals. (a... Coastal Zone Management, NOAA, using procedures to be established at the time of the appeal, and which...

  14. Quality assurance testing of a high performance steel bridge in Virginia.

    DOT National Transportation Integrated Search

    2005-01-01

    One of the original objectives of this study was to recommend appropriate procedures for welding bridge members of high performance steel HPS70W to assure quality welds. The final objective was to determine whether hydrogen-induced microcracking migh...

  15. QUALITY ASSURANCE HANDBOOK FOR AIR POLLUTION MEASUREMENT SYSTEMS: VOLUME IV - METEOROLOGICAL MEASUREMENTS (REVISED - AUGUST 1994)

    EPA Science Inventory

    Procedures on installing, acceptance testing, operating, maintaining and quality assuring three types of ground-based, upper air meteorological measurement systems are described. he limitations and uncertainties in precision and accuracy measurements associated with these systems...

  16. 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

  17. 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 clinical need were crucial beginning for this hospital's growing program.

  18. 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.

  19. 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.

  20. 7 CFR 1710.408 - Quality assurance plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AGRICULTURE GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Energy... accordance with quality assurance plans meeting standards designed to achieve the purposes of this subpart... pump) the new system must be designed and installed by certified and insured professionals acceptable...

  1. [Quality control in anesthesiology].

    PubMed

    Muñoz-Ramón, J M

    1995-03-01

    The process of quality control and auditing of anesthesiology allows us to evaluate care given by a service and solve problems that are detected. Quality control is a basic element of care giving and is only secondarily an area of academic research; it is therefore a meaningless effort if the information does not serve to improve departmental procedures. Quality assurance procedures assume certain infrastructural requirements and an initial period of implementation and adjustment. The main objectives of quality control are the reduction of morbidity and mortality due to anesthesia, assurance of the availability and proper management of resources and, finally, the well-being and safety of the patient.

  2. External Quality Assurance Programs Managed by the U.S. Geological Survey in Support of the National Atmospheric Deposition Program/Mercury Deposition Network

    USGS Publications Warehouse

    Latysh, Natalie E.; Wetherbee, Gregory A.

    2007-01-01

    The U.S. Geological Survey (USGS) Branch of Quality Systems operates external quality assurance programs for the National Atmospheric Deposition Program/Mercury Deposition Network (NADP/MDN). Beginning in 2004, three programs have been implemented: the system blank program, the interlaboratory comparison program, and the blind audit program. Each program was designed to measure error contributed by specific components in the data-collection process. The system blank program assesses contamination that may result from sampling equipment, field exposure, and routine handling and processing of the wet-deposition samples. The interlaboratory comparison program evaluates bias and precision of analytical results produced by the Mercury Analytical Laboratory (HAL) for the NADP/MDN, operated by Frontier GeoSciences, Inc. The HAL's performance is compared with the performance of five other laboratories. The blind audit program assesses bias and variability of MDN data produced by the HAL using solutions disguised as environmental samples to ascertain true laboratory performance. This report documents the implementation of quality assurance procedures for the NADP/MDN and the operating procedures for each of the external quality assurance programs conducted by the USGS. The USGS quality assurance information provides a measure of confidence to NADP/MDN data users that measurement variability is distinguished from environmental signals.

  3. Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York--July 1999 through June 2001

    USGS Publications Warehouse

    Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

    2006-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's LabMaster data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality-control samples analyzed from July 1999 through June 2001. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, calcium, chloride and nitrate (ion chromatography and colormetric method) and sulfate. The total aluminum and dissolved organic carbon procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits. The calcium and specific conductance procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The magnesium procedure was biased for the high-concentration and low concentration samples, but was within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 14 of 15 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 17 of the 18 analytes. At least 90 percent of the samples met data-quality objectives for all analytes except ammonium (81 percent of samples met objectives), chloride (75 percent of samples met objectives), and sodium (86 percent of samples met objectives). Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality over the time period, with most ratings for each sample in the good to excellent range. The P-sample (low-ionic-strength constituents) analysis had one satisfactory rating for the specific conductance procedure in one study. The T-sample (trace constituents) analysis had one satisfactory rating for the aluminum procedure in one study and one unsatisfactory rating for the sodium procedure in another. The remainder of the samples had good or excellent ratings for each study. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 89 percent of the samples met data-quality objectives for 10 of the 14 analytes; the exceptions were ammonium, total aluminum, dissolved organic carbon, and sodium. Results indicate a positive bias for the ammonium procedure in all studies. Data-quality objectives were not met in 50 percent of samples analyzed for total aluminum, 38 percent of samples analyzed for dissolved organic carbon, and 27 percent of samples analyzed for sodium. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 91 percent of the samples analyzed for calcium, chloride, fluoride, magnesium, pH, potassium, and sulfate. Data-quality objectives were met by 75 percent of the samples analyzed for sodium and 58 percent of the samples analyzed for specific conductance.

  4. Quality Assurance: Enhancing or Threatening Higher Education?

    ERIC Educational Resources Information Center

    Taousanidis, Nikolaos I.; Antoniadou, Myrofora A.

    2010-01-01

    There is an increasing marketization of commodity services and, the authors argue, higher education is suffering heavily from this trend. Higher education institutions (HEIs) are currently subject to quality assurance and other externally imposed procedures that have been successfully applied in the private sector. This article analyses the…

  5. FINDING THE BALANCE - QUALITY ASSURANCE REQUIREMENTS VS. RESEARCH NEEDS

    EPA Science Inventory

    Investigators often misapply quality assurance (QA) procedures and may consider QA as a hindrance to developing test plans for sampling and analysis. If used properly, however, QA is the driving force for collecting the right kind and proper amount of data. Researchers must use Q...

  6. FINDING THE BALANCE - QUALITY ASSURANCE REQUIREMENTS VS. RESEARCH NEEDS

    EPA Science Inventory

    Investigators often misapply quality assurance (QA) procedures and may consider QA as a hindrance to developing test plans for
    sampling and analysis. If used properly, however, QA is the driving force for collecting the right kind and proper amount of data.
    Researchers must...

  7. 40 CFR 75.21 - Quality assurance and quality control requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., as defined in § 72.2, k=2) of plus or minus 1.0 percent (calculated combined standard uncertainty of... system according to the quality assurance and quality control procedures in appendix B of this part. (2... requirements of Method 2, 6C, 7E, or 3A in Appendices A-1, A-2 and A-4 to part 60 of this chapter (supplemented...

  8. Quality assurance and organizational effectiveness in hospitals.

    PubMed Central

    Hetherington, R W

    1982-01-01

    The purpose of this paper is to explore some aspects of a general theoretical model within which research on the organizational impacts of quality assurance programs in hospitals may be examined. Quality assurance is conceptualized as an organizational control mechanism, operating primarily through increased formalization of structures and specification of procedures. Organizational effectiveness is discussed from the perspective of the problem-solving theory of organizations, wherein effective organizations are those which maintain at least average performance in all four system problem areas simultaneously (goal-attainment, integration, adaptation and pattern-maintenance). It is proposed that through the realization of mutual benefits for both professionals and the bureaucracy, quality assurance programs can maximize such effective performance in hospitals. PMID:7096096

  9. European Approaches to Quality Assurance: Models, Characteristics and Challenges.

    ERIC Educational Resources Information Center

    van Damme, D.

    2000-01-01

    Examines models, characteristics, and challenges of quality assurance in higher education in the Netherlands, Belgium, Germany, Denmark, France, Finland, Italy, and Spain. Notes a common move toward institutional autonomy and output oriented steering, and the absence of accreditation procedures comparable to those in Anglo-Saxon countries. Finds…

  10. U.S. Geological Survey quality-assurance plan for surface-water activities in Kansas, 2015

    USGS Publications Warehouse

    Painter, Colin C.; Loving, Brian L.

    2015-01-01

    This Surface Water Quality-Assurance Plan documents the standards, policies, and procedures used by the Kansas Water Science Center (KSWSC) of the U.S. Geological Survey (USGS) for activities related to the collection, processing, storage, analysis, and publication of surface-water data.

  11. Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York - July 2001 Through June 2003

    USGS Publications Warehouse

    Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

    2009-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2001 through June 2003. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for six of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, chloride, magnesium, nitrate (ion chromatography), potassium, and sodium. The calcium procedure was biased throughout the analysis period for the high-concentration sample, but was within control limits. The total monomeric aluminum and fluoride procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum, pH, specific conductance, and sulfate procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 16 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for the dissolved organic carbon or specific conductance procedures. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 21 analytes. At least 90 percent of the samples met data-quality objectives for all procedures except total monomeric aluminum (83 percent of samples met objectives), total aluminum (76 percent of samples met objectives), ammonium (73 percent of samples met objectives), dissolved organic carbon (86 percent of samples met objectives), and nitrate (81 percent of samples met objectives). The data-quality objective was not met for the nitrite procedure. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated satisfactory or above data quality over the time period, with most performance ratings for each sample in the good-to-excellent range. The N-sample (nutrient constituents) analysis had one unsatisfactory rating for the ammonium procedure in one study. The T-sample (trace constituents) analysis had one unsatisfactory rating for the magnesium procedure and one marginal rating for the potassium procedure in one study and one unsatisfactory rating for the sodium procedure in another. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 90 percent of the samples met data-quality objectives for 10 of the 14 analytes; the exceptions were acid-neutralizing capacity, ammonium, dissolved organic carbon, and sodium. Data-quality objectives were not met in 37 percent of samples analyzed for acid-neutralizing capacity, 28 percent of samples analyzed for dissolved organic carbon, and 30 percent of samples analyzed for sodium. Results indicate a positive bias for the ammonium procedure in one study and a negative bias in another. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 90 percent of the samples analyzed for calcium, chloride, magnesium, pH, potassium, and sodium. Data-quality objectives were met by 78 percent of

  12. Quality Procedures in the European Higher Education Area and Beyond--Second ENQA Survey. ENQA Occasional Papers 14

    ERIC Educational Resources Information Center

    Costes, Nathalie; Crozier, Fiona; Cullen, Peter; Grifoll, Josep; Harris, Nick; Helle, Emmi; Hopbach, Achim; Kekalainen, Helka; Knezevic, Bozana; Sits, Tanel; Sohm, Kurt

    2008-01-01

    Quality assurance for higher education in Europe has developed significantly since 2002, and has increasingly influenced, and been influenced by, the Bologna Process. A major step in the Bologna Process was taken at the ministerial meeting in Bergen in May 2005, with the adoption of the Standards and Guidelines for Quality Assurance in the…

  13. European Standards for Quality Assurance and Institutional Practices of Student Assessment in the UK, the Netherlands and the Czech Republic

    ERIC Educational Resources Information Center

    Kohoutek, Jan

    2014-01-01

    This article analyses the student assessment procedures of 12 universities in the UK, the Netherlands and the Czech Republic with respect to their alignment with the European standards and guidelines on the quality of assessing higher education students (European Standards and Guidelines for Quality Assurance [ESG] 1.3). Based on qualitative…

  14. Developing cross-sectoral quality assurance for cataract surgery in the statutory quality assurance program of the German health care system: Experiences and lessons learned.

    PubMed

    Bramesfeld, Anke; Pauletzki, Jürgen; Behrenz, Lars; Szecsenyi, Joachim; Willms, Gerald; Broge, Björn

    2015-08-01

    Since 2001, statutory external quality assurance (QA) for hospital care has been in place in the German health system. In 2009, the decision was taken to expand it to cross-sectoral procedures. This novel and unprecedented form of national QA aims at (1) making the quality procedures comparable that are provided both in inpatient and outpatient care, (2) following-up outcomes of hospital care after patients' discharge and (3) measuring the quality of complex treatment chains across interfaces. As a pioneer procedure a QA procedure in cataract surgery QA was developed. Using this as an example, challenges of cross-sectoral QA are highlighted. These challenges relate, in particular, to three technical problems: triggering cases for documentation, following-up patients' after hospital discharge, and the burden of documentation in outpatient care. These problems resulted finally in the haltering of the development of the QA procedure. However, the experiences gained with this first development of cross-sectoral QA inspired the reorientation and further development of the field in Germany. Future cross-sectoral QA will rigorously aim at keeping burden of documentation small. It will draw data for QA mainly at three sources: routine data, patient surveys and peer reviews using indicators. Policy implications of this reorientation are discussed. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. UK key performance indicators and quality assurance standards for colonoscopy.

    PubMed

    Rees, Colin J; Thomas Gibson, Siwan; Rutter, Matt D; Baragwanath, Phil; Pullan, Rupert; Feeney, Mark; Haslam, Neil

    2016-12-01

    Colonoscopy should be delivered by endoscopists performing high quality procedures. The British Society of Gastroenterology, the UK Joint Advisory Group on GI Endoscopy, and the Association of Coloproctology of Great Britain and Ireland have developed quality assurance measures and key performance indicators for the delivery of colonoscopy within the UK. This document sets minimal standards for delivery of procedures along with aspirational targets that all endoscopists should aim for. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

  17. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

  18. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

  19. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

  20. 21 CFR 211.100 - Written procedures; deviations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

  1. t4 Workshop Report*

    PubMed Central

    Bouhifd, Mounir; Beger, Richard; Flynn, Thomas; Guo, Lining; Harris, Georgina; Hogberg, Helena; Kaddurah-Daouk, Rima; Kamp, Hennicke; Kleensang, Andre; Maertens, Alexandra; Odwin-DaCosta, Shelly; Pamies, David; Robertson, Donald; Smirnova, Lena; Sun, Jinchun; Zhao, Liang; Hartung, Thomas

    2017-01-01

    Summary Metabolomics promises a holistic phenotypic characterization of biological responses to toxicants. This technology is based on advanced chemical analytical tools with reasonable throughput, including mass-spectroscopy and NMR. Quality assurance, however – from experimental design, sample preparation, metabolite identification, to bioinformatics data-mining – is urgently needed to assure both quality of metabolomics data and reproducibility of biological models. In contrast to microarray-based transcriptomics, where consensus on quality assurance and reporting standards has been fostered over the last two decades, quality assurance of metabolomics is only now emerging. Regulatory use in safety sciences, and even proper scientific use of these technologies, demand quality assurance. In an effort to promote this discussion, an expert workshop discussed the quality assurance needs of metabolomics. The goals for this workshop were 1) to consider the challenges associated with metabolomics as an emerging science, with an emphasis on its application in toxicology and 2) to identify the key issues to be addressed in order to establish and implement quality assurance procedures in metabolomics-based toxicology. Consensus has still to be achieved regarding best practices to make sure sound, useful, and relevant information is derived from these new tools. PMID:26536290

  2. Ambient Monitoring Technology Information Center (AMTIC)

    EPA Pesticide Factsheets

    This site contains information on ambient air quality monitoring programs, monitoring methods, quality assurance and control procedures, and federal regulations related to ambient air quality monitoring.

  3. QUALITY ASSURANCE STUDY OF MARINE LIPID CLASS DETERMINATION USING CHROMAROD/IATROSCAN( REG. TRADEMARK) THIN-LAYER CHROMATOGRAPHY-FLAME IONIZATION DETECTOR

    EPA Science Inventory

    An Iatroscan thin-layer chromatorgraphy-flame ionization detector has been utilized to quantify lipid classes in marine samples. This method was evaluated relative to established quality assurance (QA) procedures used for the gas chromatographic analysis of PCBs. A method for ext...

  4. QUALITY SYSTEMS AND IMPLEMENTATION PLAN FOR A PILOT STUDY OF CHILDREN'S TOTAL EXPOSURE TO PERSISTENT PESTICIDES AND OTHER PERSISTENT ORGANIC PESTICIDES (CTEPP)

    EPA Science Inventory

    The Quality System Implementation Plan (QSIP) describes the quality assurance and quality control procedures developed for the CTEPP study. It provides the QA/QC procedures used in recruitment of subjects, sample field collection, sample extraction and analysis, data storage, and...

  5. Quality-assurance data for routine water analyses by the U.S. Geological Survey laboratory in Troy, New York - July 2003 through June 2005

    USGS Publications Warehouse

    Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

    2009-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2003 through June 2005. Results for the quality-control samples for 20 analytical procedures were evaluated for bias and precision. Control charts indicate that data for five of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, pH, silicon, and sodium. Seven of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: dissolved organic carbon, chloride, nitrate (ion chromatograph), nitrite, silicon, sodium, and sulfate. The calcium and magnesium procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum and specific conductance procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 17 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 22 analytes. At least 85 percent of the samples met data-quality objectives for all analytes except total monomeric aluminum (82 percent of samples met objectives), total aluminum (77 percent of samples met objectives), chloride (80 percent of samples met objectives), fluoride (76 percent of samples met objectives), and nitrate (ion chromatograph) (79 percent of samples met objectives). The ammonium and total dissolved nitrogen did not meet the data-quality objectives. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality over the time period, with ratings for each sample in the satisfactory, good, and excellent ranges or less than 10 percent error. The P-sample (low-ionic-strength constituents) analysis had one marginal and two unsatisfactory ratings for the chloride procedure. The T-sample (trace constituents)analysis had two unsatisfactory ratings and one high range percent error for the aluminum procedure. The N-sample (nutrient constituents) analysis had one marginal rating for the nitrate procedure. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 84 percent of the samples met data-quality objectives for 11 of the 14 analytes; the exceptions were ammonium, total aluminum, and acid-neutralizing capacity. The ammonium procedure did not meet data quality objectives in all studies. Data-quality objectives were not met in 23 percent of samples analyzed for total aluminum and 45 percent of samples analyzed acid-neutralizing capacity. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 86 percent of the samples analyzed for calcium, chloride, fluoride, magnesium, pH, potassium, sodium, and sulfate. Data-quality objectives were not met by samples analyzed for fluoride. 

  6. Quality Assurance and Control Considerations in Environmental Measurements and Monitoring

    NASA Astrophysics Data System (ADS)

    Sedlet, Jacob

    1982-06-01

    Quality assurance and quality control have become accepted as essential parts of all environmental surveillance, measurements, and monitoring programs, both nuclear and non-nuclear. The same principles and details apply to each. It is primarily the final measurement technique that differs. As the desire and need to measure smaller amounts of pollutants with greater accuracy has increased, it has been recognized that quality assurance and control programs are cost-effective in achieving the expected results. Quality assurance (QA) consists of all the actions necessary to provide confidence in the results. Quality control (QC) is a part of QA, and consists of those actions and activities that permit the control of the individual steps in the environmental program. The distinction between the two terms is not always clearly defined, but a sharp division is not necessary. The essential principle of QA and QC is a commitment to high quality results. The essential components of a QA and QC program are a complete, written procedures manual for all parts of the environmental program, the use of standard or validated procedures, participation in applicable interlaboratory comparison or QA programs, replicate analysis and measurement, training of personnel, and a means of auditing or checking that the QA and QC programs are properly conducted. These components are discussed below in some detail.

  7. Quality-assurance plan for water-quality activities in the North Florida Program Office, Florida District

    USGS Publications Warehouse

    Berndt, Marian P.; Katz, Brian G.

    2000-01-01

    In accordance with guidelines set forth by the Office of Water Quality in the Water Resources Division of the U.S. Geological Survey, a quality-assurance plan was created for use by the Florida District's North Florida Program Office in conducting water-quality activities. This plan documents the standards, policies, and procedures used by the North Florida Program Office for activities related to the collection, processing, storage, analysis, and publication of water-quality data.

  8. [Maintainance of a research tissue bank. (Infra)structural and quality aspects].

    PubMed

    Schmitt, S; Kynast, K; Schirmacher, P; Herpel, E

    2015-11-01

    The availability of high quality human tissue samples and access to associated histopathological and clinical data are essential for biomedical research. Therefore, it is necessary to establish quality assured tissue biobanks that provide high quality tissue samples for research purposes. This entails quality concerns referring not only to the biomaterial specimen itself but encompassing all procedures related to biobanking, including the implementation of structural components, e.g. ethical and legal guidelines, quality management documentation as well as data and project management and information technology (IT) administration. Moreover, an integral aspect of tissue biobanks is the quality assured evaluation of every tissue specimen that is stored in a tissue biobank and used for projects to guarantee high quality assured biomaterial.

  9. 40 CFR 792.35 - Quality assurance unit.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

  10. 40 CFR 792.35 - Quality assurance unit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

  11. 40 CFR 792.35 - Quality assurance unit.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

  12. 40 CFR 792.35 - Quality assurance unit.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

  13. 40 CFR 792.35 - Quality assurance unit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

  14. Development of a framework of quality assurance practices for a radon passive dosemeter service.

    PubMed

    D'Alessandro, M; Leonardi, F; Tonnarini, S; Trevisi, R; Veschetti, M

    2010-06-01

    Etched track detectors are widely used for the detection of radon and its decay products. The reliability of radon measurement performed with such devices requires that laboratories producing analytical data are able to provide results of the required quality. The need for uniform results from laboratories at an international level therefore requires the implementation of a quality assurance programme, the harmonization of criteria, sampling procedures, calculations and the reporting of results, agreed on the basis of fundamental principles and international standards. The quality assurance programme described here is the first step on the way to ISO/IEC 17025 certification for the RI-RN (ISPESL) laboratory.

  15. Laboratory and quality assurance protocols for the analysis of herbicides in ground water from the Management Systems Evaluation Area, Princeton, Minnesota

    USGS Publications Warehouse

    Larson, S.J.; Capel, P.D.; VanderLoop, A.G.

    1996-01-01

    Laboratory and quality assurance procedures for the analysis of ground-water samples for herbicides at the Management Systems Evaluation Area near Princeton, Minnesota are described. The target herbicides include atrazine, de-ethylatrazine, de-isopropylatrazine, metribuzin, alachlor, 2,6-diethylaniline, and metolachlor. The analytical techniques used are solid-phase extraction, and analysis by gas chromatography with mass-selective detection. Descriptions of cleaning procedures, preparation of standard solutions, isolation of analytes from water, sample transfer methods, instrumental analysis, and data analysis are included.

  16. 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

  17. 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.

  18. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and linearity checks (e.g., how gases are to be injected..., and when calibration adjustments should be made). Identify any calibration error test and linearity...

  19. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and linearity checks (e.g., how gases are to be injected..., and when calibration adjustments should be made). Identify any calibration error test and linearity...

  20. 48 CFR 410.002 - Procedures.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ACQUISITION PLANNING MARKET RESEARCH 410.002 Procedures. Market research must include obtaining information on the commercial quality assurance practices as an alternative for Government inspection and testing...

  1. 48 CFR 410.002 - Procedures.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ACQUISITION PLANNING MARKET RESEARCH 410.002 Procedures. Market research must include obtaining information on the commercial quality assurance practices as an alternative for Government inspection and testing...

  2. 48 CFR 410.002 - Procedures.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ACQUISITION PLANNING MARKET RESEARCH 410.002 Procedures. Market research must include obtaining information on the commercial quality assurance practices as an alternative for Government inspection and testing...

  3. 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.

  4. CTEPP STANDARD OPERATING PROCEDURE FOR DETECTION AND QUANTIFICATION OF TARGET ANALYTES BY GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) (SOP-5.24)

    EPA Science Inventory

    This standard operating procedure describes the method used for the determination of target analytes in sample extracts and related quality assurance/quality control sample extracts generated in the CTEPP study.

  5. Performance analysis of a film dosimetric quality assurance procedure for IMRT with regard to the employment of quantitative evaluation methods.

    PubMed

    Winkler, Peter; Zurl, Brigitte; Guss, Helmuth; Kindl, Peter; Stuecklschweiger, Georg

    2005-02-21

    A system for dosimetric verification of intensity-modulated radiotherapy (IMRT) treatment plans using absolute calibrated radiographic films is presented. At our institution this verification procedure is performed for all IMRT treatment plans prior to patient irradiation. Therefore clinical treatment plans are transferred to a phantom and recalculated. Composite treatment plans are irradiated to a single film. Film density to absolute dose conversion is performed automatically based on a single calibration film. A software application encompassing film calibration, 2D registration of measurement and calculated distributions, image fusion, and a number of visual and quantitative evaluation utilities was developed. The main topic of this paper is a performance analysis for this quality assurance procedure, with regard to the specification of tolerance levels for quantitative evaluations. Spatial and dosimetric precision and accuracy were determined for the entire procedure, comprising all possible sources of error. The overall dosimetric and spatial measurement uncertainties obtained thereby were 1.9% and 0.8 mm respectively. Based on these results, we specified 5% dose difference and 3 mm distance-to-agreement as our tolerance levels for patient-specific quality assurance for IMRT treatments.

  6. [Quality assurance in geriatric rehabilitation--approaches and methods].

    PubMed

    Deckenbach, B; Borchelt, M; Steinhagen-Thiessen, E

    1997-08-01

    It did not take the provisions of the 5th Book of the Social Code for quality assurance issues to gain significance in the field of geriatric rehabilitation as well. While in the surgical specialties, experience in particular with external quality assurance have already been gathered over several years now, suitable concepts and methods for the new Geriatric Rehabilitation specialty are still in the initial stages of development. Proven methods from the industrial and service sectors, such as auditing, monitoring and quality circles, can in principle be drawn on for devising geriatric rehabilitation quality assurance schemes; these in particular need to take into account the multiple factors influencing the course and outcome of rehabilitation entailed by multimorbidity and multi-drug use; the eminent role of the social environment; therapeutic interventions by a multidisciplinary team; as well as the multi-dimensional nature of rehabilitation outcomes. Moreover, the specific conditions of geriatric rehabilitation require development not only of quality standards unique to this domain but also of quality assurance procedures specific to geriatrics. Along with a number of other methods, standardized geriatric assessment will play a crucial role in this respect.

  7. 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 determine the quantity of each taxon present in the semi-quantitative samples or to list the taxa present in qualitative samples. The processing guidelines provide standardized laboratory forms, sample labels, detailed sample processing flow charts, standardized format for electronic data, quality-assurance procedures and checks, sample tracking standards, and target levels for taxonomic determinations. The contract laboratory (1) is responsible for identifications and quantifications, (2) constructs reference collections, (3) provides data in hard copy and electronic forms, (4) follows specified quality-assurance and quality-control procedures, and (5) returns all processed and unprocessed portions of the samples. The U.S. Geological Survey's Quality Management Group maintains a Biological Quality-Assurance Unit, located at the National Water-Quality Laboratory, Arvada, Colorado, to oversee the use of contract laboratories and ensure the quality of data obtained from these laboratories according to the guidelines established in this document. This unit establishes contract specifications, reviews contractor performance (timeliness, accuracy, and consistency), enters data into the National Water Information System-II data base, maintains in-house reference collections, deposits voucher specimens in outside museums, and interacts with taxonomic experts within and outside the U.S. Geological Survey. This unit also modifies the existing sample processing and quality-assurance guidelines, establishes criteria and testing procedures for qualifying potential contract laboratories, identifies qualified taxonomic experts, and establishes voucher collections.

  8. Implementation of Programmatic Quality and the Impact on Safety

    NASA Technical Reports Server (NTRS)

    Huls, Dale Thomas; Meehan, Kevin

    2005-01-01

    The purpose of this paper is to discuss the implementation of a programmatic quality assurance discipline within the International Space Station Program and the resulting impact on safety. NASA culture has continued to stress safety at the expense of quality when both are extremely important and both can equally influence the success or failure of a Program or Mission. Although safety was heavily criticized in the media after Colimbiaa, strong case can be made that it was the failure of quality processes and quality assurance in all processes that eventually led to the Columbia accident. Consequently, it is possible to have good quality processes without safety, but it is impossible to have good safety processes without quality. The ISS Program quality assurance function was analyzed as representative of the long-term manned missions that are consistent with the President s Vision for Space Exploration. Background topics are as follows: The quality assurance organizational structure within the ISS Program and the interrelationships between various internal and external organizations. ISS Program quality roles and responsibilities with respect to internal Program Offices and other external organizations such as the Shuttle Program, JSC Directorates, NASA Headquarters, NASA Contractors, other NASA Centers, and International Partner/participants will be addressed. A detailed analysis of implemented quality assurance responsibilities and functions with respect to NASA Headquarters, the JSC S&MA Directorate, and the ISS Program will be presented. Discussions topics are as follows: A comparison of quality and safety resources in terms of staffing, training, experience, and certifications. A benchmark assessment of the lessons learned from the Columbia Accident Investigation (CAB) Report (and follow-up reports and assessments), NASA Benchmarking, and traditional quality assurance activities against ISS quality procedures and practices. The lack of a coherent operational and sustaining quality assurance strategy for long-term manned space flight. An analysis of the ISS waiver processes and the Problem Reporting and Corrective Action (PRACA) process implemented as quality functions. Impact of current ISS Program procedures and practices with regards to operational safety and risk A discussion regarding a "defense-in-depth" approach to quality functions will be provided to address the issue of "integration vs independence" with respect to the roles of Programs, NASA Centers, and NASA Headquarters. Generic recommendations are offered to address the inadequacies identified in the implementation of ISS quality assurance. A reassessment by the NASA community regarding the importance of a "quality culture" as a component within a larger "safety culture" will generate a more effective and value-added functionality that will ultimately enhance safety.

  9. Quality Management Plan for EPA Region 1

    EPA Pesticide Factsheets

    The QMP describes policies, procedures & management systems within EPA NE that govern quality assurance & quality control activities supporting the transparency & scientific defensibility of environmental data collected, used & disseminated by the Region.

  10. 21 CFR 106.90 - Coding.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

  11. 21 CFR 106.90 - Coding.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

  12. 21 CFR 106.90 - Coding.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

  13. Surface-water quality-assurance plan for the U.S. Geological Survey Washington Water Science Center

    USGS Publications Warehouse

    Mastin, Mark C.

    2016-02-19

    This Surface-Water Quality-Assurance Plan documents the standards, policies, and procedures used by the U.S. Geological Survey Washington Water Science Center (WAWSC) for activities related to the collection, processing, storage, analysis, and publication of surface-water data. This plan serves as a guide to all WAWSC personnel involved in surface-water data activities, and changes as the needs and requirements of the WAWSC change. Regular updates to this plan represent an integral part of the quality-assurance process. In the WAWSC, direct oversight and responsibility by the hydrographer(s) assigned to a surface-water station, combined with team approaches in all work efforts, assure highquality data, analyses, reviews, and reports for cooperating agencies and the public.

  14. [Quality management in intensive care medicine].

    PubMed

    Martin, J; Braun, J-P

    2014-02-01

    Treatment of critical ill patients in the intensive care unit is tantamount to well-designed risk or quality management. Several tools of quality management and quality assurance have been developed in intensive care medicine. In addition to external quality assurance by benchmarking with regard to the intensive care medicine, peer review procedures have been established for external quality assurance in recent years. In the process of peer review of an intensive care unit (ICU), external physicians and nurses visit the ICU, evaluate on-site proceedings, and discuss with the managing team of the ICU possibilities for optimization. Furthermore, internal quality management in the ICU is possible based on the 10 quality indicators of the German Interdisciplinary Society for Intensive Care Medicine (DIVI, "Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin"). Thereby every ICU has numerous possibilities to improve their quality management system.

  15. [Quality assurance and quality management in intensive care].

    PubMed

    Notz, K; Dubb, R; Kaltwasser, A; Hermes, C; Pfeffer, S

    2015-11-01

    Treatment success in hospitals, particularly in intensive care units, is directly tied to quality of structure, process, and outcomes. Technological and medical advancements lead to ever more complex treatment situations with highly specialized tasks in intensive care nursing. Quality criteria that can be used to describe and correctly measure those highly complex multiprofessional situations have only been recently developed and put into practice.In this article, it will be shown how quality in multiprofessional teams can be definded and assessed in daily clinical practice. Core aspects are the choice of a nursing theory, quality assurance measures, and quality management. One possible option of quality assurance is the use of standard operating procedures (SOPs). Quality can ultimately only be achieved if professional groups think beyond their boundaries, minimize errors, and establish and live out instructions and SOPs.

  16. [Quality management in intensive care medicine].

    PubMed

    Martin, J; Braun, J-P

    2013-09-01

    Treatment of critical ill patients in the intensive care unit is tantamount to well-designed risk or quality management. Several tools of quality management and quality assurance have been developed in intensive care medicine. In addition to extern quality assurance by benchmarking with regard to the intensive care medicine, peer review procedures have been established for external quality assurance in recent years. In the process of peer review of an intensive care unit (ICU), external physicians and nurses visit the ICU, evaluate on-site proceedings, and discuss with the managing team of the ICU possibilities for optimization. Furthermore, internal quality management in the ICU is possible based on the 10 quality indicators of the German Interdisciplinary Society for Intensive Care Medicine (DIVI, "Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin"). Thereby every ICU has numerous possibilities to improve their quality management system.

  17. Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York-July 1997 through June 1999

    USGS Publications Warehouse

    Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

    2006-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data for the time period addressed in this report were stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality- control samples analyzed from July 1997 through June 1999. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration and (or) low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, ammonium, calcium, chloride, specific conductance, and sulfate. The data from the potassium and sodium analytical procedures are insufficient for evaluation. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 11 of 13 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. Blank analysis results for chloride showed that 22 percent of blanks did not meet data-quality objectives and results for dissolved organic carbon showed that 31 percent of the blanks did not meet data-quality objectives. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 14 of the 18 analytes. At least 90 percent of the samples met data-quality objectives for all analytes except total aluminum (70 percent of samples met objectives) and potassium (83 percent of samples met objectives). Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality for most constituents over the time period. The P-sample (low-ionic-strength constituents) analysis had good ratings in two of these studies and a satisfactory rating in the third. The results of the T-sample (trace constituents) analysis indicated high data quality with good ratings in all three studies. The N-sample (nutrient constituents) studies had one each of excellent, good, and satisfactory ratings. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 80 percent of the samples met data-quality objectives for 9 of the 13 analytes; the exceptions were dissolved organic carbon, ammonium, chloride, and specific conductance. Data-quality objectives were not met for dissolved organic carbon in two NWRI studies, but all of the samples were within control limits for the last study. Data-quality objectives were not met in 41 percent of samples analyzed for ammonium, 25 percent of samples analyzed for chloride, and 30 percent of samples analyzed for specific conductance. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 84 percent of the samples analyzed for calcium, chloride, magnesium, pH, and potassium. Data-quality objectives were met by 73 percent of those analyzed for sulfate. The data-quality objective was not met for sodium. The data are insufficient for evaluation of the specific conductance results.

  18. Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

    PubMed

    Yamanaka, Ashley; Fialkowski, Marie Kainoa; Wilkens, Lynne; Li, Fenfang; Ettienne, Reynolette; Fleming, Travis; Power, Julianne; Deenik, Jonathan; Coleman, Patricia; Leon Guerrero, Rachael; Novotny, Rachel

    2016-09-02

    Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region. Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site. Results were summarized to examine and align the implementation of protocol procedures across diverse settings. Data collection protocols focused on food and physical activity were adhered to closely; however, protocols for handling completed forms and ensuring data security showed more variability. Quality assurance protocols are common in the clinical literature but are limited in multi-site community-based studies, especially in underserved populations. The reduction in the number of QA problems found in the second as compared to the first data collection periods for the intervention study attest to the value of this assessment. This paper can serve as a reference for similar studies wishing to implement quality assurance protocols of the data collection process to preserve data integrity and enhance the validity of study findings. NIH clinical trial #NCT01881373.

  19. Development and implementation of a quality assurance infrastructure in a multisite home visitation program in Ohio and Kentucky.

    PubMed

    Ammerman, Robert T; Putnam, Frank W; Kopke, Jonathan E; Gannon, Thomas A; Short, Jodie A; Van Ginkel, Judith B; Clark, Margaret J; Carrozza, Mark A; Spector, Alan R

    2007-01-01

    As home visitation programs go to scale, numerous challenges are faced in implementation and quality assurance. This article describes the origins and implementation of Every Child Succeeds, a multisite home visitation program in southwestern Ohio and Northern Kentucky. In order to optimize quality assurance and generate new learning for the field, a Web-based system (eECS) was designed to systematically collect and use data. Continuous quality assurance procedures derived from business and industry have been established. Findings from data collection have documented outcomes, and have identified clinical needs that potentially undermine the impact of home visitation. An augmented module approach has been used to address these needs, and a program to treat maternal depression is described as an example of this approach. Challenges encountered are also discussed.

  20. 21 CFR 106.20 - Ingredient control.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis... prepared by the infant formula manufacturer shall be sampled and analyzed for each relied-upon nutrient...

  1. Reaching a Conclusion--Procedures and Processes of Judgement Formation in School Inspection Teams

    ERIC Educational Resources Information Center

    Dedering, Kathrin; Sowada, Moritz G.

    2017-01-01

    School inspections have become an important instrument of quality assurance and quality development in many European countries. So far, the focus of empirical research on school inspections has been on the acceptance of the procedure among the school-internal actors, its influence for internal quality development and its effects on student…

  2. [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.

  3. Quality assurance for kilo- and megavoltage in-room imaging and localization for off- and online setup error correction.

    PubMed

    Balter, James M; Antonuk, Larry E

    2008-01-01

    In-room radiography is not a new concept for image-guided radiation therapy. Rapid advances in technology, however, have made this positioning method convenient, and thus radiograph-based positioning has propagated widely. The paradigms for quality assurance of radiograph-based positioning include imager performance, systems integration, infrastructure, procedure documentation and testing, and support for positioning strategy implementation.

  4. 21 CFR 106.20 - Ingredient control.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

  5. 21 CFR 106.20 - Ingredient control.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

  6. 21 CFR 106.20 - Ingredient control.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

  7. Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York - July 2005 through June 2007

    USGS Publications Warehouse

    Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

    2009-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2005 through June 2007. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: total aluminum, calcium, magnesium, nitrate (colorimetric method), potassium, silicon, sodium, and sulfate. Eight of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: total aluminum, calcium, dissolved organic carbon, chloride, nitrate (ion chromatograph), potassium, silicon, and sulfate. The magnesium and pH procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The acid-neutralizing capacity, total monomeric aluminum, nitrite, and specific conductance procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicated that the procedures for 16 of 17 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 21 analytes. At least 93 percent of the samples met data-quality objectives for all analytes except acid-neutralizing capacity (85 percent of samples met objectives), total monomeric aluminum (83 percent of samples met objectives), total aluminum (85 percent of samples met objectives), and chloride (85 percent of samples met objectives). The ammonium and total dissolved nitrogen did not meet the data-quality objectives. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project met the Troy Laboratory data-quality objectives for 87 percent of the samples analyzed. The P-sample (low-ionic-strength constituents) analysis had two outliers each in two studies. The T-sample (trace constituents) analysis and the N-sample (nutrient constituents) analysis had one outlier each in two studies. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 85 percent of the samples met data-quality objectives for 11 of the 14 analytes; the exceptions were acid-neutralizing capacity, total aluminum and ammonium. Data-quality objectives were not met in 41 percent of samples analyzed for acid-neutralizing capacity, 50 percent of samples analyzed for total aluminum, and 44 percent of samples analyzed for ammonium. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 86 percent of the samples analyzed for calcium, magnesium, pH, potassium, and sodium. Data-quality objectives were met by 76 percent of the samples analyzed for chloride, 80 percent of the samples analyzed for specific conductance, and 77 percent of the samples analyzed for sulfate.

  8. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... in section 2.3 of this appendix and the Hg emission tests described in §§ 75.81(c) and 75.81(d)(4). 1.2Specific Requirements for Continuous Emissions Monitoring Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and...

  9. U.S. Geological Survey Noble Gas Laboratory’s standard operating procedures for the measurement of dissolved gas in water samples

    USGS Publications Warehouse

    Hunt, Andrew G.

    2015-08-12

    This report addresses the standard operating procedures used by the U.S. Geological Survey’s Noble Gas Laboratory in Denver, Colorado, U.S.A., for the measurement of dissolved gases (methane, nitrogen, oxygen, and carbon dioxide) and noble gas isotopes (helium-3, helium-4, neon-20, neon-21, neon-22, argon-36, argon-38, argon-40, kryton-84, krypton-86, xenon-103, and xenon-132) dissolved in water. A synopsis of the instrumentation used, procedures followed, calibration practices, standards used, and a quality assurance and quality control program is presented. The report outlines the day-to-day operation of the Residual Gas Analyzer Model 200, Mass Analyzer Products Model 215–50, and ultralow vacuum extraction line along with the sample handling procedures, noble gas extraction and purification, instrument measurement procedures, instrumental data acquisition, and calculations for the conversion of raw data from the mass spectrometer into noble gas concentrations per unit mass of water analyzed. Techniques for the preparation of artificial dissolved gas standards are detailed and coupled to a quality assurance and quality control program to present the accuracy of the procedures used in the laboratory.

  10. Quality-assurance data for routine water quality analyses by the U. S. Geological Survey laboratory in Troy, New York; July 1993 through June 1995

    USGS Publications Warehouse

    Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

    2001-01-01

    A laboratory for analysis of low-ionic strength water has been developed at the U.S. Geological Survey (USGS) office in Troy, N.Y., to analyze samples collected by USGS projects in the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data are stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of quality-assurance/quality-control data. This report presents and discusses samples analyzed from July 1993 through June 1995. Quality-control results for 18 analytical procedures were evaluated for bias and precision. Control charts show that data from seven of the analytical procedures were biased throughout the analysis period for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, dissolved inorganic carbon, dissolved organic carbon (soil expulsions), chloride, magnesium, nitrate (colorimetric method), and pH. Three of the analytical procedures were occasionally biased but were within control limits; they were: calcium (high for high-concentration samples for May 1995), dissolved organic carbon (high for highconcentration samples from January through September 1994), and fluoride (high in samples for April and June 1994). No quality-control sample has been developed for the organic monomeric aluminum procedure. Results from the filter-blank and analytical-blank analyses indicate that all analytical procedures in which blanks were run were within control limits, although values for a few blanks were outside the control limits. Blanks were not analyzed for acid-neutralizing capacity, dissolved inorganic carbon, fluoride, nitrate (colorimetric method), or pH. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in 14 of the 18 procedures. Data-quality objectives were met by more than 90 percent of the samples analyzed in all procedures except total monomeric aluminum (85 percent of samples met objectives), total aluminum (70 percent of samples met objectives), and dissolved organic carbon (85 percent of samples met objectives). Triplicate samples were not analyzed for ammonium, fluoride, dissolved inorganic carbon, or nitrate (colorimetric method). Results of the USGS interlaboratory Standard Reference Sample Program indicated high data quality with a median result of 3.6 of a possible 4.0. Environment Canada's LRTAP interlaboratory study results indicated that more than 85 percent of the samples met data-quality objectives in 6 of the 12 analyses; exceptions were calcium, dissolved organic carbon, chloride, pH, potassium, and sodium. Data-quality objectives were not met for calcium samples in one LRTAP study, but 94 percent of samples analyzed were within control limits for the remaining studies. Data-quality objectives were not met by 35 percent of samples analyzed for dissolved organic carbon, but 94 percent of sample values were within 20 percent of the most probable value. Data-quality objectives were not met for 30 percent of samples analyzed for chloride, but 90 percent of sample values were within 20 percent of the most probable value. Measurements of samples with a pH above 6.0 were biased high in 54 percent of the samples, although 85 percent of the samples met data-quality objectives for pH measurements below 6.0. Data-quality objectives for potassium and sodium were not met in one study (only 33 percent of the samples analyzed met the objectives), although 85 percent of the sample values were within control limits for the other studies. Measured sodium values were above the upper control limit in all studies. Results from blind reference-sample analyses indicated that data

  11. 16 CFR 1.88 - Implementing procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... efforts to improve environmental quality. He will provide assistance to the staff in determining when an... Competition will supplement these procedures for their Bureaus to assure that every proposed rule and guide is...

  12. 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 severe symptoms associated with chronic treatment-refractory PTSD. Patient satisfaction responses are strongly suggestive of high therapeutic value, and further studies are indicated to determine the effectiveness, duration of action, and optimal treatment regimen.

  13. 21 CFR Appendix E to Subpart A of... - Elements To Be Considered in Developing a Two-Way Alert System

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... what circumstances an alert is required —Standard Operating Procedures (SOP's) —Mechanism of health... mechanisms 3. Enforcement Procedures —Followup mechanisms —Corrective action procedures 4. Quality Assurance...

  14. 21 CFR Appendix E to Subpart A of... - Elements To Be Considered in Developing a Two-Way Alert System

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... what circumstances an alert is required —Standard Operating Procedures (SOP's) —Mechanism of health... mechanisms 3. Enforcement Procedures —Followup mechanisms —Corrective action procedures 4. Quality Assurance...

  15. 21 CFR Appendix E to Subpart A of... - Elements To Be Considered in Developing a Two-Way Alert System

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... what circumstances an alert is required —Standard Operating Procedures (SOP's) —Mechanism of health... mechanisms 3. Enforcement Procedures —Followup mechanisms —Corrective action procedures 4. Quality Assurance...

  16. 21 CFR Appendix E to Subpart A of... - Elements To Be Considered in Developing a Two-Way Alert System

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... what circumstances an alert is required —Standard Operating Procedures (SOP's) —Mechanism of health... mechanisms 3. Enforcement Procedures —Followup mechanisms —Corrective action procedures 4. Quality Assurance...

  17. 40 CFR 58.2 - Purpose.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... data upon which to base national assessments and policy decisions. ... ambient air quality and for reporting ambient air quality data and related information. The monitoring criteria pertain to the following areas: (1) Quality assurance procedures for monitor operation and data...

  18. 21 CFR 820.181 - Device master record.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain... following information: (a) Device specifications including appropriate drawings, composition, formulation... specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality...

  19. 21 CFR 820.181 - Device master record.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain... following information: (a) Device specifications including appropriate drawings, composition, formulation... specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality...

  20. 21 CFR 820.181 - Device master record.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain... following information: (a) Device specifications including appropriate drawings, composition, formulation... specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality...

  1. [Quality assurance systems and occupational medicine system: an history twenty years along].

    PubMed

    Apostoli, Pietro

    2014-01-01

    Along the last tventy years, in our country the quality assurance systems and the occupational medicine deeply interacted both in theoretical and practical fields of interest at three levels: (i) the need of preventive and therefore of occupational medicine in quality assurance systems; (ii) the need on reverse of quality in prevention and occupational mnedicine mainly in qualification and updating process; (iii) the evidence, proofs of efficacy or appropriateness of different preventive procedures and occupational physician activities; (iv) the connection with European and national legal directives and with technical or good practice norms. Finally we discuss about the role of occupational physician as the global consultant for enterprise, as a mandatory strategic technical figure in a typical multidisciplinary processes as the implementation of the quality systems.

  2. 10 CFR 71.111 - Instructions, procedures, and drawings.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Instructions, procedures, and drawings. 71.111 Section 71... MATERIAL Quality Assurance § 71.111 Instructions, procedures, and drawings. The licensee, certificate..., procedures, or drawings of a type appropriate to the circumstances and shall require that these instructions...

  3. Quality control and assurance for validation of DOS/I measurements

    NASA Astrophysics Data System (ADS)

    Cerussi, Albert; Durkin, Amanda; Kwong, Richard; Quang, Timothy; Hill, Brian; Tromberg, Bruce J.; MacKinnon, Nick; Mantulin, William W.

    2010-02-01

    Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials, quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3. Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor, audit and communicate all research procedures (database, teleconferences, training sessions) between participants ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these strategies.

  4. [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.

  5. Comparative analysis of structural concrete quality assurance practices on nine nuclear power plant construction projects. Final report

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

    Willenbrock, J.H.; Thomas, H.R. Jr.; Burati, J.L. Jr.

    1978-06-01

    The basic objective of this research effort was to perform a comparative analysis of the Quality Assurance practices related to the structural concrete phase on nine nuclear power plant projects which are (or have been) under construction in the United States in the past ten years. This analysis identified the response of each Quality Assurance program to the applicable criteria of 10 CFR Part 50, Appendix B as well as to the pertinent regulatory requirements and industry standards. The major emphasis was placed on the construction aspects of the structural concrete phase of each project. The engineering and design aspectsmore » were examined whenever they interfaced with the construction aspects. For those aspects of the Quality Assurance system which can be considered managerial in nature (i.e., organizational relationships, types of Quality Assurance programs, corrective action procedures, etc.) an attempt has been made to present the alternative approaches that were identified. For those aspects of the Quality Assurance system which are technical in nature (i.e., the frequency of testing for slump, compressive strength, etc.) an attempt has been made to present a comparative analysis between projects and in relation to the recommended or mandated practices presented in the appropriate industry codes and standards.« less

  6. 40 CFR 58.2 - Purpose.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... QUALITY SURVEILLANCE General Provisions § 58.2 Purpose. (a) This part contains requirements for measuring ambient air quality and for reporting ambient air quality data and related information. The monitoring criteria pertain to the following areas: (1) Quality assurance procedures for monitor operation and data...

  7. 40 CFR 58.2 - Purpose.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... QUALITY SURVEILLANCE General Provisions § 58.2 Purpose. (a) This part contains requirements for measuring ambient air quality and for reporting ambient air quality data and related information. The monitoring criteria pertain to the following areas: (1) Quality assurance procedures for monitor operation and data...

  8. 40 CFR 58.2 - Purpose.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... QUALITY SURVEILLANCE General Provisions § 58.2 Purpose. (a) This part contains requirements for measuring ambient air quality and for reporting ambient air quality data and related information. The monitoring criteria pertain to the following areas: (1) Quality assurance procedures for monitor operation and data...

  9. 40 CFR 58.2 - Purpose.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... QUALITY SURVEILLANCE General Provisions § 58.2 Purpose. (a) This part contains requirements for measuring ambient air quality and for reporting ambient air quality data and related information. The monitoring criteria pertain to the following areas: (1) Quality assurance procedures for monitor operation and data...

  10. Quality in the Professions.

    ERIC Educational Resources Information Center

    Becher, Tony

    1999-01-01

    Reviews quality assurance and quality control procedures of the main requirements affecting United Kingdom medicine, pharmacy, law, accountancy, architecture, and structural engineering. Provides a taxonomy of different forms of quality maintenance and offers comparative material which may be of interest and relevance to academic readers. (EV)

  11. Enhancing E-Learning Quality through the Application of the AKUE Procedure Model

    ERIC Educational Resources Information Center

    Bremer, C.

    2012-01-01

    The paper describes the procedure model AKUE, which aims at the improvement and assurance of quality and cost efficiency in the context of the introduction of e-learning and the development of digital learning material. AKUE divides the whole planning and implementation process into four different phases: analysis, conception, implementation, and…

  12. 21 CFR 106.20 - Ingredient control.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES (Eff. until 7-10-14) Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106...

  13. NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR FORM QA/QC CHECKS (UA-C-2.0)

    EPA Science Inventory

    The purpose of this SOP is to outline the process of Field Quality Assurance and Quality Control checks. This procedure was followed to ensure consistent data retrieval during the Arizona NHEXAS project and the "Border" study. Keywords: custody; QA/QC; field checks.

    The Nation...

  14. Chemical Reactivity Testing for the National Spent Nuclear Fuel Program. Quality Assurance Project Plan

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

    Newsom, H.C.

    This quality assurance project plan (QAPjP) summarizes requirements used by Lockheed Martin Energy Systems, Incorporated (LMES) Development Division at Y-12 for conducting chemical reactivity testing of Department of Energy (DOE) owned spent nuclear fuel, sponsored by the National Spent Nuclear Fuel Program (NSNFP). The requirements are based on the NSNFP Statement of Work PRO-007 (Statement of Work for Laboratory Determination of Uranium Hydride Oxidation Reaction Kinetics.) This QAPjP will utilize the quality assurance program at Y-12, QA-101PD, revision 1, and existing implementing procedures for the most part in meeting the NSNFP Statement of Work PRO-007 requirements, exceptions will be noted.

  15. 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.

  16. 10 CFR 72.150 - Instructions, procedures, and drawings.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Instructions, procedures, and drawings. 72.150 Section 72... WASTE Quality Assurance § 72.150 Instructions, procedures, and drawings. The licensee, applicant for a... documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall require...

  17. 40 CFR 75.38 - Standard missing data procedures for Hg CEMS.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Standard missing data procedures for...) AIR PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.38 Standard missing data procedures for Hg CEMS. (a) Once 720 quality assured monitor operating hours of Hg...

  18. 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.

  19. Quality assurance procedures for environmental control and monitoring in plant growth facilities. Report of the North Central Regional 101 Committee on Growth Chamber Use

    NASA Technical Reports Server (NTRS)

    Tibbitts, T. W. (Principal Investigator)

    1986-01-01

    This report includes procedures for ensuring the quality of the environment provided for plant growth in controlled environment facilities. Biologists and engineers may use these procedures for ensuring quality control during experiments or for ensuring quality control in the design of plant growth facilities. Environmental monitoring prior to and during experiments is included in these procedures. Specific recommendations cover control, acquisition, and calibration for sensor types for the separate parameters of radiation (light), temperature, humidity, carbon dioxide, and air movement.

  20. European Quality--Adding to the Debate?

    ERIC Educational Resources Information Center

    Birtwistle, Tim

    1996-01-01

    Two pilot programs designed to improve and maintain quality in European higher education are described and compared: an audit of universities' procedures for quality assurance; and an assessment of programs of study, including teaching and learning, student characteristics, staff, facilities, and quality management. Both include institutional…

  1. Experience gained from the application of basic quality assurance procedures in a Greek university engineering department

    NASA Astrophysics Data System (ADS)

    Stamatelos, A. M.

    2010-06-01

    During the last decade, significant funding has become available to Greek public universities to support the convergence to the common European space of higher education. In a number of departments, this funding was wisely invested in the development of a quality culture, covering not only the educational process, but also the services offered by the department's administration and technical support staff. This paper presents the design and implementation of a quality-oriented studies' reform plan in the Mechanical Engineering Department, University of Thessaly in the period 2002-2008. Based on the successful experience from its application, a significant part of the personnel and students have become acquainted with basic quality assurance procedures and performance evaluation. Experience and lessons learnt from this effort are reported and discussed in this paper.

  2. National Ignition Facility quality assurance program plan revision 2

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

    Wolfe, C R

    1998-06-01

    NIF Project activities will be conducted in a manner consistent with the guidance and direction of the DOE Order on Quality Assurance (414.1), the LLNL QA Program, and the Laser Directorate QA Plan. Quality assurance criteria will be applied in a graded manner to achieve a balance between the rigor of application of QA measures and the scale, cost, and complexity of the work involved. Accountability for quality is everyone's, extending from the Project Manager through established lines of authority to all Project personnel, who are responsible for the requisite quality of their own work. The NLF QA Program willmore » be implemented by personnel conducting their activities to meet requirements and expectations, according to established plans and procedures that reflect the way business is to be conducted on the Project.« less

  3. Quality-assurance plan for water-resources activities of the U.S. Geological Survey in Idaho

    USGS Publications Warehouse

    Packard, F.A.

    1996-01-01

    To ensure continued confidence in its products, the Water Resources Division of the U.S. Geological Survey implemented a policy that all its scientific work be performed in accordance with a centrally managed quality-assurance program. This report establishes and documents a formal policy for current (1995) quality assurance within the Idaho District of the U.S. Geological Survey. Quality assurance is formalized by describing district organization and operational responsibilities, documenting the district quality-assurance policies, and describing district functions. The districts conducts its work through offices in Boise, Idaho Falls, Twin Falls, Sandpoint, and at the Idaho National Engineering Laboratory. Data-collection programs and interpretive studies are conducted by two operating units, and operational and technical assistance is provided by three support units: (1) Administrative Services advisors provide guidance on various personnel issues and budget functions, (2) computer and reports advisors provide guidance in their fields, and (3) discipline specialists provide technical advice and assistance to the district and to chiefs of various projects. The district's quality-assurance plan is based on an overall policy that provides a framework for defining the precision and accuracy of collected data. The plan is supported by a series of quality-assurance policy statements that describe responsibilities for specific operations in the district's program. The operations are program planning; project planning; project implementation; review and remediation; data collection; equipment calibration and maintenance; data processing and storage; data analysis, synthesis, and interpretation; report preparation and processing; and training. Activities of the district are systematically conducted under a hierarchy of supervision an management that is designed to ensure conformance with Water Resources Division goals quality assurance. The district quality-assurance plan does not describe detailed technical activities that are commonly termed "quality-control procedures." Instead, it focuses on current policies, operations, and responsibilities that are implemented at the management level. Contents of the plan will be reviewed annually and updated as programs and operations change.

  4. [Strategies and development of quality assurance and control in the ELSA-Brasil].

    PubMed

    Schmidt, Maria Inês; Griep, Rosane Härter; Passos, Valéria Maria; Luft, Vivian Cristine; Goulart, Alessandra Carvalho; Menezes, Greice Maria de Souza; Molina, Maria del Carmen Bisi; Vigo, Alvaro; Nunes, Maria Angélica

    2013-06-01

    The ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a cohort study composed of 15,105 adults followed up in order to assess the development of chronic diseases, especially diabetes and cardiovascular disease. Its size, multicenter nature and the diversity of measurements required effective and efficient mechanisms of quality assurance and control. The main quality assurance activities (those developed before data collection) were: careful selection of research instruments, centralized training and certification, pretesting and pilot studies, and preparation of operation manuals for the procedures. Quality control activities (developed during data collection and processing) were performed more intensively at the beginning, when routines had not been established yet. The main quality control activities were: periodic observation of technicians, test-retest studies, data monitoring, network of supervisors, and cross visits. Data that estimate the reliability of the obtained information attest that the quality goals have been achieved.

  5. The procedures manual of the Environmental Measurements Laboratory. Volume 1, 28. edition

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

    Chieco, N.A.

    1997-02-01

    This manual covers procedures and technology currently in use at the Environmental Measurements Laboratory. An attempt is made to be sure that all work carried out will be of the highest quality. Attention is focused on the following areas: quality assurance; sampling; radiation measurements; analytical chemistry; radionuclide data; special facilities; and specifications.

  6. Data Quality Assurance and Control for AmeriFlux Network at CDIAC, ORNL

    NASA Astrophysics Data System (ADS)

    Shem, W.; Boden, T.; Krassovski, M.; Yang, B.

    2014-12-01

    The Carbon Dioxide Information Analysis Center (CDIAC) at the Oak Ridge National Laboratory (ORNL) serves as the long-term data repository for the AmeriFlux network. Datasets currently available include hourly or half-hourly meteorological and flux observations, biological measurement records, and synthesis data products. Currently there is a lack of standardized nomenclature and specifically designed procedures for data quality assurance/control in processing and handling micrometeorological and ecological data at individual flux sites. CDIAC's has bridged this gap by providing efficient and accurate procedures for data quality control and standardization of the results for easier assimilation by the models used in climate science. In this presentation we highlight the procedures we have put in place to scrutinize continuous flux and meteorological data within Ameriflux network. We itemize some basic data quality issues that we have observed over the past years and include some examples of typical data quality issues. Such issues, e.g., incorrect time-stamping, poor calibration or maintenance of instruments, missing or incomplete metadata and others that are commonly over-looked by PI's, invariably impact the time-series observations.

  7. 40 CFR 98.425 - Procedures for estimating missing data.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 21 2011-07-01 2011-07-01 false Procedures for estimating missing data... estimating missing data. (a) Whenever the quality assurance procedures in § 98.424(a)(1) of this subpart... following missing data procedures shall be followed: (1) A quarterly CO2 mass flow or volumetric flow value...

  8. 40 CFR 98.425 - Procedures for estimating missing data.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Procedures for estimating missing data... estimating missing data. (a) Whenever the quality assurance procedures in § 98.424(a) of this subpart cannot... following missing data procedures shall be followed: (1) A quarterly CO2 mass flow or volumetric flow value...

  9. 40 CFR 98.425 - Procedures for estimating missing data.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 21 2014-07-01 2014-07-01 false Procedures for estimating missing data... estimating missing data. (a) Whenever the quality assurance procedures in § 98.424(a)(1) of this subpart... following missing data procedures shall be followed: (1) A quarterly CO2 mass flow or volumetric flow value...

  10. 40 CFR 98.425 - Procedures for estimating missing data.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 22 2013-07-01 2013-07-01 false Procedures for estimating missing data... estimating missing data. (a) Whenever the quality assurance procedures in § 98.424(a)(1) of this subpart... following missing data procedures shall be followed: (1) A quarterly CO2 mass flow or volumetric flow value...

  11. 40 CFR 98.425 - Procedures for estimating missing data.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Procedures for estimating missing data... estimating missing data. (a) Whenever the quality assurance procedures in § 98.424(a)(1) of this subpart... following missing data procedures shall be followed: (1) A quarterly CO2 mass flow or volumetric flow value...

  12. 77 FR 56178 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-12

    ... programs. FSIS will use the PEPRL-F-0008-04 form as a self assessment audit checklist to collect information related to the quality assurance/quality control procedures in place at in-plant and private...

  13. Summary of EPA Emission Test Methods

    EPA Pesticide Factsheets

    This document provides the publication date and rule status for the air emission test methods, performance specifications and quality assurance procedures. It is updated by the Measurement Technology Group, part of the Air Quality Assessment Div., OAQPS.

  14. EPA Geospatial Quality Council Promoting Quality Assurance in the Geospatial Coummunity

    EPA Science Inventory

    After establishing a foundation for the EPA National Geospatial Program, the EPA Geospatial Quality Council (GQC) is, in part, focusing on improving administrative efficiency in the geospatial community. To realize this goal, the GQC is developing Standard Operating Procedures (S...

  15. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.733 Section 58.733... Procedures § 58.733 Quality control tests. (a) Chemical analyses. The following chemical analyses shall be... pasteurization by means of the phosphatase test, as well as any other tests necessary to assure good quality...

  16. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality control tests. 58.733 Section 58.733... Procedures § 58.733 Quality control tests. (a) Chemical analyses. The following chemical analyses shall be... pasteurization by means of the phosphatase test, as well as any other tests necessary to assure good quality...

  17. Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P).

    PubMed

    Ventura, J; Liberman, R P; Green, M F; Shaner, A; Mintz, J

    1998-06-15

    Accuracy in psychiatric diagnosis is critical for evaluating the suitability of the subjects for entry into research protocols and for establishing comparability of findings across study sites. However, training programs in the use of diagnostic instruments for research projects are not well systematized. Furthermore, little information has been published on the maintenance of interrater reliability of diagnostic assessments. At the UCLA Research Center for Major Mental Illnesses, a Training and Quality Assurance Program for SCID interviewers was used to evaluate interrater reliability and diagnostic accuracy. Although clinically experienced interviewers achieved better interrater reliability and overall diagnostic accuracy than neophyte interviewers, both groups were able to achieve and maintain high levels of interrater reliability, diagnostic accuracy, and interviewer skill. At the first quality assurance check after training, there were no significant differences between experienced and neophyte interviewers in interrater reliability or diagnostic accuracy. Standardization of training and quality assurance procedures within and across research projects may make research findings from study sites more comparable.

  18. 40 CFR 75.35 - Missing data procedures for CO2.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Missing data procedures for CO2. 75.35... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

  19. 40 CFR 75.35 - Missing data procedures for CO2.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Missing data procedures for CO2. 75.35... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

  20. 40 CFR 75.35 - Missing data procedures for CO 2.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Missing data procedures for CO 2. 75... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

  1. 40 CFR 75.35 - Missing data procedures for CO2.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 17 2012-07-01 2012-07-01 false Missing data procedures for CO2. 75.35... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

  2. 40 CFR 98.35 - Procedures for estimating missing data.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 21 2014-07-01 2014-07-01 false Procedures for estimating missing data... Procedures for estimating missing data. Whenever a quality-assured value of a required parameter is... substitute data value for the missing parameter shall be used in the calculations. (a) For all units subject...

  3. 40 CFR 98.35 - Procedures for estimating missing data.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 22 2013-07-01 2013-07-01 false Procedures for estimating missing data... Procedures for estimating missing data. Whenever a quality-assured value of a required parameter is... substitute data value for the missing parameter shall be used in the calculations. (a) For all units subject...

  4. 40 CFR 98.35 - Procedures for estimating missing data.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Procedures for estimating missing data... Procedures for estimating missing data. Whenever a quality-assured value of a required parameter is... substitute data value for the missing parameter shall be used in the calculations. (a) For all units subject...

  5. 40 CFR 98.35 - Procedures for estimating missing data.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Procedures for estimating missing data... Procedures for estimating missing data. Whenever a quality-assured value of a required parameter is... substitute data value for the missing parameter shall be used in the calculations. (a) For all units subject...

  6. 40 CFR 98.35 - Procedures for estimating missing data.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 21 2011-07-01 2011-07-01 false Procedures for estimating missing data... Procedures for estimating missing data. Whenever a quality-assured value of a required parameter is... substitute data value for the missing parameter shall be used in the calculations. (a) For all units subject...

  7. 40 CFR 75.35 - Missing data procedures for CO 2.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 17 2014-07-01 2014-07-01 false Missing data procedures for CO 2. 75... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

  8. Near patient testing in general practice: attitudes of general practitioners and practice nurses, and quality assurance procedures carried out.

    PubMed Central

    Hilton, S; Rink, E; Fletcher, J; Sibbald, B; Freeling, P; Szczepura, A; Davies, C; Stilwell, J

    1994-01-01

    BACKGROUND. The evaluation of near patient testing in British general practice has largely been confined to studies examining individual tests or comparing equipment. AIM. This study set out to determine the attitudes of practice staff to near patient testing, and the extent to which staff undertook quality assessment. METHOD. Four types of near patient testing machines were introduced into 12 general practices in two regions of England, south west Thames and west Midlands. General practitioner and practice nurse attitudes to near patient testing were assessed by semi-structured interview before and six months after the introduction of the machines. The extent to which routine quality assurance procedures were carried out within the surgery and as part of local and national schemes was examined. RESULTS. Although 80% of general practitioners anticipated changing patient management with near patient testing, only two fifths reported having done so after six months. Nurses generally were enthusiastic at the outset, although one third were unhappy about incorporating near patient testing into their work schedules. Time pressure was the most important factor restricting uptake of near patient testing. Nurses performed quality control regularly but complete local external quality assurance procedures were established in only half the practices. All the practices participated in a national scheme for cholesterol assays. CONCLUSION. General practitioners in this study did not find near patient testing a very useful addition to their resources. Pressure on nurses' time was the most frequently reported limitation. PMID:7748669

  9. A method of setting limits for the purpose of quality assurance

    NASA Astrophysics Data System (ADS)

    Sanghangthum, Taweap; Suriyapee, Sivalee; Kim, Gwe-Ya; Pawlicki, Todd

    2013-10-01

    The result from any assurance measurement needs to be checked against some limits for acceptability. There are two types of limits; those that define clinical acceptability (action limits) and those that are meant to serve as a warning that the measurement is close to the action limits (tolerance limits). Currently, there is no standard procedure to set these limits. In this work, we propose an operational procedure to set tolerance limits and action limits. The approach to establish the limits is based on techniques of quality engineering using control charts and a process capability index. The method is different for tolerance limits and action limits with action limits being categorized into those that are specified and unspecified. The procedure is to first ensure process control using the I-MR control charts. Then, the tolerance limits are set equal to the control chart limits on the I chart. Action limits are determined using the Cpm process capability index with the requirements that the process must be in-control. The limits from the proposed procedure are compared to an existing or conventional method. Four examples are investigated: two of volumetric modulated arc therapy (VMAT) point dose quality assurance (QA) and two of routine linear accelerator output QA. The tolerance limits range from about 6% larger to 9% smaller than conventional action limits for VMAT QA cases. For the linac output QA, tolerance limits are about 60% smaller than conventional action limits. The operational procedure describe in this work is based on established quality management tools and will provide a systematic guide to set up tolerance and action limits for different equipment and processes.

  10. 40 CFR Appendix K to Part 75 - Quality Assurance and Operating Procedures for Sorbent Trap Monitoring Systems

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... until the leak check is passed. Post-test leak check ≤4% of average sampling rate After sampling ** See... the test site. The sorbent media must be obtained from a source that can demonstrate the quality...-traceable calibration gas standards and reagents shall be used for the tests and procedures required under...

  11. U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR FORM QA AND QC CHECKS (UA-C-2.0)

    EPA Science Inventory

    The purpose of this SOP is to outline the process of field quality assurance and quality control checks. This procedure was followed to ensure consistent data retrieval during the Arizona NHEXAS project and the Border study. Keywords: custody; QA/QC; field checks.

    The U.S.-Mex...

  12. 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).

  13. [5th Report of the German Association of Cardiologists in Private Practice (BNK) on Quality Assurance in Cardiac Catheterization and Coronary Intervention 2003-2005].

    PubMed

    Levenson, B; Albrecht, A; Göhring, St; Haerer, W; Herholz, H; Reifart, N; Sauer, G; Troger, B

    2007-02-01

    On behalf of the German Association of Cardiologists in Private Practice (BNK) the Steering Committee of the QuIK Registry reports on the results of the voluntary quality assurance in invasive cardiology in 2003-2005 and compares it to other data collections. In 2005 more than 70% of diagnostic (LHK) and 78% of therapeutic (PCI) cardiac catheterization procedures in private practice were entered into the registry. Altogether 229,462 LHK and 64,818 PCI were documented over the 3 years. In the reported period age of patients, percentage of acute coronary syndromes and three-vessel coronary artery disease increased in LHK as well as in PCI while consumption of contrast media and fluoroscopy time decreased. By implemented possibility of follow-up, a high rate of external auditing (monitoring) and certification QuIK remains a worldwide unique quality assurance project in cardiology. On a stable data basis over 10 years the QuIK Registry enables the implementation of quality indicators for future quality assurance purposes.

  14. 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.

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

    Sailer, S.J.

    This Quality Assurance Project Plan (QAPJP) specifies the quality of data necessary and the characterization techniques employed at the Idaho National Engineering Laboratory (INEL) to meet the objectives of the Department of Energy (DOE) Waste Isolation Pilot Plant (WIPP) Transuranic Waste Characterization Quality Assurance Program Plan (QAPP) requirements. This QAPJP is written to conform with the requirements and guidelines specified in the QAPP and the associated documents referenced in the QAPP. This QAPJP is one of a set of five interrelated QAPjPs that describe the INEL Transuranic Waste Characterization Program (TWCP). Each of the five facilities participating in the TWCPmore » has a QAPJP that describes the activities applicable to that particular facility. This QAPJP describes the roles and responsibilities of the Idaho Chemical Processing Plant (ICPP) Analytical Chemistry Laboratory (ACL) in the TWCP. Data quality objectives and quality assurance objectives are explained. Sample analysis procedures and associated quality assurance measures are also addressed; these include: sample chain of custody; data validation; usability and reporting; documentation and records; audits and 0385 assessments; laboratory QC samples; and instrument testing, inspection, maintenance and calibration. Finally, administrative quality control measures, such as document control, control of nonconformances, variances and QA status reporting are described.« less

  16. Writing standard operating procedures (SOPs) for cryostorage protocols: using shoot meristem cryopreservation as an example.

    PubMed

    Harding, Keith; Benson, Erica E

    2015-01-01

    Standard operating procedures are a systematic way of making sure that biopreservation processes, tasks, protocols, and operations are correctly and consistently performed. They are the basic documents of biorepository quality management systems and are used in quality assurance, control, and improvement. Methodologies for constructing workflows and writing standard operating procedures and work instructions are described using a plant cryopreservation protocol as an example. This chapter is pertinent to other biopreservation sectors because how methods are written, interpreted, and implemented can affect the quality of storage outcomes.

  17. 49 CFR 179.7 - Quality assurance program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... means to detect any nonconformity in the manufacturing, repair, inspection, testing, and qualification... quality control personnel. (3) Procedures to ensure that the latest applicable drawings, design calculations, specifications, and instructions are used in manufacture, inspection, testing, and repair. (4...

  18. Report: Quality Control Review of EPA OIG Reports Issued in Fiscal Year 2015

    EPA Pesticide Factsheets

    Report #16-N-0223, July 18, 2016. OIG reports issued in FY 2015 demonstrated high levels of compliance with OIG quality assurance procedures, and received average compliance scores of 90 percent or greater.

  19. VERIFICATION TESTING OF AIR POLLUTION CONTROL TECHNOLOGY QUALITY MANAGEMENT PLAN

    EPA Science Inventory

    This document is the basis for quality assurance for the Air Pollution Control Technology Verification Center (APCT Center) operated under the U.S. Environmental Protection Agency (EPA). It describes the policies, organizational structure, responsibilities, procedures, and qualit...

  20. Framework for the quality assurance of 'omics technologies considering GLP requirements.

    PubMed

    Kauffmann, Hans-Martin; Kamp, Hennicke; Fuchs, Regine; Chorley, Brian N; Deferme, Lize; Ebbels, Timothy; Hackermüller, Jörg; Perdichizzi, Stefania; Poole, Alan; Sauer, Ursula G; Tollefsen, Knut E; Tralau, Tewes; Yauk, Carole; van Ravenzwaay, Ben

    2017-12-01

    'Omics technologies are gaining importance to support regulatory toxicity studies. Prerequisites for performing 'omics studies considering GLP principles were discussed at the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Workshop Applying 'omics technologies in Chemical Risk Assessment. A GLP environment comprises a standard operating procedure system, proper pre-planning and documentation, and inspections of independent quality assurance staff. To prevent uncontrolled data changes, the raw data obtained in the respective 'omics data recording systems have to be specifically defined. Further requirements include transparent and reproducible data processing steps, and safe data storage and archiving procedures. The software for data recording and processing should be validated, and data changes should be traceable or disabled. GLP-compliant quality assurance of 'omics technologies appears feasible for many GLP requirements. However, challenges include (i) defining, storing, and archiving the raw data; (ii) transparent descriptions of data processing steps; (iii) software validation; and (iv) ensuring complete reproducibility of final results with respect to raw data. Nevertheless, 'omics studies can be supported by quality measures (e.g., GLP principles) to ensure quality control, reproducibility and traceability of experiments. This enables regulators to use 'omics data in a fit-for-purpose context, which enhances their applicability for risk assessment. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. 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.

  2. 46 CFR 160.132-13 - Approval inspections and tests for prototype davits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... reviewed under § 160.132-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.132-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...

  3. 46 CFR 160.115-13 - Approval inspections and tests for prototype winches.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... reviewed under § 160.115-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.115-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...

  4. 46 CFR 160.115-13 - Approval inspections and tests for prototype winches.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... reviewed under § 160.115-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.115-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...

  5. 46 CFR 160.115-13 - Approval inspections and tests for prototype winches.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... reviewed under § 160.115-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.115-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...

  6. 46 CFR 160.132-13 - Approval inspections and tests for prototype davits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... reviewed under § 160.132-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.132-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...

  7. 46 CFR 160.132-13 - Approval inspections and tests for prototype davits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... reviewed under § 160.132-9 of this subpart; and (C) When welding is part of the construction process, is constructed by the welding procedure and materials as per the plans reviewed under § 160.132-9 of this subpart and the welders are appropriately qualified; (ii) Assuring that the quality-assurance program of the...

  8. Saturn S-2 quality assurance techniques: Nondestructive testing processes. Volume 1: Requirements and procedures

    NASA Technical Reports Server (NTRS)

    Eller, H. H.; Sugg, F. E.

    1970-01-01

    The methods and procedures used to perform nondestructive testing inspections of the Saturn S-2 liquid hydrogen and liquid oxygen tank weldments during fabrication and after proof testing are described to document special skills developed during the program. All post-test inspection requirements are outlined including radiographic inspections procedures.

  9. [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)

  10. Quality assurance software inspections at NASA Ames: Metrics for feedback and modification

    NASA Technical Reports Server (NTRS)

    Wenneson, G.

    1985-01-01

    Software inspections are a set of formal technical review procedures held at selected key points during software development in order to find defects in software documents--is described in terms of history, participants, tools, procedures, statistics, and database analysis.

  11. 48 CFR 41.202 - Procedures.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... and/or distribution service, quality assurance, system reliability, system operation and maintenance... CONTRACTING ACQUISITION OF UTILITY SERVICES Acquiring Utility Services 41.202 Procedures. (a) Prior to executing a utility service contract, the contracting officer shall comply with parts 6 and 7 and 41.201 (d...

  12. NHEXAS PHASE I ARIZONA STUDY--LIST OF STANDARD OPERATING PROCEDURES

    EPA Science Inventory

    This document lists available protocols and SOPs for the NHEXAS Phase I Arizona study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis, (3) General laboratory procedures, (4) Quality Assurance, (...

  13. Implementation of 350-2500 nm diffuse reflectance spectroscopy and High-Performance Thin-Layer Chromatography to rapidly assess manufacturing consistency and quality of cotrimoxazole tablets in Tanzania.

    PubMed

    Kaale, Eliangiringa; Hope, Samuel M; Jenkins, David; Layloff, Thomas

    2016-01-01

    To assess the quality of cotrimoxazole tablets produced by a Tanzanian manufacturer by a newly instituted quality assurance programme. Tablets underwent a diffuse reflectance spectroscopy procedure with periodic quality assessment confirmation by assay and dissolution testing using validated HPTLC techniques (including weight variation and disintegration evaluations). Based on results from the primary test methods, the first group of product was <80% compliant, whereas subsequent groups reached >99% compliance. This approach provides a model for rapidly assuring product quality of future procurements of other products that is more cost-effective than traditional pharmaceutical testing techniques. © 2015 John Wiley & Sons Ltd.

  14. INTERIM GUIDANCE FOR DEVELOPING GLOBAL POSITIONING SYSTEM DATA COLLECTION STANDARD OPERATING PROCEDURES AND QUALITY ASSURANCE PROJECT PLANS

    EPA Science Inventory

    The United States Environmental Protection Agency Geospatial Quality Council developed this document to harmonize the process of collecting, editing, and exporting spatial data of known quality using the Global Positioning System (GPS). Each organizational entity may adopt this d...

  15. Development of a quality control test procedure for characterizing fracture properties of asphalt mixtures.

    DOT National Transportation Integrated Search

    2011-06-01

    The main objective of this study is to investigate the use of the semi-circular bend (SCB) : test as a quality assurance/quality control (QA/QC) measure for field construction. : Comparison of fracture properties from the SCB test and fatigue beam te...

  16. Eliminating Bias

    EPA Pesticide Factsheets

    Learn how to eliminate bias from monitoring systems by instituting appropriate installation, operation, and quality assurance procedures. Provides links to download An Operator's Guide to Eliminating Bias in CEM Systems.

  17. 48 CFR 46.000 - Scope of part.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Section 46.000 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE 46.000 Scope of part. This part prescribes policies and procedures to ensure that supplies and services acquired under Government contract conform to the contract's quality and quantity...

  18. Guidebook: Quality Assurance/Quality Control Procedures for Submission of Data for the Land Disposal Restrictions (LDR) Program

    EPA Pesticide Factsheets

    This document explains how to generate data which characterizes the performance of hazardous waste treatment systems in terms of the composition of treated hazardous waste streams plus treatment system operation and design.

  19. Quality assurance for respiratory care services: a computer-assisted program.

    PubMed

    Elliott, C G

    1993-01-01

    At present, the principal advantage of computer-assisted quality assurance is the acquisition of quality assurance date without resource-consuming chart reviews. A surveillance program like the medical director's alert may reduce morbidity and mortality. Previous research suggests that inadequate oxygen therapy or failures in airway management are important causes of preventable deaths in hospitals. Furthermore, preventable deaths tend to occur among patients who have lower severity-of-illness scores and who are not in ICUs. Thus, surveillance of the entire hospital, as performed by the HIS medical director's alert, may significantly impact hospital mortality related to respiratory care. Future research should critically examine the potential of such computerized systems to favorably change the morbidity and mortality of hospitalized patients. The departments of respiratory care and medical informatics at LDS Hospital have developed a computer-assisted approach to quality assurance monitoring of respiratory care services. This system provides frequent and consistent samples of a variety of respiratory care data. The immediate needs of patients are addressed through a daily surveillance system (medical director's alert). The departmental quality assurance program utilizes a separate program that monitors clinical indicators of staff performance in terms of stated departmental policies and procedures (rate-based clinical indicators). The availability of an integrated patient database allows these functions to be performed without labor-intensive chart audits.

  20. 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

  1. State of Technology for Renewal of Sewer Force Mains

    EPA Science Inventory

    This paper presents the results of a review of the state of technology for renewal of force mains (EPA, 2010). The review identified several needs, including the need for rational and common design approaches for rehabilitation systems, quality assurance/quality control procedur...

  2. Current standards for infection control: audit assures compliance.

    PubMed

    Flanagan, Pauline

    Having robust policies and procedures in place for infection control is fundamentally important. However, each organization has to go a step beyond this; evidence has to be provided that these policies and procedures are followed. As of 1 April 2009, with the introduction of the Care Quality Commission and The Health and Social Care Act 2008 Code of Practice for the NHS on the Prevention and Control of Healthcare-Associated Infections and Related Guidance, the assurance of robust infection control measures within any UK provider of health care became an even higher priority. Also, the commissioning of any service by the NHS must provide evidence that the provider has in place robust procedures for infection control. This article demonstrates how the clinical audit team at the Douglas Macmillan Hospice in North Staffordshire, UK, have used audit to assure high rates of compliance with the current national standards for infection control. Prior to the audit, hospice staff had assumed that the rates of compliance for infection control approached 100%. This article shows that a good quality audit tool can be used to identify areas of shortfall in infection control and the effectiveness of putting in place an action plan followed by re-audit.

  3. MO-A-16A-01: QA Procedures and Metrics: In Search of QA Usability

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

    Sathiaseelan, V; Thomadsen, B

    Radiation therapy has undergone considerable changes in the past two decades with a surge of new technology and treatment delivery methods. The complexity of radiation therapy treatments has increased and there has been increased awareness and publicity about the associated risks. In response, there has been proliferation of guidelines for medical physicists to adopt to ensure that treatments are delivered safely. Task Group recommendations are copious, and clinical physicists' hours are longer, stretched to various degrees between site planning and management, IT support, physics QA, and treatment planning responsibilities.Radiation oncology has many quality control practices in place to ensure themore » delivery of high-quality, safe treatments. Incident reporting systems have been developed to collect statistics about near miss events at many radiation oncology centers. However, tools are lacking to assess the impact of these various control measures. A recent effort to address this shortcoming is the work of Ford et al (2012) who recently published a methodology enumerating quality control quantification for measuring the effectiveness of safety barriers. Over 4000 near-miss incidents reported from 2 academic radiation oncology clinics were analyzed using quality control quantification, and a profile of the most effective quality control measures (metrics) was identified.There is a critical need to identify a QA metric to help the busy clinical physicists to focus their limited time and resources most effectively in order to minimize or eliminate errors in the radiation treatment delivery processes. In this symposium the usefulness of workflows and QA metrics to assure safe and high quality patient care will be explored.Two presentations will be given:Quality Metrics and Risk Management with High Risk Radiation Oncology ProceduresStrategies and metrics for quality management in the TG-100 Era Learning Objectives: Provide an overview and the need for QA usability metrics: Different cultures/practices affecting the effectiveness of methods and metrics. Show examples of quality assurance workflows, Statistical process control, that monitor the treatment planning and delivery process to identify errors. To learn to identify and prioritize risks and QA procedures in radiation oncology. Try to answer the question: Can a quality assurance program aided by quality assurance metrics help minimize errors and ensure safe treatment delivery. Should such metrics be institution specific.« less

  4. 76 FR 77739 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts and New Hampshire...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-14

    ... in EPA's Air Quality System (AQS) database. To account for missing data, the procedures found in... determination is based upon complete, certified, quality-assured ambient air quality monitoring data for the... proposing? II. What is the background for this proposed action? III. What is EPA's analysis of data for...

  5. NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE--NHEXAS FILTER HANDLING, WEIGHING AND ARCHIVING PROCEDURES FOR AEROSOL SAMPLES (RTI/ACS-AP-209-011)

    EPA Science Inventory

    This protocol describes the procedures for weighing, handling, and archiving aerosol filters and for managing the associated analytical and quality assurance data. Filter samples were weighed for aerosol mass at RTI laboratory, with only the automated field sampling data transfer...

  6. Critical Issues That Need to Be Addressed to Improve Outcomes for Patients With Carotid Stenosis.

    PubMed

    Abbott, Anne

    2016-05-01

    Significant improvement in outcomes for patients with carotid stenosis requires liberation from the historic fixation with randomization and a procedurally based, late-stage, reactive approach to medical care. We require a multipronged and multidisciplinary approach that includes all of the following: (i) removal of overreliance on, and biased use of, randomized trial data; (ii) using accurate ways to rank evidence quality and relevance; (iii) improved research reporting standards; (iv) building quality assurance and other research capability into routine practice; (v) producing evidence-true rather than evidence-based guidelines; (vi) bringing current optimal medical treatment to the community and measuring its effectiveness; (vii) funding only interventions known to help patients when and where they are treated and use the savings to fund vital research, including quality assurance in routine practice; and (viii) recognize that making the indication for carotid procedures obsolete is a good thing. © The Author(s) 2016.

  7. Lageos assembly operation plan

    NASA Technical Reports Server (NTRS)

    Brueger, J.

    1975-01-01

    Guidelines and constraints procedures for LAGEOS assembly, operation, and design performance are given. Special attention was given to thermal, optical, and dynamic analysis and testing. The operation procedures illustrate the interrelation and sequence of tasks in a flow diagram. The diagram also includes quality assurance functions for verification of operation tasks.

  8. 40 CFR 75.70 - NOX mass emissions provisions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... applicable quality assurance requirements of those appendices. (f) Missing data procedures. Except as... owner or operator using a continuous emissions monitoring system, substitute for missing data in accordance with the applicable missing data procedures in §§ 75.31 through 75.37 whenever the unit combusts...

  9. 40 CFR 75.70 - NOX mass emissions provisions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... applicable quality assurance requirements of those appendices. (f) Missing data procedures. Except as... owner or operator using a continuous emissions monitoring system, substitute for missing data in accordance with the applicable missing data procedures in §§ 75.31 through 75.37 whenever the unit combusts...

  10. 40 CFR 75.70 - NOX mass emissions provisions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... applicable quality assurance requirements of those appendices. (f) Missing data procedures. Except as... owner or operator using a continuous emissions monitoring system, substitute for missing data in accordance with the applicable missing data procedures in §§ 75.31 through 75.37 whenever the unit combusts...

  11. 21 CFR 225.165 - Equipment cleanout procedures.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Equipment cleanout procedures. 225.165 Section 225.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Assurance § 225...

  12. 40 CFR 63.2382 - What notifications must I submit and when and what information should be submitted?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... sampling and analysis procedures and quality assurance procedures. (iii) Descriptions of monitoring devices... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS... compliance assessments, inspections and repairs, and calculations used to demonstrate initial compliance...

  13. [Evaluation of quality of HIV diagnostic procedures in Poland].

    PubMed

    Parczewski, Miłosz; Madaliński, Kazimierz; Leszczyszyn-Pynka, Magdalena; Boroń-Kaczmarska, Anna

    2010-01-01

    The aim of this work was quality assessment of HIV diagnostic procedures in Poland, including human and technical resources as well as laboratory practice. Sixty questionnaires were distributed among diagnostic centers to obtain qualitative data. Basing on the survey data serological control using coded panels of HIV-1/2 samples was performed. Thirty-one filled questionnaires were received (50.8%). Surveyed laboratories perform from 350 to 5500 serological screening tests per year. In most of laboratories fourth generation assays are available, while Blood Donation Centers screen the blood both with serological assays and by HIV-RNA detection. Sanitary and Epidemiological Stations and academic laboratories hold the ISO/IEC 17025 or IS0 9001:2001 accreditation, five of the surveyed centers participate in Labquality assurance and two in Quality Control in Molecular Diagnostics programs. Data of control serological testing were received from 21 centers. In the quality control assessment 194 analyses were performed with 91 true negative, 2 false negative, 96 true positive and 5 false positive results. False negative rate of % and false positive rate of 5.2% was noted for this study. Currently, virtually no guidelines related to the HIV-diagnostics quality assurance and control in Poland are in delineated. Development of the national unified quality control system, basing on the central institution is highly desirable. National certification within the frames of the quality control and assurance program should be mandatory for all the diagnostic labs, and aim at improvement of reliability of the result distributed among clinicians and patients.

  14. The World Optical Depth Research and Calibration Center (WORCC) quality assurance and quality control of GAW-PFR AOD measurements

    NASA Astrophysics Data System (ADS)

    Kazadzis, Stelios; Kouremeti, Natalia; Nyeki, Stephan; Gröbner, Julian; Wehrli, Christoph

    2018-02-01

    The World Optical Depth Research Calibration Center (WORCC) is a section within the World Radiation Center at Physikalisches-Meteorologisches Observatorium (PMOD/WRC), Davos, Switzerland, established after the recommendations of the World Meteorological Organization for calibration of aerosol optical depth (AOD)-related Sun photometers. WORCC is mandated to develop new methods for instrument calibration, to initiate homogenization activities among different AOD networks and to run a network (GAW-PFR) of Sun photometers. In this work we describe the calibration hierarchy and methods used under WORCC and the basic procedures, tests and processing techniques in order to ensure the quality assurance and quality control of the AOD-retrieved data.

  15. 40 CFR 63.10 - Recordkeeping and reporting requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... alternative reporting arrangements, in advance, with the permitting authority in that State. Procedures... manufacturer(s) and model number(s); (G) The date of the latest CMS certification or audit; (H) The total..., nonmonitoring equipment malfunctions, quality assurance/quality control calibrations, other known causes, and...

  16. 40 CFR 96.172 - Out of control periods.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

  17. 40 CFR 96.172 - Out of control periods.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

  18. 40 CFR 96.172 - Out of control periods.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

  19. 40 CFR 96.172 - Out of control periods.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

  20. 40 CFR 96.172 - Out of control periods.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

  1. 40 CFR 96.372 - Out of control periods.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

  2. 40 CFR 96.372 - Out of control periods.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

  3. 40 CFR 96.372 - Out of control periods.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

  4. 40 CFR 96.372 - Out of control periods.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

  5. 40 CFR 96.372 - Out of control periods.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

  6. Assessment of in-situ test technology for construction control of base courses and embankments.

    DOT National Transportation Integrated Search

    2004-05-01

    With the coming move from an empirical to mechanistic-empirical pavement design, it is essential to improve the quality control/quality assurance (QC/QA) procedures of compacted materials from a density-based criterion to a stiffness/strength-based c...

  7. QALMA: A computational toolkit for the analysis of quality protocols for medical linear accelerators in radiation therapy

    NASA Astrophysics Data System (ADS)

    Rahman, Md Mushfiqur; Lei, Yu; Kalantzis, Georgios

    2018-01-01

    Quality Assurance (QA) for medical linear accelerator (linac) is one of the primary concerns in external beam radiation Therapy. Continued advancements in clinical accelerators and computer control technology make the QA procedures more complex and time consuming which often, adequate software accompanied with specific phantoms is required. To ameliorate that matter, we introduce QALMA (Quality Assurance for Linac with MATLAB), a MALAB toolkit which aims to simplify the quantitative analysis of QA for linac which includes Star-Shot analysis, Picket Fence test, Winston-Lutz test, Multileaf Collimator (MLC) log file analysis and verification of light & radiation field coincidence test.

  8. EMC Recent Additions

    EPA Pesticide Factsheets

    This page has information about recent changes to promulgated and proposed test methods, perfomance specifications, and quality assurance procedures. It also includes updates and changes to all other approved and proposed test methods.

  9. [The QuIK-Registry of the German Society of Cardiologists in private practice: countrywide and benchmarking quality assurance in invasive cardiology].

    PubMed

    Albrecht, A; Levenson, B; Göhring, S; Haerer, W; Reifart, N; Ringwald, G; Troger, B

    2009-10-01

    QuIK is the German acronym for QUality Assurance in Invasive Cardiology. It describes the continuous project of an electronic data collection in Cardiac catheterization laboratories all over Germany. Mainly members of the German Society of Cardiologists in Private Practice (BNK) participate in this computer based project. Since 1996 data of diagnostic and interventional procedures are collected and send to a registry-center where a regular benchmarking analysis of the results is performed. Part of the project is a yearly auditing process including an on-site visit to the cath lab to guarantee for the reliability of information collected. Since 1996 about one million procedures have been documented. Georg Thieme Verlag KG Stuttgart , New York.

  10. Many roads may lead to Rome: Selected features of quality control within environmental assessment systems in the US, NL, CA, and UK

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

    Günther, Markus, E-mail: markus.guenther@tu-berlin.de; Geißler, Gesa; Köppel, Johann

    As there is no one-and-only concept on how to precisely define and establish quality control (QC) or quality assurance (QA) in the making of environmental assessments (EA), this paper presents selected features of international approaches that address quality in EA systems in the USA, the Netherlands, Canada, and the United Kingdom. Based on explanative case studies, we highlight the embedding of specific quality control features within the EA systems, the objectives and processes, and relevant transparency challenges. Such features of QC/QA approaches can be considered in cases where substantial quality control and assurance efforts are still missing. Yet further researchmore » needs to be conducted on the efficacy of these approaches, which remains beyond the scope of this study. - Highlights: • We present four tools for quality control and assurance from different EA systems. • Approaches vary in institutional setting, objectives, procedures, and transparency. • Highlighted features might provide guidance in cases where QC/QA is still lacking.« less

  11. Standard operating procedures (SOPs): reason for, types of, adequacy, approval, and deviations from and revisions to.

    PubMed

    Isaman, V; Thelin, R

    1995-09-01

    Standard Operating Procedures (SOPs) are required in order to comply with the Good Laboratory Practice Standards (GLPS) as promulgated in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 40 CFR Part 160. Paragraph 160.81 (a) states: "A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study." Types of SOPs include administrative and personnel, analyses, substances, quality assurance and records, test system, equipment, and field related. All SOPs must be adequate in scope to describe the function in sufficient detail such that the study data are reproducible. All SOPs must be approved by a management level as described in a corporate organization chart. Signatures for SOP responsibility, authorship, and Quality Assurance review adds strength and accountability to the SOP. In the event a procedure or method is performed differently from what is stated in the SOP, an SOP deviation is necessary. As methods and procedures are improved, SOP revisions are necessary to maintain SOP adequacy and applicability. The replaced SOP is put into a historical SOP file and all copies of the replaced SOPs are destroyed.

  12. 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.

  13. 48 CFR 3046.793 - Waiver and notification procedures (USCG).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SECURITY, HOMELAND SECURITY ACQUISITION REGULATION (HSAR) CONTRACT MANAGEMENT QUALITY ASSURANCE Warranties... anticipated to be delivered during the life of the program); (2) The specific waiver requested, the duration...

  14. 48 CFR 3046.793 - Waiver and notification procedures (USCG).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SECURITY, HOMELAND SECURITY ACQUISITION REGULATION (HSAR) CONTRACT MANAGEMENT QUALITY ASSURANCE Warranties... anticipated to be delivered during the life of the program); (2) The specific waiver requested, the duration...

  15. LIHE Spectral Dynamics and Jaguar Data Acquisition System Measurement Assurance Results 2014.

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

    Covert, Timothy T.; Willis, Michael David; Radtke, Gregg Arthur

    2015-06-01

    The Light Initiated High Explosive (LIHE) facility performs high rigor, high consequence impulse testing for the nuclear weapons (NW) community. To support the facility mission, LIHE's extensive data acquisition system (DAS) is comprised of several discrete components as well as a fully integrated system. Due to the high consequence and high rigor of the testing performed at LIHE, a measurement assurance plan (MAP) was developed in collaboration with NW system customers to meet their data quality needs and to provide assurance of the robustness of the LIHE DAS. While individual components of the DAS have been calibrated by the SNLmore » Primary Standards Laboratory (PSL), the integrated nature of this complex system requires verification of the complete system, from end-to-end. This measurement assurance plan (MAP) report documents the results of verification and validation procedures used to ensure that the data quality meets customer requirements.« less

  16. 40 CFR 96.272 - Out of control periods.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

  17. 40 CFR 96.272 - Out of control periods.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

  18. 40 CFR 96.272 - Out of control periods.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

  19. 40 CFR 96.272 - Out of control periods.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

  20. 40 CFR 96.272 - Out of control periods.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

  1. Performance-based quality assurance/quality control (QA/QC) acceptance procedures for in-place soil testing phase 3 : [summary].

    DOT National Transportation Integrated Search

    2015-01-01

    Acceptance of earthwork construction by the Florida Department of Transportation (FDOT) : requires in-place testing conducted with a nuclear density gauge (NDG) to determine : dry density, which must obtain a required percent compaction based upon a ...

  2. Global harmonization of quality assurance naming conventions in radiation therapy clinical trials.

    PubMed

    Melidis, Christos; Bosch, Walther R; Izewska, Joanna; Fidarova, Elena; Zubizarreta, Eduardo; Ulin, Kenneth; Ishikura, Satoshi; Followill, David; Galvin, James; Haworth, Annette; Besuijen, Deidre; Clark, Catharine H; Clark, Clark H; Miles, Elizabeth; Aird, Edwin; Weber, Damien C; Hurkmans, Coen W; Verellen, Dirk

    2014-12-01

    To review the various radiation therapy quality assurance (RTQA) procedures used by the Global Clinical Trials RTQA Harmonization Group (GHG) steering committee members and present the harmonized RTQA naming conventions by amalgamating procedures with similar objectives. A survey of the GHG steering committee members' RTQA procedures, their goals, and naming conventions was conducted. The RTQA procedures were classified as baseline, preaccrual, and prospective/retrospective data capture and analysis. After all the procedures were accumulated and described, extensive discussions took place to come to harmonized RTQA procedures and names. The RTQA procedures implemented within a trial by the GHG steering committee members vary in quantity, timing, name, and compliance criteria. The procedures of each member are based on perceived chances of noncompliance, so that the quality of radiation therapy planning and treatment does not negatively influence the trial measured outcomes. A comparison of these procedures demonstrated similarities among the goals of the various methods, but the naming given to each differed. After thorough discussions, the GHG steering committee members amalgamated the 27 RTQA procedures to 10 harmonized ones with corresponding names: facility questionnaire, beam output audit, benchmark case, dummy run, complex treatment dosimetry check, virtual phantom, individual case review, review of patients' treatment records, and protocol compliance and dosimetry site visit. Harmonized RTQA harmonized naming conventions, which can be used in all future clinical trials involving radiation therapy, have been established. Harmonized procedures will facilitate future intergroup trial collaboration and help to ensure comparable RTQA between international trials, which enables meta-analyses and reduces RTQA workload for intergroup studies. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. [Development of methods and instruments for external quality assurance in inpatient parent-child rehabilitation and prevention].

    PubMed

    Neuderth, S; Lukasczik, M; Musekamp, G; Gerlich, C; Saupe-Heide, M; Löbmann, R; Vogel, H

    2013-02-01

    There so far is no standardized program for external quality assurance in inpatient parent-child prevention and rehabilitation in Germany. Therefore, instruments and methods of external quality assurance were developed and evaluated on behalf of the federal-level health insurance institutions. On the level of structure quality, a modular questionnaire for assessing structural features of rehabilitation/prevention centers, basic and allocation criteria as well as a checklist for visitations were developed. Structural data were collected in a nationwide survey of parent-child prevention and rehabilitation centers. Process and outcome quality data were collected in n=38 centers. Process quality was assessed using multiple methods (process-related structural features, case-related routine documentation, and incident-related patient questionnaires). Outcome quality was measured via patient questionnaires (n=1 799 patients). We used a multi-level modelling approach by adjusting relevant confounders on institutional and patient levels. The methods, instruments and analyzing procedures developed for measuring quality on the level of structure, processes and outcomes were adjusted in cooperation with all relevant stakeholders. Results are exemplarily presented for all quality assurance tools. For most of the risk-adjusted outcome parameters, we found no significant differences between institutions. For the first time, a comprehensive, standardized and generally applicable set of methods and instruments for routine use in comparative quality measurement of inpatient parent-child prevention and rehabilitation is available. However, it should be considered that the very heterogeneous field of family-oriented measures can not be covered entirely by an external quality assurance program. Therefore, methods and instruments have to be adapted continuously to the specifics of this area of health care and to new developments. © Georg Thieme Verlag KG Stuttgart · New York.

  4. Project Quality Assurance Plan for research and development services provided by Oak Ridge National Laboratory in support of the Westinghouse Materials Company of Ohio Operable Unit 1 Stabilization Development and Treatability Studies Program

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

    Gilliam, T.M.

    1991-05-01

    This Project Quality Assurance Plan (PQAP) sets forth the quality assurance (QA) requirements that are applied to those elements of the Westinghouse Materials Company of Ohio (WMCO) Operable Unit 1 support at Oak Ridge National Laboratory (ORNL) project that involve research and development (R D) performed at ORNL. This is in compliance with the applicable criteria of 10 CFR Part 50, Appendix B, ANSI/ASME NQA-1, as specified by Department of Energy (DOE) Oak Ridge Operations (ORO) Order 5700.6B. For this application, NQA-1 is the core QA Program requirements document. QA policy, normally found in the requirements document, is contained herein.more » The requirements of this PQAP apply to project activities that affect the quality and reliability/credibility of research, development, and investigative data and documentation. These activities include the functions of attaining quality objectives and assuring that an appropriate QA program scope is established. The scope of activities affecting quality includes organization; personnel training and qualifications; design control; procurement; material handling and storage; operating procedures; testing, surveillance, and auditing; R D investigative activities and documentation; deficiencies; corrective actions; and QA record keeping. 12 figs.« less

  5. Synthesis and quality control of fluorodeoxyglucose and performance assessment of Siemens MicroFocus 220 small animal PET scanner

    NASA Astrophysics Data System (ADS)

    Phaterpekar, Siddhesh Nitin

    The scope of this article is to cover the synthesis and quality control procedures involved in production of Fludeoxyglucose (18F--FDG). The article also describes the cyclotron production of 18F radioisotope and gives a brief overview on operations and working of a fixed energy medical cyclotron. The quality control procedures for FDG involve radiochemical and radionuclidic purity tests, pH tests, chemical purity tests, sterility tests, endotoxin tests. Each of these procedures were carried out for multiple batches of FDG with a passing rate of 95% among 20 batches. The article also covers the quality assurance steps for the Siemens MicroPET Focus 220 Scanner using a Jaszczak phantom. We have carried out spatial resolution tests on the scanner, with an average transaxial resolution of 1.775mm with 2-3mm offset. Tests involved detector efficiency, blank scan sinograms and transmission sinograms. A series of radioactivity distribution tests are also carried out on a uniform phantom, denoting the variations in radioactivity and uniformity by using cylindrical ROIs in the transverse region of the final image. The purpose of these quality control tests is to make sure the manufactured FDG is biocompatible with the human body. Quality assurance tests are carried on PET scanners for efficient performance, and to make sure the quality of images acquired is according to the radioactivity distribution in the subject of interest.

  6. 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.e. a national database, mail and service order processing software, and inspection procedures.

  7. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

    PubMed

    Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

    2014-07-01

    The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

  8. Development of the Quality Assurance/Quality Control Procedures for a Neutron Interrogation System

    NASA Astrophysics Data System (ADS)

    Obhođaš, Jasmina; Sudac, Davorin; Valković, Vladivoj

    2016-06-01

    In order to perform Quality Assurance/Quality Control (QA/QC) procedures for a system dedicated to the neutron interrogation of objects for the presence of threat materials one needs to perform measurements of reference materials (RM) i.e. simulants having the same (or similar) atomic ratios as real materials. It is well known that explosives, drugs, and various other benign materials, contain chemical elements such as hydrogen, oxygen, carbon and nitrogen in distinctly different quantities. For example, a high carbon-to-oxygen ratio (C/O) is characteristic of drugs. Explosives can be differentiated by measurement of both (C/O) and nitrogen-to-oxygen (N/O) ratios. The C/N ratio of the chemical warfare agents, coupled with the measurement of elements such as fluorine and phosphorus, clearly differentiate them from the conventional explosives. Here we present the RM preparation, calibration procedure and correlations attained between theoretical values and experimentally obtained results in laboratory conditions for C/O and N/C ratios of prepared hexogen (RDX), TNT, DLM2, TATP, cocaine, heroin, yperite, tetranitromethane, peroxide methylethylketone, nitromethane and ethyleneglycol dinitrate simulants. We have shown that analyses of the gamma ray spectra by using simple unfolding model developed for this purpose gave a nice agreement with the chemical formula of created simulants, thus the calibration quality was successfully tested.

  9. Working in Triads: A Case Study of a Peer Review Process

    ERIC Educational Resources Information Center

    Grainger, Peter; Bridgstock, Martin; Houston, Todd; Drew, Steve

    2015-01-01

    Peer review of teaching has become an accepted educational procedure in Australia to quality assure the quality of teaching practices. The institutional implementation of the peer review process can be viewed as genuine desire to improve teaching quality or an imposition from above as a measure of accountability and performativity. One approach is…

  10. Improving the Quality of Higher Education in Central Europe: Approach Based on GAP Analysis

    ERIC Educational Resources Information Center

    Hrnciar, Miroslav; Madzík, Peter

    2013-01-01

    A growing social pressure on addressing the issues of quality in administration of educational institutions has resulted in various national and international initiatives focused on development of recommendations and procedures for assurance of quality of education. The topic is getting more urgent in the period of global recession when the…

  11. 40 CFR Appendix A to Part 58 - Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... monitor. 3.3.4.4Pb Performance Evaluation Program (PEP) Procedures. Each year, one performance evaluation... Information 2. Quality System Requirements 3. Measurement Quality Check Requirements 4. Calculations for Data... 10 of this appendix) and at a national level in references 1, 2, and 3 of this appendix. 1...

  12. 40 CFR Appendix A to Part 58 - Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... monitor. 3.3.4.4Pb Performance Evaluation Program (PEP) Procedures. Each year, one performance evaluation... Information 2. Quality System Requirements 3. Measurement Quality Check Requirements 4. Calculations for Data... 10 of this appendix) and at a national level in references 1, 2, and 3 of this appendix. 1...

  13. Expert opinions and scientific evidence for colonoscopy key performance indicators.

    PubMed

    Rees, Colin J; Bevan, Roisin; Zimmermann-Fraedrich, Katharina; Rutter, Matthew D; Rex, Douglas; Dekker, Evelien; Ponchon, Thierry; Bretthauer, Michael; Regula, Jaroslaw; Saunders, Brian; Hassan, Cesare; Bourke, Michael J; Rösch, Thomas

    2016-12-01

    Colonoscopy is a widely performed procedure with procedural volumes increasing annually throughout the world. Many procedures are now performed as part of colorectal cancer screening programmes. Colonoscopy should be of high quality and measures of this quality should be evidence based. New UK key performance indicators and quality assurance standards have been developed by a working group with consensus agreement on each standard reached. This paper reviews the scientific basis for each of the quality measures published in the UK standards. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Comprehensive genomic studies: emerging regulatory, strategic, and quality assurance challenges for biorepositories.

    PubMed

    McDonald, Sandra A; Mardis, Elaine R; Ota, David; Watson, Mark A; Pfeifer, John D; Green, Jonathan M

    2012-07-01

    As part of the molecular revolution sweeping medicine, comprehensive genomic studies are adding powerful dimensions to medical research. However, their power exposes new regulatory, strategic, and quality assurance challenges for biorepositories. A key issue is that unlike other research techniques commonly applied to banked specimens, nucleic acid sequencing, if sufficiently extensive, yields data that could identify a patient. This evolving paradigm renders the concepts of anonymized and anonymous specimens increasingly outdated. The challenges for biorepositories in this new era include refined consent processes and wording, selection and use of legacy specimens, quality assurance procedures, institutional documentation, data sharing, and interaction with institutional review boards. Given current trends, biorepositories should consider these issues now, even if they are not currently experiencing sample requests for genomic analysis. We summarize our current experiences and best practices at Washington University Medical School, St Louis, MO, our perceptions of emerging trends, and recommendations.

  15. [Quality assurance of the renal applications software].

    PubMed

    del Real Núñez, R; Contreras Puertas, P I; Moreno Ortega, E; Mena Bares, L M; Maza Muret, F R; Latre Romero, J M

    2007-01-01

    The need for quality assurance of all technical aspects of nuclear medicine studies is widely recognised. However, little attention has been paid to the quality assurance of the applications software. Our work reported here aims at verifying the analysis software for processing of renal nuclear medicine studies (renograms). The software tools were used to build a synthetic dynamic model of renal system. The model consists of two phases: perfusion and function. The organs of interest (kidneys, bladder and aortic artery) were simple geometric forms. The uptake of the renal structures was described by mathematic functions. Curves corresponding to normal or pathological conditions were simulated for kidneys, bladder and aortic artery by appropriate selection of parameters. There was no difference between the parameters of the mathematic curves and the quantitative data produced by the renal analysis program. Our test procedure is simple to apply, reliable, reproducible and rapid to verify the renal applications software.

  16. Comprehensive Genomic Studies: Emerging Regulatory, Strategic, and Quality Assurance Challenges for Biorepositories

    PubMed Central

    McDonald, Sandra A.; Mardis, Elaine R.; Ota, David; Watson, Mark A.; Pfeifer, John D.; Green, Jonathan M.

    2012-01-01

    As part of the molecular revolution sweeping medicine, comprehensive genomic studies are adding powerful dimensions to medical research. However, their power exposes new regulatory, strategic, and quality assurance challenges for biorepositories. A key issue is that unlike other research techniques commonly applied to banked specimens, nucleic acid sequencing, if sufficiently extensive, yields data that could identify a patient. This evolving paradigm renders the concepts of anonymized and anonymous specimens increasingly outdated. The challenges for biorepositories in this new era include refined consent processes and wording, selection and use of legacy specimens, quality assurance procedures, institutional documentation, data sharing, and interaction with institutional review boards. Given current trends, biorepositories should consider these issues now, even if they are not currently experiencing sample requests for genomic analysis. We summarize our current experiences and best practices at Washington University Medical School, St Louis, MO, our perceptions of emerging trends, and recommendations. PMID:22706855

  17. Non-invasive characterization and quality assurance of silicon micro-strip detectors using pulsed infrared laser

    NASA Astrophysics Data System (ADS)

    Ghosh, P.

    2016-01-01

    The Compressed Baryonic Matter (CBM) experiment at FAIR is composed of 8 tracking stations consisting of roughly 1300 double sided silicon micro-strip detectors of 3 different dimensions. For the quality assurance of prototype micro-strip detectors a non-invasive detector charaterization is developed. The test system is using a pulsed infrared laser for charge injection and characterization, called Laser Test System (LTS). The system is aimed to develop a set of characterization procedures which are non-invasive (non-destructive) in nature and could be used for quality assurances of several silicon micro-strip detectors in an efficient, reliable and reproducible way. The procedures developed (as reported here) uses the LTS to scan sensors with a pulsed infra-red laser driven by step motor to determine the charge sharing in-between strips and to measure qualitative uniformity of the sensor response over the whole active area. The prototype detector modules which are tested with the LTS so far have 1024 strips with a pitch of 58 μm on each side. They are read-out using a self-triggering prototype read-out electronic ASIC called n-XYTER. The LTS is designed to measure sensor response in an automatized procedure at several thousand positions across the sensor with focused infra-red laser light (spot size ≈ 12 μm, wavelength = 1060 nm). The pulse with a duration of ≈ 10 ns and power ≈ 5 mW of the laser pulse is selected such, that the absorption of the laser light in the 300 μm thick silicon sensor produces ≈ 24000 electrons, which is similar to the charge created by minimum ionizing particles (MIP) in these sensors. The laser scans different prototype sensors and various non-invasive techniques to determine characteristics of the detector modules for the quality assurance is reported.

  18. 42 CFR 423.128 - Dissemination of Part D plan information.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... coverage determination and redetermination processes via an Internet Web site; and (iii) A system that... determination by contacting the plan sponsor's toll free customer service line or by accessing the plan sponsor's internet Web site. (8) Quality assurance policies and procedures. A description of the quality...

  19. 42 CFR 423.128 - Dissemination of Part D plan information.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... coverage determination and redetermination processes via an Internet Web site; and (iii) A system that... determination by contacting the plan sponsor's toll free customer service line or by accessing the plan sponsor's internet Web site. (8) Quality assurance policies and procedures. A description of the quality...

  20. 42 CFR 423.128 - Dissemination of Part D plan information.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... coverage determination and redetermination processes via an Internet Web site; and (iii) A system that... determination by contacting the plan sponsor's toll free customer service line or by accessing the plan sponsor's internet Web site. (8) Quality assurance policies and procedures. A description of the quality...

  1. 40 CFR 97.632 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

  2. 40 CFR 97.432 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... prospectively the certification status of the monitoring system. The data measured and recorded by the...

  3. 40 CFR 97.732 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

  4. 40 CFR 97.432 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... prospectively the certification status of the monitoring system. The data measured and recorded by the...

  5. 40 CFR 60.4172 - Out of control periods.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... certification status of the monitoring system. The data measured and recorded by the monitoring system shall not...

  6. 40 CFR 97.432 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... prospectively the certification status of the monitoring system. The data measured and recorded by the...

  7. 40 CFR 97.632 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

  8. 40 CFR 60.4172 - Out of control periods.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... certification status of the monitoring system. The data measured and recorded by the monitoring system shall not...

  9. 40 CFR 97.732 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

  10. 40 CFR 97.632 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

  11. 40 CFR 97.732 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

  12. Development of models to estimate the subgrade and subbase layers' resilient modulus from in situ devices test results for construction control.

    DOT National Transportation Integrated Search

    2008-04-01

    The objective of this study was to develop resilient modulus prediction models for possible application in the quality control/quality assurance (QC/QA) procedures during and after the construction of pavement layers. Field and laboratory testing pro...

  13. 21 CFR 1000.55 - Recommendation for quality assurance programs in diagnostic radiology facilities.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... components of an x-ray system. The quality control techniques thus are concerned directly with the equipment... in response to monitoring results. These procedures provide the organizational framework for the... control, a tube-housing assembly, a beam-limiting device, and the necessary supporting structures. Other...

  14. Performance-based quality assurance/quality control (QA/QC) acceptance procedures for in-place soil testing phase 3.

    DOT National Transportation Integrated Search

    2015-01-01

    One of the objectives of this study was to evaluate soil testing equipment based on its capability of measuring in-place stiffness or modulus values. : As design criteria transition from empirical to mechanistic-empirical, soil test methods and equip...

  15. 10 CFR 63.31 - Construction authorization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... subpart E of this part; (iii) DOE's quality assurance program complies with the requirements of subpart G...; and (vi) DOE's proposed operating procedures to protect health and to minimize danger to life or...

  16. British standard (BS) 5750--quality assurance?

    PubMed

    Pratt, D J

    1995-04-01

    BS5750 is the British Standard on "Quality Systems". Its equivalent in European Standards is EN29000 and in the International Standards Organisation ISO9000. This paper points out that these standards lay down formalised procedures and require documentation but do not ipso facto lead to quality assurance. The author points to the Japanese post-war industrial success as being an example of Total Quality Management within the framework provided by the philosophy of Dr. W. Edwards Deming (1988 and 1993). This philosophy on the management of "systems" to provide high quality products and services is briefly outlined. The author argues that improvement in prosthetic and orthotic services will not be reached through implementation of BS5750 but rather through radical rethinking and the adoption and application of the Deming philosophy.

  17. Durability of hardboard siding

    Treesearch

    Anton TenWolde; Charles Carll

    2004-01-01

    In response to concerns about hardboard siding failures, a study was performed to assess if performance in a current hardboard industry quality assurance test procedure correlated with in-service performance and how well this performance might be predicted by use of alternative or additional test procedures. A variety of laboratory tests were performed on a large...

  18. 40 CFR 63.8075 - What reports must I submit and when?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... demonstrations to verify that control devices subject to § 63.8000(d)(3) are operating as designed. (3) A... procedures and quality assurance procedures. (iii) Descriptions of monitoring devices, monitoring frequencies...) Identification of the CMS. (J) The date of the latest CMS certification or audit. (K) The operating day or...

  19. 40 CFR 63.7710 - What are my operation and maintenance requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... gases from mold vents in pouring areas and pouring stations that use a sand mold system. This operation... including quality assurance procedures. (iv) How the bag leak detection system will be maintained including...) Procedures for providing an ignition source to mold vents of sand mold systems in each pouring area and...

  20. Surface electrical properties experiment study phase, volume 3

    NASA Technical Reports Server (NTRS)

    1973-01-01

    The reliability and quality assurance system and procedures used in developing test equipment for the Lunar Experiment projects are described. The subjects discussed include the following: (1) documentation control, (2) design review, (3) parts and materials selection, (4) material procurement, (5) inspection procedures, (6) qualification and special testing, and failure modes and effects analysis.

  1. Instrument Quality Control.

    PubMed

    Jayakody, Chatura; Hull-Ryde, Emily A

    2016-01-01

    Well-defined quality control (QC) processes are used to determine whether a certain procedure or action conforms to a widely accepted standard and/or set of guidelines, and are important components of any laboratory quality assurance program (Popa-Burke et al., J Biomol Screen 14: 1017-1030, 2009). In this chapter, we describe QC procedures useful for monitoring the accuracy and precision of laboratory instrumentation, most notably automated liquid dispensers. Two techniques, gravimetric QC and photometric QC, are highlighted in this chapter. When used together, these simple techniques provide a robust process for evaluating liquid handler accuracy and precision, and critically underpin high-quality research programs.

  2. [4th report of German Association of Cardiologists in private practice (BNK) on quality assurance in cardiac catheterization and coronary intervention 1999-2002].

    PubMed

    Levenson, Benny; Albrecht, Alexander; Göhring, Stefan; Haerer, Winfried; Herholz, Harald; Kaltenbach, Martin; Reifart, Nicolaus; Sauer, Gregor; Silber, Sigmund; Troger, Bernhard

    2003-06-01

    The Society of German Cardiologists in private practice (BNK) reports about its project on quality assurance in invasive cardiology (QuIK). Results of a computerized data collection and analysis of cardiac catheterizations and interventions in the years 1999-2002 are presented. These results are compared with other registries. The QuIK-project is done voluntarily by 70% of the society's cardiologists who perform invasive methods. A total of 225,562 diagnostic and 64,895 interventional procedures are documented over the 4 years. Patient characteristics and procedural data kept unchanged. Complication rates were low (< 2%), MACE < 0.5%. There was a rising number of patients referred with acute myocardial infarction. Less time was used to complete procedures from 1 year to another. Two out of three of the centers underwent a monitoring/auditing process in 2002. The desirable post-interventional follow-up after discharge in all cases appears to be impossible to fulfill under the given economical circumstances.

  3. Integration of laboratory and process testing data

    PubMed Central

    Tyszkiewicz, Michael

    1995-01-01

    The author describes ACS Inc.'s Pro-LIMS system which integrates laboratory and process procedures. The system has been shown to be an important toolfor quality assurance in the process manufacturing industry. PMID:18924782

  4. Field Sampling Plan/Quality Assurance Project Plan Volume I of III

    EPA Pesticide Factsheets

    This document contains procedures related to the collection and analysis of soil, sediment, groundwater, surface water, air and biota samples at GE’s Pittsfield, Massachusetts facility and at other areas.

  5. 40 CFR Appendix F to Part 60 - Quality Assurance Procedures

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... automatically adjust the data to the corrected calibration values (e.g., microprocessor control) must be... calibration values (e.g., microprocessor control), you must program your PM CEMS to record the unadjusted...

  6. Readiness Review of BWXT for Fabrication of AGR 5/6/7 Compacts

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

    Marshall, Douglas William; Sharp, Michelle Tracy

    In support of preparations for fabricating compacts for the Advanced Gas Reactor (AGR) fuel qualification irradiation experiments (AGR-5/6/7), Idaho National Laboratory (INL) conducted a readiness review of the BWX Technology (BWXT) procedures, processes, and equipment associated with compact fabrication activities at the BWXT Nuclear Operations Group (BWXT-NOG) facility outside Lynchburg, VirginiaVA. The readiness review used quality assurance requirements taken from the American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance Standard (NQA-1-2008/1a-2009) as a basis to assess readiness to start compact fabrication.

  7. A comprehensive and efficient daily quality assurance for PBS proton therapy

    NASA Astrophysics Data System (ADS)

    Actis, O.; Meer, D.; König, S.; Weber, D. C.; Mayor, A.

    2017-03-01

    There are several general recommendations for quality assurance (QA) measures, which have to be performed at proton therapy centres. However, almost each centre uses a different therapy system. In particular, there is no standard procedure for centres employing pencil beam scanning and each centre applies a specific QA program. Gantry 2 is an operating therapy system which was developed at PSI and relies on the most advanced technological innovations. We developed a comprehensive daily QA program in order to verify the main beam characteristics to assure the functionality of the therapy delivery system and the patient safety system. The daily QA program entails new hardware and software solutions for a highly efficient clinical operation. In this paper, we describe a dosimetric phantom used for verifying the most critical beam parameters and the software architecture developed for a fully automated QA procedure. The connection between our QA software and the database allows us to store the data collected on a daily basis and use it for trend analysis over longer periods of time. All the data presented here have been collected during a time span of over two years, since the beginning of the Gantry 2 clinical operation in 2013. Our procedure operates in a stable way and delivers the expected beam quality. The daily QA program takes only 20 min. At the same time, the comprehensive approach allows us to avoid most of the weekly and monthly QA checks and increases the clinical beam availability.

  8. Operative blood transfusion quality improvement audit.

    PubMed

    Al Sohaibani, Mazen; Al Malki, Assaf; Pogaku, Venumadhav; Al Dossary, Saad; Al Bernawi, Hanan

    2014-01-01

    To determine how current anesthesia team handless the identification of surgical anaesthetized patient (right patient). And the check of blood unit before collecting and immediately before blood administration (right blood) in operating rooms where nurses have minimal duties and responsibility to handle blood for transfusion in anaesthetized patients. To elicit the degree of anesthesia staff compliance with new policies and procedures for anaesthetized surgical patient the blood transfusion administration. A large tertiary care reference and teaching hospital. A prospective quality improvement. Elaboration on steps for administration of transfusion from policies and procedures to anaesthetized patients; and analysis of the audit forms for conducted transfusions. An audit form was used to get key performance indicators (KPIs) observed in all procedures involve blood transfusion and was ticked as item was met, partially met, not met or not applicable. Descriptive statistics as number and percentage Microsoft excel 2003. Central quality improvement committee presented the results in number percentage and graphs. The degree of compliance in performing the phases of blood transfusion by anesthesia staff reached high percentage which let us feel certain that the quality is assured that the internal policy and procedures (IPP) are followed in the great majority of all types of red cells and other blood products transfusion from the start of requesting the blood or blood product to the prescript of checking the patient in the immediate post-transfusion period. Specific problem area of giving blood transfusion to anaesthetized patient was checking KPI concerning the phases of blood transfusion was audited and assured the investigators of high quality performance in procedures of transfusion.

  9. Well installation and documentation, and ground-water sampling protocols for the pilot National Water-Quality Assessment Program

    USGS Publications Warehouse

    Hardy, M.A.; Leahy, P.P.; Alley, W.M.

    1989-01-01

    Several pilot projects are being conducted as part of the National Water Quality Assessment (NAWQA) Program. The purpose of the pilot program is to test and refine concepts for a proposed full-scale program. Three of the pilot projects are specifically designed to assess groundwater. The purpose of this report is to describe the criteria that are being used in the NAWQA pilot projects for selecting and documenting wells, installing new wells, and sampling wells for different water quality constituents. Guidelines are presented for the selection of wells for sampling. Information needed to accurately document each well includes site characteristics related to the location of the well, land use near the well, and important well construction features. These guidelines ensure the consistency of the information collected and will provide comparable data for interpretive purposes. Guidelines for the installation of wells are presented and include procedures that need to be followed for preparations prior to drilling, the selection of the drilling technique and casing type, the grouting procedure, and the well-development technique. A major component of the protocols is related to water quality sampling. Tasks are identified that need to be completed prior to visiting the site for sampling. Guidelines are presented for purging the well prior t sampling, both in terms of the volume of water pumped and the chemical stability of field parameters. Guidelines are presented concerning sampler selection as related to both inorganic and organic constituents. Documentation needed to describe the measurements and observations related to sampling each well and treating and preserving the samples are also presented. Procedures are presented for the storage and shipping of water samples, equipment cleaning, and quality assurance. Quality assurance guidelines include the description of the general distribution of the various quality assurance samples (blanks, spikes, duplicates, and reference samples) that will be used in the pilot program. (Lantz-PTT)

  10. Chapter A10. Lakes and reservoirs: Guidelines for study design and sampling

    USGS Publications Warehouse

    Green, William R.; Robertson, Dale M.; Wilde, Franceska D.

    2015-09-29

    Within this chapter are references to other chapters of the NFM that provide more detailed guidelines related to specific topics and more detailed protocols for the quality assurance and assessment of the lake and reservoir data. Protocols and procedures to address and document the quality of lake and reservoir investigations are adapted from, or referenced to, the protocols and standard operating procedures contained in related chapters of this National Field Manual.

  11. Next generation diagnostic molecular pathology: critical appraisal of quality assurance in Europe.

    PubMed

    Dubbink, Hendrikus J; Deans, Zandra C; Tops, Bastiaan B J; van Kemenade, Folkert J; Koljenović, S; van Krieken, Han J M; Blokx, Willeke A M; Dinjens, Winand N M; Groenen, Patricia J T A

    2014-06-01

    Tumor evaluation in pathology is more and more based on a combination of traditional histopathology and molecular analysis. Due to the rapid development of new cancer treatments that specifically target aberrant proteins present in tumor cells, treatment decisions are increasingly based on the molecular features of the tumor. Not only the number of patients eligible for targeted precision medicine, but also the number of molecular targets per patient and tumor type is rising. Diagnostic molecular pathology, the discipline that determines the molecular aberrations present in tumors for diagnostic, prognostic or predictive purposes, is faced with true challenges. The laboratories have to meet the need of comprehensive molecular testing using only limited amount of tumor tissue, mostly fixed in formalin and embedded in paraffin (FFPE), in short turnaround time. Choices must be made for analytical methods that provide accurate, reliable and cost-effective results. Validation of the test procedures and results is essential. In addition, participation and good performance in internal (IQA) and external quality assurance (EQA) schemes is mandatory. In this review, we critically evaluate the validation procedure for comprehensive molecular tests as well as the organization of quality assurance and assessment of competence of diagnostic molecular pathology laboratories within Europe. Copyright © 2014 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.

  12. Global Harmonization of Quality Assurance Naming Conventions in Radiation Therapy Clinical Trials

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

    Melidis, Christos, E-mail: christos.melidis@eortc.be; Bosch, Walther R.; Izewska, Joanna

    2014-12-01

    Purpose: To review the various radiation therapy quality assurance (RTQA) procedures used by the Global Clinical Trials RTQA Harmonization Group (GHG) steering committee members and present the harmonized RTQA naming conventions by amalgamating procedures with similar objectives. Methods and Materials: A survey of the GHG steering committee members' RTQA procedures, their goals, and naming conventions was conducted. The RTQA procedures were classified as baseline, preaccrual, and prospective/retrospective data capture and analysis. After all the procedures were accumulated and described, extensive discussions took place to come to harmonized RTQA procedures and names. Results: The RTQA procedures implemented within a trial by themore » GHG steering committee members vary in quantity, timing, name, and compliance criteria. The procedures of each member are based on perceived chances of noncompliance, so that the quality of radiation therapy planning and treatment does not negatively influence the trial measured outcomes. A comparison of these procedures demonstrated similarities among the goals of the various methods, but the naming given to each differed. After thorough discussions, the GHG steering committee members amalgamated the 27 RTQA procedures to 10 harmonized ones with corresponding names: facility questionnaire, beam output audit, benchmark case, dummy run, complex treatment dosimetry check, virtual phantom, individual case review, review of patients' treatment records, and protocol compliance and dosimetry site visit. Conclusions: Harmonized RTQA harmonized naming conventions, which can be used in all future clinical trials involving radiation therapy, have been established. Harmonized procedures will facilitate future intergroup trial collaboration and help to ensure comparable RTQA between international trials, which enables meta-analyses and reduces RTQA workload for intergroup studies.« less

  13. QA in Radiation Therapy: The RPC Perspective

    NASA Astrophysics Data System (ADS)

    Ibbott, G. S.

    2010-11-01

    The Radiological Physics Center (RPC) is charged with assuring the consistent delivery of radiation doses to patients on NCI-sponsored clinical trials. To accomplish this, the RPC conducts annual mailed audits of machine calibration, dosimetry audit visits to institutions, reviews of treatment records, and credentialing procedures requiring the irradiation of anthropomorphic phantoms. Through these measurements, the RPC has gained an understanding of the level of quality assurance practiced in this cohort of institutions, and a database of measurements of beam characteristics of a large number of treatment machines. The results of irradiations of phantoms have yielded insight into the delivery of advanced technology treatment procedures.

  14. 21 CFR 1000.55 - Recommendation for quality assurance programs in diagnostic radiology facilities.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... procedure that involves irradiation of any part of the human body for the purpose of diagnosis or..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) RADIOLOGICAL HEALTH GENERAL Radiation Protection...

  15. Analysis of QA procedures at the Oregon Department of Transportation.

    DOT National Transportation Integrated Search

    2010-06-01

    This research explored the Oregon Department of Transportation (ODOT) practice of Independent Assurance (IA), : for validation of the contractors test methods, and Verification, for validation of the contractors Quality Control : (QC) data. The...

  16. Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

    PubMed

    Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

    2018-06-07

    Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

  17. 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.

  18. Long life assurance study for manned spacecraft long life hardware. Volume 4: Special long life assurance studies

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Guidelines for the selection of equipment to be used for manned spacecraft in order to assure a five year maintenance-free service life were developed. A special study was conducted to determine the adequacy of the procedures used to determine the quality and effectiveness of various components. The subjects examined are: (1) temperature cycling for acceptance of electronic assemblies; (2) accelerated testing techniques; (3) electronic part screening techniques; (4) electronic part derating practices; (5) vibration life extension of printed circuit board assemblies; and (6) tolerance funnelling and test requirements.

  19. Nuclear Technology. Course 28: Welding Inspection. Module 28-5, Qualifications.

    ERIC Educational Resources Information Center

    Espy, John

    This fifth in a series of ten modules for a course titled Welding Inspection describes qualification requirements for welding procedures and welders and the role of the nuclear quality assurance/quality control technician. The module follows a typical format that includes the following sections: (1) introduction, (2) module prerequisites, (3)…

  20. 40 CFR 97.532 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or appendix E to, part 75 of this chapter...

  1. 40 CFR 97.532 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or appendix E to, part 75 of this chapter...

  2. 40 CFR 97.532 - Monitoring system out-of-control periods.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or appendix E to, part 75 of this chapter...

  3. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... suitable for inspection. A maintenance log may be used for this purpose. The following records should be... the previous 26 unit (or stack) operating hours; and (b) the 26 clock hour data validation window for... official test log for each monitoring system. (i) The results of any certification, recertification...

  4. Needs and Benefits of Nursery Accreditation

    Treesearch

    Robert P. Karrfalt

    2005-01-01

    It appears, from observations reported by both private and public nurseries, that there are nurseries that do not have adequate quality assurance procedures. Species are being mislabeled and incorrect seed sources are being sold. It appears that some nurseries have entered the market ill prepared to provide quality seedlings. On the other hand, why should anyone listen...

  5. Modelling Student Satisfaction and Motivation in the Integrated Educational Environment: An Empirical study

    ERIC Educational Resources Information Center

    Stukalina, Yulia

    2016-01-01

    Purpose: The purpose of this paper is to explore some issues related to enhancing the quality of educational services provided by a university in the agenda of integrating quality assurance activities and strategic management procedures. Design/methodology/approach: Employing multiple regression analysis the author has examined some factors that…

  6. Quality assurance and quality control for thermal/optical analysis of aerosol samples for organic and elemental carbon.

    PubMed

    Chow, Judith C; Watson, John G; Robles, Jerome; Wang, Xiaoliang; Chen, L-W Antony; Trimble, Dana L; Kohl, Steven D; Tropp, Richard J; Fung, Kochy K

    2011-12-01

    Accurate, precise, and valid organic and elemental carbon (OC and EC, respectively) measurements require more effort than the routine analysis of ambient aerosol and source samples. This paper documents the quality assurance (QA) and quality control (QC) procedures that should be implemented to ensure consistency of OC and EC measurements. Prior to field sampling, the appropriate filter substrate must be selected and tested for sampling effectiveness. Unexposed filters are pre-fired to remove contaminants and acceptance tested. After sampling, filters must be stored in the laboratory in clean, labeled containers under refrigeration (<4 °C) to minimize loss of semi-volatile OC. QA activities include participation in laboratory accreditation programs, external system audits, and interlaboratory comparisons. For thermal/optical carbon analyses, periodic QC tests include calibration of the flame ionization detector with different types of carbon standards, thermogram inspection, replicate analyses, quantification of trace oxygen concentrations (<100 ppmv) in the helium atmosphere, and calibration of the sample temperature sensor. These established QA/QC procedures are applicable to aerosol sampling and analysis for carbon and other chemical components.

  7. Quality Assurance in Clinical Chemistry: A Touch of Statistics and A Lot of Common Sense

    PubMed Central

    2016-01-01

    Summary Working in laboratories of clinical chemistry, we risk feeling that our personal contribution to quality is small and that statistical models and manufacturers play the major roles. It is seldom sufficiently acknowledged that personal knowledge, skills and common sense are crucial for quality assurance in the interest of patients. The employees, environment and procedures inherent to the laboratory including its interactions with the clients are crucial for the overall result of the total testing chain. As the measurement systems, reagents and procedures are gradually improved, work on the preanalytical, postanalytical and clinical phases is likely to pay the most substantial dividends in accomplishing further quality improvements. This means changing attitudes and behaviour, especially of the users of the laboratory. It requires understanding people and how to engage them in joint improvement processes. We need to use our knowledge and common sense expanded with new skills e.g. from the humanities, management, business and change sciences in order to bring this about together with the users of the laboratory. PMID:28356868

  8. Long life assurance study for manned spacecraft long life hardware. Volume 2: Long life assurance studies of EEE parts and packaging

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Guidelines for the design, development, and fabrication of electronic components and circuits for use in spacecraft construction are presented. The subjects discussed involve quality control procedures and test methodology for the following subjects: (1) monolithic integrated circuits, (2) hybrid integrated circuits, (3) transistors, (4) diodes, (5) tantalum capacitors, (6) electromechanical relays, (7) switches and circuit breakers, and (8) electronic packaging.

  9. Engineering and Design: Chemical Data Quality Management for Hazardous, Toxic, Radioactive Waste Remedial Activities

    DTIC Science & Technology

    This regulation prescribes Chemical Data Quality Management (CDQM) responsibilities and procedures for projects involving hazardous, toxic and/or radioactive waste (HTRW) materials. Its purpose is to assure that the analytical data meet project data quality objectives. This is the umbrella regulation that defines CDQM activities and integrates all of the other U.S. Army Corps of Engineers (USACE) guidance on environmental data quality management .

  10. Triangle area water supply monitoring project, October 1988 through September 2001, North Carolina -- description of the water-quality network, sampling and analysis methods, and quality-assurance practices

    USGS Publications Warehouse

    Oblinger, Carolyn J.

    2004-01-01

    The Triangle Area Water Supply Monitoring Project was initiated in October 1988 to provide long-term water-quality data for six area water-supply reservoirs and their tributaries. In addition, the project provides data that can be used to determine the effectiveness of large-scale changes in water-resource management practices, document differences in water quality among water-supply types (large multiuse reservoir, small reservoir, run-of-river), and tributary-loading and in-lake data for water-quality modeling of Falls and Jordan Lakes. By September 2001, the project had progressed in four phases and included as many as 34 sites (in 1991). Most sites were sampled and analyzed by the U.S. Geological Survey. Some sites were already a part of the North Carolina Division of Water Quality statewide ambient water-quality monitoring network and were sampled by the Division of Water Quality. The network has provided data on streamflow, physical properties, and concentrations of nutrients, major ions, metals, trace elements, chlorophyll, total organic carbon, suspended sediment, and selected synthetic organic compounds. Project quality-assurance activities include written procedures for sample collection, record management and archive, collection of field quality-control samples (blank samples and replicate samples), and monitoring the quality of field supplies. In addition to project quality-assurance activities, the quality of laboratory analyses was assessed through laboratory quality-assurance practices and an independent laboratory quality-control assessment provided by the U.S. Geological Survey Branch of Quality Systems through the Blind Inorganic Sample Project and the Organic Blind Sample Project.

  11. Development of Game-Like Simulations for Procedural Knowledge in Healthcare Education

    ERIC Educational Resources Information Center

    Torrente, Javier; Borro-Escribano, Blanca; Freire, Manuel; del Blanco, Ángel; Marchiori, Eugenio J.; Martinez-Ortiz, Iván; Moreno-Ger, Pablo; Fernández-Manjón, Baltasar

    2014-01-01

    We present EGDA, an educational game development approach focused on the teaching of procedural knowledge using a cost-effective approach. EGDA proposes four tasks: analysis, design, implementation, and quality assurance that are subdivided in a total of 12 subtasks. One of the benefits of EGDA is that anyone can apply it to develop a game since…

  12. Why (Not) Assess? Views from the Academic Departments of Finnish Universities

    ERIC Educational Resources Information Center

    Huusko, Mira; Ursin, Jani

    2010-01-01

    In Europe, national quality assurance systems of higher education have begun to be established. In Finland, this development has had the consequence of forcing universities to take notice of assessment procedures. However, little is known about the procedures taking place in individual academic departments as a result of this pan-European trend.…

  13. Quality-assurance results for routine water analysis in US Geological Survey laboratories, water year 1991

    USGS Publications Warehouse

    Maloney, T.J.; Ludtke, A.S.; Krizman, T.L.

    1994-01-01

    The US. Geological Survey operates a quality- assurance program based on the analyses of reference samples for the National Water Quality Laboratory in Arvada, Colorado, and the Quality of Water Service Unit in Ocala, Florida. Reference samples containing selected inorganic, nutrient, and low ionic-strength constituents are prepared and disguised as routine samples. The program goal is to determine precision and bias for as many analytical methods offered by the participating laboratories as possible. The samples typically are submitted at a rate of approximately 5 percent of the annual environmental sample load for each constituent. The samples are distributed to the laboratories throughout the year. Analytical data for these reference samples reflect the quality of environmental sample data produced by the laboratories because the samples are processed in the same manner for all steps from sample login through data release. The results are stored permanently in the National Water Data Storage and Retrieval System. During water year 1991, 86 analytical procedures were evaluated at the National Water Quality Laboratory and 37 analytical procedures were evaluated at the Quality of Water Service Unit. An overall evaluation of the inorganic (major ion and trace metal) constituent data for water year 1991 indicated analytical imprecision in the National Water Quality Laboratory for 5 of 67 analytical procedures: aluminum (whole-water recoverable, atomic emission spectrometric, direct-current plasma); calcium (atomic emission spectrometric, direct); fluoride (ion-exchange chromatographic); iron (whole-water recoverable, atomic absorption spectrometric, direct); and sulfate (ion-exchange chromatographic). The results for 11 of 67 analytical procedures had positive or negative bias during water year 1991. Analytical imprecision was indicated in the determination of two of the five National Water Quality Laboratory nutrient constituents: orthophosphate as phosphorus and phosphorus. A negative or positive bias condition was indicated in three of five nutrient constituents. There was acceptable precision and no indication of bias for the 14 low ionic-strength analytical procedures tested in the National Water Quality Laboratory program and for the 32 inorganic and 5 nutrient analytical procedures tested in the Quality of Water Service Unit during water year 1991.

  14. Position paper: recommendations for a digital mammography quality assurance program V4.0.

    PubMed

    Heggie, J C P; Barnes, P; Cartwright, L; Diffey, J; Tse, J; Herley, J; McLean, I D; Thomson, F J; Grewal, R K; Collins, L T

    2017-09-01

    In 2001 the ACPSEM published a position paper on quality assurance in screen film mammography which was subsequently adopted as a basis for the quality assurance programs of both the Royal Australian and New Zealand College of Radiologists (RANZCR) and of BreastScreen Australia. Since then the clinical implementation of digital mammography has been realised and it has become evident that existing screen-film protocols were not appropriate to assure the required image quality needed for reliable diagnosis or to address the new dose implications resulting from digital technology. In addition, the advantages and responsibilities inherent in teleradiology are most critical in mammography and also need to be addressed. The current document is the result of a review of current overseas practice and local experience in these areas. At this time the technology of digital imaging is undergoing significant development and there is still a lack of full international consensus about some of the detailed quality control (QC) tests that should be included in quality assurance (QA) programs. This document describes the current status in digital mammography QA and recommends test procedures that may be suitable in the Australasian environment. For completeness, this document also includes a review of the QA programs required for the various types of digital biopsy units used in mammography. In the future, international harmonisation of digital quality assurance in mammography and changes in the technology may require a review of this document. Version 2.0 represented the first of these updates and key changes related to image quality evaluation, ghost image evaluation and interpretation of signal to noise ratio measurements. In Version 3.0 some significant changes, made in light of further experience gained in testing digital mammography equipment were introduced. In Version 4.0, further changes have been made, most notably digital breast tomosynthesis (DBT) testing and QC have been addressed. Some additional testing for conventional projection imaging has been added in order that sites may have the capability to undertake dose surveys to confirm compliance with diagnostic reference levels (DRLs) that may be established at the National or State level. A key recommendation is that dosimetry calculations are now to be undertaken using the methodology of Dance et al. Some minor changes to existing facility QC tests have been made to ensure the suggested procedures align with those most recently adopted by the Royal Australian and New Zealand College of Radiologists and BreastScreen Australia. Future updates of this document may be provided as deemed necessary in electronic format on the ACPSEM's website ( https://www.acpsem.org.au/whatacpsemdoes/standards-position-papers and see also http://www.ranzcr.edu.au/quality-a-safety/radiology/practice-quality-activities/mqap ).

  15. Standardizing lightweight deflectometer modulus measurements for compaction quality assurance : research summary.

    DOT National Transportation Integrated Search

    2017-09-01

    The mechanistic-empirical pavement design method requires the elastic resilient modulus as the key input for characterization of geomaterials. Current density-based QA procedures do not measure resilient modulus. Additionally, the density-based metho...

  16. Developing a laboratory protocol for asphalt binder recovery.

    DOT National Transportation Integrated Search

    2014-10-01

    Asphalt binder extraction and recovery are common laboratory procedures used to provide material for research and quality : assurance testing. The most common methods of recovery performed today include the Abson method and the rotary evaporator : (o...

  17. 48 CFR 246.601 - General.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 246.601 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Material Inspection and Receiving Reports 246.601 General. See Appendix F, Material Inspection and Receiving Report, for procedures and instructions for the use...

  18. 48 CFR 246.601 - General.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 246.601 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Material Inspection and Receiving Reports 246.601 General. See Appendix F, Material Inspection and Receiving Report, for procedures and instructions for the use...

  19. 48 CFR 246.601 - General.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 246.601 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Material Inspection and Receiving Reports 246.601 General. See Appendix F, Material Inspection and Receiving Report, for procedures and instructions for the use...

  20. 48 CFR 246.601 - General.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 246.601 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Material Inspection and Receiving Reports 246.601 General. See Appendix F, Material Inspection and Receiving Report, for procedures and instructions for the use...

  1. 48 CFR 246.601 - General.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 246.601 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Material Inspection and Receiving Reports 246.601 General. See Appendix F, Material Inspection and Receiving Report, for procedures and instructions for the use...

  2. Design and implementation of software for automated quality control and data analysis for a complex LC/MS/MS assay for urine opiates and metabolites.

    PubMed

    Dickerson, Jane A; Schmeling, Michael; Hoofnagle, Andrew N; Hoffman, Noah G

    2013-01-16

    Mass spectrometry provides a powerful platform for performing quantitative, multiplexed assays in the clinical laboratory, but at the cost of increased complexity of analysis and quality assurance calculations compared to other methodologies. Here we describe the design and implementation of a software application that performs quality control calculations for a complex, multiplexed, mass spectrometric analysis of opioids and opioid metabolites. The development and implementation of this application improved our data analysis and quality assurance processes in several ways. First, use of the software significantly improved the procedural consistency for performing quality control calculations. Second, it reduced the amount of time technologists spent preparing and reviewing the data, saving on average over four hours per run, and in some cases improving turnaround time by a day. Third, it provides a mechanism for coupling procedural and software changes with the results of each analysis. We describe several key details of the implementation including the use of version control software and automated unit tests. These generally useful software engineering principles should be considered for any software development project in the clinical lab. Copyright © 2012 Elsevier B.V. All rights reserved.

  3. Updated operational protocols for the U.S. Geological Survey Precipitation Chemistry Quality Assurance Project in support of the National Atmospheric Deposition Program

    USGS Publications Warehouse

    Wetherbee, Gregory A.; Martin, RoseAnn

    2017-02-06

    The U.S. Geological Survey Branch of Quality Systems operates the Precipitation Chemistry Quality Assurance Project (PCQA) for the National Atmospheric Deposition Program/National Trends Network (NADP/NTN) and National Atmospheric Deposition Program/Mercury Deposition Network (NADP/MDN). Since 1978, various programs have been implemented by the PCQA to estimate data variability and bias contributed by changing protocols, equipment, and sample submission schemes within NADP networks. These programs independently measure the field and laboratory components which contribute to the overall variability of NADP wet-deposition chemistry and precipitation depth measurements. The PCQA evaluates the quality of analyte-specific chemical analyses from the two, currently (2016) contracted NADP laboratories, Central Analytical Laboratory and Mercury Analytical Laboratory, by comparing laboratory performance among participating national and international laboratories. Sample contamination and stability are evaluated for NTN and MDN by using externally field-processed blank samples provided by the Branch of Quality Systems. A colocated sampler program evaluates the overall variability of NTN measurements and bias between dissimilar precipitation gages and sample collectors.This report documents historical PCQA operations and general procedures for each of the external quality-assurance programs from 2007 to 2016.

  4. Audits for advanced treatment dosimetry

    NASA Astrophysics Data System (ADS)

    Ibbott, G. S.; Thwaites, D. I.

    2015-01-01

    Radiation therapy has advanced rapidly over the last few decades, progressing from 3D conformal treatment to image-guided intensity modulated therapy of several different flavors, both 3D and 4D and to adaptive radiotherapy. The use of intensity modulation has increased the complexity of quality assurance and essentially eliminated the physicist's ability to judge the validity of a treatment plan, even approximately, on the basis of appearance and experience. Instead, complex QA devices and procedures are required at the institutional level. Similarly, the assessment of treatment quality through remote and on-site audits also requires greater sophistication. The introduction of 3D and 4D dosimetry into external audit systems must follow, to enable quality assurance systems to perform meaningful and thorough audits.

  5. Blood transfusion services in Delhi.

    PubMed

    Makroo, R N; Kumar, N D

    1993-04-01

    In 1991, approximately 40% of total blood requirement in Delhi was collected from commercial blood donors. The rest was supplied by voluntary and replacement donations in hospital-based blood banks and by voluntary blood recruiting agency (Indian Red Cross Society). This study analyses the standards of working and quality assurance in 26 blood transfusion centers in Delhi. The majority of these centers are ill-equipped and lack trained manpower. Most of these do not have adequate testing facilities and any standardized procedure for blood collection. Quality assurance scheme is not being followed and documentation and record maintenance is grossly inadequate. This reports also gives the recommendations for improvements of blood transfusion services in Delhi.

  6. Quality-assurance plan and field methods for quality-of-water activities, U.S. Geological Survey, Idaho National Engineering Laboratory, Idaho

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

    Mann, L.J.

    1996-10-01

    Water-quality activities at the Idaho National Engineering Laboratory (INEL) Project Office are part of the US Geological Survey`s (USGS) Water Resources Division (WRD) mission of appraising the quantity and quality of the Nation`s water resources. The purpose of the Quality Assurance Plan (QAP) for water-quality activities performed by the INEL Project Office is to maintain and improve the quality of technical products, and to provide a formal standardization, documentation, and review of the activities that lead to these products. The principles of this plan are as follows: (1) water-quality programs will be planned in a competent manner and activities willmore » be monitored for compliance with stated objectives and approaches; (2) field, laboratory, and office activities will be performed in a conscientious and professional manner in accordance with specified WRD practices and procedures by qualified and experienced employees who are well trained and supervised, if or when, WRD practices and procedures are inadequate, data will be collected in a manner that its quality will be documented; (3) all water-quality activities will be reviewed for completeness, reliability, credibility, and conformance to specified standards and guidelines; (4) a record of actions will be kept to document the activity and the assigned responsibility; (5) remedial action will be taken to correct activities that are deficient.« less

  7. Comprehensive Monitoring Program. Air Quality Data Assessment for 1989. Version 2.1. Volume 2

    DTIC Science & Technology

    1990-06-01

    Hg collected on Hopcalite TH media. 4.4.3.2 Basin F Data. Table 4.4-5 shows average and maximum metals values for the Basin F Remedial Monitoring...PMRMA. "Chemical Quality Assurance Plan." Version 1.0, July, 1989. Rathje and Marcero. 1976. "Improved Hopcalite Procedure for the Determination of

  8. Towards More Efficient Student Course Evaluations for Use at Management Level

    ERIC Educational Resources Information Center

    Rønsholdt, Bent; Brohus, Henrik

    2014-01-01

    In order to obtain an accreditation, the university management must implement a quality assurance system and be able to document that quality policy and procedures are followed and acted upon as appropriate. One element in this system is monitoring students' satisfaction. In this paper, we describe a method of acquiring the necessary information…

  9. 21 CFR 26.1 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... regulatory systems means that the systems are sufficiently comparable to assure that the process of... require that the respective regulatory systems have identical procedures. (c) Good Manufacturing Practices...

  10. 23 CFR 637.203 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Definitions. 637.203 Section 637.203 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS CONSTRUCTION INSPECTION AND APPROVAL Quality Assurance Procedures for Construction § 637.203 Definitions. Acceptance...

  11. Microbial ecology laboratory procedures manual NASA/MSFC

    NASA Technical Reports Server (NTRS)

    Huff, Timothy L.

    1990-01-01

    An essential part of the efficient operation of any microbiology laboratory involved in sample analysis is a standard procedures manual. The purpose of this manual is to provide concise and well defined instructions on routine technical procedures involving sample analysis and methods for monitoring and maintaining quality control within the laboratory. Of equal importance is the safe operation of the laboratory. This manual outlines detailed procedures to be followed in the microbial ecology laboratory to assure safety, analytical control, and validity of results.

  12. The role of field auditing in environmental quality assurance management.

    PubMed

    Claycomb, D R

    2000-01-01

    Environmental data quality improvement continues to focus on analytical laboratoryperformance with little, if any, attention given to improving the performance of field consultants responsible for sample collection. Many environmental professionals often assume that the primary opportunity for data error lies within the activities conducted by the laboratory. Experience in the evaluation of environmental data and project-wide quality assurance programs indicates that an often-ignored factor affecting environmental data quality is the manner in which a sample is acquired and handled in the field. If a sample is not properly collected, preserved, stored, and transported in the field, even the best laboratory practices and analytical methods cannot deliver accurate and reliable data (i.e., bad data in equals bad data out). Poor quality environmental data may result in inappropriate decisions regarding site characterization and remedial action. Field auditing is becoming an often-employed technique for examining the performance of the environmental sampling field team and how their performance may affect data quality. The field audits typically focus on: (1) verifying that field consultants adhere to project control documents (e.g., Work Plans and Standard Operating Procedures [SOPs]) during field operations; (2) providing third-party independent assurance that field procedures, quality assurance/ quality control (QA/QC)protocol, and field documentation are sufficient to produce data of satisfactory quality; (3) providing a defense in the event that field procedures are called into question; and (4) identifying ways to reduce sampling costs. Field audits are typically most effective when performed on a surprise basis; that is, the sampling contractor may be aware that a field audit will be conducted during some phase of sampling activities but is not informed of the specific day(s) that the audit will be conducted. The audit also should be conducted early on in the sampling program such that deficiencies noted during the audit can be addressed before the majority of field activities have been completed. A second audit should be performed as a follow-up to confirm that the recommended changes have been implemented. A field auditor is assigned to the project by matching, as closely as possible, the auditor's experience with the type of field activities being conducted. The auditor uses a project-specific field audit checklist developed from key information contained in project control documents. Completion of the extensive audit checklist during the audit focuses the auditor on evaluating each aspect of field activities being performed. Rather than examine field team performance after sampling, a field auditor can do so while the samples are being collected and can apply real-time corrective action as appropriate. As a result of field audits, responsible parties often observe vast improvements in their consultant's field procedures and, consequently, receive more reliable and representative field data at a lower cost. The cost savings and improved data quality that result from properly completed field audits make the field auditing process both cost-effective and functional.

  13. Between Site Reliability of Startle Prepulse Inhibition Across Two Early Psychosis Consortia

    PubMed Central

    Addington, Jean; Cannon, Tyrone D.; Cornblatt, Barbara A.; de la Fuente-Sandoval, Camilo; Mathalon, Dan H.; Perkins, Diana O.; Seidman, Larry J.; Tsuang, Ming; Walker, Elaine F.; Woods, Scott W.; Bachman, Peter; Belger, Ayse; Carrión, Ricardo E.; Donkers, Franc C.L.; Duncan, Erica; Johannesen, Jason; León-Ortiz, Pablo; Light, Gregory; Mondragón, Alejandra; Niznikiewicz, Margaret; Nunag, Jason; Roach, Brian J.; Solís-Vivanco, Rodolfo

    2014-01-01

    Prepulse inhibition (PPI) and reactivity of the acoustic startle response are widely used biobehavioral markers in psychopathology research. Previous studies have demonstrated that PPI and startle reactivity exhibit substantial within-site stability; between-site stability, however, has not been established. In two separate consortia investigating biomarkers of early psychosis, traveling subjects studies were performed as part of quality assurance procedures in order to assess the fidelity of data across sites. In the North American Prodromal Longitudinal Studies (NAPLS) Consortium, 8 normal subjects traveled to each of the 8 NAPLS sites and were tested twice at each site on the startle PPI paradigm. In preparation for a binational study, 10 healthy subjects were assessed twice in both San Diego and Mexico City. Intraclass correlations between and within sites were significant for PPI and startle response parameters, confirming the reliability of startle measures across sites in both consortia. There were between site differences in startle magnitude in the NAPLS study that did not appear to be related to methods or equipment. In planning multi-site studies, it is essential to institute quality assurance procedures early and establish between site reliability to assure comparable data across sites. PMID:23799460

  14. A Method for Developing Standard Patient Education Program.

    PubMed

    Lura, Carolina Bryne; Hauch, Sophie Misser Pallesgaard; Gøeg, Kirstine Rosenbeck; Pape-Haugaard, Louise

    2018-01-01

    In Denmark, patients being treated on Haematology Outpatients Departments get instructed to self-manage their blood sample collection from Central Venous Catheter (CVC). However, this is a complex and risky procedure, which can jeopardize patient safety. The aim of the study was to suggest a method for developing standard digital patient education programs for patients in self-administration of blood samples drawn from CVC. The Design Science Research Paradigm was used to develop a digital patient education program, called PAVIOSY, to increase patient safety during execution of the blood sample collection procedure by using videos for teaching as well as procedural support. A step-by-step guide was developed and used as basis for making the videos. Quality assurance through evaluation with a nurse was conducted on both the step-by-step guide and the videos. The quality assurance evaluation of the videos showed; 1) Errors due to the order of the procedure can be determined by reviewing the videos despite that the guide was followed. 2) Videos can be used to identify errors - important for patient safety - in the procedure, which are not identifiable in a written script. To ensure correct clinical content of the educational patient system, health professionals must be engaged early in the development of content and design phase.

  15. Long-term observations of tropospheric particle number size distributions and equivalent black carbon mass concentrations in the German Ultrafine Aerosol Network (GUAN)

    NASA Astrophysics Data System (ADS)

    Birmili, W.; Weinhold, K.; Merkel, M.; Rasch, F.; Sonntag, A.; Wiedensohler, A.; Bastian, S.; Schladitz, A.; Löschau, G.; Cyrys, J.; Pitz, M.; Gu, J.; Kusch, T.; Flentje, H.; Quass, U.; Kaminski, H.; Kuhlbusch, T. A. J.; Meinhardt, F.; Schwerin, A.; Bath, O.; Ries, L.; Wirtz, K.; Fiebig, M.

    2015-11-01

    The German Ultrafine Aerosol Network (GUAN) is a cooperative atmospheric observation network, which aims at improving the scientific understanding of aerosol-related effects in the troposphere. The network addresses research questions dedicated to both, climate and health related effects. GUAN's core activity has been the continuous collection of tropospheric particle number size distributions and black carbon mass concentrations at seventeen observation sites in Germany. These sites cover various environmental settings including urban traffic, urban background, rural background, and Alpine mountains. In association with partner projects, GUAN has implemented a high degree of harmonisation of instrumentation, operating procedures, and data evaluation procedures. The quality of the measurement data is assured by laboratory intercomparisons as well as on-site comparisons with reference instruments. This paper describes the measurement sites, instrumentation, quality assurance and data evaluation procedures in the network as well as the EBAS repository, where the data sets can be obtained (doi:10.5072/guan).

  16. Long-term observations of tropospheric particle number size distributions and equivalent black carbon mass concentrations in the German Ultrafine Aerosol Network (GUAN)

    NASA Astrophysics Data System (ADS)

    Birmili, Wolfram; Weinhold, Kay; Rasch, Fabian; Sonntag, André; Sun, Jia; Merkel, Maik; Wiedensohler, Alfred; Bastian, Susanne; Schladitz, Alexander; Löschau, Gunter; Cyrys, Josef; Pitz, Mike; Gu, Jianwei; Kusch, Thomas; Flentje, Harald; Quass, Ulrich; Kaminski, Heinz; Kuhlbusch, Thomas A. J.; Meinhardt, Frank; Schwerin, Andreas; Bath, Olaf; Ries, Ludwig; Gerwig, Holger; Wirtz, Klaus; Fiebig, Markus

    2016-08-01

    The German Ultrafine Aerosol Network (GUAN) is a cooperative atmospheric observation network, which aims at improving the scientific understanding of aerosol-related effects in the troposphere. The network addresses research questions dedicated to both climate- and health-related effects. GUAN's core activity has been the continuous collection of tropospheric particle number size distributions and black carbon mass concentrations at 17 observation sites in Germany. These sites cover various environmental settings including urban traffic, urban background, rural background, and Alpine mountains. In association with partner projects, GUAN has implemented a high degree of harmonisation of instrumentation, operating procedures, and data evaluation procedures. The quality of the measurement data is assured by laboratory intercomparisons as well as on-site comparisons with reference instruments. This paper describes the measurement sites, instrumentation, quality assurance, and data evaluation procedures in the network as well as the EBAS repository, where the data sets can be obtained (doi:10.5072/guan).

  17. The SCALE Verified, Archived Library of Inputs and Data - VALID

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

    Marshall, William BJ J; Rearden, Bradley T

    The Verified, Archived Library of Inputs and Data (VALID) at ORNL contains high quality, independently reviewed models and results that improve confidence in analysis. VALID is developed and maintained according to a procedure of the SCALE quality assurance (QA) plan. This paper reviews the origins of the procedure and its intended purpose, the philosophy of the procedure, some highlights of its implementation, and the future of the procedure and associated VALID library. The original focus of the procedure was the generation of high-quality models that could be archived at ORNL and applied to many studies. The review process associated withmore » model generation minimized the chances of errors in these archived models. Subsequently, the scope of the library and procedure was expanded to provide high quality, reviewed sensitivity data files for deployment through the International Handbook of Evaluated Criticality Safety Benchmark Experiments (IHECSBE). Sensitivity data files for approximately 400 such models are currently available. The VALID procedure and library continue fulfilling these multiple roles. The VALID procedure is based on the quality assurance principles of ISO 9001 and nuclear safety analysis. Some of these key concepts include: independent generation and review of information, generation and review by qualified individuals, use of appropriate references for design data and documentation, and retrievability of the models, results, and documentation associated with entries in the library. Some highlights of the detailed procedure are discussed to provide background on its implementation and to indicate limitations of data extracted from VALID for use by the broader community. Specifically, external users of data generated within VALID must take responsibility for ensuring that the files are used within the QA framework of their organization and that use is appropriate. The future plans for the VALID library include expansion to include additional experiments from the IHECSBE, to include experiments from areas beyond criticality safety, such as reactor physics and shielding, and to include application models. In the future, external SCALE users may also obtain qualification under the VALID procedure and be involved in expanding the library. The VALID library provides a pathway for the criticality safety community to leverage modeling and analysis expertise at ORNL.« less

  18. Development of quality measures for monitoring and improving care in gastroenterology.

    PubMed

    Germansky, Katharine A; Leffler, Daniel A

    2011-06-01

    Over the past decade, most quality assurance (QA) efforts in gastroenterology have been aimed at endoscopy. Endoscopic quality improvement was the rational area to begin QA work in gastroenterology due to the relatively acute nature of complications and the high volume of procedures performed. While endoscopy is currently the focus of most quality assurance (QA) measures in gastroenterology, more recent efforts have begun to address clinical gastroenterology practices both in the outpatient and inpatient settings. Clinical outpatient and inpatient gastroenterology is laden with areas where standardization could benefit patient care. While data and experience in clinical gastroenterology QA is relatively limited, it is clear that inconsistent use of guidelines and practice variations in gastroenterology can lead to lower quality care. In this review, we review a variety of areas in clinical gastroenterology where existing guidelines and published data suggest both the need and practicality of active QA measures. Copyright © 2011 Elsevier Ltd. All rights reserved.

  19. A survey on auditing, quality assurance systems and legal frameworks in five selected slaughterhouses in Bulawayo, south-western Zimbabwe.

    PubMed

    Masanganise, Kaurai E; Matope, Gift; Pfukenyi, Davies M

    2013-01-01

    The purpose of this study was to explore the audits, quality assurance (QA) programmes and legal frameworks used in selected abattoirs in Zimbabwe and slaughterhouse workers' perceptions on their effectiveness. Data on slaughterhouse workers was gathered through a self-completed questionnaire and additional information was obtained from slaughterhouse and government records. External auditing was conducted mainly by the Department of Veterinary Public Health with little contribution from third parties. Internal auditing was restricted to export abattoirs. The checklist used on auditing lacked objective assessment criteria and respondents cited several faults in the current audit system. Most respondents (> 50.0%) knew the purposes and benefits of audit and QA inspections. All export abattoirs had QA programmes such as hazard analysis critical control point and ISO 9001 (a standard used to certify businesses' quality management systems) but their implementation varied from minimal to nil. The main regulatory defect observed was lack of requirements for a QA programme. Audit and quality assurance communications to the selected abattoirs revealed a variety of non-compliances with most respondents revealing that corrective actions to audit (84.3%) and quality assurance (92.3%) shortfalls were not done. A high percentage of respondents indicated that training on quality (76.8%) and regulations (69.8%) was critical. Thus, it is imperative that these abattoirs develop a food safety management system comprising of QA programmes, a microbial assessment scheme, regulatory compliance, standard operating procedures, internal and external auditing and training of workers.

  20. Changes in dialysis treatment modalities during institution of flat rate reimbursement and quality assurance programs.

    PubMed

    Kleophas, Werner; Karaboyas, Angelo; Li, Yun; Bommer, Juergen; Reichel, Helmut; Walter, Andreas; Icks, Andrea; Rump, Lars C; Pisoni, Ronald L; Robinson, Bruce M; Port, Friedrich K

    2013-09-01

    Dialysis procedure rates in Germany were changed in 2002 from per-session to weekly flat rate payments, and quality assurance was introduced in 2009 with defined treatment targets for spKt/V, dialysis frequency, treatment time, and hemoglobin. In order to understand trends in treatment parameters before and after the introduction of these changes, we analyzed data from 407 to 618 prevalent patients each year (hemodialysis over 90 days) in 14-21 centers in cross-sections of the Dialysis Outcomes and Practice Patterns Study (phases 1-4, 1998-2011). Descriptive statistics were used to report differences over time in the four quality assurance parameters along with erythropoietin-stimulating agent (ESA) and intravenous iron doses. Time trends were analyzed using linear mixed models adjusted for patient demographics and comorbidities. The proportion of patients with short treatment times (less than 4 h) and low spKt/V (below 1.2) improved throughout the study and was lowest after implementation of quality assurance. Hemoglobin levels have increased since 1998 and remained consistent since 2005, with only 8-10% of patients below 10 g/dl. About 90% of patients were prescribed ESAs, with the dose declining since peaking in 2006. Intravenous iron use was highest in 2011. Hence, trends to improve quality metrics for hemodialysis have been established in Germany even after introduction of flat rate reimbursement. Thus, analysis of facility practice patterns is needed to maintain quality of care in a cost-containment environment.

  1. 24 CFR 3282.204 - IPIA services.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVELOPMENT MANUFACTURED HOME PROCEDURAL AND ENFORCEMENT REGULATIONS Manufacturer Inspection and Certification... DAPIA approved design and the quality assurance manual for that plant, and the IPIA shall perform an... to conform with the DAPIA approved designs and manuals. After the corrections required by the...

  2. 24 CFR 3282.201 - Scope and purpose.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... manufacturers of manufactured homes for sale to purchasers in the United States with respect to certification of manufactured home designs, inspection of designs, quality assurance programs, and manufactured home production... DEVELOPMENT MANUFACTURED HOME PROCEDURAL AND ENFORCEMENT REGULATIONS Manufacturer Inspection and Certification...

  3. 48 CFR 46.601 - General.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false General. 46.601 Section 46.601 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Material Inspection and Receiving Reports 46.601 General. Agencies shall prescribe procedures and...

  4. 48 CFR 2846.601 - General.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true General. 2846.601 Section 2846.601 Federal Acquisition Regulations System DEPARTMENT OF JUSTICE Contract Management QUALITY ASSURANCE Material Inspection and Receiving Reports 2846.601 General. Bureaus shall prescribe procedures and...

  5. [Compatibility of different quality control systems].

    PubMed

    Invernizzi, Enrico

    2002-01-01

    Management of the good laboratory practice (GLP) quality system presupposes its linking to a basic recognized and approved quality system, from which it can draw on management procedures common to all quality systems, such as the ISO 9000 set of norms. A quality system organized in this way can also be integrated with other dedicated quality systems, or parts of them, to obtain principles or management procedures for specific topics. The aim of this organization is to set up a reliable, recognized quality system compatible with the principles of GLP and other quality management systems, which provides users with a simplified set of easily accessible management tools and answers. The organization of this quality system is set out in the quality assurance programme, which is actually the document in which the test facility incorporates the GLP principles into its own quality organization.

  6. Requirements for Printed Wiring Boards

    NASA Technical Reports Server (NTRS)

    1984-01-01

    In order to maintain the high standards of the NASA printed wiring programs, this publication: prescribes NASA's requirements for assuring reliable rigid printed wiring boards; describes and incorporates basic considerations necessary to assure reliable rigid printed wiring boards; establishes the supplier's responsibility to train and certify personnel; provides for supplier documentation of the fabrication and inspection procedures to be used for NASA work, including supplier innovations and changes in technology; and provides visual workmanship standards to aid those responsible for determining quality conformance to the established requirements.

  7. The relationship between motivation, monetary compensation, and data quality among US- and India-based workers on Mechanical Turk.

    PubMed

    Litman, Leib; Robinson, Jonathan; Rosenzweig, Cheskie

    2015-06-01

    In this study, we examined data quality among Amazon Mechanical Turk (MTurk) workers based in India, and the effect of monetary compensation on their data quality. Recent studies have shown that work quality is independent of compensation rates, and that compensation primarily affects the quantity but not the quality of work. However, the results of these studies were generally based on compensation rates below the minimum wage, and far below a level that was likely to play a practical role in the lives of workers. In this study, compensation rates were set around the minimum wage in India. To examine data quality, we developed the squared discrepancy procedure, which is a task-based quality assurance approach for survey tasks whose goal is to identify inattentive participants. We showed that data quality is directly affected by compensation rates for India-based participants. We also found that data were of a lesser quality among India-based than among US participants, even when optimal payment strategies were utilized. We additionally showed that the motivation of MTurk users has shifted, and that monetary compensation is now reported to be the primary reason for working on MTurk, among both US- and India-based workers. Overall, MTurk is a constantly evolving marketplace where multiple factors can contribute to data quality. High-quality survey data can be acquired on MTurk among India-based participants when an appropriate pay rate is provided and task-specific quality assurance procedures are utilized.

  8. Statistical evaluation of PACSTAT random number generation capabilities

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

    Piepel, G.F.; Toland, M.R.; Harty, H.

    1988-05-01

    This report summarizes the work performed in verifying the general purpose Monte Carlo driver-program PACSTAT. The main objective of the work was to verify the performance of PACSTAT's random number generation capabilities. Secondary objectives were to document (using controlled configuration management procedures) changes made in PACSTAT at Pacific Northwest Laboratory, and to assure that PACSTAT input and output files satisfy quality assurance traceability constraints. Upon receipt of the PRIME version of the PACSTAT code from the Basalt Waste Isolation Project, Pacific Northwest Laboratory staff converted the code to run on Digital Equipment Corporation (DEC) VAXs. The modifications to PACSTAT weremore » implemented using the WITNESS configuration management system, with the modifications themselves intended to make the code as portable as possible. Certain modifications were made to make the PACSTAT input and output files conform to quality assurance traceability constraints. 10 refs., 17 figs., 6 tabs.« less

  9. 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.

  10. Extending cluster Lot Quality Assurance Sampling designs for surveillance programs

    PubMed Central

    Hund, Lauren; Pagano, Marcello

    2014-01-01

    Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance based on the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible non-parametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. PMID:24633656

  11. (abstract) Mission Operations and Control Assurance: Flight Operations Quality Improvements

    NASA Technical Reports Server (NTRS)

    Welz, Linda L.; Bruno, Kristin J.; Kazz, Sheri L.; Witkowski, Mona M.

    1993-01-01

    Mission Operations and Command Assurance (MO&CA), a recent addition to flight operations teams at JPL. provides a system level function to instill quality in mission operations. MO&CA's primary goal at JPL is to help improve the operational reliability for projects during flight. MO&CA tasks include early detection and correction of process design and procedural deficiencies within projects. Early detection and correction are essential during development of operational procedures and training of operational teams. MO&CA's effort focuses directly on reducing the probability of radiating incorrect commands to a spacecraft. Over the last seven years at JPL, MO&CA has become a valuable asset to JPL flight projects. JPL flight projects have benefited significantly from MO&CA's efforts to contain risk and prevent rather than rework errors. MO&CA's ability to provide direct transfer of knowledge allows new projects to benefit directly from previous and ongoing experience. Since MO&CA, like Total Quality Management (TQM), focuses on continuous improvement of processes and elimination of rework, we recommend that this effort be continued on NASA flight projects.

  12. The Impact of Quality Assurance Initiatives and Workplace Policies and Procedures on HIV/AIDS-Related Stigma Experienced by Patients and Nurses in Regions with High Prevalence of HIV/AIDS.

    PubMed

    Hewko, Sarah J; Cummings, Greta G; Pietrosanu, Matthew; Edwards, Nancy

    2018-02-23

    Stigma is commonly experienced by people living with HIV/AIDS and by those providing care to HIV/AIDS patients. Few intervention studies have explored the impact of workplace policies and/or quality improvement on stigma. We examine the contribution of health care workplace policies, procedures and quality assurance initiatives, and self- and peer-assessed individual nurse practices, to nurse-reported HIV/AIDS-stigma practices toward patients living with HIV/AIDS and nurses in health care settings. Our sample of survey respondents (n = 1157) included managers (n = 392) and registered/enrolled nurses (n = 765) from 29 facilities in 4 countries (South Africa, Uganda, Jamaica, Kenya). This is one of the first studies in LMIC countries to use hierarchical linear modeling to examine the contributions of organizational and individual factors to HIV/AIDS stigma. Based on our results, we argue that organizational interventions explicitly targeting HIV/AIDS stigma are required to reduce the incidence, prevalence and morbidity of HIV/AIDS.

  13. Scientific Framework for Stormwater Monitoring by the Washington State Department of Transportation

    USGS Publications Warehouse

    Sheibley, R.W.; Kelly, V.J.; Wagner, R.J.

    2009-01-01

    The Washington State Department of Transportation municipal stormwater monitoring program, in operation for about 8 years, never has received an external, objective assessment. In addition, the Washington State Department of Transportation would like to identify the standard operating procedures and quality assurance protocols that must be adopted so that their monitoring program will meet the requirements of the new National Pollutant Discharge Elimination System municipal stormwater permit. As a result, in March 2009, the Washington State Department of Transportation asked the U.S. Geological Survey to assess their pre-2009 municipal stormwater monitoring program. This report presents guidelines developed for the Washington State Department of Transportation to meet new permit requirements and regional/national stormwater monitoring standards to ensure that adequate processes and procedures are identified to collect high-quality, scientifically defensible municipal stormwater monitoring data. These include: (1) development of coherent vision and cooperation among all elements of the program; (2) a comprehensive approach for site selection; (3) an effective quality assurance program for field, laboratory, and data management; and (4) an adequate database and data management system.

  14. Extending cluster lot quality assurance sampling designs for surveillance programs.

    PubMed

    Hund, Lauren; Pagano, Marcello

    2014-07-20

    Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance on the basis of the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible nonparametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. Copyright © 2014 John Wiley & Sons, Ltd.

  15. 77 FR 4940 - Determination of Failure To Attain by 2005 and Determination of Current Attainment of the 1-Hour...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... missing data, the procedures in appendix H to 40 CFR part 50 are used to adjust the actual number of..., quality-assured and certified ambient air quality monitoring data for 2003 through 2005. In addition, EPA... and certified ambient air monitoring data showing the area has monitored attainment of the 1-hour...

  16. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... transmitters of an orifice-, nozzle-, or venturi-type fuel flowmeter under section 2.1.6 of appendix D to this... nozzle) of an orifice-, venturi-, or nozzle-type fuel flowmeter. Examples of the types of information to..., but ≤200 ppm). The out-of-control period begins upon failure of the calibration error test and ends...

  17. Quality systems in veterinary diagnostics laboratories.

    PubMed

    de Branco, Freitas Maia L M

    2007-01-01

    Quality assurance of services provided by veterinary diagnostics laboratories is a fundamental element promoted by international animal health organizations to establish trust, confidence and transparency needed for the trade of animals and their products at domestic and international levels. It requires, among other things, trained personnel, consistent and rigorous methodology, choice of suitable methods as well as appropriate calibration and traceability procedures. An important part of laboratory quality management is addressed by ISO/IEC 17025, which aims to facilitate cooperation among laboratories and their associated parties by assuring the generation of credible and consistent information derived from analytical results. Currently, according to OIE recommendation, veterinary diagnostics laboratories are only subject to voluntary compliance with standard ISO/IEC 17025; however, it is proposed here that OIE reference laboratories and collaboration centres strongly consider its adoption.

  18. 40 CFR Appendix A to Part 58 - Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... in section 4.3.1 of this appendix. 3.2.7PM2.5 Performance Evaluation Program (PEP) Procedures. The... evaluation audit means that both the primary monitor and PEP audit concentrations are valid and above 3 µg/m3... Evaluation Program (PEP) Procedures. Each year, one performance evaluation audit, as described in section 3.2...

  19. 40 CFR Appendix A to Part 58 - Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... in section 4.3.1 of this appendix. 3.2.7PM2.5 Performance Evaluation Program (PEP) Procedures. The... evaluation audit means that both the primary monitor and PEP audit concentrations are valid and above 3 µg/m3... Evaluation Program (PEP) Procedures. Each year, one performance evaluation audit, as described in section 3.2...

  20. 10 CFR 63.144 - Quality assurance program change.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

  1. 10 CFR 63.144 - Quality assurance program change.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

  2. 10 CFR 63.144 - Quality assurance program change.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

  3. If Unprofessional Conduct Is Charged by the California Board of Medical Quality Assurance

    PubMed Central

    Regardie, Arnold G.

    1977-01-01

    The right of a physician to practice his or her chosen profession must be balanced against the right of the public to be protected from unprofessional conduct by physicians. By providing notice and a hearing before imposing discipline, if any, on a physician for unprofessional conduct, the California Board of Medical Quality Assurance meets the basic requirements of procedural due process. However, although the constitutional rights of the physician may be protected in this way, the administrative disciplinary process itself is likely to be an arduous experience. A basic understanding of the nature and legal effect of such disciplinary proceedings may assist a physician in defending against the charges. PMID:919549

  4. Impact of changes in profile measurement technology on QA testing of pavement smoothness : project summary.

    DOT National Transportation Integrated Search

    2013-08-31

    For quality assurance testing, the Texas Department of Transportations (TxDOTs) Item 585 ride specification includes pay adjustment schedules that are tied to the average international roughness index (IRI), and a procedure to locate defects ba...

  5. AN AUDITING FRAMEWORK TO SUBSTANTIATE ELECTRONIC RECORDKEEPING PRACTICES

    EPA Science Inventory

    Quality assurance audits of computer systems help to ensure that the end data meet the needs of the user. Increasingly complex systems require the stepwise procedures outlined below.

    The areas reviewed in this paper include both technical and evidentiary criteria. I...

  6. Analysis of Construction Quality Assurance Procedures on Federally Funded Local Public Agency Projects

    DOT National Transportation Integrated Search

    2016-07-01

    Approximately 20 percent of the Federal-aid highway program is invested in local public agency (LPA) infrastructure projects, which is a significant portion of total Federal funds allocated to highway construction projects in the United States. In re...

  7. Quality Assurance of Real-Time Oceanographic Data from the Cabled Array of the Ocean Observatories Initiative

    NASA Astrophysics Data System (ADS)

    Kawka, O. E.; Nelson, J. S.; Manalang, D.; Kelley, D. S.

    2016-02-01

    The Cabled Array component of the NSF-funded Ocean Observatories Initiative (OOI) provides access to real-time physical, chemical, geological, and biological data from water column and seafloor platforms/instruments at sites spanning the southern half of the Juan de Fuca Plate. The Quality Assurance (QA) program for OOI data is designed to ensure that data products meet OOI science requirements. This overall data QA plan establishes the guidelines for assuring OOI data quality and summarizes Quality Control (QC) protocols and procedures, based on best practices, which can be utilized to ensure the highest quality data across the OOI program. This presentation will highlight, specifically, the QA/QC approach being utilized for the OOI Cabled Array infrastructure and data and will include a summary of both shipboard and shore-based protocols currently in use. Aspects addressed will be pre-deployment instrument testing and calibration checks, post-deployment and pre-recovery field verification of data, and post-recovery "as-found" testing of instruments. Examples of QA/QC data will be presented and specific cases of cabled data will be discussed in the context of quality assessments and adjustment/correction of OOI datasets overall for inherent sensor drift and/or instrument fouling.

  8. [Evaluating the rehabilitation process by means of peer review: examination of the methods used and findings of the 2000/2001 data collection in the somatic indications].

    PubMed

    Farin, E; Carl, C; Lichtenberg, S; Jäckel, W H; Maier-Riehle, B; Rütten-Köppel, E

    2003-12-01

    This paper reports the results of a peer review system that was implemented in the context of the quality assurance programme of the statutory German Pension Insurance scheme. The data reported refer to the 2000/2001 data collection period for medical rehabilitation in the somatic indications. Examination of inter-rater reliability for judgements of individual raters shows satisfactory results only in orthopaedics. In the quality assurance programme, rehabilitation centres are usually evaluated by the mean of 20 rater judgements. The reliability of this aggregated measure is satisfactory in all indications. The results of 561 rehabilitation centres show that those quality criteria are in particular need of improvement that refer to subjective concepts of patients (e. g., subjective theories of illness). Between peer review procedures in 1998 and 1999, the quality scores of rehabilitation centres had improved whereas between 1999 and 2000/2001, no further improvement can be shown. However, those rehabilitation centres with a low quality score in 1999 (lowest quartile of the distribution) underwent a positive development between 1999 and 2000/2001. Reasons for this trend and possibilities for improving interrater reliability of the peer review process as an element of the quality assurance programme of the German Pension Insurance scheme are discussed.

  9. NASA software documentation standard software engineering program

    NASA Technical Reports Server (NTRS)

    1991-01-01

    The NASA Software Documentation Standard (hereinafter referred to as Standard) can be applied to the documentation of all NASA software. This Standard is limited to documentation format and content requirements. It does not mandate specific management, engineering, or assurance standards or techniques. This Standard defines the format and content of documentation for software acquisition, development, and sustaining engineering. Format requirements address where information shall be recorded and content requirements address what information shall be recorded. This Standard provides a framework to allow consistency of documentation across NASA and visibility into the completeness of project documentation. This basic framework consists of four major sections (or volumes). The Management Plan contains all planning and business aspects of a software project, including engineering and assurance planning. The Product Specification contains all technical engineering information, including software requirements and design. The Assurance and Test Procedures contains all technical assurance information, including Test, Quality Assurance (QA), and Verification and Validation (V&V). The Management, Engineering, and Assurance Reports is the library and/or listing of all project reports.

  10. A Strategy to Establish a Quality Assurance/Quality Control Plan for the Application of Biosensors for the Detection of E. coli in Water.

    PubMed

    Hesari, Nikou; Kıratlı Yılmazçoban, Nursel; Elzein, Mohamad; Alum, Absar; Abbaszadegan, Morteza

    2017-01-03

    Rapid bacterial detection using biosensors is a novel approach for microbiological testing applications. Validation of such methods is an obstacle in the adoption of new bio-sensing technologies for water testing. Therefore, establishing a quality assurance and quality control (QA/QC) plan is essential to demonstrate accuracy and reliability of the biosensor method for the detection of E. coli in drinking water samples. In this study, different reagents and assay conditions including temperatures, holding time, E. coli strains and concentrations, dissolving agents, salinity and pH effects, quality of substrates of various suppliers of 4-methylumbelliferyl glucuronide (MUG), and environmental water samples were included in the QA/QC plan and used in the assay optimization and documentation. Furthermore, the procedural QA/QC for the monitoring of drinking water samples was established to validate the performance of the biosensor platform for the detection of E. coli using a culture-based standard technique. Implementing the developed QA/QC plan, the same level of precision and accuracy was achieved using both the standard and the biosensor methods. The established procedural QA/QC for the biosensor will provide a reliable tool for a near real-time monitoring of E. coli in drinking water samples to both industry and regulatory authorities.

  11. A Strategy to Establish a Quality Assurance/Quality Control Plan for the Application of Biosensors for the Detection of E. coli in Water

    PubMed Central

    Hesari, Nikou; Kıratlı Yılmazçoban, Nursel; Elzein, Mohamad; Alum, Absar; Abbaszadegan, Morteza

    2017-01-01

    Rapid bacterial detection using biosensors is a novel approach for microbiological testing applications. Validation of such methods is an obstacle in the adoption of new bio-sensing technologies for water testing. Therefore, establishing a quality assurance and quality control (QA/QC) plan is essential to demonstrate accuracy and reliability of the biosensor method for the detection of E. coli in drinking water samples. In this study, different reagents and assay conditions including temperatures, holding time, E. coli strains and concentrations, dissolving agents, salinity and pH effects, quality of substrates of various suppliers of 4-methylumbelliferyl glucuronide (MUG), and environmental water samples were included in the QA/QC plan and used in the assay optimization and documentation. Furthermore, the procedural QA/QC for the monitoring of drinking water samples was established to validate the performance of the biosensor platform for the detection of E. coli using a culture-based standard technique. Implementing the developed QA/QC plan, the same level of precision and accuracy was achieved using both the standard and the biosensor methods. The established procedural QA/QC for the biosensor will provide a reliable tool for a near real-time monitoring of E. coli in drinking water samples to both industry and regulatory authorities. PMID:28054956

  12. 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.

  13. The University of Texas Houston Stroke Registry (UTHSR): implementation of enhanced data quality assurance procedures improves data quality

    PubMed Central

    2013-01-01

    Background Limited information has been published regarding standard quality assurance (QA) procedures for stroke registries. We share our experience regarding the establishment of enhanced QA procedures for the University of Texas Houston Stroke Registry (UTHSR) and evaluate whether these QA procedures have improved data quality in UTHSR. Methods All 5093 patient records that were abstracted and entered in UTHSR, between January 1, 2008 and December 31, 2011, were considered in this study. We conducted reliability and validity studies. For reliability and validity of data captured by abstractors, a random subset of 30 records was used for re-abstraction of select key variables by two abstractors. These 30 records were re-abstracted by a team of experts that included a vascular neurologist clinician as the “gold standard”. We assessed inter-rater reliability (IRR) between the two abstractors as well as validity of each abstractor with the “gold standard”. Depending on the scale of variables, IRR was assessed with Kappa or intra-class correlations (ICC) using a 2-way, random effects ANOVA. For assessment of validity of data in UTHSR we re-abstracted another set of 85 patient records for which all discrepant entries were adjudicated by a vascular neurology fellow clinician and added to the set of our “gold standard”. We assessed level of agreement between the registry data and the “gold standard” as well as sensitivity and specificity. We used logistic regression to compare error rates for different years to assess whether a significant improvement in data quality has been achieved during 2008–2011. Results The error rate dropped significantly, from 4.8% in 2008 to 2.2% in 2011 (P < 0.001). The two abstractors had an excellent IRR (Kappa or ICC ≥ 0.75) on almost all key variables checked. Agreement between data in UTHSR and the “gold standard” was excellent for almost all categorical and continuous variables. Conclusions Establishment of a rigorous data quality assurance for our UTHSR has helped to improve the validity of data. We observed an excellent IRR between the two abstractors. We recommend training of chart abstractors and systematic assessment of IRR between abstractors and validity of the abstracted data in stroke registries. PMID:23767957

  14. 48 CFR 246.470 - Government contract quality assurance actions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... quality assurance actions. 246.470 Section 246.470 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.470 Government contract quality assurance actions. ...

  15. Quality control and quality assurance plan for bridge channel-stability assessments in Massachusetts

    USGS Publications Warehouse

    Parker, Gene W.; Pinson, Harlow

    1993-01-01

    A quality control and quality assurance plan has been implemented as part of the Massachusetts bridge scour and channel-stability assessment program. This program is being conducted by the U.S. Geological Survey, Massachusetts-Rhode Island District, in cooperation with the Massachusetts Highway Department. Project personnel training, data-integrity verification, and new data-management technologies are being utilized in the channel-stability assessment process to improve current data-collection and management techniques. An automated data-collection procedure has been implemented to standardize channel-stability assessments on a regular basis within the State. An object-oriented data structure and new image management tools are used to produce a data base enabling management of multiple data object classes. Data will be reviewed by assessors and data base managers before being merged into a master bridge-scour data base, which includes automated data-verification routines.

  16. Long-Term Ecological Monitoring Field Sampling Plan for 2007

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

    T. Haney

    2007-07-31

    This field sampling plan describes the field investigations planned for the Long-Term Ecological Monitoring Project at the Idaho National Laboratory Site in 2007. This plan and the Quality Assurance Project Plan for Waste Area Groups 1, 2, 3, 4, 5, 6, 7, 10, and Removal Actions constitute the sampling and analysis plan supporting long-term ecological monitoring sampling in 2007. The data collected under this plan will become part of the long-term ecological monitoring data set that is being collected annually. The data will be used t determine the requirements for the subsequent long-term ecological monitoring. This plan guides the 2007more » investigations, including sampling, quality assurance, quality control, analytical procedures, and data management. As such, this plan will help to ensure that the resulting monitoring data will be scientifically valid, defensible, and of known and acceptable quality.« less

  17. A failure modes and effects analysis study for gynecologic high-dose-rate brachytherapy.

    PubMed

    Mayadev, Jyoti; Dieterich, Sonja; Harse, Rick; Lentz, Susan; Mathai, Mathew; Boddu, Sunita; Kern, Marianne; Courquin, Jean; Stern, Robin L

    2015-01-01

    To improve the quality of our gynecologic brachytherapy practice and reduce reportable events, we performed a process analysis after the failure modes and effects analysis (FMEA). The FMEA included a multidisciplinary team specifically targeting the tandem and ring brachytherapy procedure. The treatment process was divided into six subprocesses and failure modes (FMs). A scoring guideline was developed based on published FMEA studies and assigned through team consensus. FMs were ranked according to overall and severity scores. FM ranking >5% of the highest risk priority number (RPN) score was selected for in-depth analysis. The efficiency of each existing quality assurance to detect each FM was analyzed. We identified 170 FMs, and 99 were scored. RPN scores ranged from 1 to 192. Of the 13 highest-ranking FMs with RPN scores >80, half had severity scores of 8 or 9, with no mode having severity of 10. Of these FM, the originating process steps were simulation (5), treatment planning (5), treatment delivery (2), and insertion (1). Our high-ranking FM focused on communication and the potential for applicator movement. Evaluation of the efficiency and the comprehensiveness of our quality assurance program showed coverage of all but three of the top 49 FMs ranked by RPN. This is the first reported FMEA process for a comprehensive gynecologic brachytherapy procedure overview. We were able to identify FMs that could potentially and severely impact the patient's treatment. We continue to adjust our quality assurance program based on the results of our FMEA analysis. Published by Elsevier Inc.

  18. Quality-assurance results for routine water analyses in U.S. Geological Survey laboratories, water year 1998

    USGS Publications Warehouse

    Ludtke, Amy S.; Woodworth, Mark T.; Marsh, Philip S.

    2000-01-01

    The U.S. Geological Survey operates a quality-assurance program based on the analyses of reference samples for two laboratories: the National Water Quality Laboratory and the Quality of Water Service Unit. Reference samples that contain selected inorganic, nutrient, and low-level constituents are prepared and submitted to the laboratory as disguised routine samples. The program goal is to estimate precision and bias for as many analytical methods offered by the participating laboratories as possible. Blind reference samples typically are submitted at a rate of 2 to 5 percent of the annual environmental-sample load for each constituent. The samples are distributed to the laboratories throughout the year. The reference samples are subject to the identical laboratory handling, processing, and analytical procedures as those applied to environmental samples and, therefore, have been used as an independent source to verify bias and precision of laboratory analytical methods and ambient water-quality measurements. The results are stored permanently in the National Water Information System and the Blind Sample Project's data base. During water year 1998, 95 analytical procedures were evaluated at the National Water Quality Laboratory and 63 analytical procedures were evaluated at the Quality of Water Service Unit. An overall evaluation of the inorganic and low-level constituent data for water year 1998 indicated 77 of 78 analytical procedures at the National Water Quality Laboratory met the criteria for precision. Silver (dissolved, inductively coupled plasma-mass spectrometry) was determined to be imprecise. Five of 78 analytical procedures showed bias throughout the range of reference samples: chromium (dissolved, inductively coupled plasma-atomic emission spectrometry), dissolved solids (dissolved, gravimetric), lithium (dissolved, inductively coupled plasma-atomic emission spectrometry), silver (dissolved, inductively coupled plasma-mass spectrometry), and zinc (dissolved, inductively coupled plasma-mass spectrometry). At the National Water Quality Laboratory during water year 1998, lack of precision was indicated for 2 of 17 nutrient procedures: ammonia as nitrogen (dissolved, colorimetric) and orthophosphate as phosphorus (dissolved, colorimetric). Bias was indicated throughout the reference sample range for ammonia as nitrogen (dissolved, colorimetric, low level) and nitrate plus nitrite as nitrogen (dissolved, colorimetric, low level). All analytical procedures tested at the Quality of Water Service Unit during water year 1998 met the criteria for precision. One of the 63 analytical procedures indicated a bias throughout the range of reference samples: aluminum (whole-water recoverable, inductively coupled plasma-atomic emission spectrometry, trace).

  19. 48 CFR 46.000 - Scope of part.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Scope of part. 46.000 Section 46.000 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE 46.000 Scope of part. This part prescribes policies and procedures to ensure that...

  20. 48 CFR 46.000 - Scope of part.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Scope of part. 46.000 Section 46.000 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE 46.000 Scope of part. This part prescribes policies and procedures to ensure that...

  1. 48 CFR 46.000 - Scope of part.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Scope of part. 46.000 Section 46.000 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE 46.000 Scope of part. This part prescribes policies and procedures to ensure that...

  2. 7 CFR 1767.70 - Record storage media.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF... retention period provided for in the master index of records, unless there is a quality transfer from one... for accuracy and documented. (b) Each borrower shall implement internal control procedures that assure...

  3. STANDARD OPERATING PROCEDURE FOR QUALITY ASSURANCE IN ANALYTICAL CHEMISTRY METHODS DEVELOPMENT

    EPA Science Inventory

    The Environmental Protection Agency's (EPA) Office of Research and Development (ORD) is engaged in the development, demonstration, and validation of new or newly adapted methods of analysis for environmentally related samples. Recognizing that a "one size fits all" approach to qu...

  4. Upper Washita River experimental watersheds: Data screening procedure for data quality assurance

    USDA-ARS?s Scientific Manuscript database

    The presence of non-stationary condition in long term hydrologic observation networks are associated with natural and anthropogenic stressors or network operation problems. Detection and identification of network operation drivers is fundamental in hydrologic investigation due to changes in systemat...

  5. 76 FR 4091 - Proposed Information Collection; Comment Request; Certification Requirements for NOAA's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-24

    ... Collection; Comment Request; Certification Requirements for NOAA's Hydrographic Product Quality Assurance... hydrographic products are proposed for certification; by which standards and compliance tests are developed, adopted, and applied for those products; and by which certification is awarded or denied. These procedures...

  6. Control of Suspect/Counterfeit and Defective Items

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

    Sheriff, Marnelle L.

    2013-09-03

    This procedure implements portions of the requirements of MSC-MP-599, Quality Assurance Program Description. It establishes the Mission Support Alliance (MSA) practices for minimizing the introduction of and identifying, documenting, dispositioning, reporting, controlling, and disposing of suspect/counterfeit and defective items (S/CIs). employees whose work scope relates to Safety Systems (i.e., Safety Class [SC] or Safety Significant [SS] items), non-safety systems and other applications (i.e., General Service [GS]) where engineering has determined that their use could result in a potential safety hazard. MSA implements an effective Quality Assurance (QA) Program providing a comprehensive network of controls and verification providing defense-in-depth by preventingmore » the introduction of S/CIs through the design, procurement, construction, operation, maintenance, and modification of processes. This procedure focuses on those safety systems, and other systems, including critical load paths of lifting equipment, where the introduction of S/CIs would have the greatest potential for creating unsafe conditions.« less

  7. Prenatal nutrition services: a cost analysis.

    PubMed

    Splett, P L; Caldwell, H M; Holey, E S; Alton, I R

    1987-02-01

    The scarcity of information about program costs in relation to quality care prompted a cost analysis of prenatal nutrition services in two urban settings. This study examined prenatal nutrition services in terms of total costs, per client costs, per visit costs, and cost per successful outcome. Standard cost-accounting principles were used. Outcome measures, based on written quality assurance criteria, were audited using standard procedures. In the studied programs, nutrition services were delivered for a per client cost of $72 in a health department setting and $121 in a hospital-based prenatal care program. Further analysis illustrates that total and per client costs can be misleading and that costs related to successful outcomes are much higher. The three levels of cost analysis reported provide baseline data for quantifying the costs of providing prenatal nutrition services to healthy pregnant women. Cost information from these cost analysis procedures can be used to guide adjustments in service delivery to assure successful outcomes of nutrition care. Accurate cost and outcome data are necessary prerequisites to cost-effectiveness and cost-benefit studies.

  8. A Situative Metaphor for Teacher Learning: The Case of University Tutors Learning to Grade Student Coursework

    ERIC Educational Resources Information Center

    Boyd, Pete; Bloxham, Sue

    2014-01-01

    In the continuing concern about academic standards in the higher education sector a great deal of emphasis has been placed on quality assurance procedures rather than on considering how university tutors learn to grade the quality of work produced by students. As part of a larger research project focused on how tutors grade student coursework,…

  9. Quality assurance for gastrointestinal endoscopy.

    PubMed

    Allen, John I

    2012-09-01

    This review concerns quality assurance for gastrointestinal endoscopic procedures, especially colonoscopy and will emphasize research and guidelines published since January 2011. Important articles from previous years have been included for background. Critical lapses in endoscope processing and administration of intravenous sedation alerted us to the infection risk of endoscopy. Increases in cost of colonoscopy, evidence for overuse and studies demonstrating missed cancers have led some to question the value of endoscopy. Despite these setbacks, the National Polyp Study (NPS) consortium published their long-term follow-up of the original NPS patients and confirmed that colonoscopy with polyp removal can reduce the risk of colorectal cancer for an extended period. In this article, we will focus on ways to improve the value of outpatient colonoscopy. The United States national quality improvement agenda recently became organized into a more coordinated effort spearheaded by several public and private entities. They comprise the infrastructure by which performance measures are developed and implemented as accountability standards. Understanding wherein a gastroenterology (GI) practice fits into this infrastructure and learning ways we can improve our endoscopic practice is important for physicians who provide this vital service to patients. This article will provide a roadmap for developing a quality assurance program for endoscopic practice.

  10. A scenario for a web-based radiation treatment planning structure: A new tool for quality assurance procedure?

    PubMed

    Kouloulias, V E; Ntasis, E; Poortmans, Ph; Maniatis, T A; Nikita, K S

    2003-01-01

    The desire to develop web-based platforms for remote collaboration among physicians and technologists is becoming a great challenge. In this paper we describe a web-based radiotherapy treatment planning (WBRTP) system to facilitate decentralized radiotherapy services by allowing remote treatment planning and quality assurance (QA) of treatment delivery. Significant prerequisites are digital storage of relevant data as well as efficient and reliable telecommunication system between collaborating units. The system of WBRTP includes video conferencing, display of medical images (CT scans, dose distributions etc), replication of selected data from a common database, remote treatment planning, evaluation of treatment technique and follow-up of the treated patients. Moreover the system features real-time remote operations in terms of tele-consulting like target volume delineation performed by a team of experts at different and distant units. An appraisal of its possibilities in quality assurance in radiotherapy is also discussed. As a conclusion, a WBRTP system would not only be a medium for communication between experts in oncology but mainly a tool for improving the QA in radiotherapy.

  11. Application Guidelines for Quality Assurance Procedures for Hybrid Microcircuits.

    DTIC Science & Technology

    1983-03-01

    INSPECTION LIMITS SYMBOL TEST CONDITIONS UNITS SUBGROUP 6 TC = -55 DEGREES C AVI0 1 SAME AS SUBGROUP 5 -0.1 5 Vpp VOS SAME AS SUBGROUP 4 50 m%LC V0 2 ... 1 . Line Certification 2 . Fabrication Techniques and Material Qualification Procedures 3. Design Guidelines e. Application Guidelines. Items a through... 1 2 . GENERAL ................... ......... ................. 3 2.1 Summary of documents generated ........................ 3 2.2 Contract objectives

  12. 48 CFR 846.408 - Single-agency assignments of Government contract quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... of Government contract quality assurance. 846.408 Section 846.408 Federal Acquisition Regulations System DEPARTMENT OF VETERANS AFFAIRS CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 846.408 Single-agency assignments of Government contract quality assurance. ...

  13. 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…

  14. 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.

  15. Structural Indicators on Graduate Employability in Europe--2016. Eurydice Report

    ERIC Educational Resources Information Center

    Riiheläinen, Jari Matti

    2017-01-01

    This publication presents some structural indicators on graduate employability in 40 European education and training systems. It examines whether countries use regular labour market forecasting to improve the employability of graduates; moreover, other indicators include the involvement of employers in external quality assurance procedures,…

  16. Sustainable Design of EPA's Campus in Research Triangle Park, NC—Environmental Performance Specifications in Construction Contracts—Section 01450 Sequence of Finishes Installation

    EPA Pesticide Factsheets

    Learn more about the special construction scheduling/sequencing requirements and procedures necessary to assure achievement of designed Indoor Air Quality (IAQ) levels for the completed project required by the EPA IAQ Program.

  17. 76 FR 9025 - Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... consumer protection, the Agency issued GLP regulations. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures (SOPs), test and control articles, quality assurance, protocol and conduct of a safety...

  18. Test/QA Plan for Verification of Leak Detection and Repair Technologies

    EPA Science Inventory

    The purpose of the leak detection and repair (LDAR) test and quality assurance plan is to specify procedures for a verification test applicable to commercial LDAR technologies. The purpose of the verification test is to evaluate the performance of participating technologies in b...

  19. Test/QA Plan (TQAP) for Verification of Semi-Continuous Ambient Air Monitoring Systems

    EPA Science Inventory

    The purpose of the semi-continuous ambient air monitoring technology (or MARGA) test and quality assurance plan is to specify procedures for a verification test applicable to commercial semi-continuous ambient air monitoring technologies. The purpose of the verification test is ...

  20. ISO 9000: The Librarian's Role.

    ERIC Educational Resources Information Center

    Dobson, Chris; Ernst, Carolyn

    1999-01-01

    Describes the special library's role in implementing ISO 9000 (i.e., a series of international quality-assurance standards developed by the International Organization of Standards). Topics discussed include document and data control, keeping the standards current, documentation of procedures, the ISO 9000 audit, and benefits for the library. (MES)

  1. 18 CFR 1301.24 - Specific exemptions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 2 2012-04-01 2012-04-01 false Specific exemptions. 1301.24 Section 1301.24 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES... Files-TVA,” and “Nuclear Quality Assurance Personnel Records-TVA” are exempted from subsections (d); (e...

  2. 18 CFR 1301.24 - Specific exemptions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 2 2011-04-01 2011-04-01 false Specific exemptions. 1301.24 Section 1301.24 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES... Files-TVA,” and “Nuclear Quality Assurance Personnel Records-TVA” are exempted from subsections (d); (e...

  3. 18 CFR 1301.24 - Specific exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 2 2014-04-01 2014-04-01 false Specific exemptions. 1301.24 Section 1301.24 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES... Files-TVA,” and “Nuclear Quality Assurance Personnel Records-TVA” are exempted from subsections (d); (e...

  4. 18 CFR 1301.24 - Specific exemptions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 2 2013-04-01 2012-04-01 true Specific exemptions. 1301.24 Section 1301.24 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES... Files-TVA,” and “Nuclear Quality Assurance Personnel Records-TVA” are exempted from subsections (d); (e...

  5. WHO expert committee on specifications for pharmaceutical preparations.

    PubMed

    2013-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

  6. 10 CFR 72.140 - Quality assurance requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

  7. 10 CFR 72.140 - Quality assurance requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

  8. 10 CFR 72.140 - Quality assurance requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

  9. 10 CFR 72.140 - Quality assurance requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

  10. 10 CFR 72.140 - Quality assurance requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

  11. 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...

  12. 10 CFR 71.103 - Quality assurance organization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and...

  13. 10 CFR 71.103 - Quality assurance organization.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and...

  14. 10 CFR 71.103 - Quality assurance organization.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and...

  15. Preface to QoIS 2009

    NASA Astrophysics Data System (ADS)

    Comyn-Wattiau, Isabelle; Thalheim, Bernhard

    Quality assurance is a growing research domain within the Information Systems (IS) and Conceptual Modeling (CM) disciplines. Ongoing research on quality in IS and CM is highly diverse and encompasses theoretical aspects including quality definition and quality models, and practical/empirical aspects such as the development of methods, approaches and tools for quality measurement and improvement. Current research on quality also includes quality characteristics definitions, validation instruments, methodological and development approaches to quality assurance during software and information systems development, quality monitors, quality assurance during information systems development processes and practices, quality assurance both for data and (meta)schemata, quality support for information systems data import and export, quality of query answering, and cost/benefit analysis of quality assurance processes. Quality assurance is also depending on the application area and the specific requirements in applications such as health sector, logistics, public sector, financial sector, manufacturing, services, e-commerce, software, etc. Furthermore, quality assurance must also be supported for data aggregation, ETL processes, web content management and other multi-layered applications. Quality assurance is typically requiring resources and has therefore beside its benefits a computational and economical trade-off. It is therefore also based on compromising between the value of quality data and the cost for quality assurance.

  16. Linkage of Maternity Hospital Episode Statistics data to birth registration and notification records for births in England 2005–2014: Quality assurance of linkage of routine data for singleton and multiple births

    PubMed Central

    2018-01-01

    Objectives To quality assure a Trusted Third Party linked data set to prepare it for analysis. Setting Birth registration and notification records from the Office for National Statistics for all births in England 2005–2014 linked to Maternity Hospital Episode Statistics (HES) delivery records by NHS Digital using mothers’ identifiers. Participants All 6 676 912 births that occurred in England from 1 January 2005 to 31 December 2014. Primary and secondary outcome measures Every link between a registered birth and an HES delivery record for the study period was categorised as either the same baby or a different baby to the same mother, or as a wrong link, by comparing common baby data items and valid values in key fields with stepwise deterministic rules. Rates of preserved and discarded links were calculated and which features were more common in each group were assessed. Results Ninety-eight per cent of births originally linked to HES were left with one preserved link. The majority of discarded links were due to duplicate HES delivery records. Of the 4854 discarded links categorised as wrong links, clerical checks found 85% were false-positives links, 13% were quality assurance false negatives and 2% were undeterminable. Births linked using a less reliable stage of the linkage algorithm, births at home and in the London region, and with birth weight or gestational age values missing in HES were more likely to have all links discarded. Conclusions Linkage error, data quality issues, and false negatives in the quality assurance procedure were uncovered. The procedure could be improved by allowing for transposition in date fields, and more discrimination between missing and differing values. The availability of identifiers in the datasets supported clerical checking. Other research using Trusted Third Party linkage should not assume the linked dataset is error-free or optimised for their analysis, and allow sufficient resources for this. PMID:29500200

  17. Speaking across the Curriculum as an Alternative Assessment Process.

    ERIC Educational Resources Information Center

    Weiss, Robert O.

    Speaking across the curriculum programs are a readily accessible venue for the assessment of oral communication competence and in some instances are already being used for such purposes. While so far the implementation of simple holistic judgments for quality assurance purposes has emerged as one practical procedure, further exploration should…

  18. The Role of International Accreditation in Promoting Academic and Professional Preparation in School Psychology

    ERIC Educational Resources Information Center

    Farrell, Peter; McFarland, Max; Gonzalez, Ruth; Hass, Michael; Stiles, Deborah A.

    2014-01-01

    The development of rigorous and universally respected quality assurance procedures that monitor and recognize the delivery of effective and ethically responsible public services has become increasingly evident in many countries. However, within professional psychology, these developments generally are located in individual countries. With a few…

  19. General Employee Training Live, Course 15503

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

    Gabel, Daniel Glen; Hughes, Heather

    This training at Los Alamos National Laboratory contains the following sections: Introduction to the Laboratory, Institutional Quality Assurance, Facilities, Policies, Procedures, and Other Requirements, Safety Expectations, Worker Protection: Occupational Safety and Health, Industrial Hygiene and Safety, Lockout/Tagout, General Employee Radiological Training, Fire Protection, Security, Emergency Operations, Occupational Health, and Environment.

  20. 32 CFR Appendix E to Part 247 - DoD Command Newspaper and Magazine Review System

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... commanders in establishing and maintaining cost-effective internal communications essential to mission accomplishment. The system also enables internal information managers to assess the cost and effective use of...-day quality assurance procedures or established critique programs. C. Review criteria. Each newspaper...

  1. 28 CFR 16.98 - Exemption of the Drug Enforcement Administration (DEA)-limited access.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... (Justice/DEA-013) (7) System to Retrieve Information from Drug Evidence (STRIDE/Ballistics) (Justice/DEA... Retrieve Information from Drug Evidence (STRIDE/Ballistics) (Justice/DEA-014) only to the extent that..., implemented internal quality assurance procedures to ensure that ESS data is as thorough, accurate, and...

  2. 28 CFR 16.98 - Exemption of the Drug Enforcement Administration (DEA)-limited access.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (Justice/DEA-013) (7) System to Retrieve Information from Drug Evidence (STRIDE/Ballistics) (Justice/DEA... Retrieve Information from Drug Evidence (STRIDE/Ballistics) (Justice/DEA-014) only to the extent that..., implemented internal quality assurance procedures to ensure that ESS data is as thorough, accurate, and...

  3. Laboratory validation of four black carbon measurement methods for the determination of non-volatile particulate matter (PM) mass emissions . . .

    EPA Science Inventory

    A laboratory-scale experimental program was designed to standardize each of four black carbon measurement methods, provide appropriate quality assurance/control procedures for these techniques, and compare measurements made by these methods to a NIST traceable standard (filter gr...

  4. 40 CFR Appendix to Subpart Eee of... - Quality Assurance Procedures for Continuous Emissions Monitors Used for Hazardous Waste Combustors

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... certification. 11. Maintaining and ensuring current certification or naming of cylinder gasses, metal solutions... reported in the English system of units, at 7 percent oxygen, 20 °C, and on a dry basis. 6.7Rounding and...

  5. Test/QA Plan for Verification of Cavity Ringdown Spectroscopy Systems for Ammonia Monitoring in Stack Gas

    EPA Science Inventory

    The purpose of the cavity ringdown spectroscopy (CRDS) technology test and quality assurance plan is to specify procedures for a verification test applicable to commercial cavity ringdown spectroscopy technologies. The purpose of the verification test is to evaluate the performa...

  6. F-35 Engine Quality Assurance Inspection

    DTIC Science & Technology

    2015-04-27

    area nor protected from common FOD items. The F135 engine final assembly area had FOD signage at the two entry lobbies of the building; however...there were no FOD signage within the engine final assembly areas. Pratt & Whitney FOD procedures also did not prevent common FOD items from entering

  7. 78 FR 48407 - Defense Federal Acquisition Regulation Supplement: Clauses With Alternates-Quality Assurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... calibration procedures under MIL-T-31000, General Specification for Technical Data Packages, Amendment 1, or MIL-T-47500, General Specification for Technical Data Packages, Supp 1, or drawings and associated... Packages, Amendment 1, or MIL-T-47500, General Specification for Technical Data Packages, Supp 1, or...

  8. 21 CFR 820.75 - Process validation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

  9. 21 CFR 820.75 - Process validation.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

  10. 21 CFR 820.75 - Process validation.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

  11. 21 CFR 820.75 - Process validation.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

  12. 21 CFR 820.75 - Process validation.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Process validation. 820.75 Section 820.75 Food and... QUALITY SYSTEM REGULATION Production and Process Controls § 820.75 Process validation. (a) Where the... validated with a high degree of assurance and approved according to established procedures. The validation...

  13. NREL: International Activities - Country Programs

    Science.gov Websites

    for use of mini-grid quality assurance and design standards and advising on mini-grid business models communities of practice and technical collaboration across countries on mini-grid development, modeling and interconnection standards and procedures, and with strengthening mini-grids and energy access programs. NREL is

  14. Reliability in fiber optic cable harness manufacturing

    NASA Astrophysics Data System (ADS)

    McCoy, Bruce M.

    Key aspects of manufacturing cable harnesses for aircraft and spacecraft that incorporate optical fiber/cables along with traditional wiring are discussed. Issues regarding feasibility of automation of assembly processes, manual assembly, testing, installation, quality assurance, reliability and maintainability are addressed. Training procedures, formal training programs, and their results are reviewed.

  15. 40 CFR 98.315 - Procedures for estimating missing data.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... measured parameters used in the GHG emissions calculations is required (e.g., carbon content values, etc... such estimates. (a) For each missing value of the monthly carbon content of calcined petroleum coke the substitute data value shall be the arithmetic average of the quality-assured values of carbon contents for...

  16. Analysis of the sources of uncertainty for EDR2 film‐based IMRT quality assurance

    PubMed Central

    Shi, Chengyu; Papanikolaou, Nikos; Yan, Yulong; Weng, Xuejun; Jiang, gyu

    2006-01-01

    In our institution, patient‐specific quality assurance (QA) for intensity‐modulated radiation therapy (IMRT) is usually performed by measuring the dose to a point using an ion chamber and by measuring the dose to a plane using film. In order to perform absolute dose comparison measurements using film, an accurate calibration curve should be used. In this paper, we investigate the film response curve uncertainty factors, including film batch differences, film processor temperature effect, film digitization, and treatment unit. In addition, we reviewed 50 patient‐specific IMRT QA procedures performed in our institution in order to quantify the sources of error in film‐based dosimetry. Our study showed that the EDR2 film dosimetry can be done with less than 3% uncertainty. The EDR2 film response was not affected by the choice of treatment unit provided the nominal energy was the same. This investigation of the different sources of uncertainties in the film calibration procedure can provide a better understanding of the film‐based dosimetry and can improve quality control for IMRT QA. PACS numbers: 87.86.Cd, 87.53.Xd, 87.57.Nk PMID:17533329

  17. Implementation of a laboratory quality assurance program: the Louisville experience.

    PubMed

    Metz, Michael J; Abdel-Azim, Tamer; Miller, Cynthia J; Lin, Wei-Shao; ZandiNejad, Amirali; Oliveira, Gustavo M; Morton, Dean

    2014-02-01

    Remakes, or the refabrication of dental prostheses, can occur as a result of inherent inaccuracies in both clinical and laboratory procedures. Because dental schools manage large numbers of predoctoral dental students with limited familiarity and expertise as related to clinical prosthodontic techniques, it is likely these schools will experience an elevated incidence of laboratory remakes and their ramifications. The University of Louisville School of Dentistry, not unlike other dental schools, has experienced remakes associated with both fixed and removable prosthodontic procedures. Limitations in faculty standardization and variable enforcement of established preclinical protocols have been identified as variables associated with the high percentage of remakes documented. The purpose of this study was to introduce the implementation of a new multidepartmental quality assurance program designed to increase consistency and quality in both information provided to commercial dental laboratories and the prostheses returned. The program has shown to be advantageous in terms of cost-effectiveness and treatment outcomes. A statistically significant decrease in remake percentages has been recorded from inception of this program in December 2010 until December 2012. Furthermore, this program has resulted in more consistent communication between the dental school and commercial dental laboratories, among faculty members, and between faculty and students.

  18. Special Report on Review of "The Department of Energy's Quality Assurance Process for Prime Recipients' Reporting for the American Recovery and Reinvestment Act"

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

    None

    2009-10-01

    The American Recovery and Reinvestment Act of 2009 (Recovery Act) was established to jumpstart the U.S. economy, create or save millions of jobs, spur technological advances in health and science, and invest in the Nation's energy future. The Department of Energy (Department) will receive an unprecedented $37 billion in Recovery Act funding to support a variety of science, energy, and environmental initiatives. The majority of the funding received by the Department will be allocated to various recipients through grants, cooperative agreements, contracts, and other financial instruments. To ensure transparency and accountability, the Office of Management and Budget (OMB) requires thatmore » recipients report on their receipt and use of Recovery Act funds on a quarterly basis to FederalReporting.gov. OMB also specifies that Federal agencies should develop and implement formal procedures to help ensure the quality of recipient reported information. Data that must be reported by recipients includes total funding received; funds expended or obligated; projects or activities for which funds were obligated or expended; and the number of jobs created and/or retained. OMB requires that Federal agencies perform limited data quality reviews of recipient data to identify material omissions and/or significant reporting errors and notify the recipients of the need to make appropriate and timely changes to erroneous reports. As part of a larger audit of recipient Recovery Act reporting and performance measurement and in support of a Government-wide review sponsored by the Recovery Accountability and Transparency Board, we completed an interim review to determine whether the Department had established a process to ensure the quality and accuracy of recipient reports. Our review revealed that the Department had developed a quality assurance process to facilitate the quarterly reviews of recipient data. The process included procedures to compare existing information from the Department's financial information systems with that reported to FederalReporting.gov by recipients. In addition, plans were in place to notify recipients of anomalies and/or errors exposed by the quality assurance process. While the Department has made a good deal of progress in this area, we did, however, identify several issues which could, if not addressed, impact the effectiveness of the quality assurance process.« less

  19. 48 CFR 37.604 - Quality assurance surveillance plans.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

  20. 48 CFR 37.604 - Quality assurance surveillance plans.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

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